This information is intended for use by health professionals

1. Name of the medicinal product

Water for Injections

2. Qualitative and quantitative composition

Each 1ml of solution contains 1ml of Water for Injections B.P.

3. Pharmaceutical form

Solvent for parenteral use

Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of 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.

4.3 Contraindications

Water for Injections should not be administered alone because it may cause haemolysis. The contraindications related to the added medicinal product should be considered.

4.4 Special warnings and precautions for use

Water for Injections is hypotonic and it should not be administered alone, because it may cause haemolysis.

4.5 Interaction with other medicinal products and other forms of interaction

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

4.6 Fertility, pregnancy and lactation

May be used during fertility, pregnancy and lactation.

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

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

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 MHRA Yellow Card Scheme: Tel: Freephone 0808 100 3352. Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No effects are anticipated if used as instructed.

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Solvents and diluting agents, including irrigating solutions, ATC code: V07AB.

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 List of excipients

None.

6.2 Incompatibilities

Water for Injections should not be mixed with any other agents unless their compatibility has been established.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

2ml, 5ml and 10ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to contain 10, 20, 50 and 100 ampoules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

For single use only.

As appropriate to the reconstituted drug.

If only part of an ampoule is used, discard the remaining solution.

Use as directed by the physician.

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

7. Marketing authorisation holder

Mercury Pharmaceuticals Ltd,

Capital House, 85 King William Street,

London EC4N 7BL, UK

8. Marketing authorisation number(s)

PL 12762/0605

9. Date of first authorisation/renewal of the authorisation

10/10/1991 / 19/03/2003

10. Date of revision of the text

25/03/2019