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MONOFER 100 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance: IRON (III) ISOMALTOSIDE 1000

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Package leaflet: Information for the user
Monofer 100 mg/ml solution for injection/infusion
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 this medicine because it
contains important information for you.

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

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1.
What Monofer is and what it is used for
2.
What you need to know before you receive Monofer
3.
How Monofer is given
4.
Possible side effects
5.
How to store Monofer
6.
Contents of the pack and other 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:

oral iron does not work or you cannot tolerate it

your doctor decides you need iron very quickly to build up your iron stores
2.
What you need to know before you receive Monofer
You must not receive Monofer:

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 anaemia not caused by iron deficiency

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

if you have liver problems such as ‘cirrhosis’ or ‘hepatitis’
Warnings and precautions
Talk to your doctor or nurse before receiving Monofer:

if you have a history of medicine allergy

if you have systemic lupus erythematosus

if you have rheumatoid arthritis

if you have severe asthma, eczema or other allergies

if you have an ongoing bacterial infection in your blood
You should tell your doctor or nurse immediately so that they can stop the infusion if necessary, if
you experience symptoms of allergic reaction, such as

swollen face, tongue or throat

difficulty to swallow

hives or difficulties to breath
Children and adolescents
Monofer is for adults only. Children and adolescents should not have this medicine.
Other medicines and Monofer
Tell your doctor if you are using, have recently used or might use any other medicines.
Monofer given together with oral iron preparations can reduce the absorption of oral iron.
Pregnancy and breast-feeding
Monofer 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 Monofer.
Driving and using machines
Ask your doctor if you can drive or operate machines after having Monofer.
3.
How Monofer is given
Your doctor or nurse will administer Monofer by injection or infusion into your vein; the Monofer 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.
4.
Possible side effects
Like all medicines Monofer can cause side effects, although not everybody gets them.
Uncommon (affects 1 to 10 users in 1,000):

blurred vision

numbness

hoarseness

nausea, vomiting, constipation, pain in and around the stomach

cramps

hypersensitivity reactions (flushing, itching, rashes, shortness of breath)

feeling hot (or fever)

soreness and sweeling near the injection site
Rare (affects 1 to 10 users in 10,000):

disturbances in heart rhythm

chest pain

loss of consciousness

seizure

dizziness, restlessness, fatigue

diarrhoea, sweating, tremor

angioedema (severe allergic reaction which causes swelling of face and throat)

pain in your muscles or joints

low blood pressure

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

slow heart rate in unborn baby

palpitations

red blood cell numbers may be affected (this would show up in some blood tests)

headache

unusual feeling on the surface of your body

temporary deafness

raised blood pressure

acute severe allergic reactions
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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
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.
Contents of the pack and 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: 1 x 1 ml, 5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 1 x 5 ml, 2 x 5 ml, 5 x 5 ml, 1 x 10
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
Distributor
Pharmacosmos UK Ltd.
Chiltern House
Unit P, Howland Road, Thame
Oxfordshire, OX9 3GQ
United Kingdom
Tel: 01844 269007
e-mail: info@pharmacosmos.co.uk
This medicinal product is authorised in the Member States of the EEA under the following names:

Austria:
Belgium:
Bulgaria:
Cyprus:
Denmark:
Estonia:
Finland:
Germany:
Greece:
Ireland:
Iceland:

Monofer
Monover
Monofer
Monofer
Monofer
Monofer
Monofer
Monofer
Monofer
Monover
Monofer

Latvia
Lithuania:
Luxemburg:
Netherlands:
Norway:
Poland:
Portugal:
Romania:
Spain:
Sweden:
United Kingdom:

Monofer
Monofer
Monover
Monofer
Monofer
Monover
Monofar
Monofer
Monoferro
Monofer
Monofer

This leaflet was last revised in 07/07/2015
--------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Calculation of the cumulative iron dose:
Iron replacement in patients with iron deficiency anaemia:
The dose and dosage schedule for Monofer must be individually established for each patient. The
optimal haemoglobin target level and iron stores may vary in different patient groups and between
patients. Please refer to official guidelines. The dose of Monofer is expressed in mg of elemental
iron.
Iron deficiency anaemia will not appear until essentially all iron stores have been depleted. Iron
therapy should therefore replenish both haemoglobin iron and iron stores.
After the current iron deficit has been corrected, patients may require continued therapy with
Monofer to maintain target levels of haemoglobin and acceptable limits of other iron parameters.
The cumulative iron dose can be determined using either the Ganzoni formula (1) or the dosing table
below (2). It is recommended to use the Ganzoni formula in patients who are likely to require individually adjusted dosing such as patients with anorexia nervosa, cachexia, obesity, pregnancy or
anaemia due to bleeding.
Haemoglobin is abbreviated Hb.
1.
Ganzoni formula:
Iron dose = Body weight(A) x (Target Hb – Actual Hb)(B) x 2.4(C) + Iron for iron stores(D)
[mg iron]
[kg]
[g/dl]
[mg iron]
(A)
(B)
(C)

(D)

It is recommended to use the patient’s ideal body weight or pre-pregnancy weight
To convert Hb [mM] to Hb [g/dl] you should multiply Hb [mM] by factor 1.61145
Factor 2.4 = 0.0034 x 0.07 x 10,000
0.0034: Iron content of haemoglobin is 0.34%
0.07: Blood volume 70 ml/kg of body weight ≈ 7% of body weight
10,000: The conversion factor 1 g/dl = 10,000 mg/l
For a person with a body weight above 35 kg, the iron stores are 500 mg or above

2.
Dosing table:
Cumulative iron dose
Hb (g/dL)

Patients with bodyweight
50 kg to <70 kg

Patients with body weight
≥70 kg

≥10

1000 mg

1500 mg

<10

1500 mg

2000 mg

Iron replacement for blood loss:
Iron therapy in patients with blood loss should supply an amount of iron equivalent to the amount of
iron represented in the blood loss.

If the Hb level is reduced: Use the Ganzoni formula considering that the depot iron does not
need to be restored:
Cumulative iron dose = Body weight x (Target Hb – Actual Hb) x 2.4
[mg iron]
[kg]
[g/dl]


If the volume of blood lost is known: The administration of 200 mg Monofer results in an
increase of haemoglobin which is equivalent to 1 unit blood:
Iron to be replaced = Number of units blood lost x 200.
[mg iron]

Administration:
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following
each administration of Monofer.
Monofer 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
Monofer injection.
Children and adolescents:
Monofer is not recommended for use in children and adolescents < 18 years due to insufficient data
on safety and efficacy.
Adults and the elderly:
Monofer can be administered either as an intravenous bolus injection, as an intravenous drip infusion
or as a direct injection into the venous limb of the dialyser.
Monofer should not be administered concomitantly with oral iron preparations, since the absorption
of oral iron might be decreased.
Intravenous bolus injection:
Monofer may be administered as an intravenous bolus injection up to 500 mg up to three times a
week at an administration rate of up to 50 mg iron/minute. It may be administered undiluted or diluted
in maximum 20 ml sterile 0.9% sodium chloride.
Intravenous drip infusion:
The cumulative iron dose required may be administered in a single Monofer infusion up to 20 mg
iron/kg body weight or as weekly infusions until the cumulative iron dose has been administered.
If the cumulative iron dose exceeds 20 mg iron/kg body weight, the dose must be split in two administrations with an interval of at least one week.
Doses up to 1000 mg must be infused over 30 min.
Doses exceeding 1000 mg must be infused over 60 min.
Monofer should be added to maximum 500 ml sterile 0.9% sodium chloride.
Injection into dialyser:
Monofer may be administered during a haemodialysis session directly into the venous limb of the
dialyser under the same procedures as outlined for intravenous bolus injection.
Please refer to the SPC for further information on Monofer.
93x18-04-03

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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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