Ferinject

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ferric carboxymaltose 180mg equivalent to iron 50mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Ferric carboxymaltose 180 mg (= iron 50mg)

Dosage:

50 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Ferric carboxymaltose 180mg equivalent to iron 50mg Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Units in package:

Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 10 mL, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Vifor (International) Inc

Therapeutic indications:

Indicated for the treatment of iron deficiency when oral iron preparations are ineffective, oral preparations cannot be used or there is a clinical need to deliver iron rapidly.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 20 mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 10 mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 2 mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 10 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 2 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze.

Authorization date:

2011-09-27

Patient Information leaflet

Vifor Pharma Pty Ltd
Version 09
1
FERINJECT

_ _
FERRIC CARBOXYMALTOSE (FER-RIK CAR-BOXY-MALT-OSE) – SOLUTION FOR
INJECTION
CONSUMER MEDICINE INFORMATION
_ _
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 given 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
GIVEN FOR
FERINJECT is given 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. It is also
used when there is a clinical
need to deliver iron rapidly.
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 FERINJECT _
-
if you are hypersensitive
(allergic) to ferric
carboxymaltose or any of
the other ingredients of
FERINJECT,
-
if you have anaemia
NOT
caused by iron deficiency,
-
if you have iron overload
(too much iron in your
body) or disturbances in
utilisation of iron.
YOU MUST TELL YOUR DOCTOR IF
-
if you are under the age of
14 years.
-
you have an infection,
asthma, eczemas, allergies
or liver disorders.
-
you are pregnant or
breastfe

Summary of Product characteristics

Ferinject Datasheet NZ E14
Page
1
of
19
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
FERINJECT (ferric carboxymaltose) 50 mg/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose.
Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose.
Each 20 mL vial contains 1000 mg of iron as ferric carboxymaltose.
EXCIPIENT(S) WITH KNOWN EFFECT:
Sodium hydroxide (for pH adjustment).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
Chemical structure
The active substance of FERINJECT is a complex of polynuclear
iron(III)-hydroxide with 4(R)-
(poly-(1
→
4)-
_O_
-

-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
1461680-64-7
3
PHARMACEUTICAL FORM
Solution for injection. FERINJECT is a dark brown, non-transparent,
colloidal solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FERINJECT is indicated for the treatment of iron deficiency when
•
oral iron preparations are ineffective
•
oral iron preparations cannot be used
•
there is a clinical need to deliver iron rapidly
The diagnosis must be based on laboratory tests.
Ferinject Datasheet NZ E14
Page
2
of
19
4.2 DOSE AND METHOD OF ADMINISTRATION
DETERMINATION OF THE CUMULATIVE IRON DOSE
The cumulative dose for repletion of iron using FERINJECT is
determined based on the patient’s
body weight and Hb level and must not be exceeded. There are two
methods for determining the
cumulative dose, the Ganzoni Method and the Simplified Method. Caution
is recommended with
the Simplified Method since it is based on experience in a single
trial in adults with median Hb 104
g/L (range 61-146 g/L) and body weight ≥35 kg – See section 5.1
PHARMACODYNAMIC
PROPERTIES, Clinical trials
Patients should be closely monitored whe