Description
Release form
Injection solution is clear or slightly opalescent, colorless or yellowish, odorless.
Packing
1 dose – ampoules (1) complete with purified horse serum diluted 1: 100 (amp. 1 pc.) – set (5) – packs of cardboard.
Pharmacological action
Type B anti-botulinum serum is a protein fraction of the blood serum of horses immunized with botulinum toxoid or type B toxin containing specific immunoglobulins.
The drug contains antioxidants that neutralize type B botulinum toxins.
Indications
– treatment and prevention of botulism.
Contraindications
Contraindications to the use of specific means of emergency prophylaxis of botulinumism:
– the presence of a history of systemic allergic reactions and complications to the previous administration of horse serum diluted 1: 100, a mixture of monovalent serums (type A, B and E), or to monovalent anti-botulinum serum or hypersensitivity to
drugs – a contraindication to the administration of anti-botulinum serum in botulism patients is the development of anaphylactic shock in determining sensitivity to horse protein.
Use in pregnancy
Use of the drug is allowed for health reasons, taking into account the possible benefits to the mother and risk to the fetus or child.
Special instructions
Precautions for using
Considering the possibility of anaphylactic shock, it is necessary to ensure medical monitoring of vaccinated for 30 minutes after the end of the drug! Premises in which the administration of anti-botulinum serum is carried out, should be provided with means of anti-shock therapy, primarily adrenaline (epinephrine).
The administration of sera (anti-botulinum and diluted) should be recorded in the medical history with the obligatory indication of the dose, method and time of administration, patient response, batch number, name of the company that manufactured the drug.
Composition
anti-botulinum serum type B5 000 IU
Dosage and administration of
Antitumor serum is used for therapeutic and prophylactic purposes.
For therapeutic purposes, serum is administered as early as possible from the moment the first symptoms of botulism appear. Prior to the administration of serum, a patient should take blood in a volume of 10 ml, urine, gastric lavage (vomit) for testing for botulinum toxin and botulism. The food product that caused the disease is also sent for research.
A mixture of monovalent sera (types A, B and E) is used to treat diseases caused by an unknown type of botulinum toxin (pathogen). With a known type of toxin (pathogen), monovalent serum of the appropriate type is used.
Regardless of the severity of the clinical symptoms, one therapeutic dose of the drug is administered intravenously, which is diluted in 200 ml of sodium chloride injection solution 0.9%, heated before introduction in warm water to a temperature of (37 ± 1) ° ¡. The rate of administration is 60-90 drops per minute. In exceptional cases, when it is impossible to carry out drip infusion, a slow jet injection of a therapeutic dose of serum with a syringe is allowed without prior dilution. To avoid possible allergic reactions. Before the start of intravenous infusion of serum, the patient is injected 60-90 mg of prednisolone jet.
Serum is administered once.
For prophylactic purposes, serum is administered to people who have consumed products that caused botulism along with the patient. Enter half the treatment dose (half the contents of the ampoule) of the serum of the same type as the type of toxin that caused the disease. If the type of toxin is not established, half the therapeutic dose of all types of monovalent serums is administered. The drug is administered intramuscularly.
Before use, the ampoule with the drug is carefully inspected. The drug is not suitable for use in ampoules with impaired integrity, lack of labeling, with a change in the physical properties of the drug (color change, the presence of unbreakable flakes), with an expired shelf life, improper storage.
Before administration, the serum ampoule is heated, keeping in water at a temperature of (37 ± 1) ° ¡ for 5 minutes.
Opening vials with serum, the procedure for administering the drug and storing the opened vials (no more than an hour) is carried out with strict observance of the rules of asepsis and antiseptics.
Serum is administered under medical supervision.
Before the introduction of anti-botulinum serum to detect sensitivity to a foreign protein, an intracutaneous test is mandatory with purified horse serum diluted 1: 100, which is complete with the drug.
Ampoules with purified horse serum diluted 1: 100 are marked in red, and with anti-botulinum serum in blue or black. Purified horse serum diluted 1: 100 is injected at a dose of 0.1 ml intradermally into the flexion surface of the forearm.
A 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.
In case of a negative intradermal test, 0.1 ml of anti-botulinum serum is injected subcutaneously. In the absence of a reaction to the latter, after 30 minutes, the entire prescribed dose of serum is administered intravenously or intramuscularly. In case of a positive intracutaneous test with purified horse serum diluted 1: 100 or in cases of allergic reactions to subcutaneous injection of undiluted serum, anti-botulinum serum is administered only for medicinal purposes under medical supervision and with special precautions: first, after intramuscular injection of 60 mg of prednisolone and antihistamines , horse-drawn purified whey diluted 1: 100 is administered subcutaneously for intracutaneous testing at intervals of 20 minutes at a dose of 0.5 ml, 2.0 ml and 5.0 ml. In the absence of reactions to these doses, 0.1 ml of anti-botulinum serum is subcutaneously administered. If there is no reaction after 30 minutes, the entire dose of serum is intramuscularly administered.
In the event of a positive reaction to one of the above doses, 180-240 mg of prednisone and, after 5-10 minutes, intramuscularly, the entire therapeutic dose of serum are injected intravenously.
Side effects
Administration of anti-botulinum serum may be accompanied by the development of immediate allergic reactions, including anaphylactic shock, as well as serum sickness.
Storage conditions
Store and transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 ° to 8 ° C out of the reach of children. Freezing is not allowed.
Expiration
2 years.
pharmacy terms for
Dosage form
injection solution
Microgen NPO, Russia
