RISEDRONATE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Διαθέσιμο από:

SANIS HEALTH INC

Φαρμακολογική κατηγορία (ATC):

M05BA07

INN (Διεθνής Όνομα):

RISEDRONIC ACID

Δοσολογία:

35MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2011-09-22

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate sodium (as the monohydrate)
35 mg Tablets
Manufacturer’s Standard
Bisphosphonates
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com
Date of Revision:
March 6, 2019
Submission Control No: 224337
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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
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
..............................................................................