Pharmacia Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221


Summary of Product Characteristics last updated on the eMC: 18/09/2009
SPC Bacteriostatic Water for Injection


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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 00032/0188, 0203, 0214, 0227).


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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


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6.4 Special precautions for storage

Store below 25oC.


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6.5 Nature and contents of container

1 ml pre-filled syringe with butyl rubber plunger stopper and tip cap containing 1 ml of solution.

Or

1 ml pre-filled syringe with butyl rubber plunger stopper, syringe tip cap, tamper evident seal and locking device containing 1 ml of solution.


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6.6 Special precautions for disposal and other handling

No special requirements.


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Administrative Data

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7. MARKETING AUTHORISATION HOLDER

Pharmacia Limited

Davy Avenue

Milton Keynes

MK5 8PH

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00032/0193


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 March 1994 / 16 March 1999


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10. DATE OF REVISION OF THE TEXT

December 2003

Legal Category: POM

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More information about this product

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Active Ingredients/Generics

 
   no active ingredients