MR

Eolarix

Measles, Rubella Vaccine, Live attenuated

Presentation

‘Eolarix’ is a mixed preparation of the highly attenuated live measles virus (Schwarz strain) prepared in chick embryo tissue, and rubella virus (RA27/3 strain) prepared in human diploid cell culture, presented as a pink pellet in a glass vial with a separate container of clear colour less sterile diluent, (Water for Injections PhEur). Each 0.5 ml dose of the reconstituted vaccine contains not less than 1000 TCID50 of the Schwarz and 1000 TCID5O of the RA27/3 rubella virus strains and not more than 25 micrograms (17 IU) of neomycin sulphate.

 

Eolarix is indicated for active immunisation of children and susceptible adults against measles and rubella.

Dosage and administration

Adults and Children: 0.5 ml of the reconstituted vaccine given by deep subcutaneous or intra muscular injection. Do not give intravenously. The vaccine should be reconstituted using the sterile diluent provided. Due to minor variations in pH. the colour of the reconstituted vaccine may vary from light orange to light red.

In children of under 12 months, persisting maternal measles antibodies may interfere with immune response. However, in situations where severe measles is common in children under this age, the benefit of vaccination at, for example, nine months may outweigh the risk of vaccine failure.

Vaccination up to 72 hours after exposure to natural measles may offer some protection, but no protection against rubella can be expected if vaccination is carried out more than 24 hours after exposure to natural rubella. Vaccination a few days before exposure to these diseases will provide substantial protection.

The vaccine is quickly inactivated by ether, alcohol or detergents and care should be taken to avoid contact with these substances when cleaning skin prior to vaccination.

Contra-indications

Never give to pregnant women, or women of child-bearing age not fully aware of the need to avoid pregnancy for one month after vaccination, since theoretically the vaccine virus could have an effect on the foetus.

Do not use Eolarix in the presence of acute febrile illness, whether active or expected, following exposure to infection other than measles or rubella. This applies particularly to active tuberculosis and respiratory tract infection. A minor infection is not a contra-indication. Eolarix’ should not be given to subjects with impaired immune responses. These include patients with primary and secondary immunodeficiencies. However, ‘Eolarix’ can be given to asymptomatic HIV-infected persons without adverse consequences to their illness and may be considered for those who are symptomatic.

‘Eolarix is contra-indicated in subjects with known systemic hypersensivity to neomycin but a history of contact dermatitis to neomycin is not a contra-indication.

Precautions

Transmission of vaccine virus to susceptible contacts, whilst accepted as a theoretical possibility, has not been regarded as a significant risk.

‘Eolarix may contain traces of chick embryo protein but this does not normally contra-indicate its use except in cases of severe hypersensitivity to eggs (past anaphylactoid reactions to egg ingestion). A solution of 1:1000 adrenaline should be available for injection in rare cases of anaphylactic reaction.

As with all injectable vaccines, appropriate medical treatment should always be readily avail able in cases of rare anaphylactic reactions following the administration of the vaccine. For this reason the vaccinee should remain under medical supervision for a short time after immunisation.

Since pyrexia may occur five to 10 days after vaccination, parents, especially of children with a personal or close family history of febrile convulsions, should be given advice about reducing fever. For example should the child appear unwell and develop a temperature, measures such as removal of clothing, tepid sponging and administration of paracetamol may be indicated. Vaccination of children with a history of convulsions may be delayed until the age of two years. Because of the possibility of interference from passive antibodies, the vaccine should not normally be given to subjects who have received blood or human plasma transfusions or human immunoglobulin within the previous three months. If the vaccine is given in these circumstances, serum antibodies should be checked at a later date.

Tuberculin testing may be carried out before or at the same time as vaccination with ‘Eolarix’. It should otherwise be delayed for about eight weeks after vaccination since false-negative results may be obtained during this period.

At least three weeks should normally intervene between the administration of any two live vaccine preparations. ‘Eolarix’ can however be given simultaneously with live oral poliomyelitis vaccine and with DTP vaccine, but at a different site.

Adverse reactions

‘Eolarix’ produces modified non-communicable attenuated measles and rubella infections in susceptible subjects. The side effects are usually mild and similar in incidence to those seen after separate administration of the respective monovalent vaccines.

Side effects are usually delayed for several days and may include rash, mild irritability, malaise, cough. pharyngitis, coryza, pyrexia, headache and lymphadenopathy. In a very few subjects convulsions may accompany the fever. Rarely, transient erthralgia and arthritis with or without effusion may occur. Immediate allergic-type reactions have been reported rarely.

Rarely, transient polyneuropathy, encephalitis or thrombocytopenic purpura could occur. Reactions at the site of injection are rare and usually mild.

There have been very rare reports of both Guillain-Barre syndrome, hemiplegia and retrobulbar neuritis. There have been isolated reports of subacute sclerosing panencephalitis (SSPE). The reported rate is less than the frequency associated with natural measles.

Pharmaceutical precautions

Protect from light ‘Eolarix Vaccine should be stored between 2 and 8C, its shelf-life then being two years and should not be frozen, (lower temperatures will not harm the vaccine but may damage the diluent container). The vaccine should be reconstituted using the sterile diluent provided and the pellet should be completely dissolved. Once reconstituted, ‘Eolarix’ be used immediately and certainly within one hour.

In clinical studies ‘Eolarix’ has produced seroconversion rates approaching 100% at measles and rubella. Similar seroconversion rates were obtained with the monovalent vaccines indicating that there is no interference between the two viruses at the doses used in ‘Eolarix’. Although the duration of immunity against measles and rubella is not known it is probably life-long.

Inactive ingredients are human albumin, lactose, sorbitol, dextran 10, arginine, amino acids for injection and also necinycin sulphate (see Presentation)

Product licence holder

SmithKline Beecham plc, Brentford, England

Any queries should be addressed to the Medical Information Department at the address below.

 SmithKline Beecham Pharmaceuticals, Welwyn Garden City, Hertfordshire AL7 1EY

Telephone: Welwyn Garden (0107) 325111

Date of preparation: November 1993

‘Eolarix is a trade mark

Monodose is a trade mark

1994 SmithKline Beecham Pharmaceuticals

Manufactured by SmithKline Beecham Biologicals s.a., Rixensart, Belgium

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