INFORMATION FOR HEALTH PROFESSIONALS
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ERVEVAX is a lyophilised preparation of the highly attenuated RA 27/3 strain of rubella virus, obtained by propagation of the virus in MRC5 human diploid cells.
ERVEVAX meets the World Health Organisation (WHO) requirements for biological substances and for rubella vaccines.
Each 0.5 ml dose of the reconstituted vaccine contains not less than 1,000 TCID50 of the RA 27/3 rubella virus strain and not more than 25mcg of neomycin sulphate.
ERVEVAX is indicated for the active immunisation of subjects against rubella virus infection from the age of 12 months onwards.
If the aim of immunisation is to protect women on an individual basis ERVEVAX should ideally be given to prepubertal girls. Susceptible females of childbearing age should also be considered for immunisation if they are not pregnant and agree to prevent pregnancy for three months following immunisation. The immediate postpartum period is also a suitable time for immunisation of such subjects.
If the aim is to interrupt the transmission of the rubella virus, ERVEVAX should ideally be given to both males and females at the age of 12 months or older. Immunisation before that age may fail due to the possible persistence of maternal rubella antibodies.
It is specially recommended to immunise children in kindergarten and primary schools because they are commonly the major source of virus dissemination in the community.
If practical, rubella serological testing may be undertaken before immunisation to determine rubella antibody titer. Should the test be positive, immunisation is not necessary.
The recommended dose of the vaccine must be administered.
A single dose of ERVEVAX - the same dose is used for both children and adults - will confer long-lasting immunity against rubella to almost every susceptible subject.
ERVEVAX is for subcutaneous administration only.
As with other vaccines, the administration of ERVEVAX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor illness, however, is not a contraindication for immunisation.
ERVEVAX 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.
ERVEVAX should not be given to subjects with impaired immune responses. These include patients with primary or secondary immunodeficiencies.
However, ERVEVAX 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.
Some protection may be obtained by immunisation up to 24 hours after exposure to natural rubella. Immunisation a few days before exposure will provide substantial protection.
As with all injectable vaccines, appropriate medication (eg adrenaline) should be readily available for treatment in case of rare anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunisation.
ERVEVAX should under no circumstances be administered intravenously.
ERVEVAX can be administered at the same time as the oral polio vaccine, the injectable trivalent diphtheria, tetanus and pertussis vaccine, mumps and measles vaccine, if this fits conveniently in an immunisation schedule. Otherwise, there should be an interval of at least one month between the administration of two different live virus vaccines. Different injectable vaccines should always be administered at different injection sites.
In subjects who have received human gammaglobulins or a blood transfusion, immunisation should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired rubella antibodies. If immunisation is performed prior to the three months delay, it is advisable to test the seroconversion about three months after immunisation.
It is contraindicated to administer ERVEVAX to pregnant women. Furthermore, pregnancy should be avoided for three months after immunisation.
Termination of pregnancy should not be recommended when inadvertent immunisation of pregnant women with ERVEVAX has been performed. The ultimate decision rests with the individual patient and her physician.
There is no human data regarding use in nursing women. Persons can be immunised where the benefit outweighs the risk.
Not applicable.
ERVEVAX produces a modified attenuated non-communicable rubella infection in susceptible subjects.
Reactions at the site of injection are usually mild and of short duration.
Systemic undesirable experiences following rubella vaccination may in rare cases resemble symptoms of natural rubella: swelling of lymph nodes, rash, fever and transient arthralgia and arthritis with or without joint effusion.
In extremely rare cases a transient polyneuropathy and idiopathic thrombocytopenic purpura have been reported.
In children, joint reaction are generally mild and of brief duration; symptoms limiting physical activity occur in less than 1% of vaccinees. In women, incidence rates are generally higher than those seen in children and the reactions tend to be more marked and of longer duration.
Very rarely, allergic reactions, including anaphylactoid reactions, have been reported.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
ERVEVAX induces an active immune response against the rubella virus in 98-99% of vaccinees.
Subjects vaccinated with the RA 27/3 strain have been monitored serologically for up to 16 years and shown to retain satisfactory antibody titers over this period.
ERVEVAX should not be mixed with other vaccines.
The lyophilised vaccine should be stored in a refrigerator between +2°C and +8°C, or in a freezer. The diluent can be stored at ambient temperatures.
When supplies of ERVEVAX™ are distributed from a central coldstore, 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 vaccine should be discarded or, if economically justified, be retested for potency before use.
The following experimental data give an indication of the stability of the vaccine and are not recommendations for storage (see special precautions for storage).
ERVEVAX™ can be kept for ten weeks when stored at room temperature (+20°C to +25°C), for four weeks at +37°C and for seven days at +45°C.
After reconstitution, the vaccine maintains its minimum required potency for at least 24 hours at +2°C - +8°C.
The expiry date of the vaccine is indicated on the label and packaging.
When stored under prescribed conditions of temperatures 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.
ERVEVAX 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 vaccine should be inspected visually for any foreign particulate matter and/or colouration prior to administration. In the event of either being observed, discard the vaccine.
ERVEVAX 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.
ERVEVAX 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 13/01/99)