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齐莘
7 years ago
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1 利 EPREX injection Epoetinum alfa 利 : Epoetinum alfa 說 EPREX(Epoetinum alfa) DNA EPREX (vial) 1000IU/0.5mL 2000IU/mL 4000IU/mL 10000IU/mL ; (syringe) 1000IU/0.5mL 2000IU/0.5mL 3000IU/0.3mL 4000IU/0.4mL 8000IU/0.8mL 10000IU/1.0mL 六不類 epoetinum alfa Epoetinum alfa 度 g ml 1, , , , epoetinum alfa Epoetinum alfa 度 g ml 1, , , , , Epoetinum alfa 理療狀療療說療療臨狀不療年 1

2 EPREX 療 platium 療療惡降量 Epoetinum alfa, 不 Epoetinum alfa 不不, 不 1-5, 量來狀, 行量,, 10 EPREX 不 (intravenous infusion) 不 1ml 量, 不若 ( ), ( ),epoetinum alfa 理度 10~12 g/dl(6.2~7.4 mmol/l), 9.5~11 g/dl(5.9~6.7 mmol/l) 臨塞, 度不度療療量, Epoetinum alfa 療,B 12 葉 epoetinum alfa 療立, : 葉 B 12 流, 量, 度, 度若 1 g/dl(0.62 mmol/l), epoetinum alfa 量療兩不臨 6-10 度, 25 IU/kg/dose 度降量, 度 12 g/dl, 療量量量降量 2

3 年若 ( ), 療兩 : : 50 IU/kg,, 量, 25 IU/kg 度,, 理度 (10-12 g/dl, mmol/l) : 量 :Hb g/dl( mmol/l) 量, 量 75~300 IU/kg 臨數度 6g/dL( 3.7 mmol/l) 度 8g/dL( 5 mmol/l) 量年療兩 : : 50 IU/kg,,, 量, 25 IU/kg 度,, 理度 ( g/dl, mmol/l) : 量 :Hb g/dl( mmol/l) 不 30kg 30kg 量例, 臨療六量 : 量 (IU/kg, ) 數量 < > 臨數 ( <6.8 g/dl, 4.2 mmol/l) ( 6.8 g/dl, 4.2 mmol/l) 量年若,epoetinum alfa 療兩 : : 50 IU/kg,, 量, 25 IU/kg 度,, 理度 (10-12 g/dl, mmol/l) : 理度 (10-12 g/dl, mmol/l) 量 IU/kg,, 量年療兩 : : 50IU/kg,,, 量, 25 IU/kg 度,, 理度 ( g/dl, mmol/l) : 不 30kg 30kg 量例, 臨療六列量 3

4 量 (IU/kg, ) 數量 < > 臨數 ( <6.8 g/dl, 4.2 mmol/l) ( 6.8 g/dl, 4.2 mmol/l) 量不年療不若,epoetinum alfa 療兩 : : 50 IU/kg,, 量, 25 IU/kg 度,, 理度 (10-12 g/dl, mmol/l) : 理度量 IU/kg, 量不 200 IU/kg, 年度 12g/dL(7.5mmol/l) 療量 150 IU/kg, 40000IU 量 epoetinum alfa, 量療, 度 1 g/dl(0.6 mmol/l) 狀來 40,000 cells/ l, 量不量療, 度 <1 g/dl(0.6 mmol/l) 狀來 <40,000 cells/ l,, 量 300 IU/kg, 60000IU 300 IU/kg 量 60000IU 療, 1 g/dl(0.6 mmol/l), 狀來 40,000 cells/ l, 量不 300 IU/kg 量 60000IU 療, <1 g/dl(0.6 mmol/l), 狀來療 <40,000 cells/ l, 療療量 : 4

5 > 1 g/dl ( 12 g/dl) 狀 > 40,000 /µl 150 IU/kg,, 40000IU/mL, < 1 g/dl 狀 < 40,000 /µl 300 IU/kg,, 60000IU < 1 g/dl 療狀 < 40,000 /µl 兩度 1 g/dl(0.6 mmol/l) 度 2 g/dl (1.25 mmol/l), 度 13 g/dl (8.1 mmol/l) 兩 1 g/dl(0.6 mmol/l) 2 g/dl(1.25 mmol/l), 12 g/dl (7.4 mmol/l), 度 epoetinum alfa 量降 25-50% 度 13 g/dl(8.1 mmol/l), 療降 12 g/dl(7.4 mmol/l), 量 25% 量 epoetinum alfa 療, 年 6 18 epoetinum alfa IU/kg,, 降不良 (PRCA), 不 epoetinum alfa ( 見 [ ] 欄 ) epoetinum alfa epoetinum alfa 療切療療不良 epoetinum alfa 若不數, epoetinum alfa 療療 5

6 , epoetinum alfa 療 epoetinum alfa epoetinum alfa 塞 / ( ), epoetin alfa 療 epoetinum alfa 不降, 不 epoetinum alfa Epoetinum alfa 療量數, 數療療不數不良年累 epoetin 不良療, 降 ( 降 1-2 g/dl), 狀數, ( 葉 B 12 不流 ) 狀數 (<20,000/mm /uL <0.5%), 數, 療降,, 行不良不良, 立 epoetinum alfa 療不療, 療,, 老年 882 臨,757 epoetinum alfa epoentium alfa,361 (47%) 年 65, 100 (13%) 年 75 老年年療異老年量狀 ( 見 [ 量 ] 欄 ) 療療臨, 數 65 老年異年度 1 g/dl(0.62 mmol/l), 不 2 g/dl(1.2 mmol/l) 降度 12g/dL 降量 epoetinum alfa 量度, 量了 epoetinum alfa 療, 療, 葉 B 12 不度降, 100 ng/ml, 200~300 mg/day( 量 100~200 mg/day) 塞, 度不量欄度尿 6

7 度 ( ), epoetinum alfa 料, 不 epoetinum alfa 不不惡 epoetinum alfa, epoetinum alfa heparin 量不, 塞女 epoetinum alfa 療, epoetinum alfa 見惡 epoetinum alfa epoetinum alfa 量, 量療兩度 1 g/dl 度 2 g/dl, 13 g/dl, 量欄量, 降塞療 (TVEs) 率 ( 見 [ ] 欄 ),, TVEs ( ), 療 ( epoetinum alfa) 了 epoetinum alfa 療, 療, 葉 B 12 不度降, 100 ng/ml, 200~300 mg/day Epoetinum alfa, 刺惡切切, Epoetin 臨不數 epoetin 不良數, 女不 12 g/dl 療, epoetinum alfa 療 ( ), 2-3 epoetinum alfa 療, cyclosporin, epoetinum alfa cyclosporine, cyclosporin 度來 cyclosporin 量離切論, epoetinum alfa G-CSF GM-CSF,epoetinum alfa, 硫降降 epoetinum alfa 罹 40,000 IU/mL epoetinum alfa trastuzumab (6 mg/kg), trastuzumab 力 7

8 量, epoetinum alfa 降率降利 epoetinum alfa 見臨料欄說 ), epoetinum alfa epoetinum alfa 力 Epoetinum alfa 療,,,, epoetinum alfa 量狀暈, 療見, Epoetinum alfa, 塞 / 塞 ( 塞 ) 塞塞塞塞不 epoetinum alfa epoetinum alfa 更易類, 度度, 見 epoetinum alfa 度, 年累療不良例 ( 見欄 ) epoetinum alfa 療見不良量惡類療,, 療列 : 狀 ( 亂狀 ) 槒, 立料切療烈, 塞, 易 ( 塞 ) acetylsalicylic acid 塞 epoetinum alfa 療 epoetinum alfa 療切 epoetinum alfa 療, 類不良率女, 療了, 療率 8

9 率塞率, epoetinum alfa 量 Epoetinum alfa 療 Epoetinum alfa 量理若度切行療理 Epoetinum alfa 刺, 類 epoetinum alfa 尿離 58% 量, 165, N-glycosidic O-glycosidic 連, 量 32,000-40,000 ATC CODE:B03XA01 裂刺刺 Epoetinum alfa 類數 ( 老老 )epoetinum alfa epoetinum alfa, 數狀數 59 Fe 度類 epoetinum alfa 刺, 不 epoetinum alfa 150 IU/kg 40,000 IU/mL, 兩量不類 epoetinum alfa 力, 狀力 AUC ( 150IU/kg, 40000IU/mL, ) 狀力 AUC ( 150IU/kg, 40000IU/mL, ) 數 AUC 臨, 療臨, epoetinum alfa 力, epoetinum alfa,epoetinum alfa 力, 1 g/dl epoetinum alfa IU/kg, 4,, IU/kg 5 9

10 6, epoetinum alfa IU/kg, 度度 12~18 度 ( ) : 論 24 量 24 量, 度 600 IU/kg, 度 - 力數年 65 年異 7 不 10 年臨, 不年 1.5 2, 不率年 IU/kg 40,000 IU/mL, 19.4± ±6.1 不類 epoetinum alfa 150 IU/kg 40,000 IU, 利度數列數 : C max C min t ½ (miu/ml) (miu/ml) (h) 150 IU/kg 143 (54.2) 18 (9.3) 19.4 (n=17) 40,000 IU 861 (445.1) 3.8 (4.27) 15.0 (n=17) AUC 40,000 IU/mL 150 IU/kg, epoetinum alfa 率 239% 120 IU/kg,epoetinum alfa 率 : 20% 療不類 epoetinum alfa 150 IU/kg 40,000 IU/mL 力, 力數度異, ( 療 ) epoetinum alfa 力 ( 療 ) 力,C max 率 C max (miu/ml) b C min (miu/ml) 療 150 IU/kg (402.7) (301.4) (n=16) a 40,000 IU 1289 (431.0) 148 (144.2) t max (h) (8.8) (28.3) t ½ (h) 28.3 (19.2) [n=7] 76.2 (45.8) CL/F (ml/h/kg) 12.1 (11.2) 5.6 (1.8) 10

11 (n=19) a 不療 150 IU/kg 357 (246.2) (n=9) a 40,000 IU (n=11) 941 (372.7) a N (20.1) (10.8) b 度來 C max [n=9] 30.0 (10.0) [n=6] 46.7 (22.29) 17.2 (7.8) 12.7 (7.5) 臨數臨老 ( 不 ) 理臨 epoetinum alfa 療, 狀年 epoetinum alfa, 兩率異行不見類, 不臨 Epoetinum alfa 不 (Ames ) 類亂老 HGPRT 臨, 500IU/kg/day 量老,, epoetinum alfa 500IU/kg/day 不力降 ; 量 IU/kg/day ; 量 IU/kg/day 降 500IU/kg/day 老, 降數, epoetinum alfa Polysorbate 80 sodium chloride disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate glycine water for injections (Pharm. Eur.) 不不不 (intravenous infusion) 2-8 (36-46 ) 不冷度 11

12 理若列, 不 : 粒冷冷 : Cilag AG : Hochstrasse 201, CH-8205 Schaffhausen, Switzerland : : 北路樓 :

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untitled 什 ~ 什 ~ 異塞裂療 ~ 行刺療刺刺不什若刺來說不數 ~ 刺量亂刺刺異狀復什 ~ 例率不了不不 ~ 刺利不例不良狀異 970429 ~ 量流降金鍊若臨 970429 量狀了臨良便便便狀臨量漏不不不流臨利行量不粒流若臨 970429 度流念女都度了度罹