Package leaflet: Information for the user

Water for Injections Noridem

water for injections
Please read this leaflet carefully before using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Acqua per preparazioni iniettabili Noridem is and what it is used for
What you need to know before using Acqua per preparazioni iniettabili Noridem
How to use Acqua per preparazioni iniettabili Noridem
Possible side effects
How to store Acqua per preparazioni iniettabili Noridem
Contents of the pack and other information

1. What Acqua per preparazioni iniettabili Noridem is and what it is used for

Acqua per preparazioni iniettabili Noridem is a special type of water that is sterile. This means
that it is very pure and can be injected.
Acqua per preparazioni iniettabili Noridem is used to dissolve or dilute certain medicines so that
they can be administered as an injection or infusion (intravenous infusion) into veins, muscles, or other
tissues of the body.

2. What you need to know before using Water for Injections Noridem

Warnings and precautions
Talk to your doctor or nurse before using Water for Injections Noridem. Water for Injections Noridem is hypotonic (more diluted than blood) and must not be administered on its own, as it may cause haemolysis (destruction of red blood cells).

Other medicines and Water for Injections Noridem
Inform your doctor if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
There are no known interactions when Water for Injections Noridem is administered with other medicines. Make sure to read the package leaflets of all your medicines, as Water for Injections Noridem is sometimes added to another medicine to dissolve or dilute it.

Pregnancy and breastfeeding
It is not known whether Water for Injections Noridem causes problems during pregnancy or breastfeeding.
Since Water for Injections Noridem is administered together with other medicines, it is important that:
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will advise you whether you should take this medicine.

3. How to use Noridem Water for Injections

This medicine is usually administered by a doctor or nurse. This product is a solvent intended for use as an injection.
The doctor or nurse will use the appropriate amount to dissolve or dilute another medicine you are receiving by injection or intravenous infusion (the doctor or nurse may refer to this as an infusion).
Noridem Water for Injections must not be mixed with other liquids.
The doctor will determine the amount (dose) of medicine you should receive and how long you should receive it.
The dose will depend on which other medicine is being dissolved or diluted with Noridem Water for Injections.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Please remember that side effects may also arise from other medicines that are dissolved or diluted with Acqua per preparazioni iniettabili Noridem.
The expected benefit of your medicine is usually greater than the risk of experiencing any harmful side effects.
Important: side effects or symptoms to watch for, and what to do if they affect you.
The first signs of having too much water in the blood are tiredness and paleness. If you experience
these symptoms, you must contact your doctor urgently.
No side effects of Acqua per preparazioni iniettabili Noridem are known; therefore, please read the package leaflets of all other medicines that are dissolved or diluted with this water.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Water for Injections Noridem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening:
Use the medicine only if it is a clear, colourless liquid. Open and use it immediately. Any unused
product must be discarded after opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Acqua per preparazioni iniettabili Noridem contains

The active substance is Water for Injections.

1 ml contains 1 g of water for injections, 5 ml contain 5 g of water for injections, 10 ml contain 10 g of water for injections, 20 ml contain 20 g of water for injections.
There are no other components in this medicinal product.

Description of the appearance of Acqua per preparazioni iniettabili Noridem and contents of the pack
Acqua per preparazioni iniettabili Noridem is a solvent for parenteral use.
Acqua per preparazioni iniettabili Noridem is a clear, colourless solution.
Each plastic vial contains 5 ml (millilitres), 10 ml or 20 ml of medicinal product. The 5 ml vials are supplied in boxes of 20 or 50 vials. The 10 ml vials are supplied in boxes of 20, 50, or 100 vials. The 20 ml vials are supplied in a box of 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia
Cyprus

Manufacturer:
DEMO S.A. INDUSTRIA FARMACEUTICA
21st Km National Road Athens–Lamia
14568 Krioneri, Attiki
Greece
T: +30 210 8161802

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Sterilt vand ”Noridem”, solvens til parenteral anvendelse
Germany Wasser für Injektionszwecke Noridem 1 g/ml Lösungsmittel zur Herstellung von Parenteralia
Ireland Water for Injections Ph. Eur.
Norway Sterilt vann Noridem, oppløsningsvæske til parenteral bruk
Portugal Água para preparações injectáveis Noridem
Sweden Vatten för injektionsvätskor Noridem, spädningsvätska för parenteral användning
Spain Agua para preparaciones inyectables Serra, disolvente para uso parenteral
Austria Wasser für Injektionszwecke Noridem – Lösungsmittel zur Herstellung von Parenteralia
Greece WATER FOR INJECTIONS/NORIDEM Διαλύτης για παρεντερική χρήση 100% v/v
Netherlands Water voor injecties Noridem, oplosmiddel voor parenteraal gebruik
Czech Republic Water for injections Noridem
Finland Injektionesteisiin käytettävä vesi Noridem, liuotin parenteraaliseen käyttöön
Hungary Injekcióhoz való víz Noridem oldószer parenterális készítményekhez
Italy Acqua per preparazioni iniettabili Noridem
Poland Aqua pro injectione Noridem
Romania Apă pentru preparate injectabile Noridem, solvent pentru preparate parenterale
Slovakia Water for injections Noridem