Histamine dihydrochloride solution 0.01% for skin diagnosis of allergic diseases

INSTRUCTION for medical use of the medicinal product Histamine Dihydrochloride 0.01% Solution for Skin Diagnosis of Allergic Diseases

Composition:

Active substance: 1 ml of solution contains 0.1 mg of histamine dihydrochloride;

Excipient: water for injections.

1 vial contains 4.5 ml of 0.01% histamine dihydrochloride solution.

Pharmaceutical form. Solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Diagnostic agents. Agents for testing allergic diseases.

ATC Code V04CL.

Immunological and biological properties.

The action of histamine dihydrochloride on skin cell receptors leads to local vasodilation and edema, papule formation, and stimulation of nerve endings, which together cause itching and neurogenic hyperemia of the adjacent skin area. Therefore, skin response to a skin prick test with histamine dihydrochloride solution is widely used to determine normal skin reactivity.

Clinical characteristics.

Indications.

Use as a positive control in performing skin tests for the diagnosis of allergic diseases.

Contraindications.

Contraindications for performing skin tests with histamine dihydrochloride solution include the presence of any skin diseases.

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

Special precautions for use.

0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases should be used under aseptic conditions.

Skin reaction to histamine solution must be positive. If the reaction is negative, allergen testing should not be performed, as this indicates skin non-reactivity, which may be associated with circulatory disorders, edema, dehydration, UV radiation exposure, general cachexia, or advanced age.

Use during pregnancy or breastfeeding.

0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases may be used during pregnancy or breastfeeding as a positive control in skin prick tests with allergens, if the physician decides to perform such testing, since pregnancy is a relative contraindication for skin allergen testing.

Ability to influence reaction rate while driving or operating machinery.

Information not available.

Method of Administration and Dosage

For performing skin tests using the prick test method (scarification test may also be performed). Skin tests should only be conducted after the physician has obtained the patient's written informed consent!

Skin tests should be applied to the inner surface of the forearm, spaced (30±10) mm apart (if not possible, on the skin of the back).

0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases should be used under aseptic conditions. Apply 1 drop of histamine dihydrochloride solution onto the skin disinfected with 70% ethyl alcohol, using a sterile dropper cap. With a sterile disposable lancet, individual for each patient, puncture the skin through the drop of histamine solution until stopped by the lancet's depth limiter. For scarification testing, use a sterile scarifier, individual for each patient, to make a 5 mm scratch through the drop of histamine solution.

Evaluation of Skin Test Results

Evaluate skin test results after 15–20 minutes (immediate-type reaction). Assess the reaction according to the table below. The skin reaction to histamine solution must be positive; if the reaction is negative, allergen testing should not be performed, as this indicates skin non-reactivity.

Skin Test Evaluation Scheme

Children.

A 0.01% solution of histamine dihydrochloride for skin diagnosis of allergic diseases may be used in pediatric practice as a positive control during skin testing with allergens by the prick-test method.

Overdose.

Not described.

Adverse reactions.

Skin testing with 0.01% histamine dihydrochloride solution does not produce adverse effects on the patient undergoing the test. To reduce itching, which is a normal skin reaction to histamine solution, after evaluation of the skin test the application site should be rinsed with running water.

Shelf life.

5 years.

The shelf life of 0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases, stored in the refrigerator and closed with a dropper cap, is 1 year, but not exceeding the total shelf life indicated on the vial.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

4.5 mL in glass vials for medicinal products, either domestically or foreign manufactured. Vials are sealed with rubber stoppers and crimped with aluminum caps.

Supplied as 1 vial with a sterile dropper cap or 10 vials placed in a cardboard box.

Each box contains an instruction leaflet.

Prescription status. Prescription only.

Manufacturer/Marketing Authorization Holder.

LLC "Immunolog", Ukraine.

Manufacturer's address and location of its business activities / Holder's and/or its representative's address.

5, Dmytro Mayboroda Street, Vinnytsia, Vinnytsia region, 21036, Ukraine.