Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DOXAPRAM HYDROCHLORIDE
Taro Pharmaceuticals (Ireland) Limited
20 Mg/Ml
Solution for Injection
2005-12-22
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1140/005/002 Case No: 2026068 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TARO PHARMACEUTICALS (IRELAND) LIMITED LOURDES ROAD, ROSCREA, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product DOXAPRAM INJECTION BP 20 MG/ML 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 17/12/2006 until . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/04/2007_ _CRN 2026068_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxapram Injection BP 20mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of sterile solution for injection contains 20 mg doxapram hydrochloride Each 5 ml of sterile solution for injection contains 100 mg doxapram hydrochloride. For excipients see 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxapram acts as a ventilatory stimulant and Doxapram Injection BP 20 mg/ml is used following anaesthesia to stimulate ventilation in the post-operative period as an aid to the reduction of post-operative pulmonary complications, Prečítajte si celý dokument