FERINJECT 50MG IRON/ML SOLUTION FOR INJECTION/INFUSION

Active substance: FERRIC CARBOXYMALTOSE

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Ferinject 50 mg iron/mL solution for injection/infusion
Ferric carboxymaltose
to addition   This medicine is subject allow quick
al monitoring. This will
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.   hat Ferinject is and what it is
W
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.   hat you need to know before
W
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 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 allergies
– if you have an infection
– if you have liver disorders
– Ferinject should not be given to children under 14 years.
– Incorrect administration of Ferinject
may cause leakage of the product at
the injection site, which may lead to

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irritation of the skin and potentially
long lasting brown discolouration at
the site of injection. The administration
must be stopped immediately when
this occurs.
How Ferinject is given
Your doctor or nurse will administer Ferinject undiluted by injection, during dialysis, or diluted by drip infusion. Ferinject
will be administered in a structure where
immunoallergic events can receive
appropriate and prompt treatment.
You will be observed for at least 30 minutes by your doctor or nurse after each
administration.
Other medicines and Ferinject
Tell your doctor if you are using, have
recently used or might use any other
medicines, including medicines obtained
without prescription. If Ferinject is given
together with oral iron preparations, then
these oral preparations could be less efficient.
Pregnancy
Ferinject has not been tested in pregnant
women. It is important to tell your doctor
if you are pregnant, think you may be
pregnant, or are planning to have a baby.
If you become pregnant during treatment,
you must ask your doctor for advice. Your
doctor will decide whether or not you
should be given this medicine.
Breast feeding
If you are breast-feeding, ask your doctor
for advice before you are given Ferinject.
It is unlikely that Ferinject represents a
risk to the nursing child.
Driving and using machines
Ferinject is unlikely to impair the ability to
drive or operate machines.
Important information about some of the
ingredients of Ferinject
This medicinal product contains
0.24  mmol (or 5.5 mg) sodium per millilitre
of undiluted solution. This has to be taken
into account by patients on a sodiumcontrolled diet.

3.   ow Ferinject is administered
H

Your doctor can administer Ferinject by
three possible routes: undiluted by injection, during dialysis, or diluted by infusion.
– By injection, you may receive up to
20   L of Ferinject, corresponding to
m
1,000 mg of iron, once a week directly
into the vein.
– If you are on dialysis, you may receive
Ferinject during a haemodialysis session via the dialyser.
– By infusion, you may receive up to
20   L of Ferinject, corresponding to
m
1,000 mg of iron, once a week directly
into the vein. Because Ferinject is
diluted with sodium chloride solution
for the infusion, it may have a volume of
up to 250 mL and appear as a brown
solution.
If you receive more Ferinject than you
should
Your doctor will take responsibility for
determining the appropriate dose and
choosing the route, frequency and duration of your treatment.
Overdose can cause accumulation of
iron in storage sites. Your doctor will
monitor iron parameters such as serum
ferritin and transferrin to avoid iron accumulation.

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LD-Pf323-07
Min. Fontsize: 11 pt
Version 02
Dimensions: 148 x 420 mm
UK
Art.-Nrn. 620601/620602
620642/620643
620734

Package leaflet: Information for the patient

4.  Possible side effects

Like all medicines, this medicine can
cause side effects, although not everybody gets them.
Serious side effects:
Tell your doctor immediately if you experience any of the following signs and
symptoms that may indicate a serious
allergic reaction: Rash (e. g. hives), itching, difficulty breathing, wheezing and/or
swelling of the lips, tongue, throat or
body.

Website:
www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.
mt
By reporting side effects you can help
provide more information on the safety of
this medicine.

5.  How to store Ferinject

Keep Ferinject out of the sight and reach
of children.

In some patients these allergic reactions
(affecting less than 1 in 1,000 people) may
become severe or life-threatening
(known as anaphylactoid reactions) and
can be associated with heart and circulation problems and loss of consciousness.
Your doctor is aware of these possible
side effects and will monitor you during
and after the administration of Ferinject.

Do not use Ferinject after the expiry date
which is stated on the label. The expiry
date refers to the last day of that month.

Other side effects that you should tell
your doctor about if they become
serious:
Common side effects (may affect up to 1
in 10 people): headache, dizziness, high
blood pressure, nausea and injection site
reactions (also see section 2).

Ferinject will normally be stored for you
by your doctor or the hospital.

Uncommon side effects (may affect up to
1 in 100 people): numbness, tingling or
prickling sensation on the skin, a change
in your taste sensation, high heart rate,
low blood pressure, redness in the face,
difficulty breathing, vomiting, indigestion,
stomach pain, constipation, diahorrea,
itching, hives, redness of the skin, rash,
muscle-, joint -and/or back pain, muscle
spasms, fever, tiredness, chest pain,
swelling of the hands and/or the feet, and
chills.

Rare side effects (may affect up to 1 in
1,000 people): inflammation of a vein,
shivering and a general feeling of discomfort, loss of consciousness, anxiety,
fainting, feeling faint, wheeze, excessive
wind (flatulence), rapid swelling of the
deep layers of the skin, paleness and
swelling of the face.
Some blood parameters may change
temporarily, which could be detected in
laboratory tests.
The following changes in blood parameters are common: decrease in blood
phosphorus and increase of a certain
liver enzyme called alanine aminotransferase.
The following changes in blood parameters are uncommon: increase in certain
liver enzymes called aspartate aminotransferase, gamma-glutamyltransferase
and alkaline phosphatase, and increase
in an enzyme called lactate dehydrogenase.
Ask your doctor for more information.
Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly
via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira

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Store in the original package. Do not
store above 30 °C. Do not freeze.
Once the Ferinject vials have been
opened, they should be used immediately. After dilution with sodium chloride
solution, the diluted solution should be
used immediately.

6.   ontents of the pack and other
C
information

What Ferinject contains
The active substance is iron (as ferric
carboxymaltose, an iron carbohydrate
compound). The concentration of iron
present in the product is 50 mg per milli­
litre. The other ingredients are sodium
hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and
water for injection.
What Ferinject looks like and contents
of the pack
Ferinject is a dark brown, non-transparent solution for injection/infusion.
Ferinject is supplied in glass vials containing:
– 2 ml solution corresponding to 100 mg
iron. Available in pack sizes of 1, 2 and
5 vials
– 10 ml solution corresponding to 500 mg
iron. Available in pack sizes of 1, 2 and
5 vials
– 20 ml solution corresponding to 1,000
mg iron. Available in a pack size of 1
vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Vifor France SA
7–13, Bd Paul Emile Victor
92200 Neuilly-sur-Seine
France
Tel. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
e-mail: contact-fr@viforpharma.com
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovak Republic, Spain, Sweden, United Kingdom: Ferinject. Belgium,
Luxembourg: Injectafer. Slovenia: Iroprem.
This leaflet was last revised in
October 2013.
For any information about this medicine,
please contact the local representative
of the Marketing Authorisation Holder.
Vifor Pharma UK Limited
The Old Stables, Bagshot Park · Bagshot
Surrey GU19 5PJ UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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