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MonoFer 100 mgml solution for infusion and injection

By Susan Wilson,2014-04-26 19:35
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MonoFer 100 mgml solution for infusion and injection

B. PACKAGE LEAFLET

    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 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

     numbness

     hoarseness

     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.

     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: 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

    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: Austria: Monofer

    Belgium: Monover

    Bulgaria: Monofer

    Denmark: Monofer

    Estonia: Monofer

    Finland: Monofer

    Germany: Monofer

    Greece: Monofer

    Ireland: Monofer

    Iceland: Monofer

    Latvia: Monofer

    Lithuania: Monofer

    Luxemburg: Monofer

    Netherlands: Monofer

    Norway: Monofer

    Poland: Monofer

    Portugal: Monofer

    Romania: Monofer

    Spain: Monofer

    Sweden: 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.

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