TAVANIC TABLETS 500 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEVOFLOXACIN AS HEMIHYDRATE

Available from:

SANOFI ISRAEL LTD

ATC code:

J01MA12

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LEVOFLOXACIN AS HEMIHYDRATE 500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic group:

LEVOFLOXACIN

Therapeutic area:

LEVOFLOXACIN

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 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.

Authorization date:

2020-07-31

Patient Information leaflet

؟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

Summary of Product characteristics

_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