RAN-TADALAFIL TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
19-07-2017

Viambatanisho vya kazi:

TADALAFIL

Inapatikana kutoka:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC kanuni:

G04BE08

INN (Jina la Kimataifa):

TADALAFIL

Kipimo:

10MG

Dawa fomu:

TABLET

Tungo:

TADALAFIL 10MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

4/28/30/56/100/500

Dawa ya aina:

Prescription

Eneo la matibabu:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0149485001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2016-07-12

Tabia za bidhaa

                                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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