COOPER WATER FOR INJECTION PREPARATIONS Injection 10Ampoule/20ml

Solution for injection preparation.

Water for injections ................................................................................................................................q.s.

For one vial or one ampoule.

Extemporaneous dilution or dissolution of preparations intended for parenteral administration.

The posology and mode of administration depend on the products dissolved in water for injection preparations.

Do not inject alone.

Special warnings

As water for injection preparations is a hypotonic solution intended for the preparation of solutions for parenteral administration, it must not be injected alone.

Precautions for use

The mixture must be prepared extemporaneously with sterile equipment and under strict aseptic conditions.

Before use, check that the solution is clear.

For vials: before use, check the integrity of the closure and disinfect the stopper.

Before dissolving a medicinal product, check its solubility and/or stability in water.

In the case of a mixture of several active substances, check their compatibility with one another.

The risks of use in pregnant or breastfeeding women are determined by the nature of the pharmaceutical products added.

The effects on the ability to drive vehicles and use machines are linked to the medicinal product(s) to be dissolved or diluted: refer to the package leaflet accompanying each medicinal product to be added.

Intravenous injection of water for injection preparations may cause haemolysis if administered alone.

The nature of the additive will determine the possible occurrence of other adverse effects.

Haemolysis may occur after infusion of large quantities of hypotonic solutions with water for injection preparations as diluent.

Signs and symptoms of overdose will also be related to the nature of the added medicinal products.

In case of accidental overdose, treatment must be interrupted and the patient must be monitored for signs and symptoms related to the medicinal products administered.

SOLVENT AND DILUENT

(V: various)

As water for injection preparations is only a vehicle for the administration of one or more pharmaceutical products, the preclinical safety data of the solution to be used will depend on the nature of the additive medicinal product.

Before opening:

• 3 years for glass vial presentations.
• 5 years for glass ampoule presentations.

After opening: the product must be used immediately.

No special precautions for storage.

No special requirements.

Marketing authorisation (AMM)

CIP 3400934095344 (Fl/1l). CIP 3400934095283 (Fl/500ml). CIP 3400934095115 (Fl/250ml). CIP 3400936534643 (10A bout/5ml). CIP 3400956584314 (100Amp bout/5ml). CIP 3400936534704 (10A bout/10ml). CIP 3400936534872 (10A bout/20ml). CIP 3400956584482 (100Amp bout/10ml).

Non Remb Séc soc (Fl/1l, Fl/250ml, Fl/500ml, 10A bout/5ml, 100Amp bout/5ml, 10A bout/10ml, 10A bout/20ml, 100Amp bout/10ml).