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A specialized edition intended for medical institutions and doctors.

Water for injections-Darnitsa

Solvents and diluents
Water for injection is used for preparing sterile solutions of medicinal and diagnostic substances intended for subcutaneous, intramuscular and intravenous administration.
Main properties
  • Release formSolvent for preparing an injection solution
  • ChildrenAllowed
  • PregnantAllowed
  • NursingAllowed
  • Release categoryNon-prescription
  • DriversAllowed
  • Temperature storage conditionsNot higher than 30 °С
Instructions for medical use

APPROVED

by the Order of the Ministry of Health of Ukraine

14.11.2019 No. 2283

Marketing Authorization

No. UA/3150/01/01

 

PACKAGE LEAFLET

for medical use of a medicinal product

WATER FOR INJECTIONS-DARNITSA

 

Qualitative and quantitative composition:

active substance: water for injection;

1 ampoule contains 2 ml or 5 ml, or 10 ml of water for injection.

 

Pharmaceutical form. Solvent for preparation of solution for injection.

Main physical and chemical properties: clear colorless liquid.

 

Pharmacotherapeutic group. Solvents and diluting agents, including irrigating solutions. ATC code V07AB.

 

Pharmacological properties.

Water for injections is pyrogen-free, chemically inactive, and has no pharmacological action.

 

Clinical particulars.

Therapeutic indications.

Water for injections should be used to prepare sterile solutions of medicinal and diagnostic products intended for subcutaneous, intramuscular, intravenous administration.

 

Contraindications.

Water for injections should not be used as a solvent for medicines and diagnostic products if another solvent is indicated in the instructions for medical use of the medicinal product. The medicinal product should not be used for washing the eyes during ophthalmic surgery.

 

Interaction with other medicinal products and other forms of interaction.

Water for injection does not exhibit pharmacological or chemical interactions with medicinal products and diagnostics intended for subcutaneous, intramuscular or intravenous administration.

 

Special warnings and precautions for use.

Water for injections is intended only for the preparation of sterile solutions of medicinal products and diagnostics intended for subcutaneous, intramuscular or intravenous administration, in the method of application of which involves the use of water for injection. Water for injections should not be injected directly intravascularly due to low osmotic pressure due to the risk of hemolysis!

 

Fertility, pregnancy and lactation.

Can be used during fertility, pregnancy and lactation.

 

 

Effects on ability to drive and use machines

Not applicable.

 

Posology and method of administration.

The preparation of solutions of medicinal and diagnostic agents using water for injection is carried out under aseptic conditions (opening ampoules, filling the syringe and containers with medicinal products with water). The amount of water for injection for the preparation of a solution of a medicinal product is determined by the instructions for medical use of the latter.

 

Children.

Can be used in pediatric practice.

 

Overdose.

Not described.

 

Undesirable effects.

Not described.

 

Shelf life. 4 years.

 

Special precautions for storage.

Store in the original package at a temperature not above 30° C.

Keep out of the reach of children.

 

Nature and contents of container.

2 ml in an ampoule; 5 ampoules in a blister; 2 blisters in a pack;

5 ml in an ampoule; 5 ampoules in a blister; 2 blisters in a pack;

2 ml or 5 ml in an ampoule, 10 ampoules in a pack; 10 ml in ampoules.

 

Category of release.

Non-prescription medicine.

 

Manufacturer. PrJSC “Pharmaceutical firm “Darnitsa”.

 

The manufacturer's location and address of the place of business.

13, Boryspilska Street, Kyiv, 02093, Ukraine.

 

Date of the last revision.

14.11.2019

Certificate