Informations for option: Water For Injections, show other option

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1. Water For Injections
2. Water For Injections

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sterilised water for injections

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 100% Water for Injections

3    PHARMACEUTICAL FORM

Solution for injection

Clear glass ampoules containing, 2ml, 5ml, 10ml or 20ml Sterilised water for injections

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Sterilised water for injections is used as a dissolvent and diluent for injectable medicines.

4.2    Posology and method of administration

Sterilised water for injections 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    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.

5.1    Pharmacodynamic properties

ATC code K4D - Other injection solutions/infusions.

Sterilised water for injections 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

6.4    Special precautions for storage

Store below 25° C

6.5    Nature and contents of container

Type I clear glass ampoules, 2ml, 5ml, 10ml and 20ml

6.6    Special precautions for disposal

Only to be used as a diluent

7    MARKETING AUTHORISATION HOLDER

Hameln Pharmaceuticals Limited,

Nexus, Hurricane Lane,

Gloucester Business Park,

Gloucester GL3 4AG,

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 01502 / 0069

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/10/2006

10    DATE OF REVISION OF THE TEXT

25/02/2015