Mycamine

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Micafungin 100mg

থেকে পাওয়া:

Seqirus (NZ) Ltd

INN (International Name):

Micafungin 100 mg

ডোজ:

100 mg

ফার্মাসিউটিকাল ফর্ম:

Powder for injection

রচনা:

Active: Micafungin 100mg Excipient: Citric acid Lactose Nitrogen Sodium hydroxide

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Astellas Pharma Tech Co Limited

থেরাপিউটিক ইঙ্গিত:

Treatment of invasive candidiasis in children & adults Treatment of oesophageal candidiasis in adults, adolescents NLT 16 yrs of age, and elderly patients for whom intravenous therapy is appropriate Prophylaxis of Candida infection in children and adult patients undergoing allogenic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count below 500 cells per microliter) for 10 or more days

পণ্য সারাংশ:

Package - Contents - Shelf Life: Vial, glass, 1 x - 100 mg - 3 years from date of manufacture stored at or below 25°C 48 hours reconstituted stored at or below 25°C 96 hours diluted stored at or below 25°C protect from light - Vial, glass, 10 x - 1000 mg - 3 years from date of manufacture stored at or below 25°C 48 hours reconstituted stored at or below 25°C 96 hours diluted stored at or below 25°C protect from light

অনুমোদন তারিখ:

2013-11-14

তথ্য লিফলেট

Mycamine

MYCAMINE

_ _
_Micafungin (as sodium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mycamine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you having Mycamine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT MYCAMINE IS USED
FOR
This medicine is used to treat:
_ _
•
adults, adolescents and children
who have a serious fungal
infection called invasive
candidiasis (an infection caused
by a yeast called
_Candida_
that
has penetrated the body)
•
adults and adolescents ≥
16 years of age who have a
fungal infection in the food pipe
(oesophagus) where treatment
into a vein is appropriate
•
adults, adolescents and children
who are at risk of developing a
_Candida_
(yeast) infection while
undergoing a certain type of
stem cell transplant or if you are
expected to have white blood
cell counts below a certain level.
This medicine belongs to a group
of medicines called echinocandins
which are used to treat infections
caused by fungal or yeast cells
called Candida.
It works by interfering with the
production of a part of the fungal
cell wall making the fungus unable
to live and grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason
.
BEFORE YOU ARE GIVEN
MYCAMINE
_WHEN YOU MUST NOT HAVE IT _
DO NOT HAVE MYCAMINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
micafungin
•
any of the ingredients listed at
the end of this leaflet
•
any other medicines belonging
to the echinocandin group.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or ot

পণ্য বৈশিষ্ট্য

1
DATA SHEET
MYCAMINE
® 50 MG AND 100 MG POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
MYCAMINE
®
50 mg powder for injection
MYCAMINE
®
100 mg powder for injection
_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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MYCAMINE is a sterile, white, powder for injection 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.
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
2
MYCAMINE must be diluted with either sodium chloride 0.9% or glucose
5% solution prior to
use (see DOSAGE AND ADMINISTRATION).
3.
PHARMACEUTICAL FORM
MYCAMINE 50 mg is a white-coloured powder for injection, containing
50.86 mg micafungin
sodium, corresponding to 50 mg micafungin.
MYCAMINE 100 mg is a white-coloured powder for injection, containing
101.73 mg
micafungin sodium, corresponding to 100 mg micafungin.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
MYCAMINE is indicated for:

Treatment of invasive candidiasis in children and adults

Treatment of oesophageal candidiasis in adults, adolescents ≥ 16
years