SUMMARY OF PRODUCT CHARACTERISTICS

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

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.

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    Fertility, 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.

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 yellow card scheme at www.mhra.gov.uk/yellowcard

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 sulphate should never exceed 50 mg. Intravenous injection sulphate may cause a sudden fall in blood pressure, bradycardia, transitory flushing, but these may be avoided or diminished 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 SPC.

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 25°C.

6.5    Nature and contents of container

10 x 5 ml ampoules

10 x 10 ml ampoules

Ph Eur Type I glass ampoules

6.6    Special precautions for disposal

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

7 MARKETING AUTHORISATION HOLDER

Funnin (UK) Limited 42-46 Booth Drive

Park Farm South Wellingborough NN8 6GT UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 20417/0107

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

08/03/1984 / 09/03/2009

10 DATE OF REVISION OF THE TEXT

28/02/2016