N-AL therapeutic "Mixture mites" - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspdrops for oral administration

Composition:

Allergen tick-borne is a water-salt extract from a mixture of mites (Dermatophagoides pteronyssinus, Dermatophygoides farinae, Acarus siro).

Preservative phenol.

Composition per ml:

Active ingredient:
Testicular allergens (aqueous allergenic extract of a mixture of ticks)	1,0, 10, 100, 1 thousand, 10 thousand PNU / ml *
Excipients:
Sodium chloride	2.50 mg
Sodium hydrogen phosphate	0.725mg
Potassium dihydrogen phosphate	0.180 mg
Polysorbate (Tween 80)	0.025 mg
Phenol	2.50 mg
Glycerol	0.50 ml
Water for injections	up to 1 ml

Description:

The drug with a content of 1, 10, 100 PNU // ml: clear, colorless liquid; 1000 PNU // ml: clear, light yellow liquid; 10,000 PNU// ml - a transparent, dark-yellow liquid.

Pharmacotherapeutic group:MIBP is an allergen

ATX: & nbsp

Allergens of insects

Pharmacodynamics:

Biological and immunological properties

The active substance of the drug is a protein-polysaccharide complex interacting with reactants (specific IgE antibodies) of patients, as a result of which blocking IgG antibodies, which provides the effect of allergen-specific immunotherapy.

Indications:

Allergen-specific immunotherapy (ASIT) of patients with increased sensitivity to a mixture of mites (Dermatophagoides pteronyssinus, Dermatophygoides farinae, Acarus siro) with a confirmed presence of an allergic reaction.

The drug can be administered from 3 years.

Contraindications:

- Primary immunodeficiency ,;

- autoimmune diseases;

- malignant neoplasms;

- cardiovascular diseases with coronary artery disease;

- hypertensive disease in the stage of decompensation;

- treatment with beta-blockers;

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

- severe form of atopic eczema;

- acute infectious diseases with an increase in temperature above 37.5 ° C;

- exacerbation of the underlying allergic disease;

- hormone-dependent allergy in children younger than 3 years;

- Pregnancy and lactation.

Dosing and Administration:

Conducting ASIT is indicated in those cases when it is impossible to exclude the contact of a sensitized patient with an allergen, and is under the control of an allergist doctor.

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 check the integrity of the vials, as well as the absence of turbidity and foreign particles.

Allergen is prescribed for oral administration once a day (morning or evening), 30 minutes before meals. The required amount of drops of the allergen is buried in a teaspoon. To the allergen you can add water with flavor additives at your choice.Allergen should be kept under the tongue for 1-2 minutes, then swallowed. Do not drink, do not seize.

ASIT can be carried out according to two schemes. Each scheme includes a course of basic and supporting immunotherapy. After the main course of ASIT, a course of maintenance immunotherapy should be conducted for 3-5 years.

The first scheme (classical) ASIT

The main course of treatment with an allergen is carried out for 5 months.

Main course of ASIT within 5 months

Concentrationportable radio	Number of drops per day
1 PNU/ ml	day	1	3	5	8	10
1 PNU/ ml	Number of drops	2	4	7	12	18
10 PNU/ ml	day	1	3	5	8	10
10 PNU/ ml	Number of drops	2	4	7	12	18
100 PNU/ ml	day	1	4	8	12	16	20	24	28
100 PNU/ ml	Number of drops	2	3	4	5	7	10	14	19
1000 PNU/ ml	day	1	4	8	12	16	20	24	28	32	36	40	44
1000 PNU/ ml	Number of drops	2	3	4	5	6	7	8	10	12	14	17	20
10000 PNU / ml	day	1	8	16	24	32	40	47	54
10000 PNU / ml	Number of drops	2	3	4	5	6	7	8	10

Allergens of lower concentrations (1, 10, 100 PNU/ ml) is usually administered three times a week (for example, Monday - Wednesday - Friday or Tuesday - Thursday - Saturday). With the appointment of elevated concentrations (1 thousand, 10 thousand PNU/ ml), the intervals between doses are prolonged and administered twice or once a week.

Supportive immunotherapy

Within 3-5 years after the treatment, it is necessary to take 10 drops of an allergen with a concentration of 10 thousand PNU/ ml once a week.

The second scheme (accelerated) main course treatment is carried out within 50 days.

Conducting the basic course of ASIT for 50 days (unified scheme for all concentrations: 1, 10, 100, 1000, 10000 JSK/ ml)

Concentration	Day	Dosing
1 PNU/ ml	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
10 PNU/ ml	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
100 PNU/ ml	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
1000 JSK / ml	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
10,000 PNU / ml	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

ASIT begins with the lowest concentration of allergen (1 PNU/ ml), then in the increasing order they pass to the following concentrations (10, 100, 1000, 10,000 PNU/ ml).

Each concentration of the drug is always used from one drop per day, and every next day the amount of drops is increased 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 3-5 years after the treatment, it is necessary to take 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 is well tolerated (no symptoms of an allergic disease), then with maintenance therapy, you can take the maximum dose of the allergen.

In case of symptoms of an allergic disease and worsening of the patient's condition, it is recommended to reduce the dose of the allergen by half the maximum dose or to cancel the drug.

Attention

1. It should be indicated to the patient that he can independently prolong the interval or reduce the dose in case of acute illness or when signs of an allergic disease appear, with subsequent notification to the attending physician. The dose should be lowered also in the event that the break during treatment exceeded in duration of 3 weeks. If the break in taking the drug exceeded more than 3 weeks, then it is necessary to reduce the concentration of the drug. If the break in taking the drug was more than 2 months, then it is necessary to start treatment with the lowest concentration of the drug 1 PNU/ ml.

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

Side effects:

There may be general malaise, drowsiness, fatigue and fever. With the development of these symptoms, the course of treatment can be continued only after consulting a physician with an allergist, which the patient should be informed about.

Interaction:

Treatment with an allergen is interrupted 14 days before the planned vaccination.

Treatment with allergens can begin by:

- 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.

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 a vial of glass 1 hydrolytic class (Ph. Eur.) with a capacity of 10 ml with a screw stopper equipped with a dropper.

A set of allergen with a content of 1, 10, 100, 1000 PNU/ ml - 1 bottle, and 10,000 PNU/ ml - 2 bottles in a cardboard box with instructions for use.

For 9 ml of an allergen with a content of 10000 PNU/ ml - 1 bottle in a cardboard box with instructions for use.

A paper label is applied to the bottle and pack.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C. Do not freeze.

Transportation

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:LSR-003619/09

Date of registration:14.05.2009

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

Illustrated instructions

Instructions

N-AL therapeutic "Mixture of mites" (N-al curative "the mix of mites")