Water For Injections
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water For Injections
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 1ml of Water for Injections B.P.
3 PHARMACEUTICAL FORM
Solvent for parenteral use
Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.
4 CLINICAL PARTICULARS
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.
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 B.P. is being used.
4.3 Contraindications
None known.
4.4 Special warnings and precautions for use
None.
Interaction with other medicinal products and other forms of interaction
4.5
None known.
4.6 Pregnancy and lactation
May be used during this period.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
None known.
4.9 Overdose
No effects anticipated with the proposed use.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
6.1 List of excipients
Not applicable.
6.2 Incompatibilities
Water for Injections B.P. should not be mixed with any other agents unless their compatibility has been established.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
2ml, 5ml and 10ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to contain 10, 20, 50 and 100 ampoules.
6.6 Special precautions for disposal
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.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharma International Ltd 4045, Kingswood Road,
City West Business Park,
Co Dublin, Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 2848/0152.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/10/1991 / 19/03/2003
10 DATE OF REVISION OF THE TEXT
06/12/2012