SPSA-vaccine (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AX (Other bacterial vaccines)

Dosage Form

SPSA-vaccine

Subcutaneous administration suspension 1 ml/dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for subcutaneous administration homogeneous, white or slightly yellowish in color, separating upon settling into a clear or opalescent supernatant liquid and a loose sediment, which completely breaks up upon shaking. The presence of non-dispersible flakes is not allowed.

Excipients: aluminum hydroxide – gel (sorbent) 1.0±0.2 mg, formaldehyde not more than 0.1 mg.

1 ml (1 dose) – ampoules (10) – cardboard boxes.

Clinical-Pharmacological Group

Vaccine for the prevention of diseases caused by staphylococcus, proteus, pseudomonas aeruginosa

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Administration of the vaccine causes the formation of specific (anti-Proteus, anti-staphylococcal, anti-pseudomonal) antibodies in vaccinated individuals and stimulates the phagocytic activity of neutrophils.

Indications

• Prevention of infections caused by opportunistic microorganisms (staphylococcus, proteus, pseudomonas aeruginosa) in individuals aged 18-60 years with a high risk of developing purulent-septic complications.

ICD codes

Dosage Regimen

If indicated, the drug is administered subcutaneously into the subscapular region within the first 72 hours after patients are admitted to the hospital or during the pre-operative preparation period.

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

Patients with extensive injuries and combined trauma, as well as patients preparing for elective surgery, are vaccinated twice with an interval of 14-20 days.

For the first injection, the vaccine is administered at a volume of 0.5 ml, and for the repeated injection – 1 ml.

Adverse Reactions

At the injection site, 15% of vaccinated individuals may experience redness and induration up to 15×15 mm in size, persisting for 48-72 hours. General and temperature reactions are usually absent. The development of anaphylactic shock is possible in some individuals. Given the possibility of anaphylactic shock development, the vaccinated person should be under medical supervision for at least 30 minutes.

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

Contraindications

• Acute infectious diseases, chronic diseases in the acute stage, allergic diseases in the acute stage (vaccinations are carried out no earlier than one month after recovery);
• Development of allergic reactions to previous administration of SPSA-vaccine;
• Hypersensitivity to the components of the vaccine.

Use in Pregnancy and Lactation

The safety of using this medical drug during pregnancy and breastfeeding has not been studied in controlled clinical trials.

Special Precautions

Ampoule opening and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis: before opening, the ampoule is shaken, the ampoule knife and the neck of the ampoule are wiped with cotton wool moistened with 70% ethyl alcohol, the ampoule is opened, the vaccine is drawn into a disposable syringe and excess air is removed from the syringe. The skin at the injection site is wiped with alcohol and the vaccine is administered subcutaneously. The drug in an opened ampoule must not be stored.

The drug is unsuitable for use in ampoules with damaged integrity or labeling, if physical properties have changed (color, presence of non-dispersible flakes), if the expiration date has expired, or if storage requirements have been violated.

On the day of vaccination, individuals to be vaccinated must be examined by a doctor (paramedic) with mandatory temperature measurement. Vaccination is not performed at a temperature above 37°C (98.6°F).

Effect on the ability to drive vehicles and machinery

No information available.

Overdose

Cases of overdose have not been described.

Drug Interactions

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

Storage Conditions

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

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.