Updated on 22/12/2011 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 06-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update section 4.6 and 4.8 of the SPC and leaflet with information on the use of conventional and atypical antipsychotics during pregnancy and the risk of abnormal muscle movements and withdrawal symptoms in newborns.
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Updated on 26/07/2011 and displayed until 22/12/2011
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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 5.1 - Pharmacodynamic Properties
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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 07-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2, 4.4, 4.5 and 4.8 - typos corrected
Section 4.6, 5.1, 6.2, 6.6, 9 - Amended to bring in line with QRD template and European SPC guidelines
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Updated on 29/07/2010 and displayed until 26/07/2011
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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: 24-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 6.4:
Protect from light. Discoloured solutions should not be used.
has been replaced with
Keep ampoules in the outer carton, in order to protect from light. Discoloured solutions should not be used.
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Updated on 04/05/2010 and displayed until 29/07/2010
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Change to section 2 - Qualitative and quantitative composition
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 06-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of ATC code in 5.1, additional information regarding excipients in 2
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Updated on 22/04/2010 and displayed until 04/05/2010
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Change to section 1 -Name of the Medicinal product
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 17-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Name change to Stemetil 12.5mg/ml Injection
Section 4.4 and 4.8 - inclusion of risk of VTE
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Updated on 15/01/2010 and displayed until 22/04/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 warning regarding hyperglycaemia or intolerance to glucose added
In section 4.8 hyperglycaemia and intolerance to glucose added.
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Updated on 18/09/2007 and displayed until 15/01/2010
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 (Special warnings and precautions for use): QT prolongation section updated, and further information regarding use with other neroleptics concomitantly, and use in elderly also added:
'Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and congenital or acquired (i.e. drug induced) QT prolongation. The risk-benefit should be fully assessed before Stemetil treatment is commenced. If the clinical situation permits, medical and laboratory evaluations (e.g. biochemical status and ECG) should be performed to rule out possible risk factors (e.g. cardiac disease; family history of QT prolongation; metabolic abnormalities such as hypokalaemia, hypocalcaemia or hypomagnesaemia; starvation; alcohol abuse; concomitant therapy with other drugs known to prolong the QT interval) before initiating treatment with Stemetil and during the initial phase of treatment, or as deemed necessary during the treatment (see also sections 4.5 and 4.8).
Avoid concomitant treatment with other neuroleptics (see section 4.5).
In randomised clinical trials versus placebo performed in a population with elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Stemetil should be used with caution with stroke risk factors.'
Section4.8 (Undesirable effects): Cardiac disorders section updated:
'Cardiac disorders: ECG changes include QT prolongation (as with other neuroleptics), ST depression, U-Wave and T-Wave changes. Cardiac arrhythmias, including ventricular arrhythmias and atrial arrhythmias, a-v block, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy, possibly related to dosage. Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.
There have been isolated reports of sudden death, with possible causes of cardiac origin (see section 4.4, above), as well as cases of unexplained sudden death, in patients receiving neuroleptic phenothiazines.'
Section 7 (Marketing Authorisation Holder): Change in MA Holder's detail
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Updated on 09/02/2007 and displayed until 18/09/2007
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of ownership from Castlemead Healthcare to Aventis Pharma trading as sanofi-aventis
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Updated on 12/09/2005 and displayed until 09/02/2007
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Change from BAN to rINN
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/09/2003 and displayed until 12/09/2005
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Improved Electronic Presentation
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Updated on 28/08/2001 and displayed until 24/09/2003
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 28/08/2001
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