RIVA-SILDENAFIL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SILDENAFIL (SILDENAFIL CITRATE)

Διαθέσιμο από:

LABORATOIRE RIVA INC.

Φαρμακολογική κατηγορία (ATC):

G04BE03

INN (Διεθνής Όνομα):

SILDENAFIL

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4/30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0136261001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-04-22

Αρχείο Π.Χ.Π.

_ _
_RIVA-SILDENAFIL - Product Monograph _
_Page 1 of 52 _
PRODUCT MONOGRAPH
PR
RIVA-SILDENAFIL
Sildenafil tablets (as sildenafil citrate)
25 mg, 50 mg and 100 mg
CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR
TREATMENT OF ERECTILE DYSFUNCTION
LABORATOIRE RIVA INC.
660 Industriel Blvd.
Blainville, Quebec
J7C 3V4
www.labriva.com
Control No.: 222945 DATE OF REVISION:
December 20, 2018
_ _
_RIVA-SILDENAFIL - Product Monograph _
_Page 2 of 52 _
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
..................................................................................
16
OVERDOSAGE
....................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 18
STORAGE AND STABILITY
..............................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 21
PART II: SCIENTIFIC INFORMATION
........................................................................