Affinoleukin® (Affinoleukin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration
Composition:

Active substance: complex of fragments of antigen-binding proteins of T-cell origin with a molecular weight of 5-8 cd.

Excipient: glycine (stabilizer) - 5.4 mg (calculated content).

Note. 1 unit Affineoleukin corresponds to the activity of the drug, prepared from 500 million leucocytes of donor blood.

The drug does not contain preservatives and antibiotics.

Description:

Amorphous mass of white color.

The dissolved preparation is a colorless, transparent solution without foreign inclusions.

Pharmacotherapeutic group:Cytokine
ATX: & nbsp
  • Other immunostimulants
    • Pharmacodynamics:

    Characteristic

    The preparation is a complex of fragments of antigen-binding proteins of T-cell origin with a molecular weight of 5-8 Kd, specific for antigens of a number of widely spread pathogens of infectious diseases and clinically healthy donors isolated from blood leukocytes. Surface antigen of hepatitis B virus and antibodies to HIV-1, HIV-2, hepatitis C virus are absent.

    Immunological properties

    Affinoleukin® contains antigen-specific cytokines of T-cell origin.In cellular immunity deficiency administering drug recovers lost and amplifies oppressed dependent cell immunoreactivity ubiquitous antigens of infectious agents such as herpes simplex viruses and hepatitis B, Staphylococcus, Streptococcus, Mycobacterium tuberculosis, Corynebacterium, yeast fungi, etc.

    Indications:As an additional component of the integrated drug treatment in adults and children two years of age for the treatment of exacerbations of severe and moderate forms of atopic dermatitis (L 20, L 20.8, L 20.9), psoriasis (L 40, L 40.1), herpetic eye disease (B 00.5) in cases of protracted course or secondary infection.
    Contraindications:

    Individual intolerance, hypersensitivity to the components of the drug, children under 2 years.

    Pregnancy and lactation:

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

    Dosing and Administration:

    The contents of the ampoule are dissolved immediately before use in 1 ml of sodium chloride solution for injection 0.9%.The drug should dissolve within no more than 15 seconds to form a colorless transparent solution, without foreign inclusions.

    Affinoleukin® is administered subcutaneously once a day 1-3 times a week. At the first injection, 0.5 units are administered and, in the absence of adverse reactions, the administered dose is increased by 0.5 units to 1 or 2 units, depending on the patient's age.

    Single dose for children should not exceed 1 unit, for adolescents and adults - 2 units. The course dose for children, as a rule, is 10 units, for teenagers and adults - 20 units.

    If at the end of the course the positive dynamics of the process was not achieved, the course should be continued in children up to 15 units, in adults - up to 30 units.

    With the onset of remission for the prevention of exacerbations, it is recommended to administer 1 unit 1-2 times per month. Do not begin prophylactic administration of the drug during remission in patients who have not previously received a drug to relieve the exacerbation.

    In cases of relapse, the course of injections is repeated.

    Side effects:
    In rare cases, when using the drug Affinoleukin ®, it is possible to raise the temperature to subfebrile values ​​(37.5 ° C), as well as the development of the following adverse reactions:

    From the muscular system: feeling of mild pain and paresthesia at the time of administration.

    From the skin: mild hyperemia of the skin at the injection site.

    In patients with atopic dermatitis and psoriasis, there may be a slight short-term increase in certain symptoms of dermatitis-hyperemia and itching.

    These reactions can not be used as a reason for discontinuing the drug, as they do not usually occur on subsequent injections.

    Overdose:

    Not registered.

    Interaction:

    Not found.

    The use of the drug is possible in combination with other drugs, but in a separate syringe.

    Special instructions:

    Do not store the drug in a dissolved form.

    A drug whose package integrity is broken (cracked ampoules), a drug without labeling, a drug with altered physical properties, in the presence of foreign inclusions is unsuitable for use.

    Effect on the ability to drive transp. cf. and fur:

    Not was studied.

    Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration.
    Packaging:

    For 0.5, 1 or 2 meals in an ampoule.

    For 10 ampoules in a pack of cardboard with instructions for use and a scarifier ampoule (if necessary).

    Storage conditions:At a temperature of 2 to 8 ° C, out of the reach of children.

    Transportation conditions

    At a temperature of 2 to 8 ° C.

    Shelf life:

    2 years.

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005203/08
    Date of registration:03.07.2008 / 21.03.2014
    Expiration Date:Unlimited
    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: & nbsp21.09.2017
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