CLINDAMYCIN INJECTION, USP SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Beschikbaar vanaf:

MYLAN PHARMACEUTICALS ULC

ATC-code:

J01FF01

INN (Algemene Internationale Benaming):

CLINDAMYCIN

Dosering:

150MG

farmaceutische vorm:

SOLUTION

Samenstelling:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

2/4/6ML

Prescription-type:

Prescription

Therapeutisch gebied:

LINCOMYCINS

Product samenvatting:

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

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2018-02-28

Productkenmerken

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