OCTREOTIDE FOR INJECTABLE SUSPENSION POWDER FOR SUSPENSION, SUSTAINED-RELEASE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

OCTREOTIDE (OCTREOTIDE ACETATE)

থেকে পাওয়া:

TEVA CANADA LIMITED

এটিসি কোড:

H01CB02

INN (আন্তর্জাতিক নাম):

OCTREOTIDE

ডোজ:

20MG

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

রচনা:

OCTREOTIDE (OCTREOTIDE ACETATE) 20MG

প্রশাসন রুট:

INTRAMUSCULAR

প্যাকেজ ইউনিট:

15G/50G

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

MISCELLANEOUS THERAPEUTIC AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0121548006; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2020-08-19

পণ্য বৈশিষ্ট্য

_OCTREOTIDE for INJECTABLE SUSPENSION _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OCTREOTIDE FOR INJECTABLE SUSPENSION
Octreotide for Injectable Suspension
Powder 10 mg, 20 mg, 30 mg octreotide (as acetate) per vial
Intramuscular injection
Synthetic octapeptide analogue of somatostatin (H01CB02)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
AUG 17, 2020
Date of Revision:
AUG 30, 2021
Submission Control No: 251358
_OCTREOTIDE for INJECTABLE SUSPENSION _
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RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
08/2021
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
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4
2
CONTRAINDICATIONS
......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.4
Administration.................................