Active substanceStaphylococcus aurexinStaphylococcus aurexin
Dosage form: & nbspsubcutaneous suspension
Composition:

Staphylococcal anaphylaxed purified adsorbed is a staphylococcal toxin rendered with formalin and heat, purified from ballast proteins, adsorbed on an aluminum hydroxide gel.

In 1.0 ml of the drug contains 10 EC (2 doses) of staphylococcal anatoxin, aluminum (sorbent) - from 0.9 to 1.3 mg, merthiolate (preservative) - from 80 to 120 μg.

Description:

The drug is a uniform suspension of white with a yellowish tinge, which separates when standing on a clear supernatant and a gentle loose sediment, completely shattered by shaking.

Pharmacotherapeutic group:MIBP
ATX: & nbsp

J.07.A.X   Other vaccines for the prevention of bacterial infections

Pharmacodynamics:

With the introduction of the drug causes the formation of specific antibodies to exotoxin staphylococcus.

Indications:

- Prevention of staphylococcal infections in people with an increased risk of disease - industrial and agricultural workers who are often injured in their work, as well as patients who are scheduled operations.

- Immunization of donors to obtain antistaphylococcal plasma and antistaphylococcal immunoglobulin.

Contraindications:

Contraindications for the use of staphylococcal purified toxoid are: acute infectious and non-infectious diseases, exacerbation of chronic diseases (use of the drug is possible not earlier than a month after recovery or remission); chronic diseases in the stage of decompensation; severe allergic reactions to food, medicinal and other substances; thymomegaly; blood diseases; malignant neoplasms. In order to identify contraindications in the preventive use of the drug, the doctor (paramedic) should conduct a survey on the day of vaccination - examination of the vaccine with mandatory thermometry.

Dosing and Administration:

The drug is injected deep into the area of ​​the lower corner of the scapula.The ampoule is shaken thoroughly before opening until a homogeneous suspension is obtained.

The drug contained in ampoules with broken integrity, marking, with changing physical properties (presence of non-breakable flakes), with expired shelf life, with violation of storage conditions is unsuitable for use.

Opening of ampoules and the procedure of immunization are carried out with strict observance of the rules of aseptic and antiseptic.

A single dose of the drug is 0.5 ml.

The drug in the opened ampoule is not subject to storage.

The course of immunization of industrial and agricultural workers consists of two injections (1 dose each) with an interval of 30 to 45 days. The first revaccination is carried out three months after the end of the course of immunization. Subsequent revaccinations are carried out at intervals of 12 months.

The course of immunization of planned surgical patients (children over 1 year and adults) consists of two injections (1 dose each) of the drug at an interval of 20 to 30 days; the second injection is carried out no later than 4-5 days before the operation.

The course of immunization of donors consists of three injections of the drug with an interval of 7 days. At the first injection, donors are injected with 1.0 ml (2 doses) of the drug, at the second injection - 1.0 ml (2 doses),at the third - 2.0 ml (4 doses).

The total amount of the drug administered to the donor for the full course of immunization is 4.0 ml (8 doses).

Immunization of donors is carried out according to the current "Instruction on the immunization of donors with staphylococcal anatoxin and the conduct of plasmapheresis for the preparation of antistaphylococcal plasma" approved by the USSR M3 02/08/07.

When selecting donors for immunization and conducting plasmapheresis, it is necessary to be guided by the general provisions stipulated in the "Instruction on medical examination of donors" approved by the M3 RF on 16.11.1998.

Side effects:

The administration of the preparation in individual grafts may be accompanied by a general and local reaction. The general reactions are characterized by slight malaise and low-grade fever (up to 37.5 ° C) lasting from 24 to 48 hours. Local reactions are characterized by the development of hyperemia and the formation at the injection site of an infiltrate with a diameter of up to 5 mm.

Hyperemia disappears within 3-4 days, the infiltration persists up to 10 days, and for some vaccinated - up to 30 days or more, as a painless seal. If there is an infiltrate, the next inoculation is performed on the opposite side.

Interaction:

Anatoxin staphylococcal purified adsorbed should be administered no earlier than 3 weeks after the previous injection of a human immunoglobulin or antistaphylococcal plasma.

Form release / dosage:Suspension for subcutaneous administration.
Packaging:In ampoules of 1.0 ml (2 doses). The package contains 10 ampoules and instructions for use.
Storage conditions:

Transportation. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Storage conditions. AT accordance with JV 3.3.2. 1248-03 at a temperature of 2 to 8 ° C in a dry, dark place. Freezing is not allowed.

Shelf life:

Shelf life - 2 years.

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

Terms of leave from pharmacies:On prescription
Registration number:P N000649 / 01
Date of registration:28.07.2008 / 19.05.2015
Expiration Date:Unlimited
The owner of the registration certificate:MEDGAMAL (a branch of the Research Institute of Epidemiology and Microbiology named after NF Gamalei RAMS GU) MEDGAMAL (a branch of the Research Institute of Epidemiology and Microbiology named after NF Gamalei RAMS GU) Russia
Manufacturer: & nbsp
Information update date: & nbsp01.09.2017
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