Solvent for measles and mumps vaccines, culture live, dry (Solvent) Instructions for Use

Marketing Authorization Holder

Vector VB State Research Center Federal State Institution of Rospotrebnadzor (Russia)

ATC Code

V07AB (Solvents and diluents, including irrigation solutions)

Dosage Form

Solvent for measles and mumps vaccines, culture live, dry

Solvent for preparation of vaccines for injection: amp. 0.5 mL, 1 mL, or 2.5 mL, 10 pcs.

Dosage Form, Packaging, and Composition

Solvent for preparation of vaccines for injection in the form of a transparent, colorless liquid.

Excipients: water for injection – up to 0.5 ml.

0.5 ml – ampoules (10) – cardboard packs in a set with an ampoule scarifier (if necessary).
1 ml – ampoules (10) – cardboard packs in a set with an ampoule scarifier (if necessary).
2.5 ml – ampoules (10) – cardboard packs in a set with an ampoule scarifier (if necessary).

Clinical-Pharmacological Group

Solution for peritoneal dialysis

Pharmacotherapeutic Group

MIBP-solvent

Indications

• Use exclusively as a solvent for reconstitution of the accompanying dry, culture live measles and mumps vaccine.

Employ only the provided solvent for this specific vaccine; do not substitute with other diluents or solvents.

ICD codes

Dosage Regimen

Transfer the exact volume of solvent specified in the vaccine instructions into the pre-opened ampoule containing the dry vaccine cake.

Use aseptic technique throughout the reconstitution procedure. Gently swirl the ampoule until the vaccine powder is completely dissolved, forming a clear, homogeneous suspension.

Administer the reconstituted vaccine immediately after preparation; do not store the mixed product.

Contraindications

• There are no known contraindications for the use of this solvent when used as directed for its intended purpose.

However, the contraindications applicable to the final reconstituted vaccine product must be strictly observed prior to administration.

Adverse Reactions

This solvent is a sterile, balanced salt solution and is not expected to cause adverse reactions when used correctly to reconstitute the vaccine.

Any adverse events following immunization are attributable to the active vaccine components and not to the solvent itself. Monitor for reactions as specified in the vaccine’s prescribing information.

Drug Interactions

No pharmacodynamic or pharmacokinetic interactions are known or expected for this solvent.

It is chemically inert and designed solely for dilution and reconstitution. The potential for interactions resides entirely with the active immunizing agents in the final vaccine preparation.

Overdose

Overdose is highly improbable with the correct use of the solvent for vaccine reconstitution.

The provided ampoule volumes are precisely matched to the dosage of the corresponding vaccine vial. Using an incorrect volume may compromise vaccine potency or stability but does not constitute a toxicological risk from the solvent.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.