Serum antibotulinic type B horse purified concentrated liquid (Solvent) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06AA04 (Botulinum antitoxin)

Dosage Form

Serum antibotulinic type B horse purified concentrated liquid

Solution for injection 5,000 IU/ 1 dose: amp. 5 pcs. in a kit with purified diluted horse serum 1:100 (amp. 5 pcs.)

Dosage Form, Packaging, and Composition

Solution for injection transparent or slightly opalescent, colorless or with a yellowish tint, odorless.

1 dose – ampoules (1) in a kit with purified diluted horse serum 1:100 (amp. 1 pc.) – kit (5) – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Serum

Pharmacotherapeutic Group

Immune sera and immunoglobulins; immune sera

Pharmacological Action

Type B antibotulinum serum is a protein fraction of the blood serum of horses immunized with botulinum toxoid or type B toxin, containing specific immunoglobulins.

The preparation contains antitoxins that neutralize botulinum toxins type B.

Indications

• Treatment and prevention of botulism.

ICD codes

Dosage Regimen

The antibotulinum serum is used for therapeutic and prophylactic purposes.

For therapeutic purposes, the serum is administered as early as possible from the moment the first symptoms of botulism appear.

Before administering the serum, 10 ml of blood, urine, and gastric lavage (vomitus) should be collected from the patient for testing for botulinum toxin and the causative agent of botulism. The food product that caused the illness is also sent for testing.

For the treatment of diseases caused by an unknown type of botulinum toxin (causative agent), a mixture of monovalent sera (types A, B, and E) is used. If the type of toxin (causative agent) is known, the monovalent serum of the corresponding type is used.

Regardless of the severity of clinical symptoms, one therapeutic dose of the preparation is administered intravenously by drip, diluted in 200 ml of 0.9% sodium chloride injection solution, warmed before administration in warm water to a temperature of (37±1)°C. The infusion rate is 60-90 drops per minute.

In exceptional cases, if drip infusion is not possible, slow jet administration of the therapeutic dose of serum with a syringe without prior dilution is allowed. To avoid possible allergic reactions, 60-90 mg of prednisolone is administered by jet to the patient before the start of the intravenous serum infusion.

The serum is administered once.

For prophylactic purposes, the serum is administered to people who consumed the same products as the patient that caused botulism. Half of the therapeutic dose (half the contents of the ampoule) of the serum of the same type as the toxin that caused the disease is administered. If the type of toxin is not established, half of the therapeutic dose of all types of monovalent sera is administered. The preparation is administered intramuscularly.

Before use, the ampoule with the preparation is carefully inspected. The preparation in ampoules with damaged integrity, missing labeling, changes in physical properties (change in color, presence of non-breaking flakes), expired shelf life, or improper storage is not suitable for use.

Before administration, the ampoule with serum is heated by holding it in water at a temperature of (37±1)°C for 5 minutes.

Opening of the serum ampoules, the procedure for administering the preparation, and storage of the opened ampoule (for no more than an hour) are carried out in strict compliance with the rules of asepsis and antisepsis.

The administration of the serum is carried out under the supervision of a physician.

Before the administration of the antibotulinum serum, an intradermal test with purified diluted horse serum 1:100, which is included in the kit with the preparation, is mandatory to detect sensitivity to foreign protein.

Ampoules with purified diluted horse serum 1:100 are marked in red, and with antibotulinum serum – in blue or black. Purified diluted horse serum 1:100 is administered in a dose of 0.1 ml intradermally into the flexor surface of the forearm.

The test is considered negative if after 20 minutes the swelling or redness at the injection site is less than 1 cm. The test is considered positive if the swelling or redness reaches 1 cm or more.

With a negative intradermal test, 0.1 ml of antibotulinum serum is administered subcutaneously. In the absence of a reaction to the latter after 30 minutes, the entire prescribed dose of serum is administered intravenously or intramuscularly.

With a positive intradermal test with purified diluted horse serum 1:100 or in cases of allergic reactions to the subcutaneous injection of undiluted serum, the antibotulinum serum is administered only for therapeutic purposes under the supervision of a physician and with special precautions: first, after intramuscular administration of 60 mg of prednisolone and antihistamines, purified diluted horse serum 1:100, intended for the intradermal test, is administered subcutaneously at 20-minute intervals in doses of 0.5 ml, 2.0 ml, and 5.0 ml.

In the absence of reactions to these doses, 0.1 ml of antibotulinum serum is administered subcutaneously. In the absence of a reaction after 30 minutes, the entire dose of serum is administered intramuscularly.

In case of a positive reaction to one of the above doses, the patient is administered 180-240 mg of prednisolone intravenously by jet and, after 5-10 minutes, the entire therapeutic dose of serum intramuscularly.

Adverse Reactions

Administration of antibotulinum serum may be accompanied by the development of immediate-type allergic reactions, including anaphylactic shock, as well as serum sickness.

Contraindications

Contraindications to the use of specific means of emergency prevention of botulism

• History of systemic allergic reactions and complications to previous administration of diluted horse serum 1:100, a mixture of monovalent sera (types A, B, and E), or to monovalent antibotulinum serum, or hypersensitivity to the preparations;
• A contraindication to the administration of antibotulinum serum in patients with botulism is the development of anaphylactic shock when determining sensitivity to horse protein.

Use in Pregnancy and Lactation

The use of the preparation 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

Given the possibility of anaphylactic shock, medical supervision of the vaccinated persons must be ensured for 30 minutes after the end of the administration of the preparation! The premises where the antibotulinum serum is administered must be equipped with means for anti-shock therapy, primarily adrenaline (epinephrine).

The administration of sera (antibotulinum and diluted) must be recorded in the medical history with mandatory indication of the dose, method and time of administration, the patient’s reaction, batch number, and the name of the manufacturer of the preparation.

Effect on the ability to drive vehicles and mechanisms

No information available.

Overdose

Not established.

Drug Interactions

Not identified.

Storage Conditions

Store and transport in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) 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.