HANZEMA CAPSULE
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
20-10-2022
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Aktiv ingrediens:
ALITRETINOIN
Tilgjengelig fra:
DR. REDDY'S LABORATORIES INC
ATC-kode:
D11AH04
INN (International Name):
ALITRETINOIN
Dosering :
30MG
Legemiddelform:
CAPSULE
Sammensetning:
ALITRETINOIN 30MG
Administreringsrute:
ORAL
Enheter i pakken:
30
Resept typen:
Prescription
Terapeutisk område:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0137581003; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2018-08-20
Preparatomtale
_Page 1 of 40_
_HANZEMA _
PRODUCT MONOGRAPH
HANZEMA
Alitretinoin
Capsules
10 mg and 30 mg
Immunomodulator
/ Anti-inflammatory agent
DIN OWNER:
DR. REDDY’S LABORATORIES, INC.
Princeton, NJ – 08540 USA
IMPORTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1 CANADA
Date of Preparation:
June 18, 2018
Date of Revision:
October 20, 2022
SUBMISSION CONTROL NO.: 264229
™
_Page 2 of 40_
_HANZEMA _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
.......................................................................
3
CONTRAINDICATIONS
.........................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
5
ADVERSE REACTIONS
........................................................................................
12
DRUG INTERACTIONS
........................................................................................
15
DOSAGE AND ADMINISTRATION
.......................................................................
18
OVERDOSAGE
....................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 19
STORAGE AND STABILITY
.................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
................................................................. 22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 22
PART II: SCIENTIFIC INFORMATION
.......................................................................
23
PHARMACEUTICAL INFORMATION
................................................................... 23
CLINICAL TRIALS
..............................................................
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