taltirelin£½剤の規制区分 処方箋医薬品 ※...
TRANSCRIPT
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TALTIRELIN
TALTIRELIN OD
(mg)(mg)
http://www.pmda.go.jp/
mg
mg()
mg
(mg)
(mg)
(mg)
(mg)
(mg)
(mg)
()
TEL0120-381-999FAX06-6394-7355
http://med.sawai.co.jp
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63()
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10
10
20
2008
2008
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(http://www.info.pmda.go.jp/)
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2008
2013
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2013(2013)
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20132510
2013
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2013
(2013)
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............................ 2 ................................... 2 ................................... 2 .......................... 2 .......................... 2 ()............................ 3 .............. 3 ............................ 3
........................ 4 ............................ 4 ........ 4 ...................... 4 .......................... 4
............................ 5 ..................................... 5 ............................... 5 .......... 6 ............ 6 .................. 7 () .......... 7 ................................... 8 ........................... 10 ............. 10 10 ................. 10 11 .................................... 10 12 ............... 10 13
.................................. 11 14 .................................. 11
........................... 12 ............................ 12 ............................ 12 ................................ 12
....................... 14 ..... 14 ................................ 14
....................... 15 ................... 15 ................... 17 .................................... 18 .................................... 18 .................................... 19 .................................... 19 ............. 19 ....................... 19
() ......... 20 ....................... 20 () ....... 20
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..................................... 20 ................... 20 ... 20 ................................. 20 ................................... 21 ........................... 22 10 ............. 22 11 ........................... 22 12 ................. 22 13 ................................. 22 14 ............................. 22 15 ............................. 23 16 ................................... 23
..................... 24 ................................. 24 ................................. 24
..................... 25 ................................. 25 ..................... 25 ........................... 25 ..................... 25 ............................... 25 ..................................... 25 ............................... 26 ......................... 26 ........................... 26 10 ........... 26 11 ....................... 26 12
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- 1 -
mg/mg
())
mg mg
1731 0331015
(21 0304004
)
261121
11212
2012 2016
2012 2016
)()[mg]
)
)
)()
()
()()
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- 2 -
1)
mg
mg
2)
3)
1722 0922001
1)()
( )
2)()
( )
( )
3)
1723
477.47
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- 3 -
()
-----------
[ ]
[]
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- 4 -
1)
2)
(99.5)(100)mol/L
3)
14.015.5(0.2g)
4)()
5)
6)
7)
22.524.5(gmol/L50mL100)
)-
)
()
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- 5 -
1)
(mm)
(mg)
(mm)
mg
7.0 120 3.0
mg
()
7.0 110 2.9
2)
mg
(30
85)
mg
(1585)
3)
mg
mg
4)
1)()
mg
-
- 6 -
2)
mg
-
mg
-
3)
mg
)()
mg()
()
)
4075
101.6 100.2
()
)
mg
)
(40)
(2575
)
(
60)
(2560
)
( k g ) 4.0 4.3 4.3 3.5 3.8
100.0 99.3 99.0 97.9 99.0
100()
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- 7 -
mg
)()
mg()
()
)
4075
101.6 101.4
()
)
mg
)
(40)
(2575
)
(
60)
(2560
)
( k g ) 4.5 4.2 3.8 3.6 4.3
100.0 98.9 101.1 102.3 100.0
100()
()
-
- 8 -
mg,)
181124
1124004
50rpm(pH1.24.06.8)100rpm(pH6.8)
12
1585
1585
1585
1585
1585
()
50rpm 50rpm
0
20
40
60
80
100
120
0 5 10 15 20 25 30
(min)
mg
(mg)
(
0
20
40
60
80
100
120
0 5 10 15 20 25 30
(min)
mg
(mg)
(
50rpm 50rpm
0
20
40
60
80
100
120
0 5 10 15 20 25 30
(min)
mg
(mg)
(
0
20
40
60
80
100
120
0 5 10 15 20 25 30
(min)
mg
(mg)
(
-
- 9 -
mg)
2429
022910
50rpm(pH1.25.06.8)
12
1585
1585
1585
1585
( )
100rpm
0
20
40
60
80
100
120
0 5 10 15 20 25 30
(min)
mg
(mg)
(
()
50rpm50rpm
0
20
40
60
80
100
120
0 5 10 15
(min)
mg
(mg)
(
0
20
40
60
80
100
120
0 5 10 15
(min)
mg
(mg)
(
-
- 10 -
mg
-
mg
-
10
mg
()
mg
()
11
12
( )
50rpm50rpm
0
20
40
60
80
100
120
0 5 10 15
(min)
mg
(mg)
(
0
20
40
60
80
100
120
0 5 10 15
(min)
mg
(mg)
(
-
- 11 -
13
14
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- 12 -
mg()
mg
1)
2)
3)
4)
5)
(1)
(2)
(3)
()
-
- 13 -
(4)
6)
(1)()()
(2)
-
- 14 -
1)
()
)
2)
3)
-
- 15 -
1)
2)
--3)
3)
mg,)
181124 1124004
12hr
/
mg(
mg)()
()
(ng/mL)
(hr) 1/2 (hr)
0-12hr (nghr/mL)
mg 3.283.38 3.61.2 2.20.4 18.7116.52 (mg) 2.991.88 4.21.7 2.61.0 17.68 7.22
(..)
-
- 16 -
mg10,11)
2429 022910
12hr
/
mg
mg)()
()90
(0.80)(1.25)
(ng/mL)
(hr) 1/2 (hr)
(nghr/mL)
mg 2.931.07 3.61.3 2.10.3 17.165.64
(mg) 2.711.08 3.51.0 2.20.4 16.496.25
mg 2.260.60 3.51.1 2.10.4 13.573.60
(mg) 2.440.66 3.31.2 2.30.6 14.093.64
(..)
-
- 17 -
90
(1.06) (0.96)(1.16)
(1.10) (0.99)(1.22)
(0.97) (0.87)(1.08)
(0.93) (0.82)(1.05)
4)
5)
6)()
1)
2)
3)
--3)
-
- 18 -
4)
mg(mg)
,)
0.3200.049hr-
mg(mg)
10,11)
[]0.3280.040hr-[]0.3380.049hr-
5)
6)
7)
mg
)
--3)
1)
2)
3)
4)
5)
-
- 19 -
1)
)
2)()
3)
4)
5)
1)
2)
)
3)
-
()
- 20 -
()
()
-
mg
-
()
)4.2
)
()
1)
2)
-
()
- 21 -
1)
2)
)()
(1)
(2)
(3)--
)()
(1)
(2)
(3)
3)
)
()()--
()
()
4)
5)
-
()
- 22 -
6)
)
10
)
)
11
(
)
12
13
14
)
(
)
mg
)
(1)
(2)
-
()
- 23 -
15
16
-
- 24 -
1)()
2)
3)
4)
1)
50(mg/kg)12)
5,000 2,000
5,000 799
946
2)
3)
4)
-
- 25 -
)
)
1)
2)()
-14
3)
mg
28(14)
mg
28(14)
-
- 26 -
[]
[]
mg/mg
10
mg
mg
11
mg
mg
12
13
14
15
()
-
- 27 -
16
mg 121685101 1190014F1068 622168501
mg 124978101 1190014F2064 622497801
17
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- 28 -
) 2012
-196-199
))() []
)49()319(2012)
))() []
)() []
10)65()461(2016)
11)() []
12) 14th 2006p.1554.
-
- 29 -
-
1606E1
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