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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: 02/02/2012
SPC Heparin (Mucous ) Injection BP

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 02/02/2012 and displayed until Current
Reasons for adding or updating:
  • Removal of one or more presentations from joint SPC following discontinuation
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Deletion of reference to Heparin (Mucous) Injection 25,000 Units/ml (PL 00043/0039R), as this product is now discontinued.
Updated on 02/06/2011 and displayed until 02/02/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   14-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.1 Therapeutic indications
Addition of:
'For the prevention of clotting in the extracorporeal circuit during haemodialysis.'

4.2 Posology and method of administration
Addition of:
'For the treatment or prevention of thrombo-embolic disorders.'
'Prevention of clotting during haemodialysis:
An initial bolus dose should be given, followed by a continuous intravenous infusion.
Adults:
Initially: 1,000 - 5,000 IU.
Maintenance:  1,000 - 2,000 IU per hour, adjusted to maintain clotting time > 40 minutes.'
Updated on 21/12/2007 and displayed until 02/06/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - 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:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 (posology) statement added in pregnancy section concerning benzyl alcohol.
Section 4.3 (Contraindications) updated to add uncontrolled severe hypertension, acute or subacute septic endocarditis, injuries and operations on the ears, abortus imminens, epidural anaesthesia, premature babies and neonates.

Section 4.4 (Warnings & Precautions) updated to add patients with increased risk of bleeding complications, hypertension, drugs affecting platelet function, intramuscular injection, lumbar puncture and thrombocytopenia. Warnings added concerning benzyl alcohol and parahydroxybenzoates.

Section 4.5 (Interactions) updated list of drugs affecting platelet function or coagulation system.

Section 4.6 (Pregnancy & Lactation) updated - heparin should be used with caution in pregnant women and only if benefits outweigh risks. Precaution required due to uteroplacental haemorrhage, especially at time of delivery. Contraindicated in women with abortus imminens. Information added on benzyl alcohol and use of this formulation in pregnancy.

Section 4.8 (undesirable effects)- section completely re-written and frequencies added.

Section 4.9 (overdose) - first paragraph re-written to reflect minor or severe haemorrhage.
Updated on 21/11/2002 and displayed until 21/12/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/02/2002 and displayed until 21/11/2002
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Active Ingredients/Generics

 
  heparin sodium