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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->其他抗生素
处方药:处方药
包装规格: 150毫克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
JHP PHARMS
生产厂家英文名:
JHP PHARMS
该药品相关信息网址1:
http://www.drugs.com/cdi/coly-mycin-m.html
该药品相关信息网址2:
http://www.rxlist.com/coly-mycin-drug.htm
该药品相关信息网址3:
http://www.jhppharma.com/products/colym.html
原产地英文商品名:
COLY-MYCIN M 150mg/vial
原产地英文药品名:
COLISTIMETHATE SODIUM
中文参考商品译名:
COLY-MYCIN M 150毫克/瓶
中文参考药品译名:
多粘菌素E甲磺酸钠
原产地国家批准上市年份:
1970/06/04
英文适应病症1:
Pseudomonas aeruginosa meningitis
英文适应病症2:
Septicemia
英文适应病症3:
Urinary tract infections
英文适应病症4:
Abdominal infections
英文适应病症5:
Post-operative infection
临床试验期:
完成
中文适应病症参考翻译1:
绿脓杆菌性脑膜炎
中文适应病症参考翻译2:
败血症
中文适应病症参考翻译3:
泌尿系统感染
中文适应病症参考翻译4:
腹部感染
中文适应病症参考翻译5:
手术后感染
药品信息:

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 详细处方信息以本药内容附件PDF文件(20125118351819.pdf)的“原文Priscribing Information”为准
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部分中文Coly-Mycin M处方资料(仅供参考)

Coly-Mycin M(多粘菌素E甲磺酸钠注射液)
英文药名:
Coly-Mycin M (Colistimethate Sodium Injection Vial)

中文参考药名: 多粘菌素E甲磺酸钠注射液
此药品需要处方

多粘菌素E甲磺酸钠 Colistimethate Sodium
中文别名:
多粘菌素E甲磺酸钠、肠粘菌素甲磺酸钠、甲磺酸粘菌素、粘菌素甲磺酸钠、粘菌素甲烷磺酸钠

英文别名: Colimicina、Colimycine、Colistimethate、Colistimethatum Natricum、Colistin Sodium Methamesulfonate、Colistin Sulphomethate Sodium、Colistinm、Colistinmethane Sulfonate Sodium、Coly-Mycin、Coly-Mycin M、Methacolimycin、Pentasodium Colitinmethanesulfate

药品类别:其它抗生素类抗感染药

适应症
本品为绿脓杆菌感染的首选药物之一,可治绿脓杆菌性脑膜炎,也可用于败血症、泌尿系统、腹部及其它手术后感染。

用法用量
肌注或皮注:每次100万单位,1日2~4次。或遵医嘱!

注意事项
主要为肾毒性及神经毒性,但比硫酸多粘菌素E小。有时会出现暂时性的感觉异常、皮肤瘙痒、视觉障碍、语言紊乱、药物热、胃肠道菌群失调等。肾功能不全者慎用。

规格
粉针剂:150mg。

Coly-Mycin® M
(colistimethate for injection, USP)

Product Summary
Therapeutic Class: Antibacterial Agent
This product is manufactured and distributed by JHP Pharmaceuticals, LLC

Product Profile:
Latex Free
Preservative Free
Bar Coded

Description
Coly-Mycin® M Parenteral (colistimethate for injection, USP) is a sterile parenteral antibiotic product which, when reconstituted is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistin-methanesulfonate (150 mg colistin base activity).

Indications and Usage
Coly-Mycin® M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin® M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Coly-Mycin® M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.

Contraindications
The use of Coly-Mycin® M Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

Warnings
Maximum daily dose should not exceed 5 mg/kg/day (2.3 mg/lb) with normal renal function.

Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care.

Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic.

Overdosage can result in renal insufficiency, muscle weakness, and apnea (see OVERDOSAGE section of Prescribing Information). See PRECAUTIONS, Drug Interactions subsection of Prescribing Information for use concomitantly with other antibiotics and curariform drugs.

Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines.

See DOSAGE AND ADMINISTRATION section of Prescribing Information for use in renal impairment.
Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antimicrobial agents including
Coly-Mycin® M Parenteral and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adverse Events
The following adverse reactions have been reported:
Gastrointestinal: gastrointestinal upset
Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia
Integumentary: generalized itching, urticaria and rash
Body as a Whole: fever
Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance
Respiratory System: respiratory distress and apnea
Renal System: nephrotoxicity and decreased urine output

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 详细处方信息以本药内容附件PDF文件(20125118351819.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-08-11
附件:
20125118351819.PDF    

 
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