Alustal "Allergen pollen meadow grass" - instructions for use, dose, side effects, contraindications

Similar drugsTo uncover

Dosage form: & nbspsubcutaneous suspension

Composition:

Per 1 ml:

active substance: adsorbed on aluminum hydroxide suspension ultrafiltrated extract of an allergen from a mixture of pollen of grasses (hedgehogs, spikelets common, long-haired, meadow grass, timothy grass) in equal proportions 0.01 IR / ml^*, 0.1 IR / ml, 1 IR / ml, 10 IR / ml.

Excipients: sodium chloride - 9 mg, phenol - 4 mg, aluminum hydroxide (in terms of aluminum) - 0.8 mg, mannitol - not more than 0.072 mg, water for injection - up to 1 ml.

^*IR / ml - The Reactivity Index is the biological standardization unit.

Description:

Homogenous suspension from white to yellowish color, settling into 2 layers: upper - colorless transparent liquid, lower - white to yellow sediment, easily broken when shaken.

Pharmacotherapeutic group:MIBP is an allergen

ATX: & nbsp

Allergens of grass pollen

Pharmacodynamics:

The exact mechanism of action of the allergen in the conduct of allergen-specific immunotherapy (ASIT) has not been fully studied.

ASIT leads to a change in the immune response of T-lymphocytes with a subsequent increase in the level of specific antibodies (IgG₄ and / or IgG₁ and, in some cases, IgA) and a decrease in the level of specific IgE. A secondary and, perhaps, a later immune response is immune deviation with a change in the immune response of specific T cells.

Indications:

Allergen-specific immunotherapy (ASIT) is indicated for patients with type 1 allergic reaction (IgE mediated), manifested in the form of rhinitis, conjunctivitis, rhinoconjunctivitis, a mild or moderate form of seasonal bronchial asthma, which has increased sensitivity to pollen of meadow grasses (hedgehogs, spikelets, long grass, meadow grass, meadow timothy, meadow timothy).

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

Contraindications:

- Hypersensitivity to any of the excipients included in the formulation;

- autoimmune diseases, immunocomplex diseases, immunodeficiencies;

- malignant neoplasms;

- uncontrolled or severe bronchial asthma (volume of forced expiration less than 70%);

- therapy with beta-blockers (including local therapy in ophthalmology);

- renal insufficiency.

Pregnancy and lactation:

Pregnancy

Do not start ASIT during pregnancy.

If pregnancy occurred during the first stage of treatment, then therapy should be discontinued. If the pregnancy has occurred during the period of maintenance therapy, the doctor should evaluate the possible benefits of ASIT, based on the general condition of the patient.

There were no reports of side effects when using ASIT in pregnant women.

Breast-feeding

It is not known whether ALYSTAL "Allergen pollens of grass grasses" is excreted in breast milk. There were no corresponding animal studies.

Therefore, the risk for newborns and infants can not be ruled out.

The decision to stop breastfeeding or stop therapy with the drug should be made taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the woman.

Dosing and Administration:

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

The safety and efficacy of treatment in children younger than 5 years are not established.

Mode of application

The drug should be treated by an allergist doctor who has appropriate training and experience in the treatment of allergic diseases.Because of the possible risk of developing systemic allergic reactions, the treatment is performed in an office equipped with a set of anti-shock drugs, necessarily including epinephrine, corticosteroids, antihistamines and beta-adrenomimetics. After each injection the patient should be observed in the allergist's office for at least 30 minutes. The patient should avoid excessive physical exertion within 24 hours after the administration of the drug.

Before each use of the drug, make sure that:

- the shelf life of the drug has not expired,

- A vial of the drug is used, the dosage of which corresponds to the treatment regimen,

- the bottle is well shaken,

- the rules of asepsis,

- use of tuberculin syringes with a volume of 1 ml with a gradation of 1/100,

- the dose of administration is set as accurately as possible.

Doses and treatment regimen

Doses of the drug are the same for all ages, determined by the scheme of treatment in accordance with generally accepted rules of ASIT, but can be changed depending on the individual reactivity of the patient.

Treatment is advisable to begin no later than 3-4 months before the expected start of the flowering season.

Treatment consists of two stages: initial and maintenance therapy.

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

The drug is administered once a week deep subcutaneously in the middle third of the shoulder, sequentially increasing the dose until the maximum tolerated dose is reached, in accordance with the treatment regimen. Therapy begins with the administration of the drug at a dosage of 0.01 IR / ml or 0.1 IR / ml, depending on the individual reactivity of the patient in accordance with the degree of severity of skin tests. At the end of the stage, the volume of the drug taken is increased to 0.8 ml by a dosage of 10 IU / ml.

The suggested schedule of administration can be changed for individual patients in accordance with individual drug tolerance and general health status in order to achieve good tolerability of ASIT.

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 duration of the initial phase is 13 to 17 weeks.

Recommended scheme of the initial course of ASIT by ALUSTAL "Allergen pollen of meadow grasses" using a different dosage preparation.

Dosage of the drug (RI / ml)

Priority injections

Day after the beginning of treatment

The volume of the drug administered (ml)

Dose

(IR)

0,01

(a bottle with a gray lid)

0,1

0,2

0,4

0,8

0,001

0,002

0,004

0,008

0,1

(a bottle with a yellow lid)

0,1

0,2

0,4

0,8

0,01

0,02

0,04

0,08

(vial with a green lid)

0,1

0,2

0,4

0,8

0,1

0,2

0,4

0,8

(bottle with a blue lid)

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, a drug with a dosage of 10 MI / ml is administered in a volume of 0.8 ml per administration. During the season of dusting of plants, it is recommended to reduce the dose 2 times.

Supportive therapy begins 15 days after the end of the initial course. The interval between injections should be 2 weeks in the first two months of maintenance therapy and between 2 and 6 weeks thereafter. The interval between injections should not exceed 6 weeks.

In accordance with the general rules of ASIT in the case of switching to a new series of drugs, the dose for the first administration is recommended to be reduced by a factor of 2 (for example, from 0.8 ml to 0.4 ml of the preparation); for subsequent injections, return to the previously used dose.

The frequency of administration of the drug and its dose can be changed for a specific patient depending on the general state of health and individual reaction to the drug.

Duration of treatment

Allergen-specific immunotherapy is recommended for 3-5 years on the basis of an assessment of the benefit-risk ratio.

If the improvement did not occur during the first flowering season, the expediency of ASIT should be reviewed.

Interruption in the use of the drug

In case of interruption in treatment between two injections, not associated with an undesirable reaction, the following scheme should be followed:

The recommended scheme of the drug after a break in treatment:

Stage	Duration of the break	Dosage
Initial stage of treatment	Up to 2 weeks	Reenter the drug in the same dosage and volume as the treatment was interrupted. Then continue the treatment according to the scheme.
	From 2 weeks to 1 month	Enter the minimum volume (0.1 ml) of the drug of the dosage at which the treatment was interrupted. Then continue the treatment according to the scheme.
	More than 1 month	Enter the minimum volume (0.1 ml) of the drug at a dosage of 10 times less (if possible *) than the dosage of the drug used before the interruption in treatment. Continue to continue treatment according to the scheme.
Supportive therapy	Less than 6 weeks	Without changes.
Supportive therapy	From 6 weeks to 6 months	Go to the initial stage of treatment, starting with the drug at a dosage of 1 R / ml in a volume of 0.1 ml, and continue the initial treatment step according to the scheme until a maintenance dosage is achieved.

* Patients, for the treatment of which the minimum dosage of the drug is used, it is necessary to go to the initial stage of treatment with the drug of this dosage.

Side effects:

Possible adverse reactions are grouped according to systems and organs and frequency of occurrence: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely ( ≥1 / 10000 to <1/1000), very rarely (<1/10000).

Like any ALUSTAL medicinal product "Allergen pollen of meadow grasses" can cause in some patients adverse reactions.

During treatment, both local and general adverse reactions may occur. These reactions can occur at the beginning of therapy and later in the treatment process.

Immediately stop using the drug and consult a doctor if the following symptoms occur: severe allergic reactions with the rapid development of symptoms such as severe itching or rash, shortness of breath, abdominal pain, symptoms associated with a drop in blood pressure (dizziness, fainting).

The tolerability of the dose may vary depending on the patient's condition.Pre-treatment with antiallergic drugs (for example, antihistamines) that reduce the frequency and severity of adverse reactions is possible.

Slower-type reactions of the type of serum sickness with arthralgia, myalgia, urticaria, nausea, adenopathy and fever are extremely rare and require the cessation of ASIT.

From the immune system: infrequently anaphylactic shock.

From the nervous system: often - headache; infrequently - dizziness, paresthesia.

From the side of the organ of vision: often - conjunctivitis.

From the respiratory system, chest and mediastinum: very often rhinitis; often - exacerbation of asthma, cough, dyspnea; infrequently - bronchospasm, irritation in the throat.

From the gastrointestinal tract: infrequently - pain in the abdomen, nausea.

From the skin and subcutaneous tissue: often - hives, itching, eczema, redness; infrequently - generalized itching.

General disorders and disorders at the site of administration: often - edema at the injection site, itching at the injection site, hyperemia at the injection site; infrequently - fever, peripheral edema.

Reactions at the injection site, characterized by the appearance of pruritus, edema and hyperemia about 2-3 cm in diameter, can be observed relatively often, but do not lead to a change in the treatment regimen.

Post-event application experience (frequency unknown): angioedema, edema of the larynx, wheezing, vomiting, discomfort, asthenia, arthralgia, myalgia, enlarged lymph nodes, subcutaneous nodules, granuloma.

If you experience any of the side effects listed in the manual or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

If the prescribed dose is exceeded, the risk of side effects and their severity increases, which requires symptomatic treatment.

Interaction:

Possible simultaneous use with drugs for symptomatic treatment of allergies (eg, antihistamines, glucocorticosteroids).

Caution should be exercised in prescribing and carrying out specific immunotherapy for patients taking tricyclic antidepressants and monoamine oxidase inhibitors, since the use of epinephrine to stop possible allergic reactions in such patients can lead to life-threatening adverse reactions.

It is advisable to avoid simultaneous use with preparations containing aluminum (for example, antacid agents), since 1 bottle of ALUSTAL "Allergen pollen of grass grasses" contains 4 mg of aluminum (in 5 ml of suspension). When prescribing the drug should take into account the possibility of accumulation of aluminum in tissues, for this reason, the drug is contraindicated in patients with renal insufficiency. The effect of aluminum on the immune system with prolonged use has not been studied.

Clinical data on vaccination against the background of drug treatment is not enough. Vaccination can be carried out without interruption in treatment only after consulting a doctor.

Joint use of the drug with beta-blockers (including local therapy in ophthalmology) is contraindicated.

Special instructions:

If necessary, before the beginning of ASIT should stabilize the symptoms of allergy appropriate therapy.

If there are infectious diseases accompanied by an increase in body temperature, and also in the case of a recent attack of bronchial asthma, confirmed by clinical data or by the data of pyclofluometry, it is necessary to suspend treatment.Renewal treatment should be after the onset of improvement and consultation of an allergist.

It is necessary to stop treatment and immediately consult a doctor if there is severe itching of the palms, hands, soles of the feet, hives, nausea, vomiting, edema of the lips, larynx accompanied by difficulty swallowing, breathing, change of voice.

ASIT should be administered with caution to patients taking tricyclic antidepressants, monoamine oxidase inhibitors.

In accordance with the rules of the ASIT, it is necessary to avoid possible errors related to:

- a choice of a vial,

- dose of the drug,

- a random intravascular injection,

- a change in the interval between two administrations,

- an incorrect evaluation of the patient's clinical status.

These risks must be taken into account before the initial stage of treatment.

1 bottle containing 45 mg sodium chloride (in 5 ml suspension). This should be considered for patients on a strict low-salt diet, especially in children.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:

Suspension for subcutaneous administration, 0.01 IR / ml, 0.1 IR / ml, 1 IR / ml, 10 IR / ml.

Packaging:

For 5.0 ml of the suspension in glass bottles, sealed with rubber stoppers and aluminum-plastic caps of gray color (0.01 IR / ml), yellow (0.1 IR / ml), green (1.0 IR / ml), blue (10.0 IU / ml).

A set of 4 bottles with a content of 0.01 IR / ml, 0.1 IR / ml, 1 IR / ml, 10 IR / ml or 1 bottle containing 10 IR / ml in a plastic box with instructions for medical use.

Storage conditions:

Store at a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Transportation conditions

At a temperature of 2 to 8 ° C. Do not freeze.

Shelf life:

18 months.

Within the specified shelf life after opening the bottle (the first puncture of the rubber plug) can be stored at a temperature of 2 to 8 ° C for 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001050

Date of registration:21.10.2011

Date of cancellation:2016-10-21

The owner of the registration certificate:Stallergen, AOStallergen, AO France

Manufacturer: & nbsp

STALLERGENES, S.A. France

Representation: & nbspStallergen Vostok, OOOStallergen Vostok, OOO

Information update date: & nbsp15.03.2016

Illustrated instructions

Instructions

Alustal "Allergen pollen of meadow grasses" (ALUSTAL "MEADOW GRASS POLLEN ALLERGEN")