Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml; Articaine hydrochloride 40 mg/mL
Dentsply Sirona (NZ) Limited
Adrenaline acid tartrate 10 µg/mL
Solution for injection
Active: Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml Articaine hydrochloride 40 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Sodium metabisulfite Water for injection
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
Indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older. Indicated only for dental procedures.
Package - Contents - Shelf Life: Cartridge, glass, Type 1, clear, with self-aspirating bromobutyl plunger and aluminium cap, 2.2 mL - 50 dose units - 2 years from date of manufacture stored at or below 25°C protect from light. Do not freeze
2016-02-16
4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000, Issue No. 3.0 1 4% ARTICADENT ® DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 _articaine hydrochloride with adrenaline (epinephrine) _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about 4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000. It does not contain all of the available information. It does not take the place of talking to your dental practitioner. All medicines have risks and benefits. Your dental practitioner has weighed the expected benefits of you using 4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000 against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DENTAL PRACTITIONER. KEEP THIS LEAFLET. You may need to read it again. WHAT 4% ARTICADENT DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 IS FOR 4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000 are given by injection to cause loss of feeling before and during dental procedures. It contains two active ingredients: Articaine hydrochloride, a local anaesthetic to prevent the pain, and adrenaline (epinephrine) (as acid tartrate), a vasoconstrictor, which makes it last longer. Adrenaline (epinephrine) 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. 4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000 belongs to a group of medicines called local anaesthetics. ASK YOUR DENTAL PRACTITIONER IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. 4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000 is not addictive. BEFORE YOU TAKE 4% ARTICADENT DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 YOU MUST NOT TAKE 4% ARTICADENT DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 IF YOU HAVE AN ALLERGY TO: • adrenaline (epinephrine) or articaine • any of the ingredients listed toward the end of this leaf Leggi il documento completo
4% ARTICADENT® DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 DATA SHEET DENTSPLY SIRONA (NZ) LTD NZ-DS Revision 2.0 Page 1 of 15 NEW ZEALAND DATA SHEET 1 PRODUCT NAME 4% Articadent ® DENTAL with Adrenaline (epinephrine) 1:100,000 Injection for Local and Regional Dental Anaesthesia 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 4% Articadent ® DENTAL with Adrenaline (epinephrine) 1:100,000 consists of Articaine hydrochloride 40 mg/mL and Adrenaline (epinephrine) (as acid tartrate) 10 micrograms/mL. ARTICAINE HYDROCHLORIDE: white to almost white powder, odourless. Articaine hydrochloride is a local anaesthetic and is a racemic mixture. Articaine hydrochloride has a partition coefficient in n-octanol/ Soerensen buffer (pH 7.35) of 17, a pKa of 7.8 and is freely soluble in water and in ethanol (96 per cent). ADRENALINE (EPINEPHRINE) (AS ACID TARTRATE): white or greyish-white or light brownish grey, odourless, crystalline powder, which slowly darkens on exposure to air and light. Adrenaline (epinephrine) (as acid tartrate) 1.8 mg is approximately equivalent to 1 mg of adrenaline (epinephrine). It is freely soluble in water and slightly soluble in ethanol (96 per cent). Adrenaline (epinephrine) (as acid tartrate) is a vasoconstrictor. CHEMICAL STRUCTURE OF ARTICAINE HYDROCHLORIDE CHEMICAL STRUCTURE OF ADRENALINE (EPINEPHRINE) ACID TARTRATE 4% ARTICADENT® DENTAL WITH ADRENALINE (EPINEPHRINE) 1:100,000 DATA SHEET DENTSPLY SIRONA (NZ) LTD NZ-DS Revision 2.0 Page 2 of 15 CHEMICAL NAME: Articaine hydrochloride: Methyl 4 ‐ methyl ‐ 3 ‐ [[(2_RS_) ‐ 2-(propylamino)propanoyl]amino]- thiophene ‐ 2 ‐ carboxylate hydrochloride Adrenaline (epinephrine) acid tartrate: (1_R_) ‐ 1 ‐ (3,4 ‐ Dihydroxyphenyl) ‐ 2 ‐ (methylamino)ethanol hydrogen (2_R_,3_R_) ‐ 2,3 ‐ dihydroxybutanedioate MOLECULAR FORMULA: Articaine hydrochloride: C13H20N2O3S.HCl Adrenaline (epinephrine) acid tartrate: C9H13NO3.C4H6O6 MOLECULAR WEIGHT: Articaine hydrochloride: 320.84 Adrenaline (epinephrine) acid tartrate: 333.3 CAS REGISTRY NUMB Leggi il documento completo