Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ORCIPRENALINE SULFATE BROMHEXINE HYDROCHLORIDE
Boehringer Ingelheim Limited
ORCIPRENALINE SULFATE BROMHEXINE HYDROCHLORIDE
10/4 mg /5m MG/5ml
Oral Suspension
Withdrawn
2009-03-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0007/015/002 Case No: 2053944 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BOEHRINGER INGELHEIM LIMITED ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ALUPENT EXPECTORANT MIXTURE 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 11/08/2008 until 31/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/08/2008_ _CRN 2053944_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alupent Expectorant Mixture 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains orciprenaline sulphate 10 mg and bromhexine hydrochloride 4 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Syrup Clear, colourless syrup with an odour of cocoa. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alupent Expectorant Mixture is indicated for conditions in which both bronchospasm and sputum are present, e.g. in asthma or bronchitis. During infective episodes a suitable antibiotic should also be given. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and administration orally: Diluent: Alupe Прочитайте повний документ