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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 15/03/2012
SPC Pentacarinat 300mg

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 15/03/2012 and displayed until Current
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 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   12-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Type IB No. C.I.z group variation to update the SPC in line with the QRD template and the Guideline on Summary of Product Characteristics (SmPC) – September 2009.
Updated on 01/03/2011 and displayed until 15/03/2012
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Type IB variation to update sections 4.5, 4.7 and 4.8 of the SPC to harmonise the UK national SPCs following PSUR, with consequential changes made to the PIL

Change to section 4.5: Following text added- foscarnet: risk of hypocalcaemia

Change to section 4.7; text changed to read-  Pentamidine has no known effect on the ability to drive and use machines. Considering the risk of dizziness, one should be careful.

Change to section 4.8: section has been re-formatted, frequencies for side effects have been provided and the side effects have been split into side effects associated with the parenteral route of administeration and inhalation route of administration.

Section 10- date changed to 03/12/2010
Updated on 19/09/2007 and displayed until 01/03/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Use of sanofi-aventis trading style
Updated on 28/09/2006 and displayed until 19/09/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/09/2006 and displayed until 28/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of product licence holder to Aventis Pharma
Updated on 28/09/2005 and displayed until 26/09/2006
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 28/02/2003 and displayed until 28/09/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 30/08/2001 and displayed until 28/02/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 28/08/2001 and displayed until 30/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  pentamidine isetionate