Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
CEFTRIAXONE AS DISODIUM HEMIHEPTAHYDRATE
VITAMED PHARMACEUTICAL INDUSTRIES LTD
J01DD04
POWDER FOR SOLUTION FOR INJECTION
CEFTRIAXONE AS DISODIUM HEMIHEPTAHYDRATE 1.0 G/VIAL
I.M, I.V
Required
ACS DOBFAR S.P. A, ITALY
CEFTRIAXONE
Ceftriaxone VIT is indicated for the treatment of the following infections in adults andchildren including term neonates (from birth):-Bacterial Meningitis- Community acquired pneumonia-Hospital acquired pneumonia-Acute otitis media-Intra-abdominal infections-Complicated urinary tract infections (including pyelonephritis)-Infections of bones and joints-Complicated skin and soft tissue infections-Gonorrhoea-Syphilis-Bacterial endocarditisCeftriaxone VIT may be used:- For treatment of acute exacerbations of chronic obstructive pulmonary diseasein adults- For treatment of disseminated Lyme borreliosis (early (stage II) and late (stageIII) in adults and children including neonates from 15 days of age.- For pre-operative prophylaxis of surgical site infections-In the management of neutropenic patients with fever that is suspected to be dueto a ceftriaxone – susceptible bacterial infection- In the treatment of patients with bacteraemia that occurs in association with, oris suspected to be associated with, any of the infections listed aboveCeftriaxone VIT should be co-administered with other antibacterial agents whenever thepossible range of causative bacteria would not fall within its spectrum.
2022-09-30
1. NAME OF THE MEDICINAL PRODUCT CEFTRIAXONE-VIT POWDER FOR SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Ceftriaxone contains: Ceftriaxone Disodium Hemiheptahydrate 1.193g Corresponding to Ceftriaxone 1.000g Excipient with known effect: Sodium 1g vial contains 3.6 mmol (or 83 mg) of sodium per vial. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 1 g powder for solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone VIT is indicated for the treatment of the following infections in adults and children including term neonates (from birth): − Bacterial Meningitis − Community acquired pneumonia − Hospital acquired pneumonia − Acute otitis media − Intra -abdominal infections − Complicated urinary tract infections (including pyelonephritis) − Infections of bones and joints − Complicated skin and soft tissue infections − Gonorrhoea − Syphilis − Bacterial endocarditis Ceftriaxone VIT 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 neon ates from 15 days of age. − For pre -operative prophylaxis of surgical site infections − In the management of neutropenic patients with fever that is suspected to be due to a ceftriaxone – susceptible bacterial infection − In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any o f the infections listed above Ceftriaxone VIT should be co-administered 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 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose depends on the severity, susceptibility, site and type of infection and on the age and hepa Aqra d-dokument sħiħ