SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Hepsal 10 I.U./ml flushing solution for maintenance of patency of intravenous devices or Heparin Sodium 10 I.U./ml flushing solution for maintenance of patency of intravenous devices.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Heparin sodium 10 I.U./ml (50 I.U. in 5ml)

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).

Heparin Sodium 10 I.U./ml Flushing Solution is indicated in any clinical circumstances in which it is desired to maintain the patency of indwelling catheters/cannulae, attendant lines or heparin locks.

4.2 Posology and method of administration

Heparin Sodium 10 I.U./ml Flushing Solution is not recommended for systemic use.

For cleaning indwelling cannulae.

Material to be used as a cannula flush (5ml; 50 units) every four hours or as required.

4.3 Contraindications

The very rare occurrence of established hypersensitivity to heparin is the only contraindication to Heparin Sodium 10 I.U./ml Flushing Solution.

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 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 Pregnancy and lactation

The safety of Heparin Sodium 10 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 (see also Section 4.4, Special Warnings and Precautions for Use).

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

None stated.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Heparin Sodium 10 I.U./ml Flushing Solution, containing only 50 I.U, of sodium heparin per ampoule (5ml), 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

The following drugs are incompatible with heparin;

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

Heparin and reteplase are incompatible when combined in solution.

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

5ml clear glass ampoules. Carton contains 10 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 29831/0112

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/02/2007

10 DATE OF REVISION OF THE TEXT

11/09/2007