Hepsal Injection 10 Iu/Ml Flushing Solution For Maintenance Of Patency Of Intravenous Devices
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES
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 Heparin Sodium 10 I.U./ml Flushing Solution for maintenance of patency of intravenous devices. In the rest of this leaflet it is called Heparin Sodium 10 I.U./ml Flushing Solution.
In this leaflet:
1. What Heparin Sodium 10 I.U./ml Flushing Solution is and what it is used for
2. Before you use Heparin Sodium 10 I.U./ml Flushing Solution
3. How to use Heparin Sodium 10 I.U./ml Flushing Solution
4. Possible side effects
5. How to store Heparin Sodium 10 I.U./ml Flushing Solution
6. Further information
1. WHAT HEPARIN SODIUM 10 I.U./ ML FLUSHING SOLUTION IS AND WHAT IT IS USED FOR
Heparin Sodium 10 I.U./ml Flushing Solution 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. Heparin Sodium 10 I.U./ml Flushing Solution 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 HEPARIN SODIUM 10 I.U./ ML FLUSHING SOLUTION
Do not use Heparin Sodium 10 I.U./ Flushing Solution if:
• you have been told you are allergic to heparin.
Pregnancy and breast-feeding
Do not use Heparin Sodium 10 I.U./ml Flushing Solution if you are pregnant or trying to become pregnant without talking to your doctor first.
Do not use Heparin Sodium 10 I.U./ml Flushing Solution if you are breast-feeding without talking to your doctor.
If you have any doubts about whether Heparin Sodium 10 I.U./ml Flushing Solution should be used for you then discuss things more fully with your doctor or nurse.
3. HOW TO USE HEPARIN SODIUM 10 I.U./ ML FLUSHING SOLUTION
• Heparin Sodium 10 I.U./ ml Flushing Solution should not be injected directly into the body.
• Heparin Sodium 10 I.U./ml Flushing Solution 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 Heparin Sodium 10 I.U./ml Flushing Solution for longer than five days.
4. POSSIBLE SIDE EFFECTS
Like many medicines Heparin Sodium 10 I.U./ml Flushing Solution 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.
1. NAME OF THE MEDICINAL PRODUCT
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 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 Sodium 10 I.U./ml Flushing Solution 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 hyper-sensitivity 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 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 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 national reporting system: United Kingdom Yellow Card Scheme www.mhra.gov.uk/yellowcard
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.
United Kingdom
Yellow Card Scheme
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:medsafety@hpra.ie
Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION
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 25°C.
• 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 Heparin Sodium 10 I.U./ml Flushing Solution contains
Heparin Sodium 10 I.U./ml Flushing Solution 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 Heparin Sodium 10 I.U./ml Flushing Solution is heparin sodium.
Other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
What Heparin Sodium 10 I.U./ml Flushing Solution looks like and the contents of the pack
Heparin Sodium 10 I.U./ml Flushing Solution 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 |
|
Heparin Sodium 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.
This leaflet was last revised in 09/2015
Ireland
HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
4.9 Overdose symptoms
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.
PwOCKHARDT
--------------------------
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 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 Ltd Ash Road North Wrexham LL13 9UF UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0112 PA 1339/10/1 MA 154/01601
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
September 2015
106935/2
Twockhardt