סימדקו 50 מג75 מג ו-75 מג

Country: Ísrael

Tungumál: hebreska

Heimild: Ministry of Health

Virkt innihaldsefni:

IVACAFTOR; IVACAFTOR; TEZACAFTOR

Fáanlegur frá:

VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL

ATC númer:

R07AX31

Lyfjaform:

טבליות מצופות פילם

Samsetning:

IVACAFTOR 75 MG; TEZACAFTOR 50 MG; IVACAFTOR 75 MG

Stjórnsýsluleið:

פומי

Gerð lyfseðils:

מרשם נדרש

Framleitt af:

VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK

Lækningarsvæði:

IVACAFTOR AND TEZACAFTOR

Leyfisdagur:

2021-04-04

Upplýsingar fylgiseðill

SYMD-PIL-0923-V1
Page 1 of 6
" )
(
-
1986
50
/"
75 "
-
75 "
100
/"
150 "
-
150 "
50
/"
75 "
-
75
"
50
"
75
"
(
tezacaftor 50 mg and ivacaftor 75 mg
)
75
"
(ivacaftor 75 mg)
100
/"
150 "
-
150
"
100
"
150
"
(
tezacaftor 100 mg and ivacaftor 150 mg
)
150
"
(ivacaftor 150 mg)
–
6
" "
. "
"
2
.
.
.
,
.
.
.
.
1
.
?
(
CF
)
6
)(
_F508del_
,
CFTR
,
CFTR
.
:
–
CFTR
–
(
potentiator
)
CFTR
,
,
CFTR
.
CFTR
.
2
. :
•
)(
(
)
(
6
"
"
.)
SYMD-PIL-0923-V1
Page 2 of 6 , ,
:
•
•
,
.
6
.
:
•
•
3
•
.
)
(
.
,
.
/
,
, ,
.
:
•
–
•
,
–
•
(
St.
John’s wort
)
–
.
,
.
.
:
•
,
,
,
–
-
•
,
–
•
, ,
–
•
–
•
–
•
–
.
.
,
, ,
,
.
SYMD-PIL-0923-V1
Page 3 of 6
,
,
.
.
.
(
,
.
)
.
/
.
.
,
.
,
.
,
.
,
.
3
.
?
.
.
.
:
6
11
-
30
"
(
50
/"
75
(
) "
75
)"
.
•
-
12
.
6
11
-
30 "
12
(
100
/"
150
"
)
(
150
"
)
.
•
-
12
.
.
,
.
.
,
.
:
•
.
6
11
-
30
"
•
6
,
.
.
•
-
6
, .
.
SYMD-PIL-0923-V1
Page 4 of 6
6
11
-
30
"
12
•
6
,
.
.
•
-
6
, .
.
.
,
.
,
.
,
. ! .
. . ,
4
.
,
.
.
. :
-
(
)
-
,
:
•
•
•
•
•
,
.
:
.
-
-
-
(
light-headedness
)
:
(
)
•
(
-
10
-
1
100
)
•
•
)
(
• , , ,
. ,
SYMD-PIL-0923-V1
Page 5 of 6
"
"
(
www.health.gov.il
)
,
:
https://sideeffects.health.gov.il
5
.
?
!
/
.
.
(exp. date)
.
.
-
25°C
.
6
.
:
,
50
/"
75 "
-
75
"
microcrystalline cellulose, hypromellose acetate succinate (HPMCAS),
croscarmellose sodium,
hypromellose (HPMC), magnesium stearate and sodium lauryl sulfate.
opadry white 20A180008 (HPMC 2910/hypromellose, hydroxypropyl
cellulose, talc and titanium
dioxide).
microcrystalline cellulose, lactose monohydrate, hypromellose acetate
succinate, croscarmellose
sodium, magnesium stearate, colloidal silicon dioxide and sodium
lauryl sulfate.
opadry II (blue) 85F105098 (polyvinyl alcohol, titanium dioxide, PEG
3350, talc, FD&C Blue
#2/Indigo Carmine Aluminum Lake) and carnauba wax.
opacode black s-1-17823 (shellac, iron oxide black, propylene glycol
and ammonium hydroxide).
100
/"
150 "
-
150
"
microcrystalline cellulose, hypromellose acetate succinate (HP