Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Mercury Pharma Group
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.mercurypharma.com
Medical Information Direct Line: 08700 70 30 33
Medical Information e-mail: medicalinformation@mercurypharma.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 2ml, 5ml, 10ml & 20ml


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

Water for Injections B.P. 2ml, 5ml, 10ml & 20ml.


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

Each 1ml of solution contains 1ml of Water for Injections B.P.


Go to top of the page
3. PHARMACEUTICAL FORM

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: For S.C., I.M. or IV. injection, or as appropriate to the reconstituted drug.

Dosage: In accordance with the particular situation for which Water for Injections B.P. 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.


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.


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 B.P. should not be mixed with any other agents unless their compatibility has been established.


Go to top of the page
6.3 Shelf life

3 years.


Go to top of the page
6.4 Special precautions for storage

Do not store above 25°C.


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

2ml, 5ml, 10ml and 20ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to contain 10, 20, 50 and 100 ampoules.


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

For S/C, I/M or I/V Injection or as appropriate to the reconstituted drug.

If only part of an ampoule is used, discard the remaining solution.

Use as directed by the physician.

Keep out of reach of children.


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 2848/0152.


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

Date of first authorization : 10/10/91.


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

August 2001



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22183/SPC/


Active Ingredients/Generics

 
  water for injection