RYMTI SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ETANERCEPT

Available from:

LUPIN PHARMA CANADA LIMITED

ATC code:

L04AB01

INN (International Name):

ETANERCEPT

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

ETANERCEPT 50MG

Administration route:

SUBCUTANEOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0151564001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-08-31

Summary of Product characteristics

_ _
_RYMTI _
_Page 1 of 87_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RYMTI
Etanercept injection
50 mg/mL, Solution for Injection in pre-filled syringe
50 mg/mL, Solution for Injection in pre-filled auto-injector pen
Manufacturer Standard
Biological Response Modifier
Lupin Pharma Canada Limited
1001 De Maisonneuve Est, Suite 304
Montreal, Quebec
H2L 4P9
Date of Approval:
August 31, 2022
Submission Control No: 234562
_ _
_RYMTI _
_Page 2 of 87_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
5
1.2
Geriatrics............................................................................................................
5
2
CONTRAINDICATIONS
...............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 5
4
DOSAGE AND ADMINISTRATION
..............................................................................
6
4.1
Dosing Considerations
........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
.................................................... 6
4.3
Administration.....................................................................................................
7
4.4
Missed
Dose.......................................................................................................
7
5
OVERDOSAGE
...........................................................................................................
7
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 8
7
WARNINGS AND PRECAUTIONS
.......................................................................