Heparin Sodium 100 Iu/Ml. I.V Flush Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Heparin sodium 100 lU/ml IV Flush Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium Ph.Eur. 100 lU/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 routine use, 2 ml containing 200 IU of heparin should be administered into the catheter/cannula every 4-8 hours or as required.
4.3 Contraindications
Known hypersensitivity to constituents
Current or history of heparin induced thrombocytopenia
Heparin Sodium 100 IU/ml i.v. flush solution contains 10 mg/ml of the preservative benzyl alcohol. These formulations must not be given to pregnant women, premature babies or neonates
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 100 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.
Heparin Sodium 100 IU/ml i.v. flush solution contains the preservative benzyl alcohol 10mg/ml. This product should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic and allergic reactions (anaphylactoid) in this age group.
Heparin Sodium 100 IU/ml i.v. flush solution contains esters of parahydroxybenzoates as a preservative system. These may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
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. However, as benzyl alcohol may cross the placenta, the use of Heparin Sodium 100 IU/ml i.v. flush solution containing benzyl alcohol should be avoided during pregnancy.
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 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.
5.1 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 pre-clinical 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
Benzyl alcohol
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Sodium citrate
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 substance, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and antihistamines.
Shelf life
6.3
3 years.
6.4 Special precautions for storage
Do not store above 250 C.
6.5 Nature and contents of container
10 x 2 ml ampoules.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Funnin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough NN8 6GT UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20417/0108
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23 October 1978/16 January 1995
10 DATE OF REVISION OF THE TEXT
28/02/2016