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澄蝴韦
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新藥品骨維壯注射劑舊藥品 BONVIVA 3MG/3ML SOLUTION FOR INJECTION B024630216 和聯生技藥業股份有限公司

1 藥品外觀變更藥品異動通知變更品項 :<17I273>Bonviva 3mg/3ml/A <17I273> 主成份 Ibandronic acid 中文名英文名代碼藥商 / 製造廠新藥品骨維壯注射劑舊藥品 BONVIVA 3MG/3ML SOLUTION FOR INJECTION B 和聯生技藥業股份有限公司 /VETTER PHARMA-FERTIGUNG GMBH & CO. KG 衛署許可證之適應症用於治療停經後婦女之骨質疏鬆症 (BMD TSCORE < -2.5 SD), 以減少脊椎骨骨折含量 / 規格給藥途徑其它藥品圖檔 3mg/3ml/A IV 外盒藥商 Roche 改為 Takeda

2 藥品外觀變更藥品異動通知變更品項 :<35B096>Bisolvon (2mg/ml,50ml)Sol'n <35B096> 主成份 Bromhexine 中文名英文名新藥品氣舒痰 (R) 液 2 毫克 / 毫升 BISOLVON (R) SOLUTION 2MG/ML 舊藥品氣舒痰液 2 公絲公撮 BISOLVON SOLUTION 2MG/ML 代碼 B A 藥商 / 製造廠衛署許可證之適應症含量 / 規格給藥途徑其它藥品圖檔台灣百靈佳殷格翰股份有限公司 /PT. BOEHRINGER INGELHEIM INDONESIA 袪痰 (2mg/ml,50ml)Sol'n PO,inhalation 臺灣百靈佳殷格翰股份有限公司 / 健喬信元醫藥生技股份有限公司健喬廠產地改為印尼, 由 ml 改為以瓶計價, 取代 35B012 Bisolvon Sol'n

3 藥品新增 < 17D125> Darbepoetin Alfa (NESP) 20mcg/0.5ml 新藥介紹藥品異動通知 < 17D125> Darbepoetin Alfa (NESP) 20mcg/0.5ml 藥理作用 / Induces erythropoiesis by stimulating the division and 作用機轉 differentiation of committed erythroid progenitor cells; induces the release of reticulocytes from the bone marrow into the bloodstream, 適應症 / 劑量 where they mature to erythrocytes. There is a dose response relationship with this effect. This results in an increase in reticulocyte counts followed by a rise in hematocrit and hemoglobin levels. When administered SubQ or I.V., darbepoetin's half-life is ~3 times that of epoetin alfa concentrations. Indication& Dosage: SC/I.V. Adult: Anemia in neoplastic disease, due to chemotherapy (non-myeloid malignancy): SC, 2.25 μg/kg q1wk; or 500 μg q3wk. Dose should be adjusted to maintain a target Hb up to 12 g/dl: Hemoglobin (Hb) Wkly doses less than a 1 g/dl increaseincrease dose to 4.5 after 6 wk increases by more than 1 g/dl in a 2 wk period or exceeds 11 g/dl exceeds 13 g/dl μg/kg Anemia of chronic renal failure: IV/SC, 0.45 μg/kg q1wk. Every-3-wk doses Increase dose to 4.5 μg/kg Reduce dose by 40% Reduce dose by 40% Hold dose until Hb is Hold dose until Hb is less than 12 g/dl. Reinstitute at a 40% dose reduction. less than 12g/dL. Reinstitute at a 40% dose reduction. Dose should be adjusted every 2 to 4 wk by 20% or 25% to maintain a target Hb up to 12 g/dl. (Hb increases rate should nt exceed 1g/dL in any 2-wk period). Conversion from huepo to darbepoetin alpha: Previous wkly huepo dose (IU) less than 2, Wkly Aranesp dose (μg)

4 2,500 to 4, ,000 to 10, ,000 to 17, ,000 to 33, ,000 to 89, ,000 or greater 200 huepo 2-3 times/wk darbepoetin alfa q1wk; huepo q1wk darbepoetin alfa q2wk. The first dose of darbepoetin alfa should be administered at the time of next planned huepo dose. Pediatric 1 yr Anemia of chronic renal failure: The use of darbepoetin alpha as the initial treatment to correct anemia in pediatric patients with chronic renal failure has not been studied. Conversion from huepo to darbepoetin alpha: Previous wkly huepo dose (IU) Wkly Aranesp dose (μg) less than 1,500 insufficient data to determine dose 1,500 to 2, ,500 to 4, ,000 to 10, ,000 to 17, ,000 to 33, ,000 to 89, ,000 or greater 200 huepo 2-3 times/wk darbepoetin alfa once a wk; huepo q1wk darbepoetin alfa q2wk. The first dose of darbepoetin alfa should be administered at the time of next planned huepo dose. Dose should be adjusted to maintain a target Hb up to 12 g/dl: Hemoglobin (Hb) Wkly doses no increase by at least a 1g/dL Increase dose by 25% within 4 wk increases by more than 1 g/dl in a 2- Reduce dose by 25%

5 使用禁忌不良反應懷孕用藥分級 (FDA) 健保規範其他 wk period approaches 12 g/dl Reduce dose by 25% Hypersensitivity to darbepoetin or any component of the formulation; uncontrolled hypertension; pure red cell aplasia (due to darbepoetin or other erythropoietin protein drugs). Dizziness, headache, seizure ; arthralgia, myalgia; GI discomfort; hyper/hypotension, edema; thrombotic disorder; injection site thrombosis; respiratory disorders; fever. C 01) 限慢性腎功能衰竭接受透析病人使用. 初次使用, 其 Hct 需 <=28%. 續用其 Hct 需 <=36%. 02) 限慢性腎功能衰竭引起之貧血使用.Scr>6mg/dl. 初次使用, 其 Hct 需 <=28%. 續用其 Hct 需 <=36%. 03) 限患有固態腫瘤且接受含鉑 (Platinum) 化療而引起之症狀性貧血, 且 Hb <8mg/dL NOTE: 取代 < 17D098> Darbepoetin Alfa (NESP) 20mcg/1ml 使用前應作體內鐵質貯存評估, 以後三至六個月追蹤 1. 如 Hb 在 8 gm/dl 以下,ferritin 小於 100 mg/dl 之值仍可能貯存不適當 2.Transferrin saturation 正常是 20 45%; 如小於 20% 有可能是鐵質缺乏 (1) 限慢性腎臟功能衰竭, 接受透析病人, 其 hematocrit (Hct) 在 28%( 含 ) 以下之病患使用 (2) 限慢性腎臟功能衰竭引起之貧血,creatinine>6 mg%, 且 hematocrit 在 28%( 含 ) 以下病患使用 (3) 使用時, 應從小劑量開始,Hct 目標依病人狀況及需要為 33% -36% 之間, 如超過 36% 即應暫停使用, 俟降至 36% 以下再投與 (4) 如 Hct 值維持在目標值一段時間 ( 一至二個月 ), 宜逐次減量, 以求得最低維持劑量 (5) 每名病人所用劑量, 一個月不超過 20000U ( 如 Eprex Recormon) 或 100mcg ( 如 Aranesp Mircera solution for injection in pre-filled syringe) 為原則, 如需超量使用, 應附病人臨床資料 ( 如年齡前月 Hct 值前月所用劑量所定目標值等等 ) 及使用理由 (6) 使用本類藥品之洗腎患者, 每週應檢查 Hct 值乙次,CAPD 及未透析患者, 如因病情需要使用本類藥品時, 每月應檢查 Hct 值乙

6 藥品圖檔次檢查費用包含於透析費用內, 不另給付 ( 未接受透析病人除外 ) (7) 使用本類藥品期間如需輸血, 請附輸血時 Hct 值及原因 3. 治療與癌症化學治療有關的貧血 : (1) 限患有固態腫瘤且接受含鉑 (platinum) 化學藥物治療而引起之症狀性貧血, 且 Hb<8 gm/dl 之病人使用對於癌症患者預期有合理且足夠的存活時間者 ( 含預期治療, 無需輔助治療者 ), 不應使用 EPO 治療貧血 (2)Epoetin beta( 如 Recormon) 與 epoetin alfa( 如 Eprex) 初劑量為 150U/Kg 每週 3 次, 最高劑量 300U/Kg 每週 3 次, 或 epoetin beta( 如 Recormon) 初劑量 30,000 單位,epoetin alfa ( 如 Eprex) 初劑量 40,000 單位, 每週 1 次, 最高劑量 60,000 單位, 每週 1 次 ;Darbepoetin alfa( 如 Aranesp) 初劑量 2.25mcg/kg, 每週 1 次, 最高劑量 4.5mcg/kg, 每週 1 次 (3) 符合下列情形之病人, 應即停止使用本類藥品之 : i)hb 超過 10 gm/dl (Hb>10 gm/dl) ii) 於接受治療第 6-8 週內若 Hb 之上升值未達 1 (4) 每次療程最長 24 週

一、胎膜

一、胎膜 : 1. 2. 3. 4. 5. 6. 7. : 1. 2. 3. 4. 1. 2. 3. 4. 0.1% 0.1% % 2 3 2 3d 2. : 1 2 3 4 1. 12 18h 3% 12% 20% 50% (2) (3) 1 2d (4), 8 12h 50 100IU 100IU 6 10mg 24h : (1) (2) (3) (4) (5) 3. (1)