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Logo HEPACCINE-B INJECTION- 27/30.1/0128
HEPACCINE-B MULTIDOSE INJECTION- 27/30.1/0129
HEPACCINE-B PAEDIATRIC INJECTION- 27/30.1/0127
HEPACCINE-B PAEDIATRIC 2 DOSE INJECTION - 27/30.1/0422
HEPACCINE-B PAEDIATRIC MULTIDOSE INJECTION- 27/30.1/0423
REGISTRATION NUMBER:
27/30.1/0423; 27/30.1/0422; 27/30.1/0129; 27/30.1/0128; 27/30.1/0127.

PROPRIETARY NAME
(and dosage form):

HEPACCINE-B INJECTION- 27/30.1/0128
HEPACCINE-B MULTIDOSE INJECTION- 27/30.1/0129
HEPACCINE-B PAEDIATRIC INJECTION- 27/30.1/0127
HEPACCINE-B PAEDIATRIC 2 DOSE INJECTION - 27/30.1/0422
HEPACCINE-B PAEDIATRIC MULTIDOSE INJECTION- 27/30.1/0423

DESCRIPTIVE NAME OF MEDICINE:
HEPATITIS-B VACCINE

PHARMACOLOGICAL CLASSIFICATION:
A.30.1 BIOLOGICALS –ANTIGEN

SCHEDULING STATUS:
S2

COMPOSITION:
EACH 1,0 mL CONTAINS:
Heat inactivated HBsAg 3 µg
Aluminium Phosphate (as Al) 0,266 mg
Thiomersal (KP) 70-120 mcg/mL
Isotonic Sodium Chloride Inj. (KP) q.s.
IDENTIFICATION:
Slightly turbid white suspension in colourless vial.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Hepaccine-B is a vaccine against hepatitis B, prepared from hepatitis B virus surface antigens. The purified surface antigens contain all of the major molecular antigens (Pre-S1 Pre-S2 and sAg) that have been recognised to be important in inducing natural immunity against the hepatitis B virus. The purified antigens are further treated with a flash-heating method to induce the formation of new antigenic forms which have been shown to have immunogenicity.

INDICATIONS:
Hepaccine-B is indicated for the immunization against Hepatitis B virus.

CONTRA-INDICATIONS:
1. Persons with hypersensitivity to any component of the vaccine.
2. Pregnancy. Safety of this vaccine during pregnancy has not been established.
3. Efficacy in immunocompromised or immunosuppressed subjects has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Primary (initial) immunization:
3 intramuscular 0,5 mL (1,5 µg) injections at monthly intervals. National Health Policy currently recommends immunization at 6 weeks, 10 weeks, 14 weeks of age.
Neonatesandchildren 10 years old or younger: 0,5 mL (1,5 µg).
Adultsand children over10 years:1 mL (3 µg).

Site of injection
Adults and children: The deltoid muscle of the upper arm.
Neonates: The buttock or lateral side of the thigh.
The vaccine should be well shaken before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions have included erythema, pain, swelling, warmth or induration, but these generally disappear within 48 hours. Systematic complaints including malaise, fatigue, nausea, fever, myalgia and arthralgia have usually been limited to the first few days following vaccination. Rash has been reported.

Precautions:
Because of the long incubation period for Hepatitis B, it is possible for unrecognised infection to be present at the time when Hepaccine-B is given. Hepaccine-B may not prevent hepatitis B in such patients.

Any serious active infection is reason for delaying the use of Hepaccine-B, except in cases where, in the opinion of the physician, withholding the vaccine may entail an even greater risk.

WARNING:
Caution and appropriate care should be exercised in administering Hepaccine-B to individuals with severely compromised cardiopulmonary status or to others in whom a febrile or systemic reaction could pose a significant risk.
Should severe anaphylactic reaction occur, epinephrine should be administered immediately. Treatment of adverse effects is symptomatic and supportive.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to side effects and special precautions. Treatment is symptomatic and supportive.

CONDITIONS OF REGISTRATION IMPOSED BY THE COUNCIL:
None.

PRESENTATION:
Hepaccine-B Pack of one monodose vial (1 mL –1 dose)
Hepaccine-B Multidose Pack of one multidose vial (5 mL –5 dose)
Hepaccine-B Paediatric Pack of one monodose vial (0,5 mL –1 dose)
Hepaccine-B Paediatric two dose vial Pack of one two dose vial (1 mL –2 dose)
Hepaccine-B Paediatric Multidose Pack of one multidose vial (5 mL –10 dose)
STORAGE INSTRUCTIONS:
Store at 2-8°C. DO NOT FREEZE.

Shake well before using. Thorough agitation at the time of administration is necessary to maintain a uniform suspension of the vaccine. Keep out of reach of children.

NAME OF APPLICANT:
Biovac S.A. c.c., 1 Manchester Road, Wadeville.

Name and address of manufacturer Cheil Foods & Chemicals Inc., Pharmaceutical Division, Dongbang Main Building,
150, 2-KA Taepyung-Ro, Chung-Ku, Seoul, Korea.
DATE OF PUBLICATION OF PACKAGE INSERT:
December 1994.
L/94L12054

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