Summary of Product Characteristics
last updated on the eMC:
04/01/2012
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 04/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.9 - Overdose
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 11-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| The key changes are:-
- Section 4.4 (Special warnings and precautions for use) of the SmPC with a warning in regard of the clinical efficacy of moxifloxacin in special types of complicated skin and skin structure infections (cSSSI).
- Sections 4.5 (Interactions with other medicinal products and other forms of interaction) and 4.9 (Overdose) of the SmPC have been adapted to the final agreed wording for QT-Interval-Prolongation as agreed by the Pharmacovigilance Working Party (PhVWP) and CMD(h).
- Section 4.3 (Contradictions), Section 4.4 (Special warnings and precautions for use), Section 4.5 (Interactions with other medicinal products and other forms of interaction) of the SmPC have been adapted to the Core Safety Profile (CSP).
- Section 7 (Marketing Authorisation Holder) - removal of the Trading style 'Bayer plc, Bayer Schering Pharma'.
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Updated on 05/08/2011 and displayed until 04/01/2012
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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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: 17-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The key changes to the SmPC are:
Section 6.4 (Special precautions) and 6.6 (Disposal) labelling of the drug product are revised to show the change in the storage condition to Do not store below 15 degrees C.
Section 6.5 (Nature and contents of container) the wording 'or bromobutyl' was added to the description of the rubber stopper.
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Updated on 26/10/2010 and displayed until 05/08/2011
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Reasons for adding or updating:
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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 4.9 - Overdose
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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: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The key changes are:
Additions to section 4.4
- in case of seizures, discontinuation of moxifloxacin and appropriate measures taken
- to use moxifloxacin with caution in patients with a history of psychiatric disease and a recommendation to discontinue treatment if a patient develops psychiatric reactions whilst receiving moxifloxacin
- that tendon inflammation and rupture can occur up to several months after discontinuing quinolone therapy
- moxifloxacin may interfere with some biological tests causing false negative results
- cases of sensory or sensorimotor polyneuropathy have been reported. As such a warning has been added that patients experiencing symptoms of neuropathy should be advised to contact their doctor before continuing treatment
Additions to section 4.8
- muscle weakness added as a rare side effect
- rare/very rare moxifloxacin side effects - "agranulocytosis", examples of self-endangering behaviour ("suicidal thoughts/attempts") added to Psychiatric Disorder side effects and "hearing impairment including deafness". "Transient loss of vision" has also been added (moved from the more general "fluoroquinolone" section (see comment below))
- very rare fluoroquinolone side effects - addition of "peripheral neuropathy" (in line with section 4.4 change) and "haemolytic anaemia"; removal of "haemolysis" and "transient loss of vision"
Additions to section 4.9
- ECG monitoring should be undertaken in the case of an overdose
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Updated on 09/03/2010 and displayed until 26/10/2010
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Reasons for adding or updating:
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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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