CLINDAMYCIN INJECTION, USP SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

J01FF01

INN (mednarodno ime):

CLINDAMYCIN

Odmerek:

150MG

Farmacevtska oblika:

SOLUTION

Sestava:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

2/4/6ML

Tip zastaranja:

Prescription

Terapevtsko območje:

LINCOMYCINS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2018-02-28

Lastnosti izdelka

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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
...........................................................