Posology : מינונים

4.2   Posology and method of administration

Posology
Sci-B-Vac is a sterile suspension for intramuscular injection.
Adult Formulation, 10 μg/ml: each 1 ml dose contains 10 μg hepatitis B surface antigen; recommended for children above the age of 10 years and adults.
Pediatric Formulation (option 1) 2.5 μg/0.5 ml: each 0.5 ml dose contains 2.5 μg hepatitis B surface antigen; recommended for neonates, infants and young children.
Pediatric Formulation (option 2) 5 μg/0.5 ml: each 0.5 ml dose contains 5 μg hepatitis B surface antigen; recommended for neonates, infants and young children in highly endemic areas.
In each formulation, the hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum per ml of vaccine.

Method of administration
Sci-B-Vac should be injected intramuscularly into the deltoid muscle in adults and children or in the anterolateral thigh in neonates, infants and young children. The vaccine may be administered subcutaneously to persons who are at high risk of hemorrhage due to thrombocytopenia or bleeding disorders. Do not inject into the gluteal muscle.
Vaccination Schedule: The vaccination regimen for all subjects consists of three (3) doses of vaccine given according to the following schedule: first dose at elected date; second dose 1 month after the first dose; third dose 6 months after the first dose.
Booster Dose: The duration of the protective effect of Sci-B-Vac against HBV is unknown at present.
A booster dose may be considered when the anti-HBs titer falls below 10 mlU/ml.

For instructions on handling of the medicinal product before administration, see section 6.6.