HEPSAL INJECTION 10 IU/ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES

Active substance: HEPARIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

HEPSAL 10 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 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 doctor first.
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the tubing should first be withdrawn and discarded.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.
You should inform your doctor or nurse immediately if you feel unwell.

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 standing.

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).

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.

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.

4.6 Use during pregnancy and lactation

4.2 Posology and method of administration

Heparin does not appear in breast milk.

Hepsal is not recommended for systemic use.

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

4.7 Effects on ability to drive and use machines

For cleaning indwelling cannulae.

None stated.

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

4.8 Undesirable effects

4.3 Contraindications
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.

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.

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 discolouration.
• 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 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

Hepsal 10 I.U./ml
Flushing Solution

29831/0112

This is a service provided by the Royal National Institute of Blind People.
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: May 2007.

None stated

contamination, the product should be used
immediately.

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

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

4.9 Overdose symptoms

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 effect.

5.2 Pharmacokinetic properties
None stated

5.3 Preclinical safety data

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.

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

6.6 Special precautions for disposal

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

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

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

6.2 Incompatibilities

Not applicable

7 MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

The following drugs are incompatible with heparin;

PL 29831/0112
PA 1339/10/1
MA 145/01601

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

9 DATE OF FIRST AUTHORISATION/RENEWAL
OF THE AUTHORISATION

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

Date of first authorisation:
11 September 2007(UK)
16 November 2007 (Republic of Ireland)

10 DATE OF REVISION OF THE TEXT

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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.

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