Immunoglobulin normal - instructions for use, dose, side effects, contraindications

Characteristics of the preparation. The human immunoglobulin is normal is a highly purified preparation of immunoglobulin G, isolated from the blood plasma of healthy donors. Each immunoglobulin series is made from a plasma mixture of at least 1000 donors, individually tested for the absence of the surface antigen of the hepatitis B virus (HBsAg) and antibodies to the hepatitis C virus and human immunodeficiency virus HIV-1 and HIV-2. The drug has low anticomplementary activity.

Immunobiological properties. The drug contains a wide range of specific antibodies against infectious agents that are capable of opsonizing and neutralizing microbes and toxins.The introduction of the drug replenishes the level of antibodies in the blood of the recipient. The drug also has nonspecific activity, manifested in increasing the resistance of the body. The introduction of the drug restores the low level of immunoglobulin G to normal values.

Pharmacokinetics:The entire administered dose of the drug comes directly into the bloodstream of the recipient immediately after administration. After approximately 6 days, an equilibrium of the distribution of the immunoglobulin between the intra- and extravascular bed is achieved.

Indications:

The drug is used without age restrictions.

As part of complex therapy:

- for the treatment of severe toxic forms of bacterial and viral infections;

- for the treatment of postoperative complications, accompanied by septicemia.

As replacement therapy:

- with primary immunodeficiency (congenital agammaglobulinemia and hypogammaglobulinemia);

- with multiple myeloma with severe form of secondary hypogammaglobulinemia and recurrent bacterial infections;

- with chronic lymphocytic leukemia with severe form of secondary hypogammaglobulinemia and recurrent bacterial infections with ineffective preventiveantibacterial therapy;

- with congenital HIV infection with recurrent infections in children.

Contraindications:

- Hypersensitivity to human immunoglobulin, especially in rare cases of a deficiency in the blood of immunoglobulin class A (IgA) and the presence of antibodies against IgA;

- hypersensitivity to the components of the drug;

- the presence of an anamnesis of allergic reactions to blood products. In cases of severe sepsis, the only contraindication for administration is an anaphylactic shock to blood products in the anamnesis.

Carefully:

Persons with allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, administration of antihistamines is recommended on the day of immunoglobulin administration and for the next 8 days. During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.

Persons suffering from diseases in the genesis of which the immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis) are leading, the drug is appointed after consultation of the relevant specialist.

There are suspicions about the relationship between the administration of intravenous immunoglobulins and the phenomena of thromboembolism, such as myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis.

Use with caution in the following risk groups:

- in persons older than 65 years;

- with hypertension;

- with diabetes mellitus;

- in case of vascular disease or history of thrombosis in the anamnesis;

- with hereditary or acquired thrombophilic disorders;

- in patients who have been in a state of immobility for a long time;

- in patients with severe hypovolemia;

- in patients with chronic diseases, in which the viscosity of the blood is increased;

- in patients with impaired renal function;

- with a reduced volume of circulating blood;

- with excessive body weight;

- with the simultaneous administration of drugs that have a nephrotoxic effect. Patients who are at risk for developing acute renal failure or thromboembolism should be given the drug at the lowest possible rate and at the lowest possible dose.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and lactation during controlled clinical trials has not been investigated.However, the long-term clinical experience of the use of immunoglobulins for intravenous administration in pregnancy shows that one should not expect any harmful effects in pregnancy, either in relation to the mother, or to the fetus or newborn.

Immunoglobulins are excreted with the mother's milk and can facilitate the transfer of protective antibodies from the mother to the newborn. The use during the period of breastfeeding is allowed on the recommendation of the attending physician.

Dosing and Administration:

The drug is administered intravenously drip.

For children a single dose of the drug is 3-4 ml / kg of body weight, but not more than 25 ml. Immediately before the administration, the drug is diluted with 0.9% sodium chloride solution or 5% glucose solution at the rate of 1 part of the preparation and 4 parts of the dilution solution. The diluted drug is not subject to storage. The diluted immunoglobulin is injected intravenously at a rate of 8-10 drops per minute (faster administration may cause the development of a collapoid reaction). Infusions are carried out daily for 3-5 days.

For adults a single dose of the drug is 25-50 ml. Immunoglobulin (without additional dilution) is injected intravenously at a rate of 30-40 drops per minute (faster administration may cause the development of a collapoid reaction).The course of treatment consists of 3-10 transfusions, conducted through 24-72 hours (depending on the severity of the disease).

Substitution therapy for primary immunodeficiency: single dose is 8-16 ml / kg body weight once. The administration is repeated every 2-4 weeks at a dose of 4-16 ml / kg of body weight to maintain the plasma IgG titer at 4-6 g / l. To determine the optimal dose and the interval between administrations, the level of IgG in the plasma should be monitored.

Replacement therapy with multiple myeloma with severe form of secondary hypogammaglobulinemia and recurrent bacterial infections: with chronic lymphocytic leukemia with severe form of secondary hypogammaglobulinemia and recurrent bacterial infections with ineffective prophylactic antibacterial therapy; with congenital HIV infection with recurrent infections in children: the dose is 4-8 ml / kg body weight. The administration is repeated after 3-4 weeks to maintain the concentration of IgG in the plasma at a level of 4-6 g / l. To determine the optimal dose and the interval between administrations, the level of IgG in the plasma should be monitored.

The drug is used only in a hospital, while observing all the rules of asepsis.The preparation is not suitable for use in bottles (bottles) with broken integrity, marking, as well as when changing color, transparency, expired shelf life, improperly stored. Before the introduction of the bottle (vials), it is maintained at a temperature of (20 ± 2) ° C for at least 2 hours.

Side effects:

The development of adverse reactions depends on the size of the dose and the rate of administration of the drug.

According to numerous studies of preparations of immunoglobulins for intravenous administration, the following side effects are possible:

- disorders of the skin and subcutaneous tissues: urticaria, rashes, itching, skin lesions;

- general disorders and disorders at the injection site: chills, fatigue, fever, asthenia, flu-like condition (chills, headache, dizziness, hyperthermia, myalgia), chest pain, general malaise, pain at the injection site;

- On the part of the digestive system: nausea, vomiting, abdominal pain, dyspepsia;

- from the side of the cardiovascular system: arterial hypotension, tachycardia, cyanosis, dyspnea. Rarely expressed decrease in arterial pressure, loss of consciousness, collapse.

In isolated cases, it is possible to develop reversible aseptic meningitis, transient hemolytic anemia, hemolysis, acute renal failure and hypercreatinemia. Since there is evidence that the administration of a high dose of immunoglobulin leads to a relative increase in blood viscosity, there is a relationship between intravenous immunoglobulin administration and thromboembolism, such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis, especially in at-risk groups.

Individuals with altered reactivity may develop allergic reactions of various types, and in extremely rare cases, anaphylactic shock, and therefore, those who receive the drug should be under medical supervision for an hour. In the room where the drug is administered, there should be antishock therapy.

Overdose:Overdose of the drug in patients at risk, especially in elderly people, as well as in patients with impaired renal function, can lead to hypervolemia and increased blood viscosity.

Interaction:

The drug can be used in complex therapy of the disease in combination with other drugs. It is not allowed to mix the drug with other drugs, for the introduction should always use a separate system for infusion.

May reduce the effectiveness of active immunization: live vaccines (against measles, mumps, rubella, chicken pox) are administered no earlier than 3 months. after administration of immunoglobulin.

In the case of measles vaccination within 1 year after the administration of immunoglobulin, the effectiveness of the vaccine may be reduced. In this regard, in patients vaccinated with the measles vaccine, it is recommended to monitor the level of antibodies.

Special instructions:

During the administration of the drug, the patient's condition should be carefully monitored.

For all patients receiving immunoglobulin, it is necessary to conduct adequate hydration (intake of sufficient amounts of fluid) before starting infusion, monitor diuresis, control creatinine concentration in the plasma, eliminate the use of loop diuretics.

The introduction of immunoglobulin can lead to a transient increase in various passively transmitted antibodies in the bloodpatient and to false-positive results of serological tests (eg, Coombs test).

Because of the presence of glucose in the drug, it is possible to increase the concentration of glucose in the blood of the patient, which affects the result of its determination. Elevated blood glucose values are determined at the time of drug administration and within 15 hours after drug administration. This fact should be taken into account when prescribing therapy for patients with diabetes mellitus.

The drug should be registered in the prescribed registration forms with the name of the drug, serial number, date of issue, expiration date, manufacturer, date of administration, dose and adverse reactions to the drug.

Effect on the ability to drive transp. cf. and fur:Information about the possible effect of the drug on the ability to drive vehicles, mechanisms. The drug does not affect the ability to drive vehicles, mechanisms, as well as activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Solution for intravenous administration, 50 mg / ml.

Packaging:For 25 or 50 ml in glass bottles.1 bottle with instructions for use in a pack of cardboard.

Storage conditions:Storage conditions.

Store in accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 ° C in a place protected from light and out of the reach of children. Freezing is not allowed.

Conditions of transportation.

Transport in accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Shelf life:1 year and 6 months. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N001594 / 01

Date of registration:04.07.2008 / 10.05.2016

Expiration Date:Unlimited

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp07.11.2017

Illustrated instructions

Instructions

The human immunoglobulin is normal (Immunoglobulinum humanum normale)