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Diafer

Document: Diafer solution for injection ENG PL change

PACKAGE LEAFLET

Package leaflet: Information for the user


Diafer® 50 mg/ml solution for injection


Iron


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.


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

1. What Diafer is and what it is used for

2. What you need to know before you receive Diafer

3. How Diafer is given

4. Possible side effects

How to store Diafer

6. Contents of the pack and other information


What Diafer is and what it is used for


Diafer contains a combination of iron and isomaltoside 1000 (a chain of sugar molecules). The type of iron in Diafer is the same as that found naturally in the body.


Diafer is used for low levels of iron (called ‘iron deficiency’) if you have chronic kidney disease and are on dialysis provided oral iron cannot be used.


Diafer is used to replenish and maintain body iron stores by repeated treatment.


What you need to know before you receive Diafer


You must not receive Diafer

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

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

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

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

if you have active liver disease


Warnings and precautions

Talk to your doctor or nurse before receiving Diafer:

if you have an ongoing bacterial infection in your blood


You should tell your doctor immediately so that they can stop the injection if necessary, if you experience symptoms of angioedema, such as

• swollen face, tongue or pharynx

• difficulty to swallow

• hives and difficulties to breath


One ml of undiluted Diafer contains up to 4.6 mg(0.2 mmol) of sodium. This has to be taken into account in patients on a sodium-controlled diet.


Children and adolescents

Diafer is not tested in children and adolescents. For that reason children and adolescents should not have Diafer.


Other medicines and Diafer

Diafer given together with oral iron preparations can reduce the absorption of oral iron. Tell your doctor if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Diafer can affect the way some medicines work. Also some other medicines can affect the way Diafer works.


Pregnancy, breast-feeding and fertility

Diaer 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.


If you are breast-feeding, ask your doctor for advice before you are given Diafer.


Driving and using machines

Diafer is unlikely to impair the ability to drive or operate machines.


How Diafer is given


Your doctor or nurse willadminister Diafer by injection into your vein or into the dialyser; Diafer 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.


If you get more Diafer than you should

A qualified person will give you Diafer. 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 Diafer can cause side effects, although not everybody gets them.


Very common (affects more than 1 user in 10):

none


Common (affects less than 1 user in 10 and more than 1 in 100):

none


Uncommon (affects 1 to 10 users in 1,000):


Rare (affects 1 to 10 users in 10,000):


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


If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.


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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Diafer


Keep Diafer out of the sight and reach of children.


Do not freeze. Hospital staff will make sure that the product is stored and disposed of correctly. Do not use this medicine after the expiry date which is stated on the ampoule and the carton. Exp. is the abbreviation used for expiry date. The expiry date refers to the last day of that month.


6. Contents of the pack and other information


What Diafer 50 mg/ml solution for injection contains


The active substance in Diafer is an iron(III) isomaltoside 1000. One millilitre of solution contains 50 mg iron as iron(III) isomaltoside 1000. A 2 ml ampoule contains 100 mg iron as iron(III) isomaltoside 1000.

The other ingredients are water for injections, sodium chloride, sodium hydroxide (pH adjuster) and hydrochloric acid (pH adjuster).


What Diafer looks like and contents of the pack


Diafer is a dark brown solution for injection contained in glass ampoule.

The pack sizes are the following:

Ampoule pack sizes: 1 x 2 ml, 5 x 2 ml, 10 x 2 ml, 25 x 2 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: Diafer

Belgium: Diafer

Bulgaria: Diafer

Czech Republic: Diafer

Germany: Diafer

Denmark: Diafer

Estonia: Diafer

Spain: Diafer

Finland: Diafer

Greece: Diafer

Croatia: Diafer

Hungary: Diafer

Ireland: Diafer

Italy: Diafer

Lithuania: Diafer

Latvia: Diafer

The Netherlands: Diafer

Norway: Diafer

Poland: Diafer

Portugal: Diafer

Romania: Diafer

Sweden: Diafer

Slovakia: Diafer

United Kingdom: Diafer


This leaflet was last revised in 2014-08-06


Other sources of information


The following information is intended for medical or healthcare professionals only:


Posology

Diafer may be administered as an up to 200 mg dosage with a maximum weekly administration of 1000 mg. If higher doses than 200 mg of iron are needed, other iron medicinal products intended for intravenous use should be used.


The iron dose must be individualised based on the clinical response to treatment including evaluation of haemoglobin, ferritin and tranferrin saturation, concommittant treatment with an erythropoiesis stimulating agent (ESA) and the dosis of ESA treatment. Targets may vary from patient to patient and depending on local guidelines.

Maintenance therapy with iv irontreatment may be given as small doses administered at regular intervals to maintain iron status tests stable within specific limits with the intent of avoiding development of iron deficiency or decline of iron test parameters below specific levels.


Paediatric population:


Diafer is not recommended for use in children and adolescents < 18 years due to insufficient data on safety and efficacy in children.


Method of administration:


Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Diafer.


Diafer 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 Diafer injection (see section 4.4).


Adults and the elderly:


Diafer can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser. It may be administered undiluted or diluted in up to 20 ml sterile 0.9% sodium chloride.


Diafer should not be administered concomitantly with oral iron preparations, since the absorption of oral iron might be decreased (see section 4.5).


Shelf life after dilution with sterile 0.9% sodium chloride


Chemical and physical in-use stability has been demonstrated for 48 hours at 30°C in dilutions with up to 20 ml sterile 0.9% sodium chloride.


From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of user.


Special precautions for disposal and other handling


Inspect ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.


Diafer is for single use only and any unused solution or waste material should be disposed of in accordance with local requirements.

Diafer must only be mixed with sterile 0.9% sodium chloride. No other intravenous dilution solutions should be used. No other therapeutic agents should be added. For dilution instructions, see section 4.2.


The diluted solution for injection should be visually inspected prior to use. Use only clear solutions without sediment.


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