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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ Telephone: +44 (0)1304 616 161 Fax: +44 (0)1304 656 221 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: 17/04/2012

SPC	Bacteriostatic Water for Injection

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
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
LEGAL CATEGORY

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1. NAME OF THE MEDICINAL PRODUCT

Bacteriostatic Water for Injections

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Not applicable

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3. PHARMACEUTICAL FORM

Sterile solution.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

None. The product is intended as a diluent for Caverject Powder for Injection (PL 00057/0944, 0941, 0942, 0943).

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4.2 Posology and method of administration

Intracavernosal injection

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4.3 Contraindications

Hypersensitivity to benzyl alcohol.

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4.4 Special warnings and precautions for use

None stated.

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4.5 Interaction with other medicinal products and other forms of interaction

None stated.

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4.6 Pregnancy and lactation

None stated.

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4.7 Effects on ability to drive and use machines

None stated.

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4.8 Undesirable effects

None stated.

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4.9 Overdose

None stated.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

None stated.

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5.2 Pharmacokinetic properties

None stated.

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5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this Summary of Product Characteristics.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Benzyl alcohol Ph.Eur

Water for injection Ph.Eur

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6.2 Incompatibilities

None stated

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6.3 Shelf life

36 months