INFORMATION FOR HEALTH PROFESSIONALS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
RIMEVAX is a lyophilised preparation of the highly attenuated Schwarz strain of measles virus, obtained by propagation of the virus in chick embryo tissue cultures.
RIMEVAX meets the World Health Organisation requirements for biological substances and for measles vaccines.
Each 0.5 ml dose of the reconstituted vaccine contains not less than 1,000 TCID50 of the Schwarz measles virus strains and not more than 25mcg of neomycin B sulphate.
RIMEVAX is indicated for the active immunisation against measles of children and susceptible adults.
The optimal age for vaccination is 15 months or older. Children below that age may not respond sufficiently to the measles component of the vaccine, due to the possible persistence of low levels of maternal measles antibodies.
This should not preclude the use of the vaccine in younger children since vaccination may be indicated in some situations. In these circumstances revaccination at or after 15 months of age should be considered.
If the aim of vaccination is to interrupt the transmission of measles in a community, RIMEVAX should be given to all children at the age of 15 months or older.
RIMEVAX is specially recommended for children living in communities such as residential schools, orphanages and similar institutions. It is also recommended for children with diseases such as mucoviscidosis, asthma and other chronic pulmonary diseases, including inactive tuberculosis or active tuberculosis under treatment, as well as chronic heart diseases in order to minimise the risk of possible serious complications of natural measles in such conditions.
Subjects who have received an inactivated measles vaccine should be revaccinated with a live vaccine in order to avoid the severe atypical form of natural measles that may occur in such individuals. In such subjects the risk of an enhanced local reaction is increased.
The recommended dose of the vaccine must be administered.
A single dose of 0.5ml of RIMEVAX - the same dose is used for both children and adults - will confer long-lasting immunity against measles to almost every susceptible subject.
As vaccination schemes vary from country to country, the advised schedule for each country must be in accordance with the national recommendations.
RIMEVAX is for subcutaneous use only.
RIMEVAX should under no circumstances be administered intravenously.
As with other vaccines, the administration of RIMEVAX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for vaccination.
RIMEVAX is contraindicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine, but a history of contact dermatitis to neomycin is not a contraindication.
Vaccines produced in chick embryo tissue cultures have been shown not to contain egg proteins in sufficient amounts to elicit hypersensitivity reactions. Persons having egg allergies, that are not anaphylactic in nature, can be considered for vaccination.
RIMEVAX should not be given to subjects with impaired immune responses. These include patients with primary or secondary immune deficiencies.
However, RIMEVAX can be given to asymptomatic HIV-infected persons without adverse consequences to their illness and may be considered for those who are symptomatic.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
Limited 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.
As with all injectable vaccines, appropriate medication (eg adrenaline) should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.
RIMEVAX should 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.
Vaccination of children with a history of convulsions should preferably not be carried out until the age of 24 months.
RIMEVAX should under no circumstances be administered intravenously.
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 oral polio vaccine, the injectable trivalent diphtheria, tetanus and pertussis vaccine and the injectable mumps and rubella vaccine, if this fits conveniently in an vaccination schedule. Otherwise there should be an interval of at least one month between the administration of two different live attenuated virus vaccines.
Different injectable vaccines should always be administered at different injection sites. 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.
It is contraindicated to administer RIMEVAX to pregnant women. Furthermore, pregnancy should be avoided for three months after vaccination.
There is no human data regarding use in nursing women. Persons can be vaccinated where the benefit outweighs the risk.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
RIMEVAX produces a modified attenuated measles infection in susceptible subjects.
During clinical studies a number of undesirable effects have been recorded. Reactions at the site of injection, when present, are usually mild and of short duration. However, local reactions characterised by marked swelling, redness and vesiculation may occur in subjects who had previously received inactivated measles vaccine.
Fever is not uncommon after administration of attenuated measles virus vaccines; temperature elevations above 39.5°C are rare. In general, fever, whether accompanied by rash or not, appears between the 5th and the 12th day after vaccination. On very rare occasions the vaccinee may develop a febrile convulsion. Rash, when it occurs, is usually mild and without generalised distribution. Other systemic manifestations associated with the vaccine viruses include malaise, vomiting, cough, coryza and headache.
During post-marketing surveillance, cases of neurological disease, such as encephalitis and encephalopathy have been rarely reported. Cases of Guillain-Barré syndrome, hemiplegia, and retrobulbar neuritis have also been very rarely reported. The risk of these neurological diseases following live measles virus vaccine administration remains far less than after natural disease. Reports of pruritus, petechial/purpuric rash, and allergic reactions (local or general) including anaphylactoid reactions, have been rare. The association of idiopathic thrombocytopenic purpura with measles vaccination has been rarely reported.
Based on estimated nationwide measles vaccine distribution in the U.S. the association of subacute sclerosing panencephalitis (SSPE) cases to measles vaccination is about one case per million vaccine doses distributed. This is less than the frequency of the association with natural measles estimated to be 5-10 per million cases of measles.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
RIMEVAX induces an active immune response against the measles viruses.
Administration of a single 0.5ml dose of RIMEVAX elicits a significant immune response in approximately 95% of subjects.
Althought the duration of the vaccine-induced immunity against measles is still undetermined, it is probably life-long.
RIMEVAX should not be mixed with other vaccines.
The lyophilised vaccine should be stored in a refrigerator between +2°C and +8°C. The diluent can be stored at ambient temperature.
When supplies of RIMEVAX are distributed from a central cold-store, it is good practice to arrange transport under refrigerated conditions, particularly in hot climates.
If the lyophilised vaccine has been accidentally exposed to high temperatures not exceeding the time and temperature limits indicated below, the expiry date no longer applies: it should preferably either be used immediately or stored at -20°C.
If it is thought that the thermal stability limits have been exceeded, the lyophilised vaccine should be discarded or, if economically justified, be retested for potency before use.
Additional information on the stability
The following experimental data give an indication of the stability of the vaccine and are not recommendations for storage (see under special precautions for storage).
Virus titers per dose of 1,000 TCID50 are maintained for at least ten weeks when stored at room temperature (+20°C to +25°C), for more than five weeks at +37°C and about seven days at +45°C.
After reconstitution, the vaccine maintains its minimum required potency for more than 24 hours at +2°C - +8°C, for three to six hours at +37°C, and for one to two hours at +45°C.
RIMEVAX is presented as a pink pellet in a glass vial. The sterile diluent is clear and colourless and presented in a glass prefilled syringe or ampoule. 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.
The expiry date of the vaccine is indicated on the label and packaging.
When stored under the prescribed conditions of temperature between +2°C and
+8°C, the shelf life is two years.
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 because of the risk of contamination. It is recommended to protect the reconstituted vaccine from direct sunlight.
The vaccine should be inspected visually for any foreign particulate matter and/or other colouration prior to administration. In the event of either being observed, discard the vaccine.
RIMEVAX must be reconstituted by adding the entire contents of the supplied container of diluent to the vaccine vial. The vaccine pellet should be completely dissolved in the diluent.
Prescription Medicine
RIMEVAX is available in monodose vials with corresponding sterile diluent containers.
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
ph (09) 367 2900
fax (09) 367 2506
23 October 2002
Ref: MDS Version 2 (Date of approval 12/01/99)