Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE
Meda Health Sales Ireland Limited
150mg Milligram
Capsule
2007-01-26
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1332/021/003 Case No: 2032305 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA1058/008/003. MEDA HEALTH SALES IRELAND OFFICE 10, DUNBOYNE BUSINESS PARK, DUNBOYNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ZAMADOL SR 150 MG PROLONGED-RELEASE CAPSULES 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 26/01/2007 until 09/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/05/2007_ _CRN 2032305_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zamadol SR 150 mg Prolonged-Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg tramadol hydrochloride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. Dark green capsules, marked ‘T150SR’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The capsules are intended for twice daily oral administration and can be taken independently of meal times, swallowed whole with water. As with all analgesic drugs the dosing of Zamadol SR Prolong Prečítajte si celý dokument