Water for preparations for injection Serra solvent for parenteral use
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Agua para preparaciones inyectables Serra is and what it is used for
- 2. What you need to know before using Serra Water for Injections
- 3. How to use Agua para Preparaciones Inyectables Serra
- 4. Possible adverse effects
- 5. Storage for Serra Injectable Preparations
- 6. Package contents and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Water for Injections Serra, solvent for parenteral use
Water for Injections
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 questions, ask your doctor, pharmacist or nurse.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Agua para preparaciones inyectables Serra is and what it is used for
- What you need to know before using Agua para preparaciones inyectables Serra
- How to use Agua para preparaciones inyectables Serra
- Possible side effects
- How to store Agua para preparaciones inyectables Serra
- Contents of the pack and other information
1. What Agua para preparaciones inyectables Serra is and what it is used for
Agua para preparaciones inyectables Serra is a special type of sterile water. This means it is highly purified and suitable for injection.
Agua para preparaciones inyectables Serra is used to dissolve or dilute certain medicines so that they can be administered by injection or infusion (drip) into the veins, muscles, or other tissues in the body.
2. What you need to know before using Serra Water for Injections
Warnings and precautions
Consult your doctor or nurse before starting to use Serra Water for Injections. Serra Water for Injections is hypotonic (more diluted than your blood) and must not be administered alone, as it may cause haemolysis (destruction of your red blood cells).
Other medicines and Serra Water for Injections
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
No interactions are known when Serra Water for Injections is administered together with other medicines. Please make sure to read the package leaflets of all your medicines, as Serra Water for Injections is added to other medicines to dissolve or dilute them.
Pregnancy and breastfeeding
It is not known that Serra Water for Injections causes problems during pregnancy or breastfeeding.
Since Serra Water for Injections is administered together with other medicines, it is important that: if you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, you consult your doctor or pharmacist before using this medicine.
Tell your doctor if you are breastfeeding a baby.
3. How to use Agua para Preparaciones Inyectables Serra
This medicine is usually administered by a doctor or nurse. This product is a solvent for injectable use.
The doctor or nurse will use the correct amount to dissolve or dilute another medication you are receiving as an injection or infusion (your doctor or nurse may refer to this as an infusion).
Agua para Preparaciones Inyectables Serra must not be mixed with oily liquids.
Your doctor will determine the amount (dose) of medication you should receive and for how long.
The dose will depend on the other medication being dissolved or diluted.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Please remember that you may also experience adverse effects related to the other medicines for which Serra Water for Injections is used to dissolve or dilute them.
The expected benefit of your medicine will generally be greater than the risk of experiencing harmful adverse effects.
Important: Adverse effects or symptoms to be aware of, and what to do if you are affected.
The first signs of having excess water in your blood are feeling tired and appearing pale. If you experience any of these symptoms, you must consult a doctor urgently.
No adverse effects of Water for Injections Serra are known; therefore, please read the package leaflet of the other medicines to which the water is added for dissolving or dilution.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage for Serra Injectable Preparations
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
After first opening:
Use your medicine only if it is a clear, colourless liquid. Open and use immediately. Any unused portion of the product should be discarded after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.
6. Package contents and other information
Composition of Water for Injections Serra
- 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.
- This medicine contains no other ingredients.
Nature of the product and package contents
Water for Injections Serra is a solvent for parenteral use.
Water for Injections Serra is a clear, colourless liquid.
Each plastic ampoule contains 5 ml (millilitres), 10 ml or 20 ml of your medicine.
The 5 ml ampoules are packed in boxes containing 20 or 50 ampoules.
The 10 ml ampoules are packed in boxes containing 20, 50 or 100 ampoules.
The 20 ml ampoules are packed in boxes containing 20 ampoules.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios SERRA PAMIES S.A.
Ctra. Castellvell, 24
43206 REUS (Tarragona)
Manufacturer
Demo S.A.
21st Km National Road Athens-Lamia
14568 Athens
Greece.
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 Διαλ?της για παρεντερικ? χρ?ση 100% v/v
Netherlands: Water for injecties Noridem, oplosmiddel voor parenteraal gebruik
Date of the most recent revision of this leaflet: 08/2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/