RISEDRONATE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Διαθέσιμο από:

SIVEM PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

M05BA07

INN (Διεθνής Όνομα):

RISEDRONIC ACID

Δοσολογία:

35MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4/30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0135301003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-07-04

Αρχείο Π.Χ.Π.

_RISEDRONATE Product Monograph _
_Page 1 of 35_
PRODUCT MONOGRAPH
Pr
RISEDRONATE
Risedronate Sodium Tablets, USP
(as the hemi-pentahydrate)
35 mg
BONE METABOLISM REGULATOR
SIVEM PHARMACEUTICALS ULC
DATE OF REVISION: June 25, 2014
4705 Dobrin
Saint-Laurent, Quebec
H4R 2P7
Submission Control No: 175592
_RISEDRONATE Product Monograph _
_Page 2 of 35_
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
...................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
18
DETAILED PHARMACOLOG