Lais Dermatofagoides - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspTablets are sublingual.

Composition:

Ingredients name	amount
Ingredients name	300 AE *	1000 AE *
Active substance
Monomer allergoid from a mixture of house dust mites in equal proportions: Dermatophagoides pteronyssinus, Dermatophagoides farinae	The quantity equivalent to 300 AE	Quantity equivalent to 1000 AE
Excipients (mg)
Silicon dioxide colloidal water	1	1
Magnesium stearate	2	2
Cellulose microcrystalline	37	37
Lactose Monohydrate	Prior to the weight of the tablet, 110 mg	Prior to the weight of the tablet, 110 mg

* The allergenic unit (AE) ~ is the unit of standardization of the firm Lofarma. 1 AE is equivalent to a 1/40 provoking dose of the corresponding unmodified allergen assessed by the nasal provoking test in volunteers that are suscibilized to Dermatophagoides pteronyssinus and Dermatophagoides farinae.

Description:Round-convex smooth homogeneous white tablets, 7 mm in diameter. With a notch on one side and engraved with a digit on the other side: 300 AE - with the number "3", 1000 AE - with the number "4".

ATX: & nbsp

Allergens of house dust mite

Pharmacodynamics:

Chemically modified allergen extract (monomer allergoid from a mixture of mites): Dermatophagoides pteronyssinus (50%) and Dermatophagoides farinae (50%): to weaken their ability to react with IgE antibodies. This suppresses their allergenic activity and, therefore, provides a favorable immunotherapeutic effect and simultaneously reduces the risk of local and systemic side effects, in contrast to natural allergens.

Indications:Sublingual allergen-specific immunotherapy (ASIT) of patients with increased sensitivity to a mixture of mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae,), with confirmed presence of an allergic reaction.

Contraindications:

- hypersensitivity to the components of the drug.

- severe systemic diseases (malignant neoplasms, autoimmune diseases, immunodeficiency, etc.)

- chronic infections, viral infections, etc.,

- cardiovascular diseases,

- severe pulmonary diseases (severe asthma, emphysema, bronchiectasis, etc.).

- simultaneous therapy with beta-blockers

- treatment of pathologies, in which the use of adrenaline is contraindicated.

Pregnancy and lactation:

Do not start specific immunotherapy during pregnancy because of the general limitations in taking medications for pregnant women.

In case of pregnancy, consult a doctor before taking the medication.

If the rate of immunotherapy is interrupted by the risk to the patient, the doctor should decide whether to continue or discontinue therapy after carefully weighing the risks to the patient at the time when the protective action of the immunotherapy stops.

If you are breastfeeding, consult your doctor before taking the medication.

Absolute contraindications to taking this medication during breastfeeding does not exist.

Dosing and Administration:

PRECAUTIONARY MEASURES

Specific immunotherapy is taken according to the individual treatment regimen. Dosages and the number of doses can be changed by the doctor according to the course of the disease. The phase of initial therapy and treatment is described in the treatment regimen in the item "Dosage and method of administration". The proposed treatment regimens are presented only for reference.

The patient is also recommended to consult a doctor to adjust the dose for colds with fever or respiratory tract infections. If a patient needs antiviral vaccination, immunotherapy may be suspended one week before vaccination and resumed two weeks after vaccination.

Avoid alcohol and heavy physical activity for several hours after taking the medication.

METHOD OF USE AND DOSES:

The tablets should be kept under the tongue until completely dissolved (1-2 minutes), then swallowed.

Take the pill whenever possible on an empty stomach.

Treatment consists of two phases. Phase 1 - the phase of the maintenance dose set (initial therapy), phase number 2 - continuation of treatment with a maintenance dose (maintenance therapy)

Initial therapy

Treatment begins with tablets of 300 AE and continue with 1000 AE tablets according to the scheme given below. Reception scheme:

Blister with tablets 300 AE day 1: 1 tablet (300 AE) day 2: 2 tablets (same as 600 AE) day 3: 3 tablets (aka 900 AE) day 4: 4 tablets (same as 1200 AE)

Next week, a blister with 1000 AE tablets is used.

After the initial phase, the treatment is continued, taking 1 tablet a day at least 2-5 times a week.

Supportive therapy

The main treatment is continued with 1000 AE tablets as described above throughout the year.

The proposed treatment regimens are given solely as recommendations. The scheme of reception is determined by the allergist doctor, based on observations and anamnesis. It is recommended to continue treatment for 3 to 5 years.

Side effects:Since the drug is a chemically modified allergen (monomeric allergoid), undesirable effects during therapy are extremely rare.Nevertheless, the occurrence of rhinitis, skin rashes, mild dyspnea and delayed reactions in the first hours after taking the drug is not ruled out. Any local (eg, itching in the mouth and lips) and / or systemic adverse events that occur during immunotherapy should be reported to the physician, who will adjust the regimen of the drug and carry out appropriate anti-allergic therapy if necessary according to the severity of the clinical picture. Such therapy may consist of oral and / or intramuscular administration of antihistamines, corticosteroids and (3-2 adrenergic agonists or adrenaline subcutaneously.

The patient should also inform his attending physician of any side effects that are not listed in the medication instructions.

Overdose:There were no side effects associated with overdose. However, taking an excess dose may cause local or systemic allergic reactions. If you notice any symptoms, tell your doctor. If you have symptoms, you need to take anti-allergic drugs (antihistamines, corticosteroids, adrenaline injections,etc.) in accordance with the severity of the clinical picture and the prescription of the doctor.

Interaction:Contraindicated taking the drug simultaneously with beta-blockers.

Special instructions:

Interruption of treatment with Lais Dermatofagoides

In case of interruption of treatment for a period of up to 2 weeks, it should be resumed by taking the last well-tolerated dose.

If the therapy was interrupted for a period longer than 2 weeks, you should consult your doctor to adjust the dosing. The physician may deviate from these dosage regimens for clinical or therapeutic purposes.

Pregnancy and lactation: Do not start specific immunotherapy during pregnancy because of the general limitations in taking medications for pregnant women.

In case of pregnancy, consult a doctor before taking the medication.

If you are breastfeeding, consult your doctor before taking the medication.

Absolute contraindications to taking this medication during breastfeeding does not exist.

Childhood: The course of immunotherapy can be started in childhood from 5 years.

Impact on the ability to drive vehicles and work with mechanisms:

The drug can cause some fatigue in some patients. As a consequence, reduced attention may affect its ability to drive vehicles and work with mechanisms.

Reception Lais Dermatofagoides for colds: It is recommended to consult a doctor to change the dose for catarrhal diseases with an increase in body temperature, as well as for respiratory tract infections.

If it is necessary to vaccinate:

If a patient is required to vaccinate against viruses or bacterial pathogens, immunotherapy may be suspended a week before vaccination and resumed two weeks after vaccination.

Simultaneous reception of Lais Dermatofagoides with food and drinks: The drug should be taken on an empty stomach.

After taking, you should not take food and drink for some time to better absorb the drug.

For several hours after taking the medication, you should refrain from alcohol.

Impact on the ability to drive vehicles and work with mechanisms

This drug may cause certain fatigue in some patients. As a consequence, reduced attention may affect its ability to drive vehicles and work with mechanisms.

Sport and physical activity: Avoid heavy physical exertion for several hours after taking the medication.

Effect on the ability to drive transp. cf. and fur:This drug may cause certain fatigue in some patients. As a consequence, reduced attention may affect its ability to drive vehicles and work with mechanisms.

Form release / dosage:

Tablets of the sublingual 300,1000 AE.

Packaging:For 10 tablets of each concentration (300 AE and 1000 AE) in separate blisters of transparent polyvinyl chloride and aluminum foil.For 1 blister with a dosage of 300 AE and 3 blisters - 1000 AE, or 3 blisters - 1000 AE per pack of cardboard with instructions for use.

Storage conditions:Store and transport at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001303

Date of registration:29.11.2011

The owner of the registration certificate:Lofarma SpALofarma SpA Italy

Manufacturer: & nbsp

Lofarma S.p.A. Italy

Representation: & nbspTD ALLERGEN COMPANY JSCTD ALLERGEN COMPANY JSCRussia

Information update date: & nbsp15.03.2016

Illustrated instructions

Instructions

Laice Dermatofagoides (LAIS Dermatophagoides)