LAVOISIER WATER FOR INJECTION PREPARATION S p prep inj 10Ampoule/2ml

Solution for injection preparation.

Water for injectable preparations ..................................................................................................... q.s.

For one vial or one ampoule.

Excipients:

Extemporaneous dilution or dissolution of preparations intended for parenteral administration.

Dosage

The posology depends on the specialties dissolved in water for injectable preparations.

Method of administration

The mode of administration depends on the specialties dissolved in water for injectable 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.

Pregnancy

The risks during use in pregnant women are determined by the nature of the pharmaceutical specialties added.

Breast-feeding

The risks during use in breastfeeding women are determined by the nature of the pharmaceutical specialties 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 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 undesirable 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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

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

The signs and symptoms of overdose will also be linked 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.

Pharmacotherapeutic class: solvent and diluent, ATC code V07AB.

(V: various)

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

Certain medicinal products may be incompatible. Medicinal products known to be incompatible must not be used.

Before adding any medicinal products, check:

• whether they are soluble in water for injections,
• whether they are stable at the pH of water for injections,
• whether they are compatible with each other.

Before opening:

3 years.

Shelf life after first use:

After opening/dilution, the product must be used immediately.

This medicinal product does not require any special storage precautions before opening.

For storage conditions of the medicine after opening, see section Shelf life.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorisation (AMM)

CIP 3400955349303 (6Fl/1000ml). CIP 3400931205036 (Fl/500ml). CIP 3400931204954 (Fl/250ml). CIP 3400955963745 (12Fl/200-250ml). CIP 3400955963516 (24Fl/50-125ml). CIP 3400955963684 (24Fl/100-125ml). CIP 3400936111356 (10Amp/5ml). CIP 3400936111417 (10Amp/10ml). CIP 3400936162105 (10Amp/20ml). CIP 3400939096858 (Fl PE/500ml). CIP 3400939096919 (10Fl/500ml). CIP 3400939097169 (Fl (PE)/1000ml). CIP 3400939097220 (10Fl/1000ml). CIP 3400939482606 (10AmpPP/10ml). CIP 3400939482774 (10AmpPP/20ml). CIP 3400957533427 (100AmpPP/5ml). CIP 3400957533595 (100AmpPP/10ml). CIP 3400957533656 (50Amp/20ml).

Not reimbursed, social security (10AmpPP/20ml, Fl/500ml, Fl/250ml, 10Amp/5ml, 10Amp/10ml, 10Amp/20ml, Fl PE/500ml, Fl (PE)/1000ml, 10AmpPP/10ml).
Hospital model(s) (6Fl/1000ml, 12Fl/200-250ml, 24Fl/50-125ml, 24Fl/100-125ml, 10Fl/500ml, 10Fl/1000ml, 100AmpPP/5ml, 100AmpPP/10ml, 50Amp/20ml).
Collect (6Fl/1000ml, Fl/500ml, Fl/250ml, 24Fl/50-125ml, 24Fl/100-125ml, 10Amp/5ml, 10Amp/10ml, 10Amp/20ml, 10Fl/500ml, 10Fl/1000ml, 10AmpPP/10ml, 10AmpPP/20ml, 100AmpPP/5ml, 100AmpPP/10ml, 50Amp/20ml).