ORAQIX Periodontal Gel lidocaine (lignocaine) 25 mg/g and prilocaine 25 mg/g

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prilocaine, Quantity: 42.5 mg; lidocaine, Quantity: 42.5 mg

Available from:

Dentsply Sirona Pty Ltd

INN (International Name):

lidocaine (lignocaine),Prilocaine

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: poloxamer; hydrochloric acid; purified water

Administration route:

Dental

Units in package:

20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For use in adults for localised anaesthesia in periodontal pockets for probing, scaling and/or root planing.

Product summary:

Visual Identification: Above the gelation temperature a clear and homogeneous gel. Below the gelation temperature a clear and homogeneous liquid.; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Room temperature

Authorization status:

Registered

Authorization date:

2008-06-23

Patient Information leaflet

Oraqix, Issue No. 2.0
_ORAQIX_
_®_
_ _
_Lidocaine (Lignocaine) and Prilocaine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Oraqix.
It does not contain all of the
information that is available. It does
not take the place of talking to your
dental practitioner.
All medicines have risks and
benefits. Your dental practitioner has
weighed the risks of you being given
this medicine against the benefits
they expect it will 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 ORAQIX IS USED FOR
Oraqix is a gel that is used for local
anaesthesia in tooth pockets. It is
used in adults to stop or relieve pain
during certain types of dental
procedures, such as scaling, probing
and root planing.
Oraqix is only available from your
dental practitioner.
This medicine belongs to a group of
medicines called local anaesthetics.
It works by making the nerves
unable to pass messages to the
brain.
Depending on the amount used,
Oraqix will either totally stop pain or
will cause a partial loss of feeling.
ASK YOUR DENTAL PRACTITIONER IF YOU
HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
There is not enough information to
recommend the use of this medicine
for children and adolescents under
the age of 18.
BEFORE YOU ARE GIVEN
ORAQIX
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN ORAQIX IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
lidocaine (lignocaine) and
prilocaine
•
any of the ingredients listed at
the end of this leaflet
•
any other similar medicines
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
YOU MUST NOT BE GIVEN ORAQIX IF
YOU HAVE CONGENITAL OR IDIOPATHIC
ME

Summary of Product characteristics

ORAQIX® PERIODONTAL GEL
DENTSPLY SIRONA PTY LTD
(LIDOCAINE (LIGNOCAINE) 25 MG/G AND PRILOCAINE 25MG/G)
PRODUCT INFORMATION
AU-PI Revision 2.0
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
ORAQIX
® PERIODONTAL GEL
(Lidocaine (Lignocaine) 25 mg/g and Prilocaine 25 mg/g)
1
NAME OF THE MEDICINE
Lidocaine (lignocaine)
Prilocaine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oraqix
®
periodontal gel contains lidocaine (lignocaine) (25 mg/g) and
prilocaine (25 mg/g)
as the active substances.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oraqix
®
periodontal gel is a clear, colourless, oil-in-water microemulsion.
Oraqix
®
is a low-
viscosity fluid at room temperature and an elastic gel at the
temperature in the periodontal
pockets.
Oraqix
®
Periodontal Gel is supplied in dental cartridges that provide 1.7 g
Oraqix
®
gel
(corresponding to 42.5 mg lidocaine (lignocaine) and 42.5 mg
prilocaine). Individually
blister-packed cartridges of Oraqix
®
are distributed in a carton of 20. Each individual blister
pack also contains a sterile blunt-tipped applicator.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oraqix
®
is indicated in adults for localised anaesthesia in periodontal
pockets for probing,
scaling and/or root planing.
4.2
DOSE AND METHOD OF ADMINISTRATION
DO NOT INJECT
Administer Oraqix
®
as a liquid. Oraqix
®
will gel upon contact with warm oral mucosa.
Oraqix
®
is not intended for use with standard dental anaesthetic syringes.
This product
should only be used with the Oraqix Dispenser™, which is available
from Dentsply Sirona
Pty Ltd.
ADULTS
On average, one cartridge (1.7 g) or less of Oraqix
®
will be sufficient for one quadrant of
the dentition. The maximum recommended dose of Oraqix
®
at one treatment session is
five cartridges, i.e. 8.5 g gel containing 212.5 mg lidocaine
(lignocaine) base and 212.5 mg
prilocaine base.
ORAQIX® PERIODONTAL GEL
DENTSPLY SIRONA PTY LTD
(LIDOCAINE (LIGNOCAINE) 25 MG/G AND PRILOCAINE 25MG/G)
PRODUCT INFORMATION
AU-PI Revisio