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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.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: 10/08/2011
SPC Combivent UDVs

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 10/08/2011 and displayed until Current
Reasons for adding or updating:
  • 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:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 and 10 has been updated.
Updated on 17/06/2011 and displayed until 10/08/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 was updated as a consequence of the section 4.8 changes requested by MHRA (inclusion of paragraph relating to paradoxical bronchospasm).
Updated on 03/06/2011 and displayed until 17/06/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 now contains information on administration which was previously given in section 6.6.

Section 6.6 has been aligned with EU SPC guidance.
Updated on 23/05/2011 and displayed until 03/06/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 – Pharmacodynamic Properties of the SPC has been updated.

Section 10 has been revised to April 2011

Updated on 29/03/2011 and displayed until 23/05/2011
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update of information to section 4.7

Update to date of revision of the text section 10
Updated on 02/12/2010 and displayed until 29/03/2011
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:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4

The changes relate to the addition of further information on cardiovascular effects and statement re the possibility of positive results with salbutamol in tests for non clinical substance abuse.

 

Section 10

Date of revision updated to September 2010
Updated on 11/02/2010 and displayed until 02/12/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • 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:   01-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.5 - the details have been revised to remove any reference to secondary packaging

 

Section 6.6 - the detailed instructions relating to information on the use with a nebuliser have been replaced with a reference to refer to the Patient information leaflet.

 

Section 10 - Date of revision updated to September 2009
Updated on 11/03/2009 and displayed until 11/02/2010
Reasons for adding or updating:
  • 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:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 has been updated in line with the current CCDS. The changes include:

- addition of frequencies based on clinical trials and ordering of information under SOC

- rewording to reflect MedDRA terminology

- 2 new side effects based on last PSUR (Atrial fibrillation and Myocardial ischaemia)

- inclusion of side effects previously only addressed in special precautions and warnings section

 

Section 10 – Date has been revised
Updated on 13/01/2009 and displayed until 11/03/2009
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:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special warnings and precautions for use has been updated in line with the current CCDS documents for this product as detailed below:

 
removal of the heading Occular complications from the 2nd paragraph

addition of bladder-neck obstruction to paragraph 5 and minor changes to the ordering of the information to facilitate the inclusion of this

addition of a information on rare occurrences of myocardial ischaemia associated with salbutamol (paragraph 6)
Updated on 21/03/2007 and displayed until 13/01/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3 addition of A clear, colourless or almost colourless solution.
Section 4.8 addition of pruritis side effect.
Updated on 13/12/2004 and displayed until 21/03/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 23/01/2004 and displayed until 13/12/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 16/08/2001 and displayed until 23/01/2004
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

 
  salbutamol sulphate
  ipratropium bromide monohydrate