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Dosage form: & nbspdrops for oral administration
Composition:

The pollen allergen is a water-salt extract from a mixture of pollen of trees (alder sticky, birch hanging, ordinary hornbeam, common hazel, slender ash, willow goat).

Composition:

Active component:

Aqueous allergenic extract pollen of trees

1, 10, 100, 1000, 10000 PNU / ml

Excipients:

Sodium chloride

2.50 mg

Sodium bicarbonate

1.375 mg

Polysorbatum (Tween 80)

0.025 mg

Phenol

2.50 mg

Glycerol

0.50 ml

Water for injections

up to 1 ml

Description:

Allergen is a clear liquid from colorless to dark yellow color.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Pollen allergens
  • Pharmacodynamics:

    Biological and immunological properties

    The main active principle of the preparation is a protein-polysaccharide complex interacting with the reactants (specific IgE antibodies) of patients, resulting in blocking IgG antibodies, which provides the effect of immunotherapy.

    Indications:

    Specific immunotherapy (SIT) of patients with increased sensitivity to pollen of trees (alder sticky, hanging birch, ordinary hornbeam, ordinary hazel, slender, willow goat) with confirmed presence of an allergic reaction.

    Contraindications:

    - Immune failure;

    - autoimmune diseases;

    - malignant neoplasms;

    - Cardiovascular diseases with coronary disease;

    - hypertensive disease in the stage of decompensation;

    - treatment with beta-blockers;

    - liver, kidney and thyroid gland diseases in the stage of decompensation;

    - severe form of atopic eczema;

    - in acute infectious diseases with a temperature increase of more than 37.5 ° C;

    - with acute development of the underlying allergic disease;

    - with hormone-dependent allergies, in children younger than 3 years;

    - during pregnancy and lactation.

    Dosing and Administration:

    Carrying out of SIT is shown in those cases when it is impossible to exclude contact of a sensitized patient with an allergen and is under the control of an allergist.

    Before taking the allergen should read the instructions for use of the drug, check the name of the allergen, the amount PNU/ ml, shelf life.

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

    Allergen is prescribed for oral administration once a day (morning or evening), 30 minutes before meals. For best effect, the allergen should be kept as long as possible in the mouth (under the tongue).The proper amount of drops of the allergen is dripped into a teaspoonful. To the allergen you can add water with flavor additives at your choice. The contents of the spoon are left for 1-2 minutes in the oral cavity. Do not drink, do not seize.

    SIT is recommended to be carried out in two ways. After the SIT, a course of maintenance immunotherapy should be conducted.

    AT first option the course of treatment with an allergen is carried out for 5 months.

    Holding SIT for 5 months

    Concentration

    Number of drops per day

    1 PNU / ml

    day

    1

    3

    5

    8

    10








    Number of drops

    2

    4

    7

    12

    18








    10 PNU / ml

    day

    1

    3

    5

    8

    10








    Number of drops

    2

    4

    7

    12

    18








    100 PNU / ml

    day

    1

    4

    8

    12

    16

    20

    24

    28





    Number of drops

    2

    3

    4

    5

    7

    10

    14

    19





    1 000 PNU / ml

    day

    1

    4

    8

    12

    16

    20

    24

    28

    32

    36

    40

    44

    Number of drops

    2

    3

    4

    5

    6

    7

    8

    10

    12

    14

    17

    20

    10,000 PNU / ml

    day

    1

    8

    16

    24

    32

    40

    47

    54





    Number of drops

    2

    3

    4

    5

    6

    7

    8

    10





    Allergens in lower concentrations are prescribed, as a rule, three times a week (for example, Monday - Wednesday - Friday or Tuesday - Thursday - Saturday). With the appointment of elevated concentrations, the intervals between doses are prolonged and administered twice or once a week.

    Supportive immunotherapy

    Within 3 years after the treatment, 10 drops of an allergen with a concentration of 10,000 PNU/ ml 1 time a week.

    In second option the course of treatment is carried out for 50 days.

    Carrying out the SIT for 50 days (a single scheme for all concentrations: 1, 10, 100, 1000, 10,000 PNU / ml)

    Day

    Dosing

    1.

    1 drop

    2.

    2 drops

    3.

    3 drops

    4.

    4 drops

    5.

    5 drops

    6

    6 drops

    7.

    7 drops

    8.

    8 drops

    9.

    9 drops

    10.

    10 drops

    SITs begin with the lowest concentration (1 PNU/ ml), then in increasing order they pass to the following concentrations (10, 100, 1000, 10000 PNU/ ml).

    Each concentration of the drug begins to be used always with one drop per day, and every next day the number of drops increases by one drop. After reaching the number of ten drops (the 10th day), the next day immediately assign one drop of the drug to the next higher concentration (the intervals between receptions of an allergen with different concentrations are inadmissible).

    Supportive immunotherapy

    Within 3 years after the treatment, 10 drops of an allergen with a concentration of 10,000 PNU/ ml 3 times a week.

    Recommendations for the doctor

    The treatment regimen can be changed depending on the patient's condition.

    If the patient tolerates treatment well, then in the flowering season, you can take the maximum dose of the allergen.

    In case of signs of allergy and deterioration of the patient's condition, we recommend reducing the dose of the allergen by half the maximum dose.

    Attention

    1.The patient can extend the interval or lower the dose alone with an acute illness or with signs of an allergic disease, and then notify the attending physician. The dose should be lowered also in the event that the break during treatment exceeded in duration of 3 weeks.

    2. All patients during the treatment should undergo the necessary forms of clinical examination.

    3. Treatment with allergens taken by the mouth is interrupted 14 days before the planned vaccination. Treatment with allergens should be carried out through:

    - 1 a week after the tuberculin test;

    - 2 weeks after the use of inactivated vaccines;

    - 4 weeks after the use of live vaccines;

    - 8-12 weeks after BCG vaccine application.

    Side effects:

    There may be general malaise, drowsiness, fatigue and fever.

    With the development of these symptoms, the course of treatment can be continued after consultation with an allergist.

    Form release / dosage:Drops for oral administration, 1 PNU / ml, 10 PNU / ml, 100 PNU / ml, 1 thousand PNU / ml, 10 thousand PNU / ml.
    Packaging:

    For 9.0 ml of an allergen with a content of 1, 10, 100, 1000 or 10,000 PNU/ ml in bottles of glass of the 1 st hydrolytic class with a capacity of 10 ml with a screw stopper equipped with a dropper.Allergen with a content of 1, 10, 100, 1000 PNU/ ml - 1 bottle, 10000 PNU/ ml - 2 bottles (6 bottles in total) in a cardboard box with instructions for use.

    Allergen for 9 ml with a content of 10000 PNU/ ml - 1 bottle in a separate cardboard box with instructions for use.

    Storage conditions:

    In the dark place 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:On prescription
    Registration number:P N 015414/01
    Date of registration:11.12.2008
    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: & nbsp04.03.2018
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