front valeant pharmaceuticals international inc · 2016-05-11 · approbation / approval valeant...
TRANSCRIPT
ÉPRE
UVES
DE
L’IM
PRIM
EUR
/ VEN
DOR’
S PR
OOF
DATE
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__ S
IGNA
TURE
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_
APP.
: __
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DAT
E:__
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APP.
: __
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DAT
E:__
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APP.
: __
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DAT
E:__
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NOM
DU
PROD
UIT
/ PRO
DUCT
NAM
E: O
UTSE
RT-T
ASM
ARNU
MÉR
O DU
PRO
DUIT
/ PR
ODUC
T NU
MBE
R: L
B009
0-01
NO COD
E À
BARR
ES /
BARC
ODE
NO.:
LB00
9001
SPÉC
IFIC
ATIO
NS
TYPE
DE
PAPI
ER /
PAPE
R TY
PE:
OFFS
ET PO
IDS
DU P
APIE
R / P
APER
WEI
GHT:
27
LB, 5
4 M
DI
MEN
SION
S: À
PLA
T / F
LAT:
23
3 ⁄ 4"
x 13
1⁄ 4"
(603
,3 m
m x
336
,6 m
m)
PL
IÉ /
FOLD
ED:
1 7 ⁄ 8
" x
1" (4
7,6
mm
x 2
5,4
mm
)
PO
INTS
DE
COLL
E / G
LUE
SPOT
S: 2
FEU
ILLE
T PL
IÉ /
FOLD
ED L
EAFL
ET:
ANGL
AIS
/ ENG
LISH
VIS
IBLE
FRAN
ÇAIS
/ FR
ENCH
VIS
IBLE
AUTR
E / O
THER
VIS
IBLE
APPR
OBAT
ION
/ APP
ROVA
L
VALE
ANT
PHAR
MAC
EUTI
CALS
INTE
RNAT
IONA
L IN
C
COUL
EUR(
S) /
COLO
R(S)
:
#1
F
B
NO
IR/B
LACK
LB00
90-0
1.in
dd
320
13/1
2/10
9:
53 A
M
23.75’’ (603,3 mm)
1.875’’ (47,6 mm)
1.0’
’ (2
5,4
mm
)
13.2
5’’
(336
,6 m
m)
FRONTTEXT AREA
Revised by: Dan SmithDate: 11/14/13
PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER INJURY IF TASMAR IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY BE CONSIDERED FOR RETREATMENT.
LB0090-01 Rev. 11/13
LB0090-01 Rev. 11/13
LB0090-01 Rev. 11/13
LB0090-01 Rev. 11/13
LB0090-01.indd 1 2013/12/10 9:53 AM
BACKTEXT AREA
23.75” (603,3 mm)
1,875’’ 47,6 mm
1.0”
(2
5,4
mm
)
13.2
5’’
(336
,6 m
m)
Revised by: Dan SmithDate: 11/05/13
Geriatric Use: Parkinson's disease is primarily an affliction of the elderly. Consequently, the mean age of patients in tolcapone clinical trials was 60 to 65 years. To investigate safety as it relates to advanc-ing age, three subgroups were identified: less than 65 years, 65 to 75 years, and greater than 75 years. There were generally no consistent age-related trends in safety parameters. However, patients greater than 75 years of age may be more likely to develop hallucinations than patients less than 75 years of age, while patients over 75 may be less likely to develop dystonia (see PRECAUTIONS: Hallucinations/-Psychotic Like Behavior). In tolcapone clinical trials, measures of therapeutic efficacy (effects on “Off” time, levodopa dose, and effects on Activities of Daily Living) were not affected by age (see CLINICAL PHARMACOLOGY: Clinical studies). Tolcapone pharmacokinetics have not been found to be affected by age (see CLINICAL PHARMACOLOGY: Special Populations).
LB0090-01 Rev. 11/13
LB0090-01.indd 2 2013/12/10 9:53 AM