Heparin Sodium BP 2500 IU/L in 0.9% w/v Sodium Chloride IV Infusion

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, nurse or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Throughout this leaflet, Heparin Sodium BP 2500 IU/L in 0.9% w/v Sodium Chloride IV Infusion will be called Heparin Sodium Solution.

In this leaflet:

1.    What Heparin Sodium Solution is and what it is used for

2.    Before Heparin Sodium is given

3.    How Heparin Sodium Solution is given

4.    Possible side effects

5.    How Heparin Sodium Solution is stored

6.    Further information

1 What Heparin Sodium Solution is and what it is used for

Heparin Sodium Solution contains a medicine called heparin. It belongs to a group of medicines called antithrombotics or anticoagulants, they stop your blood from clotting.

Heparin Sodium Solution is used to:

•    stop blood clotting when it is removed from your body, for example during dialysis. Dialysis is used to help your kidneys remove toxins from your blood

•    stop tubes that are put into your blood vessels (catheters) from getting blocked by blood clots.

2 Before Heparin Sodium Solution is given

Do not have Heparin Sodium Solution if:

•    you are allergic (hypersensitive) to the active ingredient or any of the other ingredients of Heparin Sodium Solution (listed in section 6)

•    you tend to have difficulty in stopping bleeding. Do not have Heparin Sodium Soluton if any of the above apply to you. If you are not sure talk to your doctor, nurse or pharmacist before having Heparin Sodium Solution.

Your doctor will take special care when giving you Heparin Sodium Solution if:

•    you have kidney or heart problems

•    you are at risk of losing large amounts of blood (haemorrhage)

Also you need to be checked carefully and you may need a blood potassium test to make sure Heparin Sodium Solution is suitable for you if:

•    you have kidney problems, diabetes or too much acid in your blood (metabolic acidosis)

•    you have ever been told by your doctor that you have too much potassium in your blood.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Heparin Sodium Solution.

Using other medicines

Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines you obtained without a prescription.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines, they may affect the way Heparin Sodium Solution works:

•    medicines that change the way your blood clots

•    warfarin or dicoumarol, because they may affect the results of some blood tests that are used to check how well your blood clots

•    medicines that lower the amount of potassium that passes into your urine, such as certain medicines used to treat high blood pressure, called ACE inhibitors or Angiotensin-II anatgonists.

Tests you may have with Heparin Sodium Solution

Your doctor may want to check:

•    your blood potassium level before treatment if you have certain conditions (see ‘Your doctor will take special care when giving you Heparin Sodium Solution' for more information)

•    your blood potassium level during treatment, if your treatment is going to last longer than 7 days

•    your blood levels of other substances called ‘electrolytes', such as sodium. If you are having difficulty breathing or have swollen legs and arms.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, please inform your doctor. They will advise you if this treatment is suitable for you.

Driving and using machines Heparin Sodium Solution has little or no influence on the ability to drive or use machines. Please inform your doctor and they will advise you if you can drive or use machines.

3 How Heparin Sodium Solution is given

Heparin Sodium Solution will be given to you by a doctor or nurse.

The usual dose

Your doctor will decide how much of the medicine you will need and for how long it will be given to you. This will depend on:

•    your age and weight

•    the reason you are being given the medicine

•    if it is being given to you to keep your catheter clear, the dose will depend on the type of catheter you have.

The solution will be given as a slow injection (infusion) through a plastic tube (catheter) which will be placed carefully into your vein by a doctor or nurse.

If you are given more Heparin Sodium Solution than you should have

It is unlikely that you will be given more Heparin Sodium Solution than you should, because it will be given to you by a trained and qualified person. They will discontinue the infusion straightaway if too much was given.

4 Possible Side Effects

Like all medicines, Heparin Sodium Solution can cause side effects, although not everybody gets them. The following side effects may happen with this medicine

Tell your doctor, nurse or pharmacist straight away if you notice any of the following side effects:

•    allergic reaction, the signs may include high temperature, rash, watery and red eyes

or wheezing. If you have a reaction to the medicine, it will be stopped

•    nose bleeds, unusual bruising or blood in your urine. This may mean you have been given too much Heparin Sodium Solution.

Other possible side effects

•    temporary hair loss

•    brittle bones (osteoporosis)

•    it is also possible that your blood will not clot properly for a short time after having this medicine

•    rarely, high potassium levels in your blood (usually only seen in blood tests) particularly if you have diabetes or kidney problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse straight away.

5 How Heparin Sodium Solution is stored

Keep out of the reach and sight of children. Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the product. The storage conditions, should you need them are given below.

•    Do not store above 25°C.

•    Do not use Heparin Sodium Solution after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

•    Heparin Sodium Solution must not be used if the container is damaged or the solution is not clear.

The solution should only be used once. Any left over solution should be discarded.

6 Further Information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about any thing, ask your healthcare professional.

What Heparin Sodium Solution contains The active substances are heparin sodium 2,500 International Units (IU) in each litre (L), sodium chloride (9 g/L), disodium phosphate dodecahydrate (5.8 g/L) and citric acid monohydrate (405 mg/L).

The other ingredient is sterile water (called ‘water for injections').

What Heparin Sodium Solution looks like and contents of the pack

It is supplied as a clear solution for infusion (slow injection) in a 500 ml or 1000 ml VIAFLEX plastic bag with a plastic overpouch. Do not remove from overpouch until ready for use.

Marketing Authorisation Holder and Manufacturers

The Marketing Authorisation holder is:

Baxter Healthcare Ltd Caxton Way, Thetford Norfolk, IP24 3SE United Kingdom

Send all enquires to this address.

Heparin Sodium Solution can be made at any of these addresses:

Baxter Healthcare Ltd Caxton Way, Thetford Norfolk, IP24 3SE United Kingdom

Baxter Healthcare S.A.

Castlebar, Co. Mayo Ireland

NV Baxter SA

Boulevard D'Houraing

7860-Lessines

Belgium

This leaflet was last approved in May 2009.

For information about Heparin Sodium Solution or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: 01635 206345.

Baxter and Viaflex are trademarks of Baxter International Inc.

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