CORTROSYN INJ 0.25MG POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-01-2016
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Active ingredient:
TETRACOSACTIDE
Available from:
AMPHASTAR PHARMACEUTICALS, INC.
ATC code:
H01AA02
INN (International Name):
TETRACOSACTIDE
Dosage:
0.25MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
TETRACOSACTIDE 0.25MG
Administration route:
INTRAMUSCULAR
Units in package:
0.25MG VIAL
Prescription type:
Prescription
Therapeutic area:
ADRENOCORTICAL INSUFFICIENCY
Product summary:
Active ingredient group (AIG) number: 0106365002; AHFS:
Authorization status:
APPROVED
Authorization date:
2004-05-14
Summary of Product characteristics
_Cortrosyn_
_® _
_(Cosyntropin for injection, 0.25 mg ) _
_ _
_Page 1 of 16_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CORTROSYN
®
Cosyntropin for injection, 0.25 mg
Lyophilized powder for solution
Adrenocorticotropic hormone (ACTH)
MANUFACTURED BY:
Amphastar Pharmaceuticals, Inc.
11570 6
th
Street
Rancho Cucamonga, CA 91730
USA
Date of Revision:
December 1, 2015
DISTRIBUTED BY:
Amphastar Pharmaceuticals, Inc.
2000 Ellesmere Road, Unit 16
Scarborough, Ontario
M1H 2W4
Submission Control No: 181410
_Cortrosyn_
_® _
_(Cosyntropin for injection, 0.25 mg ) _
_ _
_Page 2 of 16_
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING INSTRUCTIONS
.........................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II:
Read the complete document
