INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
‘ENGERIX-B’
‘ENGERIX-B PAEDIATRIC’

REGISTRATION NUMBERS:

‘Engerix-B’:	U/30.1/186
‘Engerix-B Paediatric’:	W/30.1/35

PROPRIETARY NAMES
(and dosage form):

‘ENGERIX-B’
‘ENGERIX-B PAEDIATRIC’

DESCRIPTIVE NAME OF MEDICINE:
Recombinant DNA hepatitis B vaccine.

PHARMACOLOGICAL CLASSIFICATION:
A.30.1 Antigens

SCHEDULING STATUS:
S2

COMPOSITION:
‘Engerix-B’and ‘Engerix-B Paediatric’ are recombinant DNA hepatitis B vaccines containing the purified surface antigen of the virus. It is produced by culture of genetically-engineered yeast cells which carry the relevant gene of the surface antigen of hepatitis B virus. The surface antigen expressed in yeast cells is purified by several physico-chemical steps and formulated as a suspension of the antigen adsorbed on aluminium hydroxide. Standardised fermentation and purification procedures ensure batch to batch consistency of ‘Engerix-B’. No substances of human origin are used in its manufacture.

‘Engerix-B’
Each dose of vaccine is contained in 1 mL and consists of 20µg of antigen protein adsorbed on 0,5 mg Al+++ aluminium hydroxide with 1:20000 thiomersal added as preservative.

‘Engerix-B Paediatric’
Each dose of vaccine is contained in 0,5 mL and consists of 10 µg of antigen protein adsorbed on 0,25 mg Al+++ as aluminium hydroxide with 1:20000 thiomersal added as preservative.

IDENTIFICATION:
‘Engerix-B’
The vaccine adsorbed on A1 (OH)3, is an aqueous suspension. Not less than 1 mL corresponding to one dose, is contained in a 3 mL monodose, neutral, colourless glass vial, closed by a grey rubber stopper, and silver fixed aluminium cap, covered by an orange flip-off cap. A fine, white deposit with a clear, colourless supernatant may form upon storage.

Engerix-B Paediatric’
Not less than 0,5 mL is contained in a 3 mL monodose, neutral, colourless glass vial closed by a grey rubber stopper, and golden fixed aluminium cap, covered by an orange flip-off cap. A fine. white deposit with a clear, colourless supernatant may form upon storage.

Pharmacological action of the Medicine:
Active immunization against hepatitis B virus infection.

Specific humoral antibodies against the surface antigen of hepatitis B virus appear in close to 100% of subjects having received three doses of ‘Engerix-B’. It has been established that protection a against hepatitis B is mediated by this type of antibody.

The recombinant DNA technology and the purification procedures used for its manufacture ensure that ‘Engerix-B’is of very high purity. It is devoid of any contaminants of blood origin.

INDICATIONS:
‘Engerix-B’ is indicated for active immunization against hepatitis B virus infection. The vaccine is of no value in the treatment of established hepatitis-B virus infection. The vaccine will not protect against infection caused by hepatitis A and Non-A non-B hepatitis viruses. As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by vaccination with Engerix-B. The vaccine can be administered at any age from birth onwards. It may be used to start a primary course of vaccination or as a booster dose. It may also be used to complete a primary course of vaccination started with plasma derived vaccines or as a booster dose in subjects who have previously received a primary course of vaccination with plasma-derived vaccines.

In areas of low prevalence of hepatitis B, vaccination is specially recommended in subjects who are at increased risk of infection. These include -

Health care personnel:
Oral surgeons, dentists, physicians and surgeons; nurses, dental 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, pathologists morticians and embalmers, blood bank and plasma fractionation workers; chiropodists; cleaning staff in hospitals who handle waste, emergency and first aid workers; ambulance staff.

Patients
Patients receiving frequent blood transfusions or clotting factor concentrates such as patients in haemodialysis and oncology units, thalassaemics, sickle-cell anaemics, cirrhotics and haemophiliacs, etc.

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 the mentally handicapped.

Persons at increased risk due to their sexual practices:
Sexually promiscuous persons, persons who repeatedly contract sexually transmitted diseases, homosexually active males, prostitutes.

Illicit users of addictive injectable drugs.

Travellers to high endemicity areas and their close contacts.

Household contacts of any of the above groups and of patients with acute or chronic hepatitis B inflection.

Others:
Police personnel, fire brigade personnel. Armed forces personnel and anybody who through their work personal lifestyle may be exposed to the hepatitis B virus.

In areas of intermediate or high prevalence vaccination should be offered to all young children and neonates as well as to adult high risk groups because most of the population is at risk of acquiring hepatitis B.

Vaccination against hepatitis B is expected in the long term to reduce not only the overall incidence of hepatitis B but also chronic complications such as chronic active hepatitis and cirrhosis. It may also decrease the incidence of primary hepatocellular carcinoma.

Contra-Indications:
Hypersensitivity to any component of the vaccine. As for any vaccine ‘Engerix-B’ should not be administered to subjects with severe febrile infections. However, the presence of a trivial infection does not contra-indicate vaccination.

Warnings:
Because of the long incubation period of hepatitis B it is possible for unrecognised infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B in such cases.

‘Engerix-B’should not be administered in the gluteal region or intradermally since these routes of administration may not result in an optimum immune response. The vaccine should never be administered intravenously.

In dialysis patients and subjects who have an impairment of the immune system, adequate antibody concentrations may not be obtained after the usual primary vaccination course and such patients may therefore require repeated administration of the vaccine.

DOSAGE AND DIRECTIONS FOR USE:
Adults and older children:
A dose of 20 µg of antigen protein in 1 mL suspension is recommended for adults and children over 10 years of age.

Neonates, infants and younger children:
A dose of 10 µg of antigen protein in 0,5 mL suspension is recommended for neonates, infants and children below 10 years of age.

‘Engerix-B’should be injected intramuscularly. In adults the injection should be given in the deltoid region but it may be preferable to inject ‘Engerix-B’in the anterolateral thigh in neonates and infants because of the small size of their deltoid muscle. Exceptionally the vaccine may be administered subcutaneously in patients with severe bleeding tendencies (e.g. haemophiliacs). The vaccine should be well shaken before use. IT MUST NOT BE GIVEN INTRAVENOUSLY.
Primary vaccination consists of three intramuscular doses of vaccine.

	1st dose:	at elected date
	2nd dose:	1 month later
	3rd dose:	6 months from the date of the first dose.

This primary course of vaccination will provide protection for several years.

In circumstances where more rapid protection is required (e.g. contacts of carriers, immunization of travellers and newborns of carrier women) a vaccination schedule of 0,1 and 2 months may be adopted Since the peak antibody levels reached after this shorter schedule of primary vaccination are lower, it is recommended that a fourth dose (booster) be given at 12 months after the first dose of vaccine. In the case of the 0,1 and 6 months primary vaccination schedule a booster dose will be required only after a few years.

In circumstances where exposure to hepatitis B virus has recently occurred (e.g. needlestick with contaminated needle) or will almost certainly occur in the near future (eg. neonates born of HBeAg positive women) ‘Engerix-B’ may be administered simultaneously with hepatitis B immunoglobulin which however must be given at a separate injection site.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly reported local reactions are soreness, erythema and swelling at the injection site as seen with all adsorbed vaccines. These reactions are mild and usually subside within two days after vaccination. Uncommon systemic complaints such as fever, headache, nausea, dizziness and fatigue have been observed in some vaccinees but the casual relationship with the vaccine has not been established.

Precautions:
The effect of the antigen on foetal development is unknown and therefore general vaccination of pregnant women cannot be recommended. However, vaccination of a pregnant woman maybe considered in order to prevent hepatitis B in high-risk situations.

As with all biologicals, a solution of 1 in 1 000 adrenaline should always be readily available for immediate use in case of a rare anaphylactic reaction.

KNOWN SYMPTOM OF OVERDOSAGE AND PARTICULARS OF TREATMENT:

PRESENTATION:

‘Engerix-B’	:	Pack of one monodose vial.
‘Engerix-B Paediatric’	:	Pack of one monodose vial.

STORAGE DIRECTIONS:
The vaccine should be shipped under refrigeration and stored at 2°C to 8°C.
DO NOT FREEZE.
The expiry date is shown on the label.
KEEP OUT OF REACH OF CHILDREN.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street, Wynberg Ext. 6,
Johannesburg 2090.

Manufactured by Smith Kline Beecham, Biologicals
Rixensart, Belgium.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19.08.1988

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