Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOXIFLOXACIN HCL
NOVUGEN PHARMA SDN. BHD.
MOXIFLOXACIN HCL
7 Tablets; 5 Tablets; 10 Tablets; 14 Tablets
PHARMANIAGA MANUFACTURING BERHAD
1 KINOLOX 400MG FILM COATED TABLETS Moxifloxacin (400mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Kinolox is used for 2. How Kinolox works 3. Before you use Kinolox 4. How to use Kinolox 5. While you are using it 6. Side effects 7. Storage and Disposal of Kinolox 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT KINOLOX IS USED FOR Kinolox is used in patients aged 18 years and above to treat infections caused by certain bacteria which include: • Infections of the sinuses. • Sudden worsening of long-term inflammation of the airways • Infection of the lower respiratory tract (pneumonia) acquired outside hospital. • Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and uterus mucous membrane. Kinolox is not sufficient on its own for treating this kind of infection hence another antibiotic in addition to Kinolox should be prescribed by your doctor for treatment of these infections. • Infection of the skin, soft tissue and infection occurring within the abdomen. HOW MAXIFLOXACIN WORKS Kinolox works by killing bacteria that cause infections. BEFORE YOU USE KINOLOX - _When you must not take it _ Do not take this medicine • If you have an allergy to Kinolox, other quinolone antibiotics or any of the other ingredients listed at the end of this leaflet • If you have serious adverse reactions in the past when using quinolones or fluroquinolone containing products • If you are pregnant or breast-feeding • If you are under 18 years of age • If you previously had problems with your tendons related to treatment with quinolone antibiotics • If you are born with or have - Any condition with abnormal heart rhythm (as in ECG) - Salt imbalance in the blood (especially low levels of potassium in the blood) - A very slow heart rhythm (bradycardia) - A weak heart (heart failure) - A history of abnormal heart rhythms Lesen Sie das vollständige Dokument
KINOLOX 400MG FILM COATED TABLETS NAME OF THE MEDICINAL PRODUCT Moxifloxacin 400 mg film coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 436.34 mg Moxifloxacin Hydrochloride (as monohydrate), equivalent to 400mg Moxifloxacin. PHARMACEUTICAL FORM Orange coloured, oval shaped biconvex film-coated tablet debossed with “N” on one side and “400” on other side. INDICATIONS Kinolox tablets are indicated for the treatment of adults (> 18 years of age) with the following bacterial infections caused by susceptible strains: • Acute sinusitis • Acute exacerbations of chronic bronchitis • Community acquired pneumonia • Mild to moderately severe inflammatory pelvic diseases (i.e. Infections of the upper female genital tract, including salpingitis and endometritis), without an associated tubo- ovarian or pelvic abscess. Kinolox 400 mg film-coated tablets are not recommended for monotherapy of mild to moderately severe inflammatory pelvic diseases. Preferably, they should be administered in combination with another suited antibiotic (such as cephalosporin), due to the increasing resistance of _Neisseria gonorrhoeae_ to moxifloxacin; that is, unless moxifloxacin-resistant _Neisseria gonorrhoeae_ can be ruled out. • Complicated skin and skin structure infections • Complicated intra-abdominal infections including polymicrobial infections such as abscesses Consideration should be given to official guidance on the appropriate use of antibacterial agents. DOSAGE AND METHOD OF ADMINISTRATION DOSE (ADULTS) The recommended dose for Kinolox is 400 mg once daily (1 film coated tablet) for the above- mentioned indications and should not be exceeded. DURATION OF TREATMENT The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations for the treatment of upper and lower respiratory tract infections are made: Bronchitis: acute exacerbation of chronic bronchitis: 5 days Pneumonia: community acquired pneumon Lesen Sie das vollständige Dokument