Heparin sodium 10 IU/ml IV flush solution

Heparin sodium 10 IU/ml I.V. flush solution

Heparin Sodium Ph. Eur. 10 IU/ml

Solution for Injection.

To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.

Method of administration

For injection into the catheter/cannula.

For routine use, 1-5 ml (10-50 IU heparin) should be administered into the catheter/cannula every 4 to 8 hours or as required.

Known hypersensitivity to constituents.

Current or history of heparin-induced thrombocytopenia.

Heparin Sodium 10 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Rigorous aseptic technique should be observed at all times in its 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 or paradoxical thrombosis, heparin should immediately be eliminated from all flushes and ports.

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.

Repeated flushing of a catheter device with heparin may result in a systemic anticoagulant effect.

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.

The safety of Heparin Sodium 10 I.U/ml Flushing Solution in pregnancy is not established, but 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.

Heparin has no or negligible influence on the ability to drive or use machines.

When used as recommended, the low dose of heparin reaching the blood is extremely unlikely to have any systemic effects. 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.

Local irritation may occur if inadvertently injected subcutaneously.

Reporting of suspected adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

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.

Not applicable

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.

Sodium chloride

Water for Injections

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.

2 years.

Do not store above 25°C.

10 x 5 ml ampoules

10 x 10 ml ampoules

Ph Eur Type 1 glass ampoules.

Any portion of the contents not used at once should be discarded.

Fannin (UK) Ltd.

DCC Vital

Westminster Industrial Estate,

Repton Road, Measham

Swadlincote

Derbyshire

England

DE127DT

PL 20417/0107

8 March 1984/21 May 1995.

11 June 2019