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. is recommended to record the batch number as well.

Precautions for use
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.

Engerix B should not be administered in the buttock or intradermally since this may result in a lower immune response.

Engerix B should under no circumstances be administered intravascularly.

As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Protection


Because of the long incubation period of hepatitis B it is possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in such cases.

The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E viruses.

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

A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases.
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Engerix B.
Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Special population


Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the HB vaccination should thus be considered on a case by case basis by the physician. In HIV infected patients, as also in patients with renal insufficiency including patients undergoing haemodialysis and persons with an impaired immune system, adequate anti-HBs antibody concentrations may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.


Preterm infants

The potential risk of apnoea and the need for respiratory monitoring for 48- 72h should be considered when administering the primary immunization series to very premature infants born < 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Sodium content
This vaccine contains less than 1mmol sodium (23 mg ) per dose , that is to say essentially "sodium free".

Effects on Driving

4.7   Effects on ability to drive and use machines
Engerix B has no or negligible influence on the ability to drive and use machines.