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  • 7/29/2019 Pre Drugs Ko

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    DRUGS REQUIRING SPECIAL HANDLING

    BIOLOGICAL PRODUCTS

    STRENGTH/FORM DOSAGE COMMENTS

    Hepatitis B vaccine Children: 5

    mcg/0.5 mL of

    HBsAg in a 0.5 mL

    single-dose vial

    Adult: 10 mcg/mL

    of HBsAg in a 1 mL

    single-dose vial

    Dialysis: 40

    mcg/mL of HBsAg

    in a 1 mL single-

    dose vial

    20 yrs: 1.0 mL

    Hepa B vaccine should be

    administered intramuscularly.

    Do not inject intravenously or

    intradermally

    Diptheria and Tetanus

    Toxoid and acellular

    pertusis vaccine

    Each 0.5mL VIAL

    contains: -2 IU (2.5

    Lf U) of diphtheria

    toxoid

    - 20 IU (5 Lf U) of

    tetanus toxoid

    -8 mcg of pertussis

    toxoid,

    - 8 mcg of

    filamentous

    haemagglutinin

    and 2.5 mcg of

    pertactin

    0.5 mL BOOSTRIX is administered by

    deep intramuscular injection,

    preferably in the deltoid region

    THE VACCINE SHOULD NEVER

    BE ADMINISTERED

    INTRAVENOUSLY.

    Haemophilus influenza

    type b (Hib) conjugate

    vaccine

    Single dose vial 0.5 mL Hib is injected into the upper le

    muscle in infants under 12

    months of age. In children over

    12 months of age the injection

    will be given in the upper arm

    muscle.

    First dose: 2 months of age

    Second dose: 4 months of age

    Third dose: 6 months of age.

    To ensure long term protection booster dose is generally given

    in the second year of life .

    Inacctivated Polio virus

    vaccine (IPV)

    Single-dose vials

    and prefilled

    syringes containing

    a 0.5-mL

    0.5 mL Children

    Primary series consists of 3

    doses of 0.5 mL. Separate first 2

    doses by at least 4 weeks, but

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    suspension for

    injection.

    preferably 8 weeks; commonly

    given at 2 and 4 mo. Give third

    dose at least 6 months, but

    preferably 12 months, after

    second dose, commonly given a

    15 to 18 mo.

    Adults

    For unvaccinated adults at

    increased risk of exposure to

    poliovirus, give primary series o

    IPV: 2 doses at 1 to 2-mo

    interval, with third dose 6 to 12

    months later. If less than 3

    months, but older than 2 month

    remain before protection is

    needed (e.g., planned

    international travel), give 3

    doses of IPV at least 1 month

    apart.

    Measles ,mumps ,and

    rubella vaccine (MMR)

    Each 0.5mL dose

    contains not less

    than:

    -103.0 CCID50 (cell

    culture infectious

    dose 50%) of the

    Schwarz measles

    -103.7 CCID50 of

    the RIT 4385

    mumps, and-103.0 CCID50 of

    the Wistar RA 27/3

    rubella virus

    Strains

    vial

    0.5 mL This vaccine is injected under

    the skin (subcutaneously) or

    into muscle. PRIORIX is

    generally injected into the uppe

    leg muscle in infants under 12

    months of age. In children over

    12 months of age and older

    children and adults the injection

    3

    This may be given in the upper

    arm muscle.

    Varicella Vaccine Each 0.5mL dose

    contains not less

    than 103.3 plaque-

    forming units of the

    varicella-zostervirus.

    vial

    0.5 mL injected under the skin

    (subcutaneously) of the

    shoulder or thigh.

    The vaccine should never be

    given intravenously.

    In children from 9 months up to

    and including 12 years, the

    appropriate time and number o

    doses that will be given will be

    determined by your doctor on

    the basis of appropriate official

    recommendations. Adults and

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    adolescents aged 13 years and

    older are generally given two

    doses at least six weeks apart.

    Each dose is given at a separate

    visit.

    The need for booster doses is

    uncertain at present.

    Pneumococcal Vaccine 0.5ml dose of

    SYNFLORIX

    contains 1

    microgram of

    Pneumococcal

    polysaccharide

    serotypes 1, 5, 6B,

    7F, 9V, 14 and

    23F and 3

    micrograms of

    Pneumococcal

    polysaccharide

    serotypes 4, 18C

    and 19F.

    0.5 mL Usually, your child will receive

    three injections with an interva

    of

    at least one month between eac

    one. The first injection can be

    given from the age of 6 weeks

    onwards. At least six months

    after

    the third injection, your child

    will

    receive an additional injection.

    (booster)

    Hepatitis A Vaccine 0.5-mL single-dose

    vials and prefilled

    syringes.

    1-mL single-dose

    vials and prefilled

    syringes

    19 yrs; 1.0

    mL

    HAV should be administered by

    intramuscular injection only.

    HAVRIX should not be

    administered in the gluteal

    region; such injections may

    result in suboptimal response.

    Do not administer this product

    intravenously, intradermally, orsubcutaneously

    Influenza Vaccine IM injection 0.5 mL The Centers for Disease Control

    and Prevention (CDC)

    recommend that everyone 6

    months and older should receiv

    the flu vaccine.

    Anthrax vaccine

    adsorbed(biothrax)

    5.0 mL multidose

    vials containing

    ten 0.5 mL doses.

    5mL Vial Biothrax is given to patient

    ntramuscularly.

    Digoxin Immune Fab,ovine

    (digiblind)

    Each vial, which

    will bind

    approximately

    0.5 mg of digoxin

    (or digitoxin),

    contains 38 mg of

    digoxin-specific

    Fab fragments

    derived from

    sheep plus 75 mg

    0.5 mg each vial Ingestion of more than 10 mg of

    digoxin in previously healthy

    adults or 4 mg of digoxin in

    previously healthy children, or

    ingestion causing steady-state

    serum concentrations greater

    than 10 ng/mL, often results in

    cardiac arrest

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    of sorbitol as a

    stabilizer and

    28 mg of sodium

    chloride.

    Diptheria Toxoid /Tetanus

    toxoid/Acellular Pertussis

    vaccine adsorbed

    Daptacel,infanrix,tripedia)

    Each 0.5 mL

    Diphtheria toxoid

    not 1 year of age, the

    deltoid is the preferred site since

    use of the anterolateral thigh

    results in frequent complaints of

    limping due to muscle pain.13

    After insertion of the needle,

    aspirate to ensure that the needl

    has not entered a blood vessel.

    Do not inject IV

    Hepatitis A vaccine

    (Inactivated)

    160/ 80 pre-filled

    syringe

    (inj) 160 antigen

    units/0.5 mL

    80 antigen

    units/0.5 mL

    0.5-mL pediatric

    dose in single-dose

    vials and prefilled

    syringes. 1-mL

    adult dose in

    single-dose vials

    For intramuscular administratio

    only.

    Children/Adolescents:

    vaccination consists of a 0.5-mL

    primarydose administered

    intramuscularly, and a 0.5-mL

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    (Avaxim) and prefilled

    syringes

    booster doseadministered

    intramuscularly 6 to 18 months

    later.

    Adults: vaccination consists of a

    1-mL primary dose administered

    intramuscularly, and a 1-mL

    booster dose administeredIntramuscularly 6 to 18 months

    later.

    Hepatitis B immune

    globulin(Bay Hep,Nabi-

    HB)

    1 mL dose in a

    single-use vial

    (>312 IU)

    5 mL dose in a

    single-use vial

    (>1560 IU)

    0.5mL This product is for intramuscula

    use only.

    The use of this product by the

    intravenous route is not

    indicated.

    Hepatitis B vaccine

    Recombinant(engerix

    B,Recombivax HB

    Vaccine inj 10

    mcg/0.5 mL

    (monodose,

    pediatric dose). 20

    mcg/mL

    (monodose, adult

    dose).

    A 1.0 mL dose of

    the formulation of

    the vaccine for use

    in

    dialysis/predialysis

    patients contains

    40 mcg of HBsAg

    IMAdult20 yr20 mcg/dose.

    Neonate, infant & childn19 yr10

    mcg/dose.

    Immune globulin Human

    (Bay Gam)

    2 mL and 10 mL

    single dose vials.

    2 mL and 10 mL 20 IU/kg body wt IM as a single

    dose.

    Immune Globulin

    Intravenous Human

    (sandoglobuli IV)

    white lyophilized

    powder in 1, 3, 6

    and 12 g size vials.

    The only diluents

    which may be

    used toreconstitute the

    product are sterile

    (0.9%) Sodium

    Chloride Injection

    USP, 5% Dextrose,

    or Sterile Water.

    The product should

    be infused at a rate

    less than 2 mg

    Ig/kg/min.

    Replacement therapy in

    primary immunodeficiency Initia

    dose: 0.4-0.8 g/kg body wt

    followed by 0.2-0.8 g/kg body w

    every 2-4 wk to obtain IgG troug

    level of at least 4-6g/L. Replacement therapy in

    secondary immunodeficiency 0.2

    0.4 g/kg body wt every 3-4 wk to

    obtain IgG trough level of at leas

    4-6 g/L.Replacement therapy in

    childn w/ AIDS 0.2-0.4 g/kg bod

    wt every 3-4 wk.Idiopathic

    thrombocytopenic purpura 0.8-1

    g/kg body wt on day 1, repeated

    once w/in 3 days or 0.4 g/kg

    body wt/day for 2-5 days.

    Influenza Virus vaccineSubviron (Fluvirin)

    0.5 mL single-doseprefilled syringe

    (3, 11) 5.0

    mL multi-dose vial

    containing 10

    doses (each dose

    is 0.5 mL) (3,11)

    0.5 mL Adults and children aged fourand over: 0,5 mL by deep

    subcutaneous or intramuscular

    injection. Young children who

    may not have been previously

    infected, or who have not

    received trivalent influenza

    vaccine in the past four years,

    https://www.mims.com/Philippines/diagnoses/Info/1207https://www.mims.com/Philippines/diagnoses/Info/1207https://www.mims.com/Philippines/diagnoses/Info/2680https://www.mims.com/Philippines/diagnoses/Info/3236https://www.mims.com/Philippines/diagnoses/Info/3236https://www.mims.com/Philippines/diagnoses/Info/3236https://www.mims.com/Philippines/diagnoses/Info/3236https://www.mims.com/Philippines/diagnoses/Info/2680https://www.mims.com/Philippines/diagnoses/Info/1207https://www.mims.com/Philippines/diagnoses/Info/1207
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    may require two doses of vaccin

    given at an interval of 4 -

    6 weeks, to ensure a protective

    antibody response.

    Influenza virus vaccine

    (Flu shield,Fluzone)

    Suspension for

    injection in a

    prefilled

    microinjection

    system, 0.1 mL

    A single 0.1 mL

    dose for

    intradermal

    injection in adults

    18 through 64

    years of age

    IM or deep SC injAdult & childn

    >36 mth 0.5 mL. Childn 6-35

    mth Limited clinical data. Doses

    of 0.25 mL or 0.5 mL have been

    used. Childn who have not been

    previously vaccinatedAdminister

    a 2nd dose after an interval of at

    least 4 wk.

    Measles Virus Vaccine live

    (attenuvax)

    The reconstituted

    vaccine is for

    subcutaneous

    administration.

    Each 0.5 mL dose

    contains not less

    than 1,000 TCID50

    (tissue culture

    infectious doses)

    of measles virus.

    0.5 mL 0.5 mL administered

    subcutaneously, preferably into

    the outer aspect of the upper

    arm.

    The recommended age for

    primary vaccination is 12 to 15

    months.

    Revaccination with M-M-RII is

    recommended prior to

    elementary school entry.

    Children first vaccinated when

    younger than 12 months of age

    should receive another dose

    between 12 to 15 months of age

    followed by revaccination prior

    to elementary school entry.

    Measles/mumps/rubellavirus vaccine MMR11

    The reconstitutedvaccine is for

    subcutaneous

    administration.

    Each 0.5 mL dose

    contains not less

    than 1,000 TCID50

    (tissue culture

    infectious doses)

    of measles virus..

    Single 0.5-mL dose administered by SC/IM inj.The dose for any age is 0.5 mL

    administered subcutaneously,

    preferably into the outer aspect

    of the upper arm.

    The recommended age for

    primary vaccination is 12 to 15

    months.

    Revaccination with M-M-RII is

    recommended prior to

    elementary school entry.

    Children first vaccinated when

    younger than 12 months of ageshould receive another dose

    between 12to15 months of age

    followed by revaccination prior

    to elementary school entry.

    Meningitis vaccine

    (menomune)

    Powd for inj

    (monodose vial +

    0.78 mL diluent)

    0.5mL SCImmunization 0.5

    mL. Revaccination for childn

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    Mumps Virus Vaccine

    (mumps vax)

    The reconstituted

    vaccine is for

    subcutaneous

    administration.

    Each 0.5 mL dose

    contains not less

    than 20,000TCID50 (tissue

    culture infectious

    doses) of mumps

    virus.

    0.5 mL The dose for any age is 0.5 mL

    administered subcutaneously,

    preferably into the outer aspect

    of the upper arm.

    The recommended age for

    primary vaccination is 12 to 15

    months.

    Individuals first vaccinated with

    MUMPSVAX at 12months of age

    or older should be revaccinated

    with M-M-R*II (Measles, Mumps

    and Rubella Virus Vaccine Live)

    prior to elementary school entry

    Revaccination may seroconvert

    primary failures or boost

    antibody titers of those

    individuals whose titers have

    declined.

    Pneumococcal vaccine(

    Diptheria Protein)-

    Prevnar

    Syringe, 1 Dose 0.5mL For infants, the immunization

    series of Prevnar consists of

    three doses of 0.5 mL each, at

    approximately 2-month interval

    followed by a fourth dose of 0.5

    mL at 12-15 months of age. The

    customary age for the first dose

    is 2 months of age, but it can be

    given as young as 6 weeks of age

    The recommended dosing

    interval is 4 to 8 weeks. Thefourth dose should be

    administered at approximately

    12-15 months of age, and at leas

    2 months after the third dose.

    Pneumococcal vaccine

    (pneumovax 23-Pnu

    immune23)

    Vaccine 0.5 mL

    (inj, single-dose

    vial, clear,

    colorless soln)

    0.5 mL Primary immunization Single 0.5

    mL inj. Reimmunization Single

    0.5 mL inj. Must not be given

    w/in 5 yr except for high-risk

    subjects or those under

    immunosuppressive therapy.

    Administer IM or SC.

    Polio vaccine Inacctivated(ipol)

    Single-dose vialsand prefilled

    syringes

    containing a 0.5-

    mL suspension for

    injection.

    0.5 mLChildrenPrimary series consists of 3 dose

    of 0.5 mL. Separate first 2 doses

    by at least 4 weeks, but

    preferably 8 weeks; commonly

    given at 2 and 4 mo. Give third

    dose at least 6 months, but

    preferably 12 months, after

    second dose, commonly given at

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    15 to 18 mo.

    Adults

    For unvaccinated adults at

    increased risk of exposure to

    poliovirus, give primary series o

    IPV: 2 doses at 1 to 2-mo interva

    with third dose 6 to 12 monthslater. If less than 3 months, but

    older than 2 months remain

    before protection is needed (e.g.

    planned international travel),

    give 3 doses of IPV at least 1

    month apart.

    Rabies Immune vaccine

    (Imovax/ rabavert)

    One vial of freeze-

    dried vaccine

    containing a single

    dose. - One sterile

    syringe containing

    diluent. A separate

    plunger is

    provided for

    insertion and use.

    - One sterile

    disposable needle

    for reconstitution.

    1.0 mL For adults and older children, th

    vaccine should be injected into

    the deltoid muscle. In infants and

    small children, the anterolateral

    aspect of the thigh may be

    preferable, depending on age an

    body mass. Care should be taken

    to avoid injection into or near

    blood vessels and nerves. If bloo

    or any suspicious discoloration

    appears in the syringe, do not

    inject but discard contents and

    repeat procedure using a new

    dose of vaccine at a different site

    Respiratory Syncytial

    Virus immune globulin

    ,Human(Respigam)

    Injection, Solution 20 mL For preventing respiratory

    syncytial virus (RSV) infection.

    Adults and children 24 months oage and olderUse is not

    recommended.

    Infants and children younger

    than 24 months of age750milligrams (mg) per kilogram

    (kg) (340.9 mg per pound) of

    body weight injected into a vein

    once a month for five months.

    Rho Immune Globulin

    Human

    1 prefilled single-

    dose syringe of

    RhoGAM

    5 prefilled single-dose syringes of

    RhoGAM

    25 prefilled single-

    dose syringes of

    RhoGAM

    50 g

    300 g

    For intramuscular use only. Do

    not inject RhoGAM or

    MICRhoGAM intravenously. In

    the case of postpartum use, theproduct is intended for maternal

    administration. Do not inject the

    newborn infant.

    Parenteral drug products should

    be inspected visually for

    particulate matter and

    discoloration prior to

    administration.

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    A single dose (approximately 50

    g)* is contained in each prefille

    syringe of MICRhoGAM. This dos

    will suppress the immune

    response to 2.5 mL of Rh-positiv

    red blood cells. MICRhoGAM is

    therefore indicated within 72hours after termination of

    pregnancy up to and including 1

    weeks gestation. At or beyond 1

    weeks gestation, RhoGAM shoulbe administered instead of

    MICRhoGAM.

    A single dose (approximately 30

    g) is contained in each prefilledsyringe of RhoGAM. This is the

    usual dose for the indications

    associated with pregnancy unles

    there is clinical or laboratory

    evidence of a fetal-maternal

    hemorrhage (FMH) in excess of

    15 mL of Rh-positive red blood

    cells. RhoGAM should be

    administered within 72 hours of

    known or suspected exposure to

    Rh-positive red blood cells.

    Rubella Virus Vaccine Live

    (attenuvax)

    The reconstituted

    vaccine is for

    subcutaneous

    administration.Each 0.5 mL dose

    contains not less

    than 1,000 TCID50

    (tissue culture

    infectious doses)

    of measles virus..

    0.5 mL 0.5 mL administered

    subcutaneously, preferably into

    the outer aspect of the upper

    arm.The recommended age for

    primary vaccination is 12 to 15

    months.

    Revaccination with M-M-RII is

    recommended prior to

    elementary school entry.

    Children first vaccinated when

    younger than 12 months of age

    should receive another dose

    between 12 to 15 months of age

    followed by revaccination prior

    to elementary school entry.Tetanus and Diptheria

    Toxoidsadsorbed(Td)

    Single-dose (0.5

    ml) vials.

    Each 0.5 ml dose

    of Td is

    formulated to

    contain the

    following active

    0.5 ml PRIMARY IMMUNIZATION

    MassBiologics Td may be used inpersons 7 years of age and older

    who have not been previously

    immunized against tetanus and

    diphtheria, as a primary

    immunization series consisting o

    three 0.5 ml doses. The first two

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    ingredients: 2 Lf of

    tetanus toxoid and

    2 Lf of diphtheria

    toxoid.

    doses are administered 4-8

    weeks apart and the third dose i

    administered 6-12 months after

    the second dose.

    Mass Biologics Td may be used

    to complete the primary

    immunization series for tetanusand diphtheria, following one or

    two doses of Diphtheria and

    Tetanus Toxoids and Pertussis

    Vaccine Adsorbed (whole-cell

    DTP), Diphtheria and Tetanus

    Toxoids and A cellular Pertussis

    Vaccine Adsorbed (DTaP) and/o

    Diphtheria and Tetanus Toxoids

    Adsorbed (DT) vaccine. Howeve

    the safety and efficacy of

    MassBiologics Td in such

    regimens have not been

    evaluated.

    ROUTINE BOOSTER

    IMMUNIZATION MassBiologicsTd may be used for routine

    booster immunization against

    tetanus and diphtheria in

    persons 7 years of age and older

    who have completed primary

    immunization against tetanus

    and diphtheria. Routine booster

    immunization against tetanusand diphtheria is recommended

    in children 11-12 years of age

    and every 10 years thereafter.

    Inject 0.5 ml of MassBiologics Tdintramuscularly. The preferred

    site is the deltoid muscle. The

    vaccine should not be injected

    into the gluteal area or areas

    where there may be a major

    nerve trunk.

    Do not administer this vaccine

    intravenously, subcutaneously, ointradermally.

    MassBiologics Td should not be

    combined through reconstitution

    or mixed with any other vaccine

    Tetanus Immunoglobulin

    (Bay Tet)

    Vials containing

    Human Tetanus

    Immunoglobulin

    equivalent to

    250 I. U. / 500 I. U.

    / 1000 I. U

    Prophylaxis :In High risk injuries

    to non-immune and immune

    patients (Above 7 Years)

    In High risk injuries to non-

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    Tetanus antitoxin

    250 / 500 / 1000

    I.U

    immune and immune patients

    (Below 7 Years)

    250 I.U. Deep IM 500 I.U. Deep IM

    (if 24 hours have not passed

    since injury or with a risk of

    heavy contamination)

    4 Units/kg or 250 I.U. Deep IMTherapeutic: Clinical tetanus

    Newborn (Tetanus Neonatorum)

    Children(Above 7 Years) &

    Adults

    250 I.U. to 500 I.U. IM and/or 25

    I.U. intrathecal. 500 to 3,000 I.U.

    IM and/or 500 I.U. intrathecal.

    It should not be administered

    intravenously.

    Tetanus Toxoid

    Tetanus toxoid adsorbed

    purogenated

    Each single dose of

    0.5 mL,of ACEL-

    IMUNE is

    formulated to

    contain9 Lf of

    diphtheria toxoid

    and 5 Lf of tetanus

    toxoid (both

    toxoids induce not

    less than 2 units of

    antitoxin per mL

    in the guinea pig

    potency test) and300

    hemagglutinating

    (HA) units of

    acellular pertussis

    vaccine.

    0.5 mL Children who have recovered

    from culture co & med pertussis

    need not receive further doses o

    a pertussis-containing vaccine7,

    but should complete the

    recommended series with

    Diphtheria and Tetanus Toxoids

    Adsorbed for pediatric USC(DT).

    It is intended for active

    immunization against diphtheria

    tetanus, and pertussis. It is not to

    be used for treatment of actual

    infection.Ifa contraindicating event td the

    pertussis vaccine component

    occurs, Diphtheria and Tetanus

    Toxoids, Adsorbed for pediatric

    use (IX) should be substituted fo

    each of the remaining doses. The

    Advisory Committee on

    Immunization Practices (ACID)

    recommends that if an immediat

    anaphylactic reaction occurs, no

    further vaccination with any of

    the three antigens in DTP shouldbe carried out.

    If passive immunization is

    required, Tetanus Immune

    Globulin (TIG) or Diphtheria

    Antitoxin are recommended.

    Varicella virus vaccine

    (varivax)

    Suspension for

    injection

    0.5 mL Children (12 months to 12 years

    of age)

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    (approximately

    0.5-mL dose)

    supplied as a

    lyophilized

    vaccine to be

    reconstituted

    using theaccompanying

    sterile diluent.

    If a second dose is administered,

    there should be a minimum

    interval of 3 months between

    doses

    Adolescents (13 years of age)

    and Adults

    Two doses of vaccine, to beadministered with a minimum

    interval of 4 weeks between

    doses.

    Varicella Zoster Immune

    Globulin

    Injection 125 units

    of varicella zoster

    immune globulin

    antibody

    125 units Administer by IV or IM injection

    Monitor patient for adverse

    effects for at least 20 minutes

    after administration of VZIG.

    Do notmix with any other drugor solution.

    Do notadminister concomitantly

    with varicella vaccine.