Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Articaine hydrochloride; Adrenaline tartrate
NewLine Pharma, S.L.
N01BB58
Articaine hydrochloride; Adrenaline tartrate
40+0.01 milligram(s)/millilitre
Solution for injection
articaine, combinations
2020-06-26
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA 40 MG/ML + 0.01 MG/ML, SOLUTION FOR INJECTION Articaine hydrochloride / Epinephrine tartrate 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 doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Articaine hydrochloride/Epinephrine NewLine Pharma is and what it is used for 2. What you need to know before you use Articaine hydrochloride/Epinephrine NewLine Pharma 3. How to use Articaine hydrochloride/Epinephrine NewLine Pharma 4. Possible side effects 5. How to store Articaine hydrochloride/Epinephrine NewLine Pharma 6. Contents of the pack and other information 1. WHAT ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA IS AND WHAT IT IS USED FOR Articaine hydrochloride/Epinephrine NewLine Pharma contains two different active substances: articaine hydrochloride and epinephrine (also known as adrenaline). Articaine hydrochloride/Epinephrine NewLine Pharma is a local anesthetic (agent which reduces or abolishes sensation, affecting a particular region). This medicine is indicated in adults and children aged 4 years and above to numb (anaesthetize) a part of the mouth during dental procedures. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA _ _ DO NOT USE ARTICAINE HYDROCHLORIDE/EPINEPHRINE NEWLINE PHARMA: If you are allergic (hypersensitive) to articaine hydrochloride, adrenaline or any of the other ingredients of this medicine (listed in section 6) If you are allergic to other ‘local anaest Les hele dokumentet
Health Products Regulatory Authority 05 May 2023 CRN00D9YS Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Articaine hydrochloride/Epinephrine NewLine Pharma 40 mg/mL + 0.01 mg/mL, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Articaine hydrochloride……………………...40.00 mg/mL Adrenaline tartrate Quantity corresponding to adrenaline………..0.01 mg/mL Excipient(s) with known effect: Sodium metabisulphite (E223)……………….0.5 mg/mL For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection for dental use. Sterile, clear and colourless solution for injection with a pH between 2.7 – 4.5 and osmolality of aproximately 267 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local or local-regional anesthesia in dentistry and dental surgical procedures in patients at least 4 years old. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The smallest possible volume of solution which will lead to an effective anaesthesia should be used. _Adults_ _ _ The quantity to be injected will be adjusted as a function of the extent of the intervention. As a general rule, one to three cartridges per session. The dose should not exceed 7 mg of articaine hydrochloride per kilogram of body weight. _Paediatric population_ _ _ Articaine hydrochloride/Epinephrine NewLine Pharma should not be used in children aged below 4 years because of safety and efficacy concerns. The quantity to be injected depends on the age and the weight of the child as well as the type of intervention to be performed. The maximum dose is 5 mg of articaine hydrochloride (0.125 mL of anaesthetic solution) per kilogram of body weight. The average dose in mg of articaine hydrochloride that can be administered in children can be calculated as follows: Weight of the child (in kilograms) x 1.33 Health Products Regulatory Authority 05 May 2023 CRN00D9YS Page 2 of 7 _Elderly _ Reduce to one-half the dose used for adults. Method of administration Local or re Les hele dokumentet