MYCAMINE 100 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

MICAFUNGIN AS SODIUM

Beschikbaar vanaf:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC-code:

J02AX05

farmaceutische vorm:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Samenstelling:

MICAFUNGIN AS SODIUM 100 MG

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

ASTELLAS IRELAND CO. LTD, IRELAND

Therapeutisch gebied:

MICAFUNGIN

therapeutische indicaties:

Adults, adolescents ≥ 16 years of age and elderly:- Treatment of invasive candidiasis.- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.Children (including neonates) and adolescents < 16 years of age:- Treatment of invasive candidiasis.- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.

Autorisatie datum:

2021-04-30

Bijsluiter

ראוד את
11458
:סקפ רפסמ ,ןיעה שאר
03-5366691
:ןופלט רפסמ
03-7501166
30.05.2018
,ה/דבכנ ת/חקור ה/אפור
ננוצרב
אפורל ןולעב ןוכדע לע ךעידוהל ו
MYCAMINE 50 MG POWDER FOR SOLUTION FOR INFUSION.
MYCAMINE 100 MG POWDER FOR SOLUTION FOR INFUSION
.
: ליעפ רמוח
MYCAMINE 50 MG: EACH VIAL CONTAINS 50 MG MICAFUNGIN (AS SODIUM).
MYCAMINE 100 MG: EACH VIAL CONTAINS 100 MG MICAFUNGIN (AS SODIUM). אפורל ןולעב םינוכדע ןלהל
(
ןמוסמ טסקט
קורי
ותועמשמ
ןוכדע
,
)הרמחה ותועמשמ בוהצ ןמוסמ טסקט
:
[…]
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Mycamine should be initiated by a physician experienced
in the management of fungal
infections.
Posology
Specimens for fungal culture and other relevant laboratory studies
(including histopathology) should be
obtained prior to therapy to isolate and identify causative
organism(s). Therapy may be instituted before the
results of the cultures and other laboratory studies are known.
However, once these results become available,
antifungal therapy should be adjusted accordingly.
depends on the body weight of the patient as given in the following
tables:
micafungin
The dose regimen of
[…]
should be administered for at least one week after resolution of
clinical
micafungin
_ _
:
Oesophageal candidiasis
signs and symptoms.
should be administered for at least one week after neutrophil
micafungin
infections:
_Candida _
Prophylaxis of
recovery.
[…]
_Treatment duration_
_ _
Invasive candidiasis: The treatment duration of
_Candida_
infection should be a minimum of 14 days. The
antifungal treatment should continue for at least one week after two
sequential negative blood cultures have
been obtained and
_AFTER_
resolution of clinical signs and symptoms of infection.
should be administered for at least one week after neutrophil
micafungin
infections:
_ida _
_Cand_
Prophylaxis of
recovery. Experience with Mycamine in patients less than 2 years of

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Mycamine 50 mg powder for concentrate for solution for infusion.
Mycamine 100 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycamine 50 mg: Each vial contains 50 mg micafungin (as sodium).
After reconstitution each ml contains 10 mg micafungin (as sodium).
Mycamine 100 mg: Each vial contains 100 mg micafungin (as sodium).
After reconstitution each ml contains 20 mg micafungin (as sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White compact powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycamine is indicated for:
Adults,
adolescents ≥
16 years of age and elderly:
-
Treatment of invasive candidiasis.
-
Treatment of oesophageal candidiasis in patients for whom intravenous
therapy is appropriate.
-
Prophylaxis of _Candida_ infection in patients undergoing allogeneic
haematopoietic stem cell
transplantation.
Children (including neonates) and adolescents < 16 years of age:
-
Treatment of invasive candidiasis.
-
Prophylaxis of _Candida_ infection in patients undergoing allogeneic
haematopoietic stem cell
transplantation.
The decision to use Mycamine should take into account a potential risk
for the development of liver
tumours (see section 4.4). Mycamine should therefore only be used if
other antifungals are not
appropriate.
CONSIDERATION SHOULD BE GIVEN TO OFFICIAL/NATIONAL GUIDANCE ON THE
APPROPRIATE USE OF ANTIFUNGAL
AGENTS.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Mycamine should be initiated by a physician experienced
in the management of fungal
infections.
2
Posology
Specimens for fungal culture and other relevant laboratory studies
(including histopathology) should
be obtained prior to therapy to isolate and identify causative
organism(s). Therapy may be instituted
before the results of the cultures and other laboratory studies are
known. However, once these results
become available, antifungal therapy should be ad