DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PRILOCAINE HYDROCHLORIDE; EPINEPHRINE (EPINEPHRINE BITARTRATE)

Commercializzato da:

DENTSPLY CANADA LIMITED

Codice ATC:

N01BB54

INN (Nome Internazionale):

PRILOCAINE, COMBINATIONS

Dosaggio:

40MG; 5MCG

Forma farmaceutica:

SOLUTION

Composizione:

PRILOCAINE HYDROCHLORIDE 40MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 5MCG

Via di somministrazione:

BLOCK/INFILTRATION

Confezione:

1.8ML

Tipo di ricetta:

Ethical

Area terapeutica:

LOCAL ANESTHETICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0211806001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2012-07-19

Scheda tecnica

PRODUCT MONOGRAPH
Dentsply 4% Prilocaine Hydrochloride Dental Injection
Prilocaine Hydrochloride Injection USP
40 mg/mL
and
Dentsply 4% Prilocaine and Epinephrine Injection 1:200,000
Prilocaine Hydrochloride and Epinephrine Injection USP
40 mg/mL
(Prilocaine hydrochloride with epinephrine 1:200,000)
Local Anesthetic
Dentsply Canada
DATE OF REVISION:
161 Vinyl Court
September 11, 2015
Woodbridge, Ontario
L4L 4A3
Control#: 186354
PRODUCT MONOGRAPH
NAME OF DRUGS
Dentsply 4% Prilocaine Hydrochloride Dental Injection
Prilocaine Hydrochloride Injection USP
40 mg/mL
and
Dentsply 4% Prilocaine and Epinephrine Injection 1:200,000
Prilocaine Hydrochloride and Epinephrine Injection USP
40 mg/mL
(prilocaine hydrochloride with epinephrine 1:200,000)
THERAPEUTIC CLASSIFICATION
Local Anesthetic for Infiltration and Nerve Block
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
4% Prilocaine Hydrochloride Formulations stabilize the neuronal
membrane and prevent the
initiation and transmission of nerve impulses thereby, effecting local
anesthetic action. Local
anesthetics of the amide type are thought to act within sodium
channels of the nerve membrane.
ONSET OF ACTION
When used for infiltration anesthesia in dental patients, the time of
onset of Dentsply 4% Prilocaine
and Epinephrine Injection 1:200,000 averages 2 minutes with duration
of soft tissue anesthesia of
approximately 2 hours. Operative anesthesia lasts up to 45 minutes.
When used for infiltration
anesthesia, Dentsply 4% Prilocaine Hydrochloride Dental Injection
has a rapid onset time of
approximately 2-3 minutes and
duration of approximately 1- 1½ hours for soft tissue anesthesia.
Dentsply 4% Prilocaine Hydrochloride Dental Injection has a
short duration for operative anesthesia of
approximately 15 minutes.
‐2‐
1
When used for inferior alveolar nerve block the time of onset of
Dentsply 4% Prilocaine and
Epinephrine Injection 1:200,000 averages approximately 2-4 minutes
with an average duration of
soft tissue anesthesia of approximately 3 hours providing 1½ hou