0916-ROA-01 10 014967 20 014966 Roche Soft Gelatin Capsules 10mg, 20mg ( ) 1. 1.1 / Retinoid ATC Code: D10BA01 1.2 10 20 1.3 1.4 / 1.5 isotretinoin; 13-cis retinoic acid (Soya oil), [Soya-bean oil(partially hydrogenated)], [Soya bean oil(hydrogenated)], (Yellow beeswax) : Gelatin, Glycerol 85%, Dry substance of karion 83(Sorbitol, Mannitol, Hydrogenated hydrolysed starch), Titanium dioxide(e171), Iron oxide red. Printing Ink: Opacode Black S-1-17823 2. 2.1 1
( - ) retinoid -( )- 2.2 ( 2.4 ) 0.5 / 0.5-1.0 / 2.0 / 120 / 16-24 8 8 2.2.1 ( 10 / ) ( 2.5.5 ) 2.3 - ( 2.4 ) 2
- ( 2.5 ) - ( 2.4 ) - ( 2.4 ) A - A ( 2.6 ) - ( 2.4 ) - isotretinoin 3
2.4 2.4.1 : - - - 1-1 1 1 2-11 5-2 3 - - - 4
- - 1 1 - - ( ) - ( ) - 5-1 2 ( ) 1 1 - - ( ) 5
- o o 1 1 - o 3 25 miu/ml 3 3 1 28 ( 6
) 3 5-30 - 7 progesterone ( ) 1 7
( 2.6 ) 7-10 ( SPF 15 ) 5-6 6 ((EM) Stevens-Johnson syndrome(sjs) (TEN)) 8
( 2.6 ) ( 2.6 ) 骺 () ( 2.4.4 ) 1 3 9
1 ( ) 3 800 mg/dl 9 mmol/l ( 2.6 ) () ( ) retinoid ( ) ( ) 10
2.4.2 ( 2.4 ) 2.4.3 2.4 2.4.4 A A ( 2.4 ) 2.5 2.5.1 (/ ) () ( ) ( [conotruncal malformations][tetralogy of Fallot] ) 2.5.2 11
2.5.3 12 2.5.4 2.5.5 isotretinoin ( 2.2.1 ) 2.5.6 2.4.1 2.6 2.6.1 / A ( ) A ( ) ( ) ( ) 12
- CPK ( 2.4 ) 骺 ( 2.4 ) ( ) ( ) ( ) ( ) ( 2.4 ) (transaminase) 13
( ) ( ) HDL ( 2.4 ) ( ) ( Wegener ) 2.6.2 Stevens-Johnson syndrome ( 2.4 ) (vigorous physical activity) 2.7 A 3. 3.1 3.1.1 isotretinoin all-trans retinoic acid (tretinoin) 14
isotretinoin 3.1.2 / (Propionibacterium acnes) 3.2 isotretinoin isotretinoin 3.2.1 Isotretinoin 80 2-4 (C max ) 310 / ( 188-473 / ) isotretinoin isotretinoin (plasma) (blood) 1.7 isotretinoin 3.2.2 Isotretinoin ( 99.9 ) (= ) 0.1 Isotretinoin 15
40 2 isotretinoin (C min,ss) 120-200 / 4-oxo-isotretinoin isotretinoin 2-5 isotretinoin isotretinoin 3.2.3 isotretinoin 3 4-oxo-isotretinoin tretinoin (alltrans retinoic acid) 4-oxo-tretinoin 4-oxo-isotretinoin 2.5 glucuronide conjugates Isotretinoin isotretinoin isotretinoin tretinoin (all-trans retinoic acid)(=) tretinoin isotretinoin isotretinoin 20-30% isotretinoin CYP isotretinoin 4-oxo-isotretinoin tretinoin CYP 3.2.4 isotretinoin isotretinoin 19 4-oxo-isotretinoin 29 Isotretinoin retinoid 2 retinoid 3.2.5 16
3.3 3.3.1 3.3.2 isotretinoin 3.3.3 isotretinoin isotretinoin 3.3.4 A isotretinoin isotretinoin ( 2.3 2.4 2.5 ) 3.3.5 isotretinoin LD50 2000 / 3000 / 4000 / 2 (isotretinoin 2 8 32 / / ) Isotretinoin A A Isotretinoin A 17
A isotretinoin 1-2 4. 4.1 (EXP) 4.2 / 4-1000 ( ) 2013 1 FE_CDS 5.0 Catalent Germany Eberbach GmbH Gammelsbacher strasse 2, 69412 Eberbach Germany. F. Hoffmann-La Roche Ltd. Wurmisweg, CH-4303 Kaiseraugst, Switzerland. ( ) 1 91 F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124, CH-4070 Basel, Switzerland. 3 134 9 (02) 27153111 18
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