Imbioglobulin

General characteristics. Structure:

Active ingredient: 50 mg of immunoglobulin of the person of ordinary solution in 1 ml.

Pharmacological properties:

Pharmacodynamics. The high cleaning drug IgG emitted from a human blood plasma of the healthy donors who are individually checked for lack of a surface antigen of a virus of hepatitis In (HBsAg) and antibodies to a virus of hepatitis C and the human immunodeficiency viruses VICh-1 and VICh-2. Has low anticomplementary activity as a result of additional cleaning of Ig of the aggregated proteins and impurity. Does not contain preservatives and antibiotics.

Increases contents in an organism of antibodies. Contains a wide range of the opsonizing and neutralized antibodies against bacteria, viruses and other activators. At the patients suffering from primary or secondary syndromes of an immunodeficiency provides completion of missing antibodies of the class IgG that reduces risk of an infection.

Has activity of antibodies of various specificity, and also the nonspecific activity which is shown in increase in resistance of an organism.

Pharmacokinetics. At in/in infusion bioavailability makes 100%. Between plasma and extravasated space there is a drug redistribution, and balance is reached approximately in 7 days. At persons with the normal maintenance of IgG in blood serum the period of biological semi-removal averages 21 days while at patients with primary hypo - or an agammaglobulinemia - 32 days.

Indications to use:

— replacement therapy for the purpose of prevention of infections at syndromes of primary immunodeficience: the agammaglobulinemia, usual variable immunodeficiencies connected with and - or a hypogammaglobulinemia; deficit of subclasses of IgG;

— replacement therapy for the purpose of prevention of infections at a syndrome of the secondary immunodeficience caused by a chronic lymphoid leukosis, AIDS at children or bone marrow transplantation

— idiopathic Werlhof's disease;

— a syndrome of Kawasaki (in addition to treatment by drugs of acetylsalicylic acid);

— heavy bacterial, including sepsis (in a combination with antibiotics), viral infections, prevention of infections at premature children with low body weight at the birth (less than 1500);

— Guillena-Barret's syndrome and chronic inflammatory demyelinating polyneuropathy;

— autoimmune neutropenia, partial krasnokletochny aplasia of a hemopoiesis;

— thrombocytopenia of an immune origin, including a posttransfusion purpura, isoimmune thrombocytopenia of newborns, the hemophilia caused by antibody formation to coagulation factors;

— myasthenia gravis;

— prevention and treatment of infections at therapy by cytostatics and immunodepressants;

— prevention of a usual abortion.

Route of administration and doses:

In/in kapelno. Rate of administering for children - 0.08-0.5 ml/min. depending on body weight, for adults - 1-1.5 ml/min. More bystry introduction can cause development of a collapse.

At treatment of bacterial and viral infections a single dose children - 4 ml (200 mg) on 1 kg of body weight entered 1-2 times at adults have 2 ml (100 mg) on 1 kg of body weight within 4 days.

At primary immunodeficience at patients with an inborn agammaglobulinemia and a hypogammaglobulinemia - 4-6 ml (200-300 mg) on 1 kg of body weight. A repeated course - in 3-4 weeks.

At secondary immunodeficience at patients with chronic lymphocytic leukemia - 4-10 ml (from 200 to 500 mg) on 1 kg of body weight. A repeated course - in 3-4 weeks.

Features of use:

Use at pregnancy and feeding by a breast. Immunoglobulin gets into breast milk and can promote transfer of protective antibodys to the newborn.

Special instructions. Imbioglobulin apply only in the conditions of a hospital at observance of rules of an asepsis.

Due to a possibility of development of allergic reactions of the person, received drug, have to be under medical observation. Indoors, where administer the drug, there have to be means of antishock therapy.

To persons with allergic diseases (bronchial asthma, atopic dermatitis, a recurrent small tortoiseshell) or inclined to allergic reactions, administration of drug is carried out against the background of antihistaminic HP. At the same time it is recommended to continue their introduction within 8 days after the termination of a course of treatment.

To persons with diseases in which genesis leaders are immunopathological mechanisms (collagenoses, immune diseases of blood, nephrite) drug is appointed after consultation of the corresponding specialist.

In the period of an aggravation of allergic process administration of drug is carried out according to the conclusion of the allergist according to vital indications.

Temporary increase in maintenance of antibodies in the patient's blood after administration of immunoglobulin can cause in a false manner positive takes of serological tests.

It is impossible to exceed the speed of intravenous administration in view of a possibility of development of kollaptoidny reactions.

Before introduction bottles maintain at a temperature of 20±2 °C not less than 2 h. The muddy and containing a deposit drug is not subject to use.

Imbioglobulin's introduction is registered in the established registration forms with the indication of number of a series, date of production, a period of validity, manufacturer, a dose and the nature of reaction to administration of drug.

It is necessary to phone (fax) or telegraph in the State scientific research institute of standardization and control of medical biological supplies of L. A. Tarasevich about cases of the increased reactogenicity (GISK of L. A. Tarasevich) with the subsequent submission of medical documentation.

Side effects:

Within the first days after administration of drug slight increase of body temperature, allergic reactions are possible.

Sometimes there are a headache, nausea, dizziness, vomiting, abdominal pains, diarrhea, the dispepsichesky phenomena, arterial hypo - or hypertensia, tachycardia, cyanosis, short wind, feeling of a prelum or thorax pain; seldom - heavy hypotonia, a collapse, a loss of consciousness, a hyperthermia, a fever, the increased sweating, feeling of fatigue, an indisposition, dorsodynias, mialgiya, numbness, inflows of heat or a cryesthesia. In exclusively exceptional cases at individual intolerance development of anaphylactic reactions is possible.

Interaction with other medicines:

Transfusion therapy by immunoglobulin for intravenous administration can be combined with other medicines, in particular, antibiotics.

Administration of immunoglobulins can weaken (for 1.5-3 months) action of live vaccines against such viral diseases as measles, a rubella, epidemic parotitis and chicken pox (inoculations should be carried out by the specified vaccines not earlier than in 3 months).

After introduction of high doses of immunoglobulin its influence can last in some cases up to one year.

Not to apply along with calcium a gluconate at babies.

Contraindications:

— hypersensitivity to immunoglobulins of the person, especially at patients with deficit is IgA due to formation of antibodies to it.

Storage conditions:

To store in the dry, protected from light place at a temperature not above 2-8 °C. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

25 ml - bottles (1) - packs cardboard.
50 ml - bottles (1) - packs cardboard.
100 ml - bottles (1) - packs cardboard.
20 ml - bottles (1) - packs cardboard.
200 ml - bottles (1) - packs cardboard.