NOROMBY SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ENOXAPARIN SODIUM

Dostępny od:

JUNO PHARMACEUTICALS CORP.

Kod ATC:

B01AB05

INN (International Nazwa):

ENOXAPARIN

Dawkowanie:

20MG

Forma farmaceutyczna:

SOLUTION

Skład:

ENOXAPARIN SODIUM 20MG

Droga podania:

SUBCUTANEOUS

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HEPARINS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-10-14

Charakterystyka produktu

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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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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