Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOXIFLOXACIN HCL
HEALOL PHARMACEUTICALS SDN. BHD.
MOXIFLOXACIN HCL
2 x 5tablet Tablets
Aurobindo Pharma Limited, Unit-VII (SEZ)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MOXIWAR 400 (MOXIFLOXACIN TABLETS 400MG) Moxifloxacin Hydrochloride (400mg) 1 WHAT IS IN THIS LEAFLET 1. What MOXIWAR 400 is used for 2. How MOXIWAR 400 works 3. Before you use MOXIWAR 400 4. How to use MOXIWAR 400 5. While you are using it 6. Side effects 7. Storage and Disposal of MOXIWAR 400 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS MOXIWAR 400 USED FOR MOXIWAR 400 is used to treat bacterial infections in adults (≥18 years old) caused by susceptible strains of bacteria. This medication is usually used to treat the infections listed below: • Acute sinusitis (inflammation of your sinuses). • Sudden flare ups of chronic bronchitis (inflammation of your lung airways) • Community acquired pneumonia (lung infection) • Mild to severe inflammatory pelvic disease (infections of the upper female genital tract) • Complicated skin and skin structure infections • Complicated intra- abdominal infections including abscesses HOW MOXIWAR 400 WORKS Moxifloxacin is a broad spectrum antibiotic which kills many types of bacteria. It inhibits a type of enzyme in the bacteria, stopping it from forming new bacterial cells. BEFORE YOU USE MOXIWAR 400 -When you must not use it It is important to tell your doctor before taking MOXIWAR 400 in case of hypersensitivity to moxifloxacin or other quinolone type antibiotics or any of the excipients contained in this product. The use of moxifloxacin in patients below 18 years of age is not recommended. Please seek your doctor or pharmacist’s advice before taking this medication if: • You had a history of tendon disease/ disorder with use of antibiotics. • You are pregnant or breastfeeding. • You have heart related health problems (e.g. abnormal heart beat, slow heartbeat, heart failure) • You have impaired liver function. • You have electrolyte imbalances (potassium imbalance). -Before you start to use it It is important to tell your doctor before taking MOXIWAR Les hele dokumentet
NAME OF DRUG PRODUCT : Moxifloxacin Tablets 400 mg (TRADE) NAME OF PRODUCT : MOXIWAR 400 STRENGTH : 400 mg PHARMACEUTICAL DOSAGE FORM : Film-coated Tablet. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each film-coated tablet contains Moxifloxacin Hydrochloride Ph.Eur. equivalent to Moxifloxacin 400 mg. PHARMACEUTICAL FORM: Dull red colored, modified capsule shaped film-coated tablets debossed with “E 18” on one side and plain on the other side. ROUTE OF ADMINISTRATION: Oral CLINICAL PARTICULARS: THERAPEUTIC INDICATIONS: Moxifloxacin tablets are indicated for the treatment of adults (> 18 years of age) with the following bacterial infections caused by susceptible strains: • Acute sinusitis • Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis* *MOXIWAR 400 should be only used: When Pseudomonas is considered AND patient is allergic to antipseudomonal penicillins/cephalosporins; For resistant organisms with no other alternative antibiotics available. • 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. Moxifloxacin tablets 400 mg 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. POSOLOGY AND METHOD OF ADMINISTRATION: POSOLOGY _ADULTS: _The recommended dose for Moxifloxacin is 400mg once daily (1 film-coated tablet) for the above mentioned indicati Les hele dokumentet