Summary of Product Characteristics
last updated on the eMC:
18/01/2012
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 18/01/2012 and displayed until Current
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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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| Date of revision of text on the SPC: 30-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update the storage conditions of the finished product from ‘Do not store above 30°C’ to ‘Do not store above 25°C’.
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Updated on 20/01/2009 and displayed until 18/01/2012
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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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: 28-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 - 'Ciloxan eye ointment will be indicated for adults and children as follows:
Adults and children 1 year and above' added
Section 4.2 - 'Adults and children 1 year and above' added
Section 4.3 - Amended to 'Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to quinolones'
Section 4.4 - Paragraph amended
Section 4.6 - Heading 'Lactation' added
Section 4.8 - New paragraph added after the heading 'Skin Effects'
Section 5.2 - 'There are no pharmacokinetic data available in respect of use in children' added
Section 5.3 - 'The degree of cartilage involvement was found to be dependent on age, specieis and dosage. With 30mg/kg ciprofloxacin in the effect on the joint was minimal.' added
Section 9 - '11/08/2008' added
Section 10 - '28/10/2008' added
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Updated on 03/11/2005 and displayed until 20/01/2009
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Reasons for adding or updating:
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