Water For Injections
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Water for Injections Ph.Eur.
Water for Injections
Please read all of this leaflet carefully. It includes important information on
how you should take this medicine correctly and safely.
• Keep this leaflet. You may need to read it again.
• If you are the parent of a child who is to be given this medicine, read the leaflet replacing ‘you’ with 'your child’ throughout.
• This medicine is prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor, nurse or pharmacist.
• If you have any further questions, please ask your doctor, nurse or pharmacist.
In this leaflet:
1. What Water for Injections is and what it is used for
2. Before you use Water for Injections
3. How to use Water for Injections
4. Possible side effects
5. How to store Water for Injections
6. Further information
1. What Water for Injections is and what it is used for
Water for Injections is a special type of water that is sterile. This means that it is very clean and can be injected. Water for Injections is used to dissolve or dilute some medicines so that they can be given as an injection or an infusion (a drip) into veins, muscles or other tissues in the body.
2. Before you use Water for Injections
Take special care with Water for Injections: Water for Injections is hypotonic (more dilute than your blood) and it should not be given on its own, because it may cause haemolysis (destroy your red blood cells).
Using other medicines: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained with a prescription. There are no known interactions when Water for Injections is given with other medicines. Please make sure you read the leaflets for all your medicines, as Water for Injections is added to another medicine such as to dissolve or dilute it.
Pregnancy and breast-feeding: Water for Injections is not known to cause problems during pregnancy or breast-feeding.
As Water for Injections is given with other medicines, it is important that:
• If you are pregnant, or think you may be pregnant you must tell your doctor
* If you are breast feeding you must tell your doctor.
Your doctor will advise you if you should have this medicine.
3. How to use Water for Injections
A doctor or a nurse will usually give you this medicine. This product is a solvent for use as an injection.Your doctor or nurse will use the correct amount to dissolve or dilute another medicine that you are receiving as an injection or a drip (your doctor or nurse may call this an infusion). Water for injections should not be mixed with oily liquids. Your doctor will decide the amount (dose) of your medicine that you should receive and how long you will need to take it for. The dose will depend on what other medicine it is being used to dissolve or dilute. If you have any further questions on the use of your medicine, ask your doctor, nurse or pharmacist.
Please read the other side of this leaflet.
Technical Information Leaflet
Water for Injections
This leaflet provides information for the healthcare professional. There is a separate Patient Information Leaflet.
1. NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph.Eur.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 1 g water for injections. 5ml contain 5g water for injections. 10ml contain 10g water for injections. 20ml contain 20g water for injections.
3. PHARMACEUTICAL FORM
Solvent for parenteral use. A clear liquid.
CLINICAL PARTICULARS
4.1 Therapeutic Indications:
Water for Injections is used as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.
4.2 Posology and Method of Administration:
Dosage: The volume given and administration rate are dependent upon the additive. Administration: For parenteral use.
The directions for use of the additive will dictate the administration route.
The solution should only be used if it is clear without visible particles.
4.3 Contraindications: Contraindications related to the additive.
4.4 Special Warnings and Precautions for Use: Water for Injections is hypotonic and it should not be administered alone, because it may cause haemolysis.
4.5 Interaction with other Medicinal Products and other Forms of Interaction Interactions related to the additive.
4.6 Pregnancy and Lactation
This solvent does not present any hazard to the pregnant woman, to the foetus or to the breastfed child, however the hazard depends upon the additive.
4.7 Effects on Ability to Drive and Use Machines: Not known.
4.8 Undesirable Effects:
None are known for Water for Injections, so any undesirable effects may be related to the additive.
Intravenous administration can lead to haemolysis if it is administered alone.
4.9 Overdose:
Haemolysis may occur following infusion of large volumes of hypotonic solutions using sterile water for injections as diluent. The signs and symptoms of overdose may also be related to the nature of the additive. In the event of accidental overdose, the treatment should be discontinued
4. Possible side effects
Like all medicines, Water for Injections can cause side effects, but not everyone gets them. Remember that you may also get side effects from the other medicines that Water for Injections is being used to dissolve or dilute. The expected benefit of your medicine will usually be greater than the risk of you suffering any harmful side effects.
Important: Side effects or symptoms to look out for, and what to do if you are affected. The first signs of having too much water in your blood are feeling tired and looking pale. If you get any of these symptoms you must seek urgent medical advice.
Side effects are not known for Water for Injections so please read the leaflet for all your other medicines that the water is being added to dissolve or dilute. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Water for Injections
Keep this medicine out of the sight and reach of children. Do not use Water for injections after the expiry date given on the carton and the label after 'EXP'. The expiry date refers to the last day of the month. Store below 25° C. After first opening: Only use your medicine if it is clear and colourless liquid. Open it and use it straight away. Any unused product should be discarded after opening. Medicines should not be disposed of via waster water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Water for Injections contains
The active substance is Water for Injections.
1ml contains 1g water for injections, 5ml contain 5g water for injections,
10ml contain 10g water for injections, 20ml contain 20g water for injections.
There are no other ingredients in this medicine.
What Water for Injections looks like
Water for injections is a solvent for parenteral use.
Water for Injections is a clear, colourless liquid.
Contents of the pack: Each plastic ampoule will contain 5ml (millilitres), 10ml or 20ml of your medicine. 5 and 10ml ampoules come in a box of 50 ampoules. 20ml ampoules come in a box of 20 ampoules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit. 115, 1065 Nicosia, Cyprus.
Manufacturer: Demo S.A., 21st Km National Road Athens-Lamia, 14568 Athens, Greece.
This medicinal product is authorised in the Member States if the EEA under the following names:
UK: Water for Injections Ph.Eur.
BE: Water for Injections Noridem Ph Eur DK: Sterilt vand Noridem
ES: Water for Injections Noridem, solvent for parenteral use.
IE: Water for Injections Ph Eur.
SE: Vatten for injektiosvatskor Noridem
DE: Wasserfur Injektionszwecke Noridem 1mg/ml Losungsmittel zur Herstellung von Parenteralia
NO: Vann til injeksjonsvaesker Noridem PT: Agua para Injectaveis Noridem
This leaflet was approved in January 2014.
If this leaflet is difficult to see or read please contact the following address for help: Fannin Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18, Ireland, Tel +353-1-2907000.
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and the patient should be observed for the appropriate signs and symptoms related to the additive administered.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties:
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions V07A B01. Not applicable.
5.2 Pharmacokinetic Properties: Not applicable.
5.3 Preclinical Safety Data: Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients: None.
6.2 Incompatibilities: Incompatible with oily liquids.
6.3 Shelf Life:
2 years.
From a microbiological point of view, the product should be used immediately after opening. 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 reconstitution / dilution has taken place in controlled and validated aseptic conditions.
6.4 Special Precautions for Storage:
Unopened product: Store below 25°C.
Opened product: For storage conditions of the opened, reconstituted or diluted medicinal product, see section 6.3.
6.5 Nature and Contents of Container:
Polypropylene ampoules, of 5 or 10 ml, packed into cartons of 50 ampoules, or of 20 ml, packed into cartons of 20 ampoules.
6.6 Instructions for Use and Handling:
After single use, product should be discarded. Any unused product should be discarded.
MARKETING AUTHORISATION HOLDER
Noridem Enterpirses Ltd., Evagorou & Makariou, Mitsi Building 3, Suit. 115, 1065 Nicosia, Cyprus.
8. MARKETING AUTHORISATION NUMBERS
PL 24598/0001 PA 1122/1/1
38074330-4