INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo HEBAGAM® IM solution for intramuscular injection
REGISTRATION NUMBER
T/30.2/746

PROPRIETARY NAME
(and dosage form):

HEBAGAM® IM solution for intramuscular injection

DESCRIPTIVE NAME OF THE MEDICINE
Human hepatitis B immunoglobulin

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS
S4

COMPOSITION
Hebagam IM contains gammaglobulin derived from pooled human plasma, sourced from non-remunerated healthy donors, with a high titre of antibodies to the hepatitis B surface antigen (HBsAg).
Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to the hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Hebagam IM is prepared by cold ethanol fractionation, to further reduce the risk of viral transmission.
Each 2 mL ampoule contains 200 IU (100 IU/mL) of hepatitis B antibodies.
This preparation contains no antimicrobial preservatives and is stabilised with glycine.

IDENTIFICATION
A clear, pale yellow or light brown liquid exhibiting slight opalescence.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Hepatitis B immunoglobulin confers passive immunity against hepatitis B virus.

INDICATIONS
Hebagam IM is indicated for post-exposure prophylaxis following either parenteral exposure (e.g. accidental "needle-stick"), direct mucous membrane contact, or oral ingestion of HBsAg-positive materials, such as blood, plasma or serum.
Hebagam IM is indicated for the temporary protection of infants born to HBsAg-positive mothers (especially those who are HBeAg-positive), since these infants are at risk of acquiring hepatitis B infection. Infants born to HBsAg-positive mothers should receive hepatitis B immunoglobulin and the first dose of hepatitis B vaccine at the same time.
Hebagam IM is indicated for persons who have been in sexual or intimate physical contact with HBsAg-positive persons.

CONTRA-INDICATIONS
Intramuscular injections are not advocated for patients with bleeding disorders.
The risk-benefit ratio in patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products should be considered.
The safety of intramuscular immunoglobulin in pregnancy has not been established in controlled clinical trials.
Hebagam IM is not appropriate for the treatment of any type of hepatitis B infection.
This intramuscular preparation must not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE
INDICATIONS SINGLE DOSE                                SPECIAL INSTRUCTIONS
Needle-stick injury
Mucosal exposure
Sexual exposure		         >10 years : 500 IU       
        5-9 years : 300 IU       
<5 years : 200 IU                		Treat preferably within 48 hours, and not more than 7 days after exposure.
Repeat after 28 days unless recipient has been shown to be immune or has received hepatitis B vaccine
Newborn babies born to HBsAg positive mothers (especially those who are HBeAg positive)         200 IU Treat preferably at birth, or within 48 hours after birth.
First dose of hepatitis B vaccine must be administered at the same time.
Warm the ampoule to body temperature before injecting intramuscularly.
Administer immunoglobulin and vaccine at different sites.
Discard any unused portion.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Local reactions, with pain and tenderness, may occur at the injection site. Headache, fever, chills, flushing, lightheadedness, backache, nausea and cutaneous reactions have also been reported.
Anaphylactic reactions may occur especially if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, must be immediately available when administering Hebagam IM.
Persons with selective IgA deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material.
Infectious diseases due to the transmission of infectious agents, cannot be totally excluded.
Hebagam IM is not routinely recommended for persons at continued risk of hepatitis B infection - such as laboratory personnel, chronic dialysis patients, travellers to endemic areas and institutionalised patients - where active immunisation with hepatitis B vaccine is preferable.
Immunoglobulin administration may impair, for a period of at least 6 weeks and up to 3 months, the efficacy of live attenuated virus vaccines such as measles, mumps, rubella and varicella. These vaccines should be administered at least 14 days prior to or 3 months after administration of Hebagam IM.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
None known.

PRESENTATION
2 mL, single dose, clear, colourless glass ampoule.

STORAGE DIRECTIONS
Transport within 72 hours below 37°C.
Store between 2°C and 8°C.
Do not freeze.
Protect from light.
Keep out of reach of children.

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATAL BIOPRODUCTS INSTITUTE
Reg. No. 94/02044/08

PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone: (031) 719 6789         Telefax: (031) 708 5614


DATE OF PUBLICATION OF PACKAGE INSERT
8/96

P 0983 6/98

Amendment date: 18 June 1998         Date of Approval: 26 June 1998
Updated on this site: September 1999

Please note that the Natal Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at (+27)(+31) 719 6789 or 082 870 3705 or 082 895 0056.

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