Negara: Taiwan
Bahasa: China
Sumber: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Maxacalcitol
台灣中外製藥股份有限公司 台北市松山區敦化北路260號3樓 (23060795)
H05BX
注射劑
Maxacalcitol (8818001100) MCG
盒裝
製 劑
限由醫師使用
Nipro Pharma Corporation Ise Plant 647-240, Ureshinotengeji-cho, Matsusaka-shi, Mie 515-2302, Japan JP
Other anti-parathyroid agents
接受維持性血液透析治療病人之次發性副甲狀腺機能亢進。
有效日期: 2023/05/17; 英文品名: OXAROL Injection 2.5μg
2018-05-17
• OXAROL ® Injection 2.5 µg 5 µg [ 1 mL ] Maxacalcitol 2.5 µg 5 µg Dibasic sodium phosphate hydrate, Sodium dihydrogen phosphate dihydrate, Polysorbate 20, Sodium chloride, Anhydrous ethanol, Water for Injection pH 7.80 - 8.20 1 3 intact-PTH < 500 pg/mL HS-PTH < 40,000 pg/mL 5 µg intact-PTH ≥ 500 pg/mL HS-PTH ≥ 40,000 pg/mL 10 µg 2.5 µg 10 µg PTH PTH 20 µg intact-PTH ≤ 150 pg/mL ® 1. ® 1 ® 2 2. 1 D D ® ® D 2 ® ® 2 11.5 mg/dL 5.75 mEq/L 11.0 mg/dL 4.0 g/dL mg/dL = mg/dL - g/dL + 4.0 3 4 ® PTH ® 3. ® Alfacalcidol Calcitriol PTH Teriparatide Digoxin ® CYP3A4 Ketoconazole ® ® CYP3A4 ® ® 4. 4196 1115 26.6% 1316 933 22.2% 85 2.0% CK CPK 64 1.5% 42 1.0% 25 0.6% 1 22.2% ® 11.5 mg/dL 5.75 mEq/ L ® 11.0 mg/dL 5.5 mEq/L 2 ≥ 0.1% < 0.1% ® 2.5 OXAROL ® INJECTION 2.5 ΜG 027425 ® 5 OXAROL ® INJECTION 5 ΜG 027424 <2.0 > ( 1 ) 17 Ichikawa F, et al. Nephrology. 1998; 4: 391. 18 Internal data: Pharmacological study Effect on osteoblasts, in vitro . 19 Internal data: pharmacokinetic study mass balance study . 20 Internal data: pharmacokinetic study in vitro metabolizing organs . 21 Internal data: pharmacokinetic study Investigation of metabolic enzymes, in vitro . 22 Internal data: clinical study drug use surveillance . 23 Internal data: clinical study healthy subjects . 1 100 10 ºC JPI Oct 2015 version 07 260 3 Nipro Pharma Corporation Ise Plant 647-240, Ureshinotengeji-cho, Matsusaka-shi, Mie, Japan ( 4 ) / AST GOT ALT GPT CK CPK LDH Al-P X 5. 1 2 96 65 12 12.5% ® 881 64 83 9.4% 6. ® ® ® 1.1 µg/kg/day maxacalcitol 7. ® 8. 1 ® 2 ® one-point-cut 3 ® 9. 1 F344/DuCrj 24 maxacalcitol F344 18 maxacalcitol 2 977 ® 34 3.5% 38 ECG 15 1 AV T 6 3 ECG ® ECG 1 1 1 i 6 3.3 µg 6.6 µg AUC 0 pg • h/mL 354 135 795 192 min 108.1 45.9 138.7 39.9 mL/h/kg 237 70 174 50 mL/kg 259 48 362 32 maxacalcitol 0 1 2 h pg/mL 1000 100 3.3 µg/body 0 1 2 3 4 h pg/mL 1000 100 6.6 µg/body ii 5 2 1 4 3.3 µg ® 1 1 2 2 14 26 10-17.5 µg ® 1 1 AUC maxacalcitol 2 1 mass balance 200 µg [ 2 β - 3 H ] maxac Baca dokumen lengkapnya