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

Logo HEBAGAM® IM (solution for intramuscular injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

HEBAGAM® IM (solution for intramuscular injection)

COMPOSITION
Descriptive name:
Human
hepatitis B immunoglobulin
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 (HCV) 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. In addition, only plasma pools tested and found non-reactive for anti-HIV-1 & -2, HBsAg and anti-HCV by serological testing; and for HIV, HCV, hepatitis B virus (HBV) and hepatitis A virus (HAV) by Nucleic Acid Amplification Techniques (NAT), are used in the manufacture of Hebagam IM.
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.

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

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

INDICATIONS
Hebagam IM
is used for immunoprophylaxis of hepatitis B:
- In case of accidental exposure e.g. skin pricks, spillage into eye or mouth, bites or scratches, contamination of abrasions, in non-immunised subjects (including persons whose vaccination is incomplete or status unknown).
- In the newborn of a hepatitis B virus carrier-mother.
- In persons who have been in sexual or intimate physical contact with HBsAg-positive persons.
- In haemodialysed patients, until vaccination has become effective.
- In subjects who did not show an immune response (no measurable hepatitis B antibodies or < 10 IU/L of hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients, including excipients.

WARNINGS
This intramuscular preparation must not be given intravenously, because of the risk of shock.
Intramuscular injections are not advocated for patients with bleeding disorders (Refer “Special Precautions”).

INTERACTIONS
Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Human hepatitis B immunoglobulin should be administered three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the 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.

PREGNANCY AND LACTATION
The safety of intramuscular immunoglobulin in pregnancy and lactation has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

DOSAGE AND DIRECTIONS FOR USE
INDICATIONS SINGLE DOSE SPECIAL INSTRUCTIONS
Needle-stick injury
Mucosal exposure
Sexual exposure
Age:10 years to adult : 500 IU
Age 5 - 9 years (inclusive): 300 IU
Age 0 - 4 years (inclusive) : 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.
Haemodialysis 8 - 12 IU/kg (Maximum 500 IU) Hebagam IM administration may need to be repeated every 2 months until seroconversion following vaccination.
Newborn babies born to HBsAg positive mothers (especially those who are hepatitis B envelope antigen (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.
Hebagam IM administration may need to be repeated until seroconversion following vaccination.
In subjects who do not show an immune response after vaccination and for whom continuous prevention is necessary Adults: 500 IU
Children: 8 IU/kg
Every 2 months
(a minimum protective antibody titre is considered to be 10 IU/L)
In all of the above situations, vaccination against hepatitis B virus is highly recommended. The first dose can be injected on the same day as human hepatitis B immunoglobulin, however at different sites.

Method of administration
Warm the ampoule to body temperature before injecting intramuscularly. The usual recommended site for adults is the deltoid; for infants, the lateral aspect of the thigh is preferable.
If a large volume (>2 mL for children or >5 mL for adults) is required, it is recommended that this be administered in divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites to avoid interference with the active antibody response.
This medicinal product must not be mixed with other medicinal products
Any unused product or waste material should be disposed of in accordance with local procedures.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
The following undesirable effects have been reported with intramuscular immunoglobulins:
Skin & Appendages Disorders: Cutaneous reactions, local reactions
Central & Peripheral Nervous System Disorders: Headache, lightheadedness
Gastrointestinal System: Nausea
Vascular (Extracardiac): Flushing
Body as a Whole - General: Pain and tenderness at injection site, chills, back ache, fever

Special Precautions
Hebagam IM
is not appropriate for the treatment of any type of hepatitis B infection.
Intramuscular injections are not advocated for persons with bleeding disorders unless special precautions are taken.
True hypersensitivity reactions are rare.
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 immunoglobulin A (IgA) deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitization and subsequent reaction to IgA-containing material. The risk-benefit ratio in patients with a history of IgA deficiency or severe anaphylactic reactions to plasma products should be considered.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products on a routine basis.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
It is strongly recommended that when Hebagam IM is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product
Hebagam IM is not routinely recommended for persons at continued risk of hepatitis B infection - such as laboratory personnel, chronic dialysis patients, travelers to endemic areas and institutionalised patients - where active immunization with hepatitis B vaccine is preferable.

Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Consequences of an overdose are not known.

IDENTIFICATION
A colourless, pale yellow to light brown liquid exhibiting a slight opalescence.

PRESENTATION
200 IU in a single dose, clear, colourless 2 mL glass ampoule.

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

REGISTRATION NUMBER
T/30.2/746

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone:         086 016 2472
Telefax:         031 708 5614

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2012/03/26

NAMIBIA         S2
Reg. No.:         04/30.2/1144

2011/07P50

Updated on this site: August 2014
Source: Pharmaceutical Industry

Disclaimer:
Please note that the National 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 (031) 714 6700 or +27 082 870 3705 or +27 082 320 3306
.
Email: info@nbisa.org.za

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2014