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hameln pharmaceuticals ltd
Nexus, Gloucester Business Park, Gloucester, GL3 4AG Telephone: +44 (0)1452 621 661 Fax: +44 (0)1452 632 732 WWW: http://www.hameln.co.uk Medical Information e-mail: drugsafety@hameln.co.uk Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 25/04/2012

SPC	Water for Injections BP

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
ADMINISTRATIVE DATA
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Water for Injections BP.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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

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3. PHARMACEUTICAL FORM

Sterile injection.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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

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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.

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4.3 Contraindications

None known.

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4.4 Special warnings and precautions for use

None known.

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

None known.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

None known.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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

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5.2 Pharmacokinetic properties

Not Applicable.

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5.3 Preclinical safety data

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

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

None.

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6.2 Incompatibilities

None known.

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6.3 Shelf life

60 months for ampoules.

60 months for vials 1ml to 30ml.

36 months for vials 50ml to 200ml.

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6.4 Special precautions for storage

Do not store above 25° C.

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6.5 Nature and contents of container

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

Type II clear glass vials, 1ml, 2ml, 10ml, 20ml, 30ml, 50ml, 100ml and 200ml, with a bromobutyl rubber stopper. Plastic outer cap and inner aluminium ring packed in cardboard cartons to contain either 10 vials or 25 vials.

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6.6 Special precautions for disposal and other handling

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

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ADMINISTRATIVE DATA

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7. MARKETING AUTHORISATION HOLDER

hameln pharmaceuticals ltd

Gloucester

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8. MARKETING AUTHORISATION NUMBER(S)

PL 01502 / 0003R