JAMP-SILDENAFIL R TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SILDENAFIL (SILDENAFIL CITRATE)

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

C02KX

INN (Διεθνής Όνομα):

ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

SILDENAFIL (SILDENAFIL CITRATE) 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0136261004; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-04-12

Αρχείο Π.Χ.Π.

1
_JAMP-SILDENAFIL R (sildenafil citrate) Product Monograph_
PRODUCT MONOGRAPH
PR
JAMP-SILDENAFIL R
Sildenafil Tablets, USP
20 mg sildenafil (as sildenafil citrate)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Pulmonary Arterial Hypertension
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Submission Control No: 256307
Date of Revision:
October 14, 2021
2
_JAMP-SILDENAFIL R (sildenafil citrate) Product Monograph_
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
........................................................................................................
9
DRUG INTERACTIONS
......................................................................................................
14
DOSAGE AND ADMINISTRATION
..................................................................................
23
OVERDOSAGE
.....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 24
STORAGE AND STABILITY
..............................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
........................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 28
PART II: SCIENTIFIC INFORMATION
......................................................................