JAMP POSACONAZOLE SUSPENSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

POSACONAZOLE

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

J02AC04

INN (Nama Internasional):

POSACONAZOLE

Dosis:

40MG

Bentuk farmasi:

SUSPENSION

Komposisi:

POSACONAZOLE 40MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0152201001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-09-02

Karakteristik produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP POSACONAZOLE
posaconazole
Suspension, 40 mg / mL, Oral
Antifungal Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
August 30, 2022
Submission Control Number: 248523
Product Monograph
_JAMP Posaconazole (posaconzole oral suspension)_
Page 2 of 57
RECENT MAJOR LABEL CHANGES
Not Applicable
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
.............................................................................................................
5
1.1
Pediatrics
..................................................................................................................
5
1.2
Geriatrics
..................................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND
ADMINISTRATION .................................................................................
6
4.1
Dosing Considerations
..............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................... 7
4.4
Administration
..........................................................................................................
8
4.5
Missed Dose
.............................................................