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Dosage form: & nbspinjection
Composition:

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

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

Description:Anti-butulinic serum E type serum 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 E.
    Indications:

    Treatment and prevention of botulism.

    Contraindications:

    Contraindications to the use of specific emergency prevention 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 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% solution of sodium chloride, warmed before 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 (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) ° 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, edema 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 intradermal test subcutaneously injected with 0.1 ml of undiluted anti-botulinum serum. 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:

    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, 10,000 IU / dose.
    Packaging:

    Anti-butulinic serum E type serum 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.

    Issue in the set. 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 an ampoule of horse serum diluted 1: 100 diluted with red paint, on the ampoule of serum anti-botulinum type E - 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.

    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-001214
    Date of registration:22.07.2011 / 20.03.2014
    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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