Finished product reference
Tetanus Immune Globulin
Injection · Parenteral · 250 IU/1mL
- List code
- 1202
- Pharmacologic class
- Human hyperimmune immunoglobulin (anti-tetanus)
What it is and how it works
A preparation of human immunoglobulin G with a high titre of antibodies against tetanus toxin, obtained from plasma of immunised donors. It provides immediate passive immunity by neutralising circulating tetanospasmin before it binds to nerve tissue; it does not neutralise toxin already fixed to neurons.
Indications
Post-exposure prophylaxis of tetanus in patients with tetanus-prone wounds who are not adequately immunised or whose immunisation status is uncertain (given together with tetanus vaccine at a separate site); treatment of clinical tetanus.
Dosage and administration (summary)
For prophylaxis, usually 250 IU by intramuscular injection, increased (e.g. to 500 IU) for heavily contaminated wounds, burns or delayed treatment; higher doses are used for treatment of clinical tetanus according to specialist protocols.
Contraindications
Hypersensitivity to human immunoglobulins; intramuscular injection is contraindicated in severe thrombocytopenia or other coagulation disorders.
Warnings and precautions
Allergic and, rarely, anaphylactic reactions may occur, especially in IgA-deficient patients with anti-IgA antibodies; observe the patient after injection. Products derived from human plasma carry a theoretical risk of transmitting infectious agents despite viral inactivation steps. It may interfere with the response to live viral vaccines given within the following months.
Pregnancy
No harmful effects are expected; it may be given in pregnancy when indicated.
Storage and supply
Store refrigerated at 2–8 °C; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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