APPRILON CAPSULE (IMMEDIATE AND DELAYED RELEASE)

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DOXYCYCLINE (DOXYCYCLINE MONOHYDRATE)

Fáanlegur frá:

GALDERMA CANADA INC

ATC númer:

J01AA02

INN (Alþjóðlegt nafn):

DOXYCYCLINE

Skammtar:

40MG

Lyfjaform:

CAPSULE (IMMEDIATE AND DELAYED RELEASE)

Samsetning:

DOXYCYCLINE (DOXYCYCLINE MONOHYDRATE) 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

14/28

Gerð lyfseðils:

Prescription

Lækningarsvæði:

TETRACYCLINES

Vörulýsing:

Active ingredient group (AIG) number: 0105569008; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2011-11-14

Vara einkenni

_ _
_APPRILON Product Monograph _
_Page 1 of 28_
PRODUCT MONOGRAPH
Pr
APPRILON
®
Doxycycline
Modified-Release Capsule, 40 mg
(as doxycycline monohydrate)
Anti-Rosacea
GALDERMA CANADA INC.
55 Commerce Valley Dr. W., 4th floor
Thornhill, Ontario L3T 7V9
Date of Preparation:
November 09, 2011
Date of Revision:
May 31, 2018
Submission Control No: 214275
_ _
_APPRILON Product Monograph _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
CLINICAL TRIALS
....................................................................................