Country: Malta
Language: English
Source: Medicines Authority
ARTICAINE HYDROCHLORIDE, ADRENALINE
Septodont 58 Rue du Pont de Créteil, 94100 SAINT MAUR DES FOSSES, France
N01BB58
ARTICAINE HYDROCHLORIDE 40 mg/ml ADRENALINE 10 µg/ml
SOLUTION FOR INJECTION
ARTICAINE HYDROCHLORIDE 40 mg/ml ADRENALINE 10 µg/ml
POM
ANESTHETICS
Authorised
2005-06-30
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SEPTANEST WITH ADRENALINE 1/200,000 40 MG/ML + 5 MICROGRAMS/ML, SOLUTION FOR INJECTION SEPTANEST WITH ADRENALINE 1/100,000 40 MG/ML + 10 MICROGRAMS/ML, SOLUTION FOR INJECTION articaine hydrochloride/adrenaline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your dentist, doctor or pharmacist. − If you get any side effects, talk to your dentist, doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Septanest with adrenaline is and what it is used for 2. What you need to know before you are given Septanest with adrenaline 3. How to use Septanest with adrenaline 4. Possible side effects 5. How to store Septanest with adrenaline 6. Contents of the pack and other information 1. WHAT SEPTANEST WITH ADRENALINE IS AND WHAT IT IS USED FOR Septanest with adrenaline is used to numb (anaesthetise) your oral cavity during dental procedures. This medicine contains two active substances: • articaine, a local anaesthetic which prevents pain, and • adrenaline, a vasoconstrictor which narrows the blood vessels at the site of injection, and thereby prolongs the effect of articaine. It also decreases bleeding during surgery. You will be given Septanest with adrenaline by a dentist. Septanest with adrenaline is for children over 4 years of age (ca. 20 kg in body weight), adolescents and adults. Depending on the kind of dental procedure performed, the dentist will choose between the two medicines: • Septanest with adrenaline 1/200,000 is usually used for simple and short dental procedures • Septanest with adrenaline 1/100,000 is more adapted to procedures lasting longer or with possible significant bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SEPTANEST WITH ADRENALINE DO NOT USE SEPTANEST WITH ADRENALIN Read the complete document
PAGE 1 OF 16 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 16 1 NAME OF THE MEDICINAL PRODUCT Septanest with adrenaline 1/200,000 40 mg/ml + 5 micrograms/ml, solution for injection Septanest with adrenaline 1/100,000 40 mg/ml + 10 micrograms/ml, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Septanest with adrenaline 1/200,000 40 mg/ml + 5 micrograms/ml, solution for injection 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate). Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate). Septanest with adrenaline 1/100,000 40 mg/ml + 10 micrograms/ml, solution for injection 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate). Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate). Excipients with known effect: sodium metabisulfite (E223), sodium chloride, sodium hydroxide. Septanest with adrenaline contains 0.76 mg sodium per 1 ml of solution i.e. 1.29 mg/1.7 ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local and loco-regional anaesthesia in dental procedures. Septanest with adrenaline is indicated in adults, adolescents and children above 4 years of age (or from 20 kg (44 lbs) of body weight). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For professional use by physicians or dentists only. Posology For all populations, the lowest dose leading to effective anaesthesia should be used. The necessary dosage must be determined on an individual basis. For a routine procedure, the normal dose for adult patients is of 1 cartridge, but the contents of less of a cartridge may be sufficient for effective anaesthesia. At the discretion of the Read the complete document