Serum antitetanicum purificatum concentratum (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06AA02 (Tetanus antitoxin)

Dosage Forms

	Serum antitetanicum purificatum concentratum	Solution for intramuscular and subcutaneous administration 10,000 IU: amp. 5 pcs.
		Solution for intramuscular and subcutaneous administration 20,000 IU: amp. 5 pcs.
		Solution for intramuscular and subcutaneous administration 50,000 IU: amp. 5 pcs.
		Solution for intramuscular and subcutaneous administration 3,000 IU: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Amps (5) in a set with diluted horse serum 1:100 (amp. 1 ml) and an ampoule knife – cardboard packs.

Amps (5) in a set with diluted horse serum 1:100 (amp. 1 ml) and an ampoule knife – cardboard packs.

Amps (5) in a set with diluted horse serum 1:100 (amp. 1 ml) and an ampoule knife – cardboard packs.

Amps (5) in a set with diluted horse serum 1:100 (amp. 1 ml) and an ampoule knife – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Serum

Pharmacotherapeutic Group

Immune sera and immunoglobulins; immune sera

Pharmacological Action

The drug is a protein fraction of the blood serum of horses immunized with tetanus toxoid or toxin, containing specific immunoglobulins, purified and concentrated by peptic digestion and salt fractionation.

It contains chloroform in a concentration not exceeding 0.1%.

It is supplied in a set with purified diluted horse serum 1:100.

It neutralizes tetanus toxin.

Indications

• Emergency specific prophylaxis and treatment of tetanus.

ICD codes

Dosage Regimen

Tetanus treatment: tetanus serum is administered to patients as early as possible from the onset of the disease in a dose of 100,000-200,000 IU.

The serum is administered intravenously or into the spinal canal after checking sensitivity to foreign protein. Depending on the severity of the disease, the administration of the serum is repeated until reflex convulsions disappear.

Emergency tetanus prophylaxis involves primary surgical treatment of the wound and, if necessary, creating specific immunity against tetanus.

Emergency specific tetanus prophylaxis is carried out for

• Injuries with violation of the integrity of the skin and mucous membranes;
• Frostbite and burns of the second, third and fourth degrees;
• Out-of-hospital abortions;
• Childbirth outside medical institutions;
• Gangrene or necrosis of tissues of any type, abscesses;
• Animal bites;
• Penetrating injuries of the gastrointestinal tract.

For emergency specific prophylaxis of tetanus, the following are used

• Adsorbed Tetanus Toxoid (ATT);
• Human Tetanus Immunoglobulin (HTIG);
• In the absence of HTIG – Purified Concentrated Liquid Tetanus Serum (PCLTS).

ATT and HTIG are administered in accordance with the instructions for use of these drugs.

Tetanus serum for the purpose of emergency tetanus prophylaxis is administered subcutaneously in a dose of 3,000 IU.

Before the administration of tetanus serum, an intradermal test with purified diluted horse serum 1:100 is performed to detect sensitivity to foreign protein. For the tests, syringes with a division price of 0.1 ml and thin needles are used. The diluted serum is administered intradermally into the flexor surface of the forearm in a volume of 0.1 ml. The reaction is read after 20 minutes.

The test is considered negative if the diameter of the swelling or redness appearing at the injection site is less than 1 cm. The test is considered positive if the swelling or redness reaches a diameter of 1 cm or more.

In case of a negative intradermal test, tetanus serum is administered subcutaneously in an amount of 0.1 ml (a sterile syringe is used, the opened ampoule is covered with a sterile napkin). If there is no reaction after 30 minutes, the entire prescribed dose of serum is administered subcutaneously (for prophylactic purposes), intravenously or into the spinal canal (for therapeutic purposes) using a sterile syringe.

In case of a positive intradermal test or if an anaphylactic reaction occurs to the subcutaneous injection of 0.1 ml of tetanus serum, its further administration is contraindicated. In this case, the administration of HTIG is indicated.

The administration of the drug is recorded in the established accounting form indicating the date of vaccination, dose, manufacturer of the drug, batch number, reaction to the administration of the drug.

The drug is not suitable for use if the integrity is broken or the labeling is missing, if the expiration date has expired, if the physical properties have changed, and if stored improperly.

Adverse Reactions

Sometimes the administration of the serum is accompanied by various allergic reactions: immediate (immediately after the administration of the serum or after a few hours), early (on days 2-6) and delayed (on the 2nd week and later). These reactions are manifested by a symptom complex of serum sickness (fever, itching and skin rashes, joint pain, etc.) and in rare cases by anaphylactic shock.

Given the possibility of shock when administering tetanus 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 anti-shock therapy means.

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

Contraindications

There are no contraindications for the use of tetanus serum.

Storage Conditions

The serum is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F).

Shelf Life

Shelf life – 3 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.