Immunoglobulin of the person normal

General characteristics. Structure:

Active ingredient: 1,5 ml of immunoglobulin of the person normal in 1 dose.

Excipients: glycine. Drug does not contain preservatives and antibiotics.

Pharmacological properties:

Pharmacodynamics. Drug represents strong solution immunological of the active protein fraction allocated with a fractionation method alcohol at a temperature below 0 °C from a blood plasma of healthy donors. For production of a series of immunoglobulin use the plasma received not less than from 1000 healthy donors who are individually checked for lack of a surface antigen of a virus of hepatitis In (HBsAg) of antibodies to a virus of hepatitis C and the human immunodeficiency viruses VICh-1 and VICh-2.

Concentration of protein in immunoglobulin makes from 9,5 to 10,5%.

The stabilizer glycine in concentration (2,25±0,75) %. Drug does not contain preservatives and antibiotics.

Effective agent are the immunoglobulins having activity of antibodies of various specificity.

Drug has also nonspecific activity, increasing resistance of an organism.

Pharmacokinetics. Cmax of antibodies in blood is reached in 24-48 h, T1/2 of antibodies makes 3-4 weeks of an organism.

Indications to use:

— prevention of hepatitis A, measles, whooping cough, meningococcal infection, poliomyelitis, flu;

— treatment hypo - and agammaglobulinemias;

— for increase in resistance of an organism in the period of reconvalescence of infectious diseases.

Route of administration and doses:

Immunoglobulin is entered intramusculary into an upper outside quadrant of a buttock mshshcha or the outside surface of a hip. It is forbidden to administer the drug intravenously. Before an ampoule injection with drug maintain within 2 hours at the room temperature.

Opening of ampoules and the procedure of introduction are carried out at strict observance of rules of an asepsis and antiseptics. In order to avoid foaming drug is gathered in the syringe a needle with a wide gleam.

Drug in the opened ampoule is not subject to storage. Drug in ampoules with the broken integrity or marking is unsuitable to use, at change of physical properties (discoloration, solution opacification, existence of not breaking flakes), at the expired period of validity and non-compliance with storage conditions.

The dose of immunoglobulin and frequency rate of its introduction depend on indications to use.

Prevention of hepatitis A. The drug is administered once in doses: to children from 1 to 6 years - 0,75 ml, up to 10 years - 1,5 ml, are more senior than 10 years and adult - 3 ml. Repeated administration of immunoglobulin in case of need of prevention of hepatitis A is shown not earlier than in 2 months.

Prevention of measles. The drug is administered once from 3-month age to the persons who did not have measles and not vaccinated against an infection no later than 6 days after contact with the patient. The drug dose to children (1,5 or 3 ml) is established depending on the state of health and time which passed from the moment of contact. To adults, and also children at contact with multi-infections the drug is administered in a dose 3 ml.

Prevention and treatment of flu. The drug is administered once in doses: to children up to 2 years - 1,5 ml, from 2 to 7 years - 3 ml, are more senior than 7 years and adult - 4,5-6 ml. At treatment of severe forms of flu administration of immunoglobulin in the same dose is shown repeated (in 24-48 h).

Prevention of whooping cough. The drug is administered at an interval of 24 h in a single dose of 3 ml to the children who did not have whooping cough and are not imparted (not completely vaccinated) against whooping cough in perhaps earlier terms after contact with the patient twice, but not later than 3 days.

Prevention of a meningococcal infection. The drug is administered once to children aged from 6 months till 7 years no later than 7 days after contact with the patient with a generalized form of a meningococcal infection in doses of 1,5 ml (to children up to 3 years) also by 3 ml (to children 3 years are more senior).

Prevention of poliomyelitis. The drug is administered once in doses of 3-6 ml to not vaccinated or defectively imparted by a poliomyelitic vaccine children in perhaps earlier terms after contact with sick poliomyelitis.

Treatment hypo - and agammaglobulinemias. The drug is administered in a dose 1 ml on 1 kg of body weight, the calculated dose can be entered into 2-3 receptions at an interval of 24 h. The subsequent administrations of immunoglobulin carry out according to indications not earlier than in 1 month.

Increase in resistance of an organism in the period of reconvalescence of acute infectious diseases with a long current and at chronic pneumonia.

The drug is administered in a single dose 0,15-0,2 ml on 1 kg of body weight. Frequency rate of introduction (to 4 injections) is defined by the doctor; intervals between injections make 2-3 days.

Features of use:

Use for children. Use for children according to indications is possible.

At babies not to apply together with calcium a gluconate.

Special instructions. Immunoglobulin is applied only on doctor's orders. Administration of immunoglobulin is registered in the established registration forms with the indication of number of a series, date of issue, a period of validity, manufacturer, Date of Introduction, a dose, the nature of reaction to administration of drug.

After administration of immunoglobulin of an inoculation against measles and epidemic parotitis carry out not earlier than in 3 months. After vaccination against these infections immunoglobulin should be entered not earlier than in 2 weeks; in case of need 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 to or after 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 °C within the first days after administration of drug can develop.

At certain people with the changed reactivity allergic reactions of various type, and in exclusively exceptional cases - an acute anaphylaxis, in this regard the person who administered the drug can develop, have to within 30 min. after its introduction be under medical observation. Venues of inoculations have to be provided with means of antishock therapy.

Interaction with other medicines:

It is not established.

Contraindications:

— heavy allergic reactions to introduction of blood preparations of the person in the anamnesis.

Purpose of antihistaminic drugs is recommended to the persons having allergic diseases or having heavy allergic reactions in the anamnesis in day of administration of immunoglobulin and a current of the next 3 days.

To persons, the suffering system immune diseases (diseases of blood, connecting fabric, nephrite, etc.) it is necessary to enter immunoglobulin against the background of the corresponding therapy.

Storage conditions:

Storage and transportation according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C in the place, unavailable to children. Freezing is not allowed. A period of validity - 2 years. Drug is not subject to expired use.

Issue conditions:

According to the recipe

Packaging:

1.5 ml - ampoules (10) - packs cardboard.
1.5 ml - ampoules (5) - packagings planimetric plastic (1) - packs cardboard.
1.5 ml - ampoules (5) - packagings planimetric plastic (2) - packs cardboard.
1.5 ml - ampoules (10) - packagings planimetric plastic (1) - packs cardboard.
1.5 ml - ampoules (10) - packagings planimetric plastic (2) - packs cardboard.