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Logo RABIGAM® IM (solution for intramuscular injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

RABIGAM® IM (solution for intramuscular injection)

COMPOSITION
Descriptive name:
Human
rabies immunoglobulin
Rabigam IM contains gammaglobulin derived from pooled human plasma, sourced from non-remunerated healthy donors, with a high titre of antibodies to the rabies virus.
Each unit of plasma has been individually testedand 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.
Rabigam 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 Rabigam IM.
Each 2 mL ampoule contains 300 IU (150 IU/mL) rabies virus antibodies.
This preparation contains no antimicrobial preservative and is stabilised with glycine.

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

PHARMACOLOGICAL ACTION
Rabies immunoglobulin confers passive immunity against rabies.
The pharmacodynamic effects in vivo of the specific neutralising antibodies against rabies virus are not fully documented, but rabies immunoglobulin has been proven to be effective in preventing the rabies infection.

INDICATIONS
Rabigam IM
is indicated as post-exposure prophylaxis of rabies infection for all persons known or suspected to have been exposed to the rabies virus, especially cases of major exposure, in accordance with the WHO recommendations.
Risk Category Type of Exposure Action to be taken
        I Touching/feeding animal, licking of skin None, if case history is reliable. If history is not reliable, treat as for category II.
        II Nibbling of uncovered skin, superficial scratch without bleeding Apply wound treatment.
Administer vaccine.
Do not administer anti-rabies immunoglobulin.
Stop vaccination if animal is rabies negative on laboratory test, or remains healthy after 10 days observation.
        III Bites/scratches which penetrate the skin and draw blood, licking of mucous membranes or broken skin Apply wound treatment.
Administer vaccine.
Administer anti-rabies immunoglobulin.
Stop vaccination if animal is rabies negative on laboratory test, or remains healthy after 10 days observation.
WHO Expert Consultation on Rabies, First Report. WHO Technical Report Series 931 2005; WHO, Geneva.

For rabies prevention in category III exposures, combined treatment with immunoglobulin (passive immunisation) and vaccine (active immunisation) is absolutely essential. The only exception is for individuals previously immunised with rabies vaccine and whose antibody titre has been recently confirmed as adequate, who should be treated with the vaccine only.
Rabigam IM must be administered for category III exposures, irrespective of the interval between exposure and initiation of treatment, up to the seventh day after the first dose of vaccine was given.

CONTRA-INDICATIONS
Because of the life-threatening risk due to rabies, there are no contra-indications to the administration of rabies immunoglobulin.
Rabigam IM is not indicated for patients with proven immunity to rabies.

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 and varicella for a period of up to 3 months. 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 4 months.
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 this medicinal product for use 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
The standard recommended dose is 20 IU per kilogram body mass administered at the same time, but at a different anatomical site, as the vaccine. This dose is applicable to both children and adults.
The recommended dose should not be exceeded.
Method of administration
Warm the ampoule to body temperature before intramuscular injection.
The immunoglobulin and the vaccine should be administered at two different sites of the body, using different syringes, to avoid interference with the active antibody response.
Injections of the immunoglobulin should preferably be administered in the bitten site. The immunoglobulin should be carefully infiltrated in the depth of, and around the wound if anatomically possible. Any remainder should be injected intramuscularly at a site distant from that used for the rabies vaccine.
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.
If suturing is necessary, ensure that the wound has been adequately infiltrated with immunoglobulin locally before suturing.
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.
Note:
Laboratory diagnosis should not delay initiation of treatment, but failure to detect rabies virus in the offending animal may warrant the halting of treatment.
Rabies immunoglobulin must be administered as soon as possible (that is, on the day that treatment is started) after suspected exposure to rabies, in conjunction with rabies vaccine.
If initiation of treatment is delayed for any reason, rabies immunoglobulin should still be given, regardless of the interval between exposure and treatment, up to the seventh day after the first dose of vaccine was given.

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

Special Precautions
Repeated doses of the rabies immunoglobulin should not be administered once rabies vaccine treatment has been started, because this could prevent full development of the active immunity expected from the vaccine.
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 Rabigam 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 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 Rabigam 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 a slight opalescence.

PRESENTATION
300 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/30.2/748

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.:        04/30.2/1048

2011/07P53

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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