AVSOLA POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

INFLIXIMAB

Dostupné z:

AMGEN CANADA INC

ATC kód:

L04AB02

INN (Medzinárodný Name):

INFLIXIMAB

Dávkovanie:

100MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

INFLIXIMAB 100MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

5ML

Typ predpisu:

Prescription

Terapeutické oblasti:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0144162001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-03-12

Súhrn charakteristických

_AVSOLA_
_®_
_ _
_Page 1 of 116_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AVSOLA
®
Infliximab for injection
Powder for Solution, Sterile, Lyophilized, 100 mg/vial, Intravenous
Infusion
Biological Response Modifier
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, ON L5N 0A4
Date of Initial Authorization:
March 12, 2020
Date of Revision:
May 17, 2022
Submission Control No: 259724
© 2020-2021 Amgen Canada Inc., all rights reserved.
_ _
_AVSOLA_
_®_
_ _
_Page 2 of 116_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
XX/XXXX
7 WARNINGS AND PRECAUTIONS, Immune, Live Vaccines/Therapeutic
Infectious Agents
XX/XXXX
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
XX/XXXX
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women, 7.1.2 Breast-feeding
XX/XXXX
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................
2
TABLE OF CONTENTS
...............................................................................................
2
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
............................................. 6
4
DOSAGE AND
ADMINISTRATION......................................................................
6
4.1
Dosing Considerations
.......................................................................
6
4.2
Recommended Dose and D