Summary of Product Characteristics
last updated on the eMC:
19/03/2012
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 19/03/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 01-Jun-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 6.3, shelf life has been changed from 40months to 48 months
|
|
Updated on 31/03/2011 and displayed until 19/03/2012
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 18-Mar-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.9
Over dosage may result in skin irritation has been changed to
Over dosage may result in skin irritation
Misuse:
Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.
Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma.
Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not
induce vomiting.
Section 10
Revision date has changed from April 2010 to 18/03/2011
|
|
Updated on 05/08/2010 and displayed until 31/03/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 15-Apr-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
6.5 Nature and contents of container - 25g removed
VapoRub ointment is packed into 40g, 50g, 90g and 100g opaque, blue, polypropylene jars, closed with a green polypropylene thread screw cap and containing a 2mm thick PET/LDPE/EPE/LDPE/PET cap liner.
|
|
Updated on 25/10/2007 and displayed until 05/08/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
