This information is intended for use by health professionals

1. Name of the medicinal product

Sterilised Water for Injections

2. Qualitative and quantitative composition

Each mL contains 100% of Sterilised Water for Injections

3. Pharmaceutical form

Solvent for parenteral use.

Single-use vial containing 2.5 or 5 mL of Sterilised Water for Injections

4. Clinical particulars
4.1 Therapeutic indications

Sterilised 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

Sterilised 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

None known.

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.

Sterilised 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

Sterilised 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

Sterilised 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

Sterilised Water for Injections must not be mixed with other medicinal products unless their compatibility has been established.

6.3 Shelf life

Unopened

4 years.

Opened

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage

Do not store above 30°C. Do not freeze.

6.5 Nature and contents of container

Type I clear glass 5 mL vial closed with a halobutyl rubber stopper and an aluminium overseal with a polypropylene flip off tamper evident cap.

Pack sizes: 2.5 mL or 5 mL

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

For single use.

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

Keep out of sight and reach of children.

7. Marketing authorisation holder

Bio Products Laboratory Limited,

Dagger Lane,

Elstree,

Hertfordshire,

WD6 3BX,

United Kingdom.

Tel: +44(0) 20 8957 2200

Fax: +44 (0) 20 8957 2608

E-mail: [email protected]

8. Marketing authorisation number(s)

PL 08801/0057

9. Date of first authorisation/renewal of the authorisation

15/08/2014

10. Date of revision of the text

15/08/2014