INCLUNOX SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ENOXAPARIN SODIUM

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

B01AB05

INN (nume internaţional):

ENOXAPARIN

Dozare:

40MG

Forma farmaceutică:

SOLUTION

Compoziție:

ENOXAPARIN SODIUM 40MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HEPARINS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-11-05

Caracteristicilor produsului

_Inclunox _
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
INCLUNOX
®
Enoxaparin sodium solution for injection, 100 mg/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
INCLUNOX
® HP
Enoxaparin sodium solution for injection, 150 mg/mL (High Potency)
120 mg/0.8 mL
150 mg/mL
(Subcutaneous or Intravenous Use Only)
Anticoagulant/Antithrombotic Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Approval:
November 5, 2020
Submission Control No: 233987
_ _
_Inclunox _
_Page 2 of 73_
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATIONS
....................................................................................................................4
Pediatrics
..............................................................................................................................4
Geriatrics
..............................................................................................................................4
2
CONTRAINDICATIONS ..................................................................................................5
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 ........................................................