RISEDRONATE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Dostopno od:

SANIS HEALTH INC

Koda artikla:

M05BA07

INN (mednarodno ime):

RISEDRONIC ACID

Odmerek:

35MG

Farmacevtska oblika:

TABLET

Sestava:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG

Pot uporabe:

ORAL

Enote v paketu:

4

Tip zastaranja:

Prescription

Terapevtsko območje:

BONE RESORPTION INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-09-22

Lastnosti izdelka

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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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_Page 2 of 51_
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
..............................................................................