Special Warning : אזהרת שימוש

4.4.   Special warnings and precautions for use

As with all vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of rare anaphylactic reaction following vaccination. AVAXIM 160 U should only be given by a physician or health care worker trained in the administration of vaccines.
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.
AVAXIM 160 U has not been studied in patients with impaired immunity. The immune response to AVAXIM 160 U could be impaired by immunosuppressive treatment or in immunodeficiency states. In such cases, it is recommended to measure the antibody response to be sure of protection and, if possible, to wait for the end of any suppressive treatment before vaccination. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended although the antibody response may be limited.
Because of the incubation period of hepatitis A, infection may be present but not clinically apparent at the time of vaccination. The effect of AVAXIM 160 U on individuals late in the incubation period of hepatitis A has not been documented.
Individuals having grown up in areas of high endemicity and/or with a history of jaundice may be immune to hepatitis A, in which case the vaccine is unnecessary. Testing for antibodies to hepatitis A prior to a decision on immunisation should be considered in such situations. If not, seropositivity against hepatitis A is not a contraindication. AVAXIM 160 U is as well tolerated in seropositive as in seronegative subjects (see Section 4.8).
AVAXIM 160 U does not provide protection against infection caused by hepatitis B virus, hepatitis C virus, hepatitis E virus or by other liver pathogens.
As no studies have been performed with AVAXIM 160 U in subjects with liver disease, the use of this vaccine in such subjects should be considered with care.
As with any vaccine, vaccination may not result in a protective response in all susceptible vaccinees.

AVAXIM 160 U contains ethanol, phenylalanine, potassium and sodium AVAXIM 160 U contains small amounts of ethanol (alcohol), less than 100 mg per dose.
AVAXIM 160 U contains 10 microgram phenylalanine in each 0.5 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.
AVAXIM 160 U contains less than 1mmol of potassium (39 mg) and sodium (23 mg) per dose, that is to say essentially 'potassium-free' and 'sodium-free'.

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