Water For Injections Bp Solvent For Parental Use
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— PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG • 34209 Melsungen, Germany
solvent for parenteral use
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BlBRAUN Melsungen AG
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you notice any side effects, talk to your doctor or pharmacist. This includes any possible effects not listed in this leaflet. See section 4.
1 What Water for Injections BP is and what it is used for.
2 What you need to know before you use Water for Injections BP.
3 How to use Water for Injections BP
4 Possible side effects.
5 How to store Water for Injections BP
6 Contents of the pack and other information
Water for Injections BP is sterile water for injections.
This is used for the preparation and dilution of medicines that are to be administered into your vein (parenteral use).
There are no known situations in which Water for Injections BP should not be used.
Water for injections BP must not be used alone. Your doctor will dissolve or dilute another medicine in water for injection before the ready prepared medicine is administered to you.
There are no known interactions with other medicines.
There are no known interactions with food or drink
Water for Injections BP can be used during pregnancy and breast-feeding.
Water for Injections BP has no influence on the ability to drive and use machines.
This medicine is administered to you by a doctor or healthcare professional.
The method of administration depends on the instructions given for the medicinal product to be dissolved or diluted. The medicinal product should be reconstituted or diluted immediately before use.
The dosage of Water for Injections BP and the duration of the application are in accordance with the instructions pertaining to the medicine dissolved or diluted.
An overdose is very unlikely as this medicine is only for preparation and dilution of parenteral preparations.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects,although not everybody gets them.
There are no known side effects if the instructions for use are followed. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container and the outer carton after “EXP". The expiry date refers to the last day of the month.
For the product in plastic ampoules: Do not store above 25°C.
There are no special precautions for storage for product in polyethylene containers.
Do not use this medicine if you notice the container is damaged and the liquid is unclear or coloured.
For single use only. Discard any unused medicine.
• 100 ml Water for Injections BP Water for Injections 100 ml
Water for Injections BP is a solvent for parenteral use: it is used to dissolve or dilute medicine that are to be administered into your vein.
It is a clear, colourless liquid
Schwarz 210x297 mm 25/13103121/1014 Latus: 733 GroBbritannien Font size 9
Marketing Authorisation Holder & Manufacturer
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany Postal address:
34209 Melsungen, Germany Telephone: +49-(0)-5661-71-0 Fax: +49-(0)-5661-71-4567
This leaflet was last revised in January 2014
It is available in:
• Plastic polyethylene ampoules, contents: 5 ml, 10 ml, 20 ml supplied in packs of:
20 x 5 ml, 20 x 10 ml, 20 x 20 ml, 100 x 5 ml, 100 x 10 ml, 10 0 x 20 ml
• Plastic propylene ampoules, contents: 10 ml, 20 ml supplied in packs of:
20 x 10 ml, 100 x 10 ml, 20 x 20 ml, 100 x 20 ml
• Bottles of low- density polyethylene (LD-PE), contents: 50 ml, 100 ml, 250 ml, 500 ml, 1000ml
supplied in packs of:
20 x 50 ml, 10 x 100 ml, 20 x 100ml, 10 x 250 ml, 20 x 250 ml, 10 x 500 ml, 10 x 1000 ml
Not all pack sizes may be marketed.
After preparation of the ready-to-use medicinal product From a microbiological point of view, the ready-to-use preparations should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
For the preparation of parenteral solutions usual hygiene precautions to maintain sterility must be adhered to.
B. Braun Melsungen AG
34209 Melsungen Germany
Schwarz 210x297 mm 25/13103121/1014 Latus: 733 GroRbritannien Font size 9