您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8473 处方药 8099 非处方药 268 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国内客服电话:
国际免费电话:


QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 美国药房
产地国家: 美国
所属类别: 激素内分泌药物->甲状腺激素类药及抗甲状腺激素药物
处方药:处方药
包装规格: 1微克/毫升 15毫升/瓶
计价单位:
  点击放大  
生产厂家英文名:
Validus Pharmaceuticals LLC
该药品相关信息网址1:
https://www.rxlist.com/rocaltrol-drug.htm
该药品相关信息网址2:
https://rocaltrol.us/
原产地英文商品名:
Rocaltrol Oral Solution 1ug/mL 15mL/bottle
原产地英文药品名:
calcitriol
中文参考商品译名:
Rocaltrol口服液 1微克/毫升 15毫升/瓶
中文参考药品译名:
骨化三醇
原产地国家批准上市年份:
2009/07/23
英文适应病症1:
Treatment of secondary hyperparathyroidism and metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL / min) who have not undergone dialysis
英文适应病症2:
Hypocalcemia and the resulting metabolic bone disease in patients with chronic renal dialysis
英文适应病症3:
Treatment of postoperative hypotension and its postoperative hypoparathyroidism, idiopathic hypoparathyroidism and pseudohypoparathyroidism
临床试验期:
完成
中文适应病症参考翻译1:
中度至重度慢性肾功能衰竭(Ccr 15至55 mL / min)尚未进行透析的患者继发性甲状旁腺功能亢进和代谢性骨病的治疗
中文适应病症参考翻译2:
慢性肾透析患者的低钙血症和由此产生的代谢性骨病
中文适应病症参考翻译3:
术后低位血症的治疗及其在术后甲状旁腺功能减退症,特发性甲状旁腺功能减退症和假性甲状旁腺功能减退症
药品信息:

---------------------------------------------------------------
详细处方信息以本药内容附件PDF文件(20212723334328.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文Rocaltrol口服液处方资料(仅供参考)

【英文名称】Rocaltrol

【适用症】

---透析前患者:

Rocaltrol适用于中度至重度慢性肾功能衰竭(Ccr 15至55 mL / min)尚未进行透析的患者继发性甲状旁腺功能亢进和代谢性骨病的治疗。在儿童中,肌酐清除率必须针对1.73平方米的表面积进行校正。血清iPTH水平≥100pg/ mL强烈提示继发性甲状旁腺功能亢进。

---透析患者:

Rocaltrol用于治疗慢性肾透析患者的低钙血症和由此产生的代谢性骨病。在这些患者中,Rocaltrol给药可增强钙吸收,降低血清碱性磷酸酶水平,并可降低甲状旁腺激素水平升高和纤维囊性骨炎的组织学表现和缺陷性矿化。

---甲状旁腺功能减退症患者:

Rocaltrol也适用于术后低位血症的治疗及其在术后甲状旁腺功能减退症,特发性甲状旁腺功能减退症和假性甲状旁腺功能减退症患者中的临床表现

【用法用量】

每位患者必须仔细确定Rocaltrol的最佳日剂量。 Rocaltrol可以胶囊(0.25mcg或0.50mcg)或口服溶液(1mcg / mL)口服给药。 Rocaltrol治疗应始终以尽可能低的剂量开始,如果不仔细监测血清钙,则不应增加。

Rocaltrol治疗的有效性取决于每位患者每天摄入足够但不过量的钙摄入量的假设。建议患者每天至少摄入600毫克钙。美国成人钙的RDA为800mg至1200mg。为了确保每位患者每天摄入足够的钙,医生应该开具钙补充剂或指导患者采取适当的饮食措施。

由于胃肠道钙吸收的改善,Rocaltrol的一些患者可能维持较低的钙摄入量。倾向于发生高钙血症的患者可能仅需要低剂量的钙或根本不需要补充。

在使用Rocaltrol治疗的滴定期间,应每周至少检查两次血清钙水平。当确定Rocaltrol的最佳剂量时,应每月检查血清钙水平(或如下所示,针对个体适应症)。血压钙估计的样本应该在没有止血带的情况下进行。

---透析患者:

推荐的Rocaltrol初始剂量为0.25 mcg /天。如果未观察到疾病状态的生化参数和临床表现的令人满意的反应,则剂量可以以4至8周的间隔增加0.25mcg /天。在此滴定期间,应每周至少两次获得血清钙水平,如果注意到高钙血症,应立即停药,直至出现正常血糖(见预防措施:一般情况)。应定期测定磷,镁和碱性磷酸酶。

血清钙水平正常或仅略微降低的患者可能每隔一天对Rocaltrol剂量0.25 mcg做出反应。大多数接受血液透析的患者对0.5至1 mcg /天的剂量有反应。 口服Rocaltrol可使某些尿毒症患者的血浆离子钙正常化,但未能抑制甲状旁腺功能亢进。在这些具有自主甲状旁腺功能亢进的个体中,口服Rocaltrol可能有助于维持正常血钙,但尚未被证明是对甲状旁腺功能亢进的充分治疗。

---甲状旁腺功能减退症:

Rocaltrol的推荐初始剂量为每天0.25 mcg /天。如果未观察到疾病的生化参数和临床表现的令人满意的反应,则可以以2至4周的间隔增加剂量。在剂量滴定期间,应每周至少两次获得血清钙水平,如果注意到高钙血症,应立即停用Rocaltrol,直至出现正常血糖(见预防措施:一般情况)。还应认真考虑降低膳食钙的摄入量。应定期测定血清钙,磷和24小时尿钙。

大多数成年患者和6岁及以上的儿科患者对剂量的反应在每天0.5 mcg至2 mcg的范围内。患有甲状旁腺功能减退症的1至5岁年龄组的儿科患者通常每天给予0.25 mcg至0.75 mcg。患有低于6岁的假性甲状旁腺功能减退症的治疗患者数量太少,无法提出剂量建议。

甲状旁腺功能减退症患者偶尔会出现吸收不良症状;因此,可能需要更大剂量的Rocaltrol。

---透析前患者:

对于3岁及以上的成人和儿科患者,推荐的Rocaltrol初始剂量为0.25 mcg /天。如果需要,该剂量可以增加至0.5mcg /天。

对于小于3岁的儿科患者,推荐的Rocaltrol初始剂量为10至15 ng / kg /天。

【禁忌】

Rocaltrol不应给予高钙血症或维生素D毒性证据的患者。 在对Rocaltrol(或同类药物)或任何非活性成分已知过敏的患者中禁用Rocaltrol是禁忌的。

【INDICATION】

---Predialysis Patients:

Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.

---Dialysis Patients:

Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.

---Hypoparathyroidism Patients:

Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism

【DOSAGE AND ADMINISTRATIO】

The optimal daily dose of Rocaltrol must be carefully determined for each patient. Rocaltrol can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Rocaltrol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.

The effectiveness of Rocaltrol therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

Because of improved calcium absorption from the gastrointestinal tract, some patients on Rocaltrol may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all.

During the titration period of treatment with Rocaltrol, serum calcium levels should be checked at least twice weekly. When the optimal dosage of Rocaltrol has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

---Dialysis Patients:

The recommended initial dose of Rocaltrol is 0.25 mcg/day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, dosage may be increased by 0.25 mcg/day at 4- to 8-week intervals. During this titration period, serum calcium levels should be obtained at least twice weekly, and if hypercalcemia is noted, the drug should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.

Patients with normal or only slightly reduced serum calcium levels may respond to Rocaltrol doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

Oral Rocaltrol may normalize plasma-ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyper-function, oral Rocaltrol may be useful to maintain normocalcemia but has not been shown to be adequate treatment for hyperparathyroidism.

---Hypoparathyroidism:

The recommended initial dosage of Rocaltrol is 0.25 mcg/day given in the morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease is not observed, the dose may be increased at 2- to 4-week intervals. During the dosage titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia is noted, Rocaltrol should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Careful consideration should also be given to lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically.

Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1- to 5-year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.

Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of Rocaltrol may be needed.

---Predialysis Patients:

The recommended initial dosage of Rocaltrol is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. This dosage may be increased if necessary to 0.5 mcg/day.

For pediatric patients less than 3 years of age, the recommended initial dosage of Rocaltrol is 10 to 15 ng/kg/day.

【CONTRAINDICATIONS】

Rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of Rocaltrol in patients with known hypersensitivity to Rocaltrol (or drugs of the same class) or any of the inactive ingredients is contraindicated.

---------------------------------------------------------------
详细处方信息以本药内容附件PDF文件(20212723334328.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2021-02-08
附件:
20212723334328.pdf    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国内客服电话:     国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com