VORTIMAL

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

VORICONAZOLE

Disponible des:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Codi ATC:

J02AC03

formulario farmacéutico:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

VORICONAZOLE 200 MG/VIAL

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

ANFARM HELLAS S.A., GREECE

Área terapéutica:

VORICONAZOLE

indicaciones terapéuticas:

Vortimal is a broad spectrum, triazole antifungal agent and is indicated as follows:- Treatment of invasive aspergillosis.- Treatment of candidaemia in non-neutropenic patients.- Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).- Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Vortimal should be administered primarily to immunocompromised patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients

Data d'autorització:

2022-10-31

Informació per a l'usuari

K.S. Kim International Ltd-part of S.K.-Pharma Group
Moshe Aviv Tower, Jabotinsky 7, 35
th
floor, Ramat Gan, Israel 5252007
Tel.: [phone], Fax: [phone]
www.sk-pharma.com
רבמטפס
2018
ה/אפור
ה/דבכנ
,
ה/דבכנ ת/חקור
, רישכתה :ןודנה
–
VORTIMAL
200 MG/VIAL
ORICONAZOLE
V
NFUSION
I
OLUTION FOR
S
ONCENTRATE FOR
C
OWDER FOR
P
ןוכדע לע עידוהל וננוצרב
ףדמה ייח
ןודנבש רישכתה לש
.
ל ונכדוע ףדמה ייח
-
36
.םישדוח
םינוכדע וכרענ ,ףסונב
.אפורל ןולעב
יוניש השענ םהב םיפיעסל קר תסחייתמ וז
העדוה
םושירה יאנתב יוניש וא הרמחה הווהמה
:
שגדומ טסקט
בוהצב
עמשמ
ו
חה
הרמ
.
.םיפסונ םיירונימ םינוכדע םימייק
:תרשואמה היוותהה
Vortimal is a broad spectrum, triazole antifungal agent and is
indicated as follows:
•
Treatment of invasive aspergillosis.
•
Treatment of candidaemia in non-neutropenic patients.
•
Treatment of fluconazole-resistant serious invasive Candida infections
(including C. krusei).
•
Treatment of serious fungal infections caused by Scedosporium spp. and
Fusarium spp.
Vortimal should be administered primarily to immunocompromised
patients with progressive, possibly life
threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell transplant (HSCT)
recipients
וכדעה
םינ
יתוהמה
םי
שענש
ו
ןולעב
ה אפורל
םני
:
4
.8 UNDESIRABLE EFFECTS
[…]
The most commonly reported adverse reactions were visual disturbances
impairments, pyrexia, rash,
vomiting, nausea, diarrhoea, headache, peripheral oedema, liver
function test abnormal, respiratory distress
and abdominal pain.
[…]
_Dermatological reactions _
Dermatological reactions were very common in patients treated with
voriconazole in clinical trials, but these
patients had serious underlying diseases and were receiving multiple
concomit

Fitxa tècnica

1
VORTIMAL
1.
NAME OF THE MEDICINAL PRODUCT
Vortimal
200 mg powder for solution for infusion
2.
QUALITATIVE AN
D QUANTITATIVE COMPOSITION
Each vial contains 200 mg of voriconazole.
After reconstitution each ml contains 10 mg of voriconazole. Once
reconstituted further dilution
is required before administration.
Excipient with known effect
Each vial contains 225.6 mg sodium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrated solution for infusion is a white to off white
lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vortimal is a broad spectrum, triazole antifungal agent and is
indicated as follows:
-
Treatment of invasive aspergillosis.
-
Treatment of candidaemia in non-neutropenic patients.
-
Treatment of fluconazole-resistant serious invasive
_Candida_
infections (including
_C. krusei_
).
-
Treatment of serious fungal infections caused by
_Scedosporium_
spp. and
_Fusarium_
spp.
Vortimal should be administered primarily to immunocompromised
patients with progressive,
possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell transplant
2
(HSCT) recipients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and
hypocalcaemia should be
monitored and corrected, if necessary, prior to initiation and during
voriconazole therapy (see
section 4.4).
It is recommended that Vortimal is administered at a maximum rate of 3
mg/kg per hour over 1 to
3 hours.
Treatment
_Adults _
Therapy must be initiated with the specified Intravenous loading dose
regimen of Vortimal to
achieve adequate plasma concentrations on Day 1. Intravenous treatment
should be continued for
at least 7 days before switching to oral treatment (see section 5.1).
Once the patient is clinically
improved and can tolerate medication given by mouth, the oral tablet
form or oral suspension form
of voriconazole may be utilized. On the basis of the high ora