4% Articadent DENTAL with Adrenaline (Epinephrine) 1:100,000

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml; Articaine hydrochloride 40 mg/mL

Предлага се от:

Dentsply Sirona (NZ) Limited

INN (Международно Name):

Adrenaline acid tartrate 10 µg/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml Articaine hydrochloride 40 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Sodium metabisulfite Water for injection

Вид предписание :

Prescription

Произведено от:

Boehringer Ingelheim Pharma GmbH & Co KG

Терапевтични показания:

Indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older. Indicated only for dental procedures.

Каталог на резюме:

Package - Contents - Shelf Life: Cartridge, glass, Type 1, clear, with self-aspirating bromobutyl plunger and aluminium cap, 2.2 mL - 50 dose units - 2 years from date of manufacture stored at or below 25°C protect from light. Do not freeze

Дата Оторизация:

2016-02-16

Листовка

4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000, Issue
No. 3.0
1
4% ARTICADENT
®
DENTAL WITH
ADRENALINE (EPINEPHRINE) 1:100,000
_articaine hydrochloride with adrenaline (epinephrine) _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about 4%
Articadent DENTAL with
adrenaline (epinephrine)
1:100,000. It does not contain
all of the available information.
It does not take the place of
talking to your dental
practitioner.
All medicines have risks and
benefits. Your dental practitioner
has weighed the expected
benefits of you using 4%
Articadent DENTAL with
adrenaline (epinephrine)
1:100,000 against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DENTAL
PRACTITIONER.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT 4% ARTICADENT
DENTAL WITH
ADRENALINE
(EPINEPHRINE) 1:100,000
IS FOR
4% Articadent DENTAL with
adrenaline (epinephrine)
1:100,000 are given by injection
to cause loss of feeling before
and during dental procedures. It
contains two active ingredients:
Articaine hydrochloride, a local
anaesthetic to prevent the pain,
and adrenaline (epinephrine)
(as acid tartrate), a
vasoconstrictor, which makes it
last longer. Adrenaline
(epinephrine) narrows the blood
vessels at the site of injection,
which keeps the anaesthetic
where it’s needed for a longer
time) and controls bleeding
during the surgery.
4% Articadent DENTAL with
adrenaline (epinephrine)
1:100,000 belongs to a group of
medicines called local
anaesthetics.
ASK YOUR DENTAL PRACTITIONER IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
4% Articadent DENTAL with
adrenaline (epinephrine)
1:100,000 is not addictive.
BEFORE YOU TAKE 4%
ARTICADENT DENTAL
WITH ADRENALINE
(EPINEPHRINE) 1:100,000
YOU MUST NOT TAKE 4%
ARTICADENT DENTAL WITH
ADRENALINE (EPINEPHRINE)
1:100,000 IF YOU HAVE AN
ALLERGY TO:
•
adrenaline (epinephrine) or
articaine
•
any of the ingredients listed
toward the end of this leaf

Данни за продукта

4% ARTICADENT® DENTAL WITH ADRENALINE (EPINEPHRINE)
1:100,000
DATA SHEET
DENTSPLY SIRONA (NZ) LTD
NZ-DS Revision 2.0
Page 1 of 15
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
4% Articadent
®
DENTAL with Adrenaline (epinephrine) 1:100,000 Injection for Local and
Regional Dental Anaesthesia
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
4% Articadent
®
DENTAL with Adrenaline (epinephrine) 1:100,000 consists of
Articaine hydrochloride 40 mg/mL and Adrenaline (epinephrine) (as acid
tartrate) 10
micrograms/mL.
ARTICAINE HYDROCHLORIDE: white to almost white powder, odourless.
Articaine hydrochloride is a local anaesthetic and is a racemic
mixture. Articaine
hydrochloride has a partition coefficient in n-octanol/ Soerensen
buffer (pH 7.35) of 17, a
pKa of 7.8 and is freely soluble in water and in ethanol (96 per
cent).
ADRENALINE (EPINEPHRINE) (AS ACID TARTRATE): white or greyish-white or
light brownish grey,
odourless, crystalline powder, which slowly darkens on exposure to air
and light.
Adrenaline (epinephrine) (as acid tartrate) 1.8 mg is approximately
equivalent to 1 mg of
adrenaline (epinephrine). It is freely soluble in water and slightly
soluble in ethanol (96 per
cent).
Adrenaline (epinephrine) (as acid tartrate) is a vasoconstrictor.
CHEMICAL STRUCTURE OF ARTICAINE HYDROCHLORIDE
CHEMICAL STRUCTURE OF ADRENALINE (EPINEPHRINE) ACID TARTRATE
4% ARTICADENT® DENTAL WITH ADRENALINE (EPINEPHRINE)
1:100,000
DATA SHEET
DENTSPLY SIRONA (NZ) LTD
NZ-DS Revision 2.0
Page 2 of 15
CHEMICAL NAME:
Articaine hydrochloride:
Methyl 4
‐
methyl
‐
3
‐
[[(2_RS_)
‐
2-(propylamino)propanoyl]amino]-
thiophene
‐
2
‐
carboxylate hydrochloride
Adrenaline (epinephrine) acid tartrate:
(1_R_)
‐
1
‐
(3,4
‐
Dihydroxyphenyl)
‐
2
‐
(methylamino)ethanol hydrogen (2_R_,3_R_)
‐
2,3
‐
dihydroxybutanedioate
MOLECULAR FORMULA:
Articaine hydrochloride:
C13H20N2O3S.HCl
Adrenaline (epinephrine) acid tartrate: C9H13NO3.C4H6O6
MOLECULAR WEIGHT:
Articaine hydrochloride:
320.84
Adrenaline (epinephrine) acid tartrate: 333.3
CAS REGISTRY NUMB