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Canusal 100 I.U./Ml Flushing Solution For Maintenance Of Patency Of Intravenous Devices

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your doctor or nurse.

-    This medicine has been prescribed for you. It should not be shared with other patients.

The name of your medicine is Canusal 100 I.U./ml flushing solution for maintenance of patency of intravenous devices. In the rest of this leaflet it is called Canusal.

In this leaflet:

1.    What Canusal is and what it is used for

2.    Before you use Canusal

3.    How to use Canusal

4.    Possible side effects

5.    How to store Canusal

6.    Further information

1. WHAT CANUSAL IS AND WHAT IT IS USED FOR

Canusal 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. Canusal 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. BEFORE YOU USE CANUSAL

Do not use Canusal if:

• you have been told you are allergic to heparin.

Pregnancy and breast-feeding

Do not use Canusal if you are pregnant or trying to become pregnant without talking to your doctor first

Do not use Canusal if you are breast-feeding without talking to your doctor.

If you have any doubts about whether Canusal should be used for you then discuss things more fully with your doctor or nurse.

3. HOW TO USE CANUSAL

•    Canusal should not be injected directly into the body.

•    Canusal 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are to be taken from the tubing which has been rinsed with this product, the heparin in the tubing should first be withdrawn and discarded.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 Canusal for longer than five days.

4. POSSIBLE SIDE EFFECTS

Like many medicines Canusal may cause side effects in some patients, although not everybody gets them, particularly when treatment is first started.

•    It can cause bleeding and occasionally a serious blood disorder (thrombocytopenia) which can cause thrombosis (clotting in the blood vessels).

•    Rarely, allergic reactions can occur.

You should inform your doctor or nurse immediately if you feel unwell.

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1    NAME OF THE MEDICINAL PRODUCT

Canusal 100 I.U./ml flushing solution for maintenance of patency of intravenous devices

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Heparin sodium 100 I.U./ml (200 I.U. in 2ml)

For excipients see 6.1

3    PHARMACEUTICAL FORM

Flushing solution for maintenance of patency of intravenous devices

A colourless or straw coloured liquid, free from turbidity and from matter that deposits on standing.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Heparin is an anticoagulant and acts by potentiating the naturally occurring inhibitors of thrombin and factor X (Xa).

Canusal is indicated in any clinical circumstances in which it is desired to flush an intravenous catheter or cannula with a low concentration of heparin to ensure patency prior to administration of an intravenous injection.

4.2    Posology and method of administration

Not recommended for systemic use.

For cleaning indwelling cannulae.

Material to be used as an intravascular cannula or catheter flush in doses of 200 units every 4 hours or as required.

4.3    Contraindications

Do not use when there is established hypersensitivity to heparin.

4.4    Special warnings and precautions for use

Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins.

Rigorous aseptic technique should be observed at all times in its use.

Platelet counts should be measured in patients receiving heparin flushes for longer than five days (or earlier in patients with previous exposure to heparin). In those who develop thrombocytopenia or paradoxical thrombosis, heparin should immediately be eliminated from all flushes and ports.

Repeated flushing of a catheter device with heparin may result in a systemic anticoagulant effect.

4.5    Interaction with other medicinal products and other forms of interactions

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter results of the desired blood tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood sample is taken.

4.6    Pregnancy and lactation

The safety of Canusal in pregnancy is not established, but the dose of heparin involved would not be expected to constitute a hazard.

Heparin does not appear in breast milk.

4.7    Effects on ability to drive and use machines

None stated.

4.8    Undesirable effects

Used as directed, it is extremely unlikely that the low levels of heparin reaching the blood will have any systemic effect. However, there have been rare reports of immune-mediated thrombocytopenia and thrombosis in patients receiving heparin flushes (see also Section 4.4, Special Warnings and Precautions for Use).

5. HOW TO STORE CANUSAL

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

•    The medicine should not be used if the expiry date on the ampoule has passed. The expiry date refers to the last day of the month.

•    Do not use if the contents of the ampoule show signs of deterioration such as discolouration.

•    This medicine should not be stored above 25°C.

•    Store in the original package in order to protect from light.

•    Any portion of the contents not used at once should be discarded.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Canusal contains

Canusal 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 ingredient in Canusal is heparin sodium. Other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

What Canusal looks like and the contents of the pack

Canusal is a colourless or straw-coloured liquid. The registered pack size is 10 glass ampoules.

X-PIL Information

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

Canusal 100I.U./ml Flushing Solution

29831/0111

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

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.

Leaflet prepared: July 2007.

WOCKHAKDT'

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Hypersensitivity reactions to heparin are rare. They include urticaria, conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of oppression, fever, chills, angioneurotic oedema and anaphylactic shock.

4.9 Overdose

Not applicable

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Canusal, containing only 200 I.U. of sodium heparin per ampoule (2ml), is used for flushing indwelling cannulae. This is unlikely to produce blood levels of heparin having any systemic effect.

5.2    Pharmacokinetic properties

None stated

5.3    Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium chloride Water for injections Hydrochloric acid 3M Sodium hydroxide 3M

6.2    Incompatibilities

Heparin and reteplase are incompatible when combined in solution.

Amikacin sulphate, gentamicin sulphate, netilmicin sulphate, pethidine hydrochloride, promethazine hydrochloride and tobramycin sulphate.

If reteplase and heparin are to be given through the same line this, together with any Y-lines, must be thoroughly flushed with a 0.9% saline or a 5% glucose solution prior to and following the reteplase injection.

6.3    Shelf life

Unopened - 36 months

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately.

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

6.4    Special precautions for storage

Do not store above 25°C Store in the original package

6.5    Nature and contents of container

2ml clear glass ampoules

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK.

8    MARKETING AUTHORISATION NUMBER(S)

PL 29831/0111

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11 September 2007

10    DATE OF REVISION OF THE TEXT

WOCKHAKDT'