Ferric carboxymaltose 50 mg iron/ml solution for injection/infusion

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Saatavilla:

Rowex Ltd Newtown Bantry, Co. Cork, , Ireland

ATC-koodi:

B03AC

INN (Kansainvälinen yleisnimi):

IRON 50 mg/ml

Lääkemuoto:

SOLUTION FOR INJECTION/INFUSION

Koostumus:

IRON 50 mg/ml

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIANEMIC PREPARATIONS

Tuoteyhteenveto:

Licence number in the source country: NOT APPLICAPABLE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-11-17

Pakkausseloste

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERRIC CARBOXYMALTOSE 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 Ferric carboxymaltose is and what it is used for
2. What you need to know before you use Ferric carboxymaltose
3. How Ferric carboxymaltose is administered
4. Possible side effects
5. How to store Ferric carboxymaltose
6. Contents of the pack and other information
1.
WHAT FERRIC CARBOXYMALTOSEIS AND WHAT IT IS USED FOR
Ferric carboxymaltose 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.
Ferric carboxymaltose 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 USE FERRIC CARBOXYMALTOSE
YOU MUST NOT RECEIVE FERRIC CARBOXYMALTOSE
•
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
Page 2 of 8
Talk to your doctor or nurse before receiving Ferric carboxymaltose:
if you have a history of medicine allergy
•
if you have systemic lupus erythema

Valmisteyhteenveto

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Ferric carboxymaltose 50 mg iron/mL dispersion for injection/infusion}
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of dispersion 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).
Excipient(s) with known effect
One mL of dispersion contains up to 5.9 mg (0.26 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
Ferric carboxymaltose} 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 Ferric carboxymaltose}.
Ferric carboxymaltose} 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 Ferric carboxymaltose} administration (see section 4.4).
Posology
The posology of Ferric carboxymaltose} 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 _
Page 2 of 12
The individual iron need for repletion using Ferric carboxymaltose} is
determined based on the
p