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  药店国别: 瑞士药房
产地国家: 瑞士
所属类别: 抗癌药物->治疗骨肉瘤
处方药:处方药
包装规格: 120毫克/1.7毫升/小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
Amgen
该药品相关信息网址1:
http://www.xgeva.com/
该药品相关信息网址2:
http://www.rxlist.com/xgeva-drug.htm
原产地英文商品名:
XGEVA INJECTION 120mg/1.7ml/vial/box
原产地英文药品名:
DENOSUMAB
中文参考商品译名:
癌骨瓦注射剂 120毫克/1.7毫升/小瓶/盒
中文参考药品译名:
地诺单抗
原产地国家批准上市年份:
2010/11/18
英文适应病症1:
Substance of bone metastases
临床试验期:
完成
中文适应病症参考翻译1:
实质肿瘤骨转移
药品信息:
1 适应症与用途 1.1 实质肿瘤骨转移 XGEVA适用于实体肿瘤已有骨转移之成人病患,预防发生骨骼相关事件。 1.2 重要的使用限制 XGEVA并不适用于预防多发性骨髓瘤患者发生骨骼相关事件[参见临床试验(14)]。 2 用法用量 本药限由医师使用 2.1 建议剂量 XGEVA建议剂量为每4週一次于上臂、大腿或腹部皮下注射120毫克。 应补充钙质与维生素D,以治疗或预防低血钙症[参见警语和注意事项(5.1)]。 2.2 准备与施打 施打前应目视检查XGEVA是否有微粒异物或变色的现象。XGEVA为无色至淡黄色的澄清溶液, 并可能含有微量的透明至白色的蛋白质微粒。如果溶液有变色或溷浊的现象,或溶液中含有许多颗粒或微粒异物,请不要使用。 在施打之前,可先将XGEVA自冰箱中取出,然后让其在保留于原始包装盒中的情况下自然达到 室温(最高不超过25°C/77°F)。此过程通常需要15至30分钟。切勿以任何其他方式将XGEVA加 温[参见包装规格/贮存与操作(16)]。 请使用27号针头抽取及注射小瓶中的全部内容物。请勿重複将针头插入小瓶。请将单次使用后 或针头插过的小瓶予以丢弃。 3 剂型与剂量规格 120毫克/1.7毫升(70毫克/毫升)单次使用小瓶装。 4 禁忌 无。 5 警语和注意事项 5.1 低血钙症 XGEVA可能会引发严重的低血钙症。在开始使用XGEVA治疗之前,应先矫治既有的低血钙症。 应监测血钙浓度,并视需要补充钙、镁及维生素D。将XGEVA与其他可能会降低血钙浓度的药 物併用时,应更加频繁地监测浓度。在上市之后,曾有发生严重症状性低血钙症的报告[参见不 良反应(6.2)]。请嘱咐患者,出现低血钙症的症状时,应与健康照护专业人员联络[参见不良反应 (6.1)与病患谘询须知(17)]。 根据使用较低剂量之denosumab所进行的临床试验,在肌酸酐廓清率低于30毫升/分钟或正在 接受透析治疗的患者中,发生严重低血钙症的风险要高于肾功能正常的患者。在一项针对55位未罹患癌症且肾功能不全程度各异之患者投予单剂60毫克denosumab的试验中,17位肌酸酐 廓清率低于30毫升/分钟或正在接受透析治疗的患者有8位出现校正后血钙浓度低于8.0 mg/dL 的现象,而在12位肾功能正常的患者中则无人出现这种现象。目前尚未针对肌酸酐廓清率低于 30毫升/分钟或正在接受透析治疗的患者评估过在每4週投予120毫克之建议疗程下发生低血钙 症的风险。 5.2 颚骨坏死(ONJ) 接受XGEVA治疗的患者可能会发生颚骨坏死(ONJ),其表现包括颚骨疼痛、骨髓炎、骨炎、骨 骼腐蚀、牙齿或牙周感染、牙痛、齿龈溃疡、或齿龈糜烂。牙科手术后口腔或颚骨持续疼痛或 伤口癒合缓慢可能也是ONJ的表现。在一项针对骨转移患者所进行的临床试验中,接受XGEVA 治疗的患者有2.2%于中位曝药量达13剂之后发生ONJ;在这些患者中,有79%有拔牙、口腔卫 生不良或是使用牙科器材的病史[参见不良反应(6.1)]。在一项针对有高骨转移风险之前列腺癌患 者(denosumab尚未被核准用于此类患者)所进行的临床试验中,有5.4%的患者于中位曝药量达 20剂之后发生ONJ。 在开始使用XGEVA治疗之前及使用XGEVA治疗期间,应定期进行口腔检查,并採取适当的口腔 预防措施。应嘱咐患者保持良好的口腔卫生习惯。使用XGEVA治疗期间应避免进行侵入性的牙 科处置。 在使用XGEVA期间疑似发生或确定发生ONJ的患者应接受牙医师或口腔外科医师的照护。对此 类患者,以大范围的牙科手术来治疗ONJ可能会使病情更加恶化。 5.3 怀孕 对孕妇投予XGEVA可能会造成胎儿伤害。根据动物研究的发现,预期XGEVA会造成不良的生殖 影响。食蟹猴的研究显示,出生前接触denosumab会导致流产、死产及出生后死亡的发生率升 高,并会出现缺乏周边淋巴结、骨骼生长异常及新生儿生长减慢的现象[参见特殊族群之使用 (8.1)]。 对于孕妇使用XGEVA,目前尚无任何适当且控制良好的研究。应嘱咐女性患者在使用XGEVA治 疗期间要避免怀孕。如果患者在怀孕期间使用本药,或在使用本药期间怀孕,应告知患者胎儿 可能面临的风险。 6 不良反应 下列不良反应除了在下文中会论及之外,在本彷单的其他段落中也有详细的说明:  低血钙症[参见警语和注意事项(5.1)]  颚骨坏死[参见警语和注意事项(5.2)] 在接受XGEVA治疗的患者中,最为常见的不良反应(每位病患发生率高于或等于25%)为疲倦/无 力、低磷酸盐血症及噁心(参见表1)。 在接受XGEVA治疗的患者中,最为常见的严重不良反应为呼吸困难。 最常导致停用XGEVA的不良反应为骨坏死及低血钙症。 6.1 临床试验的经验 由于临床研究的进行条件差异极大,因此,在一种药物的临床研究中所观察到的不良反应发生 率不可直接和其他临床试验中的发生率进行比较,也可能无法反映实务中所观察到的发生率。 曾在三项随机、双盲、双虚拟试验 (即试验1、2和3) 中评估过XGEVA的安全性[参见临床试验 (14)],在这三项试验中,共有2841位前列腺癌、乳癌或其他实质肿瘤发生骨转移,或多发性骨 髓瘤出现溶骨性病变的患者接受了至少一剂XGEVA的治疗。在试验1、2和3中,患者经随机分 组后即分别接受每4週皮下注射120毫克XGEVA,或每4週静脉(IV)输注4毫克(视肾功能减弱的情 形调整剂量) zoledronic acid的治疗。进入试验的条件包括血钙浓度(校正值)为8至11.5mg/dL (2至2.9毫莫耳/升),以及肌酸酐廓清率为30毫升/分钟或更高;曾接受静脉注射双磷酸盐治疗的 患者,以及有ONJ或颚骨骨髓炎之病史、患有须进行口腔外科手术治疗之活动性牙齿疾病或颚 骨疾病、牙科/口腔手术伤口尚未癒合、或是计划要进行任何侵入性牙科处置的患者,都被排除 于研究之外。在研究期间,每4週即监测一次血清生化值(包括钙与磷)含量。建议补充钙质与维 生素D,但并未要求一定要补充。 患者持续使用XGEVA治疗的中位期间为12个月(范围:0.1–41个月),持续参与研究的中位期间 为13个月(范围:0.1–41个月)。在接受XGEVA治疗的患者中,有46%为女性。有85%为白人, 5%为西班牙人/拉丁美洲人、6%为亚洲人,并有3%为黑人。中位年龄为63岁(范围:18–93岁)。 接受XGEVA治疗的患者有75%同时接受化学治疗。 1 INDICATIONS AND USAGE   1.1 substance of bone metastases   XGEVA applies to adult patients have bone metastases of solid tumors, prevention of skeletal-related events.   1.2 Important Limitations   XGEVA is not indicated for the prevention of bone in patients with multiple myeloma-related events [see Clinical Trials (14)].   2 Dosage Limit the use of the drug by a physician 2.1 The recommended dose   XGEVA recommended dose is once every four weeks in the upper arm, thigh or abdomen subcutaneous injection of 120 mg.   Should supplement calcium and vitamin D, to treat or prevent hypocalcemia [see Warnings and Precautions (5.1)].   2.2 Preparation and facilities to play   Facilities should be visually inspected before playing XGEVA for particulate matter and discoloration. XGEVA is a colorless to pale yellow clear solution, And may contain trace amounts of protein particles transparent to white. If the solution is discolored or muddy cloud phenomenon, or the solution contains many particles or particulate matter, please do not use.   Before applying to play, you can simply remove XGEVA from the refrigerator, and then allowed to keep the original in case of natural reached box At room temperature (not exceeding 25 ° C/77 ° F). This process usually takes 15-30 minutes. Never in any other way will add XGEVA Wen [See Packing / Storage and Operation (16)].   Use the extraction needle 27 and the injection of the entire contents of the vial. Do not repeat the needle into the vial. Keep after a single use Or a needle inserted through the vial be discarded.   3 DOSAGE FORMS AND STRENGTHS Specifications   120 mg / 1.7 ml (70 mg / mL) single use small bottles.   4 taboo   None.   5 Warnings and Precautions   5.1 hypocalcemia   XGEVA may cause severe hypocalcemia. Before you start using XGEVA treatment, treatment should be existing hypocalcemia. Calcium concentration should be monitored and, if necessary supplement of calcium, magnesium and vitamin D. The XGEVA with other calcium concentration may decrease drug Substance when used, the concentration should be monitored more frequently. After the listing, had severe symptomatic hypocalcemia reported to occur [see no Adverse reactions (6.2)]. Please when asked patients, symptoms of hypocalcemia, and health care professionals should contact [see Adverse Reactions (6.1) and patient consultation Instructions (17)].   Clinical trials based on the use of lower doses of denosumab conducted in creatinine clearance less than 30 ml / min or is Patients receiving dialysis therapy, severe hypocalcemia risk than patients with normal renal function. Not in a cancer for 55 and varying degrees of renal dysfunction in patients administered a single dose of 60 mg denosumab trial, 17 creatinine Patients clearance less than 30 ml / min or are receiving dialysis treatment has eight appear after correcting calcium concentrations below 8.0 mg / dL Phenomenon, and in 12 patients with normal renal function is unmanned this phenomenon. Yet for creatinine clearance below 30 ml / min or in patients undergoing dialysis treatment assessed hypocalcemia occurred every four weeks at 120 mg administered under the proposed treatment The risk of disease.   5.2 osteonecrosis of the jaw (ONJ)   Patients receiving XGEVA treatment of osteonecrosis of the jaw can occur (ONJ), its performance, including the jaw bone pain, osteomyelitis, osteitis, bone Iliac corrosion, dental or periodontal infection, pain, ulcers gum, or gum erosion. After oral or dental surgery persistent pain or jaw bone Slow wound healing may also ONJ performance. In a clinical trial for patients with bone metastases conducted, accept XGEVA 2.2% of patients treated at a median ONJ occurs after drug exposure amounted to 13; Of these patients, 79% had extractions, oral health Health and dental equipment or use bad history [see Adverse Reactions (6.1)]. In one targeted at high risk of bone metastases in prostate cancer patients Clinical trials were (denosumab has not been approved for such patients) performed in 5.4% of patients with a median exposure of the drug reached at ONJ occurs after 20.   XGEVA use during treatment and before you start using XGEVA treatment, oral examination should be conducted regularly and take appropriate oral Preventive measures. Patients should be instructed to maintain good oral hygiene habits. Use XGEVA therapy should be avoided during invasive dental Section disposal.   Determining the occurrence or suspected occurrence of ONJ in patients should receive dentist or oral surgeon's care during use XGEVA. This Class of patients, with a wide range of dental surgery to treat ONJ may make the disease worse.   5.3 Pregnancy   XGEVA administered to pregnant women may cause fetal harm. According to the findings from animal studies, XGEVA is expected to cause adverse reproductive Affected. Cynomolgus monkey study shows that prenatal exposure to denosumab will lead to the incidence of abortion, stillbirth and neonatal death up High, and there will be a lack of peripheral lymph nodes, bone growth abnormalities and neonatal growth slows phenomenon [see Use in Specific Populations (8.1)]. For pregnant women XGEVA, currently no adequate and well-controlled studies yet. Female patients should be instructed in the use of XGEVA treatment To avoid becoming pregnant during treatment. If the patient use of the drug during pregnancy, or in the use of the drug during pregnancy, the fetus should inform patients Possible risks faced. 6 ADVERSE REACTIONS   The following adverse reactions will be discussed below in addition to outside, in the other paragraphs of this instruction sheet is also described in detail:    hypocalcemia [see Warnings and Precautions (5.1)]  osteonecrosis of the jaw [see Warnings and Precautions (5.2)]   In patients receiving XGEVA treatment, the most common adverse reactions (incidence per patient than or equal to 25%) were fatigue / No Force, hypophosphatemia, and nausea (see Table 1).   In patients receiving XGEVA treatment, the most common serious adverse reactions were dyspnea.   The most common adverse reactions leading to disable XGEVA of osteonecrosis and hypocalcemia.   6.1 Clinical Trials Experience   As a result of differences in conditions of great clinical study, therefore, a clinical study of adverse reactions observed in the drug occurred Other rates are not directly incidence of clinical trials comparing practice may not reflect the incidence observed.   Worked in three randomized, double-blind, double virtual test (ie, test 1, 2 and 3) evaluated XGEVA security [see Clinical Trials (14)], in which three trials, a total of 2,841 prostate cancer, breast cancer and other solid tumors of bone metastasis, or multiple bone Patients with myeloma osteolytic lesions appear received at least one dose of XGEVA treatment. In test 1, 2 and 3, patients were randomized points Group were treated after subcutaneous injection of 120 mg every 4 weeks XGEVA, or every four weeks intravenous (IV) infusion of 4 mg (depending on the situation weakened kidney function Shaped dose adjustment) zoledronic acid treatment. Entered the testing conditions include calcium concentration (correction) of 8 to 11.5mg/dL (2 至 2.9 mmol / l), and creatinine clearance rate of 30 ml / min or greater; had received intravenous bisphosphonate salt treatment Patients, as well as a history of ONJ or osteomyelitis of the jaw bone there, people must be active oral surgical treatment of dental disease or jaw Bone disease, dental / oral surgical wounds have not yet healed, the patient or plan to conduct any invasive dental procedures, have been excluded In the study. During the study period, that is monitored once every four weeks serum biochemical values (including calcium and phosphorus) content. Recommended calcium supplement and Victoria Vitamin D, but not required by law to add.   During the period in which patients continued use of XGEVA treatment was 12 months (range 0.1 to 41 months), continued to participate in the study the median Was 13 months (range 0.1 to 41 months). In patients receiving XGEVA treatment, 46% were female. 85% were white, 5% of Hispanic / Latino, 6 percent were Asian, and 3 percent were black. The median age was 63 years (range :18-93 years). XGEVA treated patients, 75% also received chemotherapy.
更新日期: 2019-5-8
附件:
20195822150121.pdf    

 
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