ATRIDOX GEL (CONTROLLED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

Disponibil de la:

DEN-MAT HOLDINGS, LLC

Codul ATC:

A01AB22

INN (nume internaţional):

DOXYCYCLINE

Dozare:

8.8%

Forma farmaceutică:

GEL (CONTROLLED-RELEASE)

Compoziție:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 8.8%

Calea de administrare:

SUBGINGIVAL

Unități în pachet:

250ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBACTERIALS

Rezumat produs:

Active ingredient group (AIG) number: 0105569007; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2000-07-05

Caracteristicilor produsului

PM-001 ATRIDOX
®
_Product Monograph_
Page 1 of 27
ECR#27139
Rev Date: 23 June 2021
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATRIDOX
® CONTROLLED-RELEASE DOXYCYCLINE GEL
8.8% w/w Doxycycline (as Hyclate)
in DOXYGEL™ Delivery System
Antimicrobial Agent for Periodontitis
Manufactured by:
Den-Mat Holdings, LLC
Date of Initial Approval:
1017 W. Central Ave.
July 5, 2000
Lompoc, CA 93436
U.S.A.
Imported by:
Date of Revision:
Radiant Global Logistics
June 28, 2021
3520 Laird Rd., unit 4
Mississauga, Ontario,
Canada L5L 5Z7
Distributed by:
Henry Schein
345 Townline Rd
Niagara on the Lake,
ON, L0S 1J0, CA
Submission Control No: 242758
PM-001 ATRIDOX
®
_Product Monograph_
Page 2 of 27
ECR#27139
Rev Date: 23 June 2021
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
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
........................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.3
Administration
.....................................................................................................
5
4.4
Reconstitution
.......................................................................