FONDAPARINUX SODIUM INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

FONDAPARINUX SODIUM

Dostupné s:

DR REDDY'S LABORATORIES LTD

ATC kód:

B01AX05

INN (Mezinárodní Name):

FONDAPARINUX

Dávkování:

5MG

Léková forma:

SOLUTION

Složení:

FONDAPARINUX SODIUM 5MG

Podání:

SUBCUTANEOUS

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

Direct Factor Xa Inhibitors

Přehled produktů:

Active ingredient group (AIG) number: 0146781002; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2013-05-23

Charakteristika produktu

_Page 1 of 65 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR FONDAPARINUX SODIUM INJECTION
Sterile Solution
2.5 mg / 0.5 mL
5 mg / 0.4 mL
7.5 mg / 0.6 mL
10 mg / 0.8 mL
For Subcutaneous (SC) or Intravenous (IV) Use
Synthetic Antithrombotic
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 Initial Approval:
July 20, 2012
Date of Revision:
September 15, 2021
Submission
Control No: 256275
_Page 2 of 65 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................................3
1
INDICATIONS..............................................................................................................3
1.1
Pediatrics
..............................................................................................................3
1.2
Geriatrics
..............................................................................................................3
2
CONTRAINDICATIONS
...............................................................................................3
3
DOSAGE AND ADMINISTRATION
..............................................................................4
3.1
Dosing Considerations
............................................................................................4
3.2
Recommended Dose and Dosage
Adjustment..............................................................4
3.3
Administration
.......................................................................................................7
3.4
Missed Dose
..........................................................................................................7
4
OVERDOSAGE.............................................................................................................7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.........................8
6
WARNINGS AND PRECAUTIONS
...............................................................