Therapeutic staphylococcal vaccine staphylococcal antifagin (Solution) Instructions for Use

Marketing Authorization Holder

Biomed named after I.I.Mechnikov, PJSC (Russia)

ATC Code

J07AX (Other bacterial vaccines)

Dosage Form

Therapeutic staphylococcal vaccine (staphylococcal antifagin)

Solution for subcutaneous administration 1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for s/c administration transparent, colorless or light yellow in color, with a specific odor.

Excipients : phenol – (0.2±0.05)%.

1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the treatment of infections caused by staphylococci

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Administration of the drug in accordance with the approved regimen causes the formation of specific antimicrobial anti-staphylococcal immunity in vaccinated individuals.

Indications

Treatment of pustular diseases of staphylococcal etiology

• Staphyloderma;
• Abscesses, furuncles, and carbuncles of the skin;
• Hordeolum and other deep inflammations of the eyelids;
• Pyoderma.

The vaccine is approved for use from 6 months of age.

ICD codes

Dosage Regimen

The therapeutic staphylococcal vaccine is administered subcutaneously into the shoulder area or the subscapular area.

The course of treatment for adults and children from 7 years of age consists of single daily injections according to the following scheme

Day 1 – 0.2 ml

Day 2 – 0.3 ml

Day 3 – 0.4 ml

Day 4 – 0.5 ml

Day 5 – 0.6 ml

Day 6 – 0.7 ml

Day 7 – 0.8 ml

Day 8 – 0.9 ml

Day 9 – 1.0 ml

For children from 6 months to 7 years, the dose for the first injection is 0.1 ml. In the absence of a reaction, the drug is administered daily according to the specified scheme, sequentially increasing each dose by 0.1 ml (for the second injection – 0.2 ml; for the third – 0.3 ml, etc.) over 9 days.

The use of the vaccine in children aged from 6 months to 7 years must additionally be agreed with the attending physician.

In case of prematurity (birth weight less than 2.5 kg), treatment is carried out provided the child has reached normal age indicators.

Each subsequent dose of the drug is administered at a distance of 20-30 mm from the site of previous injections or in the other arm.

For diseases with widespread skin lesions that occur with relapses, it is advisable to conduct a repeated course of treatment according to the same scheme after 10-15 days.

If a local or general reaction develops, the subsequent administration of the vaccine is carried out after the reaction has disappeared, in the same dose as the previous one. In case of a pronounced reaction to the vaccine administration (increase in body temperature to 38°C (100.4°F) and above, significant pain in the inflammatory foci, infiltrate at the injection site more than 20 mm in diameter), at the discretion of the attending physician, it is possible to extend the interval between injections to 2-3 days, repeat or reduce the dose for subsequent injections.

The drug is not suitable for use in ampoules with damaged integrity, missing or poorly readable labeling, if physical properties have changed (presence of opalescence, sediment), if the expiration date has expired, or if stored improperly.

Precautions for use

Opening the vaccine ampoule and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The vaccine in the opened ampoule must be used immediately.

Features of the drug’s action upon first administration

After the first 2 injections, pain in the inflammatory foci may increase.

Features of the drug’s action upon its withdrawal

Not identified.

If one or several doses are missed, the last administered dose should be repeated and then treatment should be continued according to the specified scheme.

Adverse Reactions

Skin hyperemia and slight pain may develop at the injection site. In some patients, the administration of the drug may be accompanied by an increase in temperature by 0.5-1°C (30.2°F). If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

• Children’s age from birth to 6 months;
• Rickets of II and III degree;
• Hypotrophy of II and III degree;
• Diseases of the endocrine system;
• Diseases of the liver and kidneys;
• Allergic diseases;
• Angioedema;
• Bronchial asthma;
• Widespread eczema;
• Chronic bronchitis, unspecified;
• Asthmatic bronchitis;
• Diseases of the central nervous system;
• Acute infectious (non-staphylococcal etiology) and non-infectious diseases, including the period of convalescence; chronic diseases in the stage of exacerbation or decompensation. Treatment with the staphylococcal vaccine is carried out no earlier than one month after clinical recovery (remission).

Use in Pregnancy and Lactation

Vaccination is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in liver diseases.

Use in Renal Impairment

Contraindicated in kidney diseases.

Pediatric Use

Contraindication: children’s age from birth to 6 months

Special Precautions

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles.

Overdose

No symptoms of overdose have been identified with the use of the therapeutic staphylococcal vaccine.

Drug Interactions

Not established.

Storage Conditions

In a dry place, protected from light, at a temperature of 2 to 10°C (50°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.