VANCOMYCIN HYDROCHLORIDE CAPSULES, USP

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Dostopno od:

FRESENIUS KABI CANADA LTD

Koda artikla:

J01XA01

INN (mednarodno ime):

VANCOMYCIN

Odmerek:

250MG

Farmacevtska oblika:

CAPSULE

Sestava:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 250MG

Pot uporabe:

ORAL

Enote v paketu:

20

Tip zastaranja:

Prescription

Terapevtsko območje:

GLYCOPEPTIDES

Povzetek izdelek:

Active ingredient group (AIG) number: 0131315006; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2021-11-30

Lastnosti izdelka

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Vancomycin Hydrochloride Capsules - Product Monograph
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Page 1 of 24
PRODUCT MONOGRAPH
PR
VANCOMYCIN HYDROCHLORIDE CAPSULES, USP
vancomycin (as vancomycin hydrochloride)
125 mg and 250 mg
USP
Antibiotic
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite100 November 22, 2017
Toronto, ON, M9W 0C8
Submission Control No: 196466
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Vancomycin Hydrochloride Capsules - Product Monograph
_ _
Page 2 of 24
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT
INFORMATION.....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
................................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
................................................................................................................
6
DRUG INTERACTIONS
................................................................................................................
7
DOSAGE AND ADMINISTRATION
............................................................................................
7
OVERDOSAGE
...............................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
8
STORAGE AND STABILITY
........................................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................ 9
PART II: SCIENTIFIC INFORMATION
....................................................................................
10
PH