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HEPSAL INJECTION 10 IU/ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES
Active substance(s): HEPARIN
HEPSAL 10 I.U./ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF
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 Hepsal 10 I.U./ml flushing solution for maintenance of patency
of intravenous devices. In the rest of this leaflet it is called Hepsal.
In this leaflet:
1. What Hepsal is and what it is used for
2. Before you use Hepsal
3. How to use Hepsal
4. Possible side effects
5. How to store Hepsal
6. Further information
1. WHAT HEPSAL IS AND WHAT IT IS USED FOR
Hepsal 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. Hepsal is used to
wash and rinse the inside of catheters, cannulas and other surgical forms of tubing to ensure
they do not become blocked while they are in use.
2. BEFORE YOU USE HEPSAL
Do not use Hepsal if:
• you have been told you are allergic to heparin.
Pregnancy and breast-feeding
Do not use Hepsal if you are pregnant or trying to become pregnant without talking to your
Do not use Hepsal if you are breast-feeding without talking to your doctor.
If you have any doubts about whether Hepsal should be used for you then discuss things
more fully with your doctor or nurse.
3. HOW TO USE HEPSAL
• Hepsal should not be injected directly into the body.
• Hepsal is used for cleaning catheters, cannulas and other surgical forms of tubing by
flushing with 5ml (50 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the heparin in the tubing should first be withdrawn and discarded.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 Hepsal for longer than five days.
4. POSSIBLE SIDE EFFECTS
Like many medicines Hepsal 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.
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
national reporting systems listed below.
Yellow Card Scheme
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
By reporting side effects you can help provide more information on the safety of this
5. HOW TO STORE HEPSAL
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
• This medicine should not be stored 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.
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 Hepsal contains
Hepsal 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 10 international units per ml.
Each 5ml ampoule contains 50 international units of heparin sodium.
The active ingredient in Hepsal is heparin sodium. Other ingredients are sodium chloride,
water for injections, hydrochloric acid and sodium hydroxide.
What Hepsal looks like and the contents of the pack
Hepsal is a colourless or straw-coloured liquid. The registered pack size is 10 glass
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Hepsal 10 I.U./ml Flushing Solution
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Marketing Authorisation holder and Manufacturer
Marketing Authorisation holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF,
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was last revised in 09/2015
1. NAME OF THE MEDICINAL PRODUCT
Hepsal 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 a full list of excipients, see section 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
4. CLINICAL INDICATIONS
4.1 Therapeutic indications
Heparin is an anticoagulant and acts by potentiating the naturally occurring inhibitors of
thrombin and factor X (Xa).
Hepsal 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
Hepsal 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.
The very rare occurrence of established hypersensitivity to heparin is the only
contraindication to Hepsal.
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
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 Use during pregnancy and lactation
The safety of Hepsal 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
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
national reporting system:
Yellow Card Scheme
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
4.9 Overdose symptoms
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hepsal, 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
5.2 Pharmacokinetic properties
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
Water for injections
Hydrochloric acid 3M
Sodium hydroxide 3M
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 – 3 years
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
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
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd
Ash Road North
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:
11 September 2007(UK)
16 November 2007 (Republic of Ireland)
10 DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.