LEVOFLOXACIN injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Saadav alates:

Zydus Lifesciences Limited

INN (Rahvusvaheline Nimetus):

LEVOFLOXACIN

Koostis:

LEVOFLOXACIN ANHYDROUS 25 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Zydus Lifesciences Limited
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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

Toote omadused

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
ZYDUS LIFESCIENCES LIMITED
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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