HEPARIN SODIUM 100 I.U./ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES., CANUSAL 100 I.U./ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Canusal 100 I.U./ml flushing solution for maintenance of patency of intravenous devices or Heparin Sodium 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 the full list of excipients, see section 6.1

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.

4.1 Therapeutic indications

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

Heparin Sodium 100 I.U./ml Flushing Solution 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

Hypersensitivity to the active substance or to any of the other excipients listed in section 6.1.

Concomitant use of intravenous diclofenac with heparin (including low dose heparin) is contraindicated.

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.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days or earlier in patients with previous exposure to heparin. In patients who develop thrombocytopenia or paradoxical thrombosis, heparin treatment should be stopped immediately and heparin eliminated from all flushes and ports.

Heparin induced thrombocytopenia (HIT) and heparin induced thrombocytopenia with thrombosis (HITT) can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT or HITT.

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 interaction 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 Fertility, pregnancy and lactation

The safety of Heparin Sodium 100 I.U./ml Flushing Solution 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. Pulmonary embolism has been reported as thromboembolic complications of heparin-induced thrombocytopenia. Heparin should be discontinued immediately in patients who develop thrombocytopenia.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Heparin Sodium 100 I.U./ml Flushing Solution, 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.

6.1 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 sulfate, gentamicin sulfate, netilmicin sulfate, pethidine hydrochloride, promethazine hydrochloride and tobramycin sulfate.

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

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 Limited

Ash Road North

Wrexham Industrial Estate

Wrexham

LL13 9UF

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 29831/0111

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/06/1991 / 16/02/2007