JETREA SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

OCRIPLASMIN

থেকে পাওয়া:

THROMBOGENICS NV

এটিসি কোড:

S01XA22

INN (আন্তর্জাতিক নাম):

OCRIPLASMIN

ডোজ:

1.25MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

OCRIPLASMIN 1.25MG

প্রশাসন রুট:

INTRAVITREAL

প্যাকেজ ইউনিট:

0.3 ML IN 2ML VIAL

প্রেসক্রিপশন টাইপ:

Schedule D

থেরাপিউটিক এলাকা:

EENT DRUGS, MISCELLANEOUS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0154610002; AHFS:

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2020-03-20

পণ্য বৈশিষ্ট্য

_ _
_JETREA Product Monograph _
_Page 1 of 22_
PRODUCT MONOGRAPH
Pr
JETREA
®
ocriplasmin solution for intravitreal injection
2.5 mg/mL
Professed Standard
Ophthalmological
SPONSOR:
ThromboGenics N.V.
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Submission Control No: 218435
Date of Approval: September 27, 2018
_ _
_JETREA Product Monograph _
_Page 2 of 22_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
16
PHARMACEUTICAL INFO