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  药店国别: 德国药房
产地国家: 芬兰
所属类别: 神经系统药物->镇静、催眠、抗焦虑及抗惊厥药
处方药:处方药
包装规格: 10 mL/vial, 4 vial/pack
计价单位:
  点击放大  
生产厂家英文名:
Orion Pharma GmbH
该药品相关信息网址1:
https://www.dexdor.eu
该药品相关信息网址2:
https://www.drugs.com/uk/dexdor.html
该药品相关信息网址3:
https://en.wikipedia.org/wiki/Dexmedetomidine
原产地英文商品名:
Dexdor 100 micrograms/ml concentrate for solution for infusion 4 vials x 10ml (Minimum Order: 3)
原产地英文药品名:
dexmedetomidine hydrochloride
中文参考商品译名:
Dexdor 100微克/毫升浓缩液用于输注溶液 4小瓶x 10毫升 (最低订单:3)
中文参考药品译名:
盐酸右美托咪定
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Sedation in tracheal intubation and mechanical ventilation for surgical patients undergoing general anesthesia.
临床试验期:
完成
中文适应病症参考翻译1:
用于行全身麻醉的手术患者气管插管和机械通气时的镇静。
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(20189218301427.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分Dexdor处方资料(仅供参考)

Dexdor(dexmedetomidine hydrochloride盐酸右美托咪定)

药物形式

可注射的准备

产品类型

药房只有医院使用

右美托咪(Dexdor®)被推荐为用于在NHS威尔士成人重症监护病房的镇静一个选项(ICU)的患者需要镇静水平比觉醒不深响应于言语刺激(对应里士满搅拌镇静缩放[RASS] 0到-3)。

治疗适应症

在ICU需要镇静水平响应于言语刺激不深觉醒成人患者的镇静(重症监护病房,重症监护室)(对应于值0至3的Scala里士满镇静 - 搅拌(里士满激动 - 镇静量表,RASS)。 组成

每毫升浓缩液含有相当于100微克右美托咪定的右美托咪定盐酸盐。

每个2ml小瓶含有200mcg右美托咪定。

每个4ml小瓶含有400mcg右美托咪定。

每个10ml小瓶含有1000mcg右美托咪定。

稀释后最终溶液的浓度为4mcg / ml。

有关辅料的完整列表,请参阅第6.1节。

赋形剂

氯化钠;注射用水。

禁忌

对活性物质或任何赋形剂过敏。

如果不刺激(通过心脏起搏器),则进入高级心脏传导阻滞(2级或3级)。 不受控制的低血压。

急性脑血管病。

用量

仅供医院使用。 Dexdor应由专门管理需要重症监护的患者的医疗保健专业人员管理。 用量: 已经插管和镇静的患者可以改用右美托咪定,初始输注速度为0.7 mcg / kg / h,然后可以在0.2到1的剂量范围内逐渐改变, 4 mcg / kg / h,直至达到所需的镇静水平,这取决于患者的反应。对于体弱患者,应考虑较低的初始输注率。右美托咪定是非常有效的,输液速度现在表示。剂量调整后,在一小时之前不能达到新的稳态镇静水平。 不应超过最大剂量1.4 mcg / kg / h。使用最大剂量Dexdor达不到足够镇静作用的患者应改用替代镇静药物。

不推荐使用负荷剂量的Dexdor,并且与不良反应增加有关。

必要时,可以给予异丙酚或咪达唑仑,直到达到Dexdor的临床效果。 使用Dexdor超过14天没有经验。必须定期重新评估Dexdor使用时间长于此时间。

特殊人群

老年患者:老年患者通常不需要调整剂量。 肾功能损害:肾功能不全患者无需调整剂量。 肝功能损害:Dexdor在肝脏中代谢,在肝功能损害患者中应谨慎使用。可考虑减少维持剂量(见4.4和5.2节)。 儿科人群:Dexdor在0至18岁儿童中的安全性和有效性尚未确定。目前可用的数据在4.8,5.1和5.2节中描述,但是没有关于该术语的建议。

管理方法:

Dexdor只能通过稀释静脉输注给药,使用受控输液装置。有关在给药前稀释药品的说明,请参阅第6.6节。

警告和注意事项

Dexdor应该用于重症监护设置,不建议在其他环境中使用。在使用Dexdor输液期间,所有患者必须接受持续的心脏监测。应在非插管患者中监测呼吸。 Dexdor不应用作插管诱导剂或在肌肉松弛药物使用过程中提供镇静作用。 Dexdor通过simpaticolitica中央的动作降低心脏速率和血压,但在较高浓度下导致末梢血管收缩导致高血压(参见第5.1节)。

Dexdor通常不会引起深度镇静,患者很容易被唤醒。

因此Dexdor不适合谁不能忍受的影响此配置文件的患者,例如那些需要连续深度镇静或伴有严重不稳定cardiovas

由于Dexdor不应通过加载或推注剂量给药,因此使用该药的患者应准备使用替代镇静剂进行急性躁动控制或在手术过程中,特别是在治疗的最初几小时内。 给患有既往心动过缓的患者服用右美托咪定时应谨慎行事。

Dexdor对心率<60的患者的影响数据非常有限,应特别注意此类患者。心动过缓通常不需要治疗,但通常对抗胆碱能药物有反应或必要时减少剂量。高运动训练和低静息心率的患者可能对α-2受体激动剂的心动过缓作用特别敏感,并且已报道有短暂窦性停搏的病例。

的Dexdor效应的降血压可以是在这些患者具有更大的意义预先存在的低血压,低血容量,慢性或减少储备功能性低血压,诸如用于治疗重度心室功能障碍和老年患者(尤其是如果不向升压药响应);这些案件值得特别协助(见第4.3节)。低血压通常不需要特殊治疗,但必要时,使用该药的患者必须准备干预剂量减少,液体和/或血管收缩剂。

自主神经系统周围活动减少(例如由于脊髓损伤)的患者在开始输注Dexdor后可能有更明显的血液动力学变化,因此应小心治疗。

主要在负荷剂量期间观察到短暂性动脉高血压对外周血管收缩的影响,因此不建议这样做。通常不需要治疗高血压,但建议降低连续输注的速度。 在更高的浓度下,局部血管收缩在缺血性心脏病或严重脑血管疾病患者中可能更为重要,因此应密切监测。对于出现心肌或脑缺血迹象的患者,应考虑减少剂量或停止治疗。

在给予右美托咪定与其他镇静物质或心血管活动时应谨慎,因为可能会出现累加效应。

一些接受过Dexdor的患者在受到刺激时会醒来并发出警报。在没有其他临床症状和体征的情况下,这不应被视为缺乏疗效的证据。

在严重肝功能不全的情况下应谨慎行事,因为过量的剂量可能会增加不良反应的风险,过度镇静或由于右美托咪定清除率降低而导致的延长效应。

Dexdor似乎不能抑制癫痫发作,不应该用作癫痫状态的唯一治疗方法。 严重的神经系统疾病(如颅脑损伤和神经外科后),并在这些情况下被限制于使用Dexdor的经验,应谨慎使用,特别是如果需要深度镇静。 Dexdor可以减少脑血流量和颅内压,选择治疗时必须考虑到这一点。

当长期使用后突然停止时,α-2激动剂很少与戒断反应相关。如果患者在右美托咪定停用后不久出现躁动和高血压,则应考虑这种可能性。

目前尚不清楚右美托咪定在恶性高热易感人群中是否安全,因此不建议使用。如果长期不明原因发热,应停用Dexdor治疗。

与人肝微粒体。体外研究表明,右美托咪定与CYP2B6具有显性代谢的底物之间存在潜在的体内相互作用。 它在体外观察由CYP1A2,CYP2B6,CYP2C8,CYP2C9和CYP3A4的右美托咪诱导,并且不能在体内排除诱导。这种诱导的临床意义尚不清楚。 必须考虑的降血压作用的可能性,并bradicardizzanti与造成这些影响,例如β受体阻滞剂等药物治疗的患者时,虽然与艾司洛尔的相互作用的研究是适度的附加效果。

不良影响

安全概要摘要:

用美托咪定最常报道的不良反应是低血压,高血压和心动过缓,这发生,分别在大约25%,15%和13%的患者。 低血压和心动过缓也是与右美托咪定相关的最常见的严重不良反应,在ICU随机分组的患者中发生率为1.7%和0.9%。 不良反应表: 在表1中列出的不良反应,从临床试验在重症监护的组合数据收集3137名随机化患者(1879用美托咪定治疗,864用活性的比较处理,并用安慰剂治疗的394)。 根据以下惯例,不良反应按频率顺序排列,最常见的是:非常常见(≥1/ 10),常见(≥1/ 100; <1/10),不常见(≥1/ 1,000; <1/100),罕见(≥1/ 10,000; <1/1,000),非常罕见(<1 / 10,000)。

代谢和营养障碍

常见:高血糖,低血糖;

罕见:代谢性酸中毒,低蛋白血症。

精神疾病

常见:激动;

罕见:幻觉。

心脏疾病

很常见:心动过缓*;

常见:心肌缺血或梗塞,心动过速;

罕见:一度房室传导阻滞,心输出量减少。

血管疾病:

非常常见:低血压*,高血压*。

呼吸道,胸腔和纵隔疾病

罕见:呼吸困难。

胃肠道疾病

常见:恶心,呕吐,口干;

罕见:腹胀。

给药相关的系统性疾病和病症

常见:禁欲症,体温过高;

罕见:药物无效,口渴。

*参见描述所选不良反应的部分

所选不良反应的描述:

临床上显着的低血压或心动过缓应按4.4节所述进行治疗。

在未接受重症监护并接受右美托咪定治疗的相对健康的受试者中,心动过缓偶尔会导致窦性停搏或停顿。这些症状对腿的抬起和使用抗胆碱能药如阿托品或格隆溴铵有反应。在孤立的病例中,心动过缓已经发展到预先存在的心动过缓患者的心搏停止期。 高血压与使用负荷剂量有关,这种反应可以通过避免这种负荷剂量或通过降低输注速度或负荷剂量来减少。

儿科人群:

儿童经验有限;大多数数据来自短期暴露。文献报道了一例新生儿体温过低的心动过缓。 怀孕和哺乳期

妊娠:

关于在孕妇中使用右美托咪定的数据不足。 对动物的研究表明存在生殖毒性(见5.3节)。人类的潜在风险尚不清楚。除非明确需要,否则不应在怀孕期间使用Dexdor。

泌乳:

大鼠可获得的数据显示牛奶中的右美托咪定排泄或代谢物。不能排除新生儿的风险。 应考虑是否停止母乳喂养或停止右美托咪定治疗的决定,考虑到母乳喂养对儿童的益处以及对女性的治疗益处。

育: 在大鼠生育研究中,右美托咪定对男性或女性生育能力没有影响。

存储

该药品不需要任何特殊的储存条件。

对于稀释的药品的储存条件,请参见6.3。

与人肝微粒体。体外研究表明,右美托咪定与CYP2B6具有显性代谢的底物之间存在潜在的体内相互作用。与人肝微粒体。体外研究表明,右美托咪定与CYP2B6具有显性代谢的底物之间存在潜在的体内相互作用。 它在体外观察由CYP1A2,CYP2B6,CYP2C8,CYP2C9和CYP3A4的右美托咪诱导,并且不能在体内排除诱导。这种诱导的临床意义尚不清楚。 必须考虑的降血压作用的可能性,并bradicardizzanti与造成这些影响,例如β受体阻滞剂等药物治疗的患者时,虽然与艾司洛尔的相互作用的研究是适度的附加效果。

不良影响

安全概要摘要:

用美托咪定最常报道的不良反应是低血压,高血压和心动过缓,这发生,分别在大约25%,15%和13%的患者。 低血压和心动过缓也是与右美托咪定相关的最常见的严重不良反应,在ICU随机分组的患者中发生率为1.7%和0.9%。 不良反应表: 在表1中列出的不良反应,从临床试验在重症监护的组合数据收集3137名随机化患者(1879用美托咪定治疗,864用活性的比较处理,并用安慰剂治疗的394)。 根据以下惯例,不良反应按频率顺序排列,最常见的是:非常常见(≥1/ 10),常见(≥1/ 100; <1/10),不常见(≥1/ 1,000; <1/100),罕见(≥1/ 10,000; <1/1,000),非常罕见(<1 / 10,000)。

代谢和营养障碍

常见:高血糖,低血糖;

罕见:代谢性酸中毒,低蛋白血症。

精神疾病

常见:激动;

罕见:幻觉。

心脏疾病

很常见:心动过缓*;

常见:心肌缺血或梗塞,心动过速;

罕见:一度房室传导阻滞,心输出量减少。

血管疾病:

非常常见:低血压*,高血压*。

呼吸道,胸腔和纵隔疾病

罕见:呼吸困难。

胃肠道疾病

常见:恶心,呕吐,口干;

罕见:腹胀。

给药相关的系统性疾病和病症

常见:禁欲症,体温过高;

罕见:药物无效,口渴。

*参见描述所选不良反应的部分

所选不良反应的描述:

临床上显着的低血压或心动过缓应按4.4节所述进行治疗。

在未接受重症监护并接受右美托咪定治疗的相对健康的受试者中,心动过缓偶尔会导致窦性停搏或停顿。这些症状对腿的抬起和使用抗胆碱能药如阿托品或格隆溴铵有反应。在孤立的病例中,心动过缓已经发展到预先存在的心动过缓患者的心搏停止期。 高血压与使用负荷剂量有关,这种反应可以通过避免这种负荷剂量或通过降低输注速度或负荷剂量来减少。

儿科人群:

儿童经验有限;大多数数据来自短期暴露。文献报道了一例新生儿体温过低的心动过缓。 怀孕和哺乳期

妊娠:

关于在孕妇中使用右美托咪定的数据不足。 对动物的研究表明存在生殖毒性(见5.3节)。人类的潜在风险尚不清楚。除非明确需要,否则不应在怀孕期间使用Dexdor。

泌乳:

大鼠可获得的数据显示牛奶中的右美托咪定排泄或代谢物。不能排除新生儿的风险。 应考虑是否停止母乳喂养或停止右美托咪定治疗的决定,考虑到母乳喂养对儿童的益处以及对女性的治疗益处。

育: 在大鼠生育研究中,右美托咪定对男性或女性生育能力没有影响。

存储

该药品不需要任何特殊的储存条件。

对于稀释的药品的储存条件,请参见6.3。

它在体外观察由CYP1A2,CYP2B6,CYP2C8,CYP2C9和CYP3A4的右美托咪诱导,并且不能在体内排除诱导。这种诱导的临床意义尚不清楚。 必须考虑的降血压作用的可能性,并bradicardizzanti与造成这些影响,例如β受体阻滞剂等药物治疗的患者时,虽然与艾司洛尔的相互作用的研究是适度的附加效果。

不良影响

安全概要摘要:

用美托咪定最常报道的不良反应是低血压,高血压和心动过缓,这发生,分别在大约25%,15%和13%的患者。 低血压和心动过缓也是与右美托咪定相关的最常见的严重不良反应,在ICU随机分组的患者中发生率为1.7%和0.9%。 不良反应表: 在表1中列出的不良反应,从临床试验在重症监护的组合数据收集3137名随机化患者(1879用美托咪定治疗,864用活性的比较处理,并用安慰剂治疗的394)。 根据以下惯例,不良反应按频率顺序排列,最常见的是:非常常见(≥1/ 10),常见(≥1/ 100; <1/10),不常见(≥1/ 1,000; <1/100),罕见(≥1/ 10,000; <1/1,000),非常罕见(<1 / 10,000)。

代谢和营养障碍

常见:高血糖,低血糖;

罕见:代谢性酸中毒,低蛋白血症。

精神疾病

常见:激动;

罕见:幻觉。

心脏疾病

很常见:心动过缓*;

常见:心肌缺血或梗塞,心动过速;

罕见:一度房室传导阻滞,心输出量减少。

血管疾病:

非常常见:低血压*,高血压*。

呼吸道,胸腔和纵隔疾病

罕见:呼吸困难。

胃肠道疾病

常见:恶心,呕吐,口干;

罕见:腹胀。

给药相关的系统性疾病和病症

常见:禁欲症,体温过高;

罕见:药物无效,口渴。

*参见描述所选不良反应的部分

所选不良反应的描述:

临床上显着的低血压或心动过缓应按4.4节所述进行治疗。

在未接受重症监护并接受右美托咪定治疗的相对健康的受试者中,心动过缓偶尔会导致窦性停搏或停顿。这些症状对腿的抬起和使用抗胆碱能药如阿托品或格隆溴铵有反应。在孤立的病例中,心动过缓已经发展到预先存在的心动过缓患者的心搏停止期。 高血压与使用负荷剂量有关,这种反应可以通过避免这种负荷剂量或通过降低输注速度或负荷剂量来减少。

儿科人群:

儿童经验有限;大多数数据来自短期暴露。文献报道了一例新生儿体温过低的心动过缓。 怀孕和哺乳期

妊娠:

关于在孕妇中使用右美托咪定的数据不足。 对动物的研究表明存在生殖毒性(见5.3节)。人类的潜在风险尚不清楚。除非明确需要,否则不应在怀孕期间使用Dexdor。

泌乳:

大鼠可获得的数据显示牛奶中的右美托咪定排泄或代谢物。不能排除新生儿的风险。 应考虑是否停止母乳喂养或停止右美托咪定治疗的决定,考虑到母乳喂养对儿童的益处以及对女性的治疗益处。

育: 在大鼠生育研究中,右美托咪定对男性或女性生育能力没有影响。

存储

该药品不需要任何特殊的储存条件。

对于稀释的药品的储存条件,请参见6.3。

Pharmaceutical form

INJECTABLE PREPARATION

Product type

PHARMACY ONLY HOSPITAL USE

Dexmedetomidine (Dexdor®) is recommended for use in NHS Wales for the sedation of adult intensive care units (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale [RASS] 0 to -3).

Therapeutic indications

For the sedation of adult patients in Intensive Care Unit (ICU) who need a level of sedation no deeper than waking in response to verbal stimulation (corresponding to the value from 0 to 3 of the Richmond Sedation-Agitation Scale ( Richmond Agitation-Sedation Scale, RASS). Composition

Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 mcg of dexmedetomidine.

Each 2 ml vial contains 200 mcg of dexmedetomidine.

Each 4 ml vial contains 400 mcg of dexmedetomidine.

Each 10 ml vial contains 1000 mcg of dexmedetomidine.

The concentration of the final solution after dilution is 4 mcg / ml.

For a full list of excipients, see section 6.1.

Excipients

Sodium chloride; water for injections.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Advanced heart block (grade 2 or 3) if not stimulated (by pacemakers). Uncontrolled hypotension.

Acute cerebrovascular conditions.

Dosage

For hospital use only. Dexdor should be administered by healthcare professionals who specialize in the management of patients requiring intensive care. dosage: Patients already intubated and sedated can switch to dexmedetomidine with an initial infusion rate of 0.7 mcg / kg / h, which can then be gradually changed within the dose range of 0.2 to 1, 4 mcg / kg / h until reaching the desired level of sedation that depends on the patient's response. For frail patients a lower initial infusion rate should be considered. Dexmedetomidine is very potent and the infusion rate is expressed for now. After dose adjustment, a new steady-state sedation level can not be reached before one hour. The maximum dose of 1.4 mcg / kg / h should not be exceeded. Patients who do not achieve adequate sedation with the maximum dose of Dexdor should be switched to an alternative sedative medicine.

Use of a loading dose of Dexdor is not recommended and is associated with increased adverse reactions.

If necessary, propofol or midazolam can be administered until the clinical effects of Dexdor are achieved. There is no experience in using Dexdor for more than 14 days. The use of Dexdor for a longer time than this must be regularly re-evaluated.

Special populations

Elderly patients: no dose adjustment is normally required for elderly patients. Renal impairment: no dose adjustment is required for patients with renal impairment. Hepatic impairment: Dexdor is metabolised in the liver and should be used with caution in patients with hepatic impairment. A reduced maintenance dose may be considered (see sections 4.4 and 5.2). Pediatric population: The safety and efficacy of Dexdor in children aged 0 to 18 years has not been established. The currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on the posology can be made.

Method of administration:

Dexdor should only be given by diluted intravenous infusion, using a controlled infusion device. For instructions on dilution of the medicinal product before administration, see section 6.6.

Warnings and precautions

Dexdor should be used in intensive care settings and is not recommended for use in other environments. During the infusion with Dexdor, all patients must undergo constant cardiac monitoring. Respiration should be monitored in non-intubated patients. Dexdor should not be used as an induction agent for intubation or to provide sedation during the use of muscle relaxant medicines. Dexdor reduces heart rate and blood pressure through a central sympatholytic action, but at higher concentrations causes peripheral vasoconstriction leading to hypertension (see section 5.1).

Dexdor does not normally cause deep sedation and patients can easily be awakened.

Dexdor is therefore not suitable for patients who do not tolerate this effect profile, for example those requiring continuous deep sedation or severe cardiovas instability

Since Dexdor should not be administered by loading or bolus dose, those using this medicine should be prepared to use an alternative sedative for acute control of agitation or during procedures, especially during the first hours of treatment . Caution should be exercised when administering dexmedetomidine to patients with pre-existing bradycardia.

Data on the effects of Dexdor in patients with heart rate <60 are very limited and special care should be taken with such patients. Bradycardia does not normally require treatment but generally responds to anti-cholinergic medicines or dose reduction if necessary. Patients with high athletic training and low resting heart rate may be particularly sensitive to bradycardic effects of alpha-2 receptor agonists and cases of transient sinus arrest have been reported.

The hypotensive effects of Dexdor may be of greater importance in those patients with pre-existing hypotension (especially if they do not respond to vasopressors), hypovolaemia, chronic hypotension or reduced functional reserve, such as patients with severe ventricular dysfunction and elderly patients; these cases merit special assistance (see section 4.3). Hypotension normally does not require specific treatment, but, where necessary, those who use this medicine must be prepared to intervene with dose reduction, liquids and / or vasoconstrictors.

Patients with reduced peripheral activity of the autonomic nervous system (eg due to spinal cord injury) may have more pronounced haemodynamic changes after starting the infusion with Dexdor and therefore should be treated with care.

Transient arterial hypertension to the effects of peripheral vasoconstriction was observed mainly during the loading dose, which is therefore not recommended. Treatment of hypertension is generally not necessary, but it may be advisable to decrease the rate of continuous infusion. At greater concentrations, local vasoconstriction may be of greater importance in patients with ischemic heart disease or severe cerebrovascular disease and therefore should be closely monitored. Dose reduction or treatment discontinuation should be considered in patients who develop signs of myocardial or cerebral ischemia.

Caution should be exercised in the administration of dexmedetomidine with other sedating substances or with cardiovascular activity, as additive effects may occur.

Some patients who have received Dexdor are awaken and alert when stimulated. In the absence of other clinical signs and symptoms this should not be regarded as evidence of lack of efficacy.

Caution should be exercised in case of severe hepatic insufficiency as excessive dosage may increase the risk of adverse reactions, excessive sedation or a prolonged effect as a consequence of reduced dexmedetomidine clearance.

Dexdor does not appear to suppress epileptic seizures and should not be used as the only treatment in epileptic states. Experience with the use of Dexdor in severe neurological diseases (such as head injury and after neurosurgery) is limited and should be used with caution in these cases, especially if deep sedation is required. Dexdor can reduce cerebral blood flow and intracranial pressure and this must be taken into account when choosing therapy.

Alpha-2 agonists were rarely associated with withdrawal reactions when they were suddenly stopped after prolonged use. This possibility should be considered if the patient develops agitation and hypertension shortly after dexmedetomidine is suspended.

It is not known whether the use of dexmedetomidine is safe in individuals susceptible to malignant hyperthermia and therefore its use is not recommended. Treatment with Dexdor should be discontinued in case of prolonged fever of unknown origin.

with human liver microsomes. An in vitro study suggests the existence of a potential in vivo interaction between dexmedetomidine and substrates with dominant metabolism by CYP2B6. Induction by dexmedetomidine on CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP3A4 was observed in vitro and induction in vivo can not be excluded. The clinical significance of this induction is not known.

The possibility of major hypotensive and bradycardic effects in patients treated with other medicinal products causing such effects, eg beta blockers, should be considered, although in an interaction study with esmolol the additional effects were modest.

Undesirable effects

Summary of the safety profile:

The most frequently reported adverse reactions with dexmedetomidine are hypotension, hypertension, and bradycardia, which occur in approximately 25%, 15%, and 13% of patients, respectively.

Hypotension and bradycardia were also the most frequent serious adverse reactions related to dexmedetomidine which occurred in 1.7% and 0.9% of patients randomized in the ICU.

Table of adverse reactions:

The adverse reactions listed in Table 1 were collected from the combined data of intensive care clinical trials involving 3,137 randomized patients (1,879 treated with dexmedetomidine, 864 treated with active comparator medicines, and 394 treated with placebo). Adverse reactions are ranked in order of frequency, the most frequent first, according to the following convention: very common (≥ 1/10), common (≥ 1/100; <1/10), uncommon (≥ 1 / 1,000; <1/100), rare (≥ 1 / 10,000; <1/1,000), very rare (<1 / 10,000).

Metabolism and nutrition disorders

Common: Hyperglycemia, hypoglycemia;

Uncommon: Metabolic acidosis, hypoalbuminemia.

Psychiatric disorders

Common: Agitation;

Uncommon: Hallucinations.

Cardiac disorders

Very common: Bradycardia *;

Common: Myocardial ischemia or infarction, tachycardia;

Uncommon: First-degree atrioventricular block, decreased cardiac output.

Vascular disorders:

Very common: Hypotension *, hypertension *.

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnea.

Gastrointestinal disorders

Common: Nausea, vomiting, dry mouth;

Uncommon: Abdominal distension.

Systemic disorders and conditions related to the administration of

Common: Abstinence syndrome, hyperthermia;

Uncommon: Ineffective medicine, thirst.

* See the section on describing the selected adverse reactions

Description of selected adverse reactions:

Clinically significant hypotension or bradycardia should be treated as described in section 4.4.

In relatively healthy subjects not in intensive care and treated with dexmedetomidine, bradycardia occasionally resulted in sinus arrest or pauses. The symptoms responded to the lifting of the legs and the use of anticholinergics such as atropine or glycopyrrolate. In isolated cases bradycardia has progressed to periods of asystole in patients with pre-existing bradycardia. Hypertension has been associated with the use of a loading dose and this reaction can be reduced by avoiding this loading dose or by reducing the rate of infusion or the amount of the loading dose.

Pediatric population:

There is limited experience in children; most of the data were obtained from short-term exposures. A single case of hypothermic bradycardia in a newborn has been reported in the literature. Pregnancy and breastfeeding

Pregnancy:

There are insufficient data on the use of dexmedetomidine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk in the human species is not known. Dexdor should not be used during pregnancy unless clearly necessary.

Lactation:

Data available in the rat showed dexmedetomidine excretion or metabolites in milk. Risks for newborns can not be excluded. The decision whether to discontinue breast-feeding or to discontinue dexmedetomidine therapy should be considered taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility: v In rat fertility studies, dexmedetomidine had no effect on male or female fertility.

Storage

This medicine does not require any special storage conditions.

For storage conditions of the diluted medicinal product, see section 6.3.

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 详细处方信息以本药内容附件PDF文件(20189218301427.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-08-31
附件:
20189218301427.pdf    

 
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