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

Logo INTRAGAM IM® 2 mL (solution for intramuscular injection)
INTRAGAM IM® 5 mL (solution for intramuscular injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

INTRAGAM IM® 2 mL (solution for intramuscular injection)
INTRAGAM IM
® 5 mL (solution for intramuscular injection)

COMPOSITION
Descriptive name:
Human
normal immunoglobulin for intramuscular injection
Intragam IM contains gammaglobulin derived from pooled human plasma sourced from not less than 1000 non-remunerated, healthy donors. Intragam IM 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 (HBsAg), antibodies to the hepatitis C virus (HCV) and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Intragam IM is prepared by the cold ethanol fractionation method 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 Intragam IM.
Each millilitre of Intragam IM contains 160 mg of human protein of which at least 90% is immunoglobulin G (IgG).
Intragam IM has a hepatitis A antibody titre of at least 100 IU/mL.
This preparation contains no antimicrobial preservatives and is stabilised with glycine.

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

PHARMACOLOGICAL ACTION
Intragam IM
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 immunoglobulin G (IgG) levels is 3 to 4 weeks.

INDICATIONS
Prophylaxis
Hepatitis A (infectious hepatitis): Intragam IM 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 IM should be given to persons exposed less than 1 week previously.
Measles: Intragam IM 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 IM.
Substitution and Replacement Therapy
Intragam IM is indicated for the treatment of primary antibody deficiency syndromes and secondary antibody deficiency states.

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 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. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.
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 immunoglobulins 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
Indication         Dose
Hepatitis A prophylaxis        
Pre-exposure prophylaxis:
Travelers to endemic areas
       
Visit duration <3 months
Visit duration >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

Method of administration
Warm the ampoule to body temperature before injecting intramuscularly.
If a large volume (>2 mL for children or >5 mL for adults) is required, it is recommended to administer this in divided doses at different sites.
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: Cutaneous reactions, local reactions
Gastrointestinal System: Nausea
Central & Peripheral Nervous System: Headache, lightheadedness
Vascular (Extracardiac) Disorders: Flushing
Body as a Whole - General: Pain and tenderness at injection site, chills, backache, fever
Special Precautions
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, should be immediately available when administering Intragam IM.
Persons with selective immunoglobulin A (IgA) deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation 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 every time that Intragam 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.

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 slight opalescence.

PRESENTATION
Intragam 2 mL:
single dose, clear, colourless, 2 mL glass ampoule.
Intragam 5 mL: single dose, clear, colourless, 5 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
Intragam IM 2 mL
: T/30.2/740
Intragam IM 5 mL: T/30.2/741

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.:
Intragam ® IM 2 mL: 04/30.2/1738
Intragam ® IM 5 mL: 04/30.2/1140

2011/07P51

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

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