RIVA AZITHROMYCIN TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

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17-03-2015

Virkt innihaldsefni:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE)

Fáanlegur frá:

LABORATOIRE RIVA INC.

ATC númer:

J01FA10

INN (Alþjóðlegt nafn):

AZITHROMYCIN

Skammtar:

600MG

Lyfjaform:

TABLET

Samsetning:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) 600MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

6

Gerð lyfseðils:

Prescription

Lækningarsvæði:

OTHER MACROLIDES

Vörulýsing:

Active ingredient group (AIG) number: 0126072005; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2013-07-31

Vara einkenni

                                _ _
_RIVA-Azithromycin _
_ _
_Page 1 of 56 _
PRODUCT MONOGRAPH
Pr
RIVA-AZITHROMYCIN
Azithromycin Tablets USP
250 mg and 600 mg
Antibiotic
LABORATOIRE RIVA INC.
660 Industriel blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
Control No. 182319
Date of Revision:
March 17, 2015
_ _
_RIVA-Azithromycin _
_ _
_Page 2 of 56 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
..........................................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................................
19
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...................................................
                                
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