Scandonest 3%

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Mepivacaine hydrochloride 3%;  

Available from:

Ivoclar Vivadent Ltd

INN (International Name):

Mepivacaine hydrochloride 3%

Dosage:

3 %

Pharmaceutical form:

Solution for injection

Composition:

Active: Mepivacaine hydrochloride 3%   Excipient: Sodium chloride Sodium hydroxide Water for injection

Units in package:

Cartridge, 50 x 1.8mL, 90 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Moehs Catalana SL

Therapeutic 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.

Product summary:

Package - Contents - Shelf Life: Cartridge, 50 x 1.8mL - 90 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Cartridge, 50 x 2.2mL - 110 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze

Authorization date:

1980-07-17

Summary of Product characteristics

SCANDONEST 2% SPECIAL & SCANDONEST 3% - NEW ZEALAND DATA SHEET
1
1 PRODUCT NAME
Scandonest 2% Special : Mepivacaine hydrochloride 2% (20mg/mL) with
adrenaline 1:100,000,
Injection Solution
Scandonest 3% : Mepivacine hydrochloride 3% (30mg/mL), Injection
Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MEPIVACAINE HYDROCHLORIDE
CAS [1722-62-9]
MW : 282.81
Chemical name :
(1-Methyl-2-piperidyl)formo-2´,6´-xylidide hydrochloride
Chemical formula :
C
15
H
22
N
2
O,HCl
White crystalline powder, freely soluble in water and in alcohol, very
slightly soluble in
dichloromethane.
Mepivacaine hydrochloride is a local anaesthetic and is a racemic
mixture.
ADRENALINE
CAS [51-43-4]
MW : 183.2
Chemical name :
(R)-1-(3,4-di-hydroxyphenyl)-2-methylaminoethanol
Chemical formula :
C
9
H
13
NO
3
A white to greyish-white, crystalline powder, sparingly soluble in
water, practically insoluble in alcohol
and ether.
Adrenaline is a vasoconstrictor
SCANDONEST 2% SPECIAL & SCANDONEST 3% - NEW ZEALAND DATA SHEET
2
QUANTITATIVE COMPOSITION
SCANDONEST 2% SPECIAL
CARTRIDGE 2.2 ML
CARTRIDGE 1.8 ML
ACTIVE INGREDIENTS
Mepivacaine hydrochloride
44 mg
36 mg
Adrenaline
22 µg
18 µg
OTHER INGREDIENTS
Sodium chloride
14.3 mg
11.7 mg
Potassium metabisulfite
2.64 mg
2.16 mg
Disodium edetate
0.55 mg
0.45 mg
Sodium hydroxide solution
(for pH adjustment)
(for pH adjustment)
Hydrochloric acid
(for pH adjustment)
(for pH adjustment)
Water for injections q.s.
2.2 mL
1.8 mL
SCANDONEST 3%
CARTRIDGE 2.2 ML
CARTRIDGE 1.8 ML
ACTIVE INGREDIENTS
Mepivacaine hydrochloride
66 mg
54 mg
OTHER 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.
3 PHARMACEUTICAL FORM
Injection solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC 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.
SCANDONEST
2%
SPECIAL
is
recommended
f