Water for injection

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT WATER FOR INJECTIONS (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: colorless clear liquid.

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

Pharmacological properties.

Pyrogen-free water for injections is chemically inert and has no pharmacological activity.

Clinical characteristics.

Indications.

Water for injections is used for the preparation of sterile solutions of medicinal and diagnostic agents intended for subcutaneous, intramuscular, and intravenous administration.

Contraindications.

Water for injections should not be used as a solvent for medicinal and diagnostic agents if the product's instructions for medical use specify another solvent. The medicinal product should not be used for eye irrigation during ophthalmic surgery.

Interaction with other medicinal products and other forms of interactions.

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 used only for the preparation of sterile solutions of medicinal and diagnostic agents intended for subcutaneous, intramuscular, or intravenous administration, when 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 speed 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 is carried out under aseptic conditions (opening of ampoules, filling syringes and containers with medicinal agents with water). The amount of Water for Injections for preparing a medicinal agent solution is determined by the instructions for medical use of the latter.

Children. May be used in pediatric practice.

Overdose.

Not described.

Side effects.

Not described.

Reporting of suspected side effects

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

2 mL in a polyethylene ampoule. 10 ampoules per cardboard pack.

5 mL in a polyethylene ampoule. 10 or 50 ampoules per cardboard pack.

Dispensing category. Over-the-counter.

Manufacturer. LLC "FARMASEL".

Manufacturer's address and place of business.
3, Prorizna Street, Village Kvitneve, Brovary District, Kyiv Oblast, Ukraine, 07408.