VFEND- voriconazole tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

voriconazole (UNII: JFU09I87TR) (voriconazole - UNII:JFU09I87TR)

Inapatikana kutoka:

Cardinal Health

INN (Jina la Kimataifa):

voriconazole

Tungo:

voriconazole 50 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

VFEND is indicated for use in the treatment of the following fungal infections: Invasive aspergillosis. 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, MICROBIOLOGY). Candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds (see CLINICAL STUDIES, MICROBIOLOGY). Esophageal candidiasis (see CLINICAL STUDIES, MICROBIOLOGY). Serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii ) and Fusarium spp. including Fusarium solani, in patients intolerant of, or refractory to, other therapy (see CLINICAL STUDIES, MICROBIOLOGY). Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative o

Bidhaa muhtasari:

Powder for Solution for Injection VFEND I.V. for Injection is supplied in a single use vial as a sterile lyophilized powder equivalent to 200 mg VFEND and 3200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). Individually packaged vials of 200 mg VFEND I.V.       (NDC 0049-3190-28) Tablets VFEND 50 mg tablets; white, film-coated, round, debossed with "Pfizer" on one side and "VOR50" on the reverse.      Bottles of 30 (NDC 0049-3170-30) VFEND 200 mg tablets; white, film-coated, capsule shaped, debossed with "Pfizer" on one side and "VOR200" on the reverse.      Bottles of 30 (NDC 0049-3180-30) Powder for Oral Suspension VFEND for Oral Suspension is supplied in 100 mL high density polyethylene (HDPE) bottles. Each bottle contains 45 g of powder for oral suspension. Following reconstitution, the volume of the suspension is 75 mL, providing a usable volume of 70 mL (40 mg voriconazole/mL). A 5 mL oral dispenser and a press-in bottle adaptor are also provided.      (NDC 0049-3160-44) VFEND I.V. for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND 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 - Intravenous Administration). VFEND Tablets should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND Powder for Oral Suspension should be stored at 2° – 8°C (36° – 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 18 months. The reconstituted suspension should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.

Idhini hali ya:

New Drug Application

Tabia za bidhaa

VFEND- VORICONAZOLE TABLET, FILM COATED
CARDINAL HEALTH
----------
VFEND I.V.
(VORICONAZOLE) FOR INJECTION
VFEND TABLETS
(VORICONAZOLE)
VFEND (VORICONAZOLE) FOR ORAL SUSPENSION
DESCRIPTION
VFEND (voriconazole), a triazole antifungal agent, is available as a
lyophilized powder for solution
for intravenous infusion, film-coated tablets for oral administration,
and as a powder for oral
suspension. The structural formula is:
Voriconazole is designated chemically as
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-
1-(1_H_-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C
H F N O and a molecular weight
of 349.3.
Voriconazole drug substance is a white to light-colored powder.
VFEND I.V. is a white lyophilized powder containing nominally 200 mg
voriconazole and 3200 mg
sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear
glass vial.
VFEND I.V. is intended for administration by intravenous infusion. It
is a single-dose, unpreserved
product. Vials containing 200 mg lyophilized voriconazole are intended
for reconstitution with Water
for Injection to produce a solution containing 10 mg/mL VFEND and 160
mg/mL of sulfobutyl ether
beta-cyclodextrin sodium. The resultant solution is further diluted
prior to administration as an
intravenous infusion (see DOSAGE AND ADMINISTRATION).
VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive
ingredients include lactose
monohydrate, pregelatinized starch, croscarmellose sodium, povidone,
magnesium stearate and a
coating containing hypromellose, titanium dioxide, lactose monohydrate
and triacetin.
VFEND for Oral Suspension is a white to off-white powder providing a
white to off-white orange-
flavored suspension when reconstituted. Bottles containing 45 g powder
for oral suspension are
intended for reconstitution with water to produce a suspension
containing 40 mg/mL voriconazole. The
inactive ingredients include colloidal silicon dioxide, titanium
dioxide, xanthan gum, sodium citrate
dihydrate, sodium benzoate, anhydrous citric acid, natural