Package leaflet: Information for the user

Aqua pro injectione Noridem, solvent for preparation of parenteral medicines
water for injections
Please read all of this leaflet carefully before use, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Aqua pro injectione Noridem is and what it is used for
Important information before use of Aqua pro injectione Noridem
How to use Aqua pro injectione Noridem
Possible side effects
How to store Aqua pro injectione Noridem
Contents of the pack and other information

1. What Aqua pro injectione Noridem is and what it is used for

Aqua pro injectione Noridem is a special type of water which is sterile. This means that
it is very pure and can be injected.
Aqua pro injectione Noridem is used to dissolve or dilute certain
medicines so that they can be administered by injection or infusion (intravenous drip) into a vein, muscle,
or other tissues in the body.

2. Important information before using Aqua pro injectione Noridem

Warnings and precautions
Before starting treatment with Aqua pro injectione Noridem, you should discuss this with your doctor or nurse.
Aqua pro injectione Noridem is hypotonic (more diluted than blood) and must not be administered alone, as it may cause haemolysis (destruction of red blood cells).

Aqua pro injectione Noridem and other medicines
You must tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
No interactions are known when Aqua pro injectione Noridem is administered with other medicines.
You should carefully read the package leaflets of all medicines you are taking, because Aqua pro injectione Noridem is added to another medicine, for example to dissolve or dilute it.

Pregnancy and breastfeeding
It is not known whether Aqua pro injectione Noridem causes problems during pregnancy or breastfeeding.
Since Aqua pro injectione Noridem is administered together with other medicines, it is important that:
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Your doctor will advise whether you should receive this medicine.

3. How to use Aqua pro injectione Noridem

This medicine is usually administered by a doctor or nurse. This product is a solvent for injection.
The doctor or nurse will use the appropriate amount to dissolve or dilute another medicine that the patient is receiving by injection or infusion (the doctor or nurse may refer to this as an infusion).
Aqua pro injectione Noridem must not be mixed with oily liquids.
The doctor will decide the amount (dose) of the medicine the patient should receive and how long it should be given.
The dose will depend on which other medicine is being dissolved or diluted.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It should be remembered that adverse reactions may also occur after using other medicines
which are dissolved or diluted using the medicine Aqua pro injectione Noridem.
The expected benefits of using the medicine usually outweigh the risk of harmful
adverse reactions.
Important: Adverse reactions or symptoms to which attention should be paid, and what to do if
they occur.
The first signs of excess water in the blood are feeling tired and paleness. If any of these symptoms occur,
immediate medical help must be sought.
No adverse reactions of Aqua pro injectione Noridem are known; therefore, the package leaflet of each of the other medicines to which water is added for dissolution or dilution should be read.
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet are observed, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions allows the collection of further information on the safety of using this medicine.

5. How to store Aqua pro injectione 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:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
After first opening:
This medicine should only be used if it is a clear, colourless solution. Open and use immediately. After use, any unused portions of the product must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Aqua pro injectione Noridem contains

The active substance is water for injections.

1 ml contains 1 g of water for injections, 5 ml contains 5 g of water for injections, 10 ml contains 10 g of water for injections, 20 ml contains 20 g of water for injections.
This medicine contains no other ingredients.

What Aqua pro injectione Noridem looks like and contents of the pack
Aqua pro injectione Noridem is a solvent for the preparation of parenteral medicinal products.
Aqua pro injectione Noridem is a clear, colourless liquid.
Each plastic ampoule contains 5 ml, 10 ml or 20 ml of the medicine. 5 ml ampoules are supplied in cardboard boxes containing 20 or 50 ampoules. 10 ml ampoules are supplied in cardboard boxes containing 20, 50 or 100 ampoules. 20 ml ampoules are supplied in a cardboard box containing 20 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Noridem Enterprises Limited
Makariou & Evagorou 1
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus
T: +30 210 8161802, F: +30 2108161587

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece

This medicinal product is authorised in the European Economic Area countries 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