CORTROSYN INJ 0.25MG POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TETRACOSACTIDE

Disponibbli minn:

AMPHASTAR PHARMACEUTICALS, INC.

Kodiċi ATC:

H01AA02

INN (Isem Internazzjonali):

TETRACOSACTIDE

Dożaġġ:

0.25MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

TETRACOSACTIDE 0.25MG

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

0.25MG VIAL

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ADRENOCORTICAL INSUFFICIENCY

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0106365002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2004-05-14

Karatteristiċi tal-prodott

_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: