PMS-TADALAFIL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TADALAFIL

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

G04BE08

INN (mednarodno ime):

TADALAFIL

Odmerek:

20MG

Farmacevtska oblika:

TABLET

Sestava:

TADALAFIL 20MG

Pot uporabe:

ORAL

Enote v paketu:

4/30

Tip zastaranja:

Prescription

Terapevtsko območje:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0149485002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-07-12

Lastnosti izdelka

PRODUCT MONOGRAPH
PR PMS-TADALAFIL
Tadalafil Tablets, House Standard
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)
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
TREATMENT OF ERECTILE DYSFUNCTION AND
BENIGN PROSTATIC HYPERPLASIA (ED/BPH)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, 4XHEHF
H4P 2T4
www.pharmascience.com
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November , 2019
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_ _
_pms-TADALAFIL Product Monograph Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 18
STORAGE AND STABILITY
.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMAC