Water for Injections BP is indicated to be used as a solvent for dilution and reconstitution of suitable medicinal products for parenteral administration.

Posology

The dosage administered will be dictated by the nature of the additive used.

The administration rate will be dependent upon the dose regimen of the prescribed drug.

Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. The solution should only be used if it is clear without visible particles.

Method of administration

For parenteral use.

The directions for use will be dependent upon the appropriate medicinal product to which this solvent is added, which will dictate the appropriate volumes as well as administration route.

Water for Injections should not be administered alone because it may cause haemolysis.

The contraindications related to the added medicinal product should be considered.

Water for Injections is hypotonic and should not be administered alone as it may cause hemolysis.

The possible clinical interactions between the different medicinal products to be dissolved should be considered.

The risks during use are determined by the nature of the added medicinal products.

None known.

May cause haemolysis if administered alone.

The nature of the additive will determine the likelihood of any 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

No effects are anticipated if used as instructed.

Haemolysis may occur following infusion of large volumes of hypotonic solutions using water for injections as a diluent.

The signs and symptoms of overdose will also be related to the nature of the medicinal product being added. In the event of accidental overdose, the treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the medicinal product administered.

Pharmacotherapeutic group: Solvents and Diluting Agents.

ATC code: VO7AB.

Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacodynamics will depend on the nature of the drug added.

Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacokinetics will depend on the nature of the drug added.

Water for Injections being only the vehicle for the administration of the added medicinal product, the preclinical safety data for the solutions in use will depend on the nature of the drug added.

None.

None known.

60 months for ampoules.

60 months for 1ml, 10ml and 30ml vials.

48 months for 20ml vials

36 months for 50ml and 200ml vials.

24 months for 100ml vials

Do not store above 25° C.

Ampoules

Type I clear glass ampoules, 2ml, 5ml, 10ml and 20ml packed in cardboard cartons to contain 10 ampoules.

Vials

• Type I clear glass vial, 10ml, with a bromobutyl rubber stopper.

• Type I clear glass vial, 20ml and 100ml, with a chlorobutyl rubber stopper.

• Type II clear glass vials, 1ml, 2ml, 30ml, 50ml and 200ml, with a bromobutyl rubber stopper.

Plastic outer cap and inner aluminium ring packed in cardboard cartons to contain either 1, 10 vials or 25 vials.

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