Immunoglobulin anti-Cytomegaloviral person

General characteristics. Structure:

Active ingredients - specific antibodies to a cytomegalovirus;

the stabilizer – glycine (glycine, the aminoacetic acid).

Main properties: drug is immunological the active protein fraction allocated from the blood plasma of the person cleared and concentrated by a fractionation method alcohol, which passed a stage of a virus inactivation solvent-detergentnym by method. Protein content in 1,0 ml of drug from 0,09 g to 0,11 g. Transparent or slightly opalescent, colourless or yellowish liquid. In the course of storage emergence of an insignificant deposit which disappears when stirring is possible. Drug contains antibodies to a cytomegalovirus. Drug does not contain preservative and antibiotics, in raw materials there are no antibodies to VICh-1, VICh-2, to a virus of hepatitis C and a surface antigen of a virus of hepatitis In (HBsAg).

Pharmacological properties:

The operating basis of drug are the antibodies specific to a cytomegalovirus, in particular immunoglobulin G. Specific activity of drug is caused by virus neutralizing action of antibodies. Besides, immunoglobulin G, causes immunomodulatory effect, influencing different links of immune system of the person, and increases nonspecific resistance of an organism.

Indications to use:

Drug is used for the purpose of treatment of a Cytomegaloviral infection, various on clinical manifestations, at adults and children, in particular:

-        a Cytomegaloviral infection at pregnant women with the complicated obstetric anamnesis for the prevention of disturbances of a course of pregnancy (the prevention of threat of not incubation, development of fetoplacental insufficiency, pre-natal death of a fruit);

-        TsMV-infections at nonpregnant women with the complicated obstetric anamnesis for the prevention of disturbances of a course of pregnancy which is planned;

-        primary TsMV-infection at pregnant women with the neslozhnenny anamnesis for the prevention of obstetric complications;

-        TsMV-infections at newborns and children of younger age who are given birth by the infected mothers and have clinical signs of a disease;

-        TsMV-infections of adults with damage of the central nervous system (CNS).

Route of administration and doses:

Immunoglobulin is entered intramusculary.

For treatment of a Cytomegaloviral infection at pregnant and nonpregnant women with the burdened obstetric anamnesis immunoglobulin is entered by 4-5 times on 1,5 ml (1 ampoule) with an interval of 3 or 5 days depending on a condition of the patient.

For treatment of the TsMV-infection with defeat of TsNS adult immunoglobulin is entered by 5 times with a two-day interval in number of 4,5 ml (3 ampoules on 1,5 ml).

For treatment of the TsMV-infection at newborns immunoglobulin is entered by 3 times with an interval of 2-3 days on 0,5 ml/kg/days.

For treatment of the TsMV-infection at children of younger age immunoglobulin is entered by 4-5 times with an interval of 5 days on 1,5 ml (1 ampoule).

Features of use:

Administration of drug is intravenously forbidden!

After administration of immunoglobulin the measles and epidemic parotitis inoculation is carried out not earlier than in 2-3 months. After vaccination against these infections immunoglobulin is entered not earlier than in 2 weeks. In need of use of immunoglobulin before this term vaccination against measles or epidemic parotitis should be repeated. Other infections inoculations can be carried out to any terms before administration of immunoglobulin.

Side effects:

Reactions to administration of immunoglobulin, as a rule, are absent. In rare instances local reactions in the form of a hyperemia and temperature increase to ^{37,5 0C} within the first days can develop. At certain people with the changed reactivity allergic reactions of various type, and in exclusively exceptional cases - an acute anaphylaxis can develop. In this regard the persons who received drug have to be under medical observation within 30 minutes. Rooms of carrying out inoculations have to be provided with means of antishock therapy.

Interaction with other medicines:

Reasonablly combined use of immunoglobulin and gantsiklovir or foskarnet.

Contraindications:

Administration of immunoglobulin is contraindicated to the persons having heavy allergic reactions to introduction of proteinaceous blood preparations of the person in the anamnesis. Or having a serious allergic illness in the anamnesis, in day of administration of immunoglobulin and in the next 3 days antihistaminic drugs are recommended to the patients having allergic diseases. To the persons suffering from immune general diseases (diseases of blood, connecting fabric, nephrite, etc.), it is necessary to enter immunoglobulin against the background of the corresponding therapy.

Overdose:

It was not studied.

Storage conditions:

In the dry, protected from light place at a temperature from 2 °C to 8 °C.

Issue conditions:

According to the recipe

Packaging:

In ampoules on 1,5 ml (1 dose) and 3,0 ml (2 doses) on 10 ampoules in a box with a corrugated insert or with a polymeric insert from a film polyvinyl chloride for placement and fixing of ampoules.