Mucinex Fast-Max冷

Mucinex Fast-Max冷Manufacturers

• Reckitt Benckiser LLC
  

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  Mucinex Fast-Max冷|Reckitt Benckiser LLC

  

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  不要把超过指导(见过量warni吗ng) do not take more than 12 liquid gels in any 24-hour period adults and children 12 years of age and older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

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• Reckitt Benckiser LLC
  

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  Mucinex Fast-Max冷|Dr. Reddy's Laboratories Limited

  

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  Sirolimus tablets are to be administered orally once daily, consistently with or without food [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

  Tablets should not be crushed, chewed or split. Patients unable to take the tablets should be prescribed the solution and instructed in its use.

  The initial dose of sirolimus tablets should be administered as soon as possible after transplantation. It is recommended that sirolimus tablets be taken 4 hours after administration of cyclosporine oral solution (MODIFIED) and or/cyclosporine capsules (MODIFIED) [see Drug Interactions (7.2)].

  Frequent sirolimus tablets dose adjustments based on non-steady-state sirolimus concentrations can lead to overdosing or underdosing because sirolimus has a long half-life. Once sirolimus tablets maintenance dose is adjusted, patients should continue on the new maintenance dose for at least 7 to 14 days before further dosage adjustment with concentration monitoring. In most patients, dose adjustments can be based on simple proportion: new sirolimus tablets dose = current dose x (target concentration/current concentration). A loading dose should be considered in addition to a new maintenance dose when it is necessary to increase sirolimus trough concentrations: sirolimus tablets loading dose = 3 x (new maintenance dose - current maintenance dose). The maximum sirolimus tablets dose administered on any day should not exceed 40 mg. If an estimated daily dose exceeds 40 mg due to the addition of a loading dose, the loading dose should be administered over 2 days. Sirolimus trough concentrations should be monitored at least 3 to 4 days after a loading dose(s).

  Two milligrams (2 mg) of sirolimus oral solution have been demonstrated to be clinically equivalent to 2 mg sirolimus tablets; hence, are interchangeable on a mg-to-mg basis. However, it is not known if higher doses of sirolimus oral solution are clinically equivalent to higher doses of sirolimus tablets on a mg-to-mg basis [see Clinical Pharmacology (12.3)].

  2.1 Patients at Low- to Moderate-Immunologic Risk

  Sirolimus Tablets and Cyclosporine Combination Therapy

  For de novo renal transplant patients, it is recommended that sirolimus oral solution and tablets be used initially in a regimen with cyclosporine and corticosteroids. A loading dose of sirolimus tablets equivalent to 3 times the maintenance dose should be given, i.e. a daily maintenance dose of 2 mg should be preceded with a loading dose of 6 mg. Therapeutic drug monitoring should be used to maintain sirolimus drug concentrations within the target-range [see Dosage and Administration (2.3)].

  Sirolimus Tablets Following Cyclosporine Withdrawal

  移植后2至4个月，应在4到8周内逐渐停止环孢素，并应调整Sirolimus片剂剂量以获得目标范围内的Sirolimus全血谷浓度[见剂量和给药（见2.3）]。由于环孢素抑制了西罗莫司的代谢和运输，因此在停用环孢霉素时，西罗莫司的浓度可能会降低，除非增加了西罗莫司片剂剂量，否则浓度可能会降低[参见临床药理学（12.3）]。

  2.2 Patients at High-Immunologic Risk

  In patients with high-immunologic risk, it is recommended that sirolimus tablets be used in combination with cyclosporine and corticosteroids for the first 12 months following transplantation [see Clinical Studies (14.3)]. The safety and efficacy of this combination in high- immunologic risk patients has not been studied beyond the first 12 months. Therefore, after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient.

  对于接受环孢霉素的西罗莫司片的患者，应在移植后第1天以高达15 mg的负载剂量开始蛋白木片治疗。从第2天开始，应给出5 mg/天的初始维护剂量。在第5天到第7天之间应获得一个槽水平，然后应调整Sirolimus片剂的每日剂量[参见剂量和给药（2.3）]。

  The starting dose of cyclosporine should be up to 7 mg/kg/day in divided doses and the dose should subsequently be adjusted to achieve target whole blood trough concentrations [see Dosage and Administration (2.3)]. Prednisone should be administered at a minimum of 5 mg/day.

  Antibody induction therapy may be used.

  2.3 Therapeutic Drug Monitoring

  建议所有患者对Sirolimus槽浓度进行监测，尤其是在那些可能改变药物代谢的患者中，在肝损伤患者中重量低于40 kg的患者，当Sirolimus片剂的剂量发生变化时并在同时施用强CYP3A4诱导剂和抑制剂期间[见药物相互作用（7）]。

  Therapeutic drug monitoring should not be the sole basis for adjusting sirolimus tablets therapy. Careful attention should be made to clinical signs/symptoms, tissue biopsy findings, and laboratory parameters.

  When used in combination with cyclosporine, sirolimus trough concentrations should be maintained within the target-range [see Clinical Studies (14), Clinical Pharmacology (12.3)]. Following cyclosporine withdrawal in transplant patients at low- to moderate-immunologic risk, the target sirolimus trough concentrations should be 16 to 24 ng/mL for the first year following transplantation. Thereafter, the target sirolimus concentrations should be 12 to 20 ng/mL.

  西罗里木斯的上述24小时槽浓度范围是基于色谱方法。目前，在临床实践中，西罗里木素全血浓度正在通过色谱和免疫测定方法测量。由于测得的西罗莫司全血浓度取决于所使用的测定的类型，因此这些不同方法获得的浓度不可互换[请参见警告和预防措施（5.15），临床药理学（12.3）]。应根据用于确定Sirolimus槽浓度的测定法进行对靶向范围的调整。由于结果是分析和实验室依赖性的，并且结果可能会随着时间的推移而变化，因此必须通过详细了解所使用的现场测定法进行对目标治疗范围的调整。因此，应与执行测定法的实验室保持沟通。关于不同测定方法的讨论中包含在2000年4月的临床治疗学中，第22卷，补充剂B [参见参考文献（15）]。

  2.4 Patients with Low Body Weight

  The initial dosage in patients ≥ 13 years who weigh less than 40 kg should be adjusted, based on body surface area, to 1 mg/m2/day. The loading dose should be 3 mg/m2.

  2.5 Patients with Hepatic Impairment

  It is recommended that the maintenance dose of sirolimus tablets be reduced by approximately one third in patients with mild or moderate hepatic impairment and by approximately one half in patients with severe hepatic impairment. It is not necessary to modify the sirolimus tablets loading dose [see Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  肾功能受损的患者不需要调整剂量[请参阅特定人群中的使用（8.7）]。

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• Reckitt Benckiser LLC
  

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  Mucinex Fast-Max冷|Reckitt Benckiser LLC

  

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  不要把超过指导(见过量warni吗ng) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

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• Reckitt Benckiser LLC
  

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  Mucinex Fast-Max冷|Reckitt Benckiser LLC

  

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  在任何24小时的成年人和12岁以上的儿童中，不要服用超过指示（请参阅过量警告）：每4小时1包1包。将一包含量溶解到8盎司的热水中并搅拌；饮热。在15分钟内消费。12岁以下的儿童：不要使用

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