Ferinject 50mg iron/ml solution for injection/infusion (20ml vial)
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
26-06-2023
Summary of Product characteristics
(SPC)
26-06-2023
Active ingredient:
IRON
Available from:
Vifor France SA 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex, France
ATC code:
B03AC
INN (International Name):
IRON 50 mg
Pharmaceutical form:
SOLUTION FOR INJECTION/INFUSION
Composition:
IRON 50 mg
Prescription type:
POM
Therapeutic area:
ANTIANEMIC PREPARATIONS
Authorization status:
Withdrawn
Authorization date:
2010-04-09
Patient Information leaflet
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERINJECT 50 MG IRON/ML SOLUTION FOR INJECTION/INFUSION
Ferric carboxymaltose
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ferinject is and what it is used for
2.
What you need to know before you receive Ferinject
3.
How Ferinject is given
4.
Possible side effects
5.
How to store Ferinject
6.
Contents of the pack and other information
1.
WHAT FERINJECT IS AND WHAT IT IS USED FOR
Ferinject is an antianaemic preparation, a medicine that is used to
treat anaemia. It contains iron in the
form of an iron carbohydrate. 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 is involved in
many other functions necessary for maintenance of life in the human
body.
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 lack of red blood cells due to iron deficiency.
Before administration, your doctor will perform a blood test to
determine the dose of Ferinject you
require.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FERINJECT
YOU MUST NOT RECEIVE FERINJECT
-
if you are allergic (hypersensitive) to the product or any of the
other ingredients of this medicine
(listed in section 6).
-
if you have experienced seriou
Read the complete document
Summary of Product characteristics
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This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse
reactions. See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Ferinject 50 mg iron/mL solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 50 mg of iron as ferric carboxymaltose.
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 1,000 mg of iron as ferric carboxymaltose.
One mL of solution contains up to 5.5 mg (0.24 mmol) sodium, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion. Dark brown, non-transparent, aqueous
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferinject is indicated for treatment of iron deficiency when oral iron
preparations are ineffective or
cannot be used. The diagnosis of iron deficiency must be based on
laboratory tests.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following
each administration of Ferinject.
Ferinject should only be administered when staff trained to evaluate
and manage anaphylactic
reactions is immediately available, in an environment where full
resuscitation facilities can be
assured. The patient should be observed for adverse effects for at
least 30 minutes following
each Ferinject administration (see section 4.4).
Posology
The posology of Ferinject follows a stepwise approach: [1]
determination of the individual iron need,
[2] calculation and administration of the iron dose(s), and [3]
post-iron repletion assessments. These
steps are outlined below:
_Step 1: Determination of the iron need_
The individual iron need for repletion using Ferinject is determined
based on the
Read the complete document
