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DIAFER 50 MG/ML SOLUTION FOR INJECTION

Active substance(s): IRON (III) ISOMALTOSIDE 1000

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Package leaflet: Information for the user

Diafer® 50 mg/ml solution for injection
Iron
Read all of this leaflet carefully before you start using 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.
In this leaflet:
1.
What Diafer is and what it is used for
2.
What you need to know before you use Diafer
3.
How to use Diafer
4.
Possible side effects
5.
How to store Diafer
6.
Contents of the pack and other information
1.

What Diafer is and what it is used for

Diafer contains a combination of iron and isomaltoside 1000 (a chain of sugar
molecules). The type of iron in Diafer is the same as that found naturally in the body.
Diafer is used for low levels of iron (called ‘iron deficiency’) if you have chronic kidney
disease and are on dialysis.
Diafer is used to replenish and maintain body iron stores by repeated treatment.
2.

What you need to know before you use Diafer

Do not use Diafer

if you have anaemia that is not caused by low levels of iron (deficiency), such
as ‘haemolytic’ anaemia

if you have too much iron (overload) or a problem in the way your body uses iron

if you are allergic (hypersensitive) to iron isomaltoside 1000 or any of the other
ingredients of Diafer (listed in section 6)

if you have a history of asthma, eczema or any other atopic allergies

if you have active liver disease

if you suffer from ‘rheumatoid’ arthritis and you have symptoms at the moment
(active inflammation).
Warnings and precautions
Talk to your doctor before having Diafer:

if you have problems with inflammation

if you have an ongoing bacterial infection in your blood
You should tell your doctor immediately so that they can stop the injection if necessary,
if you experience symptoms of angioedema, such as

swollen face, tongue or pharynx

difficulty to swallow

hives and difficulties to breath
Children and adolescents
Diafer is not tested in children and adolescents. For that reason children and
adolescents should not have Diafer.
Other medicines and Diafer
Diafer given together with oral iron preparations can reduce the absorption of oral iron.
Tell your doctor if you are taking or have recently taken or might take any other medicines.
This includes medicines obtained without a prescription and herbal medicines. This is
because Diafer can affect the way some medicines work. Also some other medicines
can affect the way Diafer works.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or is planning to
have a baby, ask your doctor for advice before using this medicine. Diafer should not
be used during the first three months of pregnancy.
Your doctor will decide if the possible risks outweigh the expected benefit of treatment
with Diafer during pregnancy. He or she will then decide if you should be treated with
Diafer, if it is clearly necessary. Treatment should generally be confined to the last six
months of pregnancy.
It is not known whether the active ingredients of Diafer are excreted into human breast
milk. There is no information available on the possible effects of Diafer on male and
female fertility.
Driving and using machines
Diafer is unlikely to impair the ability to drive or operate machines.
3.

How to use Diafer

A qualified person will give you Diafer.
You will have Diafer by injection into your vein or into the dialyser.
Your doctor will calculate the dose for you and determine the appropriate
administration form and frequency.
If you get more Diafer than you should
A qualified person will give you Diafer. It is unlikely that you will have too much.
They will monitor your dose and blood to avoid iron building up in your body.
4.

Possible side effects

Like all medicines Diafer can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in 10):

none
Common (affects less than 1 user in 10 and more than 1 in 100):

none

Uncommon (affects 1 to 10 users in 1,000):

blurred vision

numbness

hoarseness

nausea, vomiting, constipation, pain in and around the stomach

cramps

hypersensitivity reactions (flushing, itchiness, rash, shortness of breath)

feeling hot (or fever)

soreness and swelling near the injection site
Rare (affects 1 to 10 users in 10,000):

disturbances in heart rhythm

chest pain

loss of consciousness

seizure

dizziness, restlessness, fatigue

diarrhoea, sweating, tremor

angioedema (serious allergic reaction which causes swelling of the face and throat)

pain in your muscles and joints

low blood pressure

altered mental status
Very rare (affects less than 1 user in 10,000):

slow heart rate in foetus

palpitations

affection of red blood cells (this would show up in some blood tests)

headache

unusual feeling on the surface of your body

temporary deafness

raised blood pressure

acute severe allergic reactions
If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet.
5.

How to store Diafer

Keep out of the reach and sight of children.
Do not freeze. Hospital staff will make sure that the product is stored and disposed of
correctly. Do not use this medicine after the expiry date which is stated on the ampoule.
Exp. is the abbreviation used for expiry date. The expiry date refers to the last day of that month.
6.

Contents of the pack and other information

What Diafer contains
The active substance in Diafer is an iron(III) isomaltoside 1000. One millilitre of solution
contains 50 mg iron as iron(III) isomaltoside 1000. A 2 ml ampoule contains 100 mg
iron as iron(III) isomaltoside 1000.
The other ingredients are water for injections, sodium chloride, sodium hydroxide
(pH adjuster) and hydrochloric acid (pH adjuster).
What Diafer looks like and contents of the pack
Diafer is a dark brown solution contained in glass ampoule.
The pack sizes are the following:
Ampoule pack sizes: 1 x 2 ml, 5 x 2 ml, 10 x 2 ml, 25 x 2 ml
Marketing Authorisation Holder and Manufacturer
Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark
Tel.: +45 59 48 59 59. Fax: +45 59 48 59 60
E-mail: info@pharmacosmos.com
This medicinal product is authorised in the Member States of the EEA under
the following names:
Italy: Diafer.
Poland: Diafer.
Sweden: Diafer.
United Kingdom: Diafer
This leaflet was last revised in 02/2013
Other sources of information
The following information is intended for medical or healthcare professionals only:
Posology
Diafer may be administered as an up to 200 mg dosage with a maximum weekly
administration of 1000 mg. If higher doses than 200 mg of iron are needed, other
iron medicinal products intended for intravenous use should be used.
The iron dose must be individualised based on the clinical response to treatment
including evaluation of haemoglobin, ferritin and tranferrin saturation, concommittant
treatment with an erythropoiesis stimulating agent (ESA) and the dosis of ESA treatment.
Targets may vary from patient to patient and depending on local guidelines.
Maintenance therapy with iv iron treatment may be given as small doses administered
at regular intervals to maintain iron status tests stable within specific limits with the
intent of avoiding development of iron deficiency or decline of iron test parameters
below specific levels.
Paediatric population:
Diafer is not recommended for use in children and adolescents < 18 years due to
insufficient data on safety and efficacy in children.
Method of administration:
Anaphylactoid reactions to parenteral iron are usually evident within a few minutes,
and close observation is necessary to ensure recognition. If at any time during the
intravenous administration of Diafer, any signs of a hypersensitivity reaction or
intolerance are detected, administration must be stopped immediately.
Resuscitative medication and personnel trained to evaluate and handle anaphylactoid
reactions should be available whenever a dose of parenteral iron is administered.
Adults and the elderly:
Diafer can be administered either as an intravenous bolus injection or during a
haemodialysis session directly into the venous limb of the dialyser. It may be
administered undiluted or diluted in up to 20 ml sterile 0.9% sodium chloride.
Diafer should not be administered concomitantly with oral iron preparations, since the
absorption of oral iron might be decreased (see section 4.5).
Please refer to the SPC for further information on handling of Diafer.

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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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