2% XYLOCAINE DENTAL WITH ADRENALINE 1:80,000 2.2mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adrenaline (epinephrine) acid tartrate, Quantity: 22.7 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 12.5 microgram/mL); lidocaine hydrochloride monohydrate, Quantity: 21.3 mg/mL (Equivalent: lidocaine hydrochloride, Qty 20 mg/mL)

Available from:

Dentsply Sirona Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intramuscular, Dental, Infiltration

Units in package:

2.2mL x 500, 2.2mL x 100, 2.2 mL x 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 25 JULY 2003 : Lidocaine (lignocaine) solutions are indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. Lidocaine (lignocaine) solutions with adrenaline (epinephrine) are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

Product summary:

Visual Identification: Clear, colourless solution, practically free of visible particles; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

Xylocaine

Dental
1(3)
2% XYLOCAINE
 DENTAL WITH
ADRENALINE (EPINEPHRINE) 1:80,000
Lidocaine (lignocaine) hydrochloride monohydrate
Adrenaline (epinephrine) acid tartrate
CONSUMER MEDICINE INFORMATION
________________________________________________________________________
WHAT IS IN THIS LEAFLET
________________________________________________________________________
XYLOCAINE
and
LIDOCAINE (ALSO
KNOWN AS LIGNOCAINE),
are different
names for the same medicine -
which is used as to stop pain during
dental procedures. It is only called
XYLOCAINE DENTAL
in this leaflet.
This leaflet answers some of the
common questions people ask about
XYLOCAINE DENTAL
. It does not
contain all the information that is
known about
XYLOCAINE DENTAL
.
It does not take the place of talking
to your dentist or pharmacist.
All medicines have risks and
benefits. Your dentist will have
weighed the risks of you being
given
XYLOCAINE DENTAL
against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DENTIST OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to
read it again.
________________________________________________________________________
WHAT XYLOCAINE
DENTAL IS FOR
________________________________________________________________________
XYLOCAINE DENTAL
is used to prevent
or relieve pain during dental
procedures, but it will not put you
to sleep.
XYLOCAINE DENTAL
belongs to a
group of medicines called local
anaesthetics. It is injected into the
mouth where it makes the nerves
unable to pass messages to the
brain.
Depending on the amount used,
XYLOCAINE DENTAL
will either totally
stop pain or will cause a partial loss
of feeling.
XYLOCAINE DENTAL
contains
adrenaline (also known as
epinephrine) to make it last longer.
Adrenaline (epinephrine) makes the
blood vessels at the site of injection
narrower, which means you bleed
less and it is easier for your dentist
to see what is happening.
Your dentist will have explained
why you are being treated with
XYLOCAINE DENTAL
.
FOLL

Summary of Product characteristics

2% XYLOCAINE
® DENTAL WITH
ADRENALINE (EPINEPHRINE) 1:80,000
PRODUCT INFORMATION DENTSPLY SIRONA PTY LTD
______________________________________________________________________________________
AU-PI Revision 6.0
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
2% XYLOCAINE
® DENTAL WITH ADRENALINE (EPINEPHRINE) 1:80,000
(lidocaine (lignocaine) hydrochloride monohydrate and adrenaline
(epinephrine) acid tartrate)
1
NAME OF THE MEDICINE
lidocaine (lignocaine) hydrochloride monohydrate
adrenaline (epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 contains:
lidocaine (lignocaine) hydrochloride monohydrate
46.9 milligram /2.2 mL
equivalent to lidocaine (lignocaine) base
38.1 milligram /2.2mL
adrenaline (epinephrine) acid tartrate
49.9 microgram /2.2mL
equivalent to adrenaline (epinephrine) base
27.5 microgram /2.2mL
Lidocaine (lignocaine) is classed as a membrane stabilising agent and
is a local anaesthetic of
the amide type. Adrenaline (epinephrine) is a potent sympathomimetic.
Excipient with known effect: sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 is a clear, colourless
solution,
practically free of visible particles, and is available in 2.2 mL
standard and self-aspirating
cartridges
NOTE:
1.
Adrenaline (epinephrine)-containing solutions contain the antioxidant
sodium metabisulphite,
1.1 mg/2.2 mL.
2.
All Dentsply Sirona Xylocaine dental cartridges (with adrenaline
(epinephrine)) are paraben
free and for single use in a single patient only. Remaining unused
contents should be
discarded.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lidocaine (lignocaine) solutions are indicated for the production of
local anaesthesia in routine
dental procedures and oral surgery by means of infiltration and nerve
block techniques.
2% XYLOCAINE
® DENTAL WITH
ADRENALINE (EPINEPHRINE) 1:80,000
PRODUCT INFORMATION DENTSPLY SIRONA PTY LT