药品信息: 商品名称
BRONICA颗粒10 %
药品定价上市日期
1995年11月
销售日期
1995年12月
储存,到期日期等。
存储
在室温下储存。存储块中的光开口后。
失效日期
用于在包装盒上的显示的有效期限。
(的东西。要及时使用尽可能开放后,即使在有效期限内)
组成
活性成分的1g中
塞曲司特100毫克
添加剂
羟丙基纤维素,羧甲基纤维素钙,滑石,聚氧乙烯( 160 )聚氧丙烯(30 )二醇,结晶纤维素,玉米淀粉,乳糖水合物
行为
剂型
颗粒
颗粒的颜色
淡黄色至橙黄色
一般指定为
周塞曲司特颗粒
效果或疗效
支气管哮喘
剂量和用法
通常情况下,每天一次,我晚饭口服给药后在成人80毫克塞曲司特。
这都涉及到剂量和用法使用说明
照顾等方式来启动低剂量给药( 40mg /日)于中老年人。 (见“行政老人” )
注意事项
细心管理
(它应慎用于下列患者进行管理。 )
1 。
(见“行政老人” )老人
2 。
肝衰竭患者
可引起黄疸,肝功能异常[此药。此外,暴发性肝炎的报道很少。 ]
重要注意事项
1 。
这种药物是不同的支气管扩张药和类固醇等,因为它不是一种药物,降低了症状迅速发作已经发生了,这就是它应该被充分地解释给患者。
2 。
当给予患者季节性这种药物,并且在考虑好发季节,是管理从之前开始,一直持续到好发季节结束。
3 。
如果您是此药物在支气管哮喘患者的管理过程中,我有一个癫痫大发作,建议类固醇激素或支气管扩张剂的管理。
4 。
如果在接受长期类固醇治疗,以实现减肥的类固醇由于这种药物的患者,可以进行足够缓慢地进行管理。
5 。
需要注意的是患者能够通过使用这种药物,以减少激素维持量量,如果要取消这种药物的管理,有基础疾病恶化的风险,这一点很重要。
相互作用
注组合
(注组合)
1,药品名称,例如药物已经报道溶血性贫血解热抗炎剂,如非那西丁,头孢类抗生素等。
临床症状和治疗,机制等
亚急性,大鼠,狗和猴子的慢性毒性研究中, ( 100mg/kg的/天或更多,为300mg/kg /天,狗和猴大鼠)溶血性贫血已经观察到在高剂量。 1-5)
有一种可能性,即在用药物引起的溶血性贫血,当组合使用时,应仔细观察组合使用溶血性贫血的风险增加,停止给药并在出现任何异常发现它采取适当的措施,如。
2 ,药品名称,如阿司匹林
临床症状和治疗,机制等
研究的相互作用,以人血清蛋白(有时在体外)结合的,药物的未结合的浓度是通过加入阿司匹林的增加了26 %。
副作用
的副作用,如概述表达状况
97案件824箱子期间( 11.8 % ) ,观察到的副作用,包括异常的实验室测试值210案件3,267例( 6.4 % )使用在性能上市后监测(复试底)的研究批准的时间已经。
以下副作用是在自发报告观察到的,或类似的研究。
临床上显著的不良反应
与高架像黄疸, AST ( GOT ) ,即( 0.2 % )的出现(GPT )肝功能不全严重的ALT键。此外,暴发性肝炎( 0.1 % )的报道。患者应仔细观察,并进行肝功能检查(每月一次)定期,政府应该终止,如果任何异常的观察,并应采取适当的措施。
其他副作用
过敏注1 )
小于0.1-5%
皮疹,瘙痒
肝注2 )
小于0.1-5%
升高的AST( GOT ) ,谷丙转氨酶( GPT ) , AL -P , LDH , γ-GTP的
消化器官
小于0.1-5%
恶心,食欲不振,胃部不适,腹痛,腹泻,便秘,口干,味觉障碍亏损
消化器官
小于0.1%的
呕吐
血
小于0.1-5%
贫血,嗜酸粒细胞增多
血
小于0.1%的
在皮肤上,等下出血的血小板减少,鼻出血,出血倾向
神经精神
小于0.1-5%
嗜睡,头痛,头晕,胸闷
神经精神
小于0.1%的
失眠,震颤,麻木
其他
小于0.1-5%
心悸,乏力
其他
小于0.1%的
潮热,水肿
其他的副作用笔记
终止政府当局应如注1 ) ,并采取适当措施。
患者应仔细观察,并在同一时间进行肝功能检查)注2 )定期(1个月,政府应停药,如果任何异常的观察,并应采取适当的措施。
Trade name
Bronica Granules 10%
Drug pricing listing date
November 1995
Date of the sale
December 1995
STORAGE, expiration date, etc.
STORAGE
Stored at room temperature. Be stored block the light after opening.
Expiration date
Be used for the expiration date of the display on the box.
(The thing. To be used promptly as possible after opening, even within the expiration date)
Composition
1g of active ingredient in
Seratrodast 100mg
Additive
Hydroxypropyl cellulose, carmellose calcium, talc, polyoxyethylene (160) polyoxypropylene (30) glycol, crystalline cellulose, corn starch, lactose hydrate
Behavior
Dosage form
Granules
The color of the granules
Pale yellow to orange yellow
General designation for
Seratrodast Zhou granules
Effect or efficacy
Bronchial asthma
Dosage and usage
Usually, once a day, I administered orally after dinner as a 80mg seratrodast in adults.
Usage Notes that are related to the dose and usage
Take care, etc. to start the administration of low-dose (40mg / day) in the elderly. (See section "administration for the elderly")
PRECAUTIONS
Careful administration
(It should be administered with caution in the following patients.)
1.
(See section "administration for the elderly") Elderly
2.
Patients with liver failure
which can cause jaundice, liver function abnormalities [this drug. In addition, fulminant hepatitis have been reported rarely. ]
Important Precautions
1.
This drug is different bronchodilators, and steroids, etc., because it is not a drug that reduces the symptoms promptly and seizure is happening already, this is that it should be fully explained to the patient.
2.
When administered to patients with seasonal this drug, and that in consideration of the predilection season, was administered starting from just before, is continued until predilection season ends.
3.
If you are during administration of this drug in patients with bronchial asthma, I had a grand mal seizure, it is recommended that the administration of steroids or bronchodilators.
4.
If in patients receiving long-term steroid therapy, to achieve a weight loss of steroid due to this drug, it can be performed slowly enough managed.
5.
It is important to note that patients were able to decrease the amount of steroid maintenance dose through the use of this drug, if you want to cancel the administration of this drug, there is a risk of the underlying disease worse.
Interaction
Note combination
(Note the combination)
1. Drug name, such as drug have been reported hemolytic anemia antipyretic anti-inflammatory agents such as phenacetin, cephem antibiotic, etc.
Clinical symptoms, and Treatment, mechanisms, etc.
Subacute, chronic toxicity study in rats, dogs and monkeys, (100mg/kg / day or more, 300mg/kg / day in dogs and monkeys in rats) hemolytic anemia have been observed at higher doses. 1-5)
there is a possibility that the increased risk of hemolytic anemia to be used in combination with drugs that cause hemolytic anemia, should be carefully observed when used in combination, to stop the administration and if any abnormalities are found It take appropriate measures, such as.
2. Drug name, such as aspirin
Clinical symptoms, and Treatment, mechanisms, etc.
Study of the interaction to human serum protein binding ( in vitro sometimes in), unbound concentration of the drug is increased 26% by the addition of aspirin.
Side effect
Overview of side effects such as expression situation
97 cases of 824 cases during (11.8%), the observed side effects including abnormal laboratory test values 210 cases of 3,267 patients (6.4%) use performance post-marketing surveillance in the (re-examination at the end) in the study of time of approval have been.
The following side effects are observed in spontaneous reporting, or the like of the study.
Clinically significant adverse reactions
With elevated like jaundice, AST (GOT), ALT of (GPT) liver dysfunction severe that (0.2%) appears. Moreover, fulminant hepatitis (0.1%) have been reported. Patients should be carefully observed and perform liver function tests (once a month) regularly, administration should be discontinued and if any abnormalities are observed, and appropriate measures should be taken.
Other side effects
Hypersensitivity Note 1)
0.1-5% less than
Rash, itching
Liver Note 2)
0.1-5% less than
Elevated AST (GOT), ALT (GPT), AL-P, LDH, of γ-GTP
Digestive organ
0.1-5% less than
Nausea, loss of appetite, stomach discomfort, abdominal pain, diarrhea, constipation, dry mouth, taste disturbance
Digestive organ
Less than 0.1%
Vomiting
Blood
0.1-5% less than
Anemia, and eosinophilia
Blood
Less than 0.1%
Thrombocytopenia, epistaxis, bleeding tendency of bleeding under the skin, etc.
Neuropsychiatric
0.1-5% less than
Drowsiness, headache, dizziness, lightheadedness
Neuropsychiatric
Less than 0.1%
Insomnia, tremor, numbness
Other
0.1-5% less than
Palpitations, fatigue
Other
Less than 0.1%
hot flashes, edema
Notes of the side effects of other
Be discontinued administration should such Note 1), and take appropriate measures.
Patients should be carefully observed and perform liver function tests at a time) Note 2) regularly (1 month, administration should be discontinued and if any abnormalities are observed, and appropriate measures should be taken.
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