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Leo Laboratories Limited
Longwick Road, Princes Risborough, Bucks., HP27 9RR
Telephone: +44 (0)1844 347 333
Fax: +44 (0)1844 276 385
Medical Information e-mail: medical-info.uk@leo-pharma.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 31/01/2008
SPC Heparin sodium 100 IU/ml I.V. flush solution (Leo Laboratories Ltd)

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 31/01/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Contraindications (Section 4.3): Addtion of hypersensitivity to constituents, heparin-induced thrombocytopenia, premature babies and neonates.

Warnings & precautions (Section 4.4): Addition of platelet count monitoring, thrombocytopenia and hypersensitivity to LMWH. Addition of warnings concerning benzyl alcohol and parahydroxybenzoates.

Interactions (Section 4.5): Advice concerning taking of blood samples for laboratory analysis.

Pregnancy & lactation (Section 4.6): Addition of statement to avoid use in pregnancy due to benzyl alcohol content and 'Heparin does not cross the placental barrier and is not excreted in breast milk.'

Driving and using machines (Section 4.7): Addition of 'Heparin has no or negligible influence on the ability to drive or use machines.'

Undesirable effects (Section 4.8): Addition of thrombocytopenia, hypersensitivity reactions and local irritation.

Overdose (Section 4.9): Addition of information on signs of overdose and action required.

 
Updated on 29/01/2002 and displayed until 31/01/2008
Reasons for adding or updating:
  • Change from datasheet to SPC

Active Ingredients/Generics

 
  heparin sodium