RAN-TADALAFIL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TADALAFIL

Dostopno od:

RANBAXY PHARMACEUTICALS CANADA INC.

Koda artikla:

G04BE08

INN (mednarodno ime):

TADALAFIL

Odmerek:

5MG

Farmacevtska oblika:

TABLET

Sestava:

TADALAFIL 5MG

Pot uporabe:

ORAL

Enote v paketu:

4/28/30/56/100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0149485004; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-07-12

Lastnosti izdelka

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PRODUCT MONOGRAPH
PR
TARO-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)
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Control# 283119
DATE OF
PREPARATION:
MAR 08, 2024
_Pr_
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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