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Faster and Safer Protection Against Hepatitis B

Pharmaceutical Form :
Solution for injection for intramuscular administration.
Presentation :
vial 500 IU and 150 IU.
Indications :
Prevention of hepatitis B, after incidental exposure with the hepatitis B virus or for
people with continuous risk of infection with hepatitis B virus.
Dosage :
1.
24 hours after incidental exposure of hepatitis B virus containing blood.
Not vaccinated: Small amount 500 IU + vaccine (children: 8 IU/kg* + vaccine);
Large amount 50 IU/kg + vaccine (children: 50 IU/kg* + vaccine). If
vaccination not possible: Small amount 500 IU; repeat after 2 and 4 months
(children: 8 IU/kg* + repeat after 2 and 4 months); Large amount 50 IU/kg;
500 IU after 2 and 4 months (children 8 IU/kg; repeat after 2 and 4 months).
For people who has been vaccinated: Titre too low (< 10mIU/ml); Small
amount 500 IU + booster or 2 x 500 IU (children: 8 IU/kg + booster or 2 x 8
IU/kg); Large amount 50 IU/kg + booster (children 50 IU/kg + booster). If
antibody titre unknown (test not possible); Small amount 500 IU (children: 8
IU/kg); Recommendation: still test after 3 months; Large amount 50 IU/kg
2.

(children: 50 IU/kg); recommendation: still test after 3 months.

The administration of HepBQuin should occur within 24 hours. The first
dose or booster of hepatitis B vaccine should be given as soon as possible

(preferably within 7 days after administration of HepBQuin).

3.
In the event of continuous or repeated risk of infection, in this situation,
active immunisation with hepatitis B vaccine is preferred. If vaccination
against hepatitis B is not possible or when vaccination has not led to
(sufficient)

antibody

formation,

then

consideration

may

be

given

to

administering a dose of 500 IU (5ml) to adults and 8 IU HepBQUin per kg body

weight (0,08 ml) to children every two months.
Special Precaution :
Prior systemic allergic reactions to human Ig, severe thrombocytopenia, coagulation
disorder, pregnancy.
Method of Administration :
The product should be administered slowly as a deep intramuscular injection (in
neonates into the anterolateral side of the thigh). When administering a large dose
(>5 ml) it is advisable to divide the dose over several injection sites. It is
recommended

that

the

product

be

warmed

to

body

temperature

before

administration. For protection of neonates from hepatitis B, the injection should be

carried out within 2 hours after birth. For other indications, administration should be
carried out as quickly as possible, and any case within 24 hours after
contamination; after this period, it is doubtful whether the treatment has any
beneficial effect. If hepatitis B vaccine is being administered simultaneously, the
vaccination should be carried out to the opposite side of the body.
Contraindications :
Known intolerance to the product or other products with a similar composition of the
homologous immunoglobulin. This applies also to patients with selective IgA
deficiency in whom anti-IgA antibodies have been detected.
Storage :
Should be store between 2 8C protected from light. Instructions for use and
handling. It is recommended that the product be warmed to body temperature
before administration.
Price :
1 vial --- IDR 3.950.000,- excl Vat 10%
Incl Vat --- IDR 4.345.000,-