ARDANEST 4% with adrenaline (epinephrine) 1:100,000

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Adrenaline acid tartrate 0.018 mg/mL equivalent to adrenaline (epinephrine) base 0.01 mg/mL;  ;  ; Articaine hydrochloride 40 mg/mL

Tilgængelig fra:

DE Healthcare Limited

INN (International Name):

Adrenaline acid tartrate 0.018 mg/mL (equivalent to adrenaline (epinephrine) base 0.01 mg/mL)

Dosering:

40mg/mL 0.01 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Adrenaline acid tartrate 0.018 mg/mL equivalent to adrenaline (epinephrine) base 0.01 mg/mL     Articaine hydrochloride 40 mg/mL Excipient: Citric acid monohydrate Hydrochloric acid Sodium chloride Sodium hydroxide Sodium metabisulfite Water for injection

Recept type:

Prescription

Fremstillet af:

Cambrex Profarmaco Milano Srl

Terapeutiske indikationer:

ARDANEST 4% with adrenaline (epinephrine) 1:100,000 and ARDANEST 4% with adrenaline (epinephrine) 1:200,000 are indicated for infiltration anaesthesia and nerve block anaesthesia in dentistry. ARDANEST 4% with adrenaline (epinephrine) 1:100,000 is especially indicated for more complex dental procedures requiring prolonged anaesthesia.

Produkt oversigt:

Package - Contents - Shelf Life: Cartridge, glass, Type 1, 1.8 mL closed with rubber stopper at one end and rubber disk with aluminium cap on the other - 50 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Cartridge, glass, Type 1, 1.8 mL closed with rubber stopper at one end and rubber disk with aluminium cap on the other - 100 dose units - 24 months from date of manufacture stored at or below 30°C protect from light

Autorisation dato:

2013-11-21

Produktets egenskaber

ARDANEST
22 July 2021
1 of 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ARDANEST 4% with adrenaline (epinephrine) 1:100,000 solution for
injection
ARDANEST 4% with adrenaline (epinephrine) 1:200,000 solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARDANEST 4% WITH ADRENALINE (EPINEPHRINE) 1:100,000
1 mL of solution for injection contains articaine hydrochloride 40.00
mg and adrenaline (epinephrine,
as tartrate) 0.01 mg.
One cartridge (1.8 mL) contains articaine hydrochloride 72.00 mg and
adrenaline (epinephrine, as
tartrate) 0.018 mg.
Each 1.8 mL cartridge contains: 0.71 mg of sodium.
For the full list of excipients, see section 6.1.
ARDANEST 4% WITH ADRENALINE (EPINEPHRINE) 1:200,000
1 mL of solution for injection contains articaine hydrochloride 40.00
mg and adrenaline (epinephrine,
as tartrate) 0.005 mg.
One cartridge (1.8 mL) contains articaine hydrochloride 72.00 mg and
adrenaline (epinephrine, as
tartrate) 0.009 mg.
Each 1.8 mL cartridge contains: 0.71 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection, for local and regional dental anaesthesia.
The solution is a clear, non-opalescent, colourless liquid with a pH
ranging from 3.0 to 4.3. The
osmolality of the solution is approximately 267 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARDANEST 4% WITH ADRENALINE (EPINEPHRINE) 1:100,000
and
ARDANEST 4% WITH ADRENALINE
(EPINEPHRINE) 1:200,000
are indicated for infiltration anaesthesia and nerve block anaesthesia
in
dentistry.
ARDANEST 4% WITH ADRENALINE (EPINEPHRINE) 1:100,000
is especially indicated for
more complex dental procedures requiring prolonged anaesthesia.
ARDANEST
22 July 2021
2 of 12
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The smallest possible volume of solution that will lead to effective
anaesthesia should be used.
For extraction of maxillary teeth, 1.7 mL
ARDANEST 4% WITH ADRENALINE (EPINEPHRINE)
1:100,000
or
ARDANEST 4% WITH ADRENALINE (EPINEPHRINE) 1:200,000
per tooth suffices in most
cases, thereby a