3% Citanest DENTAL with Octapressin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Active ingredient:

Felypressin 0.54 µg/mL; Prilocaine hydrochloride 3% (30mg/ml.);  

Available from:

Dentsply Sirona (NZ) Limited

INN (International Name):

Felypressin 0.03 IU/mL (0.46µg/ml.)

Pharmaceutical form:

Solution for injection

Composition:

Active: Felypressin 0.54 µg/mL Prilocaine hydrochloride 3% (30mg/ml.)   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Units in package:

Cartridge, glass, Self aspirating 100x1.8mL, 180 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

PolyPeptide Laboratories AB

Therapeutic indications:

Infiltration anaesthesia in dentistry, where there is no need for profound ischaemia in the injected area.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, 50x1.8mL - 90 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Self aspirating 50x1.8mL - 90 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Aspirating, 50x2.2mL - 110 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, 50x2.2mL - 110 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, 100x1.8mL - 180 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Self aspirating 100x1.8mL - 180 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Aspirating, 100x2.2mL - 220 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, 100x2.2mL - 220 mL - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-31

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
                                
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Summary of Product characteristics

                                3% CITANEST
® DENTAL WITH OCTAPRESSIN
®
DATA SHEET
DENTSPLY SIRONA (NZ) LTD
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
3% Citanest
®
DENTAL with Octapressin
®
Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
3% Citanest
®
DENTAL with Octapressin
®
injection 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
®
is a sterile aqueous solution. The pH of the
solution is 3.5-5.2.
3% Citanest
®
DENTAL with Octapressin
®
injection solution in a standard and self-aspirating
glass cartridge.
The finished products is a clear and colourless solution packed in a
carton containing 100
units of 1.8 mL or 2.2 mL Type 1 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. The ampoules and cartridges are free from preservatives
and are intended
for single use only.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Infiltration anaesthesia in dentistry, where there is no need for
profound ischaemia in the
injected area.
•
Regional nerve block anaesthesia in dentistry.
4.2 DOSE AND METHOD OF ADMINISTRATION
3% Citanest
®
DENTAL
with Octapressin
®
has a rapid onset of action after infiltration
anaesthesia, with an average of 2-3 minutes. Inferior alveolar nerve
block requires 5
minutes or more to take full effect. The duration of effective
anaesthesia varies in individuals
and depends on the type of block. The average duration of useful
anaesthesia after
infiltration is 45 minutes. After successful regional block, e.g.
inferior alveolar nerve block,
anaesthesia lasts for 2 hours or longer.
Injections should always be made slowly with careful aspiration before
and intermittently
during injection to avoid inadvertent intravascular injection, which
may have toxic effects.
The lowest dose that results in effective anaesthesia should be used.
The dose will a
                                
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