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As with all injectable vaccines, appropriate medical treatment, and in particular adrenaline, should be available for immediate management of any anaphylactic or hypersensitivity reactions occurring after vaccine administration.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures be in place to avoid any injury from faints.
Immunogenicity of the vaccine could be impaired by immunosuppressive treatment or in immunodeficient subjects. It is recommended to delay vaccination until the completionof any immunosuppressive treatment. Subjects with chronic immunodeficiency such as HIV infection may be vaccinated if the underlying immunodeficiency allows the induction of an antibody response, even if limited.
Because of the incubation period of hepatitis A, infection may be present but not clinically apparent at the time of vaccination. It is not known whether VIVAXIM will prevent hepatitis A in this case.
VIVAXIM does not protect against infections caused by other liver pathogens such as hepatitis B, hepatitis C or hepatitis E viruses.
ViVAXIM does not protect against infection by Salmonella enterica other than serotype typhi.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
ViVAXIM contains phenylalanine, ethanol, potassium and sodium: ViVAXIM contains 10 microgram phenylalanine in each 1 mL dose which is equivalent to 0.17 microgram/kg for a 60 kg person. Phenylalanine may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
ViVAXIM contains 2 mg of alcohol (ethanol) in each 1 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.
ViVAXIM contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'potassium-free' and 'sodium-free'.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Take special care with VIVAXIM: To make sure that the vaccine is not administered by the intravascular route (the needle must not penetrate a blood vessel).
Not to inject VIVAXIM in the buttock as this may induce a smaller immune response (because of the variable amount of fat tissue in this region of the body).
If the patient is receiving a treatment that lowers immune deficiency or if the patient presents deficient immune defences the immune response to the vaccine may be reduced.
If the patient suffers from blood clotting disorders; VIVAXIM must be injected subcutaneously.
If the patient may soon be exposed to hepatitis A or typhoid fever, care must be taken as protection conferred by VIVAXIM only appears 14 days after vaccination.
Fainting can occur (especially in adolescents) following, or even before, any vaccination as a psychogenic response to the needle injection. Therefore tell the doctor or nurse if the children fainted with a previous injection.
EFFECT ON ABILITY TO DRIVE AND USE MACHINES: VIVAXIM has a minor influence on the ability to drive and use machines. Dizziness have been observed as an uncommon reaction (≥1/1000, <1/100) following administration of this vaccine (see Adverse Reactions).
