FERINJECT iron (as ferric carboxymaltose) 100mg/2mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ferric carboxymaltose, Quantity: 360 mg (Equivalent: iron, Qty 100 mg)

Available from:

Seqirus Pty Ltd

INN (International Name):

Ferric carboxymaltose

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

1 x 2ml vial, 5 x 2ml vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FERINJECT is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,The diagnosis of iron deficiency must be based on laboratory tests.,FERINJECT is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,The diagnosis of iron deficiency anaemia must be based on laboratory tests.

Product summary:

Visual Identification: Dark brown, non-transparent, colloidal solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-04-21

Patient Information leaflet

Vifor Pharma Pty Ltd
Version 10
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

210913
Ferinject Product Information
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
-
FERINJECT
®
(FERRIC
CARBOXYMALTOSE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ferric carboxymaltose
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.
3
PHARMACEUTICAL FORM
Solution for intravenous use. 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.
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.
210913
Ferinject Product Information
Page 2 of 18
Patients should be closely monitored when large single doses of
FERINJECT (>200 mg iron)
are administered since the safety data are limited.
Post repletion, regular assessments should be done to ensure that iron
levels are corrected and
maintained.
_Ganzoni Method _
Cumulative Iron Dose = Body Weight
_kg_
x (Target Hb – Actual Hb
_g/L_
) x 0.24 + Iron Stores
_mg_
where
Target Hb = 130 g/L for body weight <35 kg and 150 g/L for bo