injection - food and drug administration · injection 5,000 mc g/ 5 ml (1,000 mcg/ml) for...
TRANSCRIPT
octreotide acetateINJECTION
Rx only
50 mcg/mL
octre
otid
e ac
etat
eIN
JEC
TIO
N
50 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mcgInactive ingredientslactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information.
Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.
Instructions for Use
One-point-cut ampul with cut below colored point
To open, hold as shown with thumb above point and snap off backwards
Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasseCH-4332 Stein, Switzerland
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis 1256727
NDC 0078-0180-01Unit Dose Package
NDC 0078-0180-01Unit Dose Package
NDC
0078
-018
0-01
Unit
Dose
Pac
kage
For Subcutaneous Injection 10 Ampuls/1 mL size
50 m
cg/m
L 10
Am
puls/
1 m
L siz
eoctreotide acetate
INJEC
TION
NDC 0078-0180-01Unit Dose Package
50 mcg/m
L 10 Am
puls/1 mL size
Please open here Please open here
EXP.LOT
120 x 105 x 20.51256727US
1256727
octreotide acetateINJECTION
Rx only
100 mcg/mL
octre
otid
e ac
etat
eIN
JEC
TIO
N
100 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 mcgInactive ingredientslactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information.
Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.
Instructions for Use
One-point-cut ampul with cut below colored point
To open, hold as shown with thumb above point and snap off backwards
Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasseCH-4332 Stein, Switzerland
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis 1256728
NDC 0078-0181-01Unit Dose Package
NDC 0078-0181-01Unit Dose Package
NDC
0078
-018
1-01
Unit
Dose
Pac
kage
For Subcutaneous Injection 10 Ampuls/1 mL size
100
mcg
/mL
10 A
mpu
ls/1
mL
size
octreotide acetateIN
JECTIO
N
NDC 0078-0181-01Unit Dose Package
100 mcg/m
L 10 Am
puls/1 mL size
Please open here Please open here
EXP.LOT
120 x 105 x 20.51256728US
octreotide acetateINJECTION
Rx only
500 mcg/mL
octre
otid
e ac
etat
eIN
JEC
TIO
N500 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mcgInactive ingredientslactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information.Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.
Instructions for Use
One-point-cut ampul with cut below colored point
To open, hold as shown with thumb above point and snap off backwards
Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasseCH-4332 Stein, Switzerland
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis 1256731
NDC 0078-0182-01Unit Dose Package
NDC 0078-0182-01Unit Dose Package
NDC
0078
-018
2-01
Unit
Dose
Pac
kage
For Subcutaneous Injection 10 Ampuls/1 mL size
500
mcg
/mL
10 A
mpu
ls/1
mL
size
octreotide acetateIN
JECTIO
N
NDC 0078-0182-01Unit Dose Package
500 mcg/m
L 10 Am
puls/1 mL size
Please open here Please open here
EXP.LOT
120 x 105 x 20.51256731US
1256731
Sandostatinoctreotide acetateINJECTION1,000 mcg/5 mL (200 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 200 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, d scard w thin 14 days.Mfd. by Novartis Pharma Stein AG
Rx onlyNDC 0078-0183-25
©Novartis
US
Sandostatinoctreotide acetateINJECTION1,000 mcg/5 mL (200 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 200 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, d scard w thin 14 days.Mfd. by Novartis Pharma Stein AG
Rx onlyNDC 0078-0183-25
©Novartis
USSandostatinoctreotide acetateINJECTION1,000 mcg/5 mL (200 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 200 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, d scard w thin 14 days.Mfd. by Novartis Pharma Stein AG
Rx onlyNDC 0078-0183-25
©Novartis
US12
5673
4B12
5673
4B12
5673
4B
EXP./
LOT
EXP./
LOT
EXP./
LOT
1256
734A
2567
34A
2567
34A
1,000 mcg/5 mL (200 mcg/mL)
1,000 mcg/5 m
L (200 mcg/mL)
STORE REFRIGERATED AT 2°C to 8°C (36°F to 46°F); PROTECT FROM LIGHT.AFTER INITIAL USE, DISCARD WITHIN 14 DAYS
FOR SUBCUTANEOUS INJECTION
FOR SUBCUTANEOUS INJECTION
Total Volume 5 mL Multi-Dose Vial
Total Volume 5 m
L M
ulti-Dose Vial
Please open here Please open here
Sandostatin®
octreotide acetate INJECTIONEach mL of aqueous solution contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 mcgInactive ingredients:lactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgphenol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL DOSAGE: See package insert for dosage information.STORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, discard within 14 days. At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.
Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasse, CH-4332 Stein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis
octreotide acetateINJECTION
octreotide acetateIN
JECTION
1,00
0 m
cg/5
mL
(200
mcg
/mL)
FOR
SUBC
UTAN
EOUS
INJE
CTIO
NTo
tal V
olum
e 5
mL
Mul
ti-Do
se V
ial
octr
eotid
e ac
etat
eIN
JECT
ION
Rx only
1256736
1256736
EXP.LOT
NDC 0078-0183-25
NDC
0078
-018
3-25
NDC 0078-0183-25
NDC 0078-0183-25
Sandostatinoctreotide acetate Rx only
NDC 0078-0184-25
©Novartis
INJECTION5,000 mcg/5 mL (1,000 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 1,000 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, discard with n 14 days.Mfd. by Novartis Pharma Stein AG
Sandostatinoctreotide acetate Rx only
NDC 0078-0184-25
©Novartis
INJECTION5,000 mcg/5 mL (1,000 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous so ution contains: octreotide (as acetate) 1,000 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from ight.After nitial use, discard within 14 days.Mfd. by Novartis Pharma Stein AG
Sandostatinoctreotide acetate Rx only
NDC 0078-0184-25
©Novartis
INJECTION5,000 mcg/5 mL (1,000 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous so ution contains: octreotide (as acetate) 1,000 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from ight.After nitial use, discard within 14 days.Mfd. by Novartis Pharma Stein AG
1256
740A
1256
740B
1256
740C
US
EXP./
LOT
EXP./
LOT
EXP./
LOT
2567
40A
1256
740B
1256
740C
US25
6740
A12
5674
0B12
5674
0CUS
5,000 mcg/5 mL (1,000 mcg/mL)
STORE REFRIGERATED AT 2°C to 8°C (36°F to 46°F); PROTECT FROM LIGHT.AFTER INITIAL USE, DISCARD WITHIN 14 DAYS
FOR SUBCUTANEOUS INJECTIONTotal Volume 5 mL Multi-Dose Vial
Total Volume 5 m
L M
ulti-Dose Vial
Please open here Please open here
Sandostatin®
octreotide acetate INJECTIONEach mL of aqueous solution contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,000 mcgInactive ingredients:lactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgphenol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL DOSAGE: See package insert for dosage information.STORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, discard within 14 days. At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.
Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasse, CH-4332 Stein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis
octreotide acetateINJECTION
octreotide acetateIN
JECTION
5,00
0 m
cg/5
mL
(1,00
0 mcg
/mL)
FOR
SUBC
UTAN
EOUS
INJE
CTIO
N
5,000 mcg/5 m
L (1,000 mcg/mL)FOR SUBCUTANEOUS INJECTION
Tota
l Volu
me
5 m
L M
ulti-
Dose
Via
l
octr
eotid
e ac
etat
eIN
JECT
ION
Rx only
NDC 0078-0184-25
NDC 0078-0184-25ND
C 00
78-0
184-
25
NDC 0078-0184-25
1256743
1256743
1256743
EXP.LOT
XXXX
For Subcutaneous Injection10 x 1 mL Single-Dose Vials
NDC 0781-3166-95
OCTREOTIDE Acetate Injection50 mcg/mL
NDC 0781-3166-95
OCTREOTIDE Acetate Injection50 mcg/mL
For Subcutaneous Injection10 x 1 mL Single-Dose Vials
Each mL of aqueous solution contains:Octreotide (as acetate)...................50 mcg
Inactive ingredients:Lactic Acid, USP.............................3.4 mgMannitol, USP..................................45 mgSodium Bicarbonate,USP...........................qs to pH 4.2 ± 0.3
Water for Injection, USP.............qs to 1 mL
Dosage: See package insert for dosageinformation.
Store refrigerated between 2ºCto 8ºC(36ºFto 46ºF). Protect from light.At room temperature, (20ºC to 30ºC or70ºF to 86ºF), Octreotide Acetate is stablefor 14 days if protected fromlight.KEEP THIS AND ALL DRUGS OUT OFTHE REACH OF CHILDREN.
01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540
NDC0781-3166-95
OCTR
EOTID
EA
cetate Injectio
n5
0 m
cg/m
L
XXXXXXX
10 x 1 mL Single-D
ose V
ials
XXXX
For Subcutaneous Injection10 x 1 mL Single-Dose Vials
NDC 0781-3167-95
OCTREOTIDE Acetate Injection100 mcg/mL
NDC 0781-3167-95
OCTREOTIDE Acetate Injection100 mcg/mL
For Subcutaneous Injection10 x 1 mL Single-Dose Vials
Each mL of aqueous solution contains:Octreotide (as acetate).................100 mcg
Inactive ingredients:Lactic Acid, USP.............................3.4 mgMannitol, USP..................................45 mgSodium Bicarbonate, USP............................qs to pH 4.2 ± 0.3Water for Injection, USP.............qs to 1 mL
Dosage: See package insert for dosage information.
Store refrigerated between 2ºCto 8ºC (36ºFto 46ºF). Protect from light.At room temperature, (20ºC to 30ºC or70ºF to 86ºF), Octreotide Acetate is stablefor 14 days if protected from light.KEEP THIS AND ALL DRUGS OUT OF THEREACH OF CHILDREN.
01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540
NDC0781-3167-95
OCTR
EOTID
EA
cetate Injectio
n10
0 m
cg/m
L
XXXXXXX
10 x 1 mL Single-D
ose V
ials
XXXX
XXXXXXX
For Subcutaneous Injection10 x 1 mL Single-Dose Vials
NDC 0781-3168-95
OCTREOTIDE Acetate Injection500 mcg/mL
NDC 0781-3168-95
OCTREOTIDE Acetate Injection500 mcg/mL
For Subcutaneous Injection10 x 1 mL Single-Dose Vials
Each mL of aqueous solution contains:Octreotide (as acetate).................500 mcg
Inactive ingredients:Lactic Acid, USP.............................3.4 mgMannitol, USP..................................45 mgSodium Bicarbonate, USP............................qs to pH 4.2 ± 0.3Water for Injection, USP.............qs to 1 mL
Dosage: See package insert for dosage information.
Store refrigerated between 2ºCto 8ºC (36ºFto 46ºF). Protect from light.At room temperature, (20ºC to 30ºC or70ºF to 86ºF), Octreotide Acetate is stablefor 14 days if protected from light.KEEP THIS AND ALL DRUGS OUT OF THEREACH OF CHILDREN.
01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540
10 x 1 mL Single-D
ose V
ials
NDC0781-3168-95
OCTR
EOTID
EA
cetate Injectio
n5
00
mcg
/mL
Lot:
Exp.:
RSS 10307813165757
NDC 0781-3165-75
OCTREOTIDEAcetate Injection
For Subcutaneous Injection
1,000 mcg/5 mL(200 mcg/mL)
Each mL of aqueous solutioncontains: Octreotide (asacetate) 200 mcgStorage: Refrigerate at 2°Cto 8°C (36°F to 46°F); protectfrom light. After initial use,discard within 14 days.01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540
XXXXX
Total Volume 5 mL Multi-Dose Vial
XXXXXXX
Storage: Refrigerate at2ºC to 8ºC (36ºF to 46ºF);protect from light. Afterinitial use, discard within14 days.
At room temperature,(20ºC to 30ºC or 70ºF to86ºF), Octreotide Acetateis stable for 14 days ifprotected from light.
KEEP THIS AND ALLDRUGS OUT OF THEREACH OF CHILDREN.
Each mL of aqueoussolution contains:Octreotide(as acetate) .........200 mcg
Inactive Ingredients:Lactic Acid, USP ....... 3.4 mgMannitol, USP............ 45 mgPhenol, USP ..............5.0 mgSodium Bicarbonate,USP ......qs to pH 4.2 ± 0.3
Water for Injection,USP ..................qs to 1 mL
DOSAGE: See packageinsert for dosageinformation.
Manufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540
01-2015M
NDC 0781-3165-75
OCTREOTIDEAcetateInjection
ForSubcutaneousInjection
1,000 mcg/5 mL(200 mcg/mL)
NDC 0781-3165-75
OCTREOTIDEAcetate Injection1,000 mcg/5 mL
(200 mcg/mL)
Total Volume 5 mL Multi-
Dose Vial
ForSubcutaneousInjection
Total Volume 5 mLMulti-Dose Vial
(b) (4)
(b) (4)
Lot:
Exp.:
RSS 10307813164750
NDC 0781-3164-75
OCTREOTIDEAcetate Injection
For Subcutaneous Injection
5,000 mcg/5mL(1,000 mcg/mL)
Each mL of aqueous solutioncontains: Octreotide (asacetate) 1,000 mcgStorage: Refrigerate at 2°Cto 8°C (36°F to 46°F); protectfrom light. After initial use,discard within 14 days.01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540
XXXXX
Total Volume 5 mL Multi-Dose Vial
XXXXXXX
Storage: Refrigerate at2ºC to 8ºC (36ºF to 46ºF);protect from light. Afterinitial use, discard within14 days.
At room temperature,(20ºC to 30ºC or 70ºF to86ºF), Octreotide Acetateis stable for 14 days ifprotected from light.
KEEP THIS AND ALLDRUGS OUT OF THEREACH OF CHILDREN.
Each mL of aqueoussolution contains:Octreotide(as acetate) ......1,000 mcg
Inactive Ingredients:Lactic Acid, USP ....... 3.4 mgMannitol, USP............ 45 mgPhenol, USP ..............5.0 mgSodium Bicarbonate,USP ......qs to pH 4.2 ± 0.3
Water for Injection,USP ..................qs to 1 mL
DOSAGE: See packageinsert for dosageinformation.
Manufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540
01-2015M
NDC 0781-3164-75
OCTREOTIDEAcetate Injection5,000 mcg/5 mL(1,000 mcg/mL)
Total Volume 5 mL Multi-
Dose Vial
ForSubcutaneousInjection
NDC 0781-3164-75
OCTREOTIDEAcetateInjection
ForSubcutaneousInjection
5,000 mcg/5 mL(1,000 mcg/mL)
Total Volume 5 mLMulti-Dose Vial
(b) (4)
(b) (4)