ACH-VORICONAZOLE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VORICONAZOLE

Dostopno od:

ACCORD HEALTHCARE INC

Koda artikla:

J02AC03

INN (mednarodno ime):

VORICONAZOLE

Odmerek:

200MG

Farmacevtska oblika:

TABLET

Sestava:

VORICONAZOLE 200MG

Pot uporabe:

ORAL

Enote v paketu:

12

Tip zastaranja:

Prescription

Terapevtsko območje:

AZOLES

Povzetek izdelek:

Active ingredient group (AIG) number: 0150242002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-06-10

Lastnosti izdelka

_ACH- Voriconazole Product Monograph_
Page 1 of 57
PRODUCT MONOGRAPH
Pr
ACH-Voriconazole
voriconazole tablets
50 mg and 200 mg
ANTIFUNGAL AGENT
Accord Healthcare Inc.
3535 boul. St. Charles, suite 704,
Kirkland, QC, H9H 5B9
Canada
Date of Preparation:
June 1, 2015
SUBMISSION CONTROL NO: 172122, 184723
_ACH- Voriconazole Product Monograph_
Page 2 of 57
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ............. Error! Bookmark
not defined.
SUMMARY PRODUCT INFORMATION ......................... ERROR! BOOKMARK
NOT DEFINED.
INDICATIONS AND CLINICAL USE ............................... ERROR!
BOOKMARK NOT DEFINED.
CONTRAINDICATIONS
......................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................
5
ADVERSE REACTIONS
....................................................................................................
11
DRUG INTERACTIONS
.....................................................................................................
18
DOSAGE AND ADMINISTRATION
.................................................................................
24
OVERDOSAGE
...................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 27
STORAGE AND STABILITY
............................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 29
PART II: SCIENTIFIC INFORMATION
..................................................................................
31
PHARMACEUTICAL INFORMATION
............................................................................
31
CLINICAL TRIALS
............................................................. ERROR!
BOOKMARK NOT DEFINED.
DETAILED PHARMACOLOGY
...................................