NOROMBY HP SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ENOXAPARIN SODIUM

Fáanlegur frá:

JUNO PHARMACEUTICALS CORP.

ATC númer:

B01AB05

INN (Alþjóðlegt nafn):

ENOXAPARIN

Skammtar:

120MG

Lyfjaform:

SOLUTION

Samsetning:

ENOXAPARIN SODIUM 120MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HEPARINS

Vörulýsing:

Active ingredient group (AIG) number: 0131860002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2020-10-14

Vara einkenni

_ _
_NOROMBY _
_Page 1 of 78_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NOROMBY
TM
Enoxaparin sodium
Solution for injection, 100 mg/mL
BP
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
(Subcutaneous or Intravenous Use Only)
Pr
NOROMBY
TM HP
Enoxaparin sodium
Solution for injection, 150 mg/mL
BP
120 mg/0.8 mL
150 mg/mL
(Subcutaneous or Intravenous Use Only)
ATC Code: B01AB05
Anticoagulant/Antithrombotic Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Initial Approval:
October 14, 2020
Date of Revision:
February 12, 2021
Submission Control No: 233058
_ _
_NOROMBY _
_Page 2 of 78_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................4
1
INDICATIONS
..............................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics
............................................................................................................4
2
CONTRAINDICATIONS................................................................................................4
3
DOSAGE AND
ADMINISTRATION...............................................................................5
3.1
Dosing
Considerations.........................................................................................5
3.2
Recommended Dose and Dosage Adjustment
.....................................................5
3.3
Administration
.....................................................................................................8
3.4
Missed Dose
.....................................................................................................10
4
OVERDOSAGE
..........................................................................................................10
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND
PACKAGING................