Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
NALOXONE HYDROCHLORIDE DIHYDRATE
Mercury Pharmaceuticals (Ireland) Ltd
20 anhyd mg/ml
Solution for Inj/Inf
1989-10-03
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0073/111/001 Case No: 2071149 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ANTIGEN PHARMACEUTICALS LTD CHANDLER HOUSE, CASTLE STREET, ROSCREA, CO TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product NALOXONE HYDROCHLORIDE 20 MICROGRAMS/ML SOLUTION FOR INJECTION OR INFUSION the particulars of which are set out in 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 30/04/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/06/2010_ _CRN 2071149_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Naloxone Hydrochloride 20 micrograms/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 20 micrograms (0.02mg) Naloxone Hydrochloride present as Naloxone hydrochloride dihydrate. Each 2 ml of solution contains 40 micrograms (0.04mg) Naloxone Hydrochloride present as Naloxone hydrochloride dihydrate Excipients: Each 1ml contains 3.53 mg sodium Each 2 ml contains 7.06 mg sodium For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear colourless sterile solution. 4 CLINICAL PARTICULARS 4 সম্পূর্ণ নথি পড়ুন