N-AL therapeutic "Mixture of molds of domestic" - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspdrops for oral administration

Composition:

Allergen is a water-salt extract from a mixture of molds (fungi) of domestic (Aspergillus fumigatus, Aspergillus niger, Penicillinum sp., Mucor sp., Rhizopus sp.). Preservative phenol.

Composition per ml:

Active ingredient:
Fungal Allergens (aqueous allergenic extract of a mixture of molds of domestic)	0,1; 1,0; 10; 100; 1000 PNU / ml
Excipients:
Sodium chloride	2.50 mg
Sodium hydrogen phosphate	0.725 mg
Potassium dihydrogen phosphate	0.180 mg
Polysorbate (Tween 80)	0.025 mg
Phenol	2.50 mg
Glycerol (glycerol)	0.50 ml
Water for injections	up to 1.0 ml

*PNU (protein N unit) - an international unit adopted to express the concentration of protein nitrogen in allergens, equal to the content of 0.00001 mg of protein nitrogen.

Description:

The drug with a content of 0.1; 1.0; 10; 100 PNU /ml * - clear, colorless liquid; 1000 PNU/ ml - a clear, yellow liquid.

Pharmacotherapeutic group:MIBP is an allergen

ATX: & nbsp

Allergens of mold and yeast fungi

Pharmacodynamics:

Biological and immunological properties

The active substance of the drug is a protein-polysaccharide complex interacting with reactants (specificIgE 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 who are hypersensitive to a mixture of molds of domestic (Aspergillus fumigatus, Aspergillus niger, Penicillinum sp., Mucor sp., Rhizopus sp.) with confirmed presence of an allergic reaction.

The drug can be administered from 3 years.

Contraindications:

- Primary immunodeficiencies;

- 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 of 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

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

Allergens of lower concentrations (0.1, 1, 10 PNU / ml) are prescribed, usually three times a week (for example, Monday - Wednesday - Friday or Tuesday - Thursday - Saturday). With the appointment of elevated concentrations (100, 1000 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 the allergen withconcentration of 1000 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: 0.1, 1, 10, 100, 1000 PNU / ml)

Concentration	Day	Dosing
0.1 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
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 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 (0.1 PNU / ml), then in increasing order, they pass to the following concentrations (1, 10, 100, 1000 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 prescribed one drop of the drug at the next higher concentration (the intervals between allergen receptions with different concentrations are unacceptable).

Supportive immunotherapy

Within 3-5 years after the treatment, it is necessary to take 10 drops of the allergen with a concentration of 1000 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.

Attention

1. It should be indicated to the patient that he can independently prolong the interval or lower the dose in case of acute illness or with the appearance of signs of an allergic disease with subsequent notification of 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 - 0.1 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 consultation with an allergist, about which the patient should be informed.

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 ingestion, 0.1 PNU / ml, 1 PNU / ml, 10 PNU / ml, 100 PNU / ml, 1 thousand PNU / ml.

Packaging:

For 9.0 ml of the allergen with a content of 0.1, 1.0, 10, 100, 1000 PNU/ ml in a bottle of glass 1 of hydrolytic class with a capacity of 10 ml.

A set of 6 vials of allergens with a content of 0.1, 1.0, 10, 100 PNU/ ml - 1 bottle and with a content of 1000 PNU/ ml - 2 bottles in a cardboard box with instructions for use.

Allergen with a content of 1000 PNU/ ml 1 bottle of 9 ml in a cardboard box with instructions for use.

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-004117/09

Date of registration:26.05.2009

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 molds of domestic" (N-AL CURATIVE "THE MIX OF HOUSE MOLDS")