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Immunoglobin kospleksny drug (PILES)

Препарат Иммуноглобулиновый косплексный препарат (КИП). ФГУП НПО «Микроген» Россия


Producer: Federal state unitary enterprise NPO Mikrogen Russia

Code of automatic telephone exchange: J06BA01

Release form: Liquid dosage forms. Lyophilisate for solution preparation.

Indications to use: Intestinal infections. Coloenteritis.


General characteristics. Structure:

Active ingredient: 300 mg of immunoglobulin human normal (from them: 50-70% in t.ch.igg, 15-25% of IgM, 15-25% of IgA).

Excipients: glycine.




Pharmacological properties:

Pharmacodynamics. The immunostimulating drug. Increases specific immunity, increases the content of immunoglobulins and antibodies to enterobakteriya (shigellas, salmonellas, escherichias, etc.) and to enteroviruses. Immunobiological properties of drug are caused by the maintenance of IgG, IgA, IgM which are its part.

Drug represents the lyophilized complex of immunoglobulins of the classes IgG, IgM, IgA allocated from a blood plasma of healthy donors. All plasma used in production is checked for lack of a surface antigen of a virus of hepatitis In (HbsAg), antibodies to a hepatitis C virus, the human immunodeficiency viruses VICh-1 and VICh-2, by the PTsR method on lack of RNA to a virus of hepatitis C, RNA to HIV and DNA to a hepatitis B virus. Not less than 97% of crude protein make immunoglobulins of the classes IgG, IgA, IgM. Drug does not contain preservatives and antibiotics.


Indications to use:

— complex treatment of the acute intestinal infections caused by enterobakteriya at children aged from 1 month up to 14 years.


Route of administration and doses:

1-2 times a day within 5 days are applied through a mouth on 1 dose equal to contents of one bottle. Before use drug is dissolved in 5 ml (1/2 tablespoons) of boiled water of room temperature by easy stirring by no more than 5 minutes. The dissolved drug represents colourless transparent liquid, weak opalescence is allowed. Drug is used on an empty stomach in 30 minutes prior to food. Drug in the opened bottle is not subject to storage.


Features of use:

Use at pregnancy and feeding by a breast. Drug is not intended for use for adults.

Use for children. It is applied at children aged from 1 month up to 14 years according to indications.

Special instructions. Precautionary measures at use. Drug cannot be used at disturbance of integrity or lack of marking of a bottle, in the presence of rough foreign inclusions, at change of physical properties of drug, at disturbance of temperature condition of storage.

Administration of drug is registered in the established registration forms with the indication of number of a series, period of validity, manufacturer, Date of Introduction, a dose and nature of reaction to administration of drug (at its development).

Influence on ability to driving of motor transport and to control of mechanisms. Drug does not exert impact on control of vehicles, and also the activity demanding the increased concentration of attention and speed of psychomotor reactions.


Side effects:

Reaction to introduction usually is absent. Sometimes, persons with the raised allergization, can have local reactions in the form of a local polymorphic enanthesis. In case of skin rash appoint antihistaminic drugs.


Interaction with other medicines:

Undesirable interactions with other medicines are noted.

Use in a complex with antibiotics, chemotherapeutic means and bacteriophages is possible.


Contraindications:

— allergic reactions (skin rash, a Quincke's disease (Quincke's edema), an acute anaphylaxis) to immunoglobulin or other blood preparations of the person (including in the anamnesis).


Overdose:

Cases of overdose are not revealed.


Storage conditions:

To transport according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. To store according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C in the place, unavailable to children. A period of validity - 3 years.


Issue conditions:

According to the recipe


Packaging:

300 mg - bottles (5) - packs cardboard.



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