Sterile Water For Irrigation
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterile Water for Irrigation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient:
Water for Injections BP 100.0% v/v
3. PHARMACEUTICAL FORM
Sterile irrigation fluid.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Recommended for use when sterile pyrogen-free water is required. For the irrigation of wounds and cavities. As a diluent for antiseptic solutions.
4.2 Posology and Method of Administration
For the irrigation of wounds and cavities.
Adults, children and the elderly: Use as required.
4.3 Contra-indications
Not to be used for intravenous infusion.
4.4 Special Warnings and Precautions for Use
4.5 Interactions with other Medicaments and other forms of Interaction
There are no known interactions with this product.
4.6 Pregnancy and Lactation
This product is safe for use during pregnancy and lactation.
4.7 Effects on Ability to Drive and Use Machines
This product does not affect the ability to drive or use machines.
4.8 Undesirable Effects
There are no known side effects to this product.
4.9 Overdose
There is a possibility of fluid absorption, if this occurs in excess hypervolaemia, haemolysis and renal failure may result. Treat symptomatically paying particular attention to restoring the electrolyte balance.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
No pharmacological particulars are stated.
5.2 Pharmacokinetic Properties
No pharmacokinetic particulars are stated.
5.3 Preclinical Safety Data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
No excipients present.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
24 months from the date of manufacture.
6.4 Special Precautions for Storage
Store between 5°C and 25 °C.
6.5 Nature and Contents of Container
PVC which complies with EP VI 2.2.3 1990 (Containers for intravenous infusion).
Closures :
(a) radiofrequency weld
(b) polycarbonate plug
(c) PVC plug
Pack Sizes: 3000 ml, 1000 ml, 500 ml, 150 ml and 100 ml
6.6 Instruction for Use/Handling
7 MARKETING AUTHORISATION HOLDER
CaridianBCT Northern Ireland Ltd
T/A Ivex Pharmaceuticals
Old Belfast Road
Millbrook
Larne
Northern Ireland BT40 2SH United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 21538/0001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
12th April 2005
10 DATE OF REVISION OF THE TEXT
03/06/2009