WATER FOR INJECTABLE PREPARATIONS PROAMP Solvent for parenteral preparation 10Ampoule/10ml

Water for injections....................................................................................................................1 g

For 1 mL

One ampoule of 5 ml contains 5 g of water for injection preparations.

One ampoule of 10 ml contains 10 g of water for injection preparations.

One ampoule of 20 ml contains 20 g of water for injection preparations.

Sterile PROAMP water for injection preparations is used as a vehicle for the dilution and reconstitution of pharmaceutical specialties for parenteral administration.

Dosage

The dosage of the reconstituted preparation will be dictated by the nature of the added product. The rate of administration will depend on the dosage regimen of the prescribed medicine.

After addition of the prescribed additives, the dosage generally depends on the patient's age, weight, clinical condition and biological test results.

Method of administration

The solution is intended for diluting medicines prior to their administration. The instructions for use of the added specialty will determine the appropriate volumes as well as the route of administration.

Water for injection medicine must not be administered alone.

Contraindications related to the added pharmaceutical specialty must be taken into account.

Warning

Water for injection preparations is hypotonic and must not be injected alone.

Do not use for intravenous injection without restoring isotonicity by means of an appropriate solution.

When water for injection preparations is used as a diluent for hypertonic solutions, appropriate dilution must be carried out in order to get as close as possible to isotonicity.

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

When large volumes are administered, the ionic balance must be monitored regularly.

Large-volume presentations are intended for use as a raw material during dilution in pharmaceutical preparations. They are not directly intended for intravenous administration.

Precautions for use

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

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

After addition, the mixture must be administered immediately.

Before use, check that the solution is clear.

No known cases of interaction.

The possible interactions of the medicinal products to be dissolved must be taken into consideration.

The risks of use during pregnancy and breastfeeding are linked to the nature of the added products.

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 injectable preparations causes haemolysis if it is administered alone.

The nature of the added specialty will determine the likelihood of occurrence of other adverse effects.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

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

The signs and symptoms of overdose will also be linked to the nature of the added medicinal product.

In the event of accidental overdose, treatment must be discontinued and the patient must be monitored for signs and symptoms related to the medicinal product administered.

Pharmacotherapeutic class: Solvent and diluent, ATC code: V07AB.

As water for injectable preparations is only a vehicle for the administration of a medicinal product, the pharmacodynamic properties will depend on the nature of the added medicinal product.

As water for injectable preparations is only a vehicle for the administration of a medicinal product, the pharmacokinetic properties will depend on the nature of the added medicinal product.

As water for injectable preparations is only a vehicle for the administration of a medicinal product, the preclinical safety data will depend on the nature of the added medicinal product.

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.

3 years

Store at a temperature not exceeding 25°C.

No special requirements for disposal.