B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Monofer? 100 mg/ml solution for injection/infusion
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’
• 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
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 trained and qualified person will give you Monofer under the supervision of a doctor. Due to risk of allergic reactions you must be under close observation when given Monofer and total dose infusions should only be given at the hospital.
How you will be given Monofer
You will have Monofer by injection or infusion into your vein. Monofer may also be given as a total dose infusion.
; 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 not given as a total dose infusion.
If you get more Monofer than you should
A trained and qualified person will give you Monofer. 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.
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
• pain in and around the stomach (abdominal pain), being sick (vomiting), constipation • cramps
• feeling hot (or fever)
• soreness and sweeling (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.
• 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: 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
Marketing Authorisation Holder and Manufacturer
Tel.: +45 59 48 59 59
Fax: +45 59 48 59 60
This medicinal product is authorised in the Member States of the EEA under the following names: Austria: Monofer
United Kngdom: Monofer
This leaflet was last approved in 2009-11-26.
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.