TAVANIC TABLETS 500 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

LEVOFLOXACIN AS HEMIHYDRATE

Dostupné z:

SANOFI ISRAEL LTD

ATC kód:

J01MA12

Forma lieku:

FILM COATED TABLETS

Zloženie:

LEVOFLOXACIN AS HEMIHYDRATE 500 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

SANOFI WINTHROP INDUSTRIE, FRANCE

Terapeutické skupiny:

LEVOFLOXACIN

Terapeutické oblasti:

LEVOFLOXACIN

Terapeutické indikácie:

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.

Dátum Autorizácia:

2020-07-31

Príbalový leták

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كفقوت

Súhrn charakteristických

_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