FONDAPARINUX SODIUM INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FONDAPARINUX SODIUM

Disponibil de la:

DR REDDY'S LABORATORIES LTD

Codul ATC:

B01AX05

INN (nume internaţional):

FONDAPARINUX

Dozare:

10MG

Forma farmaceutică:

SOLUTION

Compoziție:

FONDAPARINUX SODIUM 10MG

Calea de administrare:

SUBCUTANEOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

Direct Factor Xa Inhibitors

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-05-23

Caracteristicilor produsului

_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
...............................................................