Instructions

Instructions / Instruction for use: IRS 19 Nasal Spray

Trade name of the drug – IRS 19

International nonproprietary name: mixture of bacterial lysates: S.pneumoniae, type I, II, III, V, VIII, XII + Haemophilus influenzae, type B + Klebsiella pneumoniae ss pneumoniae + Staphylococcus aureus ss aureus + Acinetobacter calcoaceticus + Moraxella catarrhalis + Neisseria subflava + Neisseria perflava + S.pyogenes group A + S.dysgalactiae group C + Enterococcus faecium + Enterococcus faecalis + S.group G].

Dosage form: nasal spray

Composition:
100 ml

Active substances:
lysates of bacteria * 43.27 mL
* The composition of the bacterial lysates:
Streptococcus pneumoniae, type I 1,11 ml
Streptococcus rpeshpotae, 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 in 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:
4.25 g glycine
sodium thimerosal is not more than 1.2 mg
The flavor on the basis of nerol ** 12.50 mg
Purified water to 100 ml

** Composition based flavoring nerol: linalool, alpha-terpineol, geraniol, methyl anthranilate, limonene, geranilatsetat, linalyl acetate, diethylene glycol monoethyl ether, phenylethyl alcohol.

Description
Transparent colorless or yellowish white liquid with a faint characteristic odor.
Pharmacotherapeutic group
Immunostimulatory preparation based on bacterial lysates.

ATX code: R07AX

Immunological properties
IRS 19 enhances specific and nonspecific immunity.
When spraying IRS 19 is formed a fine aerosol that covers the nasal mucosa, which leads to the rapid development of local immune response. The specific protection due to locally formed antibodies of immunoglobulin class of secretory type A (IgA), preventing the fixation and reproduction of pathogens to mucosal infection. Non-specific immune defenses is to increase the phagocytic activity of macrophages and increase the content of lysozyme.

Appointment for IRS 19
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, and others.
Restoring local immunity after an influenza and other viral infections.
Preparations for planned surgery at the ENT-organs and in the postoperative period.
IRS 19 can be assigned to both adults and children from 3 months of age.

Contraindications
Hypersensitivity to the drug or its components in history. IRS 19 should not be administered to patients with autoimmune diseases.
Use during pregnancy
There is no sufficient data on the potential teratogenic or toxic effects on the fetus during pregnancy, so the use of the drug during pregnancy is not recommended.

Dosing and Administration
The drug is used intranasally by aerosol administration of one dose (1 dose = 1 short pressure sprayer).
to prevent adults and children from 3 months to 1 dose of the drug in each nostril 2 times a day for 2 weeks (to start a course of treatment is recommended for 2-3 weeks before the expected rise of morbidity);
for the treatment of acute and chronic diseases of the upper respiratory tract and bronchi:
Children from 3 months to 3 years for a single dose of the drug in each nostril 2 times a day, after a preliminary release of mucous discharge, until the disappearance of symptoms of the infection.
children older than 3 years and adults at a single dose of the drug in each nostril 2 to 5 times a day until the disappearance of symptoms of infection;
to restore the local immunity after children and adults suffering influenza and other respiratory viral infections and 1 dose of the drug in each nostril two times a day for 2 weeks;
in preparation for the planned surgery and in the postoperative period in adults and children 1 dose of the drug in each nostril 2 times a day for 2 weeks (to start a course of treatment is recommended for 1 week before the planned surgery).
Early treatment can occur such reactions as sneezing and increased nasal discharge. As a rule, they are of short duration. If these reactions will take a severe course, reduce the frequency of administration of the drug or to cancel it.
Very important! The device functions correctly only when the following conditions:
Put the nozzle on the bottle how to align her and gently, without effort, click on it. Now the device is ready for use.

When spraying PREPARATION TO HOLD bottle upright and not throw back its head.
If you tilt the bottle while spraying, a propellant will flow for a few seconds and the device will become worthless.
it is not recommended to remove With regular use of the drug attachment.
If the drug is left on for a long time without use, a drop of liquid can evaporate and the resulting crystals clog the nozzle outlet opening. This phenomenon occurs more often when the nozzle is removed and placed in the upper end of the package near the bottle bottom, without first washing and to dry it. If the nozzle is clogged, press it several times, so that the liquid could pass under the influence of excess pressure. If this does not help, lower the nozzle for a few minutes in warm water.
Side effect
During the reception IRS®19 may experience the following side effects such as related and unrelated to the action of the drug.
Skin reactions: In rare cases, there may be hypersensitivity reactions (urticaria, angioedema) and erythema -like erythema and eczema-like skin reaction.

From the upper respiratory tract and the respiratory system: rarely - asthma and cough.In rare cases, early treatment can be observed:
increase in temperature (≥ 39 ° C) for no apparent reason, nausea, vomiting,
abdominal pain, diarrhea, nasopharyngitis, sinusitis, laryngitis, bronchitis.
Described isolated cases of the appearance of thrombocytopenic purpura, and erythema nodosum.
When the above symptoms it is recommended to consult a doctor.

Overdose
Cases of overdose are unknown.

Interaction with other drugs
Cases of negative interactions with other drugs known.
In the case of the onset of clinical symptoms of the bacterial infection is possible antibiotics due to the ongoing use of IRS 19.

Special Instructions
Early treatment is possible in rare instances an increase in temperature (≥ 39 ° C). In this case, treatment should be discontinued. However, we must distinguish between this state of fever accompanied by malaise, which may be associated with the development of diseases of upper respiratory tract. In the presence of clinical signs of systemic bacterial infection should be considered whether the use of systemic antibiotics.
In the appointment of drugs based on bacterial lysates with the aim of immune stimulation to patients with asthma may cause asthma attacks. In this case, it is recommended to stop treatment or take drugs of this class in the future.

Precautions for use
Spray bottle:
Keep away from heat above 50 ° C and from direct sunlight;
not to pierce the vial;
Not burn bottle, even if it is empty.
Effects on ability to control cars and other mechanisms
Application IRS 19 has no effect on psychomotor functions associated with driving or running machinery.

Release Form
Nasal Spray.
20 ml spray bottle in a colorless transparent low alkaline glass, coated with a protective layer of plastic, pressurized nitrogen, with a continuous valve, complete with nozzle HDPE white. On the bottle is glued or self-adhesive label is applied to the marking on the protective plastic layer by screen printing or dry offset.1 cylinder complete with a nozzle and the instructions for use is placed in a cardboard box.

Conditions of storage and transportation
In the upright position at a temperature above 25 ° C. Do not freeze.Keep out of the reach of children!

Shelf life
3 years.
The drug should not be used after the expiration date printed on the package.

Conditions of supply of pharmacies
Without recipe.