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Dosage form: & nbspsolution for intramuscular and subcutaneous administration
Composition:

The preparation is a protein fraction of the blood serum of horses hyperimmunized with diphtheria toxoid, containing antitoxic antibodies, purified and concentrated by peptic digestion and salt fractionation.

1 ml of serum contains not less than 1500 international antitoxic units of activity (ME).

Description:

Concentrated antifungal horse serum - Popaque or slightly opalescent colorless or yellowish tinged liquid without sediment.

Comes complete with Horse serum diluted 1: 100 serum, which is a clear, colorless liquid without sediment.

Pharmacotherapeutic group:MIBP - serum
ATX: & nbsp
  • Diphtheria Antitoxin
  • Pharmacodynamics:

    Immunological properties

    Antibodies contained in the drug neutralize diphtheria exotoxin.

    Indications:

    Treatment of patients with diphtheria.

    Contraindications:

    Clinical contraindications for the use of serum antidiphtheria are absent.

    Pregnancy and lactation:

    The safety of the use of this medication during pregnancy and during lactation during clinical trials has not been investigated.

    Dosing and Administration:

    A single dose of serum is: for localized forms 10000-20000 ME, diphtheria of the larynx 40000 - 50000 ME, with a subtotal form of 40000-50000 ME, toxic I degree 50000-70000 ME, toxic II degree 60000-80000 ME, hemorrhagic 100000-120000 ME.

    If there is no effect, serum administration can be repeated after 12-24 hours using the same doses.

    Serum is administered intramuscularly and subcutaneously. As a rule, the maximum volume of a drug administered in one place should not exceed 10 ml.

    Before the first introduction of serum without fail put cutaneous test with an equine serum diluted 1: 100 serum (ampoule marked in red) to determine the patient's sensitivity to horse serum proteins. Serum horse purified diluted 1: 100 is injected in a volume of 0.1 ml intradermally into the flexor surface of the forearm. The reaction is taken into account after 20 minutes. The sample is considered negative if the diameter of the edema and (or) redness appearing at the injection site is less than 1 cm. The sample is considered positive if the edema and / or redness reaches a diameter of 1 cm or more.

    With a negative skin test, serum antidiphtheria (ampoule marked in blue or black color) is administered in a volume of 0.1 ml subcutaneously to the area of ​​the middle third of the shoulder.

    In the absence of a local or general reaction via (45±15) min is administered intramuscularly to the area of ​​the upper third of the anterior-external surface of the thigh or buttock the appointed dose of serum antidiphtheria, heated to a temperature of (36 ± 1) ° C. The patient who received the serum should be under the supervision of the doctor for an hour.

    With a positive intradermal test, the serum is administered only according to vital indications under the supervision of a physician and with special precautions. Initially, injected serum under the skin serum antidiphtheria diluted in doses of 0.5 ml, 2 ml, 5 ml (diluted serum is prepared immediately before use, introducing 0.1 ml of serum antidiphtheria in 9.9 ml sterile sodium chloride solution 0.9%) at intervals 20 minutes. In the absence of a reaction to these doses, 0.1 ml of serum is administered subcutaneously with antidiphtheria. In the absence of reaction, after 30 minutes, all the prescribed amount of serum is administered intramuscularly. In the case of a positive reaction to one of the above doses,serum antidiphtheria is not injected or injected under anesthesia, having a syringe ready with a 0.1% solution of epinephrine hydrochloride or a 0.2% solution of noradrenaline hydrotartrate.

    All manipulations are carried out by separate sterile syringes, the opened ampoule is closed with a sterile napkin, stored at a temperature (20 ± 2) ° C not more than 1 hour.

    An uncovered ampoule with an equine serum diluted 1: 100 is not subject to storage.

    Side effects:

    The introduction of serum can lead to the development of anaphylactic shock and other allergic reactions of immediate type, as well as the symptomatic complex of serum sickness (fever, skin rashes, arthralgia) appearing early (on days 2-6) and distant (on week 2), duration from several hours to several weeks.

    Overdose:

    Not installed.

    Interaction:

    Not installed.

    Special instructions:

    Precautions for use

    1. Given the possibility of developing an anaphylactic shock, for every vaccinated person it is necessary to provide medical supervision within one hour after the introduction of serum. Vaccination sites should be provided with anti-shock therapy.

    Persons who have received antidiphtheria serum should be warned about the need to seek immediate medical attention in case of signs characteristic of serum sickness.

    2. Before the administration of the drug be sure put an intradermal test with horse serum diluted 1: 100 dilution to detect sensitivity to the foreign protein.

    3. The preparation is not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color, transparency, presence of unbreakable flakes), expired, with improper storage.

    Effect on the ability to drive transp. cf. and fur:No information.
    Form release / dosage:Solution for intramuscular and subcutaneous administration, 10,000 IU / mL.
    Packaging:

    Concentrated antifungal horse serum, solution for intramuscular and subcutaneous administration - 10,000 ME in ampoules.

    Horse serum, diluted 1: 100 diluted, solution for intradermal administration - 1 ml in ampoules.

    Issued in the kit. The kit consists of 1 ampoule of serum of antidiphtherist horse purified concentrated (marking is applied in blue or black color) and1 ampoule of horse serum diluted 1: 100 (labeled in red).

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

    When packing ampoules with notches, a ring of fracture and a point for opening, the ampoule knife or ampoule scaper is not put.

    Storage conditions:

    Transportation conditions. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

    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.

    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-001409
    Date of registration:21.12.2011 / 29.04.2013
    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: & nbsp13.03.2016
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