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Heparin Sodium 100 I.U./ml flushing solution for maintenance of patency of intravenous devices (Wockhardt UK Ltd) (PL 29831/0111)

Active Ingredient:
heparin sodium
Company:  
Wockhardt UK Ltd See contact details
About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 08 Oct 2018
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Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0111.

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Heparin Sodium 100 I.U/ml Flushing Solution for maintenance of patency of intravenous devices (PL 29831/0111)

Package leaflet: Information for the user

HEPARIN SODIUM 100 I.U./ml FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES

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 further questions, please ask your doctor or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Heparin Sodium 100 I.U./ml Flushing Solution for maintenance of patency of intravenous devices. In the rest of this leaflet, it is called Heparin Sodium 100 I.U./ml Flushing Solution.

What is in this leaflet

1. What Heparin Sodium 100 I.U./ml Flushing Solution is and what it is used for
2. What you need to know before you use Heparin Sodium 100 I.U./ml Flushing Solution
3. How to use Heparin Sodium 100 I.U./ml Flushing Solution
4. Possible side effects
5. How to store Heparin Sodium 100 I.U./ml Flushing Solution
6. Contents of the pack and other information

1. What Heparin Sodium 100 I.U./ml Flushing Solution is and what it is used for

Heparin Sodium 100 I.U./ml Flushing Solution is heparinised saline which is heparin dissolved in a salt water solution.

Heparin is an anti-clotting agent and is produced naturally in the body. Heparin Sodium 100 I.U./ml Flushing Solution is used to wash and rinse the inside of intravenous catheters and cannulas (surgical forms of tubing) to ensure they do not become blocked while they are in use.

2. What you need to know before you use Heparin Sodium 100 I.U./ml Flushing Solution
Do not use Heparin Sodium 100 I.U./ml Flushing Solution:
  • if you are allergic to heparin or any of the other ingredients of this medicine (listed in section 6).
  • if you are about to be treated for pain and inflammation with intravenous diclofenac

Take special care with Heparin flush

Before you have Heparin flush, tell your doctor:

  • If you are allergic (hypersensitive) to low molecular weight heparins, such as tinzaparin, enoxaparin or dalteparin.

If you have Heparin flush regularly for more than five days, your doctor may take regular blood tests. This is to check the level of platelets (a type of cell) in your blood while you have your medicine. Depending on the result the doctor may tell you to stop having this medicine straight away.

Also your doctor may take a blood test up to several weeks after the end of your heparin treatment. Again, this is so the doctor can check the level of the platelets in your blood.

Pregnancy, breast-feeding and fertility

Do not use Heparin Sodium 100 I.U./ml Flushing Solution if you are pregnant or trying to become pregnant without talking to your doctor first

Do not use Heparin Sodium 100 I.U./ml Flushing Solution if you are breast-feeding without talking to your doctor.

If you have any doubts about whether Heparin Sodium 100 I.U./ml Flushing Solution should be used for you then discuss things more fully with your doctor or nurse.

3. How to use Heparin Sodium 100 I.U./ml Flushing Solution
  • Heparin Sodium 100 I.U./ml Flushing Solution should not be injected directly into the body.
  • Heparin Sodium 100 I.U./ml Flushing Solution is used for cleaning catheters and cannulas (surgical forms of tubing) by flushing with 2ml (200 units) every four hours or as required.
  • The doctor will decide which dose is best to be used.
  • If blood for tests are to be taken from the tubing which has been rinsed with this product, the heparin in the tubing should first be withdrawn and discarded.
  • Aseptic techniques should be used at all times during its use to avoid contamination.
  • Your doctor will check your blood if you use Heparin Sodium 100 I.U./ml Flushing Solution for longer than five days.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them, particularly when treatment is first started.

  • It can cause bleeding and occasionally a serious blood disorder (thrombocytopenia)
  • Thrombocytopenia may result in the formation of dangerous blood clots causing chest pains, shortness of breath, coughing, feeling faint, dizziness or loss of consciousness. If thrombocytopenia develops, Heparin treatment should be stopped immediately.
  • Rarely, allergic reactions can occur.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How to store Heparin Sodium 100 I.U./ml Flushing Solution

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

  • Do not use this medicine after the expiry date which is stated on the ampoule. The expiry date refers to the last day of that month.
  • Do not use if the contents of the ampoule show signs of deterioration such as discolouration.
  • Do not store above 25ºC.
  • Store in the original package in order to protect from light.
  • Any portion of the contents not used at once should be discarded.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Heparin Sodium 100 I.U./ml Flushing Solution contains

Heparin Sodium 100 I.U./ml Flushing Solution is heparinised saline which is heparin dissolved in a salt water solution. It is available as a sterile heparinised saline flush solution in one strength of 100 international units per ml. Each 2ml ampoule contains 200 international units of heparin sodium.

The active substance is heparin sodium.

The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

What Heparin Sodium 100 I.U./ml Flushing Solution looks like and contents of the pack

Heparin Sodium 100 I.U./ml Flushing Solution is a colourless or straw-coloured liquid.

The registered pack size is 10 glass ampoules.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product Name Reference Number

Heparin Sodium 100 I.U./ml Flushing Solution 29831/0111

This is a service provided by the Royal National Institute of Blind People.

Marketing Authorisation holder and Manufacturer

Marketing Authorisation holder:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

This leaflet was last revised in 06/2018

106932/4

Wockhardt UK Ltd
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Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
WWW
www.wockhardt.co.uk
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
Medical Information e-mail
[email protected]