【商 品 名】择泰　Zometa 【通 用 名】唑来膦酸　Zoledronic　acid 【药物分类】影响骨代谢的药物 【化学名为】1-羟基-2-(咪唑-1-yl)-亚乙基-1,1-二磷酸一水化物 【分 子 式】C5H10N2O7P2·H2O  【分 子 量】290.11. 【性　　状】本品为白色冻干粉. 【适 应 症】用于恶性肿瘤引起的高钙血症(HCM) 【用法用量】 成人和老年人:对于HCM患者(白蛋白修正的血清钙≥(greater than or equal to)3.0mmol/L或12mg/dl),推荐剂量为4mg,用0.9%氯化钠或5%葡萄糖溶液100mL稀释,进行不少于15分钟静脉输注. 白蛋白修正的血清钙(mg/dL)=患者血钙(mg/dL)+0.8×[中位血清白蛋白(g/L)-患者血清白蛋白(g/L). 给药前必须测试患者的水化状态,治疗中尿排量应维持2L/天,应根据患者的临床状态进行给药.由于该药对肾功能损害可能导致肾衰的危险性,一次给药剂量不得超过4mg. 再次治疗:血钙浓度重又升高而需再次治疗的病例是有限的(只出现在8mg剂量组中).再次治疗必须与前一次至少相隔7-10天.同时,治疗前应检测患者的血清肌酐水平. 肾功能不全患者:到目前为止的研究表明,对于轻度、中度肾功能损伤的患者无需调整剂量和给药时间(血清肌酐<400umol/L或4.5mg/dl). 肝功能不全者:由于临床上严重肝功能不全患者的病例数有限,因此,对于此类患者没有特别的建议. 【规　　格】4mg x 1 瓶 【贮　　藏】30°C以下保存. 【有 效 期】三年 INDICATION ZOMETA is a treatment for hypercalcemia of malignancy (HCM; a condition resulting in high calcium blood levels due to cancer). ZOMETA is also used to reduce and delay bone complications due to multiple myeloma and bone metastases from solid tumors; used with anti-cancer medicines. ZOMETA is not an anti-cancer therapy. If you have prostate cancer, you should have failed treatment with at least one hormonal therapy prior to taking ZOMETA. IMPORTANT SAFETY INFORMATION Do not use ZOMETA if you have had a severe allergic reaction to zoledronic acid or any components of ZOMETA. These reactions, including rare cases of hives and angioedema (swelling often near your eyes and lips), and very rare cases of life-threatening allergic reactions, have been reported. ZOMETA is in a class of drugs called bisphosphonates, and contains the same active ingredient as that found in Reclast® (zoledronic acid). If you are treated with ZOMETA, you should not be treated with Reclast. If you have HCM, you should drink plenty of clear fluids before using ZOMETA. If you have kidney problems, tell your doctor. The risk of adverse reactions (especially related to the kidney) may be greater for you. ZOMETA treatment is not for patients with severe kidney problems. Patients with kidney problems on multiple cycles of ZOMETA or other bisphosphonates are at greater risk for further kidney problems. It is important to get your blood tests while you are receiving ZOMETA. Your doctor will monitor your kidney function before each dose. Tell your doctor if you are on other drugs, including aminoglycosides, loop diuretics, and drugs which may be harmful to the kidney. Osteonecrosis of the jaw (ONJ) has been reported mainly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving anti-cancer drugs and corticosteroids, which may make it more likely to get ONJ. If you have advanced breast cancer or a type of cancer called multiple myeloma, or if you have had dental extraction, periodontal disease, local trauma, including poorly fitting dentures, you may be at greater risk of getting ONJ. Many reports of ONJ involved patients with signs of local infection, including bone/bone marrow inflammation. You should maintain good oral hygiene and have a dental examination with preventive dentistry prior to beginning ZOMETA. While on treatment, avoid invasive dental procedures, if possible, as recovery may take longer. If you develop ONJ while on bisphosphonate therapy, dental surgery may worsen the condition. If you require dental procedures, there are no data available to suggest whether stopping ZOMETA treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Based on your condition, your doctor will determine the treatment plan you will receive. Do not use ZOMETA if you are pregnant or plan to become pregnant, or if you are breast-feeding. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, including ZOMETA. Do not continue using ZOMETA if severe symptoms develop, as some patients had the symptoms reappear after taking ZOMETA or another bisphosphonate again. In aspirin sensitive patients, bronchoconstriction (tightening of the airways in the lungs) has been observed while taking bisphosphonates. If you are an HCM patient with liver problems, talk to your doctor about whether ZOMETA is appropriate for you. HCM patients may experience flu-like symptoms (fever, chills, flushing, bone pain and/or joint or muscle pain). Common side effects in HCM patients include fever, nausea, constipation, anemia, shortness of breath, diarrhea, abdominal pain, worsening of cancer, insomnia, vomiting, anxiety, urinary tract infection, low phosphate levels, confusion, agitation, a fungal infection called moniliasis, low potassium levels, coughing, skeletal pain, low blood pressure, and low magnesium levels. Redness and swelling may occur at the site that you are injected. Common side effects for patients with multiple myeloma and bone metastases due to solid tumors include bone pain, nausea, fatigue, anemia, fever, vomiting, constipation, shortness of breath, diarrhea, weakness, muscle pain, anorexia, cough, joint pain, lower-limb swelling, worsening of your cancer, headache, dizziness (excluding vertigo), insomnia, decreased weight, back pain, numbness/tingling, and abdominal pain. These side effects are listed regardless of any potential association with the medications used in registration studies of ZOMETA in bone metastases patients. Eye-related side effects may occur with bisphosphonates, including ZOMETA. Cases of swelling related to fluid build-up in the eye, as well as inflammation of the uvea, sclera, episclera, conjunctiva, and iris of the eye have been reported. Patients with multiple myeloma and bone metastases from solid tumors should be taking an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily. ------------------------------------------------------------------ 原产地英文商品名: ZOMETA 4mg/5ml/Vial 原产地英文药品名: ZOLEDRONIC ACID 中文参考商品译名: 择泰 4毫克/5毫升/瓶 中文参考药品译名: 唑来磷酸 中文参考化合物名称: 1-羟基-2-(咪唑-1-yl)-亚乙基-1,1-二磷酸一水化物 产地国家: 美国 所属类别: 抗癌药物->抗肿瘤 处方药:处方药 包装规格: 4毫克/5毫升/瓶 销售单价(美元 US$): 1612 美元 销售单价(人民币 RMB): 10641元 计价单位: 瓶