SANDOZ POSACONAZOLE TABLET (DELAYED-RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

POSACONAZOLE

Inapatikana kutoka:

SANDOZ CANADA INCORPORATED

ATC kanuni:

J02AC04

INN (Jina la Kimataifa):

POSACONAZOLE

Kipimo:

100MG

Dawa fomu:

TABLET (DELAYED-RELEASE)

Tungo:

POSACONAZOLE 100MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

AZOLES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0152201002; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-02-20

Tabia za bidhaa

_ _
_Sandoz Posaconazole _
_Page 1 of 58 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ® POSACONAZOLE
Posaconazole delayed-release tablet
Delayed-Release Tablets, 100 mg, Oral
Antifungal Agent
Sandoz Canada Inc.
110 de Lauzon
Boucherville, Québec
J4B 1E6
Date of Initial Authorization:
February 12, 2020
Date of Revision:
July 7, 2022
Submission Control Number: 261601
_ _
_Sandoz Posaconazole _
_Page 2 of 58 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2022
9 DRUG INTERACTIONS, 9.4 Drug-Drug Interaction
07/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND
ADMINISTRATION......................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
.................................