Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ADRENALINE ACID TARTRATE; ARTICAINE HYDROCHLORIDE
Galla Dental Corporation Sdn Bhd
ADRENALINE ACID TARTRATE; ARTICAINE HYDROCHLORIDE
1.8ml mL
Novocol Pharmaceutical of Canada, Inc.
POSICAINE® 200 (articaine hydrochloride 4% with epinephrine/adrenaline 1:200,000 Injection) Local Anaesthetic for Dental Use CLINICAL PHARMACOLOGY POSICAINE is a local anaesthetic that has the reversible effect of blocking the conduction of painful sensations. POSICAINE decreases nerve conduc- tion by diminishing the sodium ion influx during the action potential period. The epinephrine is a vasoconstrictor added to POSICAINE to slow down the passage into the general circulation and thus ensure the prolonged maintenance of an active tissue concentration. The anaesthesia is obtained rapidly (1 to 3 minutes) and lasts for 45 minutes per cartridge. Injected in the mouth by the submucosal route with a solution containing 1:200,000 epinephrine, articaine reaches the blood concentration peak about 17 minutes after the injection. The half-life elimination is very short: about 25 minutes. Articaine is excreted mainly through the urine with total elimina- tion of 76 % and 89 % following intramuscular and intravenous administration, respectively. Two unidentified metabolites of articaine are detected in the urine following intramuscular injection accounting for 87 % and 2 % of the administered dose. No metabolites are detected in the blood following intravenous administration. INDICATIONS AND CLINICAL USE POSICAINE is indicated for infiltration anaesthesia and nerve block anaesthesia during minor procedures in dentistry. CONTRAINDICATIONS POSICAINE is contraindicated in patients with known allergies to dental anaesthetics. POSICAINE is also contraindicated in patients with sepsis near the proposed injection site, severe shock, paroxysmal tachycardia, frequent arrhythmia, neurological disease, severe hypertension or in patients with asthma who may have bronchospastic allergic reactions induced by sulphites. Since POSICAINE contains epinephrine the caution required of any vaso- constrictor drug is in order. WARNINGS POSICAINE, along with other local anaesthetics, is capable of producing methaemoglobinaemia. The clinical sign Læs hele dokumentet