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sanofi-aventis

sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 02/09/2010
SPC Pentacarinat Ready-to-Use 300mg/5ml nebuliser solution

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

Updated on 02/09/2010 and displayed until Current
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4:

Section 4.4 is updated to include the following: 'Baseline blood pressure should be established and patients should receive the drug lying down. Blood pressure should be closely monitored during administration and at regular intervals until treatment is concluded'.

'The benefit of aerosolised pentamidine therapy in patients at high risk of pneumothorax should be weighed against the clinical consequences of such a manifestation'

Editorial updates also

 

Section 4.5: Section 4.5 is updated to include the following:

'Foscarnet: risk of hypocalcaemia'.

 

Section 4.6:

Editorial updates to Section 4.6.

 

Section 4.7:

The following sentence has been added to Section 4.7: 'Considering the risk of dizziness, one should be careful.'

 

Section 4.8:

Side effects section updated to improve readability.

 

Section 10:

Date of revision is now August 2010

 

Updated on 16/07/2007 and displayed until 02/09/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update section
7 MAH details
10 date of revision
Updated on 29/09/2006 and displayed until 16/07/2007
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Updates to
Section 4.4: To include a statement on necessary caution required if the QTc exceeds 500 ms on receipt of pentamidine isethionate therapy.
Section 4.5: To list the classes of medicinal product known to prolong the QT interval with which caution is advised when concomitantly used with pentamidine isethionate i.e. phenothiazines, tricyclic antidepressants, terfenadien and astemizole, IV erythromycin, halofantrine, and quinolene antibiotics.
Section 10: Date of revision.
 

 

Updated on 04/09/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2004
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update sections 4.8, 6.1, 10 - administrative
Updated on 03/12/2003 and displayed until 04/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 30/06/2003 and displayed until 03/12/2003
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/06/2003 and displayed until 30/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Pentamidine Isethionate

Versions

 
02/09/2010 to Current
16/07/2007 to 02/09/2010
29/09/2006 to 16/07/2007
04/09/2006 to 29/09/2006
03/12/2003 to 04/09/2006
30/06/2003 to 03/12/2003
10/06/2003 to 30/06/2003
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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