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 and the batch number of the administered product should be clearly recorded.

As with all injectable vaccines, appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Vaccination should be postponed in subjects suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.


Syncope (fainting) can occur following, or even before, any vaccination 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.

Hepatitis B has a long incubation period. Sci-B-Vac may not prevent hepatitis B infection in individuals who have an unrecognised hepatitis B infection at the time of vaccine administration.

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

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

Caution and appropriate care should be exercised in administering the vaccine to individuals with severe compromised cardiopulmonary status or to others in whom a febrile or systemic reaction could pose a significant risk.

Thrombocytopenia and coagulation disorders
As with other intramuscular injections, the vaccine should be given with caution in subjects receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these subjects.

Immunodeficiency
Immunocompromised persons may have a diminished immune response to Sci-B-Vac . There are limited data available among immunocompromised population. Attention should be given to ensure that a protective antibody level is maintained as defined by national recommendations and guidelines.

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 hepatitis B infection can be severe in these patients: the Sci-B-Vac vaccination should thus be considered on a case by case basis by the physician.

Hepatitis B surface antigen (HBsAg) derived from hepatitis B vaccines has been transiently detected in blood samples following vaccination. Serum HBsAg detection may not have diagnostic value within 28 days after administration of Sci-B-Vac .

Renal impairment
Pre-haemodialysis and haemodialysis patients are at risk of exposure to hepatitis B virus and have a higher risk of becoming chronically infected. Attention should be given to ensure that a protective antibody level is achieved and maintained as defined by national recommendations and guidelines.


Excipients with known effect
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium- free’.

Potassium
This medicinal product contains less than 1 mmol potassium (39 mg) per dose, i.e. is essentially ‘potassium-free’.

Effects on Driving

4.7   Effects on ability to drive and use machines

Sci-B-Vac has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 (e.g. fatigue, headache, dizziness) may temporarily affect the ability to drive or operate machines.