TAVANIC 500 MG SOLUTION FOR I.V. INFUSION

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

LEVOFLOXACIN AS HEMIHYDRATE

Disponible des:

SANOFI - AVENTIS ISRAEL LTD

Codi ATC:

J01MA12

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

LEVOFLOXACIN AS HEMIHYDRATE 5 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Grupo terapéutico:

LEVOFLOXACIN

Área terapéutica:

LEVOFLOXACIN

indicaciones terapéuticas:

In adults for whom intravenous therapy is considered to be appropriate, Tavanic solution for infusion is indicated for the treatment of the following infections when due to levofloxacin - susceptible micro-organisms: Community- acquired pneumonia, Complicated urinary tract infections including pyelonephritis, Skin and soft tissue infections.

Data d'autorització:

2020-07-31

Informació per a l'usuari

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
11.2014
םש
רישכת
:תילגנאב
IV 500 MG TAVANIC
רפסמ
:םושיר
1194329962
םש
לעב
םושירה
SANOFI AVENTIS ISRAEL LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
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םירכזומ
ןאכ
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יתת
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תוחיטב
.
עדימ
אלמ
ןתינ
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ןולעב
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.
תורמחהה
תושקובמה
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לע
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טסקט
רסוהש
ןמוסמ
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םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.8 UNDESIRABLE
EFFECTS
עדימ
שדח
ףסוהש
ןמוסמ
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עדימל ,
אלמ
ףיעסב
הז
שי
ןייעל
ןולעב
:
…….
Eye disorders
Rare ( ≥ 1/10000 to < 1/1000(
Visual disturbances such as blurred vision (see section 4.4)
Not Known:
Transient vision loss (see section 4.4)
Uveitis
……..
ב"צמ
ובש ,ןולעה
נמוסמ
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Fitxa tècnica

1
1.
NAME OF THE MEDICINAL PRODUCT
TAVANIC
500 MG SOLUTION FOR I.V. INFUSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution for infusion contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
Excipients with known effect:
100 ml of solution for infusion contains 15.8 mmol of sodium, which is
363 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear greenish-yellow isotonic solution
with pH of 4.3 to 5.3 and osmolarity of 282-322
mOsm/litre.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults for whom intravenous therapy is considered to be
appropriate, Tavanic solution for infusion
is indicated for the treatment of the following infections when due to
levofloxacin-susceptible
microorganisms:
• Community-acquired pneumonia.
• Complicated urinary tract infections including pyelonephritis.
• Skin and soft tissue infections.
Before prescribing Tavanic, consideration should be given to national
and/or local guidance on the
appropriate use of fluoroquinolones.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tavanic solution for infusion is administered by slow intravenous
infusion once or twice daily. The
dosage depends on the type and severity of the infection and the
susceptibility of the presumed
causative pathogen. Treatment with Tavanic after initial use of the
intravenous preparation may be
completed with an appropriate oral presentation according to the SPC
for the film-coated tablets and
2
as considered appropriate for the individual patient. Given the
bioequivalence of the parenteral and
oral forms, the same dosage can be used.
Posology
The following dose recommendations can be given for Tavanic:
_Dosage in patients with normal renal function (creatinine clearance
>_
_50 ml/min) _
INDICATION
DAILY DOSE REGIMEN
_(according to severity) _
TOTAL DURATION OF
TREATMENT
1
_(according to severity) _
Community-acquired pneumonia
500 mg once or twice daily
7 - 14 days
Pyelonephritis
500 mg once daily
7 - 10 days
Complicated ur