Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

General recommendations

As with other vaccines, the administration of Havrix should be postponed in individuals suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination.

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 are in place to avoid injury from faints.

Havrix will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver.


Individuals may be in the incubation period of a hepatitis A infection at the time of vaccination. It is not known whether Havrix will prevent hepatitis A in such cases.

As with any vaccine, a protective immune response may not be elicited in all vaccinees.

The immune response to Havrix could be impaired in immunocompromised individuals. Those individuals always require administration of a 2-dose vaccination schedule.

Havrix should be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to them. Exceptionally and if in accordance with official recommendations, the vaccine may be administered subcutaneously to these individuals. However, this route of administration may lead to suboptimal anti-HAV antibody response.
With both routes of administration, firm pressure should be applied to the injection site (without rubbing) for at least two minutes post injection.

Excipients

Havrix 720 Junior contains 83 micrograms phenylalanine in each dose.
Havrix 1440 Adult contains 166 micrograms phenylalanine in each dose.
Phenylalanine may be harmful for individuals with phenylketonuria (PKU).
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially “potassium- free”.

Effects on Driving

4.7    Effects on ability to drive and use machines

Havrix has no or negligible influence on the ability to drive and use machines.