Hepatitis B Vaccine (rDNA) (Adult) suspension for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hepatitis B surface antigene

Available from:

Serum Institute of India Pvt Ltd.

ATC code:

J07BC01

INN (International Name):

hepatitis B surface antigene

Dosage:

20mcg/dose

Pharmaceutical form:

suspension for injection

Units in package:

(50) glass vial 1ml (1 dose)

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-08-30

Patient Information leaflet

SII
DESCRIPTION
Hepatitis B vaccine (rDNA) is a non infectious recombinant DNA
Hepatitis B vaccine. It contains purified surface antigen
of the virus obtained by culturing genetically-engineered _Hansenula
polymorpha_ yeast cells having the surface antigen
gene of the Hepatitis B virus. The Hepatitis B surface antigen (HBsAg)
expressed in the cells of _Hansenula polymorpha_ is
purified through several chemical steps and formulated as a suspension
of the antigen adsorbed on aluminium
hydroxide and thiomersal is added as preservative. The vaccine does
not contain any material of human or animal
origin. The vaccine meets the requirements of W.H.O. when tested by
the methods outlined in W.H.O., TRS 978 (2013).
COMPOSITION
PAEDIATRIC
Each dose of 0.5 ml contains :-
10 mcg of purified Hepatitis B surface antigen
+++
Adsorbed on Aluminium hydroxide (Al
) 0.25 mg to 0.40 mg
Preservative : Thiomersal 0.005%
Produced in _Hansenula polymorpha_ (yeast)
Dose : 0.5 ml by intramuscular injection
ADULT
Each dose of 1 ml contains :-
20 mcg of purified Hepatitis B surface antigen
+++
Adsorbed on Aluminium hydroxide (Al
) 0.50 mg to 0.80 mg
Preservative : Thiomersal 0.005 %
Produced in _Hansenula polymorpha_ (yeast)
Dose : 1 ml by intramuscular injection
INDICATIONS
Hepatitis B vaccine is indicated for active immunisation against
hepatitis B infection in subjects considered at risk of
exposure to HBV-positive material.
Immunisation against hepatitis B is expected in the long term to
reduce not only the incidence of this disease, but also
its chronic complications such as chronic active hepatitis B and
hepatitis B associated cirrhosis and primary
hepatocellular carcinoma.
In areas of low prevalence of hepatitis B, immunisation with hepatitis
B vaccine is recommended for neonates/infants
and adolescents as well as for subjects who are, or will be, at
increased risk of infection such as:
uHealth Care Personnel.
uPatients receiving frequent blood products.
uPersonnel and residents of institution.
uPersons at increased risk due to their

Summary of Product characteristics

SERUM INSTITUTE OF INDIA PVT
LTD.
HEPATITIS B VACCINE (RDNA) (ADULT)
SMPC - SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
HEPATITIS-B VACCINE (RDNA) (ADULT) - SINGLE DOSE / 10 DOSES
2. QUALITATIVE AND QUANTATIVE COMPOSITION
Each dose of 1 ml contains
Purified Hepatitis B Surface Antigen. 20 mcg
Adsorbed on Aluminum Hydroxide (Al
+++
) 0.5 mg to 0.8mg
Preservative: Thiomersal 0.005 %
Produced in
_Hansenula polymorpha_
(yeast)
3. PHARMACEUTICAL FORM
Suspension for injection
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Hepatitis-B vaccine is indicated for active immunization against
Hepatitis B infection in
subjects considered at risk of exposure to HBV-positive material
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSE –
20 mcg dose (in 1ml suspension) is recommended for adults aged 20
years and above.
IMMUNIZATION SCHEDULE
Primary immunization. - A series of three intramuscular injections is
required to achieve
optimal protection.
The following immunization schedules can be recommended:
- 0, 1, 6 months
- 0, 1, 2 months (rapid schedule)
The immunization schedule should be adapted to meet local immunization
recommendations.
SERUM INSTITUTE OF INDIA PVT
LTD.
HEPATITIS B VACCINE (RDNA) (ADULT)
BOOSTER DOSE
The need for the booster dose in healthy individuals who have received
the full primary
immunization, is not recommended. It would seem advisable to recommend
a booster dose
when Anti-HBs antibody titres fall below 10 IU/L for all people at
risk and especially for
patients who are immunocompromised (HIV infected patients) or those on
haemodialysis.
SPECIAL DOSAGE RECOMMENDATIONS :
_DOSAGE RECOMMENDATION FOR NEONATES BORN OF MOTHERS WHO ARE HBV _
_CARRIERS._
The 0, 1, 2 month immunization schedule is recommended, and should
start at birth.
Concomitant
administration
of
Hepatitis
B
immunoglobulin
not
necessary,
but
when
Hepatitis B immunoglobulin is given simultaneously with Hepatitis-B
vaccine, a separate
injection site must be chosen.
_DOSAGE RECOMMENDATION FOR KNOWN OR PRESUMED EXPOS