Water For Injection Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100% Water for Injections Ph.Eur.
3 PHARMACEUTICAL FORM
Sterile injection
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Water for Injections BP is used as a dissolvent and diluent for injectable medicines
4.2 Posology and method of administration
Water for Injections BP is administered by intravenous injection.
Dosage for adults (including the elderly) and children: as required, by intravenous injection.
4.3 Contraindications
None known
4.4 Special warnings and precautions for use
None known
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
None known
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
None known.
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
None known
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Water for Injections BP is dissolvent and diluent for injectable medicines
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None known
6.3 Shelf life
60 months for ampoules.
60 months for vials 1ml to 30ml.
48 months for vials 20ml 36 months for vials 50ml to 200ml.
6.4 Special precautions for storage
Do not store above 25°C
SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT
Water for Injections BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100% Water for Injections Ph. Eur.
3. PHARMACEUTICAL FORM Sterile injection.
4. CLINICAL PARTICULARS
4.9 Therapeutic indications
Water for Injections BP is used as a dissolvent and diluent for injectable medicines.
4.10 Posology and method of administration
Water for Injections BP is administered by Intravenous Injection. Dosage for Adults (including the elderly) and Children:- as required, by intravenous injection.
Contra-indications
4.11
None known.
4.12 Special warnings and precautions for use
None known.
4.13 Interactions with other medicinal products and other forms of interactions
None known.
4.14 Pregnancy and lactation
None known.
4.15 Effects on ability to drive and use machines
None known.
4.16 Undesirable effects
None known.
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 at: www.mhra.gov.uk/yellowcard.
4.17 Overdose
None known.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Water for Injections BP is used as a dissolvent and diluent for injectable medicines.
5.2 Pharmacokinetic properties
Not Applicable.
5.3 Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List of excipients
None.
6.2 Incompatibilities
None known.
6.3 Shelf life
60 months for ampoules.
60 months for vials 1ml to 30ml.
48 months for vials 20ml 36 months for vials 50ml to 200ml.
6.4 Special precautions for storage
Do not store above 25° C.
6.5 Nature and contents of container
Ampoules
Type I clear glass ampoules, 2ml, 5ml, 10ml and 20ml packed in cardboard cartons to contain 10 ampoules.
Vials
• Type I clear glass vial, 10ml, with a bromobutyl rubber stopper.
• Type I clear glass vial, 20ml, with a chlorobutyl rubber stopper.
• Type II clear glass vials, 1ml, 2ml, 30ml, 50ml, 100ml and 200ml, with a bromobutyl rubber stopper.
Plastic outer cap and inner aluminium ring packed in cardboard cartons to contain either 10 vials or 25 vials.
6.6 Instructions for use, handling and disposal
Use as directed by a physician. Only to be used as a diluent. ADMINISTRATIVE DATA
7. MARKETING AUTHORISATION HOLDER
hameln pharmaceuticals ltd
Gloucester
UK
8. MARKETING AUTHORISATION NUMBER
PL 01502 / 0003R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
27th June 1986/ 6th May 2005
10. DATE OF (PARTIAL) REVISION OF TEXT
6.6 Special precautions for disposal
Use as directed by a physician Only to be used as a diluent
7 MARKETING AUTHORISATION HOLDER
Hameln Pharmaceuticals Limited
Gloucester
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 01502/0003R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/06/1986 / 05/05/2005
10 DATE OF REVISION OF THE TEXT
18/11/2016