INSTRUCTIONS for medical use of the medicinal product WATER FOR INJECTIONS

Composition:

Active substance: water for injections;

1 ampoule contains 2 ml or 5 ml of water for injections.

Pharmaceutical form. Solvent for parenteral use.

Main physico-chemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Solvents and diluents. ATC code V07A B.

Pharmacological properties.

Water for injections is apyrogenic, chemically inert, and has no pharmacological activity.

Clinical characteristics

Indications. For the preparation of sterile solutions of medicinal and diagnostic agents intended for subcutaneous, intramuscular, or intravenous administration.

Contraindications. Do not use Water for Injections as a solvent for medicinal and diagnostic agents if another solvent is specified in the instructions for medical use of the medicinal product. Do not use for eye irrigation during ophthalmic surgery.

Interaction with other medicinal products and other forms of interaction. Water for Injections does not exhibit pharmacological or chemical interaction with medicinal and diagnostic agents intended for subcutaneous, intramuscular, or intravenous administration.

Special precautions for use.

Water for injections is intended solely for the preparation of sterile solutions of medicinal and diagnostic agents designated for subcutaneous, intramuscular, or intravenous administration, in cases where the method of application specifies the use of water for injections. Water for injections must not be administered directly intravascularly due to its low osmotic pressure, which poses a risk of causing hemolysis.

Use during pregnancy or breastfeeding. May be used during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery. Does not affect.

Method of Administration and Dosage

Preparation of solutions of medicinal and diagnostic agents using Water for Injections must be carried out under aseptic conditions (opening of ampoules, filling of syringes, and containers with medicinal agents with water). The amount of Water for Injections required to prepare a medicinal agent solution is specified in the instructions for medical use of the respective agent.

Children. May be used in pediatric practice.

Overdose. Not described.

Side effects.

Not described.

Reporting suspected side effects. Reporting of side effects after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 2 ml or 5 ml in polymer ampoules, 10 ampoules per pack.

Supply category. Over-the-counter.

Manufacturer. Private Joint-Stock Company "Infuziya".

Manufacturer's location and address of its business activity. 84A Nemyrivske Shose St., Vinnytski Khotory, Vinnytsia district, Vinnytsia region, 23219, Ukraine.