Ferinject 50 mg iron/mL dispersion for injection/infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-04-2023
Summary of Product characteristics
(SPC)
08-06-2023
Active ingredient:
IRON CARBOXYMALTOSE
Available from:
Vifor France
ATC code:
B03AC
INN (International Name):
IRON CARBOXYMALTOSE
Dosage:
50 iron milligram(s)/millilitre
Pharmaceutical form:
Dispersion for injection/infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Iron, parenteral preparations
Authorization status:
Marketed
Authorization date:
2008-04-11
Patient Information leaflet
230210_PIL-YV007/YV080/YV013/MR/E34 T IE03
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERINJECT 50 MG IRON/ML DISPERSION FOR INJECTION/INFUSION
Ferric carboxymaltose
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 administered
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 a medicine that contains iron.
Medicines that contain iron are used when you do not have enough iron
in your body. This is called
iron deficiency.
Ferinject is used to treat iron deficiency when:
–
oral iron is not effective enough.
–
you cannot tolerate oral iron.
–
your doctor decides you need iron very quickly to build up your iron
stores.
The doctor will determine whether you have iron deficiency by
performing a blood test.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FERINJECT
YOU MUST NOT RECEIVE FERINJECT
–
if you are allergic (hypersensitive) to ferric carboxymaltose or any
of the other ingredients of this
medicine (listed in section 6).
–
if you have experienced serious allergic (hypersensitive) reactions to
other injectable iron
preparations.
–
if you have anaemia
NOT
caused by iron deficiency.
–
if you have an iron overload (too much iron in your body) or
disturbances in the utilisation of iron.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Ferinject:
–
if you have a history of medicine allergy.
–
if you have systemic lupus erythematosus.
–
if you have rheumatoid arthritis.
–
if you have severe asthma, eczema or other alle
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
08 June 2023
CRN00DLXR
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferinject 50 mg iron/mL dispersion for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of dispersion contains ferric carboxymaltose corresponding to
50 mg iron.
Each 2 mL vial contains ferric carboxymaltose corresponding to 100 mg
iron.
Each 10 mL vial contains ferric carboxymaltose corresponding to 500 mg
iron.
Each 20 mL vial contains ferric carboxymaltose corresponding to 1,000
mg iron.
Excipient(s) with known effect
One mL of dispersion 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
Dispersion for injection/infusion. Dark brown, non-transparent,
aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ferinject is indicated for the treatment of iron deficiency when (see
section 5.1):
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.
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 patient's body
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