Sterile Water For Irrigation
SUMMARY 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 solution for irrigation and diluent.
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
Sterile water may be used in all age groups and patient populations as required.
For the irrigation of wounds and cavities.
4.3 Contraindications
The contraindications related to the added antiseptic should be considered.
4.4
Special warnings and precautions for use
Not to be used for intravenous infusion.
4.5 Interaction with other medicinal products and other forms of interaction
There are no known interactions with this product. When used for dilution of antiseptics, any possible clinical interactions should be considered.
4.6 Fertility, pregnancy and lactation
Pregnancy
Sterile water can be used during pregnancy.
Breastfeeding
Sterile water can be used during breast-feeding.
Fertility
No effects on human reproduction are anticipated.
The risks during use are determined by the nature of the added antiseptics.
4.7 Effects on ability to drive and use machines
Sterile water has no influence on the ability to drive and use machines.
4.8 Undesirable effects
There are no known side effects to this product.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
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.
The pharmacodynamics will depend on the nature of the antiseptic added.
5.2 Pharmacokinetic properties
No pharmacokinetic particulars are stated. The pharmacokinetics will depend on the nature of the antiseptic added.
5.3 Preclinical safety data
None stated. The preclinical safety data will depend on the nature of the antiseptic added.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.
6.2 Incompatibilities
Sterile water should not be mixed with any other agents unless their compatibility has been established.
Shelf life
6.3
24 months from the date of manufacture.
6.4 Special precautions for storage
Store below 25oC. Do not refrigerate.
6.5 Nature and contents of container
PVC containers.
Closures:
(a) radiofrequency weld
(b) polycarbonate plug
(c) PVC plug
Pack Sizes: 3000ml, 1000ml, 500ml, 150ml and 100ml Not all pack sizes may be marketed.
6.6 Special precautions for disposal
For single use only.
Discard any unused portion.
Use only if the solution is clear without visible particles and the container is undamaged.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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
08/11/2016