ERFA-AMIKACIN SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-10-2022
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Active ingredient:
AMIKACIN (AMIKACIN SULFATE)
Available from:
SEARCHLIGHT PHARMA INC
ATC code:
J01GB06
INN (International Name):
AMIKACIN
Dosage:
250MG
Pharmaceutical form:
SOLUTION
Composition:
AMIKACIN (AMIKACIN SULFATE) 250MG
Administration route:
INTRAMUSCULAR
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
AMINOGLYCOSIDES
Product summary:
Active ingredient group (AIG) number: 0111922001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-06-03
Summary of Product characteristics
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ERFA-AMIKACIN ™
Amikacin solution injection
Amikacin (as Amikacin Sulfate)
250 mg / mL
Intramuscular or intravenous administration
Manufacturer’s standard
Antibiotic
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, Quebec
H3J 1M1
Submission Control No.: 267160
Date of Preparation:
OCT
11, 2022
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TABLE OF CONTENTS
SUMMARY PRODUCT INFORMATION
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3
ACTION AND CLINICAL PHARMACOLOGY
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3
INDICATIONS AND CLINICAL USE
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4
CONTRAINDICATIONS
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4
WARNINGS
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4
PRECAUTIONS
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6
ADVERSE REACTIONS
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8
OVERDOSAGE
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9
DOSAGE AND ADMINISTRATION
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9
PHARMACEUTICAL INFORMATION
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11
DOSAGE FORMS AND COMPOSITION
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11
STORAGE AND
STABILITY...................................................................................................
12
PACKAGING
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12
MICROBIOLOG
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