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  药店国别: 法国药房
产地国家: 意大利
所属类别: 作用于呼吸系统药物->肺炎
处方药:处方药
包装规格: 500毫克 BT1
计价单位:
   
生产厂家中文参考译名:
GSK
生产厂家英文名:
GSK
该药品相关信息网址1:
https://www.ema.europa.eu/en/medicines/human/referrals/fortum
原产地英文商品名:
FORTUM 500MG powder for solution for injection BT1
原产地英文药品名:
ceftazidime
中文参考商品译名:
复达欣 500毫克粉末用于注射溶液 BT1
中文参考药品译名:
头孢他啶
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Nosocomial pneumonia
英文适应病症2:
Broncho-pulmonary infections in cystic fibrosis
英文适应病症3:
Bacterial meningitis
英文适应病症4:
Chronic suppurative otitis media
英文适应病症5:
Malignant otitis externa
临床试验期:
完成
中文适应病症参考翻译1:
院获得性肺炎
中文适应病症参考翻译2:
囊性纤维化中的支气管肺部感染
中文适应病症参考翻译3:
细菌性脑膜炎
中文适应病症参考翻译4:
慢性化脓性中耳炎
中文适应病症参考翻译5:
恶性外耳炎
药品信息:

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详细处方信息以本药内容附件PDF文件(201932420553422.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文复达欣处方资料(仅供参考)


【英文名称】
FORTUM

【禁忌】

对头孢他啶,任何其他头孢菌素或6.1节中列出的任何赋形剂过敏。

对任何其他类型的β-内酰胺抗菌剂(青霉素,单环内酰胺和碳青霉烯类)的严重超敏反应(例如过敏反应)的历史。

【适用证】

Fortum适用于治疗成人和儿童(包括新生儿)(出生时)下列感染。

•医院获得性肺炎

•囊性纤维化中的支气管肺部感染

•细菌性脑膜炎

•慢性化脓性中耳炎

•恶性外耳炎

•复杂的尿路感染

•复杂的皮肤和软组织感染

•复杂的腹腔内感染

•骨和关节感染

•CAPD患者透析相关的腹膜炎。

与上述任何感染相关或可能与之相关的菌血症患者的治疗。

头孢他啶可用于治疗怀疑由细菌感染引起的发热的中性粒细胞减少患者。 头孢他啶可用于经尿道前列腺电切术(TURP)患者的尿路感染的围手术期预防。

头孢他啶的选择应考虑其抗菌谱,主要限于需氧革兰氏阴性菌(见4.4和5.1节)。 只要可能的致病菌范围不属于其活性范围,头孢他啶就应与其他抗菌药物共同给药。

应考虑关于适当使用抗菌剂的官方指南。

【用法用量】

成人和儿童≥40公斤

囊性纤维化中的支气管肺部感染:每8小时100至150毫克/千克/天,每天最多9克

发热性中性粒细胞减少症:每8小时2克

医院获得性肺炎:每8小时2克

细菌性脑膜炎:每8小时2克

菌血症:每8小时2克

骨和关节感染:每8小时1-2克

复杂的皮肤和软组织感染:每8小时1-2克

复杂的腹腔内感染:每8小时1-2克

CAPD患者透析相关的腹膜炎:每8小时1-2克

复杂的尿路感染:每8小时或12小时1-2克

儿童<40公斤

复杂的尿路感染:100-150mg / kg /天,分三次给药,最大6g /天

慢性化脓性中耳炎:100-150 mg / kg /天,分3次服用,最大6 g /天

恶性外耳炎:100-150 mg / kg /天三次分剂量,最大6 g /天

中性粒细胞减少的儿童:150 mg / kg /天,分三次服用,最多6 g /天

囊性纤维化中的支气管肺部感染:150 mg / kg /天,分3次给药,最大6 g /天

【Therapeutic indications】

Fortum is indicated for the treatment of the infections listed below in adults and children including neonates (from birth).

• Nosocomial pneumonia

• Broncho-pulmonary infections in cystic fibrosis

• Bacterial meningitis

• Chronic suppurative otitis media

• Malignant otitis externa

• Complicated urinary tract infections

• Complicated skin and soft tissue infections

• Complicated intra-abdominal infections

• Bone and joint infections

• Peritonitis associated with dialysis in patient on CAPD.

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing transurethral resection of the prostate (TURP).

The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1).

Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causive bacteria would not fall within its spectrum of activity.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

【Posology and method of administration】

Adults and children ≥ 40 kg

Broncho-pulmonary infections in cystic fibrosis: 100 to 150 mg/kg/day every 8 h, maximum 9 g per day

Febrile neutropenia:2 g every 8 h

Nosocomial pneumonia:2 g every 8 h

Bacterial meningitis:2 g every 8 h

Bacteraemia:2 g every 8 h

Bone and joint infections:1-2 g every 8 h

Complicated skin and soft tissue infections:1-2 g every 8 h

Complicated intra-abdominal infections:1-2 g every 8 h

Peritonitis associated with dialysis in patients on CAPD:1-2 g every 8 h

Complicated urinary tract infections:1-2 g every 8 h or 12 h

Children < 40 kg

Complicated urinary tract infections:100-150 mg/kg/day in three divided doses, maximum 6 g/day

Chronic suppurative otitis media:100-150 mg/kg/day in three divided doses, maximum 6 g/day

Malignant otitis externa:100-150 mg/kg/day in three divided doses, maximum 6 g/day

Neutropenic children:150 mg/kg/day in three divided doses, maximum 6 g/day

Broncho-pulmonary infections in cystic fibrosis:150 mg/kg/day in three divided doses, maximum 6 g/day

【Contraindications】

Hypersensitivity to ceftazidime, to any other cephalosporin or to any of the excipients listed in section 6.1.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

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详细处方信息以本药内容附件PDF文件(201932420553422.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-3-17
附件:
201932420553422.pdf    

 
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