Serum antigangrenosum polyvalentum purificatum concentratum equinum (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06AA05 (Antigangrene serum)

Dosage Form

Serum antigangrenosum polyvalentum purificatum concentratum equinum

Solution for injection 30,000 IU: amp. 1 pc. in a kit with diluted horse serum 1:100 (amp. 1 ml) 1 pc.

Dosage Form, Packaging, and Composition

Solution for injection transparent or slightly opalescent, colorless or with a yellowish tint, without sediment.

30,000 IU – ampoules – cardboard packs /in a kit with diluted purified horse serum 1:100 (ampoules) 1 ml – 1 pc./ – for medical and preventive institutions.

Clinical-Pharmacological Group

Immunological preparation. Serum

Pharmacotherapeutic Group

MIBP-serum

Pharmacological Action

The antibodies contained in the serum neutralize the toxins of anaerobic microbes Clostridium perfringens type A, Clostridium oedematiens type A, Clostridium septicum.

Indications

• Employ for the treatment of established gas gangrene to neutralize circulating exotoxins produced by clostridial species.
• Administer for the prophylaxis of gas gangrene in individuals with heavily contaminated wounds, crush injuries, or traumatic wounds involving devitalized tissue, particularly when surgical debridement is delayed.

Initiate prophylactic administration as soon as possible after the injury for maximum efficacy.

ICD codes

Dosage Regimen

For prophylactic use, administer a single dose of 30,000 IU intramuscularly immediately following a high-risk injury.

For therapeutic use in established infection, administer a single dose of 150,000 IU intravenously.

Inject the IV dose very slowly to minimize the risk of adverse reactions. The necessity for repeated therapeutic doses is determined by the clinical response.

Adverse Reactions

Monitor closely for immediate and delayed hypersensitivity reactions due to the equine protein origin.

Immediate reactions include anaphylactic shock, urticaria, and hypotension.

Delayed reactions manifest as serum sickness, typically occurring 2 to 14 days post-administration, characterized by fever, skin rash, arthralgia, and lymphadenopathy.

These symptoms may persist from several hours to several weeks.

Contraindications

• Avoid administration in patients with a known history of severe hypersensitivity to any component of the preparation or to other equine-derived antisera.

There are no other absolute contraindications for life-threatening gas gangrene; however, exercise extreme caution in individuals with a history of atopy or allergy.

Use in Pregnancy and Lactation

Use is allowed for vital indications, taking into account the possible benefit for the mother and the risk for the fetus or child.

Use in Hepatic Impairment

Used according to indications.

Use in Renal Impairment

Used according to indications.

Pediatric Use

Used according to indications.

Geriatric Use

Used according to indications.

Special Precautions

Given the possibility of shock during the administration of antigangrene serum, each vaccinated person must be provided with medical supervision for 1 hour after administration of the drug. Vaccination sites must be provided with means for anti-shock therapy.

Persons who have received antigangrene serum should be warned about the need to immediately seek medical help if signs characteristic of serum sickness appear.

Drug Interactions

Concomitant use with antibacterial agents, surgical debridement, and hyperbaric oxygen is standard for gas gangrene management.

Premedication with antihistamines or corticosteroids may be considered to mitigate the risk of allergic reactions or serum sickness, though efficacy is not guaranteed.

No known pharmacokinetic interactions exist.

Overdose

No specific antidote exists for an overdose of antitoxin.

The primary risk of excessive dosing is a heightened incidence and severity of hypersensitivity reactions, including anaphylaxis and serum sickness.

Manage overdose with immediate symptomatic and supportive care, focusing on treating allergic manifestations and maintaining vital functions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.