Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
CEFTRIAXONE AS SODIUM
NEOPHARM (ISRAEL) 1996 LTD
J01DD04
POWDER FOR SOLUTION FOR INJ/INF
CEFTRIAXONE AS SODIUM 1000 MG/VIAL
I.V, I.M
Required
LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL
CEFTRIAXONE
CEFTRIAXONE
* Ceftriaxone-Fresenius 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-Fresenius 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 infectionsIn the management of neutropenic patients with fever that is suspected to be due to a bacterial infectionIn the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above* Ceftriaxone-Fresenius should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.* Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
2018-04-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CEFTRIAXONE – FRESENIUS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg of ceftriaxone (as sodium). Excipient with known effect: Sodium For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. For I.V/ I.M administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone -Fresenius 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 -Fresenius 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 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 of the infections listed above. Ceftriaxone -Fresenius should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum. 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 hepatorenal function of the patient. The doses recommended in the tables below are the generally recommend Soma hati kamili