IRS 19 - instructions for use, dose, side effects, contraindications

Active substanceLysates of the bacterium mixture [Streptococcus pneumoniae, type I + Streptococcus pneumoniae, type II + Streptococcus pneumoniae, type III + Streptococcus pneumoniae, type V + Streptococcus pneumoniae, type VIII + Streptococcus pneumoniae, type XII + Haemophilus influenzae, type B + Klebsiella pneumoniae ss pneumoniae + Staphylococcus aureus ss aureus + Acinetobacter calcoaceticus + Moraxella catarrhalis + Neisseria subflava + Neisseria perflava + Streptococcus pyogenes group A + Streptococcus dysgalactiae group C + Enterococcus faecium + Enterococcus faecalis + Streptococcus group G]Lysates of the bacterium mixture [Streptococcus pneumoniae, type I + Streptococcus pneumoniae, type II + Streptococcus pneumoniae, type III + Streptococcus pneumoniae, type V + Streptococcus pneumoniae, type VIII + Streptococcus pneumoniae, type XII + Haemophilus influenzae, type B + Klebsiella pneumoniae ss pneumoniae + Staphylococcus aureus ss aureus + Acinetobacter calcoaceticus + Moraxella catarrhalis + Neisseria subflava + Neisseria perflava + Streptococcus pyogenes group A + Streptococcus dysgalactiae group C + Enterococcus faecium + Enterococcus faecalis + Streptococcus group G]

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IRS® 19

spray nazal.

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Dosage form: & nbspnasal spray

Composition:

On 100 ml

Active substances:

bacterial lysates * 43,27 ml

* Composition of bacterial lysates:

Streptococcus pneumoniae, type I 1.11 ml

Streptococcus pneumoniae, type II 1,11 ml

Streptococcus pneumoniae, type III 1,11 ml

Streptococcus pneumoniae, type V 1,11 ml

Streptococcus pneumoniae, type VIII 1.11 ml

Streptococcus pneumoniae, type XII 1.11 ml

Haemophilus influenzae, type AT 3,33 ml

Klebsiella pneumoniae ss pneumoniae 6,66 ml

Staphylococcus aureus ss aureus 9.99 ml

Acinetobacter calcoaceticus 3,33 ml

Moraxella catarrhalis 2,22 ml

Neisseria subflava 2,22 ml

Neisseria perflava 2,22 ml

Streptococcus pyogenes group A 1,66 ml

Streptococcus dysgalactiae group C 1,66 ml

Enterococcus faecium 0,83 ml

Enterococcus faecalis 0,83 ml

Streptococcus group G 1.66 ml

Excipients:

Glycine 4.25 g

Sodium methyldiolate not more than 1.2 mg

Flavor based on nerol ** 12.50 mg

Water purified to 100 ml

** Nerol-based flavor composition: linalol, alpha-terpineol, geraniol, methyl anthranilate, limonene, geranilacetate, linalyl acetate, diethyleneglycol monoethyl ether, phenylethyl alcohol.

Description:

Transparent colorless or yellowish tinged liquid with a weak specific odor.

Pharmacotherapeutic group:Immunostimulating drug based on bacterial lysates

ATX: & nbsp

R.07.A.X Other preparations for the treatment of respiratory diseases

Pharmacodynamics:

IRS® 19 increases specific and nonspecific immunity.

When spraying �?РС® 19, a fine aerosol is formed which covers the mucous membrane of the nose, which leads to a rapid development of the local immune response. Specific protection is due to locally formed antibodies of the class of secretory immunoglobulins of the type A (IgA), preventing the fixation and reproduction of pathogens of infection on the mucosa. Nonspecific immunoprotection is manifested in an increase in the phagocytic activity of macrophages and an increase in the lysozyme content.

Indications:

- Prevention of chronic diseases of the upper respiratory tract and bronchi

- Treatment of acute and chronic diseases of the upper respiratory tract and bronchi, such as rhinitis, sinusitis, laryngitis, pharyngitis, tonsillitis, tracheitis, bronchitis, etc.

- Restoration of local immunity after influenza and other viral infections.

- Preparation for routine surgical intervention on the ENT organs and in the postoperative period.

IRS® 19 can be administered to adults and children from 3 months of age.

Contraindications:

- Hypersensitivity to the drug or its components in the anamnesis.

- IRS® 19 should not be given to patients with autoimmune diseases.

Pregnancy and lactation:

There is insufficient data on the potential for teratogenic or toxic effects on the fetus during pregnancy, so use of the drug during pregnancy is not recommended.

Dosing and Administration:

The drug is administered intranasally by aerosol administration of 1 dose (1 dose = 1 short pressing of the atomizer).

- in order to prevent adults and children from 3 months to 1 dose of drug in each nasal passage 2 times a day for 2 weeks (start treatment is recommended 2-3 weeks before the expected increase in incidence);

- for the treatment of acute and chronic diseases of the upper respiratory tract and bronchi:

- children from 3 months to 3 years, one dose of the drug in each nasal passage 2 times a day, after prior release from the mucous discharge, until the symptoms of infection disappear.

- children older than 3 years and adults, one dose of the drug in each nasal passage 2 to 5 times a day until the symptoms of infection disappear;

- to restore local immunity to children and adults after a previous influenza and other respiratory viral infections at 1 dose of drug in each nasal passage 2 times a day for 2 weeks;

- in preparation for routine surgery and in the postoperative period for adults and children 1 dose of drug per each nasal passage 2 times a day for 2 weeks (it is recommended to begin treatment one week before the planned surgery).

At the beginning of treatment, reactions such as sneezing and increased discharge from the nose may occur. As a rule, they are of a short-term nature. If these reactions take a heavy flow, should reduce the frequency of administration of the drug or cancel it.

Very important! The device functions correctly only under the following conditions:

Put the nozzle on the vial, center it and gently, without effort, press it.

The device is now ready for use.

AT THE SPRAY OF THE PREPARATION, WE NEED TO KEEP THE VAPOR IN THE VERTICAL POSITION AND DO NOT TUMBLE THE HEAD.

If you tilt the bottle during spraying, the propellant will leak out in a few seconds and the device will become unusable.

With regular use of the drug, the nozzle should not be removed.

If the drug is left for a long time without use, a drop of liquid may evaporate and the formed crystals will clog the outlet of the nozzle.This phenomenon occurs most often when the nozzle is removed and put into the package top end down next to the bottle, without previously washing and drying it. If the nozzle is clogged, press it a few times so that the liquid can under the influence of excessive pressure. If this does not help, lower the nozzle for a few minutes into warm water.

Side effects:

During the reception of IRS®19, the following side effects may be noted, either related or unrelated to the action of the drug.

Skin reactions: in rare cases, hypersensitivity reactions (urticaria, angioedema) and skin erythema-like and eczematoid reactions are possible.

From the ENT organs and respiratory organs: in rare cases - asthma attacks and cough.

In rare cases at the beginning of treatment can be observed:

temperature increase (≥39 ° C) for no apparent reason, nausea, vomiting, abdominal pain, diarrhea, rhinopharyngitis, sinusitis, laryngitis, bronchitis.

Single cases of thrombocytopenic purpura and erythema nodosum are described.

If you experience any of the above symptoms, it is recommended that you consult a doctor.

Overdose:

Cases of overdose are unknown.

Interaction:

Cases of negative interaction with other drugs are unknown.

In the case of the emergence of clinical symptoms of bacterial infection, antibiotics may be prescribed against the backdrop of continued use of IRS® 19.

Special instructions:

At the beginning of treatment in rare cases, an increase in temperature (> 39 ° C) is possible. In this case, treatment should be canceled. However, it is necessary to distinguish this state from an increase in body temperature accompanied by malaise, which may be associated with the development of diseases of the ENT organs. In the presence of systemic clinical signs of bacterial infection should consider the appropriateness of the appointment of systemic antibiotics.

When prescribing drugs based on bacterial lysates for the purpose of immunostimulation, asthma attacks may occur in patients with bronchial asthma. In this case, it is recommended to stop treatment and not take this class of drugs in the future.

Precautions for use

Bottle spray:

- protect from heating above 50 ° C and from direct sunlight;

- do not pierce the bottle;

- Do not burn the bottle even if it is empty.

Effect on the ability to drive transp. cf. and fur:The use of IRS® 19 does not affect the psychomotor functions associated with driving a car or controlling cars and machinery.

Form release / dosage:

Spray nasal.

Packaging:

20 ml per aerosol container of clear transparent low-alkali glass, covered with a protective layer of plastic under nitrogen pressure, with a continuous valve, complete with a white high-density polyethylene nozzle. A self-adhesive label is applied to the cylinder or labeled on the protective layer of plastic by screen printing or dry offset printing.

1 cylinder complete with a nozzle and instructions for use are placed in a cardboard box.

Storage conditions:

In a strictly vertical position at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children!

Shelf life:

3 years.

The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012103 / 01

Date of registration:21.06.2010 / 17.05.2016

Expiration Date:Unlimited

The owner of the registration certificate:PHARMSTANDART-TOMSKHIMFARM, OJSC PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Manufacturer: & nbsp

MYLAN LABORATORIES SAS France

Information update date: & nbsp15.11.2017

Illustrated instructions

Instructions

IRS® 19 (IRS® 19)