Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
LEVOFLOXACIN AS HEMIHYDRATE
SANOFI ISRAEL LTD
J01MA12
FILM COATED TABLETS
LEVOFLOXACIN AS HEMIHYDRATE 500 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
LEVOFLOXACIN
LEVOFLOXACIN
Tavanic Tablets 500 mg is indicated in adults for the treatment of the following infections:- Acute pyelonephritis and complicated urinary tract infections - Chronic bacterial prostatitisIn the below-mentioned infections, Tavanic should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.- Acute bacterial sinusitis - Acute exacerbations of chronic obstructive pulmonary disease including bronchitis - Community-acquired pneumonia- Complicated skin and soft tissue infections.Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
2020-07-31
؟ءاودلا لامعتسإ ةيفيك .3 .بيبطلا تاميلعت بسح رضحتسملا لامعتسإ ً امئاد بجي رادقملا صوصخب ً اقثاو نكت مل اذإ يلديصلا نم وأ بيبطلا نم حاضيتسلإا كيلع .رضحتسملاب جلاعلا ةقيرطو يئاودلا رادقملا قلعتي .طقف بيبطلا لبق نم ناددحي جلاعلا ةقيرطو يئاودلا رادقملا بسح جلاعلا ةرتف ديدحت متي .مسجلا يف هناكمبو كيدل ثولتلا عونب يئاودلا .ثولتلا ةدش ريغت لاف ،يغبني امم ىوقأ وأ يغبني امم فعضأ ءاودلا ريثأت نأب ترعش اذإ .كبيبط نم كلذ نع حضوتسإ لب ،كسفن ءاقلت نم يئاودلا رادقملا ىلكلا يف لكاشم مهيدل نو ّ نسمو رابك .ضفخأ ً ايئاود ً ارادقم بيبطلا كيطعي نأ زئاجلا نم .هب ىصوملا يئاودلا رادقملا زواجت زوجي لا .نيقهارملل وأ لافطلأل ءاودلا اذه ءاطعإ زوجي لا .ءاملا نم سأك عم ءاودلا علب بجي .قحسلا زوجي لا !غضملا زوجي لا لوانت لجأ نم صرقلا هجو ىلع يذلا رطشلا طخ يف صرقلا رطش ناكملإاب .ةجاحلا دنع يئاود رادقم فصن ،ةضومحلا تاداضم ،ءايتوتلا تافاضإ ،ديدحلا صارقأ ً ايلاح لوانتت تنك اذإ تافلاركوس وأ نيزوناديد هردق ينمز لصاف كرت بجي .كيناڤات عم ةيوس ةيودلأا هذه لوانت زوجي لاف ● .كيناڤات لوانت دعب وأ لبق لقلأا ىلع نيتعاس سمشلا نم كدلج محإ نيموي ةدملو ءاودلا اذهب جلاعلا للاخ سمشلل رشابملا ضرعتلا نع عانتملإا بجي دق امم سمشلل ً اساسح رثكأ حبصي كدلج نلأ .هلوانت نع كفقوت Aqra d-dokument sħiħ
_TAVA-TABLETS-500MG-SPC-26.0 OCTOBER2022 _ 1. NAME OF THE MEDICINAL PRODUCT Tavanic Tablets 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of Tavanic 500 mg contains 500 mg of levofloxacin as active substance corresponding to 512.46 mg of levofloxacin hemihydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pale yellowish-white to reddish-white, oblong, biconvex film-coated tablets with score-line. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tavanic Tablets 500 mg is indicated in adults for the treatment of the following infections: • Acute pyelonephritis and complicated urinary tract infections • Chronic bacterial prostatitis In the below-mentioned infections, Tavanic should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. • Acute bacterial sinusitis • Acute exacerbations of chronic obstructive pulmonary disease including bronchitis • Community-acquired pneumonia • Complicated skin and soft tissue infections. Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tavanic tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Tavanic tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dosage can be used. _ _ _ _ _ _ _ _ 2 _POSOLOGY_ The following dose recommendations can be given for Tavanic: _DOSAGE IN PATIENTS WITH NORMAL RENAL FUNCTION_ (creatinine clearance> 50 Aqra d-dokument sħiħ