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Dosage form: & nbspinjection
Composition:

Serum anti-botulinum type B is a protein fraction of blood serum of horses immunized with botulinum toxoid or type B toxin containing specific immunoglobulins.

One ampoule of serum contains one treatment dose, which is 5,000 international units (ME).

Description:Serum protivobotulinicheskoy type B is a clear or slightly opalescent colorless or yellowish tinged liquid, without sediment.

Available in the kit with serum equine diluted 1: 100, which is a clear, colorless liquid, without sediment.

Pharmacotherapeutic group:MIBP serum
ATX: & nbsp
  • Botulinum antitoxin
  • Pharmacodynamics:Immunological properties
    The preparation contains antitoxins that neutralize botulinum toxins of type B.
    Indications:Treatment and prevention of botulism.
    Contraindications:

    Contraindications to the use of specific means of emergency prophylaxis of botulinumism:

    1. Presence in the anamnesis of systemic allergic reactions and complications on previous introduction of equine serum diluted 1: 100, mixtures of monovalent sera (type A, B and E), or monovalent serum anti-botulinum or hypersensitivity to drugs.

    2. Contraindication to the introduction of anti-botulinum serum in patients with botulism is the development of anaphylactic shock in determining sensitivity to horse protein.

    Pregnancy and lactation:The use of the drug is allowed for life indications, taking into account the possible benefits for the mother and the risk to the fetus or child.
    Dosing and Administration:

    Anti-botulinum serum is used for therapeutic and prophylactic purposes.

    With a curative purpose Serum is administered as soon as possible from the time of the onset of the first symptoms of botulism. Before the introduction of serum, the patient should take blood in the volume of 10 ml, urine, gastric lavage (vomit) for research on botulinum toxin and causative agent of botulism. The study also sends the food product that caused the disease.

    For the treatment of diseases caused by an unknown type of toxin (causative agent) of botulism, a mixture of monovalent sera (type A, B and E) is used.

    With a known type of toxin (pathogen) a monovalent serum of the appropriate type is used.

    Regardless of the severity of clinical symptoms, intravenous drip is administered one treatment dose of the drug, which is diluted in 200 ml of sodium chloride solution for injection 0.9%, pre-warmed before administration in warm water to a temperature of (37 ± 1) ° C. The rate of administration is 60-90 drops per minute. In exceptional cases, if drip infusion is not possible, a slow jet injection of a therapeutic dose of serum with a syringe is permitted without prior dilution.

    To avoid possible allergic reactions prior to the initiation of intravenous infusion of serum, 60-90 mg of prednisolone is injected strickenly.

    Serum is administered once.

    For preventive purposes serum is administered to people who at the same time used the products that caused the disease with botulism. Enter half the treatment dose (half the contents of the ampoule) of the same type of serum as the type of toxin that caused the disease. If the type of toxin is not established, enter half the treatment dose of all types of monovalent sera. The drug is administered intramuscularly.

    Before use, the ampoule with the drug is carefully inspected. The preparation is not suitable for use in ampoules with broken integrity, lack of marking, changing the physical properties of the preparation (discoloration, presence of non-breaking flakes), expired shelf life, improper storage.

    Before the injection, the ampoule with serum is heated, keeping in water at a temperature of (37 ± 1) FROM 5 minutes.

    Opening of ampoules with serum, the procedure for administering the drug and storing the opened ampoule (not more than an hour) is carried out with strict adherence to the rules of aseptic and antiseptic.

    Serum administration is performed under the supervision of a physician.

    Before the introduction of serum anti-botulinum to identify sensitivity to the foreign protein is mandatory intradermal with an equine serum diluted 1: 100 serum, which is complete with the drug.

    Ampoules with serum of horse purified diluted 1: 100 are marked in red, and with serum anti-botulinum - in blue or black.

    Serum horse purified diluted 1: 100 is administered at a dose of 0.1 ml intradermally to the flexor surface of the forearm.

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

    For a negative intracutaneous sample, 0.1 ml of serum is injected subcutaneously anti-butulinic. If there is no response to the latter After 30 minutes, the entire prescribed dose of serum is administered intravenously or intramuscularly.

    With a positive intradermal test with serum of horse purified diluted 1: 100 or in cases of allergic reactions to subcutaneous injection of undiluted serum anti-botulinum serum is administered only for medical purposes under the supervision of a physician and with special precautions: at first, after intramuscular injection of 60 mg of prednisolone and antihistamines, hypodermically serum equine diluted 1: 100 diluted, intended for intradermal test, with an interval of 20 minutes in a dose of 0.5 ml, 2.0 ml and 5.0 ml. Without reactions to these doses subcutaneously 0.1 ml of serum is injected with anti-botulinum. In the absence of reaction after 30 minutes intramuscularly administered the entire dose of serum.

    In case of a positive reaction to one of the above doses, 180-240 mg of prednisolone is injected intravenously, and after 5-10 minutes, intramuscularly the entire therapeutic dose of serum.
    Side effects:The introduction of anti-botulinum serum may be accompanied by the development of immediate allergic reactions, including anaphylactic shock, as well as serum sickness.
    Overdose:Not installed.
    Interaction:Not identified.
    Special instructions:

    Given the possibility of anaphylactic shock, it is necessary to ensure medical supervision of the vaccinated within 30 minutes after the end of the drug administration.

    Premises in which the serum is administered anti-botulinum should be provided with anti-shock therapy, primarily epinephrine.

    The introduction of serum (anti-botulinum and diluted) should be recorded in the medical history with the obligatory indication of the dose, method and time of administration, the patient's reaction, the serial number, the name of the enterprise that produced the drug.
    Effect on the ability to drive transp. cf. and fur:No information.
    Form release / dosage:Solution for injection, 5000 IU / dose.
    Packaging:

    Serum protivobotulinicheskoy type B - 5000 IU per ampoule. the volume of the drug in the ampoule depends on the activity of the serum.

    Horse serum, diluted 1: 100 - 1 ml in the ampoule.

    Issued in the kit. The kit consists of 1 ampoule of anti-botulinum serum and 1 ampoule of horse serum diluted 1: 100 diluted.

    For 5 sets in a pack of cardboard along with instructions for use and a knife ampoule or scarifier ampoule.

    Marking on the ampoule of horse serum diluted 1: 100 diluted with red paint, on the ampoule of serum anti-botulinum type B - blue or black paint.

    When using ampoules with notches, a break ring or an opening point an ampoule knife or a scarifier ampoule does not invest.
    Storage conditions:

    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C, out of reach of children. Freezing is not allowed.

    Conditions of transportation. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.
    Shelf life:2 years.
    The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001213
    Date of registration:27.07.2011 / 24.05.2013
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp17.03.2016
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