eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Goldshield Group Limited
Goldshield Group Limited, No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK
Telephone: +44 (0)208 588 9100
Fax: +44 (0)208 686 0807
WWW: http://www.goldshieldgroup.com
Medical Information Direct Line: 08700 70 30 33
Medical Information e-mail: medicalinformation@goldshieldgroup.com
Customer Care direct line: +44 (0)208 588 9273
Medical Information Fax: +44 (0)208 686 0807

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: 06/08/2009
SPC Water for Injections BP 1.2ml, 2ml, 5ml, 10ml and 20ml glass ampoules


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Water for Injections BP 1.2ml, 2ml, 5ml, 10ml and 20ml glass ampoules.


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Water for Injections BP/Ph. Eur. 1.2ml, 2ml, 5ml, 10ml and 20ml ampoules.


Go to top of the page
3. PHARMACEUTICAL FORM

Solvent for parenteral use.

Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.


Go to top of the page
4.2 Posology and method of administration

Route of administration: As appropriate to the reconstituted drug.

Dosage: In accordance with the particular situation for which Water for Injections BP is being used.


Go to top of the page
4.3 Contraindications

None known.


Go to top of the page
4.4 Special warnings and precautions for use

None known.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Pregnancy and lactation

May be used during this period.


Go to top of the page
4.7 Effects on ability to drive and use machines

None known.


Go to top of the page
4.8 Undesirable effects

None known.


Go to top of the page
4.9 Overdose

No effects anticipated with the proposed use.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Not applicable.


Go to top of the page
5.2 Pharmacokinetic properties

Not applicable.


Go to top of the page
5.3 Preclinical safety data

No further relevant information other than that which is included in other sections of the

Summary of Product Characteristics.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipients

Not applicable.


Go to top of the page
6.2 Incompatibilities

Water for Injections BP should not be mixed with any other agents unless their compatibility has been established.


Go to top of the page
6.3 Shelf life

5 years (60 months).

If only part of the contents of an ampoule is used, the remaining solution should be discarded.


Go to top of the page
6.4 Special precautions for storage

Keep the container in the outer carton in order to protect from light.

Do not store above 25°C.


Go to top of the page
6.5 Nature and contents of container

1.2ml, 2ml, 5ml, 10ml and 20ml clear glass ampoules, glass, type 1 Ph. Eur. borosilicate glass packed in cardboard cartons to contain 10 ampoules.


Go to top of the page
6.6 Special precautions for disposal and other handling

Not applicable.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PL 02848/5924R.


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first PL : 26 September 1986

Date of last renewal : 08 February 1999


Go to top of the page
10. DATE OF REVISION OF THE TEXT

March 2008



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22182/SPC/


Active Ingredients/Generics

 
  water for injection