CLARITHROMYCIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CLARITHROMYCIN

Dostopno od:

SIVEM PHARMACEUTICALS ULC

Koda artikla:

J01FA09

INN (mednarodno ime):

CLARITHROMYCIN

Odmerek:

500MG

Farmacevtska oblika:

TABLET

Sestava:

CLARITHROMYCIN 500MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER MACROLIDES

Povzetek izdelek:

Active ingredient group (AIG) number: 0123752002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-07-21

Lastnosti izdelka

_CLARITHROMYCIN _
_Page 1 of 84_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLARITHROMYCIN
clarithromycin tablets
Film-coated tablets, 250 mg and 500 mg, Oral
Manufacturer’s Standard
Antibiotic
NOTE: WHEN USED IN COMBINATION WITH ACID ANTISECRETORY DRUGS AND OTHER
ANTIMICROBIALS FOR THE ERADICATION OF HELICOBACTER PYLORI, THE PRODUCT
MONOGRAPH FOR THOSE AGENTS SHOULD BE CONSULTED.
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
Canada H4R 2P7
www.sivem.ca
Submission Control Number: 2
67776
Date of Initial Authorization:
JUL 21, 2015
Date of
Revision:
OCT
24, 2022
_CLARITHROMYCIN _
_Page 2 of 84_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2022
7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2
Breast-feeding
10/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1 Pediatrics
.......................................................................................................................
5
1.2 Geriatrics
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5
2
CONTRAINDICATIONS
....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 6
4
DOSAGE AND ADMINISTRATION
....................................................................................
7
4.1 Dosing Considerations
.......................