METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
06-05-2014
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:
METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
H02AB04
INN (Alþjóðlegt nafn):
METHYLPREDNISOLONE
Skammtar:
5G
Lyfjaform:
POWDER FOR SOLUTION
Samsetning:
METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G
Stjórnsýsluleið:
INTRAMUSCULAR
Einingar í pakka:
80ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ADRENALS
Vörulýsing:
Active ingredient group (AIG) number: 0106290010; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2015-10-16
Vara einkenni
PRODUCT MONOGRAPH
METHYLPREDNISOLONE SODIUM SUCCINATE
FOR INJECTION
USP
methylPREDNISolone
Sterile Powder
40mg, 125mg, 500 mg, 1 g, 5 g Vials
GLUCOCORTICOID/ ANTI-INFLAMMATORY
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
May 5, 2014
Toronto, Ontario
M1B 2K9
CONTROL NO.:173204
Page 2 of 29
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................3
SUMMARY PRODUCT
INFORMATION........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS...................................................................................................5
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE REACTIONS
.................................................................................................10
DRUG
INTERACTIONS..................................................................................................11
DOSAGE AND
ADMINISTRATION..............................................................................14
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL
PHARMACOLOGY.............................................................17
STORAGE AND
STABILITY..........................................................................................19
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................20
PART II: SCIENTIFIC
INFORMATION....................................................................21
PHARMACEUTICAL INFORMATION
........................................................................21
CLINICAL
TRIALS.........................................................................................................
22
DETAILED
PHARMACOLOGY.....................................................................................23
T
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