Water for preparations for injection FisioPharma

PACKAGE LEAFLET

WATER FOR INJECTION - FISIOPHARMA

Pharmacotherapeutic category
Solvents and diluents, including cleansing solutions
Therapeutic indications
Preparation of injectable formulations.
Contraindications
Water for injection is a vehicle for various medicinal products; therefore, for contraindications, refer to the “Contraindications” section of the package leaflet of the medicinal product to be administered.
Precautions for use
Use immediately after opening the container. The solution must be clear, colourless and free from visible particles. Any unused residue must not be used.
Continuous administration may cause fluid overload, congestive state and decreased electrolyte concentration; continuous administration without potassium supplementation may lead to hypokalaemia (reduced potassium concentration in the blood).
Interactions
Water for injection is a vehicle for various medicinal products; therefore, for interactions with other medicinal products, refer to the “Interactions” section of the package leaflet of the medicinal product to be administered.
Special warnings
Pregnancy and breastfeeding
Water for injection is a vehicle for various medicinal products; therefore, for precautions to be taken during pregnancy and breastfeeding, refer to the package leaflet of the medicinal product to be administered.
Effects on ability to drive and use machines
Water for injection is a vehicle for various medicinal products; therefore, for effects on the ability to drive and use machines, refer to the package leaflet of the medicinal product to be administered.
Dosage, method and time of administration
Use for extemporaneous solutions, dilutions or suspensions of injectable medicines or other sterile preparations.
Select the volume to be used according to the dilution requirements of the injectable preparation.
Water for injection is a vehicle for various medicinal products; therefore, for incompatibilities, refer to the package leaflet of the medicinal product to be administered.
Overdose
Water for injection is a vehicle for various medicinal products; therefore, for overdose, refer to the package leaflet of the medicinal product to be administered.
Undesirable effects
Disturbances of metabolism and nutrition
Continuous administration may cause fluid overload, congestive state and decreased electrolyte concentration.
Water for injection is a vehicle for various medicinal products; therefore, for undesirable effects, refer to the package leaflet of the medicinal product to be administered.
Expiry date and storage:
Expiry date: see date on the packaging.
The expiry date refers to the product in its original, undamaged packaging, correctly stored.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
For storage conditions after dilution with the medicinal product to be administered, refer to the package leaflet of the medicinal product to be administered.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer in use. This will help protect the environment.
Keep this medicinal product out of the sight and reach of children.
Composition:
Sterile, pyrogen-free water for injection.
When examined under optimal visibility conditions, it is clear, colourless and free from suspended particles.
It must not contain antimicrobial agents or other additives.
Pharmaceutical form and contents
Solvent for parenteral use
Ampoules of 1 ml in boxes of 1, 5, 10, 50 and 100 ampoules
Ampoules of 2 ml in boxes of 1, 5, 10, 50 and 100 ampoules
Ampoules of 3 ml in boxes of 1, 5, 10, 50 and 100 ampoules
Ampoules of 5 ml in boxes of 1, 5, 10, 50 and 100 ampoules
Ampoules of 10 ml in boxes of 1, 5, 10, 50 and 100 ampoules
Vials of 20 ml in boxes of 1 vial
Vials of 50 ml in boxes of 1 vial
Vials of 100 ml in boxes of 1 vial
Marketing Authorisation Holder
Fisiopharma srl – Nucleo Industriale - 84020 Palomonte (SA) Italy
Manufacturer
Fisiopharma srl – Nucleo Industriale - 84020 Palomonte (SA) Italy
AIFA Determination of 23/12/2010