Description
The main active ingredient of the allergen is a protein-polysaccharide complex used to diagnose hypersensitivity to cocksfoot grass pollen in patients by skin tests and to apply it for the immunotherapy of hay fever and atopic asthma.
Presentation
Solution for application on scarified skin, intracutaneous and subcutaneous administration, 10000 PNU/ml in 5,0 ml vials; test control fluid in 4.5 ml vials; diluting liquid in 4.5 ml vials. Available in combination with . 1 vial of allergen, 7 vials of diluting liquid, 1 vial of test control fluid, 1 empty sterile vial in the cardboard package with a package insert.
Ingredients
The allergen is an aqueous saline extract of the protein-polysaccharide complexes - 10,000 PNU/ml*, isolated from cocksfoot grass pollen by extraction in neutral phosphate buffered saline.
The phosphate buffered saline contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrogen phosphate dodecahydrate (equivalent to 0.56 mg of sodium dihydrogen phosphate) - 1.4 mg, potassium dihydrogen phosphate - 0.36 mg, phenol (preservative) - 2.0 - 4.0 mg, water for injection - 1 ml. The above salt concentration is estimated, it is not detectable in the finished product.
Note:
* PNU (proteinnitrogenunit) is an international unit accepted to express the concentration of protein nitrogen in allergens, equal to the content of 1x10-5 mg of protein nitrogen.
The test control and diluting liquids are available in combination with the allergen
The test control liquid – phosphate buffered saline contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrogen phosphate dodecahydrate (equivalent to 0.56 mg of sodium dihydrogen phosphate) - 1.4 mg, potassium dihydrogen phosphate - 0.36 mg, phenol (preservative) - 2.0 - 4.0 mg, water for injection - 1 ml.
The diluting liquid – phosphate buffered saline with added polysorbate-80 contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrogen phosphate dodecahydrate (equivalent to 0.56 mg of sodium dihydrogen phosphate) - 1.4 mg, potassium dihydrogen phosphate - 0.36 mg, phenol (preservative) - 2.0 - 4.0 mg, polysorbate-80 - 0,005 µl, water for injection - 1 ml.
Indications
Specific diagnosis and specific immunotherapy of pollinosis and atopic asthma caused by hypersensitivity to cocksfoot grass pollen.
Indications for diagnosis are clinical manifestations of the disease and history data
Indications for specific immunotherapy are defined by the allergist based on the history, clinical manifestations of the disease, results of the skin test, taking into account the contraindications.
