Anidulafungine Sandoz 100 mg, poeder voor concentraat voor oplossing voor infusie

Nchi: Uholanzi

Lugha: Kiholanzi

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

Viambatanisho vya kazi:

ANIDULAFUNGINE

Inapatikana kutoka:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC kanuni:

J02AX06

INN (Jina la Kimataifa):

ANIDULAFUNGINE

Dawa fomu:

Poeder voor concentraat voor oplossing voor infusie

Tungo:

FRUCTOSE (D-) ; MANNITOL (D-) (E 421) ; MELKZUUR (L-,+ VORM) (E 270) ; NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 80 (E 433) ; STIKSTOF (HEAD SPACE) (E 941) ; ZOUTZUUR (E 507)

Njia ya uendeshaji:

Intraveneus gebruik

Eneo la matibabu:

Anidulafungin

Idhini ya tarehe:

2019-01-02

Taarifa za kipeperushi

Sandoz B.V.
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Anidulafungine Sandoz
®
100 mg, poeder voor concentraat voor oplossing voor infusie
RVG 120340
1311-v5
1.3.1.3 Bijsluiter
September 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANIDULAFUNGINE SANDOZ
® 100 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR 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 or pharmacist or
nurse.
-
If you or your child get any side effects, talk to your doctor or
pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What [Nationally completed name] is and what it is used for
2. What you need to know before you or your child use [Nationally
completed name]
3. How to use [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
_ _
[Nationally completed name] 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.
[Nationally completed name] belongs to a group of medicines called
echinocandins. These medicines
are used to treat serious fungal infections.
[Nationally completed name] prevents normal development of fungal cell
walls. In the presence of
[Nationally completed name], 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 [NATIONALLY
COMPLETED NAME]
_ _
DO NOT USE [NATIONALLY COMPLETED NAME]
- if you are allergic to anidulafungin, other echinocandins (e.g.
caspofungin acetate), or any o

Tabia za bidhaa

Sandoz B.V.
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Anidulafungine Sandoz 100 mg, poeder voor
1311-v4
concentraat voor oplossing voor infusie
RVG 120340
1.3.1.1 Samenvatting van de Productkenmerken
September 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anidulafungine Sandoz 100 mg, poeder voor concentraat voor oplossing
voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg anidulafungin. The reconstituted concentrate
for solution for infusion
contains 3.33 mg/mL anidulafungin and the diluted solution for
infusion contains 0.77 mg/mL
anidulafungin.
Excipient with known effect
Each vial contains 100 mg of fructose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white cake or powder.
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 [Nationally completed name] 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.
Sandoz B.V.
Page 1/14
Anidulafungine Sandoz 100 mg, poeder voor
1311-v4
concentraat voor oplossing voor infusie
RVG 120340
1.3.1.1 Samenvatting van de Productkenmerken
September 2020
_Patients with renal and hepatic impa