TREPROSTINIL INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TREPROSTINIL (TREPROSTINIL SODIUM)

Available from:

DR REDDY'S LABORATORIES LTD

ATC code:

B01AC21

INN (International Name):

TREPROSTINIL

Dosage:

2.5MG

Pharmaceutical form:

SOLUTION

Composition:

TREPROSTINIL (TREPROSTINIL SODIUM) 2.5MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0148361002; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-12-30

Summary of Product characteristics

_ _
_ Treprostinil Injection Product Monograph _
_Page 1 of 36 _
PRODUCT MONOGRAPH
PR
TREPROSTINIL INJECTION
1 mg / mL, 2.5 mg / mL, 5 mg / mL and
10 mg / mL of treprostinil
(as treprostinil sodium)
Vasodilator
MANUFACTURED BY:
DR. REDDY’S LABORATORIES
LTD.
Bachupally – 500 090 India
IMPORTED AND DISTRIBUTED BY:
DR. REDDY'S LABORATORIES CANADA INC.
Mississauga ON L4W 4Y1 Canada
DATE OF PREPARATION:
December 24, 2021
Control No: 237082
_ _
_ Treprostinil Injection Product Monograph _
_Page 2 of 36 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 21
PART II: SCIENTIFIC INFORMATION
.......................................................................