ACH-TADALAFIL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

TADALAFIL

متاح من:

ACCORD HEALTHCARE INC

ATC رمز:

G04BE08

INN (الاسم الدولي):

TADALAFIL

جرعة:

10MG

الشكل الصيدلاني:

TABLET

تركيب:

TADALAFIL 10MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-05-14

خصائص المنتج

_ _
_ _
_ACH-TADALAFIL Page 1 of 50_
PRODUCT MONOGRAPH
Pr
ACH-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)
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
TREATMENT OF ERECTILE DYSFUNCTION AND
BENIGN PROSTATIC HYPERPLASIA (ED/BPH)
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Preparation:
May 13, 2021
Submission Control Number: 233576
_ _
_ _
_ACH-TADALAFIL Page 2 of 50_
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
...................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 16
STORAGE AND STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
..................................................