Vaccines and Immunological Agents
= Additional active ingredients
Lyophilized prep. of live attenuated oka strain of varicella-zoster virus. Reconstitut. vac. cont. not less than 103.3 pl-form-units (PFU) varicella-zoster virus.
VARICELLA ZOSTER VIRUS VACCINES
PRESENTATION AND DOSSAGE
VIAL: 1 X 0.5 ML
Active immunization against varicella in healthy patients only from 12 months of age.
Hypersensitivity, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms, individuals receiving immunosuppressive therapy, primary and acquired immunodeficiency states, history or congenital or hereditary immunodeficiency.
As with other vaccines, the administration should be postponed in subjects suffering from acute severe febrile illness. In healthy subjects the presence of a minor infection, however, is not a contra-indication for vaccination. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. As for other varicella vaccines, cases of varicella disease have been shown to occur in persons who have previously received Varilrix. These breakthrough cases are usually mild, with a fewer number of lesions and less fever and cough with respect to cases in unvaccinated individuals. Transmission of the Oka vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees. However, transmission has not been confirmed to occur in the absence of vaccine-associated cutaneous lesions in the vaccinee. The mild nature of the rash in the healthy contacts indicates that the virus remains attenuated after passage through human hosts. This product should not be administered intradermally. It must under no circumstances be administered intravenously. Vaccination should be deferred in patients with a family history of congenital or hereditary immunodeficiency, until the patient’s own immune system has been evaluated. A separate sterile needle and syringe should be used for administration of each dose to prevent transfer of infectious diseases. Needles should be disposed of properly and should not be recapped. For full details see prescribing information.
General disorders and administration site conditions: Very common: pain, redness Common: swelling at the injection site*, fever (oral/axillary temperature 37.5°C or rectal temperature 38.0°C)*
Skin and subcutaneous tissue disorders: Common: rash
Swelling at the injection site and fever were reported very commonly in studies conducted in adolescents and adults. Swelling was also reported very commonly after the second dose in children under 13 years of age. On average, the reactogenicity after the second dose was not higher than after the first dose. No differences were seen in the reactogenicity profile between initially seropositive and initially seronegative subjects.
High-risk patients: There are only very limited data from clinical trials available in patients at high risk of severe varicella. However, vaccine-associated reactions (principally papulo-vesicular eruptions and fever) are usually mild. As in healthy subjects, redness, swelling and pain at the site of injection are mild and transient.
In subjects who have received immune globulins or a blood transfusion, vaccination should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired varicella antibodies.
Salicylates should be avoided for 6 weeks after varicella vaccination as Reye’s Syndrome has been reported following the use of salicylates during natural varicella infection.
Healthy subjects: This product can be administered at the same time as any other vaccine. Different injectable vaccines should always be administered at different injection sites. Should a measles containing vaccine not be given at the same time, it is recommended that an interval of at least one month should be respected since it is recognized that measles vaccination may lead to short lived suppression of the cell mediated immune response.
High-risk patients: This product should not be administered at the same time as other live attenuated vaccines. Inactivated vaccines may be administered in any temporal relationship to this product, given that no specific contra-indication has been established. However, different injectable vaccines should always be administered at different injection sites.
Children 12 months up to and including 12 years of age: Children from the age of 12 months up to and including 12 years of age should receive 2 doses of Varilrix to ensure optimal protection against varicella.
It is preferable to administer the second dose at least 6 weeks after the first dose but in no circumstances less than 4 weeks.
Adolescents and adults from 13 years of age and above: From 13 years of age and above: 2 doses. It is preferable to administer the second dose at least 6 weeks after the first dose but in no circumstances less than 4 weeks.
High risk patients
In high-risk patients additional doses of vaccine might be required.
A single dose of Varilrix may be administered to those who have already received a single dose of another varicella-containing vaccine.
A single dose of Varilrix may be administered followed by a single dose of another varicellacontaining vaccine.
Cases of accidental administration of more than the recommended dose of Varilrix have been reported. Amongst these cases, the following adverse events were reported: lethargy and convulsions. In the other cases reported as overdose there were no associated adverse events.
PREGNANCY & LACTATION
Pregnancy: It is contra-indicated to administer VARILRIX to pregnant women, because the possible effects on foetal development are unknown. Furthermore, pregnancy should be avoided for three months after vaccination.
Lactation: There are no data regarding use in breastfeeding women.
MANUFACTURER & DISTRIBUTER:
License Holder: GlaxoSmithKline Israel Ltd.