Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
LIDOCAINE HYDROCHLORIDE
Roche Products Limited
LIDOCAINE HYDROCHLORIDE
3.5 Millilitre
Solution for Injection
Withdrawn
2007-11-15
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rocephin IM Solvent Ampoules 3.5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 3.5 ml of 1.06% lidocaine hydrochloride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solvent for parenteral use A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a solvent for Rocephin for intramuscular administration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION See 4.1. 4.3 CONTRAINDICATIONS Use in persons hypersensitive to lidocaine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE None. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION Not applicable. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2006_ _CRN 2030172_ _page number: 1_ 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Not applicable. 5.2 PHARMACOKINETIC PROPERTIES Not applicable. 5.3 PRECLINICAL SAFETY DATA Not applicable. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Water for injections 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE 5 years. 6.4 SPECIAL PRECAUTIONS FOR STORAGE None. 6.5 NATURE AND CONTENTS OF CONTAINER Ph. Eur. Type I glass ampoule containing 3.5 ml of solvent. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT A solvent for addition to Rocephin vials for intramuscular injection. 7 MARKETING AUTHORISATION HOLDER Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom IRISH MEDICINES BOARD ________ Izlasiet visu dokumentu