ERFA-AMIKACIN SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

AMIKACIN (AMIKACIN SULFATE)

Saatavilla:

SEARCHLIGHT PHARMA INC

ATC-koodi:

J01GB06

INN (Kansainvälinen yleisnimi):

AMIKACIN

Annos:

250MG

Lääkemuoto:

SOLUTION

Koostumus:

AMIKACIN (AMIKACIN SULFATE) 250MG

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

AMINOGLYCOSIDES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0111922001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-06-03

Valmisteyhteenveto

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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
- 2 -
TABLE OF CONTENTS
SUMMARY PRODUCT INFORMATION
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3
ACTION AND CLINICAL PHARMACOLOGY
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3
INDICATIONS AND CLINICAL USE
......................................................................................
4
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS
..................................................................................................................................
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
.................................................................................
11
DOSAGE FORMS AND COMPOSITION
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11
STORAGE AND
STABILITY...................................................................................................
12
PACKAGING
..............................................................................................................................
12
MICROBIOLOG