ACTONEL TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
12-08-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
Fáanlegur frá:
ALLERGAN PHARMA CO.
ATC númer:
M05BA07
INN (Alþjóðlegt nafn):
RISEDRONIC ACID
Skammtar:
5MG
Lyfjaform:
TABLET
Samsetning:
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
28
Gerð lyfseðils:
Prescription
Lækningarsvæði:
BONE RESORPTION INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0135301002; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2019-01-04
Vara einkenni
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACTONEL
®
Risedronate Sodium (as the hemi-pentahydrate) Tablets, USP
5 mg, 30 mg, 35 mg, and 150 mg
Pr
ACTONEL DR
®
Risedronate Sodium (as the hemi-pentahydrate) Delayed-Release Tablets
35 mg
Bisphosphonates
Allergan Pharma Co.
Markham, Ontario
L6G 0B5
Date of Preparation:
August 3, 2017
Submission Control No: 205107
2
TABLE OF CONTENTS
PAGE
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
......................................................................................................13
DOSAGE AND ADMINISTRATION
..................................................................................16
OVERDOSAGE
.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
................................................................18
STORAGE AND STABILITY
..............................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................24
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..............................................................................26
CLINICAL TRIALS
...............................................
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