Avelox 400 mg/250 ml solution for infusion
Last Updated on eMC 18-May-2017 View document | Bayer plc Contact details
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 18-May-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
- 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: 05-May-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
- Updated following the request of the PSUSA assessment report to update sections 4.4 and 4.8 of the SmPC to add the adverse reaction vasculitis with a frequency very rare and to modify the warnings on hypersensitivity reactions and peripheral neuropathy.
Updated on 26-Aug-2015 and displayed until 18-May-2017
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
- 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: 11-Jun-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
Updated on 06-Jul-2015 and displayed until 26-Aug-2015
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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: 01-Sep-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
· Following approval of the Renewal, Sections 2, 3, 4.8, 5.1, 6.1 and 10 have been updated.
Updated on 28-Nov-2012 and displayed until 06-Jul-2015
Reasons for adding or updating:
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 18-May-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are :Amendment to Section 10
Updated on 12-Oct-2012 and displayed until 28-Nov-2012
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 4.3 - Contraindications
- 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 4.8 - Undesirable Effects
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01-Mar-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
- Section 4.2: a paragraph on sequential therapy has been added to the tablets SmPC; IV editorial changes only.
- Section 4.5: examples of medication that can reduce potassium levels have been added and other editorial changes made.
- Section 4.6: a paragraph on fertility has been added and editorial changes made.
- Section 4.8: self-endangering has been changed to self-injurious; peripheral neuropathy and polyneuropathy have been added; anorexia has been replaced by decreased appetite and food intake. Other editorial changes have been made.
- Section 5.1: disk diffusion break points have been added and microbial susceptibility has been updated.
- Section 6.5: clarification of pack contents.
- Sections 2, 3, 4.3, 4.4, 5.2: editorial changes in line with new templates.
- Section 1: removal of black triangle.
Updated on 04-Jan-2012 and displayed until 12-Oct-2012
Reasons for adding or updating:
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- Change to section 7 - Marketing Authorisation Holder
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:
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'.
Updated on 05-Aug-2011 and displayed until 04-Jan-2012
Reasons for adding or updating:
- Change to section 6. 4 - Special Precautions for Storage
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 date of revision of the text
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:
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.
Updated on 26-Oct-2010 and displayed until 05-Aug-2011
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- 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): YES
Free-text change information supplied by the pharmaceutical company:
The key changes are: - 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 - 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 4.4
- 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))
Additions to section 4.9
- ECG monitoring should be undertaken in the case of an overdose
Updated on 09-Mar-2010 and displayed until 26-Oct-2010
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): YES
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
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