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155
1.
Sildenafil/Sandoz 25 mg
Sildenafil/Sandoz 50 mg
Sildenafil/Sandoz 100 mg
2.
Sildenafil/Sandoz 25 mg . 25 mg sildenafil ( citrate).
Sildenafil/Sandoz 50 mg . 50 mg sildenafil ( citrate).
Sildenafil/Sandoz 100 mg . 100 mg sildenafil, ( citrate).
, 6.1.
3. . . Sildenafil/Sandoz 25 mg .
Sildenafil/Sandoz 25 mg , , -
«25» .
,
.
Sildenafil/Sandoz 50 mg . Sildenafil/Sandoz 50 mg , -
,
«50» .
.
.
Sildenafil/Sandoz 100 mg . Sildenafil/Sandoz 100 mg , -
,
«100» .
.
4. . 4.1 . -
,
, . -
Sildenafil/Sandoz, .
4.2 . . .
50 mg
. 75 100 mg -
25 mg, .
100 mg.
. Sildenafil/Sandoz ,
(. . 5.2).
. -
.
. ,
« »,
( = 30 - 80 ml/min).
sildenafil
( <30 ml/min)
25 mg. ,
50 mg, 75 mg 100 mg.
.
(.. ) sildenafil ,
25 mg.
, 50mg, 75mg 100mg.
. Sildenafil/Sandoz
18 .
. -
, , sildenafil (. . 4.4),
25 mg
CYP3A4 (. . 4.5).
,
- sildenafil. ,
sildenafil
25 mg (. . 4.4 4.5).
4.3 . . -
/
(cGMP) (. . 5.1), sildenafil -
( )
. , -
sildenafil, -
(.. -
, ). Sildenafil/
Sandoz
(),
PDE5 ( . 4.4). sildenafil -
:
, ( < 90/50 mmHg), -
,
,
( -
).
4.4 .
,
,
.
, -
. sildenafil
(. . 5.1).
sildenafil,
. -
-
(.. )
,
. Sildenafil/Sandoz -
(. . 4.3).
,
Sildenafil/Sandoz,
, , , ,
, ,
. , , -
.
Sildenafil/Sandoz
.
.
,
sildenafil, -
( , Peyronie)
(
, ).
sildenafil,
, .
. -
sildenafil PDE5.
, Sildenafil/
Sandoz ( . 4.3).
sildenafil (. . 4.5). , sildenafil
- , -
(. . 4.5).
4 sildenafil.
,
-
sildenafil. -
sildenafil 25 mg (. . 4.2). ,
.
sildenafil in
vitro. ,
sildenafil . ,
sildenafil
.
Sildenafil/Sandoz .
4.5 -
. sildenafil. in vitro.
sildenafil 3A4 ( ) 2C9
( ) P450 (CYP). ,
sildenafil.
in vivo.
sildenafil,
CYP3A4 ( , , ). -
, sildenafil -
CYP3A4,
25 mg.
HIV, ,
P450, (500
mg ) sildenafil ( 100 mg)
Cmax sildenafil 300% (4 )
AUC sildenafil 1.000% (11 ). 24
sildenafil 200 ng/ml ,
5 ng/ml sildenafil
.
P450. sildenafil -
.
sildenafil (. . 4.4)
sildenafil 25 mg
48 .
HIV, , -
CYP3A4, (1200 mg )
sildenafil ( 100 mg) Cmax
sildenafil 140% AUC sildenafil 210%. sildenafil
(. . 4.2).
CYP3A4,
.
100 mg sildenafil , -
CYP3A4, (500 mg
5 ), (AUC) sildenafil
182%. -
( 500 mg 3 ) AUC,
Cmax, tmax, -
sildenafil . (800 mg),
P450 CYP3A4, -
56% sildenafil ,
sildenafil (50 mg) . grapefruit
CYP3A4
sildenafil . -
( / ) -
sildenafil.
,
sildenafil,
CYP2C9 ( , , ),
CYP2D6 ( ,
), ,
, -
, , -
CYP450 ( ). To nicorandil
.
sildenafil.
sildenafil . in vitro. sildenafil
1A2, 2C9, 2C19, 2D6, 2E1 3A4
(IC50 > 150) P450.
sildenafil , , 1 -
, Sildenafil/Sandoz
.
sildenafil ,
.
in vivo.
/ cGMP (. . 5.1), sildenafil
(. . 4.3).
sildenafil - ,
-
. 4
sildenafil (. . 4.2 4.4 ). -
, - doxazosin (4 mg 8 mg) sildenafil (25
mg, 50 mg, 100 mg )
(BPH) doxazosin.
7/7 mm Hg, 9/5 mm Hg 8/4 mm Hg
6/6 mm Hg, 11/4 mm Hg 4/5 mm
Hg, . sildenafil doxazosin
doxazosin,
. -
, . -
, sildenafil (50 mg) (250 mg)
(40 mg), CYP2C9. sildenafil (50 mg)
(150 mg). sildenafil (50 mg)
80 mg/dl. -
: ,
- , , ,
( ), -
, - -
,
sildenafil
. , sildenafil
(100 mg) ,
8 mmHg.
7 mmHg.
,
sildenafil (. . 5.1).
sildenafil (100 mg)
HIV, ,
CYP3A4.
4.6 K . Sildenafil/Sandoz .
, sildenafil
, .
4.7 .
.
sildenafil,
Sildenafil/Sandoz,
.
4.8 . Sildenafil/Sandoz
8691 , 67, -
, .
sildenafil ,
, , , , -
.
, > 9 , '
.
, -
.
( -
(1/10), (1/100 <1/10), (1/1.000 <1/100), -
(1/10.000 <1/1.000), ,
,
.
, ,
. , -
.
1: -
' ,
-
.
-
,
,
, ,
,
, ,
,
(), ,
.
,
*
,
,
,
, ,
,
, ,
,
Steven-Johnson,
(TEN)
,
,
* : . -
5
(PDE5), sildenafil.
4.9 . 800 mg, , -
-
, .
200 mg
(, , , , , -
). , -
.
, sildenafil
.
6. . 6.1 -
, , , , -
, , ,
(indigo carmine aluminium lake) ( E132)
6.2 . .
6.3 . 3
6.4 . -
.
6.5 . (blisters) Aclar/.
. 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 28 .
.
6.6 . .
7. . Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl, A
8. () . 25mg: 44446/30-06-2010
50mg: 44447/30-06-2010, 100mg: 44448/30-06-2010
9. / . 30-06-2010
10. . 09-08-2012
Sildenafil/Sandoz
« »
spc sildenafil 21x28.indd 1
2/24/14 12:24 PM
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