CLINDAMYCIN INJECTION, USP SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

J01FF01

INN（国際名）:

CLINDAMYCIN

投薬量:

150MG

医薬品形態:

SOLUTION

構図:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

2/4/6ML

処方タイプ:

Prescription

治療領域:

LINCOMYCINS

製品概要:

Active ingredient group (AIG) number: 0105830002; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2018-02-28

製品の特徴

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_Page 1 of 36_
PRODUCT MONOGRAPH
Pr
CLINDAMYCIN INJECTION, USP
CLINDAMYCIN PHOSPHATE
150 MG/ML CLINDAMYCIN (AS CLINDAMYCIN PHOSPHATE)
STERILE SOLUTION
ANTIBIOTIC
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
August 16, 2016
Submission Control No: 197320
_ _
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_Page 2 of 36_
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
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
15
STORAGE
AND
STABILITY
.................................................................................................
17
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION
.................................................................................
19
DETAILED
PHARMACOLOGY
...........................................................