Χώρα: Αρμενία
Γλώσσα: Αγγλικά
Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ceftriaxone (ceftriaxone sodium)
Hankook Korus Pharm Co.
J01DD04
ceftriaxone (ceftriaxone sodium)
1000mg
powder for solution for i/m and i/v injection
(1) and (10) glass vial
Prescription
Registered
2020-09-30
Leaflet insert To be prescribed ATC Code: J01DD04 CEFTRIAXONE-ASTERIA INJ. 0.5G, 1G (CEFTRIAXONE SODIUM) POWDER FOR SOLUTION FOR I/M,I/V INJECTION BROAD-SPECTRUM CEPHALOSPORIN ANTIBIOTIC DESCRIPTION THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Ceftriaxone-Asteria Inj. is a long acting, broad spectrum cephalosporin antibiotic for parenteral use. TYPE OF DOSAGE FORM Ceftriaxone sodium is a white to slightly yellowish crystalline powder. ROUTE OF ADMINISTRATION • intramuscular injection • intravenous injection STERILE / RADIOACTIVE STATEMENT Not applicable. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: ceftriaxone sodium in the form of the disodium salt. Vials containing dry substance equivalent to 0.5 g, 1 g ceftriaxone. Solvent for parenteral use: The solvent ampoule for i.v. injection contains sterile water for injections and for i.m. injection contains 1% lidocaine hydrochloride solution. 1 ml solvent for i.m. injection contains 10.66 mg lidocaine hydrochloride monohydrate equivalent to 10 mg anhydrous lidocaine hydrochloride. Ceftriaxone-Asteria Inj. contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone. CLINICAL PARTICULARS THERAPEUTIC INDICATION(S) Ceftriaxone-Asteria is indicated for the treatment of the following infection in adults and children including term neonates (from birth): Bacterial meningitis Community acquired pneumonia Hospital acquired pneumonia Acute otitis media Intra-abdominal infection Complicated urinary tract infections( including pyelonephritis) Infections of bones and joints Complicated skin and soft tissue infections Gonorrhoea Syphilis Leaflet insert Bacterial endocarditis Ceftriaxone-Asteria may be used: For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age. For pre-operative prophylaxis of surgical site infections. In the man Διαβάστε το πλήρες έγγραφο
Summary of Product Characteristic CEFTRIAXONE-ASTERIA INJ. 0.5G, 1G (CEFTRIAXONE SODIUM) POWDER FOR SOLUTION FOR I/M, I/V INJECTION BROAD-SPECTRUM CEPHALOSPORIN ANTIBIOTIC 1. NAME OF THE MEDICINAL PRODUCT Ceftriaxone-Asteria Inj. 1g Ceftriaxone-Asteria Inj. 0.5 g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1g or 0.5 g ceftriaxone as ceftriaxone sodium. 3. PHARMACEUTICAL FORM Powder for solution for intramuscular injection and intravenous injection. Ceftriaxone sodium is a white to slightly yellowish crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION(S) Ceftriaxone-Asteria is indicated for the treatment of the following infection in adults and children including term neonates (from birth): Bacterial meningitis Community acquired pneumonia Hospital acquired pneumonia Acute otitis media Intra-abdominal infection Complicated urinary tract infections( including pyelonephritis) Infections of bones and joints Complicated skin and soft tissue infections Gonorrhoea Syphilis Bacterial endocarditis Ceftriaxone-Asteria may be used For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age. For pre-operative prophylaxis of surgical site infections. Summary of Product Characteristic In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection In the treatment of patients with bacteraemia that occurs in association with or is suspected to be associated with, any of the infection listed above Ceftriaxone-Asteria should be co administrated with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4.) Consideration should be given to official guidelines on the appropriate use of antibacterial agents. 4.2 DOSAGE AND ADMINISTRATION The dose depends on the seve Διαβάστε το πλήρες έγγραφο