Serum against gangrene polyvalent horse purified concentrated liquid (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06AA05 (Antigangrene serum)

Dosage Form

Serum against gangrene polyvalent horse purified concentrated liquid

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

Dosage Form, Packaging, and Composition

1 dose – ampoules (1) in a kit with purified diluted horse serum 1:100 (amp. 1 ml) 1 pc. and an ampoule knife – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Serum

Pharmacotherapeutic Group

MIBP-serum

Pharmacological Action

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

Indications

• Treatment and prevention of gas gangrene.

ICD codes

Dosage Regimen

For prophylactic purposes, the serum is administered intramuscularly as soon as possible after the injury.

For therapeutic purposes, the serum is administered intravenously, very slowly, by the drip method, usually mixed with warmed to body temperature 0.9% sodium chloride injection solution at a rate of 100-400 ml per 100 ml of serum.

The serum is warmed to (36±0.5)°C and administered: first 1 ml over 5 minutes, then 1 ml per minute.

The serum must be administered by a doctor, or under their supervision. The amount of serum administered depends on the clinical condition of the patient.

Usually, the therapeutic dose of antigangrene serum is 150 thousand IU: antiperfringens – 50,000 IU, antioedematiens – 50,000 IU, antisepticum – 50,000 IU.

Before the administration of antigangrene serum, an intradermal test with purified diluted horse serum 1:100 (ampoule marked in red) is mandatory to check the patient’s sensitivity to horse serum proteins. Purified diluted horse serum 1:100 is administered in a volume of 0.1 ml intradermally into the flexor surface of the forearm (use syringes with a graduation of 0.1 ml and thin needles). The reaction is assessed after 20 minutes. The test is considered negative if the diameter of the swelling and/or redness appearing at the injection site is less than 1 cm. The test is considered positive if the swelling and/or redness reach a diameter of 1 cm or more.

With a negative intradermal test, antigangrene serum (ampoule marked in blue) is administered subcutaneously in an amount of 0.1 ml. If there is no reaction after 30 minutes, the entire prescribed dose of serum is administered intramuscularly (for prophylactic purposes) or intravenously (for therapeutic purposes).

With a positive intradermal test, the serum is administered only for absolute indications under the supervision of a doctor and with special precautions. First, antigangrene serum diluted in doses of 0.5 ml, 2.0 ml, 5.0 ml is administered subcutaneously (the diluted serum is prepared immediately before use by adding 0.1 ml of antigangrene serum to 9.9 ml of 0.9% sodium chloride injection solution) at 20-minute intervals. If there is no reaction to these doses, 0.1 ml of antigangrene serum is administered subcutaneously. If there is no reaction after 30 minutes, the entire prescribed amount of serum is administered intramuscularly (for prophylactic purposes) or intravenously (for therapeutic purposes). In case of a positive reaction to one of the aforementioned doses, antigangrene serum is not administered or is administered under anesthesia, having a syringe with 0.1% adrenaline hydrochloride solution or 0.2% noradrenaline hydrotartrate solution ready.

All manipulations are performed with separate sterile syringes. The opened ampoule with antigangrene serum is covered with a sterile napkin and stored at a temperature of (20±2)°C for no more than 1 hour. The opened ampoule with purified diluted horse serum 1:100 is not subject to storage.

Adverse Reactions

Administration of the serum may lead to the development of anaphylactic shock and other immediate-type allergic reactions, as well as the symptom complex of serum sickness (fever, skin rashes, arthralgias), appearing in early (2-6 days) and remote (on the 2nd week) periods, lasting from several hours to several weeks.

Contraindications

There are no contraindications for the use of antigangrene serum.

Use in Pregnancy and Lactation

The use of the drug is allowed for vital indications, taking into account the possible benefit for the mother and the risk for the fetus or child.

Special Precautions

Precautionary measures for use

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

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

The preparation in ampoules with damaged integrity or missing labeling, with changed physical properties (color, transparency, presence of non-dispersible flakes), with an expired shelf life, or stored improperly is unsuitable for use.

Effect on the ability to drive vehicles and mechanisms

No information available.

Overdose

Not established.

Drug Interactions

Not identified.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature from 2 to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

Shelf Life

Shelf life – 2 years.

Dispensing Status

For medical and preventive institutions.

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.