SELEXID TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PIVMECILLINAM HYDROCHLORIDE

Verfügbar ab:

KNIGHT THERAPEUTICS INC.

ATC-Code:

J01CA08

INN (Internationale Bezeichnung):

PIVMECILLINAM

Dosierung:

200MG

Darreichungsform:

TABLET

Zusammensetzung:

PIVMECILLINAM HYDROCHLORIDE 200MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

PENICILLINS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0158390001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-05-10

Fachinformation

_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
Knight Therapeutics Inc.
3400 de Maisonneuve W. Suite 1055
Montreal, QC Canada H3Z 3B8
www.gud-knight.com
Date of Initial Authorization:
June 12, 2019
Date of Revision:
May 09, 2023
Submission Control Number: 270390
® Registered trademark of Karo Pharma 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
...................................................