TAVANIC 500 MG SOLUTION FOR I.V. INFUSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEVOFLOXACIN AS HEMIHYDRATE

Available from:

SANOFI - AVENTIS ISRAEL LTD

ATC code:

J01MA12

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

LEVOFLOXACIN AS HEMIHYDRATE 5 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

LEVOFLOXACIN

Therapeutic area:

LEVOFLOXACIN

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 micro-organisms: Community- acquired pneumonia, Complicated urinary tract infections including pyelonephritis, Skin and soft tissue infections.

Authorization date:

2020-07-31

Patient Information leaflet

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
!דבלב
םירכזומ
ןאכ
קר
יתת
םיפיעסה
םהב
השענ
יוניש
תוחיטב
.
עדימ
אלמ
ןתינ
אוצמל
ןולעב
אלמה
.
תורמחהה
תושקובמה
תונמוסמ
לע
עקר
בוהצ
.
טסקט
רסוהש
ןמוסמ
וקב
םודא
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.8 UNDESIRABLE
EFFECTS
עדימ
שדח
ףסוהש
ןמוסמ
בוהצב
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
תו
תורמחהה
תושקובמה
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עקר
בוהצ
.

Summary of Product characteristics

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