VORICONAZOLE injection, powder, lyophilized, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)

Saatavilla:

Zydus Lifesciences Limited

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus . There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1) 14.5 and Microbiology (12.4) ]. Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4) ]. Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5) and Microbiology (1

Tuoteyhteenveto:

Powder for Solution for Injection Voriconazole for injection is supplied in a single dose vial as a sterile lyophilized powder equivalent to 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). This container closure is not made with natural rubber latex. Voriconazole for injection unreconstituted vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Voriconazole for injection is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with water for injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [see Dosage and Administration (2.1) ].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

VORICONAZOLE - VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ZYDUS LIFESCIENCES LIMITED
----------
VORICONAZOLE FOR INJECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Container Label
NDC 70771-1413-1
Voriconazole
for Injection
200 mg per vial
Sterile Single-Dose Vial
For Intravenous Infusion Only
RX ONLY
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton Label
NDC 70771-1413-1
Voriconazole
for Injection
200 mg per vial
Sterile Single-Dose Vial
For Intravenous Infusion Only
1 VIAL
RX ONLY
VORICONAZOLE
voriconazole injection, powder, lyophilized, for solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1413
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)
VORICONAZ OLE
10 mg in 1 mL
Zydus Lifesciences Limited
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SULFOBUTYLETHER .BETA.-CYCLODEXTRIN (UNII: 2PP9364507)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1413-1
1 in 1 CARTON
01/03/2019
1
20 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA208983
01/03/2019
LABELER -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1413) , MANUFACTURE(70771-1413)
Revised: 11/2022