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Dosage form: & nbspintradermal solution
Composition:

The drug D-AL diagnostic "Mixture of molds external" is a water-salt extract from a mixture of molds (fungi) of external (Alternaria, Botrytis, Cladosporium, Fusarium, Monilia) for carrying out intradermal tests, 1000 PNU / ml. Preservative is phenol.

Composition per ml:

Active ingredient:

Allergens of fungal (water allergenic mixture of molds externa)

1000 PNU/ ml

Excipients:

Sodium chloride

5.0 mg

Potassium diphosphate

0.36 mg

Sodium Phosphate

1.43 mg

Polysorbatum (Tween 80)

0.025 mg

Phenol

2.50 mg

Water for injections

up to 1 ml

*PNU/ ml (protein N unit) -international unit adopted to express the concentration of protein nitrogen in allergens, equal to 0.00001 mg of protein nitrogen.

Available in the kit with control solution "Control I".

"CONTROL I" - orthophosphate buffer of sodium chloride.

Composition per ml:

Sodium chloride

5.0 mg

Sodium Phosphate

1.43 mg

Potassium diphosphate

0.375 mg

Polysorbatum (Tween 8 0)

0.050 mg

Phenol

1-5 mg

Water for injections

up to 1 ml

Description:The drug D-AL diagnostic "Mixture of molds external": PYellow colored grease.
Control solution "Control I ": clear, colorless liquid.
Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Allergens of mold and yeast fungi
  • Pharmacodynamics:

    Biological and immunological properties

    The active substance of the drug is a protein-polysaccharide complex of water-salt allergenic extract, which makes it possible to diagnose a patient with an intradermal test having an increased sensitivity to this kind of mold fungi.

    The ability of the allergen to interact with specific antibodies (reactions) of the patient and cause the skin reaction of a sensitized organism causes the diagnostic capabilities of the drug.

    Indications:

    Diagnosis of hypersensitivity to molds external (Alternaria, Botritis, Cladosporium, Fusarium, Monilia) in patients with 3 years.

    Contraindications:

    The presence in the anamnesis of the reaction of the anaphylactic type on skin testing is a contraindication for carrying out an intradermal test.

    Pregnancy and lactation:During pregnancy, the formulation of an intradermal test is not performed.
    During lactation, the intradermal test can be carried out only after the conclusion of an allergist.
    Dosing and Administration:

    Before taking the allergen should read the instructions for use of the drug, check the name of the allergen, expiration date.

    It is necessary to verify the integrity of the vials, as well as the absence of turbidity, foreign particles.

    The drug causes a positive skin reaction in the form of blistering and hyperemia in persons having increased sensitivity to a mixture of molds external.

    A skin test with the D-AL diagnostic drug "Mixture of molds external" is performed with the mandatory simultaneous conduct of negative and positive controls to assess nonspecific skin reactivity. A negative control is an orthophosphate buffer solution of sodium chloride (Control I). Positive control is a 0.01% solution of histamine * (0.1 g / ml), which is not part of the kit.

    The skin reaction to histamine should be positive, to "Control I" - negative. If the skin reacts positively to "Control I" or a negative reaction to the histamine solution, the samples with the allergen are not taken into account.

    Intradermal tests are placed on the skin with disinfected 70% ethyl alcohol. Using sterile disposable injection needles, intradermal bloodless administration of 0/01 ml of an allergen, Control I and 0.01% histamine solution at a distance of not less than 20 mm from each other is performed.Preparations are dialed in compliance with all the rules of aseptic in labeled syringes with a capacity of 1.0 ml. After carrying out in / to the sample vials are stored in refrigerators at a temperature of 2 to 8 ° C.

    *Note:

    Preparation of 0.01% histamine solution (dilution 1: 10000)

    A 0.01% histamine solution is prepared by diluting histamine dihydrochloride with 0.1% (FSP 42-0010-0010-00) - 1 part, solution of sodium chloride isotonic 0.9% for injection (FS 42-2595-94) - 9 parts. Shelf life of the solution - within 6 hours from the date of preparation.

    The reaction is taken into account after 15-20 minutes.

    The reaction is considered positive where the average size (diameter) of the blister D is 4 mm or more. The average size D is due to the maximum diameter of the blister (D1) and the diameter of the blister perpendicular to the maximum diameter (D2). The average size D = (D1 + D2): 2. The diameter of the blisters is measured using a scale ruler.

    The reaction intensity is evaluated according to the criteria given in the table.

    Evaluation of the intensity of the reaction D-AL DIAGNOSTIC TEST for intradermal samples

    (after 15-20 minutes) - an immediate reaction

    Degree of reaction

    The size and nature of the reaction

    0

    Hyperemia, blister less than 3 mm

    1

    Blister 3 to 5 mm

    2

    Blister from 6 to 10 mm

    3

    Blister more than 10 mm, pseudopodia possible

    The presence of a skin reaction to an allergen of intensity 1, 2, 3 of the reaction class is a criterion for the patient to have an increased sensitivity to a mixture of molds external.

    Causes of a pseudo-negative test:

    - Within a few weeks after the maximum clinical manifestations of allergic reactions, a period of lack of skin reactivity is possible, after 1-3 months the reactivity is restored;

    - Absence of skin reaction in case of vascular collapse;

    - suppression of reactivity as a result of the influence of drugs.

    Side effects:

    Adverse reactions of the anaphylactic type are rare. They appear during the first 20 minutes after the test. For conducting diagnostic tests, a specific outpatient clinic should have the medicines and the means necessary to stop acute anaphylactic conditions, as well as qualified medical personnel. After setting the skin test, patients should be under medical supervision for at least 30 minutes.

    Assisting with general reactions and anaphylactic shock

    In the event that after the introduction of the allergen the patient develops general weakness or agitation, anxiety, a feeling of fever throughout the body, redness of the face, rash, cough, shortness of breath, abdominal pain, the following measures should be taken:

    First aid first aid

    1. Immediately stop the introduction of the allergen, put the patient (head below the legs), turn his head to the side, push the lower jaw, remove the removable dentures.

    2. Apply a tourniquet above the injection site for 25 minutes.

    3. Finish the injection site with 0.3-0.5 ml of 0.1% solution of adrenaline with 4.5 ml of 0.9% sodium chloride solution.

    4. In the limb free from the tourniquet, add 0.3-0.5 ml of a 0.1% solution of epinephrine n / c or IM.

    5. Place ice or a bubble with cold water on the injection site for 10-15 minutes.

    6. Call a physician immediately.

    First medical aid

    If 1-5 items are executed and the effect is absent, you should:

    1. Enter 0.3-0.5 ml of a 0.1% solution of epinephrine subcutaneously at intervals of 5-10 minutes. The multiplicity and dose of adrenaline administered depend on the severity of the reaction and the indices of blood pressure. In severe anaphylactic shock, the adrenaline solution must be administered intravenously in 20 ml of a 40% solution of glucose.The total dose of epinephrine should not exceed 2 ml. It should be remembered that repeated administration of small doses of epinephrine is more effective than a single dose of a large dose.

    2. If blood pressure does not stabilize, intravenous drip of norepinephrine (or mezatonum) 0.2-1.0-2.0 ml per 500 ml of 5% glucose solution should be urgently started.

    3. Intramuscularly or intravenously, inject glucocorticosteroid drugs: prednisolone 60-120 mg, dexamethasone 8-16 mg or hydrocortisone succinate or hemisuccinate 125-250 mg.

    4. Intramuscularly introduce 2 ml of 0.1% solution of Tavegil or 2.5% solution of suprastin.

    5. With bronhospazme 10.0 ml of a 2.4% solution of euphyllin is intravenously injected on a 0.9% solution of sodium chloride.

    6. Cardiac glycosides, respiratory analeptics (strophanthine, korglikon, kordiamin) are introduced according to the indications.

    7. If necessary, suck off mucus from the respiratory tract, vomit and perform oxygen therapy.

    8. All patients with anaphylactic shock should be hospitalized. Transportation of patients, is carried out after, removal from a threatening state or resuscitation team, tk.in the course of evacuation, a repeated drop in blood pressure and the development of collapse are possible.

    Doses of injectable drugs and tactics of the doctor are determined by the clinical picture, but in all cases, first of all, the introduction of adrenaline, glucocorticoids, antihistamines is necessary.

    The introduction of antihistamine preparations phenothiazine series (pifolen, diprazine, etc.) and calcium preparations is not recommended.

    Interaction:

    Before setting intradermal It is not recommended to take medicine that can affect its result.

    Recommended intervals between taking medications and performing skin tests:

    Antihistamines 1 generation

    3 days

    Antihistamines 3 generations

    21 day

    Cyproheptadine

    7 days

    Ketofifen

    14 days

    Astemizole

    60 days

    Neuroleptics

    10 days

    Psychopharmacological means

    (tricyclic antidepressants)

    7 days

    The use of blockers of histamine receptors H2, chromolite, corticosteroids in doses up to 15 mg, prednisolone or its equivalent, theophylline derivatives does not affect the test result.

    Beta-blockers can increase the reactivity of the skin.

    Form release / dosage:Solution for intradermal administration, 1000 PNU / ml (complete with control solution).
    Packaging:

    For 5.0 ml of the allergen and 5.0 ml of "Control I" in bottles of glass with a rubber stopper and with capsule. Set of 1 bottle of allergen and 1 bottle of "Control I" in a cardboard box with instructions for use.

    For 5.0 ml of the allergen and 5.0 ml of "Control I" in bottles of glass of the 1 st hydrolytic class (Ph. Eur.) with a capacity of 6.5 ml with a rubber stopper and with capsule. Set of 1 bottle of allergen and 1 bottle of "Control I" in a cardboard box with instructions for use.

    Storage conditions:

    In the dark place at a temperature of 2 to 8 ° C. Do not freeze.

    Transportation

    At a temperature of 2 to 8 ° C. Do not freeze.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-001944/09
    Date of registration:16.03.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:SEVAFARMA a.o.SEVAFARMA a.o. Czech Republic
    Manufacturer: & nbsp
    SEVAPHARMA, a.s. Czech Republic
    Representation: & nbspSEVAFARMA a.o.SEVAFARMA a.o.
    Information update date: & nbsp17.03.2017
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