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Logo INTRAGAM ® 2 mL solution for intramuscular injection
INTRAGAM ® 5 mL solution for intramuscular injection

REGISTRATION NUMBER
Intragam 2 mL T/30.2/740
Intragam 5 mL T/30.2/741

PROPRIETARY NAME
(and dosage form):

INTRAGAM ® 2 mL solution for intramuscular injection
INTRAGAM
® 5 mL solution for intramuscular injection

DESCRIPTIVE NAME OF MEDICINE
Human
normal immunoglobulin for intramuscular injection

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS
S4

COMPOSITION
Intragam
contains 16% gammaglobulin derived from pooled human plasma sourced from more than 1000 non-remunerated, healthy South African donors. Intragam contains antibodies to a wide variety of pathogens to which the donors have been exposed.
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.
Intragam is prepared by the cold ethanol fractionation method to further reduce the risk of viral transmission.
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
Intragam
confers passive immunity to the patient by supplementing the immunoglobulin levels. Opsonisation and neutralisation of microbes and toxins have been documented.
The half-life in the circulation of individuals with normal IgG levels is 3 to 4 weeks.

INDICATIONS
Prophylaxis:
* Hepatitis A (infectious hepatitis): Intragam is effective as both pre-and post-exposure prophylaxis and provides protection for at least 3 months.
The major indications are:
(a)        Pre-exposure prophylaxis for travellers to endemic areas.
(b)        Post-exposure prophylaxis with Intragam should be given to persons exposed less than 1 week previously.
* Measles: Intragam is effective for the prevention and modification of measles in susceptible persons exposed less than one week previously.
If specific immune prophylaxis is required, the hyperimmune preparation should be used in preference to Intragam.

Substitution and Replacement Therapy:
* Intragam is indicated for the treatment of primary antibody deficiency syndromes and secondary antibody deficiency states.

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 immunoglobulins in pregnancy has not been established in controlled clinical trials.

WARNING:
This intramuscular preparation must not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE
Warm the ampoule to body temperature before injecting intramuscularly.
Discard any unused portion.
If large doses (> 5 mL) are required, it is advisable to administer them in divided doses at different sites.

Indication         Dose
Hepatitis A Prophylaxis 
Pre-exposure prophylaxis:
Travellers to endemic areas
 
Visit < 3 months
Visit > 3 months (continued exposure)
0,02 mL/kg
0,06 mL/kg every 4-6 months
Post-exposure prophylaxis:
Within one week of household contact
0,02 - 0,04 mL/kg
Measles prophylaxis 
Within one week of contact 0,2 - 0,25 mL/kg (maximum 15 mL)
Susceptible immunocompromised children 0,5 mL/kg (maximum 15 mL)
Replacement Therapy 
Congenital immunoglobulin deficiencies 0,2 - 0,5 mL/kg repeat every 4-8 weeks
Transient hypogammaglobulinaemia 0,2 - 0,5 mL/kg repeat when necessary

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Local reactions, which include 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, should be immediately available when administering Intragam.
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. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products.
The antibodies in immunoglobulin preparations may interfere with live virus vaccine responses (measles, mumps, rubella and varicella). Administration of these vaccines should be delayed for 3 months after treatment with immunoglobulin.

PRESENTATION
2 mL and 5 mL, single dose, clear, colourless glass ampoules.

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 APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone: (031) 719-6789         Telefax: (031) 708 5614

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2/95

2004/01P51

Date of Amendment: 18 June 1998         Date of Approval: 26 June 1998

Updated on this site: June 2010
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 (0)31 714 6700 or +27 (0)82 870 3705 or +27 (0)82 895 0056
.

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