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COSMOFER 50MG/ML SOLUTION FOR INJECTION AND FOR INFUSION

Active substance(s): IRON DEXTRAN COMPLEX

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Package Leaflet: Information for the User
CosmoFer®, 50 mg/ml
solution for injection and for infusion
Iron(III)
Read all of this leaflet carefully

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

If you have any further questions, ask your doctor, nurse 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, nurse or pharmacist.
In this leaflet
1.
What CosmoFer is and what it is used for
2.
Before you are given CosmoFer
3.
How CosmoFer is given
4.
Possible side effects
5.
How CosmoFer will be stored
6.
Further information
1.

What CosmoFer is and what it is used for

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

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

you have taken iron by mouth and it has not worked

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

Before you are given CosmoFer

CosmoFer is for adults only. Children should not have this medicine.
You should not be given CosmoFer 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 having this medicine injected into a vein (intravenous injection) and you
have a history of asthma, eczema or any other allergies. Your doctor or nurse may
give the injection into your muscle in this case

you have a history of allergy to any other drugs

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

you have a bacterial or viral infection, because CosmoFer can make the
infection worse

you suffer from ‘rheumatoid’ arthritis and you have symptoms at the moment
(active inflammation)

you have kidney problems, such as acute kidney failure.
Do not have CosmoFer if any of the above applies to you. If you are not sure, talk to your
doctor, nurse or pharmacist before having CosmoFer.
Take special care with CosmoFer
Using CosmoFer carries a risk of immediate severe and potentially fatal alergic reactions
(see Section 4). Check with your doctor, nurse or pharmacist before having CosmoFer if:

you have an illness of your immune system, such as ‘systemic lupus
erythematosus’ (a serious disease of the skin), or ‘rheumatoid’ arthritis. This is
because you may be more likely to have an allergic reaction with CosmoFer

you have asthma or problems with allergies or inflammation.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or
pharmacist before having CosmoFer.
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 CosmoFer can affect the way some medicines work. Also
some other medicines can affect the way CosmoFer works.
In particular tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

vitamins and minerals

iron containing medicines you take by mouth. You should not take iron by mouth
until at least 5 days after finishing CosmoFer.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or
pharmacist before having CosmoFer.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using any medicine.
CosmoFer 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 CosmoFer
during the last six months of pregnancy. He or she will then decide if you should be
treated with CosmoFer, if it is clearly necessary.
It is not known whether the active ingredients of CosmoFer are excreted into human
breast milk. Therefore, you should not use CosmoFer 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 CosmoFer.
Having blood tests while you are having CosmoFer
CosmoFer may affect the results of some blood tests to measure ‘bilirubin’ and calcium.
Tell your doctor if you have any blood test while you are having CosmoFer.
3.

How CosmoFer is given

A trained and qualified person will give you CosmoFer under the supervision of a doctor.
How you will be given CosmoFer
You will have CosmoFer by injection or infusion into your vein, or you may have it
injected into a muscle.

If you have never had CosmoFer before

You will have a small amount of the medicine first (a test dose). This is to check
that you are not allergic to it

Your doctor will monitor you closely during and immediately after you have had
CosmoFer

If no reaction happens after 60 minutes, you will have the rest of the dose.
If you have had CosmoFer before

The dose depends on your blood iron (haemoglobin) level and your weight.

Your doctor will calculate the dose for you

It is usually given to you two or three times each week.
If you get more CosmoFer than you should
A trained and qualified person will give you CosmoFer. It is unlikely that you will have too
much. They will monitor your dose so that an iron build up does not happen in your body. If
you think you have been given too much, tell your doctor or nurse straight away.
4.

Possible side-effects

Like all medicines CosmoFer can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Allergic reactions (affecting less than 1 in 100 people)
If you have an allergic reaction to CosmoFer 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.
More serious allergic reactions, may happen in the first few minutes of having CosmoFer
(affecting less than 1 in 10,000 people). The signs may include:

sudden onset of difficulty breathing (respiratory difficulty)

serious problems with your heart and circulation (cardiovascular collapse)

fatalities have been reported.
Also, there have been reports of delayed allergic reactions, that may happen a few hours
or up to four days after being given CosmoFer. The signs may include:

pain in your joints or muscles

sometimes a high temperature (fever).
Please contact your doctor if you have any of these signs.
Other side effects include
Uncommon (affecting less than 1 in 100 people):

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

blurred vision

feeling hot

cramps

numbness.
Rare (affecting less than 1 in 1,000 people):

loss of consciousness

altered mental status

seizure (fits)

dizziness, restlessness, fatigue

low blood pressure

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

uneven (irregular) heart beat, high pulse rate, chest pain

diarrhoea, sweating and tremor.
Very rare (affecting less than 1 in 10,000 people):

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

headache

unusual feeling on the surface of your body

raised blood pressure

temporary deafness

palpitations

in pregnancy, the baby’s heart rate may slow.
Some other side effects have been reported. People with ‘rheumatoid’ arthritis may
have worsening of joint pain.
Possible side effects after an injection into your vein
If you have CosmoFer into a vein, there may be reactions, such as soreness and swelling
(inflammation) around the vein. There have also been reports of inflammation of the vein.
Possible side effects after an injection into your muscle
If you have CosmoFer into a muscle, there may be reactions, such as staining of the skin,
bleeding, formation of boils, tissue damage (necrosis or atrophy) and pain.
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 CosmoFer will be stored

This medicinal product does not require any special storage conditions. Do not freeze. Inspect
ampoules visually for sediment and damage before use. Use only those containing
sediment-free, homogeneous solution. Hospital staff will make sure that the product is stored
and disposed of correctly. CosmoFer should not be used after the expiry date which is stated
on the carton and ampoule. 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 CosmoFer contains

The active substance in CosmoFer is an Iron(III)-hydroxide dextran complex. A 2 ml
ampoule contains 100 mg iron(III), a 5 ml ampoule contains 250 mg iron(III) and a
10 ml ampoule contains 500 mg iron(III)

The other ingredients are Water for injections, Sodium hydroxide (pH adjuster) and
Hydrochloric acid (pH adjuster).
What CosmoFer looks like and contents of the pack
CosmoFer is contained in clear glass ampoules. The pack sizes are the following: Packing
containing 5 x 2 ml, packing containing 10 x 2 ml, packing containing 10 x 5 ml, packing
containing 2 x 10 ml and packing containing 5 x 10 ml.
Marketing Authorisation Holder
Distributor UK and Ireland
and Manufacturer
Pharmacosmos UK Ltd.
Pharmacosmos A/S
Chiltern House
Roervangsvej 30
Unit P, Howland Road, Thame
DK-4300 Holbaek
Oxfordshire, OX9 3GQ
Denmark
United Kingdom
This leaflet was last approved: 06/2012

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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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