Universal reference book for medicines
Name of the drug: IMMUNOGLOBULIN ANTI-TESTBOOK FROM THE SERUM OF THE HUMAN BLOOD (IMMUNOGLOBULINE ANTITETANUS FROM HUMAN SERUM)

Active substance: nonappropriate

Type: Immunological preparation.
Immunoglobulin
Manufacturer: Sichuan Yuanda Shuyang Pharmaceutical (China)
Composition, form of production and packaging
The solution for the / m introduction is
clear or slightly opalescent, colorless or light yellow in color.

1 ml

tetanus antibodies specific 100 IU

Excipients: glycine (stabilizer) - 20-25 mg, sodium chloride - 7 mg, water d / and.

2.5 ml - bottles of glass (1) - packs of cardboard.

5 ml - bottles of glass (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

The active principle of the preparation is class G immunoglobulins, which possess the activity of antibodies neutralizing tetanus toxin.

PHARMACOKINETICS

C max antibodies in the blood are reached 24 - 48 hours after administration.
T 1/2 antibody from the body is 3-4 weeks.
INDICATIONS

- prevention and treatment of tetanus, especially in case of increased sensitivity of the patient to the introduction of tetanus toxoid.

DOSING MODE

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 injected into the syringe with 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 IU.

2. In the case of a large area of ​​injury and severe contamination of the wound, the 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 EFFECT

As a rule, there are no reactions to the administration of human tetanus antitetoglobulin.
In rare cases, local reactions may occur in the form of a slight hyperemia and pain in the area of ​​injection. It is possible that the temperature rises to 37.5 ° C during the first 24 hours after the administration of the drug. In individuals with altered reactivity, allergic reactions may develop, 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 anti-shock therapy.
Data on the administration of immunoglobulin are recorded in the appropriate registration forms with the number, series, date of manufacture, expiration date, manufacturer, dose and date of administration, the nature of the response to the administration.

CONTRAINDICATIONS

- Hypersensitivity to drugs containing human immunoglobulin.

SPECIAL INSTRUCTIONS

Do not drive the drug intravenously.

Do not use the drug in the presence of a sediment that does not disappear with shaking, as well as foreign formations, 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.
DRUG 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.

TERMS OF RELEASE FROM PHARMACY

For treatment and prophylactic institutions


TERMS AND CONDITIONS OF STORAGE

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.
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