Immunoglobulin human antiexposure - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspsolution for intramuscular injection

Composition:

Active substance:

- antibodies to orthopoxviruses in a titer of at least 1: 4000.

Excipient:

- stabilizer - glycine (aminoacetic acid) - (2,25 ± 0,75)%.

The drug does not contain preservatives and antibiotics.

Description:

Transparent or slightly opalescent liquid, colorless or light yellow in color. In the course of storage, a slight deposit may appear, disappearing with slight shaking.

Characteristics of the preparation.

Immunoglobulin human antipoietic is a concentrated solution of the purified fraction of immunoglobulins isolated by fractionation with ethyl alcohol from the blood plasma of healthy donors containing antibodies to orthopoxviruses in a titer of at least 1: 200.

The preparation does not contain a surface antigen of the hepatitis B virus (HBsAg) and antibodies to the hepatitis C virus and human immunodeficiency viruses HIV-1 and HIV-2.

Pharmacotherapeutic group:MIBP - globulin

ATX: & nbsp

Immunoglobulins specific

Pharmacodynamics:

Immunological properties. The active principle of the preparation is antibodies contained in the immunoglobulin and possessing specific activity to orthopoxviruses.

Indications:

- Prevention and treatment of post-vaccination complications in children from the first days of life and adults to the introduction of smallpox vaccine: generalization of the vaccination process, post-vaccinal encephalitis and other complications.

- emergency prevention and treatment of smallpox in children from the first days of life and adults.

Contraindications:

- Severe allergic reactions (in the anamnesis) for the administration of immunoglobulin or other human blood products.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and lactation during controlled clinical trials has not been investigated. The use of the drug is possible in cases where the potential benefit to the mother exceeds the potential risk to the fetus.

Dosing and Administration:

Immunoglobulin is administered intramuscularly.

Before the injection, the ampoule with the drug is kept for 2 hours at room temperature. Opening of ampoules and the procedure of administration are carried out with strict adherence to aseptic and antiseptic rules. To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen.

For the prevention of post-vaccination complications, the drug is administered primarily to vaccinated children once in a dose of 1.5 ml, adults - 3 ml immediately before vaccination.

For emergency prophylaxis of smallpox, the drug is administered once in a dose of 0.5-1.0 ml / kg body weight.

To treat postvaccinal complications, as well as for the treatment of smallpox, immunoglobulin is administered in a dose of 0.5-1.0 ml / kg of body weight, depending on the severity of the clinical course of the disease. This dose can be administered in a single dose or divided into several injections per day. The duration of treatment is determined by the attending physician.

Precautions for use.

Persons who suffer from allergic diseases or who have a history of allergic reactions, on the day of immunoglobulin and for the next 8 days, are recommended the appointment of antihistamines. Given the possibility of allergic reactions in particularly sensitive individuals, it is necessary to provide medical supervision of patients within 30 minutes after the administration of the drug. Place of therapy / drug administration should be provided with anti-shock therapy.

Do not administer the drug intravenously!

Side effects:

Side effects of immunoglobulin, as a rule, are absent. In rare cases, local reactions may develop in the form of hyperemia and rise in temperature to 37.5 ° C during the first 2 days after administration. Individuals with altered reactivity may develop allergic reactions of various types, and in exceptionally rare cases, anaphylactic shock. In this regard, people who received the drug should be under medical supervision for 30 minutes.

Overdose:Cases of overdose are not described.

Interaction:

Immunoglobulin antipoietic can be used with smallpox vaccine to prevent post-vaccination complications. Also, the drug can be used in combination with other drugs, while for the introduction should always use a separate system for infusion. Mixing of the drug with other drugs is not allowed.

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

Special instructions:

The drug in the opened ampoule is not subject to storage. The drug is not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color change, cloudiness of solution, the presence of unbreakable flakes), expired shelf life, if the storage regime is violated.

The introduction of immunoglobulin is recorded in established registration forms with the serial number, date of issue, expiration date, manufacturer, date of administration and the nature of the reaction to the administration of 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 intramuscular injection

Packaging:

For 1.5 or 3 ml (one or two doses) in the ampoule. 10 ampoules per pack with instructions for use, ampoule or ampoule knife with a knife. For 5 or 10 ampoules in a contour cell package. For 1 or 2 contour mesh packages in a pack with instructions for use and a knife ampoule or scarifier ampoule.

When packaging ampoules that have a break ring or an opening point, the ampoule knife or the ampoule scapegrator is not put in.

Storage conditions:

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C out of the reach of children.

Conditions of transportation.

Transport in accordance with JV 3.3.2.1248-03 at a temperature from 2 before 8 FROM. Freezing is not allowed.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-001579/08

Date of registration:14.03.2008 / 03.04.2014

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

Information update date: & nbsp24.10.2017

Illustrated instructions

Instructions

Human immunoglobulin antivenum (Immunoglobulin variole human)