SELEXID TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-02-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
PIVMECILLINAM HYDROCHLORIDE
Available from:
KARO HEALTHCARE AB
ATC code:
J01CA08
INN (International Name):
PIVMECILLINAM
Dosage:
400MG
Pharmaceutical form:
TABLET
Composition:
PIVMECILLINAM HYDROCHLORIDE 400MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PENICILLINS
Product summary:
Active ingredient group (AIG) number: 0158390002; AHFS:
Authorization status:
APPROVED
Authorization date:
2024-02-01
Summary of Product characteristics
_SELEXID® (pivmecillinam hydrochloride) _
_Page 1 of 34_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SELEXID®
Pivmecillinam hydrochloride Tablets
Tablets,
200 mg and 400 mg, Oral
Manufacturer Standard
Antibiotic
Karo Healthcare AB
Box 16184
SE-103 24 Stockholm
Sweden
Importer / Distributor
Knight Therapeutics Inc.
3400 de Maisonneuve W.
Suite 1055
Montreal, QC Canada H3Z 3B8
Date of Initial Approval:
FEB 01, 2024
Submission Control Number: 282104
® Registered trademark of Karo Healthcare AB used under license by
Knight Therapeutics Inc.
Montreal, QC
_ _
_SELEXID® (pivmecillinam hydrochloride) _
_Page 2 of 34_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS, Skin
05/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..............................
Read the complete document
