Water for injection Serra Pamies solvent for parenteral use

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

WATER FOR INJECTION PREPARATIONS SERRA PAMIES

solvent for parenteral use

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Water for Injection Preparations Serra Pamies is and what it is used for
2. Before you use Water for Injection Preparations Serra Pamies
3. How to use Water for Injection Preparations Serra Pamies
4. Possible adverse effects
5. Storage of Water for Injection Preparations Serra Pamies
6. Further information

1. What Agua para preparaciones inyectables Serra Pamies is and what it is used for

Agua para preparaciones inyectables Serra Pamies is sterile purified water. It is used to dilute medications prior to administration, for example, medications administered via

• injection (using a needle, for example into a vein)
• intravenous infusion (slow injection), also known as an IV drip

2. Before using Water for Injections Serra Pamies

Do not use Water for Injections Serra Pamies:

Water for Injections Serra Pamies must not be injected on its own. If injected alone into the bloodstream, it may cause red blood cells to absorb water and burst (haemolysis). This occurs because water for injections does not have the same concentration as blood.

Before administration, a healthcare professional will always mix Water for Injections Serra Pamies with one or more medicinal products.

You must read the package leaflet of the medicine or medicines to be mixed with Water for Injections Serra Pamies. These will indicate whether you can or cannot receive the solution.

Take special care with Water for Injections Serra Pamies:

Water for injections must not be administered on its own. Before using Water for Injections Serra Pamies:

• it will always be mixed with one or more medicines
• your healthcare professional will ensure that the mixture has approximately the same concentration as your blood (isotonic). Depending on the type of medicine to be administered, this means that:
  • the medicine must be diluted with Water for Injections Serra Pamies
  • another substance must be added to the mixture of Water for Injections Serra Pamies and the medicine before use

You are more likely to experience haemolysis if large volumes of hypotonic solutions of injectable water are administered (solutions that are less concentrated than your blood).

To prevent this, your doctor will take a blood sample to monitor the chemical balance in your blood (ionic balance).

Before administering medicines mixed with Water for Injections Serra Pamies, your doctor will check that:

• the medicines are stable in Water for Injections Serra Pamies
• the medicines do not interact with each other.

Use of other medicines:

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

Medicines dissolved in Water for Injections Serra Pamies may interact with each other.

Use of Water for Injections Serra Pamies with food and drink:

Consult your doctor regarding what you may eat or drink.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are pregnant or breastfeeding.

The risks to the fetus or your pregnancy will depend on the medicines used in combination with Water for Injections Serra Pamies.

The risks to the infant during breastfeeding will depend on the medicines used in combination with Water for Injections Serra Pamies.

Your doctor can advise you on the specific risks associated with each medicine.

Your doctor will administer medicines during pregnancy and breastfeeding only if absolutely essential.

Driving and using machines:

Water for Injections Serra Pamies does not affect your ability to drive or operate machinery.

The effects on your ability to drive and use machines will depend on the medicines used in combination with Water for Injections Serra Pamies. Your doctor will advise you accordingly.

3. How to use Water for Injections Serra Pamies

A doctor or nurse will administer Water for Injections Serra Pamies to you.

Your doctor will decide how much you need and when and how it will be administered. This will depend on which medications you need to take with Water for Injections Serra Pamies.

Your doctor will consider your age, weight, condition, and any other treatments you are receiving.

You must not be given Water for Injections Serra Pamies if there are particles floating in the water or if the container is damaged in any way.

If you are given more Water for Injections Serra Pamies than you should:

If you have received too much Water for Injections Serra Pamies, you may experience haemolysis. Haemolysis occurs when red blood cells absorb water and burst.

Medications mixed with Water for Injections Serra Pamies may also cause symptoms if administered in excessive amounts. The symptoms and signs of overdose will depend on the medications being used in combination with Water for Injections Serra Pamies.

If an overdose is accidentally administered, treatment will be stopped and you will be given treatment depending on your symptoms.

You should read the package leaflet of the medications mixed with Water for Injections Serra Pamies for a list of possible overdose symptoms.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medication and the amount ingested).

4. Possible adverse effects

Like all medicines, Water for Injections Serra Pamies may have adverse effects, although not everyone will experience them.

You may experience haemolysis (swelling and bursting of red blood cells) if:

• you use Water for Injections Serra Pamies alone
• Water for Injections is used to make injectable solutions or infusions that are not of similar concentration to your blood (isotonic)

If a medicine is added to Water for Injections Serra Pamies, the added medicine may cause adverse effects. These adverse effects will depend on the medicine that has been added. You should read the leaflet of the added medicine for a list of possible symptoms.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Water for Injectable Preparations Serra Pamies

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions. Store the ampoule in the outer packaging.

Expiry:

Do not use Water for Injectable Preparations Serra Pamies after the expiry date stated on the container and the ampoule label. The expiry date refers to the last day of the stated month.

Once the container has been opened, the product must be used immediately.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Water for Injections Serra Pamies

The only active substance is sterile Water for Injections. Each presentation contains 100% sterile Water for Injections.

Appearance of the medicinal product and contents of the container

Water for Injections Serra Pamies is a clear, particle-free solution and is available in the following presentations:

5 ml pack containing 1, 10, 100 (clinical pack) ampoules.

10 ml pack containing 1, 10, 50 (clinical pack), 100 (clinical pack) ampoules.

20 ml pack containing 1, 10, 100 (clinical pack) ampoules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

LABORATORIOS SERRA PAMIES, S.A.
Ctra. Castellvell, 24
43206 REUS (Tarragona)

This leaflet was approved in March 2011

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/