3 2 9 AlIG 27 P 1 52 ARC: ® LAB I,I1VI I TE D

August 24, 2009

Division of Dockets Management Food and Drug Administration (HFA-305) Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852

Subject: Reference is made to the citizen petition on Multivitamin Injection (MuVi-13) dated March 25, 2009

Dear Sir/Madam:

Reference is made to the citizen petition dated March 25, 2009 wherein Strides had requested the Commissioner of the Food and Drug Administration to declare that the drug product, MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult-Multivitamin Injection (Pharmacy Bulk Package) is suitable for consideration in an abbreviated new drug application (ANDA).

We have not received any FDA docket No. for this citizen petition until date . Hence, Strides herewith resubmits the citizen petition for MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult-Multivitamin Injection (Pharmacy Bulk Package) .

Thanking you,

Sincerely,

M.S . MohAn Chief Scientific Officer Strides Arcolab Ltd Bilekahalli, Bannerghatta Road, Bangalore - 560 076, India. Phone No : 91-80-66580105 E-mail : mohan.ms(~a,stridesarco .com

1

FIA-900q-F oy l'7-00o I CORP. OFF : 'STRIDES HOUSE', Bilekahafli, Bannerghatta Road, Bangalore - 560 076 . India .

Tel : 91-80-66580000 - Fax : 91-80-66580700/800 - e-mail : info@stridesarco.com " Web : www . t ~

March 25, 2009

Division of Dockets Management Food and Drug Administration (HFA-305) Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockviile, MD 20852

Citizen Petition Dear Sir/Madam:

- A12~ AB LIMITED

The undersigned submit this petition, in quadruplicate, pursuant to Section 5056)(2)(C) of the Federal Food, Drug and Cosmetic Act, and in accordance with 21 CFR 10.30 requesting the Commissioner of the Food and Drug Administration to declare that the drug product, MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult-Multivitamin Injection (Pharmacy Bulk Package) is suitable for consideration in an abbreviated new drug application (ANDA).

A. Action Reguested - The petitioner requests that the Commissioner of the Food and Drug Administration declare that the drug product MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult-Multivitamin Injection (Pharmacy Bulk Package) is suitable for consideration as an abbreviated new drug application (ANDA). The reference-listed drug (RLD) product upon which this petition is based is Infuvite Adult® the subject of application number 021163 and Infuvite Adult® Pharmacy Bulk Package the subject of application number 021559 manufactured by Sandoz and approved on May 18, 2000 and June 16, 2003 respectively.

Attached are the pages from the current Electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, Attachment 1 .

The petitioner seeks a change in dosage form (from the approved dosage form of injectable twin vial ; IV infusion to lyophilized powder) from that of the RLD product.

B. Statement of Grounds

The Federal Food, Drug and Cosmetic Act provides for the submission of an Abbreviated New Drug Application for a drug product that differs in dosage form from that of the listed drug provided the FDA has approved a petition that proposed filing such an application.

CORP. OFF : 'STRIDES HOUSE, BilekahafN, Bannerghatta Road, Bangalore - 560 076. India . Tel : 91-80-66580000 " Fax : 91-80-66580700/ 800 " e-mail : info @ stridesaroo.com " Web : www.stridesarco.com

1

REGD.OFF : 201, Devavrata, Sector 17, Vashi, Navi Mumbai - 400 703. India -Tel : 91-22-27892924/968/27893199 " Fax : 91-22-27892942

ARCOLAB LIMITED

MuVi 13 Adult- Multivitamin Injection for Infusion has 13 vitamins in a single vial as a lyophilized product. The same would be available in 2 presentations (Single Dose and Pharmacy Bulk Package) for the adult population . The 2 products have been developed to match the label claims of Infuvite Adult and Infuvite Adult Pharmacy Bulk Package of Sandoz (Applicant) which is a twin vial product pack with the vitamins solublized in Polysorbate 80 surfactant system . However, the excipients used in MuVi 13 Adult-Multivitamin Injection are in line with Cernevit -12 of Baxter (Applicant) which was a lyophilized vial injection, the same has been withdrawn and its our view that it would have been on grounds other than safety . The comparison of the above 2 products are tabulated below:

Ingredients Cernevit Infuvite Adult Infuvite Adult- MuVi 13 Adult (Baxter) (Sandoz) Pharmacy Bulk (Single dose /

package Pharmacy Bulk , Sandoz pack)

Orange Book RLD Discontinued Yes Yes - status Application no. 020924 021163 021559

Vial 1 " Vial l : Retinol palmitate 3500IU 3300IU 33001U 3300TU corresponding to (1 .05mg) (0.99mg) (0.99mg) (0.99mg) Retinol(Vitamin A) Cholecalciferol 200IU 200IU 200IU 200IU I (Vitamin D3) (5mcg) (5mcg) (5mc (5mc ) DLa tocopherol 10.2mg eq . to 10 IU . 10 IU 10 IU corresponding to a 11.2N , I tocopherol (Vitamin E) Ascorbic acid (Vitamin 125mg 200mg 200mg 200m g C Niacinamide (Vitamin 46mg 40mg 40mg 40mg 133) Dexpanthenol 16.15 mg eq. to 15mg 15mg 15mg corresponding to 17.25mg pantothenic acid (Vitamin 135) Pyridoxin 5.5mg eq. to 6mg 6mg 6mg Hydrochloride 4.53mg corresponding to Pyridoxine (Vitamin 136) Riboflavin Sodium 5.67mg eq. to 3.6mg 3.6mg 3 .6mg phosphate 4.14mg corresponding to Riboflavin (Vitamin B2) Thiamine HCl (Vitamin 5.8mg eq. to 6mg 6mg 6mg B I) 3.51 mg

Strides

Stildes ARCOLAB LIMITED

(Cocarboxylase tetrahydrate ! corresponding to Thiamine (B 1)

Pliytonadione (Vitamin . - 150mcg 150mcg 150mcg K)

Vial 2: Vial 2: Folic acid 414mcg 600mc 600mc 600mcg t3-Biotin 60mc 60mc 60mc 60mc Cyanocobalamin 5.5mcg 5mcg 5mcg 5mcg (Vitamin B12)

Other ingredients Glycine 250mg, Vial l: Vial 1 : Glycine 350mg, Glychocolic acid Polysorbate 80 1 .4%0, Polysorbate 80 1 .4%, Glychocolic acid 140mg, Soybean NaOH/ HCl for pH NaOH/ HCI for pH 140mg, Soybean lecithin 112.5mg. adjustment, and water adjustment, and water lecithin 110mg. Sodium hydroxide for injection for injection Sodium hydroxide and / or and / or Hydrochloric acid Vial 2: Vial 2: Hydrochloric acid to adjust pH to 5.9 Propylene glycol 30%, Propylene glycol 30%, to adjust pH to 5 .9

Citric acid and/ or Citric acid and/ or Sodium citrate for pH Sodium citrate for pH adjustment and VVFI adjustment and WFI

Final presentation Lyophilized Liquid injectable in Liquid injectable in Single dose : product in a single dual vial presentation . dual vial presentation . amber glass vial (NDC 54643-5649-0) Pharmacy bulk pack Lyophilized (NDC 64371-869- contains 2 vials, Vial 1 (NDC 54643 5649 2) product in a single 60) (5mL), Vial 2 (5 mL). contains 2 vials, Vial 1 10 mL amber glass

(50mL), Vial 2 (50 mL vial . fill in 100 mL vial)

Pharmacy bulk pack :

Lyophilized ' product in a single

100mL amber glass vial.

The proposed product has the convenience of reconstitution in a single vial before administration, unlike Infuvite, which needs to be mixed and then reconstituted .

As referenced above it can be inferred that MuVi 13 Adult and MuVi 13 Adult (Pharmacy Bulk package) can be considered pharmaceutically equivalent to the Approved Infuvite Adult (Sandoz - Application No. 021163) and Infuvite Adult Pharmacy Bulk Package (Sandoz- Application No. 021559) as on dilution as labeled the label claim of both the

3

St?ides ARCOLAB LIMITED

formulations remain the same. However, they differ in the inactive ingredients that are used for formulating the product principally because one is a twin vial injection and the other a single lyophilized vial. The inactive ingredients used in MuVi 13 Adult and MuVi 13 Adult Pharmacy Bulk Package are exactly the same as that used in previously approved Cernevit (Baxter - Application No. 020924) which has been currently withdrawn and it's our view that the same would have been withdrawn for reasons other than safety (Ref. - Federal Register / Vol. 68, No. 1591 Monday, August 18, 2003 / Notices) . While in Infuvite Polysorbate 80 has been used to solubilize the liposoluble vitamins like A, D, E and K in an aqueous medium permitting intravenous administration of these vitamins , In MuVi - 13 a combination of glycocholic acid and lecithin have been used to solubilize the liposoluble vitamins like A, D, E and K.

MuVi 13 for infusion makes available a combination of important water soluble and fat soluble vitamins in a physiologic micellar system specially formulated for incorporation into intravenous infusions. Glycocholic acid and lecithin both possessing emulsifying properties, are combined to form mixed micelles allowing the water soluble and fat soluble vitamins to solubilize in one container. The lyophilization of multivitamins for infusion produces a sterile dry powder intended for reconstitution, providing an aqueous solution . Glycine is incorporated for rapid reconstitution . In, the case of Infuvite the solublisation through the micellar system is activated by Polysorbate-80 . Both the formulations on dilution as labeled result in an injection of the same label claim. Currently there are multiple references of the usage of glycocholic acid and lecithin to solubilize liposoluble drugs for direct intravenous administration. These are listed as excipients for parenteral use in the Inactive Ingredients Guide and do not pose the risk of precipitating any possible toxic effects.

IIG listing:

Name of the Route / Dosage form Maximum Potency !, Ingredient

01 Glycocholic acid Intravenous; Powder for Injection, 14.00% Solution, Lyophilized

02 Lecithin Soybean Intravenous ; Powder for Injection, 11 .25% Solution, Lyophilized

03 Lecithin Intravenous; Injection; Powder, 21 .30%0 Hydrogenated Soy Lyophilized, For liposomal

suspension

Mannitol has been used in Infuvite as a pharmaceutical aid whereas Glycine has been used in MuVi-13 to enable faster reconstitution of the cake . However, both these excipients are unlikely to influence the bioavaiiability of the drug substance .

St?ides ARCOLAB LIMITED

The use of citric acid / sodium citrate in Infuvite is to adjust the pH whereas in MuVi-13 pH is adjusted using HCl / NaOH solution. The difference in these excipients is also unlikely to influence the bioavailability of the drug substance. Also Infuvite Adult and Infuvite Adult Pharmacy Bulk Package are dual vial liquid injectables which makes available a combination of important oil soluble and water soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions . The contents of Vial 1 have to be mixed with the contents of Vial 2 and then diluted with an intravenous infusion prior to administration . In case of MuVi-13 Adult and MuVi-13 Adult Pharmacy Bulk Package, the Iyophilized vials aie to be first reconstituted with recommended quantity of Water for Injection to obtain a clear, transparent solution, which has to be then diluted with an intravenous infusion prior to administration .

The published literature provided for approval of Cernevit-12 (application no 020924 and approval date-04/06/1999) to support the use of glycocholic acid and lecithin as excipients hold good to support the clinical wavier for MuVi-13 Adult and MuVi-13 Adult Pharmacy Bulk Package because the inactive ingredients used in Cernevit-12 are exactly similar to MuVi-13 . As per the published data, use of glyeocholic acid and lecithin are safe and well tolerated and are well suited to solubilize lipophilic drugs for intravenous use . Currently there are many approved intravenous formulations developed using glycocholic acid and lecithin as excipient for solubilization.

Therefore, both Infuvite as well as MuVi-13 have the same final dosage form prior to administration post dilution before administration and the differences in the inactive ingredients or the dosage form should not cause any difference in the systemic bioavailability of the vitamins . The proposed product will be labeled in accordance with the approved labeling of the RLD product upon which this petition is . based. Any difference in the labeling will relate only to the difference in dosage form and excipients . The uses, indications, warnings and directions for use, dosage and administration Will remain the same as that of the RLD. The RLD's (Infuvite Adult® and lnfuvite Adulto Pharmacy Bulk Package) approved labeling is provided in Attachment 2.

The proposed draft labeling of MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult-Multivitamin Injection (Pharmacy Bulk Package) is provided in Attachment 3.

Therefore, the petitioner's request for the Commissioner to find that a change in dosage form from injectabie ; IV infusion to lyophilized powder should raise no questions of safety or effectiveness, and the Agency should approve the petition .

Sties ARCOLAB LIMITED

Basis for the request for the waiver of Bioequivalence study: Criteria for granting a bioavailability waiver are set forth in 21 CFR 320.22.This section indicates that a waiver will be granted if the drug product : MuVi-13 is a parenteral solution intended solely for administration by injection, or an ophthalmic or otic solution ; and , . It contains the same active and inactive ingredients in the same concentration as a drug product that is the subject of an approved full new drug application. Both the Infuvite and MuVi-13 are clear ~ohitions on reconstitution before Injection. As indicated earlier in the table the active ingredients of MuVi-13 Adult and MuVi-13 Adult Pharmacy Bulk Package are similar to Infuvite Adult and Infuvite Adult Pharmacy Bulk Package . There are inactive ingredients in MuVi-13 Adult and MuVi-13 Adult Pharmacy Bulk Package that are not similar to Infuvite . adult and Infuvite Adult Pharmacy Bulk Package as the formulation strategy is to fall in line with Cernevit, which is a lyophilized technology . However the difference in inactive ingredients should not cause any difference in systemic bioavailability, especially these products are significantly diluted before administration. -

MuVi-13 is also exactly similar to Cernevit-12 (application no 020924 and approval date-04/06/1999) except one active ingredient i.e :, vitamin K which is present in MuVi-13 .

Hence, we request the agency to consider the above technical merits and grant us the waiver on the need for the clinical and the bio-equivalence`studies. Pediatric Waiver Request

In December 2003, Congress passed the Pediatric Research Equity Act of 2003 (PREA) that amended the Federal Food, Drug, :and, Cosmetic Act to provide the Agency authority to require drug firms to study drugs in pediatric patients, if the Agency concludes that such study would provide beneficial health data for' that' patient population . The Act specifically requires that a request for a new dosage form. is subject to a pediatric evaluation_ The act also provides for a waiver from such requirement . i£the drug :

(1) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients; and , .

(II) is not likely to be used in a substantial number of pediatric patients .

The petitioner hereby requests that a full waiver from the conduct of pediatric studies be granted for the approval of this petition to permit subsequent ANDA filing as the proposed product is not intended for treatment of patients below 1 I years of age .

StAdes ARCOLAB LIMITED

C. Environmental Impact The petitioner claims a categorical exclusion under 21 CFR 25.31 .

D. Economic Impact

The petitioner does not believe that this is applicable in this case, but will agree to provide such an analysis, if requested by the Agency . '

E. Certification

The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that It includes

. representative data and information known to the petitioner, which are unfavorable to the petition .

Thanking you,

M.S . Mohan Chief Scientific Officer Strides Arcolab Ltd Bilekahalli, Bannerghatta Road, ; Bangalore - 560 076, India. Phone No: 91-80-66580105 E-mail : mohan.ms@stridesarco.com

Attachments : 1 . Approved Drug Products with Therapeutic Equivalence Evaluations, accessed March 25, 2009

2. Labeling for the Reference-Listed Drug Infuvite Adult® and Infuvite Adule Pharmacy Bulk Package approved on September 2004 and January 2009 respectively.

3. Proposed draft labeling for MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult- Multivitamin Injection (Pharmacy Bulk Package)

Drugs @ FDA

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FAQ I Instructions I Glossary I Contact Us I CDER Home

Drug Details Drug Name(s) INFUVITE ADULT (Brand Name Drug)

FDA Application No. (NDA) 021163

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; Active Ingredient(s) CHOLECALCIFEROL; CYANOCOBALAMIN ; DEXPANTHENOL; FOLIC ACID;

NIACINAMIDE ; PYRIDOXINE HYDROCHLORIDE ; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE ; VITAMIN A PALMITATE ; VITAMIN K

Company SANDOZ Original Approval or May 18, 2000 Tentative Approval Date

Chemical Type 5 New manufacturer

Review S Standard review drug Classification

" There are no Therapeutic Equivalents " Label__info_rmation " Approval_Hlstory~_L_e_tte__rs -_Reviews.._and

Related Documents

Products on Application (NDA) #021163 Click on a column header to re-sort the table :

Drug Name

Active ... .lngredients Stren.g~h. Dome F_Qr_mlRoute

Marketin.g atoW

RLD _T_E Cctde

INFUVITE ALPHA-TOCOPHEROL ACETATE; 2 IU/ML; 40MG/ML; INJECTABLE ; Prescription Yes None' ADULT ASCORBIC ACID ; BIOTIN ; 12UGM/ML; 40 IU/ML; INJECTION

CHOLECALCIFEROL; 1 UGM/ML; 3MG/ML ; CYANOCOBALAMIN; DEXPANTHENOL ; 120UGM/ML; 8MG/ML ; FOLIC ACID ; NIACINAMIDE; 1 .2MG/ML; PYRIDOXINE HYDROCHLORIDE; 0.72MG/ML ; RIBOFLAVIN PHOSPHATE SODIUM; 1.2MG/ML; 660 IU/ML; THIAMINE HYDROCHLORIDE; VITAMIN 0.03MG/ML A PALMITATE; VITAMIN K

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Drug Details Drug Name(s) INFUVITE ADULT (Brand Name Drug) FDA Application No. (NDA) 021559

Active Ingredient(s)

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID ; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE ; PYRIDOXINE HYDROCHLORIDE ; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE ; VITAMIN K

Company SANDOZ

Original Approval or June 16, 2003 Tentative Approval Date Chemical Type 5 New manufacturer

Review S Standard review drug Classification

" There are no Therapeutic Equivalents " Label Information " Approval_History, Reviews. and Related Documents

Products on Application (NDA) #021559 Click on a column header to re-sort the table :

D.r_ug Name

Active-Ingredients $t. .r.en.qt..h _._. Do--SOW form/Route

Marketing Statua

EiLD TE C_o_d_e

INFUVITE ALPHA-TOCOPHEROL ACETATE; 2 IU/ML; 40MG/ML; INJECTABLE ; Prescription Yes None ADULT ASCORBIC ACID; BIOTIN ; 12UGM/ML; 40 IU/ML; IV

CHOLECALCIFEROL; 1UGM/ML; 3MG/ML; (INFUSION) CYANOCOBALAMIN; DEXPANTHENOL ; 120UGM/ML; FOLIC ACID ; NIACINAMIDE; 8MG/ML; 1 .2MG/ML; PYRIDOXINE HYDROCHLORIDE ; 0.72MG/ML ; RIBOFLAVIN PHOSPHATE SODIUM; 1 .2MG/ML; 660 IU/ML; THIAMINE HYDROCHLORIDE; VITAMIN 30UGM/ML A PALMITATE; VITAMIN K

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Baxter

INFUVITE ADULT Multiple Vitamins for Infusion For intravenous infusion after dilution only. Itescription Ill Afal.Tis a sterile product consisting of two 5 mL single-dose vials labeled Vral 1 and Vial 2.

Eacb 5 rnl of Wad t " cwrtains: Ascorbic acid (Vitamin C) . . . .. . . . .. . .. . . . .. . .. ... . . . .. . .. . .. . . . . 200 mg Vitamin A" (as palmitate) .. .. . . . . . . .. . .. . . . . . . . . . . . . .. . . . . . . . 3 .300 IU Vitamin D3" (cholecalciferop . .. . . . . .. .. . : . . . . .. . . . . .. : . . ... . . 2001U Thiamine (Vitamin 81) (as the hydrochloride) .. .. . .. . ... .. .. . .. . .. . .. . . . .. . . . .. . .. .. . .. ... 6 mg Riboflavin (Vitamin Bp) (as riboflavin 5-phosphate sodium) .. . . . . . . . .. . . 3.6 mg

Pyridoxine HCl (Vitamin Bs) . . . .. . .. . . :.. . . . . . . .. . . :. . . . .., . . . . . . . . 6 mg Niacinamide . .. . . . .. . .. . .. . . . . . . .. ... . . . .. . .. . . . . . . .. . . . . . . .. . .. . .. .. . . .. .40 mg

Dexpanthenol (as d-parrtothenyl alcohol) . .. . .. ... .. . .. . . . . . . .. . . . . . . . .. .. . .. . . 15 mg

Vitamin E" (dl-a-tocapheryl acetale) . .. . .. . .. . . . . ... .. . .. . .. . 10 Ill , Vitamin K-= .. .. . .. . . . .. . .. . .. . . . ... . . . .. .. . .. . .. .. . . . . .. . . . ... .. . .. . . 150 mcg

'with 1.4% potysorbate r;Q, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection,

"Polysorbate 801s used to water solubilize the oil-soluble vitamins A, D, E, arid K.

Each 5 ML of Vial 2t contakis: folic acid .., . . . . . . .. . . . .. . .. . .. .. . .. . .. . .. . . . .. . . . . .. .. . .. . .. .. . . . . . :_ 600 mcg Biotin . . . . . . .. . . . . .. .. . .. . .. . .. .. . .. . .. . .. ... .. ... . . . .. . .. . .. . . ., . . .. . .. . . . . . 60 mcg Vitamin 812 (cyanocobalamin) . . .. . . . . .. .. . .. . .. .. . . .. .. . .. . . . .. 5 mcg twith 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection .

"pqneerrs" multiple vltarMn proparsUon fe brtrarems kdoka InFUY1TE AOLY.T(Muhiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins .

Contains no more than 475 mcglL of aluminum (combined Vials 1 and 2).

Indications and Usage IlffUYITE AOALT is indicated as a daily mul6vitamin maintenance supplement for adults and children aged 11 and older receiving paremeral nutrition .

nF11YITE ABBIT is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive bums, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a "stress" situation with profound alterations in the body's metabolic demands and consequent tissue depletion o¬ nutrients. .

- The physician should not await the development of ~ clinical signs of vitamin deficiency before initiating ~~ vitamin therapy .

nIFUVRE AWH.T (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body's normal resistance and repair processes.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days., as indicated by the clinical status. Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as ni1YIIE ADULT, in recommended amourrts, is the sole source of vitamins . Blood levels of vitamins A, C, 0. and folic acid may decline in patents receiving parenteral muftivitamins as their sole source of vitamins for 4 to 6 months. Therefore, in patierds for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels . If deficiencies appear to be developing, multiples of the formulation (1 .5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a .few weeks, vitamins A and 0 should be monitored -occasionally to be certain that an excess accumulation of these vitamins is . not occurring.

Contraindications INFBVIT6 ADOLT is contraindicated where there is a pre-existing hypervitaminosis, .or a known hypersensitivity to arty of the vitamins or excipiems in the product .

Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits .

wannipgs This product contains aluminum that may be toxic . Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired . Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum .

Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcglkglday accumulate aluminum at levels associated with central nervous system and bone toxicity . Tissue loading may occur at even lower rates of administration.

Precautions If this formulation is the only source of vitamins for long periods of time, Wood concentration of each of the vitamins should be monitored, particularly vitamins A, C. D, and folic acid, to determine If deficiencies are occurring . If deficiencies are developing or when long-standing vitamin deficiencies are present. d may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in nFI1VITE All

Drug -DrngfSshdien Interacthxls: Coutlen should be sxercisel when admhdstering IIIftRRTE A=T te pstierds on rearlarin sedYnwtype inifficoagulant therapy. In such pedants, vnarrdn K may mrfagOntze the hntathrasbbrandic response to arrth:aelrrknrt dregs, such as wartxin end Its congeners. Tlerelere . paledic monnoHng of preUrnrnbhJnRi response is essential In debumdn1m the appropriate deseAs of onficesguland am".

CFUVIiE MOtT (MuHiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as Acetazolamide, Chlorothiazide sodium, Aminophylline or sodium bicarbonate. Tetracycline HCI and ampicillin may not be physically compatible with nIFl1V1iE A6111T Also, it has been reported that folic: acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions. and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions.

Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity . Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient's response to methotrexate therapy.

Pyridoxine may decrease the efficacy of levo-dopa by increasing its metabolism. Concomitant administration of hydralazine or isonlazid may increase pyridoxine requirements .

In patients with pernicious anemia, the hematologic response to vitamin 812 therapy may tie inhibited by concomitant administration of chloramphenlcol.

Several vitamins have been reported to decrease the activity of certain antibiotics . Thiamine, dboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported td decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, oxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.

Vitamin K may antagonize the hypdprothrombinemic effect of oral anticoagulants (see bolded statement above) . Consult appropriate references for additional specific vitamin-drug interactions.

Some of the vitamins in n*e4RE ADdT may react with vitamin K bisuffite or sodium bisu(tite; if bisuffde solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.

OWLettsratorlr Test hftacNons : Ascorbic acid in the urine may cause false negative urine glucose determinations.

Carcinogenesis, Mutagenesis, and impairment of Fertility., Carcinogenicity, mutagenicity, and fertility studies have not been performed with IIFUVnE ADULT

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Pregnancy. pregnancy Category C: Animal reproduction studies have not been conducted with nffUVf1E ADULT (Muttiple Vdamins for Infusion) . LW7PoiTF ApKTsrroub be given to a pregnant woman only if clearly needed . Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of BiFePRE qp(AT has not been studied in human pregnancy.

Nursing Mothers : Lactating women should follow the U .S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women . It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when eEU11nE ADIp.Tis administered to a nursing mother .

Pediatric Use : Safety and effectiveness in children below the age of 11 years have not been established .

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Adverse Reactions There have been rare reports of anaphylactoid reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine . However, the risk is negligible it thiamine is co-administered with other vitamins of the B group .

There have been rare reports of the following types of reactions: Dermatologic-rash, erytrrema, pruriGs CNS-headache, dizziness, agitation, anxiety Ophthalmic -diplopia Allergic -urticaria, shortness of breath, wheezing and angioedema.

Dverdosage The fat-soluble vitamins A, 0, and E can accumulate to harmful levels. The possibility of hypervftaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1 .5 mg/day retinol Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Water-soluble vitamins are readily excreted in the urine. Treatment of vitamin overdosage usually consists of withdrawal of the vitamin.

Dosage and Adnltnisfration nffUYIiE A=T is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids, INFUVIiE AWM.Tshould not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

For kltrarenoas teeAFog, one Asily dose of BMW AOld.r(S noll. of Vial 1 plus 5 let, of Well 2) ailed akectp to ad toss than 500 rsl, and prelera611r 1,000 rot, or IMravesms dextrose, sallow of shollar krtaslwr saionons. alscard my oaised portlo ..

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit .

~~ After INFUVITE AD(A.T is diluted in an intravenous . ~ infusion, the resulting solution should be refrigerated . ~~ unless it is to be used immediately. The solution ~~ should be used within 24 hours after dilution . Some

of the vitamins in this product, particularly A. D, and - riboflavin, are light sensitive, therefore, exposure to

light should be minimized . Manufactured by

Store earlier refrt®eratioo, 2"B°C (3lS45°Fi . SA6-PNARIMA INC. 145 Jules-Leger Street Boucherville. QC. Canada J48 7K8

How Supplied Distributed by nF0V1iE AOIAT-NDC 54693-5649-0, is available in Baxter IeaRkwe Crirpaatien boxes containing 2 vials- Vial 1 (5 mL) and Vial 2 (5 mL), Clintec Nutrition Division both vials to be used for a single dose . Deerfield, IL 60015 USA

INFe1nTE AINRr-NDC 54843-5649-1, is available in Printed in Canada boxes containing 10 vials - 5 each of Vial t (5 mL) and 1002782 D1002757 Vial 2 (5 ml .) . one Vial 1 plus one Vial 2 to be used for Rev . May 2004 a single dose .

ax only INFUVITE is a registered trademark of SAB-PHARMA INC .

Graphiques Apex Inc .

Graphiques Apex Inc.

MOM DU PRDDwT/PRDDUCT NAME: INFUVITE ADULT

NUMERO DU PRODUIT/PRODUCT NUMBER: D1OO2757

NUtANO BE PHARMACODE/PNARMACODE NUMBER : 2757

APPROBATION APPROVAL

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SPECIFICATIONS . CDULEURS/COLORS (RECTO/FRONT): PMS 287

APP.: DATE .

(vERsolBASN): PMS 287 TYPE BE PAPIER/PAPER TYPE : ALLIANCE

APP. . DATE :

?BIDS DU PAPIER/PAPER WEIGHT: 60 M OtMENS10BS (MM): A PLAT/FLAT: 136 X 2!I6 AFF. Rt:G . : DATE:

PLlE/FULDED: N/A POINTS BE COLLE/GLUE SPOTS: MIA C .Q. : DATE :

CONFORMITE DU PUAGE/CONFORMITY OF FOLDING:

NOM DU PRODUIT/PRODUCT NAME: INFUVITE AoULT

NUMtRO DU PRODUIT/PRODUCT NUMBER : 1002782

NUMERD BE PHARMACODE/PHARMACODE NUMBER : 2757

APPROBATION /APPROVAL

, EX

SPECIFICATIONS CDULEURS/COLORS (RECTO)FRONT): PMS 287

APP. : DATE :

(VERSO/BACK) : PMS 287

TYPE BE PAPIER/PAPER TYPE: ALLUINCE APP.: DATE:

PDIDS DU PAPIER/PAPER WEIGHT: 60 M

DIMENSIONS (MM): A PIAT(FLAT: 136 x 296 AFF. REG.: DATE :

PUE/FOLDED : ???? -

POINTS BE COLLE/GLUE SPOTS : N/A . C.Q . : DATE :

CONfORMITt OUPLIAGE/CONfORMITY OF FOLDING : [], :

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INFUVITE ADULT Multiple Vitamins for Infusion Each 5 at of Vial 1 contains: Each 5 ml, of Vial 2 contains: Vilanthz C. . . .. . ... .. . .. . . . . . . .. . . . . .. . .. . .. . . . .,.. .. . . .. ... . .. . .. . . ., .,. . .., . .. ., ~70 rn, a Folic acid .. . ., . . . . . .. . ., . .. . ., . ... . .. . . . . . .. . .. . .. . : .. 608 mcq Vilmnin R __ . . . ... . . . .. . .. . . . . .. . .. . . . . .. ... . . . . .. . .. . .. . . . . .,. ... . .~ . . .., ... ., 3.3001p Biotir, . ., .. ... ... . .. . .. . ... . . . . .. . ... . . . . .. . .. . . ._ . . . . . . .. 60 .mg ViLtmini? .. . .. ._ . .. . .. . .. . . . . . . ... .. ., . . .. . .. . . .. ..., .. . .. . .. . .. . . .. . . .. ... . .. . . .200itJ Cyanocobaiarrun(Btz) . . .. . .. . . . . . .. , .. . .. . . _ . .. . .6rncq Thiarnine (BU . .. . .. . . . . .. ... .. . . . . .. . .. . . . . ... .. . . . . ... . .. . .. . ... ., . . .. . . .. . .., .. . 6 m;j with .30'Y~ propylene glycui: cab~ii ac d Riboflavin tBsi . . .._ . . . . . .. . .. . .. . .. . .. . .., .. . .. . ., . ... . . . . .. . . .. ... . .. . . .. ... 3.6 mg and/or sodium atrate for pH adjus;rnene: ard water Py" ridoxiitn HCI (Bs` . .. ... . . . . .. . .. . . . . .. . .. . . . . .. . .. . .. . . .. ... . ... . .. . ... ... . .. 6 mg for injection . Niacinamid~:. .. . . .. .._. . .. . .. . . . . .. ... . .. . .. ... . . . . .. . .. . .. . . .. ... . .. . .,. . ... ... .40my Oexpaiut;enoi . . .. . .. . . . . . . .. . .. . .. ... . . . . . . . .. . . . . ." . .. . .. . . . . ... . .. . . .. . .. . ... . 15 mg Contains no mdfe than 475 rncVli. of Vitamin E (oi-<x-taanher,~I acetatel��� . �� ., ""�" ,"����� ,_� , 101U olumimnn (cornbirnvi Vial. t and <") Vitantin K _ ... . .. . .. . .. . . . . .. ... . . . .. . ... .. . .. . ... .. . . .. .,. . .. . .., .. . . .. . .. . . .. . 150 rrmcg -with 1.4°% ;)olysixtn3te 80, sodium hydroxide andlor hydrocltloric acid for pH adjustment, end wafer for injection . aKi?56

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INFINITE ADULT PHARMACY BULK PACKAGE - multiple vitamins Baxter Healthcare Corporation

INFUVITE- ADULT PHARMACY BULK PACKAGE Multiple Vitamins for Infusion

Rx only For intravenous infusion after dilution only . Pharmacy Bulk Package Not for Direct Infusion

DESCRIPTION INFUVITE ADULT (PHARMACY BULK PACKAGE) is a sterile product consisting of 2 vials -1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 ml, Vial), provided as a pharmacy bulk package. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion . Each 5 mL of Vial l contains : Ascorbic acid (Vitamin C) . . . . . . . . . . . . . . . . . . . 200 mg Vitamin A' (as palmitate) . . . . . . . . . . . . . . . 3,300 IU Vitamin D31 (cholecalciferol) . . . . . . . . . . . . . 200 IU Thiamine (Vitamin BI) (as the hydrochloride). . . . . . . . . . . . . . . . . .. . . . . . . . 6 mg Riboflavin (Vitamin BZ) (as riboflavin 5-phosphate sodium). . . 3.6 mg Pyridoxine HCl (Vitamin 136) . . . . .. . . . . . . . . . . . . . 6 mg Niacinamide . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . 40 mg ' Dexpanthenol (as d-pantothenyl alcohol) . . . . . . . . . . . . . . . . . 15 mg Vitamin El (dl-a-tocopheryl acetate) . . . . IO IU Vitamin K, 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . 150 mcg Inactive ingredients : 1 .4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. Each 5,mL of Vial 2 contains : Folic acid . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . 600 mcg Biotin . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 mcg Vitamin B12 (cyanocobalamin) . . . . . . . . . . . . . 5 mcg Inactive ingredients : 30% propylene. glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. "Aqueous" multiple vitamin preparation for intravenous infusion : INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions . The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins . Contains no more than 70 mcg/L of aluminum (combined vials 1 and 2) .

IPolysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K .

INDICATIONS AND USAGE INFUVITE ADULT (PHARMACY BULK PACKAGE) is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition . INFUVITE ADULT (PHARMACY BULK PACKAGE) is also indicated in other situations where administration by the intravenous route is required . Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a "stress" situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients . The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT (PHARMACY BULK PACKAGE) (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body's normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status . Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as INFUVITE ADULT (PHARMACY BULK PACKAGE), in recommended amounts, is the sole source of vitamins . Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months . Therefore,

page 1 of 4

in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be ' monitored to ensure maintenance of adequate levels. If deficiencies appear to be developing, multiples of the formulation (1 .5 to 3 times) may be needed for a period of time . When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring.

CONTRAINDICATIONS INFUVITE ADULT (PHARMACY BULK PACKAGE) is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K . The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits .

WARNINGS This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired . Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum . Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kglday accumulate aluminum at levels associated with central nervous system and bone toxicity . Tissue loading may occur at even lower rates of administration.

PRECAUTIONS If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring. If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in INFUVITE ADULT (PHARMACY BULK PACKAGE) .

Drug - Drug/Solution Interactions Caution should be exercised when administering INFUVITE ADULT (PHARMACY BULK PACKAGE) to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy . INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate . Tetracycline HCl and ampicillin may not be physically compatible with INFUVITE ADULT (PHARMACY BULK PACKAGE). Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions . Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient's response to methotrexate therapy. Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism . Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements . In patients with pernicious anemia, the hematologic response to vitamin B 12 therapy may be inhibited by concomitant administration of chloramphenicol. Several vitamins have been reported to decrease the activity of certain antibiotics . Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin . Bleomycin is inactivated in vitro by ascorbic acid and riboflavin . Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above) . Consult appropriate references for additional specific vitamin-drug interactions . Some of the vitamins in INFUVITE ADULT (PHARMACY BULK PACKAGE) may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.

Drug-Laboratory Test Interactions Ascorbic acid in the urine may cause false negative urine glucose determinations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT (PHARMACY BULK PACKAGE) .

page 2 of 4

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) . INFUVITE ADULT (PHARMACY BULK PACKAGE) should be given to a pregnant woman only if clearly needed. Pregnant women should follow the U.S . Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in human pregnancy . ,

Nursing Mothers Lactating women should follow the U.S . Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women . It is not known whether this drug is excreted in human milk . Because many drugs are excreted in human milk, caution should be exercised when INFUVITE ADULT (PHARMACY BULK PACKAGE) is administered to a nursing mother .

Pediatric Use Safety and effectiveness in children below the age of 11 years have not been established .

ADVERSE REACTIONS There have been rare reports of anaphylactic reactions following parenteral multivitamin administration . Rare reports of anaphylaetoid reactions have also been reported following large intravenous doses of thiamine . However, the risk is negligible if thiamine is ! coadministered with other vitamins of the B group. There have been rare reports of the following types of reactions: Dermatologic - rash, erythema, pruritis CNS - headache, dizziness, agitation, anxiety Ophthalmic - diplopia Allergic - urticaria, shortness of breath, wheezing and angioedema .

OVERDOSAGE The fat-soluble vitamins A, D, and E can accumulate to harmful levels . The possibility of hypervitaminosis A or D should be borne in mind . Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1 .5 mg/day retinol . Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Water-soluble vitamins are readily excreted in the urine . Treatment of vitamin overdosage usually consists of withdrawal of the vitamin.

DOSAGE AND ADMINISTRATION INFUVITE ADULT (PHARMACY BULK PACKAGE) is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids. INFUVITE ADULT (PHARMACY BULK PACKAGE) should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation . Preparation of INFUVITE ADULT (PHARMACY BULK PACKAGE) for intravenous feeding should be done by transferring the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. One daily 10 mL dose should be added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit . After INFUVITE ADULT (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately . The solution should be used within 24 hours after dilution . Some of the vitamins in this product, particularly A, D and riboflavin, are light sensitive; therefore, exposure to light should be minimized. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. INFUVITE ADULT (PHARMACY BULK PACKAGE) IS A PHARMACY BULK PACKAGE. IT IS NOT INTENDED FOR DIRECT INFUSION . DISCARD UNUSED PORTION.

Directions For Dispensing FromPharmacy Bulk Vial The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only . The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion . The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area): Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry,

page 3 of 4

HOW SUPPLIED INFUVITE ADULT (PHARMACY BULK PACKAGE) - NDC 54643-5649-2, is available in boxes containing 2 vials - 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial) . Mix contents of Vial 1 with Vial 2 to provide 10 single doses.

Store under refrigeration, 2-8°C (36-46°F).

Manufactured by Sandoz Canada Inc. 145 Jules-Leger Street Boucherville, Qc, Canada, J48 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada 1006123 Rev. September 2007 0 INFUVITE is a registered trademark of Sandoz Canada Inc.

MuVi 13 ADULT PHARMACY BULK PACKAGE -Multiple Vitamins

MuVi 13 ADULT PHARMACY BULK PACKAGE Multiple Vitamins for Infusion

Rx only For intravenous infusion after dilution only .

Pharmacy Bulk Package Not for Direct Infusion

DESCRIPTION :

MuVi 13 ADULT (PHARMACY BULK PACKAGE) is a sterile lyophilized product, provided as a pharmacy bulk package . A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses . The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion .

Each 5 mL of vial contains :

Ascorbic acid (Vitamin C). . . . . . . . . . . . . . . . . . . 200 mg Vitamin A (as palmitate) . . . . . . . . . . . . . . . . . . . 3,300 IU Vitamin D3 (cholecalciferol) . . . . . . . . . . . . . . 200 IU Thiamine (Vitamin BI) (as the hydrochloride) . . . . . . . . . . . . . . . . . . . . . . . . . . 6 mg Riboflavin (Vitamin Bz) (as riboflavin sodium phosphate) . . . . . . . . 3 .6 mg Pyridoxine HCl (Vitamin 136) . . . . . . . . . . . . . 6 mg Niacinamide (Vitamin B3) . . . . . . . . . . . . . . . . . . . 40 mg Dexpanthenol (Vitamin BS) (pantothenic acid) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 mg Vitamin E (dl-a-tocopheryl acetate) . . . . 10 IU Vitamin K, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 mcg Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 600 mcg Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 mcg Vitamin Blz (cyanocobalamin) . . . . . . . . . . . 5 mcg

Inactive ingredients: Glycine, Glychocolic acid, Soybean lecithin . Sodium hydroxide and/or Hydrochloric acid to adjust pH to 5 .9 .

MuVi 13 ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is a lyophilized product . It is available in a combination of important oil-soluble and water-soluble vitamins in a physiologic micellar system specially formulated for incorporation into intravenous infusions .

Page 1 of 6

Glycocholic acid and lecithin, both possessing emulsifying properties, are combined to form mixed micelles allowing the water soluble and fat soluble vitamins to solubilize in one container . Glycine is incorporated for rapid reconstitution . Contains no more than 70 mcg/L of aluminum .

INDICATIONS AND USAGE

MuVi 13 ADULT (PHARMACY BULK PACKAGE) is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition . MuVi 13 ADULT (PHARMACY BULK PACKAGE) is also indicated in other situations where administration by the intravenous route is required . Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a "stress" situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients .

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy . MuVi 13 ADULT (PHARMACY BULK PACKAGE) (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body's normal resistance and repair processes . Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status .

Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as MuVi 13 ADULT (PHARMACY BULK PACKAGE), in recommended amounts, is the sole source of vitamins . Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months . Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels . If deficiencies appear to be developing, multiples of the formulation (1 .5 to 3 times) may be needed for a period of time . When multiples of the formulation are used for more than a few weeks, vitamins A

and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring .

CONTRAINDICATIONS

MuVi 13 ADULT (PHARMACY BULK PACKAGE) is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product . Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits .

Page 2 of 6

WARNINGS

This product contains aluminum that may be toxic . Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired . Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum . Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity . Tissue loading may occur at even lower rates of administration .

PRECAUTIONS

If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring . If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in MuVi 13 ADULT (PHARMACY BULK PACKAGE).

Drug - Drug/Solution Interactions Caution should be exercised when administering MuVi 13 ADULT (PHARMACY BULK PACKAGE) to patients on warfarin sodium-type anticoagulant therapy . In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy .

MuVi 13 ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate . Tetracycline HCl and ampicillin may not be physically compatible with MuVi 13 ADULT (PHARMACY BULK PACKAGE). Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate . Direct addition to intravenous fat emulsions is not recommended . Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion . In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions . Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity . Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy . Folic acid may decrease the patient's response to methotrexate therapy . Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism . Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements . In patients with pernicious anemia, the hematologic response to vitamin B1z therapy may be inhibited by concomitant

Page 3 of 6

administration of chloramphenicol . Several vitamins have been reported to decrease the activity of certain antibiotics . Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin . Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above) . Consult appropriate references for additional specific vitamin-drug interactions . Some of the vitamins in MuVi 13 ADULT (PHARMACY BULK PACKAGE) may react with vitamin K bisulfite or sodium bisulfite ; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies .

Drug-Laboratory Test Interactions Ascorbic acid in the urine may cause false negative urine glucose determinations .

Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with MuVi 13 ADULT (PHARMACY BULK PACKAGE).

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with MuVi 13 ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) . MuVi 13 ADULT (PHARMACY BULK PACKAGE) should be given to a pregnant woman only if clearly needed . Pregnant women should follow the U.S . Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of MuVi 13 ADULT (PHARMACY BULK PACKAGE) has not been studied in human pregnancy .

Nursing Mothers Lactating women should follow the U.S . Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MuVi 13 ADULT (PHARMACY BULK PACKAGE) is administered to a nursing mother .

Pediatric Use Safety and effectiveness in children below the age of 11 years have not been established .

ADVERSE REACTIONS There have been rare reports of anaphylactic reactions following parenteral multivitamin administration . Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine. However, the risk is negligible if thiamine is coadministered with other vitamins of the B group . There have been rare reports of the following types of reactions : Dermatologic - rash, erythema, pruritis

Page 4 of 6

CNS - headache, dizziness, agitation, anxiety Ophthalmic - diplopia Allergic - urticaria, shortness of breath, wheezing and angioedema.

OVERDOSAGE The fat-soluble vitamins A, D, and E can accumulate to harmful levels . The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1 .5 mg/day retinol . Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution . Water-soluble vitamins are readily excreted in the urine . Treatment of vitamin overdosage usually consists of withdrawal of the vitamin .

DOSAGE AND ADMINISTRATION

MuVi 13 ADULT (PHARMACY BULK PACKAGE) is reconstituted by adding 50 mL of Sterile Water for Injection into the vial and gently mixing to dissolve the lyophilized powder to provide ten 5 mL single doses . It is used in adults and children aged 11 years and older when added to intravenous infusion fluids .

MuVi 13 ADULT (PHARMACY BULK PACKAGE) should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation .

Preparation of MuVi 13 ADULT (PHARMACY BULK PACKAGE) for intravenous feeding, one daily dose of MuVi 13 ADULT (PHARMACY BULK PACKAGE) 5 mL dose should be added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion.

Parenteral drug products should be inspected visually for particulate matter and

discoloration prior to administration, whenever solution and container permit . After MuVi 13 ADULT (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately . The solution should be used within 24 hours after dilution . Some of the vitamins in this

product, particularly A, D and riboflavin, are light sensitive ; therefore, exposure to light should be minimized . Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours . MuVi 13 ADULT (PHARMACY BULK PACKAGE) IS A PHARMACY BULK PACKAGE. IT IS NOT INTENDED FOR DIRECT INFUSION. DISCARD UNUSED PORTION.

Directions for Dispensing From Pharmacy Bulk Vial

The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only . The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion . The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an

Page 5 of 6

equivalent clean air compounding area). Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry .

HOW SUPPLIED MuVi 13 ADULT (PHARMACY BULK PACKAGE) - NDC XXXXX-XXX-XX, is available in 50 mL Vial .

Store under refrigeration, 2-8°C (36-46°F) .

Mfd . for Strides Inc . Somerset, NJ 08873 USA Made in India

MuVi 13 ADULT Multiple Vitamins for Infusion

For intravenous infusion after dilution only

Description MuVi 13 ADULT is a sterile lyophilized product.

Each vial contains :

Ascorbic acid (Vitamin C) . . . . . . . . . . . . . . . . . . . 200 mg Vitamin A (as palmitate) . . . . . . . . . . . . . . . . . . . 3,300 IU Vitamin D3 (cholecalciferol) . . . . . . . . . . . . . . 200 IU Thiamine (Vitamin B1) (as the hydrochloride) . . . . . . . . . . . . . . . . . . . . . . . . . . 6 mg Riboflavin (Vitamin BZ) (as riboflavin sodium phosphate). . . . . . . . 3.6 mg Pyridoxine HCl (Vitamin 136) . . . . . . . . . . . . . 6 mg Niacinamide (Vitamin B3) . . . . . . . . . . . . . . . . . . . 40 mg Dexpanthenol (Vitamin 135) (pantothenic acid) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 mg Vitamin E (dl-a-tocopheryl acetate) . . . . 10 IU Vitamin K, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 mcg Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 600 mcg Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 mcg Vitamin BlZ (cyanocobalamin) . . . . . . . . . . . 5 mcg

Inactive ingredients : Glycine, Glychocolic acid, Soybean lecithin . Sodium hydroxide and / or Hydrochloric acid to adjust pH to 5 .9

MuVi 13 ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is a lyophilized product . It is available in a combination of important oil-soluble and water-soluble vitamins in a physiologic micellar system specially formulated for incorporation into intravenous infusions .

Glycocholic acid and lecithin, both possessing emulsifying properties, are combined to form mixed micelles allowing the water soluble and fat soluble vitamins to solubilize in one container. Glycine is incorporated for rapid reconstitution . Contains no more than 475 mcg/L of aluminum

Indications and Usage

MuVi 13 ADULT is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition .

Page 1 of 5

MuVi 13 ADULT is also indicated in other situations where administration by the intravenous route is required . Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a "stress" situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients . The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy .

MuVi 13 ADULT (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body's normal resistance and repair processes . Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status . Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as MuVi 13 ADULT, in recommended amounts, is the sole source of vitamins . Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months . Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels . If deficiencies appear to be developing, multiples of the formulation (1 .5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring .

CONTRAINDICATIONS

MuVi 13 ADULT is contraindicated where there is a pre-existing hypervitaminosis, or a

known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyariocobalamin in the vitamin solution can mask serum deficits .

WARNINGS

This product contains aluminum that may be toxic . Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired . Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity .

Tissue loading may occur at even lower rates of administration .

Page 2 of 5

PRECAUTIONS

If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring . If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in MuVi 13 ADULT.

Drug - Drug/Solution Interactions: Caution should be exercised when administering MuVi 13 ADULT to patients on warfarin sodium-type anticoagulant therapy . In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners . Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy.

MuVi 13 ADULT (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate . Tetracycline HCl and ampicillin may not be physically compatible with MuVi 13 ADULT. Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate . Direct addition to intravenous fat emulsions is not recommended . Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion . In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided . A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions . Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity . Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy . Folic acid may decrease the patient's response to methotrexate therapy . Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism . Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements . In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol. Several vitamins have been reported to decrease the activity of certain antibiotics . Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin . Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above) . Consult appropriate references for additional specific vitamin-drug interactions .

Page 3 of 5

Some of the vitamins in MuVi 13 ADULT may react with vitamin K bisulfite or sodium bisulfite ; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies .

Drug-Laboratory Test Interactions Ascorbic acid in the urine may cause false negative urine glucose determinations .

Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity, and fertility studies have not been performed with MuVi 13 ADULT.

Pregnancy: Pregnancy Category C Animal reproduction studies have not been conducted with MuVi 13 ADULT (Multiple Vitamins for Infusion) . MuVi 13 ADULT should be given to a pregnant woman only if clearly needed . Pregnant women should follow the U.S . Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of MuVi 13 ADULT has not been studied in human pregnancy .

Nursing Mothers: Lactating women should follow the U.S . Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MuVi 13 ADULT is administered to a nursing mother.

Pediatric Use: Safety and effectiveness in children below the age of 11 years have not been established .

ADVERSE REACTIONS There have been rare reports of anaphylactic reactions following parenteral multivitamin administration . Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine . However, the risk is negligible if thiamine is coadministered with other vitamins of the B group . There have been rare reports of the following types of reactions : Dermatologic - rash, erythema, pruritis CNS - headache, dizziness, agitation, anxiety Ophthalmic - diplopia Allergic - urticaria, shortness of breath, wheezing and angioedema .

OVERDOSAGE

The fat-soluble vitamins A, D, and E can accumulate to harmful levels . The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1 .5 mg/day retinol . Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution .

Page 4 of 5

Water-soluble vitamins are readily excreted in the urine . Treatment of vitamin overdosage usually consists of withdrawal of the vitamin.

DOSAGE AND ADMINISTRATION

MuVi 13 ADULT (PHARMACY BULK PACKAGE) is reconstituted by adding 5 mL of Sterile Water for Injection into the vial and gently mixing to dissolve the lyophilized powder . It is used in adults and children aged I1 years and older when added to intravenous infusion fluids .

MuVi 13 ADULT should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation .

For intravenous feeding, one daily dose of MuVi 13 ADULT 5 mL added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit .

After MuVi 13 ADULT is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately . The solution should be used within 24 hours after dilution . Some of the vitamins in this product, particularly A, D and

riboflavin, are light sensitive ; therefore, exposure to light should be minimized .

Store under refrigeration, 2-8°C (36-46°F) .

HOW SUPPLIED MuVi 13 ADULT- NDC XXXXX-XXX-XX, is available in single dose vials .

Mfd . for Strides Inc . Somerset, NJ 08873 USA Made in India

Page 5 of 5

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2. Invoice to Rec .~N;D ER LtABLE FOR UNOAID CHARGES

ente (Information you would like on the i nvoice (if required))

GD 343 528 632 WW Pease quote this number if you h- an enquiry.

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