Imojev

Imojev Special Precautions

vaccine, japanese encephalitis

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Special Precautions
Before the injection of any biological, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine.
In individuals who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, the course of the vaccination must be carefully considered.
IMOJEV should under no circumstances be administered intravascularly.
Protection: As with any vaccine, vaccination with IMOJEV may not protect 100% of vaccinated individuals.
Special patient groups: For patients following a treatment with high doses of systemic corticosteroids given for 14 days or more, it is advisable to wait for at least one month or more following the interruption of therapy before carrying out the vaccination until immune function has recovered.
Effects on Fertility: A reproductive and developmental toxicity study in which female rabbits were subcutaneously administered the human dose of IMOJEV twice prior to mating showed no effects on female mating or fertility. No fertility data are available in humans.
Use in Pregnancy: (Category B2): Developmental toxicity studies in which female rabbits were subcutaneously administered the human dose of IMOJEV twice prior to mating and three times during gestation, or once between gestation days 6 to 18, or once on postnatal day 15, showed no adverse effects on pregnancy, embryo-fetal development, parturition or postnatal development. Vaccine antigen-specific antibodies were transferred to fetuses.
As with all live attenuated vaccines, pregnancy constitutes a contraindication (see Contraindications).
There is a theoretical risk that a live vaccine virus can cross the placenta and infect the fetus. It is not known whether IMOJEV can cause fetal harm when administered to a pregnant woman.
Women of childbearing age should be advised not to become pregnant for 4 weeks after vaccination.
Use in Lactation: A developmental toxicity study in which female rabbits were subcutaneously administered the human dose of IMOJEV once between gestation days 6 to 18, or once on postnatal day 15, showed no effects on pup survival, growth and development.
It is not known whether this vaccine is excreted in human milk.
IMOJEV vaccination is contraindicated in breastfeeding women (see Contraindications).
Studies with some other live, attenuated virus vaccines have shown that a lactating postpartum woman may secrete the virus in breast milk and infect a breast-fed infant.
Paediatric Use: IMOJEV is not recommended in children below the age of 9 months.
Use in the Elderly: In clinical trials, the seroconversion rates and the safety profiles were similar in elderly and adults after the administration of one dose of IMOJEV.
Genotoxicity: IMOJEV has not been tested for genotoxic potential.
Carcinogenicity: IMOJEV has not been tested for carcinogenic potential.
Effect on Laboratory Tests: Interference of IMOJEV with laboratory and/or diagnostic tests has not been studied.
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