NOROMBY SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ENOXAPARIN SODIUM

Disponible desde:

JUNO PHARMACEUTICALS CORP.

Código ATC:

B01AB05

Designación común internacional (DCI):

ENOXAPARIN

Dosis:

60MG

formulario farmacéutico:

SOLUTION

Composición:

ENOXAPARIN SODIUM 60MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

HEPARINS

Resumen del producto:

Active ingredient group (AIG) number: 0131860001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-10-14

Ficha técnica

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_NOROMBY (enoxaparin sodium solution for injection) _
_Page 1 of 91_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NOROMBY
TM
Enoxaparin sodium
Solution for injection, 100 mg/mL, Subcutaneous or Intravenous Use
20 mg/0.2 mL
30 mg/0.3 mL
40 mg/0.4 mL
60 mg/0.6 mL
80 mg/0.8 mL
100 mg/mL
Pre-filled syringes
Pr
NOROMBY
TM HP
Enoxaparin sodium (High Potency)
Solution for injection, 150 mg/mL, Subcutaneous or Intravenous Use
120 mg/0.8 mL
150 mg/mL
Pre-filled syringes
BP Standard
ATC Code: B01AB05
Anticoagulant/Antithrombotic Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Initial Authorization:
October 14, 2020
Date of Revision:
March 28, 2023
Submission Control No: 268542
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_NOROMBY (enoxaparin sodium solution for injection) _
_Page 2 of 91_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics
...............................................................................................................................
4
1.2
Geriatrics
...............................................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................................
5
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment......................................................................
6
4.4
Administration
.......................................................................................................................
9
4.5
Misse