Finished product reference
C1-estrase Inhibitor
Injection, Powder, for Solution · Parenteral · 500 IU
- List code
- 50837
- Pharmacologic class
- Complement C1-esterase inhibitor (plasma-derived or recombinant)
What it is and how it works
C1-esterase inhibitor (C1-INH) is a serine protease inhibitor that regulates the complement, contact (kallikrein–kinin), fibrinolytic and coagulation systems. Replacement in patients with hereditary C1-INH deficiency limits kallikrein activation and bradykinin generation, which mediate angioedema attacks. Products include plasma-derived C1-INH and recombinant conestat alfa.
Indications
Treatment of acute attacks of hereditary angioedema (HAE) due to C1-INH deficiency; short-term pre-procedural prophylaxis and, for some products, routine long-term prophylaxis.
Dosage and administration (summary)
Dosing is product-specific and individualised by the specialist: given by slow intravenous injection or infusion, either as a weight-based dose (IU/kg) or a fixed dose (e.g. 1000 units) according to the product’s label and indication.
Contraindications
Hypersensitivity to the product; for recombinant conestat alfa, known or suspected allergy to rabbits.
Warnings and precautions
Hypersensitivity reactions, including anaphylaxis, may occur; facilities for treatment should be available. Thromboembolic events have been reported, mainly at high (off-label) doses or in patients with risk factors such as indwelling catheters. Plasma-derived products carry a theoretical risk of transmission of infectious agents.
Pregnancy
May be used in pregnancy when clearly indicated; plasma-derived C1-INH is generally preferred for HAE in pregnancy.
Storage and supply
Store as specified by the manufacturer (typically 2–25 °C or 2–30 °C, product-dependent); 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.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.