Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
MEPIVACAINE HYDROCHLORIDE EPINEPHRINE
Septodont
MEPIVACAINE HYDROCHLORIDE EPINEPHRINE
2% w/v /1: Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0196/016/001 Case No: 2059595 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SEPTODONT 58 RUE DU PONT DE CRÉTEIL, 94 107 SAINT MAUR-DES-FOSSÉS, CEDEX, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product SCANDONEST 2% W/V/1:100,000 SPECIAL, SOLUTION FOR INJECTION The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 27/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/05/2010_ _CRN 2059595_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Scandonest 2% w/v / 1:100,000 Special, Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients - contains Potassium Metabisulphite (E224) 1.2mg (per 1ml) Also contains Sodium (<1mmol/ml) For a 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 anaesthetic for dental use, where a vasoconstrictor effect is desirable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration: Local injection (block or infiltration) To minimise the likelihood of intravascular Perskaitykite visą dokumentą