部分中文帕米膦酸二钠处方资料（仅供参考） 药品英文名 Pamidronate Disodium   药品别名 Bonin 帕米膦酸二钠  帕米膦酸   药物剂型 冻干粉针剂： 30mg/10mls、90mg/Vial。 注射液：     30mg/10mls、90mg/10mls 药理作用 本品为双膦酸类药物，体外和动物实验表明可强烈抑制羟磷灰石的溶解和破骨细胞的活性，对骨质的吸收具有显著的抑制作用，对癌症的溶骨性骨转移所致的疼痛有止痛作用，亦可用于治疗癌症所致的高钙血症。   药动学 癌症病人静脉滴注4h以上，平均有51%的药物以原形从尿中排泄，尿的排泄呈现双相动力学特点，半衰期分别为1.6和27.2h。动物实验表明，给药后迅速从循环中消除，主要分布在骨骼、肝脏、脾脏和气管软骨中。本品可长期滞留于骨组织中，半衰期的最后阶段可达300天。   适应证 恶性肿瘤并发的高钙血症和溶骨性癌转移引起的骨痛。   禁忌证 孕妇、授乳期妇女及对本品或其它双膦酸类药物过敏的病人。   注意事项 不可将本品稀释液直接推注。本品不得与其它双膦酸类药物合并使用。本品不适于儿童使用。肾功能异常者慎用。   不良反应 少数人出现轻度恶心、胸痛、胸闷、头晕乏力及轻微的肝肾功能改变等，偶见发热反应。   用法用量 治疗骨转移性疼痛：以注射用水充分溶解后稀释于不含钙离子的生理盐水或5%葡萄糖液体中，缓慢静脉滴注4h以上，浓度不得超过15mg/125ml，滴速不得大于15～30mg/2h。每次用药30～60mg。 治疗高钙血症：应严格根据血钙浓度，在医生指导下用药。 AREDIA (pamidronate disodium) INDICATION(S) Aredia (pamidronate disodium), in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia with malignancy, with or without bone metastases. The safety and efficacy of Aredia in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established. Aredia (pamidronate disodium) is indicated for the treatment of patients with moderate to severe Paget's Disease of bone. The effectiveness was demonstrated primarily in patients with serum alkaline phosphatase ≥3 times the upper limit of normal. Aredia (pamidronate disodium) is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. IMPORTANT SAFETY INFORMATION AREDIA (pamidronate disodium) is contraindicated in patients with clinically significant hypersensitivity to AREDIA or other bisphosphonates. Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of AREDIA (pamidronate disodium) should not exceed 90 mg and the duration of infusion should be no less than 2 hours. After the initial or a single dose of AREDIA, renal deterioration, progression to renal failure, and dialysis has been reported in patients. AREDIA-treated patients, particularly those with multiple myeloma and breast cancer, have reported focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, and some had gradual renal status improvement upon discontinuation of AREDIA. Serum creatinine should be assessed prior to each treatment, and those with bone metastses should have the dose withheld if renal function has deteriorated. AREDIA (pamidronate disodium) should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant or plans to breast-feed while taking this drug, the patient should be apprised of the potential harm to the fetus or baby. AREDIA is excreted intact primarily via the kidney, and the risk of renal adverse reactions may be greater in patients with impaired renal function. Caution is indicated when AREDIA is used with other potentially nephrotoxic drugs, and in multiple myeloma patients, the risk of renal dysfunction is increased when AREDIA is combined with thalidomide. Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including Aredia. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma), and dental status (dental extraction, periodontal disease, local trauma including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection including osteomyelitis. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. Symptoms were generally relieved after stopping treatment, and a subset of patients had symptoms recur after rechallenge with AREDIA or another bisphosphonate. Closely monitor serum calcium, phosphate, magnesium, potassium, creatinine, and CBC, differential, and hematocrit/hemoglobin following initiation of treatment with AREDIA. Those patients with anemia, luekopenia or thrombocytopenia should be carefully monitored in the first two weeks following treatment. Asymptomatic hypophosphatemia (12%), hypokalemia (7%) hypomagnesemia (11%) and hypocalcemia (5-12%) were reported in patients treated with AREDIA. Rare cases of symptomatic hypocalcemia (including tetany) have been reported; short-term calcium therapy may be necessary. Patients with a history of thyroid surgery may have relative hypoparathyroidism that may predispose to hypocalcemia with AREDIA. In post-marketing experience, rare instances of allergic manifestations have been reported, including hypotension, dyspnea, or angioedema, and, very rarely, anaphylactic shock. The most common adverse events (>15%) in bone metastases clinical trials, regardless of causality, were as follows: Asthenia, fatigue, diarrhea, dyspepsia, fluid overload, abdominal pain, anorexia, constipation, metastases, insomnia, nausea, vomiting, urinary tract infection, skeletal pain, fever, headache, coughing, upper respiratory tract infection, anemia, granulocytopenia, myalgias, sinusitis, and dyspnea. The most common adverse events (>15%) in the Hypercalcemia of Malignancy trials, regardless of causality, include: Fluid overload, generalized pain, hypertension, abdominal pain, anorexia, constipation, nausea, vomiting, urinary tract infection, bone pain, anemia, hypokalemia, hypomagnesemia, and hypophosphatemia. The most common adverse events (>10%) in the Paget's Disease trials, regardless of causality, include: Hypertension, arthrosis, bone pain, and headache. In hypercalcemia of malignancy trials, rare cases of uveitis, iritis, scleritis, and episcleritis have been reported, and one case each of uveitis and scleritis were found to recur upon separate rechallenge. In the absence of hypercalcemia, patients at risk of calcium or vitamin D deficiency with predominantly lytic bone metastates or multiple myeloma and patients with Paget's disease of the bone should be administered an oral calcium and vitamin D supplement. 附件: 201133020373815.pdf ------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时请以电话咨询为准！ ------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: PAMIDRONATE DISOD POWDER 90mg/Vial 原产地英文药品名: PAMIDRONATE DISODIUM 中文参考商品译名: 帕米膦酸二钠粉剂 90毫克/瓶 中文参考药品译名: 帕米膦酸二钠 中文参考化合物名称: 3-氨基-1-羟基亚丙基-1，1-二膦酸二钠五水合物 ------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: PAMIDRONATE POWDER 30mg/10mls/Vial 原产地英文药品名: PAMIDRONATE DISODIUM 中文参考商品译名: 帕米膦酸粉剂 30毫克/10毫升/瓶 中文参考药品译名: 帕米膦酸二钠 中文参考化合物名称: 3-氨基-1-羟基亚丙基-1，1-二膦酸二钠五水合物 ------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: PAMIDRONATE LIQUID 30mg/10mls/Vial 原产地英文药品名: PAMIDRONATE DISODIUM 中文参考商品译名: 帕米膦酸液 30毫克/10毫升/瓶 中文参考药品译名: 帕米膦酸二钠 中文参考化合物名称: 3-氨基-1-羟基亚丙基-1，1-二膦酸二钠五水合物 ------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: PAMIDRONATE LIQUID 90mg/10mls/Vial 原产地英文药品名: PAMIDRONATE DISODIUM 中文参考商品译名: 帕米膦酸液 90毫克/10毫升/瓶 中文参考药品译名: 帕米膦酸二钠 中文参考化合物名称: 3-氨基-1-羟基亚丙基-1，1-二膦酸二钠五水合物