Country: Taiwan
Bahasa: Cina
Sumber: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
FACTOR IX
傑特貝林有限公司 臺北市信義區基隆路1段333號16樓(1612室) (43836487)
B02BD04
注射劑
FACTOR IX (2012100700) 120IU (I
小瓶裝;;
菌 疫
限由醫師使用
CSL BEHRING GMBH EMIL-VON-BEHRING STRASSE 76,35041 MARBURG GERMANY DE
coagulation factor IX
預防及治療B型血友病(先天性第九凝血因子缺乏症)患者之出血。
註銷日期: 2019/10/05; 註銷理由: 自請註銷; 有效日期: 2020/10/23; 英文品名: BERININ P (BLOOD COAGULATION FACTOR IX,HUMAN PASTEURIZED)
已註銷
2000-10-23
10 270 5 10 1 Packmittelnr. / packaging code number Packmittel-Bezeichung/ Packaging material Packungsbeilage / package insert 800 x 270 · 1 (Code G123) Gezeichnet/Drawn by Ausgabe-Datum/ Date of edition Format Maßstab/Scale E. Baum 13.11.2012 800 x 270 mm 1 : 1 gem. PM-Blatt Ausgabe Satzanweisung-Nr./ Drawing no. Print Services Entwicklung und Grafik Graphic arts and typesetting 90 15 90 800 5 5 5 5 Pharmacode 1. “” BERININ ® P (Blood coagulation Factor IX, human pasteurized) 2. 600/1200 IU 5/10 ml 120 IU/ml (IU) (one stage clotting assay) Berinin P50 IU 167 mmol/l (3.84 mg/ml) 6.1 3. / 4. 4.1 B() 4.2 ( ) (IU) (WHO) ( ) ( ) (IU)1 mL (IU) 1% =() × (%IU/dl) × 1.0 (%IU/dl) • • • • B 20 40 IU 3 4 4.4 6.6 2 ml ( 4.4) (CVAD) CVAD / human immunodeficiency virus (HIV)hepatitis B virus (HBV)hepatitis C virus (HCV) hepatitis A virus (HAV) B19 (parvovirus B19) B19 B19 ( ) () (A B ) / 4.5 ( ) ( ) (4.4) B ( ) (HAT Type II)100,000µl 50 6-14 ( ) ( ) ( ) () B 4.4 / 4.9 6. 6.1 III (pH) 5/10 6.2 6.1 6.3 3 ≤25 16 8 6.4 2-25 6.5 600 IU10 type I ( ) () 1200 IU17 type I ( ) () 5600 IU 6 type I ( ) ( ) 101200 IU 10 type I ( ) ( ) _Berinin P 600_ 5 ml 20/20 _Berinin P 1200_ 10ml 20/20 6.6 - ( ) () - (Mix2Vial) Berinin P ( 3.2) 7. 8. / 9. 20167 10. CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany 11. (02) 236130400800-231956 8 7 6 5 4 3 2 1 000618 (%IU/dl) 20-40 30-60 60-100 30-60 80-100 () / () / () 24 1 24 3-4 8 24 24 8 24 7 30%-60% (IU/dl) 4.3 6.1 4.4 Berinin P2000 IU64 mg Berinin P ( ) (Bethesda Unit, BU) (DIC) 4.6 B 4.7 4.8 Berinin P (MedDRA) (≥ 1/10) (≥ 1/100 <1/10) (≥ 1/1,000 <1/100) (≥ 1/10,000 <1/1,000) (< 1/10,000) () () 5. 5.1 / ATCB02B D04 68,000 K XIa / B 5.2 14 23 ( 10 43 ) (IVR) 1.1 (IU/dl)/(IU/kg) ( 0.57 1.69 (IU/dl)/(IU/kg)) (MRT) 27 ( 18 40 ) 4.5 mL/h/kg ( 2.5 12.5 mL/h/kg) 5.3 Berinin P Berinin P ( ) 1 2 1. 2. 3 4 5 6 3. 4. 5. 6. 7 8 9 7. 8. 9. (On demand treatment) () 1. NAME OF THE MEDICINAL PRODUCT BERININ ® P (Blood coagulation Factor IX, human pasteurized) 2. QUALITA Baca dokumen lengkap