AURO-ZIPRASIDONE CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE)

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

N05AE04

INN (আন্তর্জাতিক নাম):

ZIPRASIDONE

ডোজ:

40MG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE) 40MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

28/30/100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

ATYPICAL ANTIPSYCHOTICS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0152272002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2018-03-15

পণ্য বৈশিষ্ট্য

AURO-ZIPRASIDONE PAGE 1 OF 57
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-ZIPRASIDONE
Ziprasidone Capsules
Capsules, 20, 40, 60, and 80 mg
Ziprasidone (as ziprasidone hydrochloride monohydrate), Oral
House Standard
Antipsychotic Agent
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
November 27, 2015
Date of Revision:
October 19, 2022
Submission Control Number: 264888
AURO-ZIPRASIDONE PAGE 2 OF 57
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF
CONTENTS……………………………………………………………………………………………………………..2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS........................................................................................................................
4
1.1
P
EDIATRICS
........................................................................................................................
4
1.2
G
ERIATRICS
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4
2
CONTRAINDICATIONS...........................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS
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5
4 DOSAGE AND
ADMINISTRATION...........................................................................................
6
4.1
D
OSING
C
ONSIDERATIONS
.....................................................................................................
6
4.2
R
ECOMMENDED
D
OSE AND
D
OSAGE
A
DJUSTMENT
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