ORGARAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DANAPAROID SODIUM

Available from:

ASPEN PHARMACARE CANADA INC.

ATC code:

B01AB09

INN (International Name):

DANAPAROID

Dosage:

750UNIT

Pharmaceutical form:

SOLUTION

Composition:

DANAPAROID SODIUM 750UNIT

Administration route:

INTRAVENOUS

Units in package:

10X0.6ML AMPS

Prescription type:

Prescription

Therapeutic area:

HEPARINS

Product summary:

Active ingredient group (AIG) number: 0126753002; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-02-09

Summary of Product characteristics

1
PRODUCT
MONOGRAPH
-
HIT
PR
ORGARAN
®
Danaparoid Sodium Injection
750 anti-Xa units/ampoule
(1250 anti-Xa units/mL)
Anticoagulant/Antithrombotic Agent
(Heparinoid)
Aspen Pharmacare Canada Inc.
111 Queen Street East, Suite 450,
Toronto, Ontario, M5C 1S2
Control No.
212405
Date of approval: February 9, 2018
2
TABLE
OF
CONTENTS
ACTIONS AND CLINICAL PHARMACOLOGY
.....................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
4
CONTRAINDICATIONS
...............................................................................................................
5
WARNINGS
.....................................................................................................................................
5
PRECAUTIONS
..............................................................................................................................
9
DRUG INTERACTIONS
.............................................................................................................
15
ADVERSE REACTIONS
.............................................................................................................
16
SYMPTOMS AND TREATMENT OF OVERDOSAGE
......................................................... 20
DOSAGE AND ADMINISTRATION
.........................................................................................
20
PHARMACEUTICAL INFORMATION
...................................................................................
27
AVAILABILITY OF DOSAGE FORM
......................................................................................
28
PHARMACOLOGY
.....................................................................................................................
29
TOXICOLOGY
.............................................................................................................................
31
CLINICAL TRIALS
..........................................................................