Package leaflet: Information for the user

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Ferrologic® 20 mg/ml

solution for injection/concentrate for solution for infusion

Active substance: Iron

What is in this leaflet:

1.    What Ferrologic® is and what it is used for

2.    What you need to know before you receive Ferrologic®

3.    How Ferrologic® is administered

4.    Possible side effects

5.    How to store Ferrologic®

6.    Contents of the pack and other information

1. What Ferrologic® is and what it is used for

Ferrologic® belongs to a group of medicines called iron preparations. It is given directly into a vein.

Ferrologic® is used to restore the iron stores in the body in patients who have iron deficiency.

The product is intended for use only in the following circumstances:

•    in patients who cannot tolerate oral iron therapy (i.e. when taken by mouth);

•    in patients who do not take oral iron therapy as recommended;

•    in patients where it is necessary to deliver iron rapidly to the iron stores;

•    in patients who have medical conditions which mean they cannot properly absorb oral iron, e.g. inflammatory bowel diseases.

Before starting treatment with Ferrologic^® a blood test should be carried out to ensure treatment with this medicine is appropriate.

Ferrologic^® should not be given at the same time as oral iron preparations, as the absorption of oral iron is reduced. Therefore, if you are switched to iron treatment by mouth it should be started at least five days after the last injection of Ferrologic®.

Pregnancy

Ferrologic^® has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

If you become pregnant during treatment, you must ask your doctor for advice. Your doctor will decide whether or not you should be given this medicine.

Breast-feeding

If you are breast-feeding, ask your doctor for advice before you are given Ferrologic^®.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Some patients may occasionally feel dizzy, drowsy or confused. If this happens, you should not drive or use machinery.

Important information about some of the ingredients of Ferrologic^®

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

2. What you need to know before you receive Ferrologic^®

You must not receive Ferrologic^®

•    if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6);

•    if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations;

•    if you have a history of:

-    asthma, narrowing of the airways accompanied by shortness of breath,

-    rash or other allergic skin reactions with inflammation accompanied by itching and dryness.

In these cases you are more susceptible to allergic reactions.

•    if your anaemia, i.e. low amount of red blood cells, is not due to a shortage of iron;

•    if you have too much iron stored in your body or your body is unable to use iron properly;

•    in early pregnancy (first three months).

Warnings and precautions

Talk to your doctor or nurse before receiving Ferrologic®.

•    if you have a history of medicine allergy.

•    if you have systemic lupus erythematosus (SLE).

•    if you have rheumatoid arthritis.

•    if you have severe asthma, eczema or other allergies.

•    if you suffer from liver disease. Your doctor will carefully monitor your blood iron levels in case Ferrologic® is given.

•    if you suffer from acute or chronic infection.

•    if you experience allergic reactions, which sometimes involve pain in the joints. These reactions were observed more frequently following an overdose.

•    If the injection is administered too quickly transient low blood pressure may occur.

•    It is important that this medicine is given directly into a vein. If it ‘leaks’ out into the tissues around the vein it can cause a severe reaction with pain, discolouration and swelling around the site where it is being given. Tell your doctor or nurse immediately if you experience any of these symptoms.

How Ferrologic is given

Your doctor or nurse will administer Ferrologic® by injection into a vein; the Ferrologic will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.

You will be observed for at least 30 minutes by your doctor or nurse after each administration.

Other medicines and Ferrologic^®

Tell your doctor if you are using, have recently taken or used or might take or use any other medicines, especially any other iron preparations.

3. How Ferrologic® is administered

Ferrologic® should only be administered directly into a vein, either by slow injection or by infusion. The latter is the preferred route. Ferrologic® must not be injected into a muscle or under the skin.

The dose of Ferrologic^® you need, will be calculated from your blood test (concentration of haemoglobin) and your weight. Your doctor will also decide how often, and for how long, you will need this treatment.

Use in children

Ferrologic^® is not recommended for use in children.

If you receive more Ferrologic^® than you should

If you receive more Ferrologic^® than you need this can lead to an accumulation of excess iron in the body tissues. If this should happen, your doctor will give you appropriate treatment (with a chelating agent) which will remove the excess iron.

If you have any further questions on the use of this product, please ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The assessment of the side effects is based on the following frequencies:

Very common:

Common:

Uncommon:

Rare:

Very rare:

Not known:

The following Ferrologic^®:

Common:

•    temporary Uncommon:

•    headache

•    dizziness

•    low blood pressure

•    collapse

•    increased blood pressure

•    increased heart rate

•    palpitations (a noticeably rapid, strong or irregular heartbeat)

•    narrowing of the airways accompanied by shortness of breath

•    swelling and inflammation reactions (sometimes involving veins) or a burning sensation around the site of injection or infusion

•    severe allergic (hypersensitivity) reactions (rarely including joint pain). They can involve swelling of the lips or tongue, wheezing, collapse and, very rarely, convulsions (fits or seizures).

If you experience a severe allergic reaction obtain medical assistance immediately.

•    swelling of hands and    feet    •    weakness

•    tiredness    •    general feeling of illness

Moreover, in spontaneous reports the following side effects have been reported: Not known:

•    decreased alertness    •    swelling of face and tongue as    well

•    light-headedness    as swelling of joints, increased

•    confusion    sweating or back pain.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Ireland:

Pharmacovigilance Section, Irish Medicines Board

Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971, Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Malta:

ADR Reporting, The Medicines Authority, Post-Licensing Directorate 203 Level 3, Rue D'Argens, GZR-1368 Gzira Website: www.medicinesauthority.qov.mt e-mail: postlicensinq.medicinesauthoritv@qov.mt

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. How to store Ferrologic®

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light. Do not freeze.

Stability of Ferrologic^® after ampoules have been opened or following dilution

Use the ampoules immediately after opening.

Use the diluted or undiluted solution immediately. Except for 0.9% of saline solution no other dilution solutions or therapeutic agents are to be used or added. Do not use Ferrologic® if you notice any of the following: sediment or a non-uniform solution.

The diluted solution must appear as brown and clear.

Any unused portion of the solution is to be discarded.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

6. Contents of the pack and other information

What Ferrologic^® contains The active substance is: iron

as a solution of iron sucrose [iron(III)-hydroxide sucrose complex]

Each millilitre of solution contains 20 mg iron as iron sucrose [iron(III)-hydroxide sucrose complex].

Each 5 ml ampoule contains 100 mg iron as iron sucrose [iron(III)-hydroxide sucrose complex].

The other ingredients are sodium hydroxide and water for injection.

What Ferrologic^® looks like and contents of the pack

Ferrologic^® is a sterile, dark brown, non transparent, aqueous solution of iron intended to be used only for intravenous injection or as a concentrate for solution for infusion. Ferrologic^® is supplied in glass ampoules each containing 5 ml solution, which is equivalent to 100 mg iron. The product is supplied in cardboard boxes containing 5 ampoules or in multi-packs comprising 10 packs, each containing 5 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg v.d.H., Germany

Manufacturer

Fresenius Medical Care Deutschland GmbH

61346 Bad Homburg v.d.H., Germany

For any information about this medicine, please contact the local

representative/distributor of the Marketing Authorisation Holder:

Ireland:

Fresenius Medical Care (Ireland) Ltd. Grattan House City Junction Business Park Malahide Road, Dublin 17

Malta:

Pharma-Cos Ltd, Pharma-Cos House, Triq C. Portanier, Santa Venera SVR 1732 United Kingdom:

Fresenius Medical Care (UK) Ltd, Nunn Brook Road, Huthwaite NG17 2HU This leaflet was last approved in: October 2013    | POM |

The following information is intended for healthcare professionals only: Administration:

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferrologic^®.

Ferrologic® should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Ferrologic^® injection. Ferrologic^® must only be administered by the intravenous route (by a slow intravenous injection or intravenous drip infusion, the latter is the preferred route of administration as this may help to reduce the risk of hypotensive episodes and paravenous leakage). Ferrologic® is a strongly alkaline solution (pH 10.5 - 11.1) and must never be administered by the subcutaneous or intramuscular route, nor is it suitable for TDI (total dose infusion) during which the total necessary iron dose equivalent to the iron depletion, is administered on a single occasion.

Intravenous drip infusion:

Ferrologic® must be diluted only in 0.9% sodium chloride solution (normal saline). Each 5 ml ampoule (100 mg iron) of Ferrologic® should be diluted in 100 ml of 0.9% saline immediately before infusion (i.e. 2 ampoules in 200 ml, etc. to max. 5 ampoules in 500 ml of normal saline). For stability reasons, dilutions of lower Ferrologic^® concentrations are not permissible.

The solution must be administered at the following rate: 100 ml in at least 15 minutes; 200 ml in at least 30 minutes; 300 ml in at least 1.5 hours; 400 ml in at least 2.5 hours; 500 ml in at least 3.5 hours.

Intravenous injection:

Ferrologic® may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute (i.e. 5 minutes per ampoule) and not exceeding 2 ampoules Ferrologic^® (200 mg iron) per injection.

After an intravenous injection, extend and elevate the patient's arm and apply pressure to the injection site for at least 5 minutes to reduce the risk of paravenous leakage.

Injection into dialyser:

Ferrologic® may be administered during haemodialysis directly into the venous line of the dialyser under the same procedures as those outlined for intravenous administration. When the total necessary dose exceeds the maximum daily dose, the administration should be split.

Handling recommendations:

Ampoules should be visually inspected for sediment and damage before use. Only those with sediment free and homogenous solution must be used.

The diluted solution must appear as brown and clear.

Incompatibilities:

Ferrologic® must only be mixed with 0.9% of sodium chloride solution.

No other intravenous dilution solutions and therapeutic agents should be used or added as there is the potential for precipitation and/or interaction.

Shelf life after first opening the container:

From a microbiological point of view, the product should be used immediately.

Shelf life after dilution with 0.9% sodium chloride solution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 22 ± 2°C. From a microbiological point of view, the diluted product should be used immediately.

003D0403/03UK-IRL-M