Orrakrutt 100 mg, poeder voor concentraat voor oplossing voor intraveneuze infusie

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Thành phần hoạt chất:

ANIDULAFUNGINE 0-WATER, FRUCTOSE VRIJ

Sẵn có từ:

Sigillata Limited Block A, 15 Castleforbes Square, Sheriff Street DUBLIN 1 (IERLAND)

Mã ATC:

J02AX06

INN (Tên quốc tế):

ANIDULAFUNGINE 0-WATER, FRUCTOSE FREE

Dạng dược phẩm:

Poeder voor concentraat voor oplossing voor infusie

Thành phần:

NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 80 (E 433) ; SACCHAROSE ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZOUTZUUR (E 507),

Tuyến hành chính:

Intraveneus gebruik

Khu trị liệu:

Anidulafungin

Tóm tắt sản phẩm:

Hulpstoffen: NATRIUMHYDROXIDE (E 524); POLYSORBAAT 80 (E 433); SACCHAROSE; WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZOUTZUUR (E 507);

Ngày ủy quyền:

2018-05-30

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ORRAKRUTT 100 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR
INTRAVENEUZE INFUSIE
Anidulafungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Orrakrutt is and what it is used for
2.
What you need to know before you or your child use Orrakrutt
3.
How to use Orrakrutt
4.
Possible side effects
5.
How to store Orrakrutt
6.
Contents of the pack and other information
1.
WHAT ORRAKRUTT IS AND WHAT IT IS USED FOR
Orrakrutt contains the active substance anidulafungin and is
prescribed in adults and in paediatric
patients aged 1 month to less than 18 years to treat a type of fungal
infection of the blood or other
internal organs called invasive candidiasis. The infection is caused
by fungal cells (yeasts) called
_Candida_
.
Orrakrutt belongs to a group of medicines called echinocandins. These
medicines are used to treat
serious fungal infections.
Orrakrutt prevents normal development of fungal cell walls. In the
presence of Orrakrutt, fungal cells
have incomplete or defective cell walls, making them fragile or unable
to grow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD USE ORRAKRUTT
DO NOT USE ORRAKRUTT:
-
if you are allergic to anidulafungin, other echinocandins (e.g.
caspofungin acetate), or any of the
other ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Orrakrutt.
Your doctor may decide to monitor you
-
for liver function more closely if you develop liver problems during
your treatment.
-
if you are given anaesthetics during your treatment with Orrakrutt.
-
for signs of an al

Đặc tính sản phẩm

1
1.
NAME OF THE MEDICINAL PRODUCT
Orrakrutt 100 mg, poeder voor concentraat voor oplossing voor
intraveneuze infusie
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off white powder, free of visible evidence of contamination
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 Orrakrutt should be initiated by a physician
experienced in the management of
invasive fungal infections.
Posology
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.
_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. Orrakrutt can be given without regard to the timing of
haemodialysis (see section 5.2).
_Other special populations_
No dosing adjustments are required for adult patients based on gender,
weight, ethnicity, HIV
positivity, or elderly (see section 5.2).
_ _
_ _
_Paediatric p