Genvac-B

GENVAC-B (Hepatitis B vaccine (Recombinant DNA)) 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.

GENVAC-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 behaviour.
Illicit users of addictive injectable drugs.
Travellers 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 previously mentioned 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, Measles, Polio vaccine (OPV and IPV) and yellow fever vaccine. It should not be mixed in the vial or syringe with any other vaccine unless it is manufactured as a combined product (e.g. DTP-Hep B).

Pediatric dose vaccine: 10 mcg dose (in 0.5 mL suspension) is recommended for neonates, infants, children and adolescents up to 19 years of age.
Adult dose vaccine: 20 mcg dose (1.0 mL suspension) is recommended for adults aged 20 years and above.
Immunisation Schedule: Primary Immunisation: A series of three intramuscular injections is required to achieve optimal protection.
The following immunisation schedules can be recommended: 6, 10, 14 weeks for infants; 0, 1, 6 months; 0, 1, 2 months (rapid schedule).
The immunisation schedule should be adapted to meet local immunisation recommendations.
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 immunisation 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 GENVAC-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 (e.g. needle stick with contaminated needle) the first dose of GENVAC-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.
Immune Deficiency: Individuals infected with human immuno-deficiency virus (HIV), both asymptomatic and symptomatic, should be immunized with Hepatitis B vaccine according to standard schedules.
Method of Administration: GENVAC-B should be injected intramuscularly 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. Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of Hepatitis B from which one or more doses of vaccine have been removed during an immunisation session may be used in subsequent immunisation sessions for up to a maximum of 28 days, provided that all of the following conditions are met (as described in the WHO policy statement: Handling of multi dose vaccine vials after opening, WHO/IVB/14.07): The vaccine is currently prequalified by WHO; The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO; The expiry date of the vaccine has not passed; The vaccine vial has been, and will continue to be, stored at WHO or manufacturer recommended temperatures; furthermore, the vaccine vial monitor, if one is attached, is visible on the vaccine label and is not past its discard point, and the vaccine has not been damaged by freezing.
The vaccine should be visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In event of either being observed, discard the vaccine.

GENVAC-B 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 GENVAC-B administration.

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 haemodialysis 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 under Dosage & Administration).
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.

The undesirable events are temporally related to the administration of Hepatitis B vaccine (Recombinant DNA). 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 liver function tests, arthralgia, myalgia, rash, pruritus, urticaria, liver function.

The Vaccine Vial Monitor (VVM) (Optional): Vaccine Vial Monitors (VVM): Use: Square is lighter than outer circle.
Discard Point: The colour of the inner square of the VVM starts with a shade that is lighter than the outer circle and continues to darken with time and/or exposure to heat.
Do not use: Square matches outer circle; Square is darker than outer circle.
Discard Point: Once a vaccine has reached or exceeded the discard point, the colour of the inner square will be the same colour or darker than the outer circle.
Inform the supervisor.
Cumulative heat exposure over time.
Vaccine Vial Monitors (VVMs) are on the cap (2 mL vial)/part of the label of GENVAC-B (Hepatitis B vaccine (Recombinant DNA)) supplied through Serum Institute of India Pvt. Ltd. The colour dot which appears on the label of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the outer circle, then the vaccine can be used. As soon as the colour of the central square is the same colour as the outer circle or of a darker colour than the outer circle, then the vial should be discarded.

GENVAC-B should be stored at 2-8°C. Do not Freeze. Discard if vaccine has been frozen.
Shelf Life: Thirty six months from the date of manufacture.

Vaccines, Antisera & Immunologicals

J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.

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