4% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML) SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ARTICAINE HYDROCHLORIDE; EPINEPHRINE (EPINEPHRINE BITARTRATE)

Commercializzato da:

DENTSPLY CANADA LIMITED

Codice ATC:

N01BB58

INN (Nome Internazionale):

ARTICAINE, COMBINATIONS

Dosaggio:

40MG; 0.005MG

Forma farmaceutica:

SOLUTION

Composizione:

ARTICAINE HYDROCHLORIDE 40MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005MG

Via di somministrazione:

BLOCK/INFILTRATION

Confezione:

1.8ML

Tipo di ricetta:

Ethical

Area terapeutica:

LOCAL ANESTHETICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0226661002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2003-12-22

Scheda tecnica

_Page 1 of 26 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
4% ASTRACAINE
® DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01 MG/ML)
(Articaine Hydrochloride 40 mg/mL and Epinephrine 1: 100,000 as
Epinephrine Bitartrate)
4% ASTRACAINE
® DENTAL WITH EPINEPHRINE 1:200,000 (0.005 MG/ML)
(Articaine Hydrochloride 40 mg/mL and Epinephrine 1: 200,000 as
Epinephrine Bitartrate)
Solutions for Injection
Local Anesthetic for Dental Use
Dentsply Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3
Date of Revision:
June 14, 2018
Submission Control No: 207235
_Page 2 of 26 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...........................................................3
1
INDICATIONS
..................................................................................................................3
1.1
PE
DIATRICS.............................................................................................................................3
1.2
GERIATRICS
............................................................................................................................3
2
CONTRAINDICATIONS
.................................................................................................3
3
DOSAGE AND
ADMINISTRATION..............................................................................4
3.1
Dosing Considerations
...............................................................................................4
3.2
Recommended Dose and Dosage Adjustment
...........................................................4
4
OVERDOSAGE
.................................................................................................................5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................6
6
WARNINGS AND PRECAUTIONS
...............................................................................7
6.1
Special Populations
..................................................................................................10
6.1.1
Pregnant Women
...........................