MYLAN-OSELTAMIVIR CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

থেকে পাওয়া:

MYLAN PHARMACEUTICALS ULC

এটিসি কোড:

J05AH02

INN (আন্তর্জাতিক নাম):

OSELTAMIVIR

ডোজ:

75MG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

10/30/100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

NEURAMINIDASE INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0139501001; AHFS:

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2023-03-01

পণ্য বৈশিষ্ট্য

_ _
_Page 1 of 51_
PRODUCT MONOGRAPH
Pr
MYLAN-OSELTAMIVIR
Oseltamivir phosphate capsules, USP
30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate)
Antiviral Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
July 4, 2018
Submission Control No: 203859
_ _
_Page 2 of 51_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
22
STORAGE AND STABILITY
.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
CLINICAL TRIALS
.........................................................................................................
27
DETAILED PHARMACOLOGY
....................................................................................
33
MICROBIOLOGY............................................................................................................
34
TOXICOLOGY
..............