3% CITANEST DENTAL WITH OCTAPRESSIN 2.2mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prilocaine hydrochloride, Quantity: 30 mg/mL; felypressin, Quantity: 0.54 microgram/mL

Available from:

Dentsply Sirona Pty Ltd

INN (International Name):

Felypressin,Prilocaine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Infiltration, Intramuscular

Units in package:

2.2mL x50, 2.2mL x100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CITANEST is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

Product summary:

Visual Identification: Clear colourless particle-free solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-05-26

Patient Information leaflet

CITANEST
®
DENTAL WITH OCTAPRESSIN
®
1
3% CITANEST
® DENTAL WITH
OCTAPRESSIN
®
_Prilocaine Hydrochloride with Felypressin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Citanest DENTAL
with Octapressin.
It does not contain all the available
information. It does not take the place
of talking to your dental practitioner or
dental nurse.
All medicines have risks and benefits.
Your dental practitioner has weighed
the risks of you using 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 CITANEST DENTAL
WITH OCTAPRESSIN IS USED
FOR
Citanest DENTAL with Octapressin is
used to prevent or relieve pain during
dental procedures, but it will not put
you to sleep.This medicine belongs to a
group of medicines called local
anaesthetics.
It is injected into the gums and works
by making the nerves unable to pass
pain messages to the brain.
Depending on the amount used, it will
either totally stop pain or will cause a
partial loss of feeling.
The felypressin makes the blood
vessels at the site of injection narrower,
which means you bleed less. It is then
easier for your dental practitioner to
see what is happening.
ASK YOUR DENTAL PRACTITIONER IF YOU
HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
CITANEST DENTAL WITH
OCTAPRESSIN
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT TAKE CITANEST DENTAL WITH
OCTAPRESSIN IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
prilocaine
•
any of the ingredients listed at
the end of this leaflet
•
any other similar medicines,
such as other local anaesthetics
e.g. Xylocaine.
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.
DO

Summary of Product characteristics

3% CITANEST
® DENTAL WITH OCTAPRESSIN
®
PRODUCT INFORMATION
DENTSPLY SIRONA PTY LTD
AU-PI Revision 5.0
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
3% CITANEST
® DENTAL WITH OCTAPRESSIN
®
(prilocaine hydrochloride and felypressin)
1
NAME OF THE MEDICINE
prilocaine hydrochloride
felypressin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
3% Citanest DENTAL with Octapressin is a clear, colourless sterile
aqueous solution
contains 30 mg/mL prilocaine hydrochloride and 0.54 micrograms/mL
felypressin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
3% Citanest DENTAL with Octapressin injection solution in a standard
and self-
aspirating glass cartridge.
The finished product is a clear and colourless solution packed in a
carton containing
either 50 or 100 units of 1.8 mL and 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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3% Citanest DENTAL with Octapressin is indicated for the production of
local
anaesthesia in routine dental procedures and oral surgery by means of
infiltration and
nerve block techniques.
4.2
DOSE AND METHOD OF ADMINISTRATION
The lowest dosage that results in effective anaesthesia should be
used. The dosage will
also depend on the area of the oral cavity to be anaesthetised, the
vascularity of the
oral tissues and the technique of anaesthesia.
RECOMMENDED DOSAGE FOR 3% CITANEST DENTAL WITH OCTAPRESSIN
(0.03 IU/mL or 0.54 μg/mL felypressin) SOLUTION FOR DENTAL
ANAESTHETIC
PROCEDURES IN THE AVERAGE, HEALTHY, 70KG ADULT PATIENT
3% CITANEST
® DENTAL WITH OCTAPRESSIN
®
PRODUCT INFORMATION
DENTSPLY SIRONA PTY LTD
AU-PI Revision 5.0
Page 2 of 10
3% CITANEST
®
DENTAL
WITH OCTAPRESSIN
®
INFILT
BLOCK
SUGGESTED DOSE
1 mL
1.5 – 2 mL
ONSET OF ACTION (APPROX)
2 min
4 min
DURATION OF ACTION (APPROX)
Pulp
Soft Tissue
40 min
2.5 hrs
90 min
3.5 hrs
NOTE:
1.
RECOMMENDED DOSES
Toxic doses vary widely bet