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Dosage form: & nbspinjection
Composition:

Anti-butulinic serum type A is a protein fraction of blood serum of horses immunized with botulinum toxoid or toxin A, containing specific immunoglobulins.

One ampoule of serum contains one treatment dose, which is 10,000 international units (ME).

Description:

Anti-butulinic serum type A 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 neutralizing botulinum toxins of type A.
    Indications:Treatment and prevention of botulism.
    Contraindications:

    Contraindications to the use of specific emergency prevention of botulinumism:

    1.The presence in the history of systemic allergic reactions and complications for the previous introduction of serum equine diluted 1: 100, a mixture 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 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 serums are 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 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 sterile isotonic 0.9% sodium chloride solution, pre-heated before the introduction 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 (changing the colors of unbreakable flakes), expired shelf life, improper storage.

    Before the injection, the ampoule with serum is heated, keeping in water at a temperature of (37 ± 1) ° C for 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 antibotulinum serum to detect sensitivity to a foreign protein, intradermal with diluted 1: 100 horse serum, which is complete with the drug.

    Ampoules with diluted 1: 100 serum are marked in red, and with antibotulinum serum - in blue or black.

    The diluted serum is administered in a dose of 0.1 ml intradermally to the flexor surface of the forearm.

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

    With a negative intracutaneous sample, 0.1 ml of undiluted anti-botulinum serum is injected subcutaneously. If there is no reaction to the latter, after 30 minutes, the entire prescribed dose of serum is administered intravenously or intramuscularly.

    With a positive intradermal test with diluted serum or in case of allergic reactions to subcutaneous injection of undiluted serum, anti-butulinic serum is administered only for medical purposes under the supervision of a physician and with special precautions: first, after intramuscular injection of 60 mg of prednisolone and antihistamines, subcutaneously diluted 1 : 100 serum intended for intradermal test, with an interval of 20 minutes at a dose of 0.5 ml, 2.0 ml and 5.0 ml. In the absence of a reaction to these doses, 0.1 ml of undiluted anti-botulinum serum is injected subcutaneously. In the absence of reaction after 30 minutes intramuscularly administered the entire dose of serum.

    In the 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.

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

    Side effects:Introduction serum anti-botulinum may be accompanied by the development of allergic reactions of immediate type, including anaphylactic shock, as well as serum sickness.
    Overdose:

    Not installed.

    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, 10,000 IU / dose.

    Packaging:

    Anti-butulinic serum type A to 10,000 IU in the 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.

    The marking on the ampoule of the serum of equine diluted horse - 1: 100 is applied with red paint, on the ampoule of serum of anti-botulinum type A - with blue or black paint.

    When using ampoules with incisions, a ring of fracture or an opening point, the ampoule opener or ampoule scaper is not inserted.
    Storage conditions:

    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.

    Transportation conditions

    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-001212
    Date of registration:22.07.2011 / 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: & nbsp18.03.2016
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