Updated on 02/07/2010 and displayed until Current
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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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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 03-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - change from "at present has not been validated for" to "has not been validated"
Section 4.8 - Added info regarding movment disorders
Section 5.3 - human data section removed
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Updated on 16/04/2009 and displayed until 02/07/2010
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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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| Date of revision of text on the SPC: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of special warning cover suicidal ideation
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Updated on 06/01/2009 and displayed until 16/04/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 02-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 - following information has been added;
Epidemiology of VFD in patients with refractory partial epilepsy was examined in an observational, open-label, multicentre, comparative, parallel group, Phase IV study, including 734 patients, at least 8 years old, with refractory partial epilepsy for at least one year.
Patients were split in three treatment groups: patients currently treated with vigabatrin (group I), patients previously exposed to vigabatrin (group II) and patients never exposed to vigabatrin (group III). The following table presents the main findings at inclusion and at the first and last conclusive evaluations in the evaluable population (n=524):
Please note, the table is not included here due to technical problems
Section 6.6 - following information has been added for the sachets;
The content of the recommended number of sachets is dissolved in at least 100 ml of water, fruit juice or milk just before administration.
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Updated on 11/09/2008 and displayed until 06/01/2009
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 02-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 24/07/2008 and displayed until 11/09/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 02-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4
Added:
Frequencies found in an open clinical study are presented in section 5.1.
A deterioration of VFD after the treatment is discontinued cannot be excluded.
Frequencies found in an open clinical study are presented in section 5.1. A possible association between the risk of visual field defects and the extent of vigabatrin exposure, both in terms of daily dose (from 1 gram to more than 3 grams) and in terms of duration of treatment (maximum
during the first three years) has been shown in this an
open clinical study.
4.6
Removed:
Data on a limited number (n=192) of exposed pregnancies are available. Congenital anomalies were reported in 14.5% of exposed pregnancies. Of these, 64.3% were major malformations. Spontaneous abortion was reported in 10.9% of exposed pregnancies.
Added:
Based on data on a limited number of exposed pregnancies with vigabatrin, available from spontaneous reports, abnormal outcomes (congenital anomalies or spontaneous abortion) were reported in the offspring of mothers taking vigabatrin.
Removed:
epilepsy itself
4.8
Removed:
Very rare cases of hepatic reactions (including hepatitis)
have been reported.
Cases of speech disorder have been reported.
Very common General disorders: Somnolence,
fatigue
(>1/10) Psychiatric disorders*:
Excitation and agitation (children)
Eye disorders: Visual field
defect
Common General disorders: Headache,
weight gain, tremor, oedema
(>1/100, <1/10) Nervous system disorders:
Dizziness, paresthesia,
disturbance of concentration and
memory
Psychiatric disorders*:
Agitation, aggression,
nervousness, irritability,
depression, thought disturbance,
paranoid reaction
Gastrointestinal disorders:
Nausea, abdominal pain
Eye disorders: Blurred vision,
diplopia, nystagmus
Uncommon Nervous system disorders: Ataxia
(>1/1,000, <1/100) Psychiatric disorders*:
Hypomania, mania, psychosis
Skin disorders: Rash
Rare General disorders:
Angioedema, urticaria
(<1/1,000) Nervous system disorders:
Encephalopathic symptoms**
Psychiatric disorders: Suicide
attempt
Eye disorders: Retinal disorder
(such as peripheral retinal atrophy)
Very rare Eye disorders: Optic neuritis,
optic atrophy
(<1/10,000) Psychiatric disorders:
Hallucinations
*Psychiatric reactions have been reported during
vigabatrin therapy. These reactions occurred in
patients with and without a psychiatric history and
were usually reversible when vigabatrin doses were
reduced or gradually discontinued (see Section 4.4
Special warnings and special precautions for use).
Depression was a common psychiatric reaction in
clinical trials but seldom required discontinuation of
vigabatrin.
**Rare reports of encephalopathic symptoms such as
marked sedation, stupor and confusion in association with
non-specific slow wave activity on electroencephalogram
have been described soon after the initiation of vigabatrin
treatment. Such reactions have been fully reversible
following dose reduction or discontinuation of vigabatrin
(see Section 4.4 Special warnings and special precautions
for use).
Laboratory data indicate that vigabatrin treatment does
not lead to renal toxicity. Decreases in ALT and AST,
which are considered to be a result of inhibition of these
aminotransferases by vigabatrin, have been observed.
Chronic treatment with vigabatrin may be associated with
a slight decrease in haemoglobin which rarely attains
clinical significance.
Added:
Undesirable effects ranked under headings of frequency
are listed below, using the following convention:
Very common (>=1/10); common (>=1/100 to <1/10);
uncommon (>=1/1,000 to <1/100); rare (>=1/10,000 to
<1/1,000); very rare (<1/10,000); Not known (cannot be
estimated from the available data).
Investigations*
Common: weight increased
Nervous system disorders
Very common: somnolence
Common: speech disorder, headache, dizziness,
paraesthesia, disturbance in attention and memory
impairment, mental impairment (thought disturbance),
tremor
Uncommon: coordination abnormal (ataxia)
Rare: encephalopathy**
Very rare: optic neuritis
Eye disorders
Very common: visual field defect
Common: vision blurred, diplopia, nystagmus,
Rare: retinal disorder (such as peripheral retinal atrophy)
Very rare: optic atrophy
Gastrointestinal disorders
Common: nausea, abdominal pain
Skin and subcutaneous tissue disorders
Uncommon: rash
Rare: angioedema, urticaria
General disorders and administration site conditions
Very common: fatigue
Common: oedema, irritability
Hepato-biliary disorders
Very rare: hepatitis
Psychiatric disorders***
Very common: excitation (children), agitation (children)
Common: agitation, aggression, nervousness, depression,
paranoid reaction
Uncommon: hypomania, mania, psychotic disorder
Rare: suicide attempt
Very rare: hallucination
*Laboratory data indicate that vigabatrin treatment does
not lead to renal toxicity. Decreases in ALT and AST,
which are considered to be a result of inhibition of these
aminotransferases by vigabatrin, have been observed.
Chronic treatment with vigabatrin may be associated with
a slight decrease in haemoglobin which rarely attains
clinical significance.
**Rare reports of encephalopathic symptoms such as
marked sedation, stupor and confusion in association with
non-specific slow wave activity on electroencephalogram
have been described soon after the initiation of vigabatrin
treatment. Such reactions have been fully reversible
following dose reduction or discontinuation of vigabatrin
(see Section 4.4 Special warnings and special precautions
for use).
***Psychiatric reactions have been reported during
vigabatrin therapy. These reactions occurred in patients
with and without a psychiatric history and were usually
reversible when vigabatrin doses were reduced or
gradually discontinued (see Section 4.4 Special warnings
and special precautions for use). Depression was a
common psychiatric reaction in clinical trials but seldom
required discontinuation of vigabatrin
7
Added:
Or trading as:
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4Y
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Updated on 19/09/2007 and displayed until 24/07/2008
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change from BAN to rINN
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 3 (Pharmaceutucal form): Physical description of sachet and tablets added
Section 6.1 (Excipients list): change of excipients from BAN to rINN.
Section 6.3 (Shelf life): Statemenet added recommending the immediate use of reconstituted powder (sachet)
Section 6.4 (Special precautions for storage): Statement added stating that Sabril sachets and tablets do not require any special storage conditions
Section 6.6 (Special precautions for disposal): Statement added recommending that the content of the recommended number of sachets is dissolved in at least 100ml of water or any other drinkable solution just before administration. Upon reconstitution, the SPC states that the solution should have a clear and yellow appearance.
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Updated on 20/09/2006 and displayed until 19/09/2007
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 9 (Date of renewal of authorisation): A renewal date of 19 June 2006 included
Section 10 (Date of revision of text): Changed to 19 June 2006
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Updated on 24/09/2004 and displayed until 20/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 13/09/2004 and displayed until 24/09/2004
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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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Updated on 13/09/2004 and displayed until 13/09/2004
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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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Updated on 19/08/2004 and displayed until 13/09/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 14/02/2002 and displayed until 19/08/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 26/06/2001 and displayed until 14/02/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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