ACCEL-SILDENAFIL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SILDENAFIL (SILDENAFIL CITRATE)

Διαθέσιμο από:

ACCEL PHARMA INC

Φαρμακολογική κατηγορία (ATC):

G04BE03

INN (Διεθνής Όνομα):

SILDENAFIL

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4/8

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0136261003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-08-03

Αρχείο Π.Χ.Π.

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_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
ACCEL-SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
House Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
Date of Revision:
December 27, 2018
SUBMISSION CONTROL NO: 222236
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_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 2 of 49_
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
......................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
12
DOSAGE AND ADMINISTRATION
................................................................................
15
OVERDOSAGE
..................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 17
STORAGE AND STABILITY
............................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
20
DOSAGE FORMS, CO