SEPTANEST 1:100,000 articaine hydrochloride and adrenaline (epinephrine) 2.2mL solution for injection

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 microgram/mL); articaine hydrochloride, Quantity: 40 mg/mL

Available from:

Specialites Septodont Pty Ltd

INN (International Name):

adrenaline (epinephrine),Articaine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium metabisulfite; water for injections; sodium hydroxide; sodium chloride

Administration route:

Dental

Units in package:

10 x 2.2mL cartridge

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For local or regional anaesthesia for both simple and complex dental procedures in adult, adolescents and children 4 years of age and older. Septanest 1:100,000 is indicated only for dental procedures.

Product summary:

Visual Identification: Clear aqueous solution in a Type 1 glass cartridge fitted with a rubber closure ("seal") and a rubber plunger.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-05-21

Patient Information leaflet

1
WHAT IS IN THIS LEAFLET
WHAT IS SEPTANEST 1:200,000 AND SEPTANEST 1:100,000 USED FOR
BEFORE YOU ARE GIVEN SEPTANEST 1:200,000 OR SEPTANEST 1:100,000
SEPTANEST 1:200,000 AND SEPTANEST 1:100,000
_Articaine hydrochloride and Adrenaline (epinephrine) acid tartrate _
_ _
CONSUMER MEDICINE INFORMATION
Please read this leaflet carefully before you use SEPTANEST 1:200,000
or SEPTANEST 1:100,000.
This leaflet answers some common questions about SEPTANEST 1:200,000
or SEPTANEST
1:100,000. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Sometimes new risks are found
even when a medicine has
been used for many years. Your doctor has weighed the expected
benefits of you taking SEPTANEST
1:200,000 or SEPTANEST 1:100,000 against the risks this medicine could
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN.
SEPTANEST
1:200,000
and
SEPTANEST
1:100,000
contain
the
active
ingredients:
Articaine
hydrochloride, a local anaesthetic to prevent the pain, and Adrenaline
(epinephrine) acid tartrate, a
vasoconstrictor, which makes it last longer (adrenaline narrows the
blood vessels at the site of
injection, which keeps the anaesthetic where it's needed for a longer
time) and controls bleeding
during the surgery.
SEPTANEST 1:200,000 and SEPTANEST 1:100,000 belong to a group of
medicines called local
anaesthetics. SEPTANEST 1:200,000 or SEPTANEST 1:100,000 is injected
into the mouth where it
makes the nerves unable to pass messages to the brain.
Your dentist will have explained why you are being given SEPTANEST
1:200,000 or SEPTANEST
1:100,000.
Follow all directions given to you by your dentist carefully. They may
differ from the information
contained in this leaflet. Ask your dentist if you want more
information.
SEPTANEST 1:200,000 and SEPTANEST 1:100,000 are not addictive.
When you must not be given SEPTANEST

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SEPTANEST 1:100,000 AND
SEPTANEST 1:200,000 (ARTICAINE HYDROCHLORIDE ,
ADRENALINE(EPINEPHRINE) ACID TARTRATE) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Articaine hydrochloride with adrenaline (epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEPTANEST 1:100,000: articaine hydrochloride 4% with adrenaline
(epinephrine) acid tartrate
1:100,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline
(epinephrine) 10µg/mL]
SEPTANEST 1:200,000: articaine hydrochloride 4% with adrenaline
(epinephrine) acid tartrate
1:200,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline
(epinephrine) 5µg/mL]
SEPTANEST
1:100,000
Per 1.7 mL
cartridge
Per 2.2 mL
cartridge
ACTIVE INGREDIENTS
Articaine hydrochloride (INN)
68.0 mg
88.0 mg
Adrenaline (epinephrine) (as acid tartrate)
17.0 µg
22.0 µg
OTHER INGREDIENTS
Sodium chloride
2.72 mg
3.52 mg
Sodium metabisulfite
0.85 mg
1.1 mg
Sodium hydroxide solution (to adjust pH)
Water for injection q.s ad
1.7 mL
2.2 mL
Contains no antimicrobial agent.
SEPTANEST
1:200,000
Per 1.7 mL
cartridge
Per 2.2 mL
cartridge
ACTIVE INGREDIENTS
Articaine hydrochloride (INN)
68.0 mg
88.0 mg
Adrenaline (epinephrine) (as acid tartrate)
8.5 µg
11.0 µg
OTHER INGREDIENTS
Sodium chloride
2.72 mg
3.52 mg
Sodium metabisulfite
0.85 mg
1.1 mg
Sodium hydroxide solution (to adjust pH)
Water for injection q.s ad
1.7 mL
2.2 mL
Contains no antimicrobial agent.
Articaine hydrochloride is a local anaesthetic
Adrenaline (epinephrine) acid tartrate is a vasoconstrictor.
2
3
PHARMACEUTICAL FORM
SEPTANEST 1:100 000 is a Clear, not opalescent, colourless solution
for injection cartridge,
practically free from visible particles. It is available in a 1.7mL or
2.2mL cartridge.
SEPTANEST 1:200 000 is a Clear, not opalescent, colourless solution
for injection cartridge,
practically free from visible particles. It is available in a 1.7mL or
2.2mL cartridge.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SEPTANEST 1:100,000 is indicated for local or regional ana