1. Name Of The Medicinal Product
Heparin sodium 10 IU/ml I.V. flush solution
2. Qualitative And Quantitative Composition
Heparin Sodium Ph. Eur. 10 IU/ml
3. Pharmaceutical Form
Solution for Injection.
4. Clinical Particulars
4.1 Therapeutic Indications
To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.
4.2 Posology And Method Of Administration
For injection into the catheter/cannula.
For routine use, 1
4.3 Contraindications
Known hypersensitivity to constituents.
Current or history of heparin-induced thrombocytopenia.
4.4 Special Warnings And Precautions For Use
As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.
Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
Heparin Sodium 10 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
For incompatibilities with other medicinal products see Section 6.2.
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 the results of the 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 dose of heparin used would not be expected to constitute a hazard.
Heparin does not cross the placental barrier and is not excreted in breast milk.
4.7 Effects On Ability To Drive And Use Machines
Heparin has no or negligible influence on the ability to drive or use machines.
4.8 Undesirable Effects
When used as recommended, the low dose of heparin reaching the blood is unlikely to have any systemic effects. However, heparin may cause thrombocytopenia and hypersensitivity reactions.
Local irritation may occur if inadvertently injected subcutaneously.
4.9 Overdose
An overdose is unlikely to occur. Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.
It is important to avoid overdosage of protamine sulphate because protamine sulphate itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine sulphate may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Water for Injections
6.2 Incompatibilities
This product is compatible with normal saline. Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and antihistamines.
6.3 Shelf Life
2 years.
6.4 Special Precautions For Storage
Do not store above 25ºC.
6.5 Nature And Contents Of Container
10 x 5 ml ampoules
Ph Eur Type 1 glass ampoules.
6.6 Special Precautions For Disposal And Other Handling
Any portion of the contents not used at once should be discarded.
7. Marketing Authorisation Holder
LEO Laboratories Limited
Longwick Road
Princes Risborough
Bucks HP27 9RR
8. Marketing Authorisation Number(S)
PL 0043/0092
9. Date Of First Authorisation/Renewal Of The Authorisation
8 March 1984/21 May 1995.
10. Date Of Revision Of The Text
November 2007
LEGAL CATEGORY
POM
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