2% NUROCAIN DENTAL WITH ADRENALINE 1:100,000 2.2mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adrenaline (epinephrine) acid tartrate, Quantity: 18.2 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 10 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; sodium metabisulfite; water for injections; hydrochloric acid; sodium hydroxide

Administration route:

Subcutaneous, Dental, Infiltration

Units in package:

2.2mL x 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code) INDICATIONS AS AT 17 JULY 2003 : 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. Lignocaine solutions with adrenaline are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-31

Patient Information leaflet

Xylocaine
/ Nurocain
Dental
1(3)
XYLOCAINE
DENTAL
NUROCAIN
DENTAL
Lignocaine hydrochloride
___________________________________________________________________________
CONSUMER MEDICINE INFORMATION
Name of consumer
Address of consumer
__________________
WHAT IS IN THIS LEAFLET
___________________________________________________________________
XYLOCAINE, NUROCAIN and
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.
The information about them is the
same.
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 is often used
with adrenaline to make it last
longer. Adrenaline 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. FOLLOW ALL
DIRECTIONS GIVEN TO YOU BY YOUR
DENTIST CAREFULLY. They may differ
from the information contained

Summary of Product characteristics

2% XYLOCAINE
®
DENTAL WITH ADRENALINE 1:80,000
2% NUROCAIN
®
DENTAL WITH ADRENALINE 1:100,000
PRODUCT INFORMATION
NAME OF DRUG
2% XYLOCAINE
®
DENTAL WITH ADRENALINE 1:80,000
contains lignocaine hydrochloride and adrenaline acid tartrate as the
active substances. The product also
contains sodium chloride, sodium metabisulfite, water for injections,
and may contain sodium hydroxide and/or
hydrochloric acid for pH adjustment to 3.0-5.0.
2% NUROCAIN
®
DENTAL WITH ADRENALINE 1:100,000 contains lignocaine hydrochloride and
adrenaline acid
tartrate as the active substances. This product also contains sodium
chloride, sodium metabisulfite, water for
injections, and may contain sodium hydroxide and/or hydrochloric acid
for pH adjustment to 3.0-5.0.
LIGNOCAINE
The CAS number for lignocaine is 137-58-6.
The chemical name for lignocaine hydrochloride is
2-Diethylaminoaceto-2 ,6 -xylidide hydrochloride. The BP
name and International Non-proprietary Name (INN) for lignocaine is
lidocaine.
The Australian Approved Name (AAN) is lignocaine hydrochloride.
Lignocaine base has a pKa of 7.85 (25°C) and a molecular weight of
234.3.
The chemical structure of lignocaine hydrochloride is:
ADRENALINE
The CAS number for adrenaline acid tartrate is 51 - 42 -3.
The chemical name for adrenaline is (R)- 1
-(3,4-Dihydroxyphenyl)-2-methylaminoethanol. The salt used in
this product is adrenaline acid tartrate. Adrenaline is also known as
epinephrine.
The Australian Approved Name is adrenaline acid tartrate.
The chemical structure of adrenaline is:
DESCRIPTION
Lignocaine is classed as a membrane stabilising agent, and is a local
anaesthetic of the amide type. Lignocaine
hydrochloride is a white crystalline powder with a molecular weight of
288.8. It is very soluble in water and
freely soluble in alcohol and chloroform. It must be protected from
light.
Adrenaline is a potent sympathomimetic.
Adrenaline acid tartrate is a white to greyish-white crystalline
powder with a molecular weight of 333.3. It is
freely soluble in water and slightly solub