When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Please note where new text has been inserted into a sentence the text has been highlighted in red:
1. NAME OF THE MEDICINAL PRODUCT
Nimotop 0.02% w/v Concentrate for Solution for Infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Addition of:
“Each 50ml vial also contains 10g of ethanol (0.2g/ml) and 2.3mg of sodium (as sodium citrate dihydrate).”
For a full list of excipients, see 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (Sterile concentrate).
A clear, yellow solution.
4.2 Posology and method of administration
Therapeutic administration
Subsection: Route of administration
“Nimotop solution must not be added to an infusion bag or bottle and msut not be moixed with other drugs.” has been changed to:
“Nimotop must not be mixed with other drugs so it should not be added to an infusion bag or bottle which contains other drugs.”
4.4 Special warnings and precautions for use
At the end of this section addition of “Nimotop should not be used in concentrated form.”
6.2 Incompatibilities
Addition of “Nimotop must not be mixed with other drugs so it should not be added to an infusion bag or bottle which contains other drugs.”
6.4 Special precautions for storage
Do not store above 25°C. Keep the vial in the outer carton to protect from light.
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15 February 1994
Date of last renewal: 15 Feburary 2009
10. DATE OF REVISION OF THE TEXT
Changed to “June 2010”
Sections 4.2, 5.1, 5.2, 5.3 and 6.6 where updated following internal review.