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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.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: 04/04/2012
SPC Integrilin 2mg solution for injection, 0.75mg solution for infusion

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 04/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - correction of typo
Section 4.8 - deletion of 'anemia' under 'very rare'
Section 5.1 - Pharmacodynamic effects - addition of “creatinine clearance” and deletion of “GFR”
Section 6.6 - addition of “medicinal product” and deletion of “material”
Section 10 - updated with new date of revision of text
Updated on 01/02/2012 and displayed until 04/04/2012
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 - Renal Impairment- Recommendation is based on pharmacodynamic and pharmacokinetic data. The available clinical evidence cannot however confirm that this dose modification results in a preserved benefit

Section 5.1 -

-Pharmacodynamic properties- Data with regards to platelet inhibition in patients with renal impairment

-Pharmacodynamic properties- Clarification on “PURSUIT” trial

-Pharmacodynamic properties – Clarification on post hoc analysis of the “EARLY ACS” trial


Section 10 - Updated with new date of revision of text
Updated on 11/08/2011 and displayed until 01/02/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Update to SmPC section 4.4 Special warnings and precautions for use
Section 10 - Update to date of revision
Updated on 13/05/2011 and displayed until 11/08/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 4.4 and 5.1 of the SPC following results from the EARLY-ACS study
Update to section 10 with date of revision
Updated on 04/03/2010 and displayed until 13/05/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 -  Section 4.1 - As per tracked changes on SmPC

Section 4.2 - Added:

"Concurrent administration of heparin is recommended unless this is contraindicated for reasons such as a history of thrombocytopaenia associated with use of heparin (see ‘Heparin administration’, section 4.4). INTEGRILIN is also intended for concurrent use with acetylsalicylic acid, as it is part of standard management of patients with acute coronary syndromes, unless its use is contraindicated."

 

Hepatic impairment:

 

It is contraindicated in patients with clinically significant hepatic impairment.

 

 

Renal impairment: Use in patients with more severe renal impairment is contraindicated

Section 4.3 - As per tracked changes on SmPC

Section 4.4 - "…Women, the elderly, patients with low body weight or with moderate renal impairment (creatinine clearance > 30 - < 50 ml/min)

Section 4.5 - Added "The combination of reduced dose tenecteplase and eptifibatide compared to placebo and eptifibatide significantly increased the risk of both major and minor bleeding when administered concomitantly in an acute ST-elevation myocardial infarction study."

Section 4.6 - Section 4.7 - As per tracked changes on SmPC

Section 4.8 - Re-write of this section

Section 4.9 - Section 10 - As per tracked changes on SmPC

 
Updated on 16/03/2007 and displayed until 04/03/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 07/11/2006 and displayed until 16/03/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 04/01/2006 and displayed until 07/11/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/03/2005 and displayed until 04/01/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  eptifibatide