ORAVERSE SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PHENTOLAMINE MESYLATE

Disponible des:

SEPTODONT

Codi ATC:

V03AB36

Designació comuna internacional (DCI):

PHENTOLAMINE

Dosis:

0.4MG

formulario farmacéutico:

SOLUTION

Composición:

PHENTOLAMINE MESYLATE 0.4MG

Vía de administración:

SUBMUCOSAL

Unidades en paquete:

10X1.7ML/50X1.7ML

tipo de receta:

Prescription

Área terapéutica:

Non-Selective Alfa-Adrenergic Blocking Agents

Resumen del producto:

Active ingredient group (AIG) number: 0107611003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2014-02-26

Fitxa tècnica

COPYRIGHT 2012 - 2013 SEPTODONT Page 1 of 17
PRODUCT MONOGRAPH
PR
ORAVERSE
PHENTOLAMINE MESYLATE INJECTION HOUSE STANDARD
PHENTOLAMINE MESYLATE INJECTION, 0.4MG/1.7ML
_ _
_ _
Alpha-adrenoreceptor blocker
_For Intraoral Submucosal Injection Only _
Sponsor: Manufacturer:
Septodont SAS Novocol Pharmaceutical of Canada, Inc.
58 Rue Du Pont De Creteil 25 Wolseley Court,
Saint-Maur Des Fosses Cambridge, Ontario,
France 94100 N1R 6X3
DATE OF PREPARATION:
FEBRUARY 24, 2014
SUBMISSION CONTROL NO: 157450
COPYRIGHT 2012 - 2013 SEPTODONT Page 2 of 17
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................................
3
SUMMARY PRODUCT INFORMATION
....................................................................................................
3
INDICATIONS AND CLINICAL
USE..........................................................................................................
3
CONTRAINDICATIONS
...............................................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................................
3
ADVERSE REACTIONS
...............................................................................................................................
4
DRUG INTERACTIONS
................................................................................................................................
6
DOSAGE AND ADMINISTRATION
............................................................................................................
7
OVERDOSAGE
..............................................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................................
8
STORAGE AND STABILITY
................................................................