Solution for allergens

INSTRUCTIONS for medical use of the medicinal product Allergen Soluble Liquid

Composition:

sodium chloride, disodium phosphate dodecahydrate (sodium phosphate dibasic), potassium dihydrogen phosphate (potassium phosphate monobasic), phenol, Tween 80, water for injections;

1 vial contains 4.5 mL of allergen soluble liquid.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Diagnostic agents. Agents for performing tests in allergic diseases.

ATC Code V04CL.

Immunological and biological properties.

Not applicable. Allergen soluble liquid is chemically inactive and does not exert pharmacological effects.

Clinical characteristics.

Indications.

Preparation of dilutions of non-infectious allergens for use in specific immunotherapy of allergic diseases and as a negative control in skin testing with allergens using the prick-test method.

Contraindications.

Contraindications for skin testing with the diluent solution include the presence of any skin diseases.

Interaction with other medicinal products and other forms of interaction. Not described.

Special precautions for use

The allergen diluent solution must be used in accordance with aseptic techniques.

Skin reaction to the allergen diluent solution should be negative; if a positive reaction occurs, allergen testing is not reliable.

The medicinal product contains potassium and sodium compounds; however, the content is less than 1 mmol (39 mg)/dose of potassium and 1 mmol (23 mg)/dose of sodium, which allows the product to be considered practically free of potassium and sodium.

Use during pregnancy or breastfeeding

Use of the allergen diluent solution during pregnancy or breastfeeding is determined by the recommendations for use of non-infectious allergens during these periods, since the allergen diluent solution is used only in conjunction with allergens (for skin testing or specific immunotherapy). The diluent solution itself has no pharmacological effect.

Ability to influence reaction rate when driving or operating machinery

No information available.

Method of Administration and Dosage

For performing skin tests using the prick test method (scarification test may also be performed).

Skin tests must be conducted only after the physician has obtained written informed consent from the patient!

Skin tests are applied on the inner surface of the forearm at a distance of (30±10) mm from each other (if not feasible, on the skin of the back).

For more detailed information regarding the preparation of allergen dilutions for specific immunotherapy of allergic diseases, refer to the instructions for medical use of medicinal products containing non-infectious allergens.

The allergen diluent solution must be used under aseptic conditions. Apply 1 drop of the allergen diluent solution onto skin disinfected with 70% ethyl alcohol, using a sterile dropper cap. Using a sterile disposable lancet, individual for each patient, puncture the skin through the drop of the diluent solution until the lancet's stop is reached. When performing a scarification test, make a 5 mm scratch through the drop of the diluent solution using a sterile scarifier, individual for each patient.

Evaluation of skin test results is performed 15–20 minutes after application (immediate-type reaction). The skin reaction to the allergen diluent solution must be negative; if a positive reaction occurs, allergen test results are invalid.

Children

The allergen diluent solution may be used in pediatric practice according to the indications specified in the section "Indications".

Overdose

Not described.

Adverse reactions.

Not described.

Shelf life. 5 years.

The shelf life of the allergen solution liquid in dropper bottles with caps, used for skin testing and stored in the refrigerator, is 1 year, but not exceeding the total shelf life indicated on the vial.

Storage conditions.

Store at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

4.5 mL in glass vials for medicinal products of domestic or foreign manufacture. The vials are closed with rubber stoppers and sealed with aluminum caps.

Packaged in sets of 10 vials placed in a cardboard box.

Each box contains an instruction leaflet for use.

Prescription status.

Prescription only.

Manufacturer/Marketing Authorization Holder.

LLC "Immunolog", Ukraine.

Address of manufacturer and location of its business activity / address of the marketing authorization holder and/or the holder's representative.

5 Dmytro Mayborody Street, Vinnytsia, Vinnytsia Oblast, 21036, Ukraine.