Summary of Product Characteristics
last updated on the eMC:
17/10/2011
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 17/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 07-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - wording changed with regards to use in children
Section 4.4 - additional systemic effects
Section 4.8 - additional undesirable effects
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Updated on 03/02/2011 and displayed until 17/10/2011
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 31-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Black Triangle has been removed.
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Updated on 04/08/2010 and displayed until 03/02/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 20-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Addition to Section 4.2:
Patients who find it difficult to synchronise aerosol actuation with inspiration of breath, may use the AeroChamber Plus™ spacer device. They should be advised by their doctor, pharmacist or a nurse in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. This may be obtained by the patients using AeroChamber Plus™ by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.
Addition to Section 4.4:
Single dose pharmacokinetic data (see section 5.2) have demonstrated that the use of Fostair with Aerochamber Plus™ spacer device in comparison to the use of standard actuator, does not increase the total systemic exposure to
formoterol and reduces the systemic exposure to beclometasone-17-monopropionate, while there is an increase for unchanged beclometasone dipropionate that reaches systemic circulation from the lung; however, since the total systemic exposure of beclometasone dipropionate plus its active metabolite does not change, there is no increased risk of systemic effects when using Fostair with the named spacer device.
Addition to Section 5.2:
The use of Aerochamber Plus™ spacer increased the lung delivery of beclometasone dipropionate active metabolite
beclometasone 17-monopropionate and formoterol of 41% and 45% respectively, in comparison to the use of standard actuator in a study conducted in healthy volunteers. The total systemic exposure was unchanged for formoterol, reduced by 10% for beclometasone 17-monopropionate and increased for unchanged beclometasone dipropionate.
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Updated on 26/01/2009 and displayed until 04/08/2010
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Reasons for adding or updating:
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Company name change or merger
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| Date of revision of text on the SPC: 23-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 7: 'Trinity-Chiesi Pharmaceuticals Ltd' has now changed name to 'Chiesi Limited'
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Updated on 18/09/2008 and displayed until 26/01/2009
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.3: Shelf life extended from 18 to 20 months.
Section 6.4: Maximum shelf-life after dispensing extended from 3 months to 5 months.
Section 6.5: Added '2 pressurised containers which provide 120 actuations each'
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Updated on 22/07/2008 and displayed until 18/09/2008
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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