Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
LEVOFLOXACIN AS HEMIHYDRATE
NEOPHARM (ISRAEL) 1996 LTD
S01AX19
SOLUTION FOR INFUSION
LEVOFLOXACIN AS HEMIHYDRATE 5 MG/ML
I.V
Required
FRESENIUS KABI NORGE AS, NORWAY
LEVOFLOXACIN
Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections: - Acute pyelonephritis and complicated urinary tract infections - Chronic bacterial prostatitisIn the below-mentioned infections levofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections:- Community-acquired pneumonia- Complicated skin and soft tissue infectionsConsideration should be given to official guidance on the appropriate use of antibacterial agents.
2021-07-31
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levofloxacin Fresenius 5mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 ML FILLED IN 100 ML BAGS: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 50 ml of solution for infusion contains 250 mg of levofloxacin as active substance. 100 ML FILLED IN 100 ML BAGS: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 100 ml of solution for infusion contains 500 mg of levofloxacin as active substance. Excipient(s) with known effect: The medicinal product contains 3.54 mg of sodium per ml. _ _ _For the full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM Solution for infusion. Yellow to greenish yellow solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections: Acute pyelonephritis and complicated urinary tract infections Chronic bacterial prostatitis In the below-mentioned infections levofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections: Community-acquired pneumonia Complicated skin and soft tissue infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofloxacin Fresenius 5mg/ml solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin Fresenius 5mg/ml after initial use of the intravenous preparation may be completed with an appropriate oral presentation as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used. _ _ _ _ _Posology _ _ _ _ _The following dose rec Baca dokumen lengkapnya