(and dosage form):
DESCRIPTIVE NAME OF MEDICINE:
Live attenuated measles vaccine (Schwarz strain) for injection.
Rimevaxis a lyophilized preparation of the highly attenuated Schwarz strain of measles virus, obtained by propagation of the virus in chick embryo tissue cultures. Each 0,5 mL dose of the reconstituted vaccine contains not less than 1 000 TCID50 of the Schwarz strain measles virus and not more than 25 µg of neomycin B sulphate.
Rimevaxis presented as a pink pellet in a glass vial together with a separate container of clear, colourless, sterile diluent. Due to minor variation of its pH, the reconstituted vaccine may vary in colour from light orange to light red without signifying deterioration of the product.
PHARMACOLOGICAL ACTION OF THE MEDICINE:
The administration of live further attenuated measles vaccine to susceptible persons results in an attenuated measles infection which confers a durable immunity against measles.
Rimevaxis indicated for the active immunization of children and susceptible adults against measles. As a result of the possible persistence of low levels of maternal antibodies up to the age of 15 months, some children below that age are not susceptible to the vaccine. The optimal age for vaccination is therefore 15 months.
However in geographical areas and in populations in which measles commonly occur under that age, the advantage of protection at an earlier age may outweigh the risk of vaccine failure. Under these circumstances, Rimevax can be administered to children from nine months of age onwards. Exceptionally, the vaccine may be administered from the age of six months. Due to the low rate of seroconversion at this age, children must be re-immunised three to six months later. Children vaccinated before the age of 9 months must be revaccinated three to six months later.
However, there is no need to routinely revaccinate children who were first vaccinated when nine months of age or older since an adequate seroconversion rate, particularly in developing countries, can be obtained at nine months of age.
Some protection may be obtained by vaccination up to 72 hours after exposure to natural measles. Vaccination a few days before exposure will provide substantial protection.
Rimevax should not be administered to subjects with severe acute respiratory or other febrile infections including active untreated tuberculosis and to subjects who, due to a history of exposure, could be in the incubation period of an infection, other than measles, to which they are known or suspected to be susceptible. However, the presence of a trivial infection does not contra-indicate vaccination.
Rimevax is contra-indicated in subjects with known systemic hypersensitivity to neomycin but a history of contact dermatitis to neomycin is not a contra-indication. Although vaccines produced on chick embryo tissue cultures have been shown not to contain egg proteins in significant amounts it is advisable not to administer Rimevaxto subjects with proven hypersensitivity to egg products.
Rimevaxshould not be given to subjects with impaired immune responses. These include patients with primary or secondary immune deficiencies. Primary immune deficiency states include hereditary cellular immune deficiencies, hypogammaglobulinaemias and dysgammaglobulinaemias. Diseases that may be accompanied by immune suppression include blood dyscrasias, leukaemia, all types of lymphoma, generalised malignancy and malignant neoplasms affecting the bone marrow or lymphatic system. Immunosuppression may also result from treatment with ACTH, corticosteroids, alkylating drugs and antimetabolites, or irradiation.
On general theoretical grounds, it is contra-indicated to administer a live virus like Rimevax to pregnant women since the effect of the Schwarz measles virus on foetal development is as yet unknown. For the same reason, pregnancy should be avoided for three months after vaccination.
DOSAGE AND DIRECTIONS FOR USE:
Rimevaxshould be reconstituted by transferring the entire contents of the container of diluent supplied to the corresponding vaccine vial. The vaccine pellet should be completely dissolved in the diluent. The entire contents of a reconstituted monodose vial or 0,5 mL of reconstituted vaccine from a multidose vial should be injected subcutaneously or intramuscularly with a sterile syringe and needle or a suitable jet indicator. Do not inject intravenously.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Rimevaxproduces a modified attenuated non-communicable measles infection in susceptible subjects.
A rise of temperature (rarely above 39,5°C) may occur after administration of further attenuated live measles virus vaccines. Children with fever may on rare occasions, exhibit febrile convulsions. Generally fever, whether accompanied by rash or not; appears between the 5th and the 12th day after vaccination. The rash is usually minimal and without generalised distribution. Other manifestations of infection with the vaccine virus include malaise, cough, coryza and headache. Thrombocytopenic purpura occurs very rarely.
Reactions at the site of injection of live measles virus vaccines are rare and usually mild.
Encephalitis and encephalopathy have been observed to occur after the administration of live measles vaccine approximately once every million doses.
Rimevaxis for subcutaneous or intramuscular use only; do not administer intravenously.
Rimevaxshould be given with caution to persons with a history or family history of allergic diseases or those with a history or family history of convulsions. As with all biologicals, a solution of 1 in 1 000 adrenaline should always be readily available for immediate injection in case of rare anaphylactic reactions. For this reason, the vaccinee should remain within easy reach for 30 minutes after vaccination.
Vaccination of children with a history of convulsions should preferably not be carried out until the age of 24 months. If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that live measles vaccine may cause a temporary depression of tuberculin skin sensitivity. This anergy may last for two months and tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
Rimevax can be administered at the same time as the injectable trivalent diphtheria, tetanus and pertussis vaccine. It can also be administered simultaneously with oral polio vaccine and injectable mumps and rubella vaccines. Otherwise there should be an interval of at least one month between the administration of two different live vaccines.
In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired measles antibodies.
The vaccine virus is quickly inactivated by ether, alcohol and detergents and care should be taken to avoid contact with these substances.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
Rimevaxis available in monodose vials each with a separate ampoule sterile diluent or in 5 and 10 dose vials, each with corresponding sterile diluent containers.
The lyophilized vaccine should be stored in a refrigerator between + 2°C and + 8°C. The diluent can be stored at ambient temperatures. When distribution or administration is not imminent, it is advisable to store the vaccine if possible at temperatures of - 20°C or less since this halts deterioration in vaccine potency. Because freezing may damage pre-filled syringes these should not be frozen. After reconstitution, the vaccine should be injected promptly or kept in a refrigerator. If it is not used within eight hours, it should be discarded. It is recommended to protect the reconstituted vaccine from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street,
Wynberg Ext. 6,
DATE OF PUBLICATION OF PACKAGE INSERT:
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