3% CITANEST

Main information

  • Trade name:
  • 3% CITANEST DENTAL WITH OCTAPRESSIN 1.8mL injection cartridge
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • 3% CITANEST DENTAL WITH OCTAPRESSIN 1.8mL injection cartridge
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220319
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220319

3% CITANEST DENTAL WITH OCTAPRESSIN 1.8mL injection cartridge

ARTG entry for

Medicine Registered

Sponsor

Dentsply (Australia) Pty Ltd

Postal Address

11-21 Gilby Road,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

26/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. 3% CITANEST DENTAL WITH OCTAPRESSIN 1.8mL injection cartridge

Product Type

Single Medicine Product

Effective date

2/12/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

INDICATIONS AS AT 23 JULY 2003 : CITANEST is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by

means of infiltration and nerve block tecniques.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Cartridge

Glass Type I Clear

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1.8 mL x 100

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Infiltration

Subcutaneous

Visual Identification

Clear colourless particle-free solution

Active Ingredients

Felypressin

.54 microgram/mL

Prilocaine hydrochloride

30 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:39:01 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

3% Citanest

®

DENTAL with

Octapressin

®

Prilocaine Hydrochloride with Felypressin

Consumer Medicine Information

Name of consumer

Address of consumer

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 not take Citanest DENTAL with

Octapressin if you have any of these

medical conditions:

a problem with abnormal blood

pigment levels

(methaemoglobinaemia).

It may not be safe for you to be given

this medicine if you have any of these

conditions.

This medicine will only be used if the

solution is clear, the package is

undamaged and the use by (expiry)

date printed on the pack has not been

passed.

Before you are given it

Tell your dental practitioner if you

have allergies to any other

medicines, foods, preservatives or

dyes.

Tell your dental practitioner if you

have or have had any of the

following medical conditions:

problems with your heart beat

rhythm or a very slow heart beat

anaemia (a decreased number of

red blood cells)

diabetes

nerve problems

liver problems

kidney problems

heart problems

malignant hyperthermia.

Tell your dental practitioner if you

are pregnant or plan to become

pregnant or are breast-feeding.

CITANEST

DENTAL WITH OCTAPRESSIN

Your dental practitioner can discuss

with you the risks and benefits

involved.

This medicine has been widely used

for dental procedures during pregnancy

with no reports of ill effects to the

mother or baby.

This medicine may enter breast milk,

but in such small amounts that there is

generally no risk of affecting the baby.

If you have not told your dental

practitioner about any of the above,

tell him/her before you are given

Citanest DENTAL with Octapressin.

Taking other medicines

Tell your dental practitioner if you

are taking any other medicines,

including any that you get without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and Citanest

DENTAL with Octapressin may

interfere with each other. These

include:

medicines used to maintain the

normal rhythm of your heart,

such as mexilitene

a type of antibiotic medicine,

known as sulphonamides, such

as sulfamethoxozole

medicines used to treat malaria,

such as quinine

medicines called nitric

compounds such as

nitroglycerin which is used to

treat angina.

These medicines may be affected by

Citanest DENTAL with Octapressin or

may affect how well it works. You

may need different amounts of your

medicines, or you may need to take

different medicines.

Your dental practitioner and

pharmacist have more information on

medicines to be careful with or avoid

while being given this medicine.

How Citanest DENTAL

with Octapressin is given

Follow all directions given to you by

your dental practitioner carefully.

They may differ from the information

contained in this leaflet.

How much you are given

The dosage you will be given will

depend on your body size, age and the

type of dental work you will be having

done.

Your dental practitioner will choose

the best dose for you. They will be

willing to discuss this decision with

you.

How it is given

Citanest DENTAL with Octapressin

will be injected by your dental

practitioner into your gum near a single

nerve, or into an area which contains a

large number of nerves.

This will result in an area of numbness

at the site or near the site of injection.

Citanest DENTAL with Octapressin

should not be injected directly into

the blood.

If you are given too much

(overdose)

The dental practitioner giving you this

medicine will be experienced in the use

of local anaesthetics, so it is unlikely

that you will be given an overdose.

However, if you are particularly

sensitive to it, or the dose is

accidentally injected directly into your

blood, you may develop problems for a

short time.

Symptoms of an overdose may include:

a numb feeling in or around the

mouth

feeling dizzy or stiff

muscle twitching.

Whenever you are given the medicine,

equipment will be available to care for

you if an overdose happens.

While you are being given

Citanest DENTAL with

Octapressin

Things you must not do

Do not eat or drink anything until

the feeling has completely returned

to your mouth.

You may burn or bite yourself.

Things to be careful of

Be careful driving or operating

machinery until you know how

Citanest DENTAL with Octapressin

affects you.

This medicine may cause dizziness,

nervousness, drowsiness, blurred

vision or feeling strange/disoriented in

some people. If you have any of these

symptoms, do not drive, operate

machinery or do anything else that

could be dangerous.

Side effects

Tell your dental practitioner as soon

as possible if you do not feel well

while you are being given Citanest

DENTAL with Octapressin.

This medicine helps most people have

pain-free visits to the dental

practitioner but it may have unwanted

side effects in a few people, although

these are rare. All medicines can have

side effects. Sometimes they are

serious, most of the time they are not.

You may need medical attention if you

get some of the side effects.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your dental practitioner to

answer any questions you may have.

Tell your dental practitioner if you

notice any of the following and they

worry you:

nervousness

dizziness

blurred vision

drowsiness

ringing in the ears

numbness

feeling strange (disoriented)

nausea

vomiting

shakes (tremor)

headache.

The above list includes side effects that

are usually mild and short lived.

CITANEST

DENTAL WITH OCTAPRESSIN

If Citanest DENTAL with

Octapressin is given wrongly or you

are very sensitive to it, any of the

following may happen. Tell your

dental practitioner immediately or

go to Accident and Emergency at

your nearest hospital:

fits

unconsciousness

breathing problems

dizziness

slow heart beat

collapse.

The above list includes very serious

side effects. If you have them, you may

have had a serious (allergic) reaction to

the medicine. You may need urgent

medical attention or hospitalisation.

Tell your dental practitioner if you

notice anything that is making you

feel unwell.

Other side effects not listed above may

also occur in some people.

After using Citanest

DENTAL with

Octapressin

Storage

Citanest DENTAL with Octapressin

will be stored by your dental

practitioner under the recommended

conditions.

It should be kept in a cool dry place

where the temperature stays below

25

°C. Protect from light.

Disposal

Any medicine from a single dose

which is not used will be disposed of

in a safe manner by your dental

practitioner.

Product Description

What it looks like

Citanest DENTAL with

Octapressin

is a clear, colourless solutions in 2.2

mL and 1.8 mL dental cartridges. Each

cartridge is distinctly colour banded for

ease of identification with green and

gold.

Ingredients

Citanest DENTAL with

Octapressin

contains 30 mg/mL of prilocaine

hydrochloride and 0.54 µg/mL of

felypressin as the active ingredients. It

also contains:

Sodium chloride

Sodium hydroxide and/or

Hydrochloric acid

Water for Injections.

This medicine does not contain lactose,

sucrose, gluten, tartrazine or any other

azo dyes.

Supplier/Sponsor

Citanest DENTAL with Octapressin is

supplied in Australia by:

DENTSPLY (Australia) Pty Ltd

11-21 Gilby Rd

Mount Waverley

Victoria, 3149 Australia

Tel: 1300 55 29 29

Citanest DENTAL with Octapressin is

supplied in New Zealand by:

Dentsply (N.Z.) Limited

11 Marshall Road

Katikati 3129

New Zealand

Tel: 0800 DENTSPLY (33 68 77)

This leaflet was prepared on

7 July 2014.

Australian Register numbers:

3% Citanest

DENTAL with

Octapressin

2.2 mL injection cartridge

AUST R 220320

3% Citanest

DENTAL with

Octapressin

1.8 mL injection cartridge

AUST R 220319

Trademarks herein are the property of the

AstraZeneca group.

CITANEST

DENTAL WITH OCTAPRESSIN

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