Instruction of application

Patient information leaflet   

for pollen allergic agents taken from:

black poplar, Chinese elm, ash-leaved maple, birch, English oak, meadow fescue, couch grass, cooksfoot grass, timothy grass, ruderal hemp, common wormwood, flint corn, estragon wormwood, ragweed, frosted orach, Zailiyskiy wormwood. 

Trade name

Plant pollen allergic agent

International nonproprietary name

Grass pollen allergen

Pharmaceutical form

Water-salt extract 10 000 PNU/ml, 5 ml

Content

One vial contains:

Active substance plant pollen                                              

Excipients: Sodium chloride, potassium dihydrogen phosphate, sodium phosphate, 4% phenol solution, water.

Description

Allergens mean water-salt extract of protein-polysaccharide complexes received from pollen of black poplar, Chinese elm, ash-leaved maple, birch, English oak, meadow fescue, couch grass, cooksfoot grass, timothy grass, ruderal hemp, common wormwood, flint corn, estragon wormwood, ragweed, frosted orach, Zailiyskiy wormwood through extraction by neutral phosphatic buffer solution. They are presented in the form of transparent liquid of light yellow to dark brown color with specific odor.

Pharmacotherapeutic group

Allergens extracts.

Code АТС V01AA

Pharmacological properties

Pollen allergens are based on protein-polysaccharide complexes, which allow diagnosing hypersensitivity to pollen through skin tests.

Indications for use

Specific diagnosis of pollinosis, atopic asthma associated with hypersensitivity to plant pollen.

Diagnostic reasons are clinical manifestation of disorder and past medical history.

Dosage and administration

The medicine is used for scratch tests performance.

Skin tests shall be performed on a once-only basis. In the case of controversial results skin test may be repeated within 2 days after reduction of local response on previous test. If result was positive, you may repeat skin test with plant allergens no more than once a month.

Together with allergens skin tests with control fluid and with 0.001% histamine solution shall be performed.

Skin tests shall be done on inner side of forearm or back skin. It is possible to perform 15 tests with different pollen allergens at one time.

Metal cap of vial (with allergen or control fluid) shall be rubbed with alcohol. Remove center cover cap by sterile forceps and clean rubber stopper with alcohol, then puncture rubber stopper by a sterile needle. Inner skin of forearm shall be wiped with 70 ˚ alcohol and dried. Place drops of tested allergens, control fluid and or   0.001% histamine solution on disinfected skin  on the distance (30 ± 10) mm apart. Use separate sterile syringe for each allergen. You may not pour allergen filled into syringe back to the vial.

Make two parallel scratches,5 mmeach, (scarification) through the drops of the medicine by sterile scarification or injection needle. Use separate needle for each allergen and for each patient. 

Accounting scheme for scarification allergic tests
 (scarification, prick test) 

Evaluation of response

description

Size and type of response

Negative

Positive

Positive

Positive

 

 

Positive

 

-

+

++

+++

 

 

++++

No wheal and hyperemia;

Wheal 2-3 mm, hyperemia;

Wheal 4-5 mm, hyperemia;

Wheal 6-10 mm, hyperemia or wheal 6-10 mmwith pseudopodium and hyperemia;

Wheal more than10 mm, hyperemia or wheal more than10 mmwith pseudopodium  hyperemia.

Results of tests may be evaluated within 15-20 minutes (immediate-type reaction). Results of tests shall be accepted only if control fluid gave negative result and 0.001% histamine solution gave positive result.

Contradictions

- exacerbation of allergic disease;

- acute infections;

- chronic diseases in stage of decompensation;

- pregnancy;

- tuberculosis at any site during exacerbation;

- Mental disorders during exacerbation;

- systemic connective tissue diseases;

- malignant disease;

- hormone therapy, therapy with antihistamines and bronchospasmolitics.

Drug interactions

Skin tests with allergens shall be performed within:

- one week after tuberculosis test;

- two weeks after administration of inactivated vaccines and therapy with antihistamines;

- four weeks after administration of replicating vaccines;

- eight – twelve weeks after administration of BCG vaccine.

Special instructions

Sensitive patients may experience systemic allergic reactions and anaphylactic shock. Therefore room, where the procedure is performed, shall be supplied with pharmacological drugs.

If during allergen administration a patient feels weakness or agitation, anxiety, feeling of heat in the body, flushing, rash, cough, abdominal pain use the following instructions:

First aid. Immediately stop administration of allergen; lay down the patient (head below the feet), turn his head to the side, push the lower jaw, remove removable dentures.

  1. If allergen was administrated into the limb, apply tourniquet above the injection site for 25 minutes.
  2. Drug the injection site with 0.3-0.5 ml of 0.1% adrenaline solution and with 4.5 ml of 0.9% sodium chloride solution.
  3. Apply ice or water bottle with cold water to injection site for 10-15 minutes
  4. Administrate subcutaneously or intramuscularly 0.3-0.5 ml of adrenalin solution (0.15-0.3 ml for children) into limb without tourniquet.
  5. Immediately call the doctor.

Release form and packaging

5.0 ml of the medicine is placed into glass vial, closed by rubber stopper and clamped by aluminum cap. 10 ml vial with package leaflet on official language and Russian language is placed into carton box.

Storage conditions

Store in dry shadowed place at a temperature of 4 ºС to 8 ºС.

Expiry date

2 years

Do not use the medicine after expiration of shelf life specified on package.

Manufacturer

Burly LLP, 34 Makatayev street, Almaty, 050002, The Republic of Kazakhstan

Phone number: 8 (727)397-75-16, phone/fax 8 (727)397-75-17

e-mail: burly@mail.ru