Feroton Injection is indicated for the treatment of iron deficiency in the following
indications:
• where there is a clinical need to deliver iron rapidly to iron stores,
• in patients who cannot tolerate oral iron therapy or who are non-compliant,
• in active inflammatory bowel disease where oral iron preparations are ineffective.
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb,
serum ferritin, serum iron, etc.).

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

Feroton Injection 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 Feroton Injection (see section 4.4).
Administration: Feroton Injection must only be administered by the intravenous route. This
may be by a slow intravenous injection or by an intravenous drip infusion.
Feroton Injection must not be used for intramuscular injection.
Adults and the elderly: The total cumulative dose of Feroton Injection, equivalent to the
total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose
for Feroton Injection must be individually determined for each patient according to the total
iron deficit calculated with the following formula:

• Below 35 kg body weight: target Hb = 130 g/l and depot iron = 15 mg/kg body weight

• 35 kg body weight and above: target Hb = 150 g/l and depot iron = 500 mg
*Factor 0.24 = 0.0034 x 0.07 x
1000
(Iron content of haemoglobin 0.34%; Blood volume
7% of body weight; Factor 1000 = conversion from
g to mg)
The total amount of Feroton Injection required in mg is determined from above calculation.
Alternatively, the total amount of Feroton Injection required in ml is determined from the
following formula or dosage table.

To convert Hb (mM) to Hb (g/l), multiply the former by 16.1145.
Example: For a patient of 60 kg body weight with an actual Hb of 60 g/l 90 ml should be
administered. (Alternatively 18 ampoules/vials of 5 ml or 36 vials of 2.5 ml should be
administered.)
Dosage: The total single dose must not exceed 200 mg of iron given not more than three
times per week. If the total necessary dose exceeds the maximum allowed single dose, then
the administration has to be split.
Children: The use of Feroton Injection has not been adequately studied in children and,
therefore, Feroton Injection is not recommended for use in children.
Intravenous drip infusion: Feroton Injection must be diluted only in sterile 0.9% m/V

sodium chloride solution:
• 2.5 ml Feroton Injection (50 mg iron)
in max. 50 ml sterile 0.9% m/V sodium chloride solution
• 5 ml Feroton Injection (100 mg iron)
in max. 100 ml sterile 0.9% m/V sodium chloride solution
• 10 ml Feroton Injection (200 mg iron)
in max. 200 ml sterile 0.9% m/V sodium chloride solution
For stability reasons, dilutions to lower Feroton Injection concentrations are not permissible.
Dilution must take place immediately prior to infusion and the solution should be
administered as follows:
• 100 mg iron (5 ml Feroton Injection) in at least 15 minutes
• 200 mg iron (10 ml Feroton Injection) in at least 30 minutes
Intravenous injection: Feroton Injection may be administered by slow intravenous
injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Feroton
Injection (200 mg iron) per injection.
Injection into dialyser: Feroton Injection may be administered during a haemodialysis
session directly into the venous limb of the dialyser under the same procedures as those
outlined for intravenous injection.

The use of Feroton Injection is contraindicated in cases of: • hypersensitivity to the active substance, to Feroton Injection or any of its excipients listed in section 6.1 • known serious hypersensitivity to other parenteral iron products • anaemias not attributable to iron deficiency • iron overload or disturbances in utilisation of iron.

Parenterally administered iron preparations can cause hypersensitivity reactions including
serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions
have also been reported after previously uneventful doses of parenteral iron complexes.
The risk is enhanced for patients with known allergies including drug allergies, including
patients with a history of severe asthma, eczema or other atopic allergy.
There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in
patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus,
rheumatoid arthritis).
Feroton Injection 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. Each patient should be observed for adverse effects for at least 30
minutes following each Feroton Injection injection. If hypersensitivity reactions or signs of
intolerance occur during administration, the treatment must be stopped immediately.
Facilities for cardio respiratory resuscitation and equipment for handling acute
anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000
adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should
be given as appropriate.
In patients with liver dysfunction, parenteral iron should only be administered after careful
risk/benefit assessment. Parenteral iron administration should be avoided in patients with
hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria
Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron
overload.
Parenteral iron must be used with caution in case of acute or chronic infection. It is
recommended that the administration of iron sucrose is stopped in patients with ongoing
bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed,
taking into account the suppression of erythropoiesis.
Hypotensive episodes may occur if the injection is administered too rapidly. Allergic
reactions, sometimes involving arthralgia, have been more commonly observed when the

recommended dose is exceeded.
Paravenous leakage must be avoided because leakage of Feroton Injection at the injection
site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin.

As with all parenteral iron preparations, Feroton Injection should not be administered
concomitantly with oral iron preparations since the absorption of oral iron is reduced.
Therefore, oral iron therapy should be started at least 5 days after the last injection of
Feroton Injection.
 

There are no adequate and well-controlled trials of Feroton Injection in pregnant women. A
careful risk/benefit evaluation is therefore required before use during pregnancy and Feroton
Injection should not be used during pregnancy unless clearly necessary (see section 4.4).
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be
treated with oral iron. Treatment with Feroton Injection should be confined to second and
third trimester if the benefit is judged to outweigh the potential risk for both the mother and
the foetus.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal/foetal development, parturition or postnatal development. Data on a limited
number of exposed human pregnancies indicated no adverse effects of Feroton Injection on
pregnancy or on the health of the foetus/newborn child.
Non metabolised Feroton Injection is unlikely to pass into the mother's milk. No wellcontrolled
clinical studies are available to date. Animal studies do not indicate direct or
indirect harmful effects to the nursing child.

In the case of symptoms of dizziness, confusion or light headedness following the
administration of Feroton In

The most frequently reported adverse drug reactions (ADRs) of Feroton Injection in clinical trials were transient taste perversion, hypotension, fever and shivering, injection site
reactions and nausea, occurring in 0.5 to 1.5% of the patients. Non-serious anaphylactoid
reactions occurred rarely.
In general anaphylactoid reactions are potentially the most serious adverse reactions (see
“Special warnings and Precautions for Use” section 4.4).
In clinical trials, the following adverse drug reactions have been reported in temporal
relationship with the administration of Feroton Injection, with at least a possible causal
relationship:
Nervous system disorders
Common (≥ 1/100, < 1/10): transient taste perversions (in particular metallic taste).
Uncommon (≥ 1/1000, < 1/100): headache, dizziness.
Rare (≥ 1/10000, < 1/1000): paraesthesia, syncope, loss of consciousness, burning
sensation.
Cardio-vascular disorders
Uncommon (≥ 1/1000, < 1/100):hypotension and collapse, tachycardia and palpitations.
Rare (≥ 1/10000, < 1/1000): hypertension.
Respiratory, thoracic and mediastinal disorders
Uncommon (≥ 1/1000, < 1/100): bronchospasm, dyspnoea.
Gastrointestinal disorders
Uncommon (≥ 1/1000, < 1/100): nausea; vomiting, abdominal pain, diarrhoea.
Skin and subcutaneous tissue disorders
Uncommon (≥ 1/1000, < 1/100): pruritus, urticaria, rash, exanthema, erythema.
Musculoskeletal, connective tissue and bone disorders

Uncommon (≥ 1/1000, < 1/100): muscle cramps, myalgia.
General disorders and administration site disorders
Uncommon (≥ 1/1000, < 1/100): fever, shivering, flushing, chest pain and tightness.
Injection site disorders such as superficial phlebitis, burning, swelling.
Rare (≥ 1/10000, < 1/1000): arthralgia, peripheral oedema, fatigue, asthenia, malaise,
feeling hot, oedema.
Immune system disorders
Rare (≥ 1/10000, < 1/1000): anaphylactoid reactions.
Moreover, in spontaneous reports the following adverse reactions have been reported:
Isolated cases: reduced level of consciousness, light-headed feeling, confusion, angiooedema,
swelling of joints, hyperhidrosis, back pain, bradycardia, chromaturia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product.
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Overdosage can cause acute iron overloading which may manifest itself as haemosiderosis.
Overdosage should be treated, if required, with an iron chelating agent.

The ferrokinetics of Feroton Injection labelled with 59Fe and 52Fe were assessed in 5 patients
with anaemia and chronic renal failure. Plasma clearance of 52Fe was in the range of 60 to
100 minutes. 52Fe was distributed to the liver, spleen and bone marrow. At two weeks after
administration, the maximum red blood cell utilisation of 59Fe ranged from 62% to 97%.

Following intravenous injection of a single dose of Feroton Injection containing 100 mg iron
in healthy volunteers, maximum iron levels, averaging 538 μmol/l, were obtained 10
minutes after injection. The volume of distribution of the central compartment corresponded
well to the volume of plasma (approximately 3 litres).
The iron injected was rapidly cleared from the plasma, the terminal half-life being approx. 6
h. The volume of distribution at steady state was about 8 litres, indicating a low iron
distribution in the body fluid. Due to the lower stability of iron sucrose in comparison to
transferrin, a competitive exchange of iron to transferrin was observed. This resulted in iron
transport of approx. 31 mg iron/24 h.
Renal elimination of iron, occurring in the first 4 h after injection, corresponds to less than
5% of the total body clearance. After 24 h the plasma levels of iron were reduced to the predose
iron level and about 75% of the dosage of sucrose was excreted.

There are no preclinical data of relevance to the prescriber that are additional to information
already in other sections of the SPC.

Water for injection
Sodium hydroxide Pellets

Feroton Injection must only be mixed with sterile 0.9% m/V sodium chloride solution. No
other solutions and therapeutic agents should be used as there is the potential for
precipitation and/or interaction. The compatibility with containers other than glass,
polyethylene and PVC is not known.

36 months (3 years) Once the Feroton™ ampoules have been opened, they should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately

Do not store above 25°C. Do not freeze.

Glass Ampoules : Clear, transparent, natural type I glass ampoule with rounded
shoulder and white seal mark on the neck and smooth surface and bulb tip off. Should be
free from critical defects. (cracks, blow outs, contamination etc)
Carton : Colored printed carton, text and color similar to approved artwork , Breadth :
90.5 +/- 1.0 mm, Length : 104.5 +/- 1.0 mm and Height : 20.5 +/- 1.0 mm
Label : Colors printed self-adhesive labels with rounded corners, Core diameter : 76+/-1.0
mm, Height : 30 +/- 1.0 mm and Length : 45.0 +/- 1.0 mm
Plastic Tray : Transparent rectangular plastic tray to keep five glass ampoules of 5 ml.
Outer length : 86.0 +/- 2.0 mm ,Outer breadth : 98.00 +/- 2.0 mm, Inner length : 78.0 +/-
2.0 mm, Inner breadth: 90.0 +/- 2.0 mm

Ampoules or vials 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.
See also 6.3 shelf-life.
Each ampoule or vial of Feroton Injection is intended for single use only. Discard any
remaining contents after first use.