M-AZITHROMYCIN TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
24-07-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
Fáanlegur frá:
MANTRA PHARMA INC
ATC númer:
J01FA10
INN (Alþjóðlegt nafn):
AZITHROMYCIN
Skammtar:
250MG
Lyfjaform:
TABLET
Samsetning:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OTHER MACROLIDES
Vörulýsing:
Active ingredient group (AIG) number: 0126072001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2020-07-28
Vara einkenni
PRODUCT MONOGRAPH
Pr
M-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Mantra Pharma Inc. Date of Revision:
9150 Leduc BLVD, Suite 201, Brossard July 24, 2020
Quebec, Canada
J4Y 0E3
Control Submission #: 240728
Pr
M-Azithromycin (as azithromycin dihydrate) Product Monograph
Page 2 of 62
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
.........................................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................................
19
OVERDOSAGE
......................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
20
STORAGE AND STABILITY
...............................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 23
PART II: SCIENTIFIC INFORMATION
......................
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