VIBATIV POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TELAVANCIN (TELAVANCIN HYDROCHLORIDE)

Tilgjengelig fra:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC-kode:

J01XA03

INN (International Name):

TELAVANCIN

Dosering :

250MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

TELAVANCIN (TELAVANCIN HYDROCHLORIDE) 250MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

GLYCOPEPTIDES

Produkt oppsummering:

Active ingredient group (AIG) number: 0152639001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-05-06

Preparatomtale

PRODUCT MONOGRAPH
Pr
VIBATIV
TM
Telavancin for injection
250 mg telavancin (as telavancin hydrochloride)/vial
750 mg telavancin (as telavancin hydrochloride)/vial
ANTIBIOTIC
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montreal, QC, Canada, H4P 2T4
Date of Revision:
February 8, 2018
Submission Control No: 210338
TM
Trademark of Theravance Biopharma group of companies, used under
license.
PENDOPHARM, Division of Pharmascience Inc. is an authorized seller of
VIBATIV
TM
.
_ _
_Product Monograph VIBATIV_
_TM_
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_Page 2 of 55_
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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
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
17
DOSAGE AND ADMINISTRATION
..............................................................................
19
OVERDOSAGE
................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 21
STORAGE AND STABILITY
.........................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 27
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL INFORMATION
......