Summary of Product Characteristics
last updated on the eMC:
24/08/2010
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 24/08/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 09-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 1 - Update name to correctly reflect pharmaceutical form
Section 3 - Update pharmaceutical form from “solution for injection” to “solution for injection/infusion”
Section 4.1 - Update to align with the SPC guidelines by mentioning that the product is indicated for use in adults and children aged 1 month and over
Section 4.2 - Addition of recommended restriction currently mentioned in section 4.4, according to the SPC guidelines.
Section 6.4 - Update statement regarding storage conditions so that it is in line with the latest QRD template. Please note that the storage conditions have not actually changed.
Addition of the following statement:
“For storage conditions of the diluted medicinal product see section 6.3.”
Section 6.5 - Update name of product to correctly reflect pharmaceutical form.
Section 6.6 - Update name of product to correctly reflect pharmaceutical form.
Section 9 - Update to date of last renewal
|
|
Updated on 02/04/2009 and displayed until 24/08/2010
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 4.2 - Posology and method of administration
-
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 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 13-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 1 - deletion of registered trademark symbol
lowercase tradename
Section 4.2 - Cross reference to 6.2 amended
Cross references to 4.5 amended in 2 places
Section 4.4 - Caution should be exercised when administering Nimbex to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate of cross-sensitivity (greater than 50%) between neuromuscular blocking agents has been reported (see section 4.3 ).
Section 4.5 - Cross reference to 4.2 amended
Text added:Treatment with anticholinesterases, commonly used in the treatment of Alzheimer’s disease e.g. donepezil, may shorten the duration and diminish the magnitude of neuromuscular blockade with cisatracurium.
Section 4.7 - This precaution is not relevant to the use of Nimbex. Nimbex will always be used in combination with a general anaesthetic and therefore the usual precautions relating to performance of tasks following general anaesthesia apply.
Section 5.2 - Cross reference to 4.4 amended
Section 6.3 - Cross reference to 6.6 amended
Section 10 - Date of approval updated to date of approval of variation
|
|
Updated on 07/11/2006 and displayed until 02/04/2009
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 30/05/2002 and displayed until 07/11/2006
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 29/05/2002 and displayed until 30/05/2002
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 16/08/2001 and displayed until 29/05/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
