Immunovak-VP-4

General characteristics. Structure:

Active ingredient: 4 mg of antigens of opportunistic microorganisms (mix of water-soluble antigens of microbic cells Staphylococcus aureus, Klebsiella pneumoniae, Proteus vulgaris, Escherichia coli).

Pharmacological properties:

Pharmacodynamics. The immunostimulating drug of a bacterial origin. Activation of key effectors of congenital and adaptive immunity is the cornerstone of the mechanism of effect of drug. Drug activates phagocytal activity of macrophages, adjusts quantity and functional activity of subpopulations of lymphocytes (CD3, SEM, CD8, CD 16, CD72), programs proliferation and activation of CD4 of T lymphocytes on Th1 of a way, increases products of IFNy and IFNct, adjusts synthesis of isotypes of immunoglobulins towards decrease in lgE and increase in IgG, IgA, slgA. Causes development of antibodies to 4 types of opportunistic microorganisms which antigens are a part of drug, and also to other types (Streptococcus pneumoniae, Haemophilus influenzae, etc.) due to existence in the used antigens of wide cross protective activity.

The clinical effect is shown in reduction of frequency of acute infections, reduction of duration of their current, reduction of weight of symptoms, and also decrease in probability of an exacerbation of chronic diseases, reduction of volume of the accepted medicines.

Indications to use:

Immunotherapy and immunoprevention at children from 3 to 18 years and adults.

Children from 3 to 15 years:

— inflammatory diseases of a respiratory organs (including chronic) in 5-7 days after the beginning of basic therapy, and also during early increase in number of respiratory infections;

— prevention of respiratory infections at the children who are often ill ORZ (more than 4 times a year), including at the children who were earlier not visiting institutions with organized children's collectives (before receipt in child care facilities - preschool, schools);

— allergic diseases (bronchial asthma, obstructive bronchitis, atopic dermatitis, pollinoses) during remission against the background of basic therapy, it is preferable during early rise in incidence or right after stopping of an aggravation against the background of basic therapy;

— the dysbacterioses caused by opportunistic microflora at atopic dermatitis.

Children are more senior than 15 years and adults:

— chronic recurrent inflammatory diseases of a respiratory organs in an aggravation stage in 5-7 days after the beginning of basic therapy, during remission, and also during early increase in number of respiratory infections;

— allergic diseases (including bronchial asthma of the mixed and infectious and allergic types, atopic dermatitis) during remission against the background of basic therapy or after stopping of aggravations against the background of basic therapy;

— prevention of respiratory infections at the persons who are often ill ORZ (more than 4 times a year), during early rise in incidence.

Route of administration and doses:

Drug is accepted according to the combined scheme intranazalno, then inside. With drug just before use by means of the syringe bring 4 ml of solvent in a bottle (chloride sodium solution of 0.9% for injections or boiled water) temperature of 18-25 °C and mix. Time of dissolution should not exceed 2 min. The dissolved drug can be stored at a temperature from 2 ° to 8 °C during 3 days and to apply in the absence of opacification.

The drug is administered intranazalno a medical pipette. At peroral introduction the necessary volume of drug is gained the syringe and transfer syringe contents to a spoon. Begin to use drug from intranasal introduction. To peroral administration of drug pass only if intranasal introduction of the patient transfers without considerable reactions (fervescence no more than to 0.5 °C, lack of a bronchospasm).

The scheme of administration of drug to children is more senior than 3 years and the adult

procedure No.	Interval between introductions	The volume of the entered solution		Way of introduction	Note
		to children	adult
1		1 drop	1 drop	In one nasal course
2	1 days	2 drops	2 drops	On 1 drop in each nasal course
3	1 days	4 drops	4 drops	On 2 drops in each nasal course
Interval between 3 and 4 introductions of 1-3 days
4		0.5 ml	2 ml	Inside (through a mouth)	Meal not less than for 1 h before administration of drug, the following meal not less than in 2 h after administration of drug
5	3-5 days	2 ml	4 ml	Inside (through a mouth)
6	3-5 days	4 ml	4 ml	Inside (through a mouth)
7	3-5 days	4 ml	4 ml	Inside (through a mouth)
8	3-5 days	4 ml	4 ml	Inside (through a mouth)
9	3-5 days	4 ml	4 ml	Inside (through a mouth)
10	3-5 days	4 ml	4 ml	Inside (through a mouth)
11	3-5 days	4 ml	4 ml	Inside (through a mouth)

At introduction of the next dose for intake it is necessary to consider intensity of reaction to the previous peroral administration of drug. At the subsequent introduction the dose of drug is not increased at fervescence more than by 0.5 °C.

At insufficiently expressed effect on condition of lack of reaction to 7-8 peroral administration of drug (if the patient's temperature no more than 37.5 °C) the course of administration of drug with the same interval of introduction in a dose of 4 ml is recommended to prolong for adults. The maximum number of peroral introductions for adults - 10; for children - 8.

Carrying out repeated courses of an immunotherapy - not earlier than in 1 year in the presence of indications.

Features of use:

Use at pregnancy and feeding by a breast. It is contraindicated at pregnancy and in the period of a lactation.

Use for children. It is contraindicated to children under 3 years (efficiency and safety is not established).

Special instructions. Before use it is necessary to make direct vision of drug: the dissolved drug has to represent yellowish color poorly opalescent liquid without suspended particles.

Drug in bottles with the broken integrity, lack of marking is not suitable for use, at change of physical properties (color, transparency, etc.), at the expired period of validity, the wrong storage.

The immunotherapy by drug is carried out against the background of basic medicinal therapy. Cancellation of medicines of basic therapy is possible according to the decision of the doctor after carrying out a course of an immunotherapy drug Immunovak-VP-4.

Side effects:

Perhaps short-term (12-24 h) fervescence to subfebrile values (37.1-37.6 °C), a nose congestion, cough, a skin itch. The specified side reactions take place independently within 1-2 days.

In case of fervescence of the patient to 38.5 °C, its preservations in 36 h after administration of drug at the level of 37.6 °C and above, and also at emergence of other side effects stop administration of drug.

At patients with bronchial asthma the aggravation of a basic disease is in rare instances possible. In case of a bronchospasm or an attack of bronchial asthma protivopristupny therapy is carried out, and the issue of further administration of drug is resolved by the allergologist.

Considering possibility of an acute anaphylaxis, in rare instances at especially sensitive persons, it is necessary to provide medical observation for imparted within 30 min. after administration of drug. Venues of an immunotherapy and immunoprevention have to be equipped with means of antishock therapy.

Interaction with other medicines:

Use in complex therapy with other medicines. Let's combine with antibiotics, antiviral, antifungal and antihistaminic drugs, bronchial spasmolytics, corticosteroids, beta-adrenergic agonists.

When carrying out an immunotherapy or immunoprevention use of other immunomodulators in 1 month prior to the beginning of a course and within 3 months after carrying out a course of an immunotherapy or immunoprevention is not recommended by drug Immunovak-VP-4.

Contraindications:

— mental diseases in the period of an aggravation;

— collagenoses;

— tubercular process of any localization in the period of an aggravation;

— chronic diseases in a decompensation stage;

— acute feverish states with a hyperthermia (> 38 °C);

— age up to 3 years (efficiency and safety is not established);

— pregnancy;

— feeding period breast;

— hypersensitivity to drug components.

Storage conditions:

Drug is stored and transported at a temperature from 2 °C to 8 °C. Transportation is allowed at a temperature from 9 °C to 25 °C lasting no more than 10 days. To store in the place, unavailable to children. A period of validity - 3 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

1 dose - bottles (10) - packs cardboard.