ORAQIX GEL

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PRILOCAINE; LIDOCAINE

Beschikbaar vanaf:

DENTSPLY CANADA LIMITED

ATC-code:

N01BB20

INN (Algemene Internationale Benaming):

COMBINATIONS

Dosering:

2.5%; 2.5%

farmaceutische vorm:

GEL

Samenstelling:

PRILOCAINE 2.5%; LIDOCAINE 2.5%

Toedieningsweg:

TOPICAL

Eenheden in pakket:

1.7G/CARTRIDGE

Prescription-type:

OTC

Therapeutisch gebied:

LOCAL ANESTHETICS

Product samenvatting:

Active ingredient group (AIG) number: 0222447001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2009-05-01

Productkenmerken

_ _
_ORAQIX_
_® _
_ (Lidocaine and Prilocaine Periodontal Gel)_
_ _
_Page 1 of 22 _
DENTSPLY Canada Ltd.
PRODUCT MONOGRAPH
ORAQIX
®
Lidocaine and Prilocaine Periodontal Gel
2.5% /2.5%
Topical Anesthetic for Periodontal Use
DENTSPLY Canada Limited
161 Vinyl Court
Woodbridge,
ON L4L 4A3
Date of Preparation:
April 30, 2009
www.dentsply.ca
Submission Control No: 120148
_ _
_ORAQIX_
_® _
_ (Lidocaine and Prilocaine Periodontal Gel)_
_ _
_Page 2 of 22 _
DENTSPLY Canada Ltd.
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND
ADMINISTRATION................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND
STABILITY..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
................................................................................14
PHARMACEUTICAL
INFORMATION..