Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ceftriaxone (ceftriaxone sodium)
Hankook Korus Pharm Co.
ceftriaxone (ceftriaxone sodium)
1000mg
powder for solution for i/m/i/v injection
Prescription
Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Ceftriaxone-Asteria Inj. 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/vial Use 1 Cetriaxone sodium 1g (potency) Active ingredient Excipient(s) None 3. PHARMACEUTICAL FORM Power for Injection 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Ceftriaxone is indicated for the treatment of the following infections caused by susceptible organisms : Lower Respiratory tract infection such as pneumonia, bronchitis, etc. Ear, nose and throat infection; renal and urinary tract injection; Sepsis, meningitis; pre- operative prophylaxis of infection; Infection of bones and joints; infection of skin, wounds and soft tissue; peritonitis, cholecystitis, cholangitis and infection of gastrointestinal tract; general infections such as gonorrhea etc.; infection in patients with impaired defence mechanisms. 4.2 Posology and method of administration Ceftriaxone may be administrated intravenously or intramuscularly. For IM injection : Ceftriaxone sodium 250mg or 500mg is dissolved in 2ml, and ceftriaxone 1g in 3.5ml of 1% lidocaine HCl solution and injected well within the body of a relatively large Summary of Product Characteristics muscle. It is recommended that not more than 1g be injected at one side. IM injection without lidocaine is painful. The lidocaine solution must never be administered IV. For IV injection : for IV injection, Ceftriaxone 250mg or 500mg is dissolved in 5ml, ceftriaxone1g in 10ml water for injection. The IV administration should be given over 2-4 minutes. Adults : the usual daily dose for adults is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of the infection. The total daily dose should not exceed 4 grams. Children : depending on the infection 50-100mg/kg should be administered up to 2g/day. The usual duration of therapy is 4-14days; generally therapy should be continued for 2days after the symptoms of infection have disappeared. 4.3 Прочитать полный документ