This information is intended for use by health professionals

1. Name of the medicinal product

Water for Injections BP.

2. Qualitative and quantitative composition

Each ml contains 100% Water for Injections Ph. Eur.

3. Pharmaceutical form

Sterile injection.

4. Clinical particulars
4.1 Therapeutic indications

Water for Injections BP is used as a dissolvent and diluent for injectable medicines.

4.2 Posology and method of administration

Water for Injections BP is administered by Intravenous Injection. Dosage for Adults (including the elderly) and Children:- as required, by intravenous injection.

4.3 Contraindications

None known.

4.4 Special warnings and precautions for use

None known.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

None known.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

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.

4.9 Overdose

None known.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Water for Injections BP is used as a dissolvent and diluent for injectable medicines.

5.2 Pharmacokinetic properties

Not Applicable.

5.3 Preclinical safety data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical particulars
6.1 List of excipients

None.

6.2 Incompatibilities

None known.

6.3 Shelf life

60 months for ampoules.

60 months for vials 1ml to 30ml.

48 months for vials 20ml

36 months for vials 50ml to 200ml.

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container

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, with a chlorobutyl rubber stopper.

Type II clear glass vials, 1ml, 2ml, 30ml, 50ml, 100ml 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.

6.6 Special precautions for disposal and other handling

Use as directed by a physician. Only to be used as a diluent.

7. Marketing authorisation holder

hameln pharmaceuticals ltd

Gloucester

UK

8. Marketing authorisation number(s)

PL 01502 / 0003R

9. Date of first authorisation/renewal of the authorisation

27th June 1986/ 6th May 2005

10. Date of revision of the text

27/01/2017