Universal reference book for medicines
Name of the drug: FOSTAL allergen pollen of trees (FOSTAL allergen tree pollen)

Active substance: nonappropriate

Type: Immunological preparation.
Allergen
Manufacturer: STALLERGENES (France)
Composition, form of production and packaging
Suspension for s / w introduction of
white with a grayish hue of color, homogeneous, with settling divided into 2 layers: the top - colorless transparent liquid, the bottom - a white precipitate with a grayish hue of color, easily broken when shaken.

1 ml

extract * allergen from a mixture of pollen of trees (alder, birch, hornbeam, hazel) 0.01 IR **

- "- 0.1 IR **

- "- 1 IR **

- "- 10 IR **

Excipients: calcium phosphate, sodium chloride, phenol, glycerol, mannitol, water d / u.

5 ml - glass bottles (4) with gray caps (0.01 IR / 1 ml), yellow (0.1 IR / 1 ml), green (1 IR / 1 ml), blue (10 IR / 1 ml) colors - plastic boxes.

5 ml - bottles of glass (1) with blue caps (10 IR / 1 ml) colors - plastic boxes.

* ultrafiltered, adsorbed on a suspension of calcium phosphate.

** the reactivity index is the biological standardization unit.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

The exact mechanism of action of the allergen in carrying out the allergen specific immunotherapy (ASIT) is not fully understood.
The following biological changes are proven:
- the appearance of specific antibodies (IgG 4 ), playing the role of "blocking antibodies";

- decrease in the level of specific IgE in the plasma for a long period;

- decrease in the reactivity of cells involved in the allergic reaction;

- increased activity of interaction between Th2 and Th1 T-cells and even Th0, leading to a positive change in the production of cytokines (reduction of IL-4 and increase of β-interferon) regulating IgE production.

In addition, ASIT induces an immune response, which allows to maintain the immunobiological memory for a long period.

The effectiveness of ASIT is higher in those cases when treatment is started in the early stages of the disease.

INDICATIONS

- ASIT patients suffering from seasonal allergic rhinitis, rhinoconjunctivitis, atopic bronchial asthma, having increased sensitivity to pollen of trees (alder, birch, hornbeam, hazel).

Immunotherapy can be given to adults and children from the age of 5.

DOSING MODE

Treatment should be performed by an allergist in an office equipped with anti-shocks, which must include adrenaline, corticosteroids, antihistamines and beta-adrenomimetics.
After each injection, the patient should be observed in the allergist's office for 30 minutes.
The dosage of the drug is the same for all ages, determined by the scheme of treatment in accordance with generally accepted rules for ASIT (see the diagram below), but can be changed depending on the individual reactivity of the patient.

Shake the bottle well before use.
The drug is injected deep into the middle third of the shoulder.
Treatment consists of two stages: an initial course and maintenance therapy.

1. The initial course of ASIT with a constant increase in the dose of the drug.

The initial course is recommended to be carried out not less than 4 months before flowering of trees, causing allergies.

Traditionally, the drug is administered 1 time / week according to the scheme below.
Therapy begins with the administration of the drug concentrations of 0.01 RI / ml or 0.1 IR / ml, depending on the individual reactivity of the patient in accordance with the degree of severity of skin tests. By the end of the stage, the dose of the drug increases to 0.8 ml of 10 RI / ml concentration.
The proposed schedule of administration can be changed for individual patients in accordance with their tolerability of the drug.
It is possible to shorten the interval between administrations up to 3 days and maximize its increase to 2 weeks. If necessary, the subsequent dose can be reduced or repeated.
The approximate scheme of the initial course of ASIT by the preparation of Fostal "Allergen pollen of trees" with the use of vials of different concentrations:

Concentration of the allergen in the vial (RI / ml) Number of injection Days Dose of the drug administered (in ml)

0.01 (bottle with gray lid) 1 2 3 4 0 7 14 21 0.1 0.2 0.4 0.8

0.1 (bottle with yellow lid) 5 6 7 8 28 35 42 49 0.1 0.2 0.4 0.8

1 (vial with a green lid) 9 10 11 12 56 63 70 77 0.1 0.2 0.4 0.8

10 (bottle with blue cover) 13 14 15 16 17 84 91 98 105 112 0.1 0.2 0.4 0.6 0.8

2. Supportive therapy with a constant dose.

At the stage of maintenance immunotherapy, the preparation concentration of 10 MI / ml is introduced in a volume of 0.8 ml per one administration.

Supportive therapy begins 15 days after the end of the initial course.

The first two injections of the maintenance course are administered at intervals of 2 weeks, then

the drug is administered once a month or less, but the maximum interval between

injections should not exceed 6 weeks.

Supportive immunotherapy is recommended for 3-5 years.

When a patient develops side effects, the maximum dose should be reduced

preparation.

SIDE EFFECT

Local reactions that characterize the development of hyperemia about 2-3 cm in diameter and edema can be observed relatively often, but do not lead to a change in the treatment regimen, but subsequent administration should be done with caution.
If there is hyperemia larger than 5 cm in diameter, the patient should be given an antihistamine
drug, increase the observation time to 60 minutes and reduce the subsequent dose of the allergen until it reaches good tolerability.

Other reactions are extremely rare and require the cessation of ASIT:


Reactions of immediate type:

- an attack of bronchial asthma, observed after the administration of the drug, requires the introduction of bronchodilators, possibly together with corticosteroids (parenterally);

- Laryngeal edema requires the introduction of a / m solution of epinephrine.
In this case, hospitalization is desirable;
- Anaphylactic shock requires immediate adrenaline and mandatory hospitalization of the patient.

Slow-motion reactions:

Reactions to the type of serum sickness with arthralgia, urticaria, nausea, adenopathy, fever are extremely rare.

CONTRAINDICATIONS

- period of worsening of the underlying allergic disease;

- severe immunodeficiencies;

- malignant diseases;

- infectious bronchial asthma;

- autoimmune diseases;

- therapy with beta-blockers.

PREGNANCY AND LACTATION

It is not recommended to use during pregnancy and breastfeeding.
If pregnancy developed during treatment, then therapy should be discontinued.
SPECIAL INSTRUCTIONS

Before each injection, make sure that:

- the shelf life of the drug has not expired,

- the activity of the drug in the vial that you are using corresponds to the scheme of application,

- the rules of asepsis,

- use of tuberculin syringes,

- The dose of administration is typed as accurately as possible.

OVERDOSE

Symptoms of drug overdose are increased manifestation of side effects, which requires the above treatment.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep out of reach of children at a temperature of 2 to 8 ° C.
Do not freeze. Shelf life - 12 months. Do not use after the expiry date printed on the package.
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