Ixiaro Special Precautions

vaccine, japanese encephalitis




Full Prescribing Info
Special Precautions
As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine.
Under no circumstances should IXIARO be administered intravascularly.
As with any other vaccine, vaccination with IXIARO may not result in protection in all cases. IXIARO will not protect against encephalitis caused by other microorganisms.
Like other intramuscular injections, this vaccine should not be administered intramuscularly to persons with thrombocytopenia, haemophilia or other bleeding disorders (see Dosage & Administration).
In adults, a seroconversion rate of 29.4% has been observed 10 days after the first vaccination, and 97.3% one week after the second vaccination. Hence, primary immunization should be completed at least one week prior to potential exposure to Japanese encephalitis virus.
Protection against Japanese encephalitis is not ensured until the second dose has been received.
Effects on the ability to drive or use machines: Ixiaro has no or negligible influence on the ability to drive and use machines.
Pregnancy: There are limited amount of data from the use of IXIARO in pregnant women.
In animal studies findings of unclear clinical relevance have been identified (see Pharmacology: Toxicology under Actions).
As a precautionary measure, the use of IXIARO during pregnancy should be avoided.
Breast-feeding: It is unknown whether IXIARO is excreted in human milk.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to IXIARO is negligible. However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided.
Fertility: A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.
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