NOROMBY SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ENOXAPARIN SODIUM

Dostupné z:

JUNO PHARMACEUTICALS CORP.

ATC kód:

B01AB05

INN (Medzinárodný Name):

ENOXAPARIN

Dávkovanie:

60MG

Forma lieku:

SOLUTION

Zloženie:

ENOXAPARIN SODIUM 60MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

HEPARINS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-10-14

Súhrn charakteristických

_ _
_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
_ _
_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