KETOROLAC TROMETHAMINE INJECTION, USP SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

KETOROLAC TROMETHAMINE

Dostupno od:

AURO PHARMA INC

ATC koda:

M01AB15

INN (International ime):

KETOROLAC

Doziranje:

30MG

Farmaceutski oblik:

SOLUTION

Sastav:

KETOROLAC TROMETHAMINE 30MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0121995002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2021-10-22

Svojstava lijeka

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