ERAXIS 100 MG

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

ANIDULAFUNGIN

Доступно од:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

АТЦ код:

J02AX06

Фармацеутски облик:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Састав:

ANIDULAFUNGIN 100 MG/VIAL

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

PHARMACIA & UPJOHN COMPANY LLC, USA

Терапеутска група:

ANIDULAFUNGIN

Терапеутска област:

ANIDULAFUNGIN

Терапеутске индикације:

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years

Датум одобрења:

2013-11-30

Информативни летак

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
) ךיראת
062102.01.
תילגנאב רישכת םש
םושירה רפסמו
ERAXIS 139.84.31584
םושירה לעב םש :
מ"עב הקיטבצמרפ רזייפ
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
Candidemia and other Candida
infections (intra-abdominal
abscess, and peritonitis
)
The recommended dose is a
single 200 mg loading dose of
ERAXIS on Day 1, followed by
100 mg daily dose thereafter.
Duration of treatment should be
based on the patient’s clinical
response. In general, antifungal
therapy should continue for at
least 14 days after the last
positive culture.
TREATMENT WITH ERAXIS SHOULD BE INITIATED BY A PHYSICIAN
EXPERIENCED IN THE MANAGEMENT OF INVASIVE FUNGAL
INFECTIONS. SPECIMENS FOR FUNGAL CULTURE SHOULD BE OBTAINED
PRIOR TO THERAPY. THERAPY MAY BE INITIATED BEFORE CULTURE
RESULTS ARE KNOWN AND CAN BE ADJUSTED ACCORDINGLY ONCE
THEY ARE AVAILABLE.
Posology
A single 200 mg loading dose should be administered on Day
1, followed by 100 mg daily thereafter. Duration of treatment
should be based on the patient’s clinical response. In general,
antifungal therapy should continue for at least 14 days after
the last positive culture.
DURATION OF TREATMENT
THERE ARE INSUFFICIENT DATA TO SUPPORT THE 100 MG DOSE FOR
LONGER THAN 35 DAYS OF TREATMENT.
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
PRECAUTIONS
Anaphylactic reactions
Anaphylactic reactions, including
shock, were reported with the use
of anidulafungin. If these
reactions occur, anidulafungin
should be discontinued and
appropriate treatment
administered.
Infusion-related reactions
In

Карактеристике производа

Eraxis LPD CC 131223
1
Pfleet 2021-0070979
ERAXIS
® 100MG
_ _
1.
NAME OF THE MEDICINAL PRODUCT
100MG
®
ERAXIS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg anidulafungin.
The reconstituted solution contains 3.33 mg/mL anidulafungin and the
diluted solution contains
0.77 mg/mL anidulafungin.
Excipient with known effect: ERAXIS
®
contains 102.5 mg fructose in each vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilised solid.
The reconstituted solution has a pH of 3.5 to 5.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of invasive candidiasis in adults and paediatric patients
aged 1 month to < 18 years (see
sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ERAXIS
®
should be initiated by a physician experienced in the management of
invasive fungal infections._ _Specimens for fungal culture should be
obtained prior to therapy. Therapy
may be initiated before culture results are known and can be adjusted
accordingly once they are
available.
Posology
_Adult population (dosing and treatment duration) _
A single 200 mg loading dose should be administered on Day 1, followed
by 100 mg daily thereafter.
Duration of treatment should be based on the patient’s clinical
response. In general, antifungal therapy
should continue for at least 14 days after the last positive culture.
There are insufficient data to support the 100 mg dose for longer than
35 days of treatment.
_Patients with renal and hepatic impairment _
No dosing adjustments are required for patients with mild, moderate,
or severe hepatic impairment. No
dosing adjustments are required for patients with any degree of renal
insufficiency, including those on
dialysis. ERAXIS
®
can be given without regard to the timing of haemodialysis (see
section 5.2).
_Other special populations _
Eraxis LPD CC 131223
2
Pfleet 2021-0070979
No dosing adjustments are required for adult patients based on ge