CLINDAMYCIN INJECTION SDZ LIQUID

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Disponible des:

SANDOZ CANADA INCORPORATED

Codi ATC:

J01FF01

Designació comuna internacional (DCI):

CLINDAMYCIN

Dosis:

150MG

formulario farmacéutico:

LIQUID

Composición:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 150MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

2/4ML

tipo de receta:

Prescription

Área terapéutica:

LINCOMYCINS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-08-01

Fitxa tècnica

_Clindamycin Injection SDZ _
_ page 1 of 35 _
PRODUCT MONOGRAPH
PR
CLINDAMYCIN INJECTION SDZ
CLINDAMYCIN INJECTION, MANUFACTURER’S STANDARD
150 mg/mL clindamycin (as clindamycin phosphate)
STERILE SOLUTION
ANTIBIOTIC
Sandoz Canada Inc.
145, Jules-Léger Street
Boucherville, QC, Canada Date of Revision: July 19, 2017
J4B 7K8
Control Number: 207196
_Clindamycin Injection SDZ _
_ page 2 of 35 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY
PRODUCT
INFORMATION
.......................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.............................................................................................
3
CONTRAINDICATIONS
..................................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..................................................................................................
5
ADVERSE
REACTIONS
..................................................................................................................
8
DRUG
INTERACTIONS
...................................................................................................................
9
DOSAGE
AND
ADMINISTRATION
.............................................................................................
11
OVERDOSAGE
...............................................................................................................................
13
ACTION
AND
CLINICAL
PHARMACOLOGY
...........................................................................
14
SPECIAL
HANDLING
INSTRUCTIONS
......................................................................................
15
STORAGE
AND
STABILITY
........................................................................................................
16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ............................................................
16
PART II: SCIENTIFIC I