CIMZIA SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

CERTOLIZUMAB PEGOL

থেকে পাওয়া:

UCB CANADA INC

এটিসি কোড:

L04AB05

INN (আন্তর্জাতিক নাম):

CERTOLIZUMAB PEGOL

ডোজ:

200MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

CERTOLIZUMAB PEGOL 200MG

প্রশাসন রুট:

SUBCUTANEOUS

প্যাকেজ ইউনিট:

1ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

MISCELLANEOUS GI DRUGS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0152646001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2017-07-04

পণ্য বৈশিষ্ট্য

_CIMZIA_
_®_
_ (certolizumab pegol) - Product Monograph _
_Page 1 of 78 _
PRODUCT MONOGRAPH
CIMZIA
®
certolizumab pegol injection
Solution for Injection 200 mg/mL
Biological Response Modifier
CIMZIA (CERTOLIZUMAB PEGOL) SHOULD BE PRESCRIBED BY PHYSICIANS WHO
HAVE SUFFICIENT
KNOWLEDGE OF RHEUMATOID ARTHRITIS AND/OR PSORIATIC ARTHRITIS AND/OR
ANKYLOSING SPONDYLITIS
AND/OR NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND/OR PLAQUE
PSORIASIS AND WHO HAVE
FULLY FAMILIARIZED THEMSELVES WITH THE EFFICACY/SAFETY PROFILE OF
CIMZIA.
UCB Canada Inc.
2060 Winston Park Drive, Suite 401
Oakville, ON
L6H 5R7
SUBMISSION CONTROL NO: 222049
DATE OF INITIAL APPROVAL:
August 12, 2009
DATE OF REVISION: November 13, 2019
®
CIMZIA is a registered trademark of the UCB Group of Companies
_CIMZIA_
_®_
_ (certolizumab pegol) - Product Monograph _
_Page 2 of 78 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
DESCRIPTION
...............................................................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
...............................................................................................4
WARNINGS AND PRECAUTIONS
..............................................................................5
ADVERSE REACTIONS
..............................................................................................
13
DRUG INTERACTIONS
............................................................................................
31
DOSAGE AND ADMINISTRATION
...........................................................................
32
OVERDOSAGE
............................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
.............................................