1. Name Of The Medicinal Product
HB-VAX® II
Recombinant Hepatitis B Vaccine, 10 micrograms/1 millilitre, Suspension for Injection, for Adults and Adolescents
2. Qualitative And Quantitative Composition
One dose of HB-VAX® II contains:
Hepatitis B surface antigen, recombinant (HBsAg) * 10 micrograms
* Surface antigen of hepatitis B virus produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3).
For excipients, see 6.1.
3. Pharmaceutical Form
Suspension for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in subjects considered at risk of exposure to hepatitis B virus.
Groups identified at increased risk of infection:
Health care personnel. Oral surgeons, dentists, physicians and surgeons, nurses, dental hygienists, paramedical personnel in close contact with patients, staff in haemodialysis, haematology and oncology units, laboratory personnel handling blood and other clinical specimens, emergency and first aid workers, ambulance staff, blood bank and plasma fractionation workers, cleaning staff in hospitals handling waste, chiropodists, morticians and embalmers.
Patients frequently receiving blood products. Patients in haemodialysis and oncology units, patients suffering from thalassaemia, sickle cell anemia, liver cirrhosis, haemophilia, and patients receiving frequent blood transfusion or clotting factor concentrates, patients receiving organ transplants.
Personnel collecting, sorting out, handling specific waste and household rubbish.
Personnel and residents of institutions. Persons with frequent and/or close contacts with high risk groups, prisoners and prison staff, residents and staff of institutions for mentally handicapped.
Persons at increased risk due to their sexual behaviour. Persons with multiple sexual partners, patients with a Sexually Transmitted Disease (STD), persons seeking treatment for an STD, prostitutes and male homosexuals.
Illicit users of addictive injectable drugs.
Travellers to areas with a high endemicity of HBV.
Persons originating from areas with a high endemicity of HBV. Adoptees, immigrants and refugees.
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 contacts with acute or chronic HBV infection.
Nevertheless, the recommendations should be adjusted in line with national vaccination policies since in some countries generalisation of vaccination is highly recommended.
4.2 Posology And Method Of Administration
Posology:
Adolescents and adults (16 years of age and older): 1 dose (10 micrograms) of 1 millilitre at each injection.
A course of vaccination should include at least three doses as follows:
1st injection: at elected date
2nd injection:
3rd injection:
This schedule allows the incorporation of several schemes in national vaccination recommendations.
The most commonly used schedules in Europe are:
0 , 1, 6 months:
two injections with an interval of one month; a third injection 6 months after the first administration.
0 , 1, 2, 12 months:
three injections with an interval of one month; a fourth dose should be administered at 12 months.
The accelerated schedule (0, 1, 2 ,12 months) may induce protective antibody levels earlier in a slightly larger proportion of vaccinees.
Booster:
Immunocompetent vaccinees:
The duration of the protective effect of HB-VAX®II in healthy vaccinees is unknown at present and the need for booster doses is not yet defined. However, some national vaccination schedules currently include recommendations for periodic booster doses.
Immunoincompetent vaccinees (e.g. dialysis patients):
A booster dose may be considered in these vaccinees if the anti-HBs level is less than 10 International Units/litre.
Special dosage recommendations for known or presumed exposure to HBV (e.g. needlestick with contaminated needle):
Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
The first dose of the vaccine should be given within 7 days of exposure and can be given simultaneously with hepatitis B immunoglobulin, but administered at a separate injection site.
Subsequent doses of vaccine, if necessary, (i.e. according to the serologic status of the patient) should be given as in the recommended schedule for this vaccine.
Method of Administration:
This vaccine is for intramuscular injection. The deltoid muscle is the preferred site for injection in adolescents and adults.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or to persons at risk of haemorrhage.
4.3 Contraindications
• Severe febrile illness.
• Hypersensitivity to any component of the medicinal product or allergic reaction after previous vaccine administration.
4.4 Special Warnings And Precautions For Use
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B 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.
In dialysis patients and persons with an impaired immune system, administration of additional doses of vaccine may be needed to obtain a protective anti-HBs titre.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or to persons at risk of haemorrhage.
This vaccine contains thiomersal as a preservative.
This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
This vaccine can be administered with hepatitis B immunoglobulin (HBIg), at a separate injection site.
This vaccine can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.
4.6 Pregnancy And Lactation
The effect of the HBsAg on foetal development has not been assessed. However, as with all inactivated viral vaccines, one does not expect harm for the foetus. Utilisation during pregnancy requires that the potential benefit justifies the potential risk to the foetus.
The effect of the administration of this vaccine on breast fed infants has not been assessed; nevertheless, this situation is not a contraindication.
4.7 Effects On Ability To Drive And Use Machines
There are no specific data. Some of the rare effects mentioned under 'Undesirable Effects', such as dizziness and headache, may affect the ability to drive or operate machinery.
4.8 Undesirable Effects
The following undesirable effects have been reported following the widespread use of the vaccine. As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
Common reactions:
Local reactions at the injection site: transient soreness, erythema, induration.
Very rare:
– elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like symptoms, serum sickness, thrombocytopenia
– dizziness, headache, paraesthesia
– nausea, vomiting, diarrhoea, abdominal pain
– arthralgia, arthritis, myalgia
– rash, alopecia, pruritus
– hypotension, syncope
– paralysis (Bell's palsy), peripheral neuropathies (polyradiculoneuritis, facial paralysis), neuritis (including Guillain-Barré Syndrome, optical neuritis, myelitis including transverse myelitis), encephalitis, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis, multiple sclerosis, seizure
– urticaria, angioedema, erythema multiforme, anaphylaxis
– lymphadenopathy
– vasculitis
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see section 4.3)
4.9 Overdose
No case of overdose has been reported.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
J: ANTI-INFECTIOUS.
Vaccines/hepatitis B
The vaccine induces specific humoral antibodies against HBsAg (anti-HBs). Development of an anti-HBs titre above 10 International Units/litre measured 1-2 months after the last injection correlates with protection to HBV infection.
In clinical trials, 96% of 1497 healthy infants, children, adolescents and adults given a 3 dose course of HB-VAX® II developed a protective level of anti-HBs (>10 International Units/litre).
The protective efficacy of a dose of hepatitis B immunoglobulin (HBIg) at birth followed by 3 doses of HB-VAX® II has been demonstrated for neonates born to mothers positive for both HBsAg and HBeAg. Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95% as compared to the infection rate in untreated historical controls.
Although the duration of the protective effect of HB-VAX® II in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.
In addition, persistence of vaccine-induced immunologic memory for HBsAg has been demonstrated through an anamnestic antibody response to a booster dose of HB-VAX® II in healthy adults given plasma-derived vaccine 5 to 7 years earlier.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Animal reproduction studies have not been conducted.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Thiomersal, aluminium hydroxide, sodium chloride, sodium borate and Water for Injections.
6.2 Incompatibilities
The vaccine should not be mixed in the same syringe with other vaccines or parenterally administered drugs.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Store between +2°C and +8°C.
DO NOT FREEZE.
6.5 Nature And Contents Of Container
1 millilitre of suspension in prefilled syringe (Type I glass) with attached needle and with a chlorobromobutyl stopper (unit pack).
1 millilitre of suspension in a vial (Type I glass).
6.6 Special Precautions For Disposal And Other Handling
Before use, the vaccine should be well shaken to obtain a slightly opaque white suspension.
7. Marketing Authorisation Holder
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8. Marketing Authorisation Number(S)
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9. Date Of First Authorisation/Renewal Of The Authorisation
14 December 1993
10. Date Of Revision Of The Text
August 2000
11. LEGAL CATEGORY
POM
® Registered Trademark
4006556/HBV/RA284/0800/A
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