Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
CEFTRIAXONE SODIUM
Roche Products Ltd
2 g Grams
Pdr for Soln Inj/Inf
1983-11-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0050/062/007 Case No: 2075450 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROCHE PRODUCTS LTD 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ROCEPHIN, 2 G GRAMS 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 02/11/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/01/2010_ _CRN 2075450_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rocephin 2 g powder for solution for injection or infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 g vial contains 2 g ceftriaxone as 2.39 g ceftriaxone sodium. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. White to yellowish-orange crystalline powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible micro-organisms (see section 5.1) and when parenteral therapy is required: o Respiratory tract infections including pneumonia, acute and chronic bronchitis Soma hati kamili