Active substanceVaccine for the treatment of staphylo-prosthetic-pseudomonas aeruginosa infectionsVaccine for the treatment of staphylo-prosthetic-pseudomonas aeruginosa infections
Dosage form: & nbsp

suspension for subcutaneous administration.

Composition:

The vaccine is a complex of purified concentrated Pseudomonas toxoid and Staphylococcus anatoxins, Staphylococcus cytoplasmic antigen and proteic polyvalent antigen sorbed on aluminum hydroxide gel.

1 dose -1 ml:

Active substances: (30 + 3) mcg, staphylococcal anatoxin purified - (7 + 1) EC, proteine ​​polyvalent antigen - (50 + 5) μg, cytoplasmic antigen of staphylococcus (1,0 + 0,1) mg.

Excipients: sorbent - aluminum hydroxide gel - (1,0 + 0,2) mg, formaldehyde - not more than 0,1 mg.

Description:

A homogeneous suspension of white or slightly yellowish color, separated upon settling on a clear or opalescent supernatant and a loose sediment that completely breaks down when shaken. Uncontaminated flakes are not allowed.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

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

Pharmacodynamics:

Immunobiological properties: The introduction of the vaccine causes in the vaccinated the formation of specific (antiprotein, antistaphylococcal, anti-synergic) antibodies, stimulates the phagocytic activity of neutrophils.

Indications:

Prevention of infections caused by opportunistic microorganisms (staphylococcus, Proteus, Pseudomonas aeruginosa), in persons aged 18-60 years with a high risk of purulent-septic complications.


Contraindications:

- Acute infectious diseases, chronic diseases in the acute stage, allergic diseases in the acute stage (vaccinations are carried out not earlier than a month after recovery);

- the development of allergic reactions to the previous administration of an ATPA vaccine;

- hypersensitivity to vaccine components.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and during breastfeeding during controlled clinical trials has not been investigated.

Dosing and Administration:

In the presence of indications, the drug is administered subcutaneously in the scapular region in the first 72 hours after admission of patients to the hospital or during preoperative preparation.

Patients with isolated traumas are vaccinated once in a volume of 0.5 ml, which is half the dose.

Patients with extensive injuries and combined injuries, as well as patients preparing for routine operations, are vaccinated twice with an interval of 14-20 days. At the first injection, the vaccine is administered in a volume of 0.5 ml, with a repeat -1 ml.


Precautions for use.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to the rules of aseptic and antiseptic: before opening, the ampoule is shaken, the ampoule knife, the ampulla neck is wiped with cotton wool soaked in water. % ethyl alcohol, open the ampoule, take the vaccine in a disposable syringe and remove excess air from the syringe. Alcohol wipes the skin at the injection site and injects the vaccine subcutaneously. The drug in the opened ampoule is not subject to storage.

The preparation is not suitable for use in ampoules with broken integrity or marking, with changing physical properties (color, presence of non-segregating flakes), with expired shelf life, violation of requirements for storage conditions.

On the day of vaccination, the vaccinated should be examined by a physician (paramedic) with obligatory thermometry. At a temperature above 37 ° C vaccination is not carried out.

Side effects:

In the area of ​​injection in 15% of the vaccinated, the appearance of hyperemia and compaction up to 15x15 mm, persisting 48-72 hours. General and temperature reactions, as a rule, are absent. Perhaps the development of anaphylactic shock in individuals. Given the possibility of developing an anaphylactic shock, the vaccinated should be under medical supervision for at least 30 minutes.

The patient should be warned about the need to inform the attending physician of all cases of adverse reactions that developed during the course of treatment with the drug.

Overdose:

Cases of overdose are not described.

Interaction:

The interval after the last inoculation with other vaccines should be at least 1 month.

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

No information.

Form release / dosage:

Suspension for subcutaneous administration.

Packaging:1 ml (1 dose) in ampoules of glass.For 10 ampoules in a box of cardboard along with instructions for use and a scapegrator ampoule. When packaging ampoules that have a break ring or a point for dissection, the ampoule scapegrator is not inserted.
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:LP-000811
Date of registration:03.10.2011/10.07.2013
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp19.06.2016
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