Země: Švédsko
Jazyk: švédština
Zdroj: Läkemedelsverket (Medical Products Agency)
lidokain; prilokain
Teva B.V.
N01BB20
lidocaine; prilocaine
25 mg/g + 25 mg/g
Kräm
makrogolglycerolhydroxistearat Hjälpämne; lidokain 25 mg Aktiv substans; prilokain 25 mg Aktiv substans
Apotek
Receptbelagt
Kombinationer
Förpacknings: Tub, 1 x 5 g (utan täckförband); Tub, 1 x 5 g (med 2 täckförband); Tub, 5 x 5 g (med 12 täckförband); Tub, 1 x 30 g
Godkänd
2014-06-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DENELA 25 MG/G + 25 MG/G CREAM (FOR 5 G AND PRE-MEDICATION PACKS) (FOR 30 G SURGICAL PACKS) LIDOCAINE/PRILOCAINE Rx: 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. OTC: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. [To be completed nationally] WHAT IS IN THIS LEAFLET: 1. What /.../ is and what it is used for? 2. What you need to know before you use /.../ 3. How to use /.../ 4. Possible side effects 5. How to store /.../ 6. Contents of the pack and other information 1. WHAT /.../ IS AND WHAT IT IS USED FOR /.../ contains two active substances called lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics. /.../ works by numbing the surface of the skin for a short time. It is put on the skin before certain medical procedures. This helps to stop pain on the skin; however you may still have the feelings of pressure and touch. _Adults, Adolescents and Children_ It can be used to numb the skin before: - Having a needle put in (for example, if you are having an injection or a blood test). - Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Denela 25 mg/g + 25mg/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine. Excipient with known effect: macrogolglycerol hydroxystearate. Each gram of cream contains 19 mg of macrogolglycerol hydroxystearate (hydrogenated polyoxyl castor oil) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White soft cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS /.../ is indicated for: - Topical anaesthesia of the skin in connection with: - needle insertion and injections eg. intravenous catheters, blood sampling or vaccination; - superficial surgical procedures, e.g.laser treatment and hair removal - in adults and in the paediatric population. - Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia in adults and adolescents ≥ 12 years. - Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents _ The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2. For further guidance on the appropriate use of the product in such procedures, please refer to _Method of administration_ . TABLE 1 ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE INDICATION/PROCEDURE DOSAGE AND APPLICATION TIME SKIN Minor procedures e.g. needle insertion and surgical treatment of localised lesions. 2 g (approx. half a 5 g tube) or approx. 1.5g/10cm 2 for 1 to 5 hours 1) Dermal surgical procedures on larger areas in a hospital setting e.g. split skin grafting. Approx. 1.5-2 g/10 cm 2 for 2 to 5 hours 1) Dermal procedures on newly shaven skin of large body areas e.g. laser hair removal (self-application by patient) Maximum recommended dose: 60g. Maximum recommended treated area: 600 cm 2 for a minimum of 1 hour, maximum 5 hours. 1) Skin of male gen Přečtěte si celý dokument