Elovac - B - Hepatitis B Vaccine B.p(R Dna) printable pdf download

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Elovac - B

PRODUCT

RANGE

Hepatitis B Vaccine B.P(r DNA)

DESCRIPTION

personnel, Military personnel etc.).

Elovac-B

(Recombinant Hepatitis - B vaccine) is a noninfectious recombinant DNA

2. Travelers to area where Hepatitis B is common.

vaccine. It is a sterile suspension of purified major surface antigen of Hepatitis B virus

3. Injectable drug abusers.

(HBV). The Hepatitis B surface antigen (HBsAg) is produced from cultures of geneti-

4. Patients who may require multiple blood transfusions.

cally engineered Pichia pastoris , containing the gene that codes for the HBsAg. The

5. Persons originating from areas of high endemicity.

HBsAg protein released by disruption of Pichia pastoris cells is purified by various

6. Persons who have sex with someone infected with HBV

physiochemical methods. The purified antigen is adsorbed on Aluminium hydroxide

7. Persons who have sex with more than one partner.

gel to get bulk vaccine. The vaccine does not contain any material of human or animal

8. Men who have sex with men.

origin.

9. People who live in the same house with someone who has chronic HBV infection.

Elovac-B

is commercially available as a sterile suspension, ready to use for

10.Infants born to HBV positive mothers.

I.M.injection. The vial must be shaken well before administration.

CONTRAINDICATIONS

Paediatric & Adolescent dose: Each 0.5ml dose contains 10mcg of Hepatitis B

Elovac-B

Should not be administered to any person who has experienced a hyper-

surface antigen (purified) adsorbed on 0.25mg Aluminium as Aluminium hydroxide

sensitivity reaction to any component of any Hepatitis B recombinant DNA vaccine.

and 0.025mg of Thiomersal as preservative.

Elovac-B

Should not be administered to subjects with severe febrile infections.

Adult dose

Each 1 ml adult dose contains 20 mcg of Hepatitis B surface antigen (purified) adsorbed

WARNINGS

on 0.5 mg Aluminium as Aluminium hydroxide and 0.05mg of Thiomersal as

Elovac-B

may not prevent infection, if the vaccinee, at the time of immunization was

preservative.

harboring an unrecognized Hepatitis B infection.

Not all vaccinees respond in the same manner to a given vaccine. The immune

CLINICAL PHARMACOLOGY

response may be dependant upon many factors. Some are mentioned below. Age

Elovac-B

generates specific protective immune response against HBsAg. For

over 40 years, Gender: Male, Smokers, Obese individuals, patients with immunodefi-

protection against HBV infection the anti-HBsAg titre (Anti-HBs antibodies) should be

ciency diseases or those receiving immuno-suppressive therapy or those who

more than or equal to 10 mlU/ml.

received the vaccine on the gluteal region, may have an unsatisfactory antibody titre.

Hence adequate anti-HBs antibody titres may not be obtained after a primary course

INDICATIONS AND USAGE

of immunization.

Elovac-B

Vaccine is indicated for immunization against infection caused by all known

In such persons additional doses of the vaccine may be required.

subtypes of Hepatitis B virus.

The vaccine does not prevent infection by Hepatitis A, Hepatitis C, Hepatitis D,

Routine vaccination

Hepatitis E or other pathogens known to infect the liver.

New born, infants, children and adolescents.

Vaccination of defined high risk populations

Pregnancy:

High risk populations

Adequate human and animal data on use during pregnancy is not available.

1. People who have a job that involves contact with human blood (Ex: Health care

Hepatitis B vaccine should be used during pregnancy only when definitely indicated,

Continued

Elovac - B - Hepatitis B Vaccine B.p(R Dna)

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