RAN-TADALAFIL TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
19-07-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
TADALAFIL
Fáanlegur frá:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC númer:
G04BE08
INN (Alþjóðlegt nafn):
TADALAFIL
Skammtar:
2.5MG
Lyfjaform:
TABLET
Samsetning:
TADALAFIL 2.5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
4/28/30/56/100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0149485003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2016-07-12
Vara einkenni
Page 1 of 48
PRODUCT MONOGRAPH
PR
RAN™-TADALAFIL
(tadalafil tablets, USP)
2.5 mg, 5 mg tablets (for _Once-a-Day_ use)
10 mg, 20 mg tablets (for _“On-Demand”_ dosing)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
TREATMENT OF ERECTILE DYSFUNCTION (ED)
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
July 17, 2017
Brampton, Ontario
L6T 1C1
Control# 207323
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 48
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
.........................................................................................................................
8
DRUG
INTERACTIONS........................................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................................
14
OVERDOSAGE
......................................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
16
STORAGE AND STABILITY
...............................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 21
PAR
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