Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Adrenaline acid tartrate 0.018 mg/mL equivalent to adrenaline (epinephrine) base 0.01 mg/mL; ; ; Articaine hydrochloride 40 mg/mL
DE Healthcare Limited
Adrenaline acid tartrate 0.018 mg/mL (equivalent to adrenaline (epinephrine) base 0.01 mg/mL)
40mg/mL 0.01 mg/mL
Solution for injection
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
Prescription
Cambrex Profarmaco Milano Srl
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.
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
2013-11-21
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 Прочетете целия документ