CEFEPIME FOR INJECTION USP POWDER FOR SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

থেকে পাওয়া:

HIKMA CANADA LIMITED

এটিসি কোড:

J01DE01

INN (আন্তর্জাতিক নাম):

CEFEPIME

ডোজ:

1G

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SOLUTION

রচনা:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G

প্রশাসন রুট:

INTRAMUSCULAR

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

FOURTH GENERATION CEPHALOSPORINS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0150504004; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2022-05-25

পণ্য বৈশিষ্ট্য

PRODUCT MONOGRAPH
Pr
CEFEPIME FOR INJECTION USP
Powder for Solution
1 g and 2 g cefepime per vial (as cefepime hydrochloride)
Antibiotic
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario, L5R 3P9
Date of Preparation: May 24, 2022
Submission Control No.: 263831
Page 2 of 38
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
....................................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................................
10
OVERDOSAGE
..................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 16
STORAGE AND
STABILITY............................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 19
PART II: SCIENTIFIC INFORMATION
.............................................................................
20
PHARMACEUTICAL INFORMATION
...........................................................................
20
CLINICAL TRIALS
.......................................................