Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefepime (cefepime hydrochloride)
Hankook Korus Pharm Co.
J01DE01
cefepime (cefepime hydrochloride)
1000mg
powder for solution for injection
(1) glass vial, (10) glass vials
Prescription
Registered
2021-11-11
To be prescribed ATC Code : J01DE01 Fourth-generation cephalosporin CEFEPIME-ASTERIA INJ. 1G Cefepime HCI 1g POWDER FOR SOLUTION FOR INJECTION [COMPOSITION] 1 VIAL CONTAINS CEFEPIME HCL---------------------------------------------------------------------------------------------------------------------1G (POTENCY) EXCIPIENTS : L-ARGININE DESCRIPTION White to yellowish crystalline powder in clear vials INDICATIONS Cefepime-Asteria is indicated in the treatment of infections caused by bacteria that are cefepime-sensitive: - lower respiratory tract infections, including nosocomial pneumonia and community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and secondary bacterial infection of acute bronchitis; - uncomplicated and complicated urinary tract infections, including pyelonephritis; - skin and subcutaneous infections; - intra-abdominal infections, including peritonitis and biliary tract infections; - gynaecological infections; - bacterial meningitis in infants and children; - In combination with other antibacterial agents in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection; - Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents. DOSAGE AND ADMINISTRATION Cefepime-Asteria can be administered via intravenous use or intramuscular use. After reconstitution, the solution is yellow to yellow-brown. The usual dose and the route of administration vary in accordance with the severity of the infection, the renal function and the general conditions of the patient. The IV route of administration is preferable in the patients with severe infections or in a life-threatening situation, particularly if there is the possibility of shock. Adults and children weighing > 40 kg with normal renal function: SEVERITY OF THE INFECTION DOSAGE AND ROUTE OF ADMINISTRATION INT Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefepime-Asteria Inj. 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/vial Use 1 _ _ Cefepime Hydrochloride 1g (potency) Active ingredient _ _ Excipients No. Chemical Name Quantity/vial Use 1 _ _ L-arginine q.s. pH Adjuster _ _ 3. PHARMACEUTICAL FORM Powder for solution for injection 3.1 DESCRIPTION White to yellowish crystalline powder in clear vials 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefepime-Asteria is indicated in the treatment of infections caused by bacteria that are cefepime-sensitive: - lower respiratory tract infections, including nosocomial pneumonia and community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and secondary bacterial infection of acute bronchitis; - uncomplicated and complicated urinary tract infections, including pyelonephritis; - skin and subcutaneous infections; - intra-abdominal infections, including peritonitis and biliary tract infections; - gynaecological infections; - bacterial meningitis in infants and children; - In combination with other antibacterial agents in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection; - Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefepime-Asteria can be administered via intravenous use or intramuscular use. After reconstitution, the solution is yellow to yellow-brown. The usual dose and the route of administration vary in accordance with the severity of the infection, the renal function and the general conditions of the patient. The IV route of administration is preferable in the patients with severe infections or in a life-threatening situation, particularly if there is the possibility of shock. Adults and Đọc toàn bộ tài liệu