Imbioglobulin - instructions for use, dose, side effects, contraindications

Immunoglobulin is a highly purified immunoglobulin G. Immunoglobulin G is obtained from the blood plasma of clinically healthy donors using a technology that includes procedures that inactivate and / or remove viruses: the method of ethanol fractionation in the cold, removal of viruses by aluminum hydroxide followed by filtration through deep filters, treatment of immunoglobulin solvents / detergent mixture, warming at 37 ° C with a low pH value for 2 days, and standing for 28 days at a temperature of 20-25 ° C.

For fractionation, a pool of plasma of no less than 1000 donors is used. All plasma used in production is tested for the absence of a surface antigen of the hepatitis B virus (HBsAg), antibodies to the hepatitis C virus,human immunodeficiency virus HIV-1 and HIV-2, using PCR for the absence of RNA of hepatitis C virus, human immunodeficiency virus RNA and HBV DNA.

Most of the immunoglobulin G is represented by a monomeric form, the remainder is made up of IgG dimers, less than 1% IgG polymers, trace amounts of IgA and IgM and immunoglobulin fragments are present. The distribution of subclasses of IgG corresponds to the distribution in normal serum.

Intravenous tolerance of the drug is achieved by removing from the preparation of specifically aggregated proteins with spontaneous anticomplementary activity.

Immunological properties: Imbioglobulin contains a wide range of specific antibodies against infectious agents that are capable of opsonization and neutralization 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 increased resistance of the body. The introduction of the drug restores a low level 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 immunoglobulin equilibrium is achieved between the inside and the extravascular bed. The biological half-life of Imbioglobulin is 21 days.

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;

- in the complex therapy of postoperative complications, accompanied by septicemia;

- primary (congenital agammaglobulinemia and hypogammaglobulinemia) and secondary immunodeficiencies.

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;

- 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:

Use with caution in the following risk groups:

- in persons older than 65 years;

- with hypertension;

- with diabetes mellitus;

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

- with hereditary or acquired thrombophilic disorders;

- in patients who have been immobile for a long time;

- in patients with severe hypovolemia;

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

- 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.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and lactation during controlled clinical trials has not been investigated. Pregnant and breast-feeding medication is prescribed with caution. 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. The rate of administration for children should be from 0.08 to 0.5 ml / min, depending on body weight, for adults -1-1.5 ml / min. A faster injection can cause the development of a collapoid reaction.

In the treatment of bacterial and viral infections a single dose of the drug should be 4 ml (0.2 g / kg) for children one or two times, for adults - 2 ml (0.1 g / kg) for 4 days.

With primary immunodeficiency single dose is from 4 to 6 ml (from 0.2 to 0.3 g / kg) once. The introduction is repeated after 3-4 weeks.

With secondary immunodeficiency in patients with chronic lymphocytic leukemia - 4-10 ml (from 0.2 to 0.5 g / kg). The introduction is repeated after 3-4 weeks.

Imbioglobulin is used only in a hospital setting, while observing all asepsis rules. Before the introduction of the bottle, it is kept at a temperature of (20 ± 2) ° C for at least 2 hours. Turbid, sediment-containing discolored preparations are not suitable.

Side effects:

The development of side effects depends on the size of the dose and the rate of administration of the drug.The likelihood of side effects decreases with a decrease in the rate of administration of the drug.

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

- flu-like syndrome: chills, headache, hyperthermia;

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

- on the part of the cardiovascular system: lowering blood pressure (BP), rarely-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 exceptionally rare cases - anaphylactic shock, in this connection, those who received the drug,should be under medical supervision. In the room where the drug is administered, there should be antishock therapy.

Overdose:

Cases of overdose are not described.

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.

Do not dilute the drug before use with any solutions, including sodium chloride injection for 0.9%.

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

Special instructions:Precautions for use

Persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, especially during the period of exacerbation, the introduction of the drug is possible only after consultation of the allergist for vital indications.

Persons suffering from diseases in the genesis of which are the leading immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis), the drug is also appointed after consultation of the relevant specialist. During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.

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

Effect on the ability to drive transp. cf. and fur:

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 infusions, 50 mg / ml.

Packaging:

For 20, 50, 100, 200 ml in bottles.

For 1 bottle (bottle) in a pack of cardboard with instructions for use.

Storage conditions:

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

Freezing is not allowed.

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C out of the reach of children. Freezing is not allowed.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000177

Date of registration:18.03.2010 / 02.07.2013

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: & nbsp08.11.2017

Illustrated instructions

Instructions

Imbioglobulin (Imbioglobulin)