SCANDONEST 3% 54mg/1.8mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mepivacaine hydrochloride, Quantity: 30 mg/mL

Available from:

Specialites Septodont Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Infiltration

Units in package:

50x54mg/1.8mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT MAY 2003: Scandonest 3% 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 solution; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-07-13

Patient Information leaflet

SCANDONEST 2% SPECIAL (WITH ADRENALINE).
SCANDONEST 3% (WITHOUT VASOCONSTRICTOR (PLAIN)).
CONSUMER MEDICINE INFORMATION
WHAT’S IN YOUR MEDICINE
SCANDONEST contains a local anaesthetic, Mepivacaine hydrochloride.
Two
different
formulations
of
SCANDONEST
are
available.
One
formulation
contains
a
vasoconstrictor
called
adrenaline.
SCANDONEST 2% SPECIAL (WITH ADRENALINE)
ACTIVE INGREDIENTS
Cartridge 2.2 mL
Cartridge 1.8 mL
Mepivacaine hydrochloride
44 mg
36 mg
Adrenaline
22 µg
18 µg
OTHER INGREDIENTS:
Sodium chloride, disodium edetate, potassium metabisulfite,
hydrochloric acid, sodium hydroxide solution, water for
injections.
SCANDONEST 3% (WITHOUT VASOCONSTRICTOR (PLAIN)).
ACTIVE INGREDIENTS
Cartridge 2.2 mL
Cartridge 1.8 mL
Mepivacaine hydrochloride
66 mg
54 mg
OTHER INGREDIENTS:
Sodium chloride, Sodium hydroxide solution, water for injections.
PRESENTATION FOR BOTH PRODUCTS:
Box of 50 cartridges for single use, containing each 2.2 mL or 1.8 mL
of solution.
WHAT YOUR MEDICINE IS USED FOR AND HOW IT WORKS
SCANDONEST 3% contains one active ingredient, Mepivacaine
hydrochloride, a local anaesthetic to prevent the pain
and is given by injection to cause loss of feeling before and during
dental procedures.
SCANDONEST 2% SPECIAL contains two active ingredients, Mepivacaine
hydrochloride, a local anaesthetic to prevent
the pain, and adrenaline, a vasoconstrictor, which makes the local
anaesthetic action of Mepivacaine 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.
Your dentist will decide which SCANDONEST product (with or without
adrenaline) is best for the procedure.
1
ADVICE BEFORE USING THE MEDICINAL PRODUCT
In deciding to use a medicine, the risks of using the medicine must be
weighed against the good it will do. This is a
decision you and your dentist will make before treatment.
THIS PRODUCT SHOULD NOT BE USED IF ANY OF THE FOLLOWING APPLY TO YOU:
-
You are allergic to adrenal

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SCANDONEST 3%
(MEPIVACAINE HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Mepivacaine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SCANDONEST
3% CARTRIDGE 2.2 ML CARTRIDGE 1.8 ML
A
CTIVE INGREDIENTS
Mepivacaine hydrochloride 66 mg 54 mg
O
THER INGREDIENTS
Sodium chloride
13.2 mg
10.8 mg
Sodium hydroxide solution (for pH adjustment) (for pH adjustment)
Water for injections q.s
2.2 mL
1.8 mL
Contains no anti-microbial agent.
Mepivacaine hydrochloride is a local anaesthetic.
Contains Mepivacaine hydrochloride 3% (30mg/mL)
3
PHARMACEUTICAL FORM
SCANDONEST 3% is a sterile aqueous injection solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SCANDONEST 3% 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
D
OSE AND METHOD OF ADMINISTRATION
One or more cartridges should be used on a single patient on one
occasion only during each
session of treatment. If only a portion of a cartridge is used, the
remainder must be discarded.
The lowest dosage that results in effective anaesthesia for the
planned treatment should be
used.
The dosage will depend upon the area of the oral cavity to be
anaesthetised, the vascularity of
the oral tissues and the technique of anaesthesia.
2
Toxic doses vary widely between patients and toxic effects may occur
after any local anaesthetic
procedure.
Careful observation of the patient must be maintained after
administration of the local
anaesthetic.
ADULTS: a single cartridge (2.2 mL) is generally sufficient. Do not
exceed three cartridges (6.6
mL).
ADOLESCENTS BETWEEN 14 AND 17 YEARS: usual dosage one cartridge (2.2
mL). Do not exceed 2
cartridges (4.4 mL) in general cases.
CHILDREN BETWEEN 6 AND 14 YEARS: usual dose is 1.35 mL. Do not exceed
2.7 mL in usual cases.
CHILDREN BETWEEN 3 AND 6 YEARS: do not exceed maximum recommended dose
of 1.8 mL.
DO NOT USE ON CHILDREN UNDER THREE YEARS OF AGE.
The product is injected eith