情報リーフレット
CONSUMER MEDICINE INFORMATION
FERINJECT
®
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about FERINJECT. It does not contain
all the available information. This does not replace talking with your doctor.
All medicines have risks and benefits. Your doctor has weighed the risks of using
FERINJECT against the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IS FERINJECT
FERINJECT is an intravenous iron preparation, a medicine that is used in the
treatment of iron deficiency conditions. It contains iron in the form of ferric
carboxymaltose, an iron carbohydrate compound. Iron is an essential element
required for the oxygen-carrying capacity of haemoglobin in red blood cells and of
myoglobin in muscle tissue. Moreover, iron plays an important role in many other vital
processes in the human body.
WHAT FERINJECT IS USED FOR
FERINJECT is used for the treatment of patients with iron deficiency, when oral iron
preparations are ineffective or cannot be used. The aim of the therapy is to replenish
body iron stores and to remedy anaemia, a reduced level of haemoglobin due to iron
deficiency.
Before administration, your doctor will perform a blood test to calculate the dose of
FERINJECT you require.
BEFORE YOU ARE GIVEN FERINJECT
WHEN YOU MUST NOT BE GIVEN IT
- if you are hypersensitive (allergic) to ferric carboxymaltose or any of the other
ingredients of FERINJECT,
- if you have ana
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製品の特徴
FERINJECT
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PRODUCT INFORMATION AU E07
PRODUCT INFORMATION
FERINJECT
®
NAME OF THE MEDICINE
FERINJECT
Ferric carboxymaltose
Chemical structure
The active substance of FERINJECT is a complex of polynuclear iron(III)-hydroxide with
4(R)-(poly-(1→4)-_O_-α-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate.
The relative molecular weight is approximately 150,000 Da, corresponding to the
empirical formula:
[FeO
x
(OH)
y
(H
2
O)
z
]
n
[{(C
6
H
10
O
5
)
m
(C
6
H
12
O
7
)}
l
]
k
, where n ≈ 10
3
, m ≈ 8, l ≈ 11, and k ≈ 4.
CAS-Number
9007-72-1
DESCRIPTION
Solution for intravenous use. FERINJECT is a dark brown, non-transparent, colloidal
solution.
Excipients
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections
PHARMACOLOGY
Pharmacodynamic properties
Ferric carboxymaltose (FCM) solution for injection/infusion contains iron in a stable ferric
state as a complex with a carbohydrate polymer designed to provide iron for the iron
transport and storage proteins in the body (transferrin and ferritin). FCM was effective in
increasing haemoglobin (Hb) and serum ferritin concentrations in patients with mild to
moderate iron-deficiency anaemia. The intravenous (IV) iron dose was 500 mg weekly for
up to 4 weeks (n=20) or 1,000 mg weekly for up to 2 weeks (n=26). With the 500 mg iron
dose, 37% of patients achieved normal Hb levels within 8 weeks and 75% achieved a
≥20 g/L increase in Hb on at least one occasion. With 1,000 mg iron, 48% of patients
achieved normal Hb levels within 6 weeks and 73% achieved a
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