CRESEMBA 200 MG IV

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ISAVUCONAZOLE AS SULFATE

Fáanlegur frá:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC númer:

J05AC05

Lyfjaform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Samsetning:

ISAVUCONAZOLE AS SULFATE 200 MG

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

ALMAC PHARMA SERVICES LIMITED, UK

Lækningarsvæði:

ISAVUCONAZOLE

Ábendingar:

Cresemba is indicated in adults for the treatment of: Invasive aspergillosis Mucormycosis in patients for whom amphotericin B is inappropriate

Leyfisdagur:

2019-04-11

Upplýsingar fylgiseðill

רזייפ
יפ
ףא
יא
הקיטבצמרפ
לארשי
עב
"
מ
חר
'
רקנש
9
,
ת
.
ד
.
12133
הילצרה
חותיפ
,
לארשי
46725
לט
:
972-9-9700500
סקפ
:
972-9-9700501
יאמ
2019
,ה/דבכנ ת/חקור ,ה/אפור
ונא
םידבכתמ
ךעידוהל
לש קוויש תליחת לע
:שדח רישכת
CRESEMBA 200 MG IV הבמסרק
200
ידירו ךות ג"מ
:תרשואמ היוותה
Cresemba is indicated in adults for the treatment of:
Invasive aspergillosis
Mucormycosis in patients for whom amphotericin B is inappropriate
קזוח
:
Isavuconazole ( As Sulfate ) 200 Mg
:ןונימ תרוצ
Powder For Concentrate For Solution For Infusion :הזירא לדוג
1 vial
:ןרצי
ALMAC PHARMA SERVICES LIMITED, UK
SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, BT63 5UA, UK
:קוושמ
Pfizer PFE Pharmaceuticals Israel Ltd. 9 Shenkar St., Herzliya
Pituach, 46725
הל ןתינ רישכתה תא הנמזה עוציב תועצמאב גיש
מ
גולובונ ספוט תאצמהב
29
'ג .
אפורל ןולעה
ןכרצל ןולע תנוכתמב
חלשנ
תופורתה רגאמב םמוסרפ ךרוצל תואירבה
דרשמל
:תואירבה דרשמ רתאבש
http://www.health.gov.il/units/pharmacy/trufot/index.asp
.
רזייפ :תרבחל תונפל ןתינ ספדומ אלמ ןולע
תלבקל ,ןיפוליחל
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
'חר
רקנש
9
.ד.ת ,
12133
,
,חותיפ הילצרה
46725
,בר דובכב
ידובע לטרוא
הנוממ תחקור

Vara einkenni

Cresemba 200 mg IV, LPD, Israel CC 06 Mar 2023
1
2022-0080678
1.
NAME OF THE MEDICINAL PRODUCT
CRESEMBA
®
200 mg IV
Powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium
sulfate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White to yellow cake
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CRESEMBA
®
is indicated in adults for the treatment of
•
invasive aspergillosis
•
mucormycosis in patients for whom amphotericin B is inappropriate (see
sections 4.4 and 5.1)
Consideration should be given to official guidance on the appropriate
use of antifungal agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Loading dose _
_ _
The recommended loading dose is one vial after reconstitution and
dilution (equivalent to 200 mg of
isavuconazole) every 8 hours for the first 48 hours (6 administrations
in total).
_Maintenance dose _
_ _
The recommended maintenance dose is one vial after reconstitution and
dilution (equivalent to 200 mg
of isavuconazole) once daily, starting 12 to 24 hours after the last
loading dose.
Duration of therapy should be determined by the clinical response (see
section 5.1).
For long-term treatment beyond 6 months, the benefit-risk balance
should be carefully considered (see
sections 5.1 and 5.3).
_Switch to oral isavuconazole _
_ _
CRESEMBA
®
is also available as hard capsules containing 100 mg isavuconazole,
equivalent to 186
mg isavuconazonium sulfate.
On the basis of the high oral bioavailability (98%, see section 5.2),
switching between intravenous and
oral administration is appropriate when clinically indicated.
Cresemba 200 mg IV, LPD, Israel CC 09 Feb 2022
2022-0080678
2
_Elderly _
_ _
No dose adjustment is necessary for elderly patients; however, the
clinical experience in elderly
patients is limited.
_Renal impairment _
_ _
No dose adjustment is necessary in patients with renal impairment,
in