Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
ROXITHROMYCIN
Kleva S.A. 189 Parnithos Avenue, 13671 Acharnai, Attiki, Greece
J01FA06
ROXITHROMYCIN 150 mg
FILM-COATED TABLET
ROXITHROMYCIN 150 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-03-29
PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. ‐ Keep this leaflet. You may need to read it again. ‐ If you have further questions, please ask your doctor or your pharmacist. ‐ This medicine has been prescribed for you personally and you should not pass it on to others. It may harm, them, even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Tirabicin is and what it is used for 2. Before you take Tirabicin 3. How to take Tirabicin 4. Possible side effects 5. Storing Tirabicin 6. Further information TIRABICIN 150MG FILM COATED TABLETS ROXITHROMYCIN ‐ The active substance is: Roxithromycin 150 mg. ‐ The other ingredients are: Excipients: Hyprolose, Poloxalcol, Povidone K30, Colloidal anhydrous silica, Magnesium stearate, Talc, Maize starch, Coating: Hypromellose, Glucose anhydrous, Titanium dioxide E171, Propylene glycol. The Marketing Authorisation Holder and Manufacturing Authorisation Holder for Tirabicin is: Kleva SA 189, PArnithos Ave. 13671, Athens‐Greece. 1. WHAT TIRABICIN IS AND WHAT IT IS USED FOR Tirabicin is available as white, round, film coated tablets in PVC/aluminium blisters. Each box contains one blister strip of 10 tablets and a patient information leaflet. Tirabicin is a broad ‐spectrum antibiotic. Roxithromycin is a semisynthetic antibacterial substance. It is a macrolide antimicrobial with a broad spectrum of action against Gram‐ positive and Gram‐negative microorganisms. Tirabicin is indicated for the treatment of the following infections due to microorganisms sensitive to roxithromycin: ‐ Upper respiratory tract infections: pharyngitis and tonsillitis due to _Streptococcus _ _pyogenes_. Acute nasosinusitis due to _Streptococcus pneumonia _ _‐ _Lower respiratory tract infections: acute bacterial aggravation of chronic bronchitis due to _Haemophilus influnzae,_ _Moraxella catarrhalis_ of _Streptococcus pneumonia _and_ Chlamydia _ _pneumonia _ _‐ _Genital tract infections except gonococcal infections Baca dokumen lengkap
Page 1 of 11 S S U U M M M M A A R R Y Y O O F F P P R R O O D D U U C C T T C C H H A A R R A A C C T T E E R R I I S S T T I I C C S S 1. NAME OF THE MEDICINAL PRODUCT TIRABICIN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Roxithromycin 150 mg / tab Roxithromycin C 41 H 76 N 2 O 15 (3R, 4S, 5S, 6R, 7R, 9R, 11S, 12R, 13S, 14R) - 4- [(2,6-dideoxy-3-C, 3-O-dimethl -a-L- ribo-hexopyranosyl) oxy] -14 -ethyl -7,12,13 -trihydroxy -10 -[(E)- [(2-methoxyethoxy) methoxy] imino]- 3,5,7,9,11,13 -hexamethyl- 6-[(3,4,6 -trideoxy -3-dimethylamino -β-D- xylo- hexopyranosyl) -oxy] oxacyclo tetradecan-2-one. 3. PHARMACEUTICAL FORM Film coated tablets 4. CLINICAL PARTICULARS 4.1. INDICATIONS TIRABICIN ® is indicated for the treatment of infections due to microorganisms sensitive to roxithromycin , especially the following: • Upper respiratory tract infections: pharyngitis and tonsilitis due to Streptococcus pyogenes. Acute nasosinusitis due to Streptococcus pneumoniae. • Low respiratory tract infections: acute bacterial aggravation of chronic bronchitis due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_. For patients with respiratory tract infections, when there is suspicion for infection due to H. influenzae, empirical therapy is not recommended. Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae and Chlamydia pneumoniae. • Genital tract infections except gonococcal ones • Non-complicated skin and soft tissues infections due to Streptococcus pyogenes or Staphylococcus aureus. Abscesses usually need surgical drainage. Page 2 of 11 4.2. POSOLGY AND METHOD OF ADMINISTRATION ADMINISTRATION : For oral admi Baca dokumen lengkap