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- another substance needs to be added to your mixture of Water for injections and medicine before use.

Haemolysis (breaking up of red blood cells) can occur if you are given Water for injections. The haemoglobin released by the damaged red blood cells may cause kidney failure in some patients.

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

Before you are given medicines mixed with Water for injections your doctor will check that:

•    the medicines are stable in Water for injections

•    the medicines will not interact with each other

Other medicines and Water for injections

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

The medicines you are using mixed with Water for injections may interact with each other.

Water for injections with food, drink and alcohol

You should ask your doctor about what you can eat or drink.

Pregnancy, breast-feeding and fertility

if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Any risk to your unborn baby or your pregnancy will depend on which medicines you are using mixed with Water for injections.

The medicines mixed with Water for injections may also cause symptoms if administered in too large quantities (over-infusion). Any signs and symptoms of overdose will depend on which medicines you are using mixed with Water for injections.

if you are accidentally given an overdose, your treatment will be stopped and you will be given treatment depending on the symptoms.

You should read the Patient information Leaflet of the medicines mixed with Water for injections for a list of possible symptoms of over-infusion.

if you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may suffer bursting (haemolysis) of your red blood cells if:

•    you use Water for injections on its own

•    Water for injections is used to make solutions for injection or infusion that are not of a similar consistency to your blood (isotonic).

if a medicine has been added to Water for injections, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added. You should read the Patient information Leaflet of the added medicine for a list of possible symptoms.

Reporting of side effects

if you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below.

By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at: www.mhra. gov.uk/yellowcard

Ireland:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

Malta:

ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D’Argens GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt

5. How to store Water for Injections

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not remove Water for injections from the outer plastic overpouch until it is to be used.

Water for injections should NOT be given to you after the expiry date which appears on the bag after EXP. The expiry date refers to the last day of that month.

Once the pack is opened Water for injections should be used straight away.

6. Contents of the pack and other information

What Water for injections contains

The only ingredient is sterile water for injections.

Each bag contains 100% sterile water for injections.

What Water for injections looks like and contents of the pack

Water for Injections is a clear and colourless solution. It is supplied in polyolefin/polyamide plastic bags (VIAFLO). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

•    50 ml

•    100 ml

•    250 ml

•    500 ml

•    1000 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

•    50 bags of 50 ml

•    50 bags of 100 ml

•    30 bags of 250 ml

•    20 bags of 500 ml

•    10 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation Holder:

Send all enquiries to this address Baxter Healthcare Ltd.

Caxton Way

Thetford Norfolk IP24 3SE United Kingdom

The following information is intended for medical or healthcare professionals only:

Handling and Preparation

Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of an infusion set.

Do not remove unit from overwrap until ready for use.

The inner bag maintains the sterility of the product.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

Water for Injections should not be infused alone.

The infusion should be made isotonic prior to parenteral administration.

Additives may be introduced before administration or during administration through the re-sealable medication port. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

The infusion should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the infusion in order to prevent air entering the system.

Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

The following fill volumes should be taken

into consideration when preparing infusions :

59 ml for the 50 ml bag

111 ml for the 100 ml bag

271 ml for the 250 ml bag

530 ml for the 500 ml bag

1040 ml for the 1000 ml bag

1.    Opening

a.    Remove the VIAFLO container from the overpouch just before use.

b.    Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired.

c.    Check the solution for limpidity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

2.    Preparation for administration after rendering isotonic

a.    Suspend container from eyelet support.

b.    Remove plastic protector from outlet port at bottom of container:

-    grip the small wing on the neck of the port with one hand,

-    grip the large wing on the cap with the other hand and twist,

-    the cap will pop off.

c.    Use an aseptic method to set up the infusion.

d. Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.

3. Techniques for injection of additive medications

Warning: Additives may be incompatible:

To add medication before administration

a.    Disinfect medication port.

b.    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

c.    Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added

medications.

To add medication during administration

a.    Close clamp on the set.

b.    Disinfect medication port.

c.    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

d.    Remove container from IV pole and/or turn to an upright position.

e.    Evacuate both ports by tapping gently while the container is in an upright position.

f.    Mix solution and medication thoroughly.

g.    Return container to in-use position, re-open the clamp and continue administration.

4.    In-use shelf-life: Additives

Chemical and physical stability of any additive at the pH of Water for Injections (4.5 to 7.0) in the container should be established prior to use.

From a microbiological point of view, the diluted product should be used immediately, unless reconstitution has taken place in controlled and validated aseptic conditions.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

5.    Incompatibilities of additive medications

As with all parenteral solutions, before adding medications, compatibility of these additives with the solution in the VIAFLO container must be assessed.

The Instructions for Use of the medicinal product to be added must be consulted.

Before adding a medicinal product, verify it is soluble and stable in water at the pH of Water for Injections (4.5 to 7.0).

Baxter and Viaflo are trademarks of Baxter International lnc.

SA-30-02-002

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