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Hepatitis B Immunoglobulin P pre-filled syringes

Marketed by Dexa Medica

Product packaging may vary from one country to another.

Ingredients in every ml

Human Protein 100 - 170 mg
Immunoglobulin at least 95 %
Antibodies to Hbs antigen at least 200 IU

Each package contains

1 syringe of 1 ml

Other details

Dosage form:Syringe; pre-filled
Flavour None

W.H.O. classification

ATC Level 1 J - Antiinfectives for systemic use
ATC Level 2 J06 - Immune Sera and Immunoglobulins
ATC Level 3 J06B - Immunoglobulins

Warnings

Pregnancy

CONSULT YOUR DOCTORSafety of this item for use during pregnancy has not been established. Please consult your doctor.

Lactation

CONSULT YOUR DOCTORSafety of this item for use during lactation has not been established. Please consult your doctor.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

SAFE IF PRESCRIBEDThis item is safe for use while operating heavy machinery.

Available in

Indonesia

Dosage information

FOR ALL AGES
– Prevention of hepatitis B in case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown):
12 IU/kg body weight, at least 500 IU, depending in the intensity of exposure, as soon as possible after exposure, and preferably within 72 hours

– Immunoprophylaxis of hepatitis B in haemodialysed patients:
8 to 12 IU/kg body weight (maximal 500 IU), every 2 months until seroconversion following vaccination.

– Prevention of hepatitis B in the newborn, of hepatitis B virus carrier-mother, at birth or as soon as possible after birth:
30 to 100 IU/kg body weight (normally 1 ml). The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination.

In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites. In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to Adults and 8 IU/kg body weight to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.

Indication

Immunoprophylaxis of hepatitis B
– In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown)
– In haemodialysed patients, until vaccination has become effective.
– In the newborn of a hepatitis B virus carrier-mother
– In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
National and/or WHO guidelines regarding protection against hepatitis B infection should be observed.