Immunoglobulin of the person normal

Immunoglobulin of the person normal – immunological means.

Form of release and structure

Dosage forms:

• Solution for intramuscular introduction (in oil) (in ampoules: on 1 ml / 1 a dose, in a cardboard pack of 10 pieces; on 1,5 ml / 1 a dose, in a cardboard pack of 10 pieces or in planimetric plastic packaging on 5 or 10 ampoules, in a cardboard pack 1 or 2 packagings; on 3 ml / 2 doses, in a cardboard pack of 10 pieces; on 3 ml / 1 a dose, in a cardboard pack of 10 pieces);
• Solution for intravenous (in/in) introductions (on 25 or 50 ml in bottles, in a cardboard pack 1 bottle);
• Solution for infusions (on 25, 50 or 100 ml in bottles, in a cardboard pack 1 bottle).

Active agent – immunoglobulin of the person normal:

• Solution for introduction in oil: in 1 ml – 100 mg;
• Solution for in/in introductions: in 1 ml – 50 mg;
• Solution for infusions: in 1 ml – 50 mg.

Indications to use

Use of drug is shown:

• Solution for introduction in oil: at therapy agamma-and gipoglobulinemiya; for prevention: whooping cough, measles, hepatitis A, meningococcal infection, flu, poliomyelitis; for increase in body resistance at infectious diseases in the period of reconvalescence;
• Solution for in/in introductions: therapy of severe forms of viral and bacterial infections; at postoperative complications at the adults and children connected with a septicaemia;
• Solution for infusions: an idiopathic Werlhof's disease (especially at acute forms at children), treatment and prevention of infectious diseases, immunodeficient inborn states (a partial, full or variation immunodeficiency, severe forms of combined immunodeficience, Viskotta-Aldrich's syndrome), and also the immunodeficiency acquired as a result of transplantation of marrow and other types of transplantations at chronic lymphocytic leukemia, at AIDS at children, a syndrome of Kawasaki (as the acetylsalicylic acid accompanying therapy).

Contraindications

Contraindications to use of Immunoglobulin of the person normal in the form of solutions for in oil and in/in introductions:

• Heavy allergic reactions in the anamnesis to introduction of blood preparations;
• Allergic diseases, including bronchial asthma, atopic dermatitis, a recurrent small tortoiseshell, and also tendency to allergic reactions in the anamnesis (the patient of this category administration of drug is possible at simultaneous use of antihistamines which continue to enter within 3 days at in oil and 8 – at in administration of immunoglobulin);
• System immune diseases, including nephrite, diseases of blood, connecting fabric (in need of immunoglobulin use introduction should be made only after consultation with the corresponding specialist and against the background of purpose of the accompanying therapy).

It is impossible to apply solution to introduction in oil at babies along with calcium a gluconate.

Use of solution for infusions is contraindicated to patients with the selection deficit of immunoglobulin A (IgA) against the background of existence of antibodies against IgA and at hypersensitivity to drug.

With care it is necessary to appoint solution for infusions during pregnancy and breastfeeding.

Route of administration and dosage

Solution for injections in oil is entered into the outside surface of a hip or an upper outside quadrant of a gluteus (in/in administration of drug – it is forbidden!) It is impossible to store drug in the opened ampoule, to use ampoules with the broken marking or tightness, in case of discoloration of solution, its opacification or existence of not breaking flakes, at disturbance of storage conditions and the expired period of validity. Within 2 hours before introduction it is necessary to sustain ampoules with drug at the room temperature. The procedure is carried out in the conditions of observance of rules of antiseptics and an asepsis. Solution is gathered in the syringe a needle with a wide gleam not to allow foaming. The dose and frequency rate of administration of immunoglobulin are appointed by the doctor on the basis of clinical indications.

The recommended dosing for prevention:

• Hepatitis A: once, to children from 1 to 6 years in a dose of 0,75 ml, up to 10 years – 1,5 ml, to patients are more senior than 10 years – 3 ml (in case of need repeated introduction is possible only in 2 months);
• Prevention of measles: once, the dose for children depends on time which passed from the moment of contact with the patient and a condition of the child, and can make 1,5 or 3 ml, in case of contact with multi-infections – 3 ml, adult – 3 ml (it is shown to the patients from age of 3 months who did not have measles and are not imparted against it no later than 6 days from the moment of contact with the patient);
• Prevention of whooping cough: to the children who were not ill and not vaccinated or not completely vaccinated against whooping cough – on 3 ml two times with a break at 24 o'clock during the mildest time, but not later than 3 days from the moment of contact with the patient;
• Prevention of a meningococcal infection: once, to children from 6 months to 3 years in a dose of 1,5 ml, from 3 to 7 years – 3 ml, within the first 7 days after contact with the patient with a generalized meningococcal infection;
• Prevention of poliomyelitis: once in doses of 3-6 ml, not completely or to the children who are not imparted by a poliomyelitic vaccine, in earlier terms after contact with sick poliomyelitis;
• For treatment and prevention of flu solution is entered once: to children up to 2 years in a dose of 1,5 ml, from 2 to 7 years – 3 ml, to patients are more senior than 7 years – 4,5-6 ml, at a severe form of a disease introduction of a dose of drug is shown repeated (in 24-48 hours);
• At therapy agamma-and gipoglobulinemiya appointment produce in a dose 1 ml on 1 kg of weight of the patient (it can be entered into 2-3 inclusion with a break in 24 h). Carrying out the subsequent purposes of drug according to indications is possible only 1 month later;
• For increase in body resistance at chronic pneumonia and in the period of reconvalescence at the long course of acute infectious diseases introduction of a single dose of 0,15-0,2 ml on 1 kg of weight of the patient is shown. Frequency rate of introduction is appointed by the doctor, but no more than 4 injections with an interval of 2-3 days.

Solution for in/in introductions part just before use 0,9% solution of sodium of chloride of isotonic or 5% glucose solution in a proportion 1:4. Ready solution of immunoglobulin is entered in/in kapelno with a speed of 8-10 thaws a minute, daily within 3-5 days. Without additional cultivation immunoglobulin can be entered in/in kapelno with a speed of 30-40 thaws a minute, a course of treatment – 3-10 transfusions which are carried out with an interval of 24-72 hours. This method of introduction can cause a kollaptoidny condition of the patient. Transfusion treatment can be carried out in combination with other medicines. A single dose for children – 3-4 ml on 1 kg of weight (but no more than 25 ml), for adults – 25-50 ml. Use of drug should be carried out only in stationary conditions with observance of rules of an asepsis. Before introduction it is necessary to sustain bottles with drug within 2 hours at the room temperature. The solutions containing a deposit or muddy are not subject to use.

Solution for infusions is entered in/in kapelno, before use drug is recommended to be warmed to body temperature or room temperature. It is possible to enter only transparent solution. Initial speed of infusion – 30 drops a minute, in 10 minutes bring speed to 40 drops a minute. Apply:

• Replacement therapy at congenital and secondary immunodeficience, including children about AIDS: on 2-8 ml on 1 kg of weight of the patient once a month before increase in level of immunoglobulin (in the absence of sufficient dynamics of growth of level or its very bystry decrease it is necessary to reduce intervals between introduction or to increase a dose to 16 ml by 1 kg of weight);
• At allogenic transplantation of marrow to the patient appoint on 10 ml to 1 kg of weight within 7 days;
• At a syndrome of Kawasaki – 32-40 ml on 1 kg of weight within 2-5 days, or 40 ml on 1 kg – once;
• At an idiopathic Werlhof's disease – 16-20 ml on 1 kg of weight, once (in case of need it is possible to repeat in 2-3 days), or on 8 ml on 1 kg of weight of the patient within 2-5 days (if necessary repetition of a course is possible);
• At heavy viral and bacterial infections, including sepsis – 8-10 ml on 1 kg of weight, daily within from 1 to 4 days;
• To premature children (with a low weight at the birth) for prevention of infections administration of drug is appointed with a break in 1-2 weeks on 10-20 ml to 1 kg of weight of the baby;
• At a chronic inflammatory demyelinating neuropathy, a syndrome to Giyena-Barra: on 8 ml on 1 kg of weight within 5 days (repetition of a course with a break in 4 weeks is allowed);
• To patients with cerebral ischemia and coronary heart disease: on 8 ml on 1 kg, daily.

Side effects

Reactions on in oil and in/in administration of immunoglobulin, usually, are absent.

Development of allergic reactions of various type up to an acute anaphylaxis is in some cases possible. Therefore patients after administration of drug have to be within 30 minutes under observation of medical staff; the room where administer the drug, has to be provided with means of antishock therapy.

In rare instances at introduction in oil local reactions in the form of a hyperemia and temperature increase within the first days to 37,5 °C can develop.

At infusional introduction development of side effects in the form of a fever, a headache, nausea, fervescence, vomiting, a dorsodynia, an ache in joints, allergic reactions is possible. Seldom – a lowering of arterial pressure, in isolated cases – symptoms of aseptic meningitis (nausea, a severe headache, vomiting, a stiff neck, fervescence, a photosensitivity and disturbance of consciousness), an acute anaphylaxis, aggravation of the available renal failures.

Special instructions

Immunoglobulin of the person normal should be applied only on doctor's orders.

Each procedure is registered in the established registration forms with the indication of date of issue, number of a series, manufacturer, a period of validity, Date of Introduction and a dose, the nature of reaction of the patient to administration of drug.

After administration of immunoglobulin of an inoculation against epidemic parotitis and measles it is necessary to carry out not earlier than in 3 months. After vaccination against these diseases it is possible to enter immunoglobulin not earlier than in 2 weeks. In case of need uses of immunoglobulin of earlier specified term vaccination should be repeated. Carrying out all other inoculations is authorized in any terms, irrespective of time of administration of drug.

Administration of drug can become the reason of false positive results of serological tests.

It is impossible to exceed the recommended infusion speed, it can cause development of heavy side effects. The entire period of infusion and 20 minutes of the patient after it has to be under control of the doctor.

Medicinal interaction

Clinically significant medicinal interaction of solution for in oil or in/in introductions it is not established.

Solution for infusions lowers activity of the weakened live vaccines against a rubella, measles, chicken pox, epidemic parotitis. In case of need administrations of immunoglobulin during the first 2 weeks after a parotitis, measles or rubella inoculation, vaccination against these diseases it is necessary to repeat in 3 months. Solution for infusions can be mixed only from 0,9% chloride sodium solution.

Terms and storage conditions

To store at a temperature of 2 up to 8 °C, not to freeze. To protect from children.

Period of validity: solution for introduction in oil – 2 years, solution for in/in introductions – 1 year.