Immunoglobulin antitetanus from human serum (Immunoglobuline antitetanus human)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHuman tetanus antiglobulinHuman tetanus antiglobulin
Dosage form: & nbspsolution for intramuscular injection
Composition:

Per 1 ml:

specific antitetan antibodies 100 ME;

stabilizer glycine (glycocol) from 20 to 25 mg, sodium chloride 7 mg, water for injection.

The drug does not contain antibiotics.

HBsAg, antibodies to HIV-1, HIV-2 and to the hepatitis C virus are absent.

Description:Transparent or slightly opalescent liquid, colorless or light yellow in color.
Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

J.06.B.B.02   Human tetanus antiglobulin

Pharmacodynamics:

Antitetanus immunoglobulin from human serum solution for intramuscular administration is a concentrated solution of purified gamma globulin fraction isolated by extraction with cold ethanol, and subjected to the ultrafiltration process, purification and viral inactivation at a value of pH 4,0 and a temperature of 23-25 ​​° C for 21 day.

Immunological properties

The effective beginning of the drug are immunoglobulins of class G, possessing the activity of antibodies, neutralizing tetanus toxin.

Pharmacokinetics:

The maximum concentration of antibodies in the blood is reached 24-48 hours after administration; the half-life of antibodies from the body is 3-4 weeks.

Indications:

The drug is designed for the prevention and treatment of tetanus, especially in the case of increased sensitivity of the patient to the introduction of tetanus toxoid.

Contraindications:

Hypersensitivity to drugs containing human immunoglobulin.

Dosing and Administration:

Immunoglobulin tetanus from human blood serum is injected intramuscularly into the anterolateral region of the thigh.

Before the injection, the vial with the drug is aged for 2 hours at a temperature of 18 to 22 ° C. Opening of bottles and the procedure of administration are carried out with strict adherence to the rules of aseptic and antiseptic. To prevent the formation of foam, the drug is drawn into a syringe, a needle with a wide lumen, another needle is used for injection. The drug in the opened vial is not subject to storage.The preparation is not suitable for use in vials with broken integrity or marking, with a change in physical properties (discoloration, cloudiness of solution, the presence of unbreakable flakes, expired shelf life, improper storage).

Setting the skin test before the introduction is not required.

Dosage

1. Dose for prevention: one adult or pediatric dose contains 250 ME.

2. In the case of a large lesion area and severe contamination of the wound A single dose can be doubled.

3. Therapeutic dose: from 3000 to 6000 ME, should be divided and introduced into different areas of the body.

Side effects:

As a rule, there are no reactions to the administration of human tetanus antitetoglobulin.

In rare cases, local reactions can develop in the form of a small hyperemia and pain in the area of ​​injection.

It is possible that the temperature can rise to 37.5 ° C in during the first day after the administration of the drug.

Individuals with altered reactivity may develop allergic reactions, and in exceptional cases - anaphylactic shock. In this regard, the person who received the drug should be under medical supervision for at least 30 minutes.Procedural rooms where immunoglobulin is administered should be provided with funds anti-shock therapy.

Data on the administration of immunoglobulin are recorded in the corresponding registration forms with the indication of the serial number, the date of manufacture of the expiration date of the enterprise- manufacturer, dose and date of administration, the nature of the reaction to the administration.

Interaction:

In case of emergency prophylaxis with tetanus toxoid and immunoglobulin, drugs should be injected into different areas of the body using different syringes.

Immunoglobulin tetanus from human blood serum should not be mixed with other drugs.

Immunoglobulin tetanus from human blood serum in the next three months after administration may impede the development of a full immune response to the introduction of live measles vaccines, mumps, chicken pox.
Special instructions:

- It is forbidden to drive the drug intravenously.

- Do not use the drug in the presence of a sediment that does not disappear when shaken, foreign entities, cracks in the vial, and a loosely closed lid of the vial.

- After opening the bottle, the prescribed dose should be immediately used.The remainder of the drug in the vial is not to be used.

Form release / dosage:Solution for intramuscular injection, 100 IU / ml.
Packaging:

In bottles of low-borsilicate glass of 2.5 ml (250 ME) and 5.0 ml (500 ME), sealed with a cork made of bromobutyl rubber with an aluminum-plastic lid.

One bottle in a cardboard box with instructions for use.

A self-adhesive label is attached to the vial.

Storage conditions:

At a temperature of 2 to 8 ° C in a dark place. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:On prescription
Registration number:LSR-010493/08
Date of registration:24.12.2008
Expiration Date:Unlimited
The owner of the registration certificate:Sichuan Yuanda Shuyan Pharmaceutical Company, Ltd.Sichuan Yuanda Shuyan Pharmaceutical Company, Ltd. China
Manufacturer: & nbsp
Representation: & nbspTD ALLERGEN COMPANY JSCTD ALLERGEN COMPANY JSCRussia
Information update date: & nbsp08.11.2017
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