MONOFER 100 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance: IRON (III) ISOMALTOSIDE 1000

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Package leaflet: Information for the user

Monofer 100 mg/ml
solution for injection/infusion
Iron
Read all of this leaflet carefully before you start using this medicine

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others.
It may harm them even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1.
What Monofer is and what it is used for
2.
Before you use Monofer
3.
How to use Monofer
4.
Possible side effects
5.
How to store Monofer
6.
Further information
1.

What Monofer is and what it is used for

Monofer contains a combination of iron and isomaltoside 1000 (a chain of sugar molecules).
The type of iron in Monofer is the same as that found naturally in the body called ‘ferritin’.
This means that you can have Monofer by injection in high doses.
Monofer is used for low levels of iron (sometimes called ‘iron deficiency’ and ‘iron
deficiency anaemia’) if:

You cannot take iron by mouth, for example you cannot tolerate it

Your doctor decides you need iron very quickly to build up your iron stores
2.

Before you use Monofer

Monofer is for adults only. Children and adolescents should not have this medicine.
Do not use Monofer if

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

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

you are allergic (hypersensitive) to active substances or any of the other
ingredients of Monofer.

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

you have liver problems such as ‘cirrhosis’ or ‘hepatitis’

if you suffer from ‘rheumatoid’ arthritis and you have symptoms at the moment
(active inflammation).
Do not take Monofer if any of the above apply to you. If you are not sure, talk to your
doctor, nurse or pharmacist before having Monofer.
Take special care with Monofer
Check with your doctor, nurse or pharmacist before having Monofer if:

you have an infection

you have asthma, eczema or problems with allergies or inflammation

you have an ongoing bacterial infection in your blood
If you are not sure if any of the above apply to you, talk to your doctor, nurse or
pharmacist before having Monofer.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any
other medicines. This includes medicines obtained without a prescription and herbal
medicines. This is because Monofer can affect the way some medicines work. Also some
other medicines can affect the way Monofer works.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any medicine.
Monofer 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 Monofer
during the last six months of pregnancy. He or she will then decide if you should be
treated with Monofer, if it is clearly necessary.
It is not known whether the active ingredients of Monofer are excreted into human
breast milk. Therefore, you should not use Monofer during breast-feeding unless your
doctor decides that it is clearly necessary.
Driving and using machines
Ask your doctor if you can drive or operate machines after having Monofer.
3.

How to use Monofer

A qualified person will give you Monofer.
How you will be given Monofer
You will have Monofer by injection or infusion into your vein. Your doctor will calculate
the dose for you and determine the appropriate administration form and frequency.
If you get more Monofer than you should
A qualified person will give you Monofer. 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 Monofer can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
You should tell your doctor or nurse immediately so that they can stop the infusion
if necessary, if you experience symptoms of angioedema, such as

swollen face, tongue or pharynx

difficulty to swallow

hives and difficulties to breath

Allergic reactions (affecting less than 1 in 100 people)
If you have an allergic reaction to Monofer tell your doctor or nurse straight away so that
they can stop it if necessary. The signs of this may include:

shortness of breath

nettle rash or hives, flushing, rashes, itching

nausea and shivering
Other side-effects include:
Uncommon (affects 1 to 10 users in 1,000):

blurred vision

numbness

hoarseness

pain in and around the stomach (abdominal pain), being sick (vomiting),
constipation

cramps

feeling hot (or fever)

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

uneven (irregular) heart beat, high pulse rate

chest pain

loss of consciousness

seizure (fits)

dizziness, restlessness, fatigue

diarrhoea, sweating, tremor

angioedema a type of severe allergic reaction, signs may include swelling

pain in your muscles or joints

low blood pressure

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

in pregnancy, the baby’s heart rate may slow.

palpitations

lower red blood cells than usual (this would show up in some blood tests)

headache

unusual feeling on the surface of your body

temporary deafness

raised blood pressure
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5.

How to store Monofer

This medicinal product does not require any special storage conditions. Hospital staff
will make sure that the product is stored and disposed of correctly. Monofer should not
be used after the expiry date which is stated on the ampoule or vial. Exp. is the
abbreviation used for expiry date. The expiry date refers to the last day of that month.
Keep out of the reach and sight of children.
6.

Further information

What Monofer contains
The active substance in Monofer is an iron(III) isomaltoside 1000.
One millilitre of solution contains 100 mg iron as iron(III) isomaltoside 1000.
A 1 ml vial/ampoule contains 100 mg iron as iron(III) isomaltoside 1000,
a 2 ml vial/ampoule contains 200 mg iron as iron(III) isomaltoside 1000,
a 5 ml vial/ampoule contains 500 mg iron as iron(III) isomaltoside 1000 and
a 10 ml vial/ampoule contains 1,000 mg iron as iron(III) isomaltoside 1000.
The other ingredients are Water for injections, Sodium hydroxide (pH adjuster) and
Hydrochloric acid (pH adjuster).
What Monofer looks like and contents of the pack
Monofer is a dark brown solution contained in glass ampoule or in glass vial with
chlorobutyle rubber stopper and aluminium cap.
The pack sizes are the following:
Ampoule pack sizes:
5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 2 x 5 ml, 5 x 5 ml, 2 x 10 ml, 5 x 10 ml
Vial pack sizes:
1 x 1 ml, 5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 1 x 5 ml, 2 x 5 ml, 5 x 5 ml, 1 x 10 ml,
2 x 10 ml, 5 x 10 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

Distributor
Pharmacosmos UK Ltd.
Chiltern House
Unit P, Howland Road, Thame
Oxfordshire, OX9 3GQ
United Kingdom
Tel: 01844 269007

This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria:
Belgium:
Bulgaria:
Cyprus:
Denmark:
Estonia:
Finland:
Germany:
Greece:
Ireland:
Iceland:

Monofer
Monover
Monofer
Monofer
Monofer
Monofer
Monofer
Monofer
Monofer
Monover
Monofer

Latvia:
Lithuania:
Luxemburg:
Netherlands:
Norway:
Poland:
Portugal:
Romania:
Spain:
Sweden:
United Kingdom:

Monofer
Monofer
Monover
Monofer
Monofer
Monover
Monofar
Monofer
Monoferro
Monofer
Monofer

This text was last revised: 07/2013
The following information is intended for medical or healthcare professionals only:
Information about the handling and use of Monofer can be found in the SPC included
in the package.

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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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