4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000 articaine hydrochloride and adrenaline (epinephrine) 2.2 mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

articaine hydrochloride, Quantity: 40 mg/mL; adrenaline (epinephrine) acid tartrate, Quantity: 18.2 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 10 microgram/mL)

Available from:

Dentsply Sirona Pty Ltd

INN (International Name):

adrenaline (epinephrine),Articaine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Submucosal, Dental

Units in package:

50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

4 percent Articadent DENTAL with Adrenaline 1:100,000 is indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older. 4 percent Articadent DENTAL with Adrenaline 1:100,000 is indicated only for dental procedures.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-10-22

Patient Information leaflet

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

Summary of Product characteristics

4% ARTICADENT® DENTAL WITH ADRENALINE (EPINEPHRINE)
1:100,000
PRODUCT INFORMATION
DENTSPLY SIRONA PTY LTD
AU-PI Revision 3.0
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
4% ARTICADENT
® DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000
(Articaine hydrochloride and adrenaline (epinephrine) (as acid
tartrate)
1
NAME OF THE MEDICINE
Articaine hydrochloride
Adrenaline (epinephrine) (as acid tartrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
4% ARTICAINE DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 is a
clear, colourless
sterile aqueous solution that contains articaine hydrochloride 4% (40
mg/mL) with
adrenaline (epinephrine) (as acid tartrate) in a 1:100,000 strength.
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.
4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 injection
also contains the
excipients with known effect, sodium metabisulfite. For the full list
of excipients, see Section
6.1 List of excipients.
3
PHARMACEUTICAL FORM
Articaine hydrochloride and adrenaline (epinephrine) (as acid
tartrate) 2.2mL injection
solution in a self-aspirating glass cartridge.
The finished product is a clear and colourless solution packed in a
carton containing 50, 2.2
mL Type I glass cartridges, closed on one end with a self-aspirating
bromobutyl rubber
plunger and at the other end by a bromobutyl disk covered by an
aluminium cap.