KINERET SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ANAKINRA

Beszerezhető a:

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

ATC-kód:

L04AC03

INN (nemzetközi neve):

ANAKINRA

Adagolás:

150MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

ANAKINRA 150MG

Az alkalmazás módja:

SUBCUTANEOUS

db csomag:

0.67 ML

Recept típusa:

Prescription

Terápiás terület:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0147441001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2010-11-09

Termékjellemzők

_KINERET_

_ (anakinra) Product Monograph _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
KINERET

Anakinra
KINERET

is produced using an _Escherichia coli (E. coli)_ bacterial expression
system. Anakinra is a
recombinant methionyl Human Interleukin-1 Receptor Antagonist.
Solution for Injection in a Prefilled Syringe
100 mg/0.67 mL
(150 mg/mL)
Subcutaneous Injection
Pharmaceutical Standard: Professed
Immunomodulatory Agent
Swedish Orphan Biovitrum AB (publ)
SE-112 76
Stockholm, Sweden
Imported by:
C.R.I.
3455 North Service Road, Unit #400
Burlington, ON
L7N 3G2
Date of Initial Authorization:
MAY 29, 2002
Date of Revision:
OCT 26, 2022
Submission Control Number: 259273
_ _
_KINERET_

_ (anakinra) Product Monograph _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
Not applicable
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
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustm