DRUGS REQUIRING SPECIAL HANDLING BIOLOGICAL PRODUCTS STRENGTH/FORM 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 singledose vial 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 Single dose vial DOSAGE <19yrs: 0.5 mL >20 yrs: 1.0 mL COMMENTS Hepa B vaccine should be administered intramuscularly. Do not inject intravenously or intradermally

Hepatitis B vaccine

Diptheria and Tetanus Toxoid and acellular pertusis vaccine

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

0.5 mL

Hib is injected into the upper leg 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 a 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

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 at 15 to 18 mo. Adults For unvaccinated adults at increased risk of exposure to poliovirus, give primary series of 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 months remain before protection is needed (e.g., planned international travel), give 3 doses of IPV at least 1 month apart. This vaccine is injected under the skin (subcutaneously) or into muscle. PRIORIX is generally injected into the upper 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.

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

Varicella Vaccine

Each 0.5mL dose contains not less than 103.3 plaqueforming units of the varicella-zoster virus. 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 of doses that will be given will be determined by your doctor on the basis of appropriate official recommendations. Adults and

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 single-dose vials and prefilled syringes. 1-mL single-dose vials and prefilled syringes 0.5 mL Usually, your child will receive three injections with an interval of at least one month between each 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) 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, or subcutaneously The Centers for Disease Control and Prevention (CDC) recommend that everyone 6 months and older should receive the flu vaccine. Biothrax is given to patient ntramuscularly. 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

Hepatitis A Vaccine

<18 yrs; 0.5 mL >19 yrs; 1.0 mL

Influenza Vaccine

IM injection

0.5 mL

Anthrax vaccine adsorbed(biothrax)

5.0 mL multidose vials containing ten 0.5 mL doses. Digoxin Immune Fab,ovine Each vial, which (digiblind) will bind approximately 0.5 mg of digoxin (or digitoxin), contains 38 mg of digoxin-specific Fab fragments derived from sheep plus 75 mg

5mL Vial 0.5 mg each vial

of sorbitol as a stabilizer and 28 mg of sodium chloride. Diptheria Toxoid /Tetanus Each 0.5 mL 0.5 mL toxoid/Acellular Pertussis Diphtheria toxoid vaccine adsorbed not <30 IU, tetanus Daptacel,infanrix,tripedia) toxoid 40 IU, pertussis toxoid 25 mcg, filamentous hemagglutinin 25 mcg, pertactin 8 mcg Haemophilus B conjugate COMVAX is 0.5 mL and Hepatitis B vaccine supplied as 7.5 recombinant (comvax) mcg PRP polysaccharide conjugated to approximately 125 mcg OMPC and 5 mcg HBsAg in a box of 10 single dose vials. Haemophilus B 0.5 mL single dose 0.5 mL conjugate(ActHib) ampoule

Vaccination usually starts with an injection given every 2 months for the first 3 doses. A booster dose is given 6 to 12 months after the first 3 doses. A second booster dose is usually given before the child enters school at 4 to 6 years. COMVAX is indicated for vaccination against invasive disease caused by Haemophilusinfluenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age born of HBsAg negative mothers. This is given through IM injection Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Administer the vaccine intramuscularly. The preferred site is into the anterolateral aspect of the mid-thigh (vastuslateralis muscle) or into the deltoid muscle. In children >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 needle has not entered a blood vessel. Do not inject IV For intramuscular administration only. Children/Adolescents: vaccination consists of a 0.5-mL primarydose administered intramuscularly, and a 0.5-mL

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

(Avaxim)

and prefilled syringes

Hepatitis B immune globulin(Bay Hep,NabiHB)

Hepatitis B vaccine Recombinant(engerix B,Recombivax HB

Immune globulin Human (Bay Gam) Immune Globulin Intravenous Human (sandoglobuli IV)

1 mL dose in a single-use vial (>312 IU) 5 mL dose in a single-use vial (>1560 IU) Vaccine inj 10 mcg/0.5 mL (monodose, pediatric dose). 20 mcg/mL (monodose, adult dose). 2 mL and 10 mL single dose vials. white lyophilized powder in 1, 3, 6 and 12 g size vials. The only diluents which may be used to reconstitute the product are sterile (0.9%) Sodium Chloride Injection USP, 5% Dextrose, or Sterile Water.

0.5mL

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 administered Intramuscularly 6 to 18 months later. This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. IMAdult20 yr 20 mcg/dose. Neonate, infant & childn19 yr 10 mcg/dose.

A 1.0 mL dose of the formulation of the vaccine for use in dialysis/predialysis patients contains 40 mcg of HBsAg 2 mL and 10 mL The product should be infused at a rate less than 2 mg Ig/kg/min.

Influenza Virus vaccine Subviron (Fluvirin)

0.5 mL single-dose prefilled syringe (3, 11) 5.0 mL multi-dose vial containing 10 doses (each dose is 0.5 mL) (3,11)

0.5 mL

20 IU/kg body wt IM as a single dose. Replacement therapy in primary immunodeficiency Initial dose: 0.4-0.8 g/kg body wt followed by 0.2-0.8 g/kg body wt every 2-4 wk to obtain IgG trough level of at least 4-6 g/L. Replacement therapy in secondary immunodeficiency 0.20.4 g/kg body wt every 3-4 wk to obtain IgG trough level of at least 4-6 g/L.Replacement therapy in childn w/ AIDS 0.2-0.4 g/kg body 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. Adults and children aged four and 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,

may require two doses of vaccine 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 0.5 mL IM or deep SC inj Adult & 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 vaccinated Administer a 2nd dose after an interval of at least 4 wk. 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. 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 age should receive another dose between 12to15 months of age followed by revaccination prior to elementary school entry. SC Immunization 0.5 mL. Revaccination for childn <4 yr 0.5 mL 2/3 yr after 1st vaccination.

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.

Measles/mumps/rubella virus vaccine MMR11

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..

Single 0.5-mL dose

Meningitis vaccine (menomune)

Powd for inj (monodose vial + 0.78 mL diluent)

0.5mL

Mumps Virus Vaccine (mumps vax)

The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 20,000 TCID50 (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. For infants, the immunization series of Prevnar consists of three doses of 0.5 mL each, at approximately 2-month intervals, 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. The fourth dose should be administered at approximately 12-15 months of age, and at least 2 months after the third dose. 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. Children Primary series consists of 3 doses 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

Pneumococcal vaccine( Diptheria Protein)Prevnar

Syringe, 1 Dose

0.5mL

Pneumococcal vaccine (pneumovax 23-Pnu immune23)

Vaccine 0.5 mL (inj, single-dose vial, clear, colorless soln)

0.5 mL

Polio vaccine Inacctivated (ipol)

Single-dose vials and prefilled syringes containing a 0.5mL suspension for injection.

0.5 mL

Rabies Immune vaccine (Imovax/ rabavert)

One vial of freezedried 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. Injection, Solution

1.0 mL

Respiratory Syncytial Virus immune globulin ,Human(Respigam)

20 mL

Rho Immune Globulin Human

1 prefilled singledose syringe of RhoGAM 5 prefilled singledose syringes of RhoGAM 25 prefilled singledose syringes of RhoGAM

50 g 300 g

15 to 18 mo. Adults For unvaccinated adults at increased risk of exposure to poliovirus, give primary series of 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 months remain before protection is needed (e.g., planned international travel), give 3 doses of IPV at least 1 month apart. For adults and older children, the 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 and body mass. Care should be taken to avoid injection into or near blood vessels and nerves. If blood 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. For preventing respiratory syncytial virus (RSV) infection. Adults and children 24 months of age and olderUse is not recommended. Infants and children younger than 24 months of age750 milligrams (mg) per kilogram (kg) (340.9 mg per pound) of body weight injected into a vein once a month for five months. For intramuscular use only. Do not inject RhoGAM or MICRhoGAM intravenously. In the case of postpartum use, the product 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.

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

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

A single dose (approximately 50 g)* is contained in each prefilled syringe of MICRhoGAM. This dose will suppress the immune response to 2.5 mL of Rh-positive red blood cells. MICRhoGAM is therefore indicated within 72 hours after termination of pregnancy up to and including 12 weeks gestation. At or beyond 13 weeks gestation, RhoGAM should be administered instead of MICRhoGAM. A single dose (approximately 300 g) is contained in each prefilled syringe of RhoGAM. This is the usual dose for the indications associated with pregnancy unless 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. 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. PRIMARY IMMUNIZATION MassBiologics Td may be used in persons 7 years of age and older who have not been previously immunized against tetanus and diphtheria, as a primary immunization series consisting of three 0.5 ml doses. The first two

ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid.

Tetanus Immunoglobulin (Bay Tet)

Vials containing Human Tetanus Immunoglobulin equivalent to

250 I. U. / 500 I. U. / 1000 I. U

doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose. Mass Biologics Td may be used to complete the primary immunization series for tetanus and 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/or Diphtheria and Tetanus Toxoids Adsorbed (DT) vaccine. However, the safety and efficacy of MassBiologics Td in such regimens have not been evaluated. ROUTINE BOOSTER IMMUNIZATION MassBiologics Td 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 tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter. Inject 0.5 ml of MassBiologics Td intramuscularly. 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, or intradermally. MassBiologics Td should not be combined through reconstitution or mixed with any other vaccine. Prophylaxis :In High risk injuries to non-immune and immune patients (Above 7 Years) In High risk injuries to non-

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 IM Therapeutic: Clinical tetanus Newborn (Tetanus Neonatorum) Children(Above 7 Years) & Adults 250 I.U. to 500 I.U. IM and/or 250 I.U. intrathecal. 500 to 3,000 I.U. IM and/or 500 I.U. intrathecal. It should not be administered intravenously. Children who have recovered from culture co & med pertussis need not receive further doses of 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. If a contraindicating event td the pertussis vaccine component occurs, Diphtheria and Tetanus Toxoids, Adsorbed for pediatric use (IX) should be substituted for each of the remaining doses. The Advisory Committee on Immunization Practices (ACID) recommends that if an immediate anaphylactic reaction occurs, no further vaccination with any of the three antigens in DTP should be carried out. If passive immunization is required, Tetanus Immune Globulin (TIG) or Diphtheria Antitoxin are recommended. Children (12 months to 12 years of age)

Tetanus Toxoid Tetanus toxoid adsorbed purogenated

Each single dose of 0.5 mL,of ACELIMUNE 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) and 300 hemagglutinating (HA) units of acellular pertussis vaccine.

0.5 mL

Varicella virus vaccine (varivax)

Suspension for injection

0.5 mL

(approximately 0.5-mL dose) supplied as a lyophilized vaccine to be reconstituted using the accompanying sterile diluent. Varicella Zoster Immune Globulin Injection 125 units of varicella zoster immune globulin antibody 125 units

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 be administered with a minimum interval of 4 weeks between doses. Administer by IV or IM injection. Monitor patient for adverse effects for at least 20 minutes after administration of VZIG. Do not mix with any other drug or solution. Do not administer concomitantly with varicella vaccine.