Država: Malta
Jezik: angleščina
Source: Medicines Authority
LEVOFLOXACIN
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
J01MA12
LEVOFLOXACIN 500 mg
FILM-COATED TABLET
LEVOFLOXACIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2011-05-23
P R O P O S E D M O C K U P A he a lth y d e ci si o n S a nd o z Lt d , 3 7 W o o lm e r W a y, B o rd o n, H a m p sh ir e ,G U 3 5 9 Q E , U ni te d K in g d o m . T: 0 1 4 2 0 4 7 8 3 0 1 F: 0 1 4 2 0 4 7 4 4 2 7 W : w w w .u k. sa nd o z. co m E : sa nd o za rt w o rk 2 @ b tc o nn e ct .c o m A RT W O RK P RO O F B O X R e f: Pr o o f no . R A A p p ro ve d ? C o lo ur s: D im e ns io ns : D a te p re p a re d : D a te a p p ro ve d : Pr e p a re d b y: A p p ro ve d b y: Fo nt s: 1 0 9 / 0 7 / 2 0 0 9 D W 0 9 / 0 7 / 2 0 0 9 R T Y e s Li ce nc e a p p lic a tio n B la ck B la ck 2 0 % 1 6 5 x 3 7 5 m m H e lv e ti c a Fo nt si ze : 7 p t A rt w o rk / R A C he ck lis t: Pr o d uc tn a m e S tr e ng th / d o sa g e PL nu m b e r S to ra g e Pa ck si ze W a rn in g s E xc ip ie nt s B ra ill e • Levofloxacin belongs to a group of medicinal products called antibacterial agents of the quinolone class. It inhibits bacterial growth by affecting the bacterial enzyme system. • Levofloxacin is used to treat mild to moderate infections in adults caused by bacteria sensitive to levofloxacin. Leofloxacin may be used to treat the following: - Acute infection of the sinuses - Acute aggravation of chronic bronchitis (inflammation of the bronchial mucous) - Pneumonia (community-acquired) - Complicated urinary tract infections including pyelonephritis (bacterial infection of the renal pelvis and tissue) - Chronic infection of the prostate caused by bacteria - Skin and tissue infection Your doctor may have prescribed a different use. You should always follow your doctor’s instructions. DO NOT TAKE LEVOFLOXACIN TABLETS if you: • are allergic (hypersensitive) to levofloxacin, other antibacterial agents of the quinolone class or any of the other ingredients of Levofloxacin Tablets. • suffer from epilepsy. • have had a history of tendon problems from using this type of medicine Preberite celoten dokument
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levofloxacin 500 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains levofloxacin hemihydrate equivalent to 500 mg levofloxacin. Excipient(s): Contains 26.54 mg lactose monohydrate._ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Light orange-pink, octagonal, biconvex film-coated tablet, with a score line on one side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults with infections of mild or moderate severity, levofloxacin is indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms: - Acute bacterial sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections, and when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection or when these have failed to resolve the infection) - Acute bacterial exacerbations of chronic bronchitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections, and when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection or when these have failed to resolve the infection) - Community-acquired pneumonia (when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection) - Complicated urinary tract infections including pyelonephritis Preberite celoten dokument