MYCAMINE POWDER FOR SOLUTION FOR INFUSION 50MGVIAL

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Micafungin sodium 50.86 mg equivalent to Micafungin

Saatavilla:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ATC-koodi:

J02AX05

Annos:

50 mg/vial

Lääkemuoto:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Koostumus:

Micafungin sodium 50.86 mg equivalent to Micafungin 50 mg/vial

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

Astellas Pharma Inc.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2013-12-18

Pakkausseloste

 
MYCAMINE
®
 POWDER FOR SOLUTION FOR INFUSION 50MG/VIAL 

NAME OF THE MEDICINE 

_Active ingredient: _micafungin (as sodium) 

_Chemical structure: _

_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Chemical name:  _Sodium 5-[(1_S_,2_S_)-2-[(3_S_,6_S_,9_S_,11_R_,15_S_,18_S_,20_R_,21_R_,24_S_,25_S_,26_S_)-3- 
[(_R_)-2-carbamoyl-1-hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[(_R_)-1- 
hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[4-[5-(4-pentyloxyphenyl)- 
isoxazol-3-yl]benzoylamino]-1,4,7,13,16,22-hexaazatricyclo-[22.3.0.0
9,13
]heptacos-6-yl]-1,2-
dihydroxyethyl]-2-hydroxyphenyl sulfate 
_ _
_Molecular formula: _C
56
H
70
N
9
NaO
23
S

_CAS registry number: _208538-73-2 

DESCRIPTION 

MYCAMINE is a sterile, white, powder for solution
for infusion containing the active 
ingredient micafungin as the sodium salt. Micafungin sodium
is a light sensitive, 
hygroscopic, amorphous, white powder that is freely soluble in
water, isotonic sodium 
chloride solution, _N,N_-dimethylformamide and
dimethylsulfoxide, slightly soluble in methyl 
alcohol, and practically insoluble in acetonitrile, ethyl alcohol
(95%), acetone, diethyl ether 
and _n_-hexane. 

MYCAMINE contains the following excipients:
lactose hydrate, anhydrous citric acid, 
sodium hydroxide. 

MYCAMINE must be diluted with
either sodium chloride 0.9% or glucose 5% solution prior 
to use (see DOSAGE AND ADMINISTRATION).  

H
N
O
O
O
NH
O
N
N
O
NH
HN
O
CH
3
OH
SO
3
Na
O
OH
NH
H
OH
H
HO
H
H
2
N
O
OH
H
H
H
OH
H
H
OH
HO
H
3
C
H
N
O
O
H
3
C
O
HO
H
H
H
H
H
H

PHARMACOLOGY 

Pharmacology 

Micafungin, the active ingredient of MYCAMINE,
is a member of the echinocandin 
lipopeptide family and inhibits non-competitively the synthesis of 1,3-
β-D-glucan, an 
essential component of fungal cell walls which is not present
in mammalian cells. 

Microbiology 

Micafungin exhibits�

Valmisteyhteenveto

MYCAMINE
® POWDER FOR SOLUTION FOR INFUSION 50 MG/VIAL
NAME OF THE MEDICINE
_Active ingredient: _micafungin (as sodium)
_Chemical structure: _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Chemical name: _Sodium
5-[(1_S_,2_S_)-2-[(3_S_,6_S_,9_S_,11_R_,15_S_,18_S_,20_R_,21_R_,24_S_,25_S_,26_S_)-3-
[(_R_)-2-carbamoyl-1-hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[(_R_)-1-
hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[4-[5-(4-pentyloxyphenyl)-
isoxazol-3-yl]benzoylamino]-1,4,7,13,16,22-hexaazatricyclo-[22.3.0.0
9,13
]heptacos-6-yl]-1,2-
dihydroxyethyl]-2-hydroxyphenyl sulfate
_ _
_Molecular formula: _C
56
H
70
N
9
NaO
23
S
_CAS registry number: _208538-73-2
DESCRIPTION
Mycamine is a sterile, white powder for solution for infusion
containing the active ingredient
micafungin as the sodium salt. Micafungin sodium is a light sensitive,
hygroscopic,
amorphous, white powder that is freely soluble in water, isotonic
sodium chloride solution,
_N,N_-dimethylformamide and dimethylsulfoxide, slightly soluble in
methyl alcohol, and
practically insoluble in acetonitrile, ethyl alcohol (95%), acetone,
diethyl ether and _n_-hexane.
Mycamine contains the following excipients: lactose monohydrate,
citric acid, sodium
hydroxide.
Mycamine must be diluted with either sodium chloride 0.9% or glucose
5% solution prior to
use (see DOSAGE AND ADMINISTRATION).
PHARMACOLOGY
H
N
O
O
O
NH
O
N
N
O
NH
HN
O
CH
3
OH
SO
3
Na
O
OH
NH
H
OH
H
HO
H
H
2
N
O
OH
H
H
H
OH
H
H
OH
HO
H
3
C
H
N
O
O
H
3
C
O
HO
H
H
H
H
H
H
Pharmacology
Micafungin, the active ingredient of Mycamine, is a member of the
echinocandin lipopeptide
family and inhibits non-competitively the synthesis of
1,3-β-D-glucan, an essential
component of fungal cell walls which is not present in mammalian
cells.
Microbiology
Micafungin exhibits fungicidal activity against most _Candida _species
and prominently
inhibits actively growing hyphae of _Aspergillus_ species.
_Breakpoints _
_ _
EUCAST MIC breakpoints for micafungin [susceptible (S); resistant
(R)]:

_Candida albicans_: S ≤0.016