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| Hepatitis
- B Vaccine (rDNA) B.P. |
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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 WHO when tested
by the methods outlined in WHO, TRS 786(1989).
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 | 0.025 mg |
| 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+++) | 0.5 mg to 0.8 mg |
| Preservative: Thiomersal | 0.05
mg |
| Produced in Hansenula
Polymorpha (yeast) |
| Dose
: 1 ml by intramuscular injection |
INDICATIONS
Hepatitis-B 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.
- Health
Care Personnel.
- Patients
receiving frequent blood products.
- Personnel
and residents of institution.
- Persons
at increased risk due to their sexual behavior.
- Illicit
users of addictive injectable drugs.
-
Travelers
to areas with a high endemicity of HBV.
- Infants
born of mothers who are HBV carries.
- Persons
originating from areas with a high endemicity of HBV.
- Others:
Police personnel, fire brigade personnel, armed forces personnel and anybody who through
their work or personal lifestyle may be exposed to HBV.
- Household
contacts of any of the above groups and of patients with acute or chronic HBV infection.
In areas of intermediate or high prevalence
of Hepatitis-B, with most of the population at risk of acquiring the disease,
immunisation should be offered to all neonates and young children. Immunisation
should also be considered for adolescents and young adults.
The vaccine can
be safely and effectively given simultaneously but at different injection site
with DTP, DT, TT, BCG, Polio vaccine (OPV and IPV) and yellow fever vaccine.
CONTRAINDICATIONS
Hepatitis-B
vaccine should not be administered to subjects with known hypersensitivity to
any component of the vaccine, or to subjects having shown signs of hypersensitivity
after previous Hepatitis-B Vaccine administration.
PRECAUTIONS AND WARNINGS
Because of the period
of latency of Hepatitis-B infection it is possible for unrecognised infection
to be present at the time of immunisation. The vaccine may not prevent Hepatitis-B
infection in such cases.
The vaccine will not prevent infection caused
by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens
known to infect the liver.
The immune response to Hepatitis-B vaccines is
related to age. In general, people over 40 years of age respond less well.
In haemodiaysis patients and persons with an impaired immune system, adequate
anti-HBs antibody titres may not be obtained after the primary immunisation course
and such patients may therefore require administration of additional doses of
vaccine (see Dosage recommendation for Immunocompromised persons)
As
with all injectable vaccines, appropriate medication (e.g. adrenaline) should
always be readily available for treatment in case of rare anaphylactic reactions
following the administration of the vaccine.
Hepatitis-B vaccine should
not be administered in the gluteal muscle or intradermally since this may result
in a lower immune response.
Hepatitis-B vaccine may be used to complete
a primary immunisation course started either with plasma-derived or with other
genetically-engineered Hepatitis-B vaccines, or as a booster dose in subjects
who have previously received a primary immunisation course with plasma-derived
or with other genetically-engineered Hepatitis-B vaccines.
ADVERSE
REACTIONS
The undersirable events are temporally related to the administration
of Hepatitis-B Vaccine. They are usually mild and confined to the first few days
of the vaccination. The most common reactions are mild soreness, erythema, induration,
fatigue, fever, malaise, influenza-like symptoms.
Less common systemic
reactions include nausea, vomiting, diarrhoea, abdominal pain, abnormal liverfunction
tests, arthralgia, mystalgia, rash, pruritus, urticaria, liver function.
DOSAGE AND ADMINISTRATION
Paediatric dose vaccine : 10 mcg dose
(in 0.5 ml suspension) is recommended for neonates, infants and children upto
10 years of age.
Adult dose vaccine : 20 mcg dose (1.0 ml suspension) is recommended
for adults and children above 10 years of age.
IMMUNISATION SCHEDULE
Primary Immunisation : A series of three intramuscular injections is required
to achieve optimal protection.
Two primary immunisation schedules can be recommended:
A rapid schedule, with immunisation at 0, 1 and 2 months, will confer protection
more quickly and is expected to provide better patient compliance.
-
Schedules which have more time between the
second and third doses, such as immunisation at 0, 1 and 6 months, may take
longer to confer protection, but will produce higher anti-HBs
antibody titres.
-
The immunisation
schedule may be adapted to meet local immunisation recommendations.
The following timing of injections gives general guidance :
| 1st dose | at elected date |
| 2nd dose | 4 to 10 weeks after the
1st dose |
| 3rd dose | 1 to
5 months after the 2nd dose |
BOOSTER
DOSE.
It would seem advisable to recommend a booster dose when the anti-HBs
antibody titre falls below 10 IU/L, particularly for all people at risk.
- After the 0, 1, 2 month primary immunisation schedule a booster
dose is recommended 12 months after the first dose. The next booster may be required
after 8 years.
- After the 0, 1, 6 month primary immunisation
schedule a booster dose may be required after 5 years after the primary
course.
SPECIAL DOSAGE RECOMMENDATIONS
DOSAGE RECOMMENDATION FOR NEONATES BORN OF MOTHERS WHO ARE HBV CARRIERS.
The 0, 1, 2 month immunisation schedule is recommended, and should start at
birth. Concommitant administration of Hepatitis-B immunoglobulin not necessary,
but when Hepatitis- B immunoglobulin is given simultaneously with Hepatitis-B
a separate injection site must be chosen.
DOSAGE RECOMMENDATION FOR KNOWN
OR PRESUMED EXPOSURE OF HBV
In circumstances where exposure to HBV has recently
occurred (eg. needlesstick with contaminated needle) the first dose of Hepatitis-B
can be administered simultaneously with Hepatitis-B immunoglobulin which however
must be given at a separate injection site. The rapid immunisation schedule should
be advised.
DOSAGE RECOMMENDATION FOR IMMUNOCOMPROMISED PERSONS.
The primary immunisation schedule for chronic haemodialysis patients or persons
who have an impaired immune system is four doses of 40 mcg at 0, 1, 2 and 6 months
from the date of first dose. The immunisation schedule should be adapted in order
to ensure that the anti-HBs antibody titre remains above the accepted protective
level of 10 IU/L
METHOD OF ADMINISTRATION
Hepatitis-B
Vaccine should be injected intramusculary in the deltoid region in adults and
children or in the anterolateral thigh in neonates, infants and young children.
The vaccine may be administered subcutaneously in patients with thrombocytopenia
or bleeding disorders. The vaccine should be well shaken before use. Only sterile
needle and syringes should be used for each injection.
STORAGE
Hepatitis-B should be stored between 2° to 8°C. Not to be frozen. Discard
if vaccine has been frozen.
PRESENTATIONS
| 0.5 ml | Single dose (Pediatric) vial |
| 5 ml | 10 doses (Pediatric) vial |
| 1 ml | Single dose (Adult) vial |
| 10 ml | 10 doses (Adult) vial |
