Human Rabies Immunoglobin (HRIG)

Registered South African indications:

• Post-exposure prophylaxis of rabies

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Because of the life-threatening risk due to rabies, there are no contraindications to the administration of rabies immunoglobulin

Cautions

• Pregnancy
• Breastfeeding
• Renal Impairment
• Hepatic Impairment
• Elderly
• Intravascular administration
• Patients deficient in IgA

Forms avail. in SA and covered in this monograph: inj

Post-exposure prophylaxis of rabies
- In people suspected to have been infected with rabies virus
- For rabies prevention in category III exposures, combined treatment with immunoglobulin (passive immunisation) and vaccine (active immunisation) is absolutely essential
- 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

• IM: 20 IU/kg

Administer together with vaccine but at different anatomical site

See additional prescribing points

See adult dosage

Pregnancy

• Caution
• The safety of this medicinal product for use in human pregnancy 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

Breastfeeding

• Caution
• Caution is recommended when administrating rabies immunoglobulin to breastfeeding women as immunoglobulins become present in breast milk. The benefit of treatment of the mother should be weighed against the risk of adverse effects and the benefits of breastfeeding to the nursing infant

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Fatigue

Cardiovascular Disorders

• Tachycardia
• Hypotension

Gastrointestinal Disorders

• Nausea and vomiting

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Skin reaction
• Erythema
• Pruritus
• Injection site reactions

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactic shock
• Fever
• Influenza-like illness

• Live attenuated virus vaccines
• Serological testing 

None routine

Administration directions

• 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 (> 2ml for children or > 5ml 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

Rabies immunoglobulin confers passive immunity against rabies. Rabies immunoglobulin binds to the rabies virus, which prevents it from invading the central nervous system.

Injection (per ml) 150iu

• Rabigam (NBI)