Hepsal Injection 10 Iu/Ml Flushing Solution For Maintenance Of Patency Of Intravenous Devices
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.
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
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
07/12/2015