KETOROLAC TROMETHAMINE INJECTION, USP SOLUTION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
20-10-2021
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:
KETOROLAC TROMETHAMINE
Fáanlegur frá:
AURO PHARMA INC
ATC númer:
M01AB15
INN (Alþjóðlegt nafn):
KETOROLAC
Skammtar:
30MG
Lyfjaform:
SOLUTION
Samsetning:
KETOROLAC TROMETHAMINE 30MG
Stjórnsýsluleið:
INTRAMUSCULAR
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0121995002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-10-22
Vara einkenni
PRODUCT MONOGRAPH
PR
KETOROLAC TROMETHAMINE INJECTION, USP
(KETOROLAC TROMETHAMINE)
STERILE SOLUTION
30 MG / ML
NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)
Auro Pharma Inc. Date of Preparation:
3700 Steeles Avenue West, Suite # 402 October 20, 2021.
Woodbridge, Ontario, L4L 8K8,
Canada
Submission
Control No: 239985
Page 2 of 40
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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
.............................................................................5
ADVERSE REACTIONS
............................................................................................
14
DRUG INTERACTIONS
............................................................................................
17
DOSAGE AND ADMINISTRATION
.........................................................................
19
OVERDOSAGE
.........................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 21
STORAGE AND STABILITY
....................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 24
PART II: SCIENTIFIC INFORMATION
.........................................................................
25
PHARMACEUTICAL INFORMATION
.....................................................................
25
DETAILED PHARMACOLOGY
................................................................................
26
TOXICOLOGY
..........................................................................................................
28
RE
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