Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
MOXIFLOXACIN HYDROCHLORIDE
LTT Pharma Limited
J01MA
MOXIFLOXACIN HYDROCHLORIDE
400 Milligram
Film Coated Tablet
Oral use
available in packs of 5.
Product subject to prescription which may not be renewed (A)
Bayer Pharma AG
Quinolone antibacterials, fluoroquinolones
FLUOROQUINOLONES
it is indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin: - Acute bacterial sinusitis (adequately diagnosed) - Acute exacerbations of chronic bronchitis (adequately diagnosed) - Community acquired pneumonia, except severe cases - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. It may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications: - Community-acquired pneumonia - Complicated skin and skin structure infections
Authorised
2015-07-31
CONTENTS OF THE PACK AND OTHER INFORMATION WHAT AVELOX CONTAINS The active substance is moxifloxacin. Each film-coated tablet contains 400 mg moxifloxacin as hydrochloride. The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate (see section _Avelox contains lactose_) and magnesium stearate. Film coating: hypromellose, macrogol 4000, iron oxide (E172) and titanium dioxide (E171). WHAT AVELOX LOOKS LIKE AND CONTENTS OF THE PACK Each dull red film-coated tablet with an oblong, convex shape with facet and a dimension of 17 x 7 millimeter is marked with “M400” on one side and “BAYER” on the other side. Avelox is packaged in cartons containing colourless polypropylene/aluminium blisters. Avelox is available in packs containing 5 film-coated tablets. THE PARALLEL PRODUCT AUTHORISATION HOLDER IS: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK. REPACKAGED BY: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK. THE MANUFACTURER IS: Bayer Pharma AG, D-51368 Leverkusen, Germany. THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovak Republic, Slovenia, Sweden, United Kingdom: AVELOX France: IZILOX Germany, Italy: AVALOX Avelox is a Bayer AG. PPA1562/158/001 Revision date: 28/07/2015 Blind or partially sighted? Is this leaflet hard to see or read? Phone LTT Pharma Limited, Tel: +44 (0)1527 505414 for help. AVELOX 400MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT • allergic reaction • increase of bilirubin Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Avelox 400mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: contains lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the Portugal._ Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 x 7 mm, and marked with “M400” on one side and “BAYER” on the other side. 4 CLINICAL PARTICULARS As per PA1410/27/1 5 PHARMACOLOGICAL PROPERTIES As per PA1410/27/1 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate. Coating: hypromellose, macrogol 4000, iron oxide (E172), titanium dioxide (E171). 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/07/2015_ _CRN 2161114_ _page number: 1_ market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Cartons containing colourless polypropylene/aluminium blisters: The film-coated tablets are available in packs of 5. 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 No special requirements. 7 MARKETING AUTHORISATION HOLDER LTT Pharma Limited Unit 18 Oxleasow Ro Soma hati kamili