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详细处方信息以本药内容附件PDF文件（201962519183424.pdf）的“原文Priscribing Information”为准
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部分中文盐酸纳布啡处方资料（仅供参考）

【英文名称】Nalbuphine Hydrochloride

【适用证】

Nalbuphine Hydrochloride Injection适用于严重到足以需要阿片类镇痛药的疼痛的治疗，并且替代治疗方法不足。 Nalbuphine Hydrochloride Injection也可用作平衡麻醉的补充剂，用于术前和术后镇痛，以及分娩和分娩时的产科镇痛。

【用法用量】

重要剂量​​和管理说明

盐酸纳布啡注射液应仅作为专门接受静脉麻醉药使用培训和强效阿片类药物呼吸系统治疗的人员进行全身麻醉的补充。

应该随时可以获得纳洛酮，复苏和插管设备以及氧气。

根据患者的疼痛严重程度，患者反应，先前的镇痛治疗经验以及成瘾，滥用和误用的风险因素，单独为每位患者开始给药方案[见警告]。

密切监测患者的呼吸抑制情况，特别是在开始治疗的前24至72小时内，以及盐酸纳布啡注射剂量增加后，并相应调整剂量[见警告]。

当溶液和容器允许时，应在给药前肉眼检查肠外药物产品的颗粒物和变色。

初始剂量

对于70 kg个体皮下，肌肉内或静脉注射，通常推荐的成人剂量为10 mg;必要时，该剂量可每3至6小时重复一次。剂量应根据疼痛的严重程度，患者的身体状况以及患者可能接受的其他药物进行调整[见警告;与苯二氮卓类药物或其他中枢神经系统抑制剂同时使用的风险]。在非耐受性个体中，推荐的单次最大剂量为20mg，最大总日剂量为160mg。

使用盐酸纳布啡注射液作为平衡麻醉的补充剂需要比镇痛推荐剂量更大的剂量。盐酸纳布啡的诱导剂量范围为0.3mg / kg至3mg / kg静脉内给药，持续10至15分钟，维持剂量为0.25至0.5mg / kg，根据需要在单次静脉内给药。使用盐酸纳布啡注射液后可能出现呼吸抑制，可用阿片类拮抗剂盐酸纳洛酮逆转。

治疗的滴定和维持

单独滴定Nalbuphine Hydrochloride Injection，剂量可提供足够的镇痛效果，并可减少不良反应。持续重新评估接受盐酸纳布啡的患者，以评估疼痛控制的维持和不良反应的相对发生率，以及监测成瘾，滥用或滥用的发展[见警告]。在改变镇痛要求（包括初始滴定）期间，处方者，医疗团队的其他成员，患者和护理人员/家庭中的频繁沟通非常重要。

如果在剂量稳定后疼痛水平增加，则在增加盐酸纳布啡剂量之前尝试确定疼痛增加的来源。如果观察到不可接受的阿片类药物相关不良反应，可考虑减少剂量。调整剂量以在疼痛管理和阿片类药物相关不良事件之间取得适当的平衡。

【禁忌】

Nalbuphine Hydrochloride Injection禁用于以下患者：

---显着的呼吸抑制[见警告]

---在未监测的环境中或没有复苏设备的情况下急性或严重的支气管哮喘[见警告]

---已知或疑似胃肠道阻塞，包括麻痹性肠梗阻[见警告]

---对纳布啡或盐酸纳布啡注射液中的任何其他成分过敏。

【INDICATIONS AND USAGE】

Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia,for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

【DOSAGE AND ADMINISTRATION】

Important Dosage and Administration Instructions

Nalbuphine Hydrochloride Injection should be administered as a supplement to general anesthesia only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.

Naloxone, resuscitative and intubation equipment and oxygen should be readily available.

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Nalbuphine Hydrochloride Injection and adjust the dosage accordingly [see WARNINGS].

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Initial Dosage

The usual recommended adult dose is 10 mg for a 70 kg individual administered subcutaneously, intramuscularly, or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be receiving [see WARNINGS; Risks from Concomitant Us e with Benzodiazepines or Other CNS Depressants]. In nontolerant individuals, the recommended single maximum dose is 20 mg with a maximum total daily dose of 160 mg.

The use of Nalbuphine Hydrochloride Injection as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia. Induction doses of nalbuphine hydrochloride range from 0.3 mg/kg to 3 mg/kg intravenously to be administered over a 10 to 15 minute period with maintenance doses of 0.25 to 0.5 mg/kg in single intravenous administrations as required. The use of Nalbuphine Hydrochloride Injection may be followed by respiratory depression which can be reversed with the opioid antagonist naloxone hydrochloride.

Titration and Maintenance of Therapy

Individually titrate Nalbuphine Hydrochloride Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving nalbuphine hydrochloride to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the nalbuphine hydrochloride dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse events.

【CONTRAINDICATIONS】

Nalbuphine Hydrochloride Injection is contraindicated in patients with:

---Significant respiratory depression [see WARNINGS]

---Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]

---Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS]

---Hypersensitivity to nalbuphine or to any of the other ingredients in Nalbuphine Hydrochloride Injection.

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详细处方信息以本药内容附件PDF文件（201962519183424.pdf）的“原文Priscribing Information”为准
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