Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Zydus Lifesciences Limited
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 25 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Levofloxacin injection is indicated for the treatment of adults (> 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Levofloxacin injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)] . Levofloxacin injection is indicated for the treatment of community-acquired pneumonia due to methicillin
Levofloxacin Injection is supplied in single-dose vials. Each vial contains a clear yellow to greenish yellow concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials and 750 mg of levofloxacin in 30 mL vials. Levofloxacin Injection in single-dose vials should be stored at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.
Abbreviated New Drug Application
Zydus Lifesciences Limited ---------- SPL MEDGUIDE Revised: 10/2023 Document Id: 05a00452-026c-4ef9-b84c-4c77aa56c51b 34391-3 Set id: 74ffa693-6859-4b92-998b-775b3245d45d Version: 8 Effective Time: 20231003 Zydus Lifesciences Limited Прочитайте повний документ
LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION ZYDUS LIFESCIENCES LIMITED ---------- LEVOFLOXACIN INJECTION SPL MEDGUIDE PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 MG/20 ML CONTAINER LABEL NDC 70771-1079-2 LEVOFLOXACIN INJECTION 500 MG/20 ML (25 MG/ML) FOR INTRAVENOUS INFUSION ATTENTION PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. 20 ML SINGLE-DOSE VIAL RX ONLY ZYDUS PHARMACEUTICALS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 MG/20 ML CARTON LABEL NDC 70771-1079-2 LEVOFLOXACIN INJECTION 500 MG/20 ML 500 MG/20 ML (25 MG/ML) FOR INTRAVENOUS INFUSION FURTHER DILUTION REQUIRED ATTENTION PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. 20 ML SINGLE-DOSE VIAL RX ONLY ZYDUS PHARMACEUTICALS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 MG/30 ML CONTAINER LABEL NDC 70771-1079-3 LEVOFLOXACIN INJECTION 750 MG/30 ML (25 MG/ML) FOR INTRAVENOUS INFUSION ATTENTION PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. 30 ML SINGLE-DOSE VIAL RX ONLY ZYDUS PHARMACEUTICALS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 MG/30 ML CARTON LABEL NDC 70771-1079-3 LEVOFLOXACIN INJECTION 750 MG/30 ML (25 MG/ML) FOR INTRAVENOUS INFUSION FURTHER DILUTION REQUIRED ATTENTION PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. 30 ML SINGLE-DOSE VIAL RX ONLY ZYDUS PHARMACEUTICALS LEVOFLOXACIN levofloxacin injection, solution PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1079 ROUTE OF ADMINISTRATION INTRAVENOUS ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH Zydus Lifesciences Limited LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS 25 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1079-2 20 mL in 1 VIAL; Type 0: Not a Combination Product 08/01/2017 2 Прочитайте повний документ