AG-AZITHROMYCIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
31-08-2020
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Aktivna sestavina:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
Dostopno od:
ANGITA PHARMA INC.
Koda artikla:
J01FA10
INN (mednarodno ime):
AZITHROMYCIN
Odmerek:
600MG
Farmacevtska oblika:
TABLET
Sestava:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 600MG
Pot uporabe:
ORAL
Enote v paketu:
30
Tip zastaranja:
Prescription
Terapevtsko območje:
OTHER MACROLIDES
Povzetek izdelek:
Active ingredient group (AIG) number: 0126072005; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2018-09-10
Lastnosti izdelka
Page 1 of 63
PRODUCT MONOGRAPH
PR
AG-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
ANGITA PHARMA INC. DATE OF REVISION:
1310 RUE NOBEL, AUGUST 31, 2020
BOUCHERVILLE, QUÉBEC
J4B 5H3
CONTROL # 241905
Page 2 of 63
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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