Ferrinemia

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Ferrinemia
20 mg iron(III) ions/ml, solution for injection and infusion
Ferri hydroxidum saccharum
Please read all of this leaflet carefully before this medicine is administered because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Ferrinemia is and what it is used for
2. What you need to know before Ferrinemia is administered
3. How Ferrinemia is administered
4. Possible side effects
5. How to store Ferrinemia
6. Contents of the pack and other information

1. What Ferrinemia is and what it is used for

Ferrinemia is a solution for intravenous injection used to replenish iron stores in the body.
Iron is used in the bone marrow for the production of haemoglobin (Hb).
Ferrinemia is used in the treatment of iron deficiency cases requiring iron supplementation.
The medicine is particularly used:

• when there is a clinical need for rapid systemic replenishment of iron stores,
• in patients who do not tolerate oral iron therapy or in whom such medicinal products cannot be administered,
• when oral iron preparations are ineffective (e.g. active inflammatory bowel disease).

2. Important information before administering Ferrinemia to the patient

When not to take Ferrinemia:

• if the patient has anaemia not caused by iron deficiency;
• if the patient's iron levels are too high or their body does not use iron properly;
• if the patient is allergic (hypersensitive) to the medicine or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced serious allergic (hypersensitivity) reactions to other injectable iron-containing medicines.

Do not administer Ferrinemia if any of the above apply. If in doubt, consult a doctor before starting treatment with Ferrinemia.

Warnings and precautions

Before starting treatment with Ferrinemia, discuss the following with a doctor or nurse:

• if the patient has previously had an allergic reaction to medicines;
• if the patient has systemic lupus erythematosus;
• if the patient has rheumatoid arthritis;
• if the patient has severe asthma, eczema, or other atopic allergy;
• if the patient has any infections;
• if the patient has liver problems.

If in doubt whether any of the above points apply, consult a doctor or pharmacist before starting treatment with Ferrinemia.

Ferrinemia and other medicines

As with all parenteral iron preparations, Ferrinemia should not be used at the same time as oral iron preparations, because the absorption of oral iron is reduced in this case.

Pregnancy and breastfeeding

Ferrinemia has not been studied with regard to use in women during the first three months of pregnancy. It is important to inform the doctor if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant.

If pregnancy occurs during treatment, medical advice should be sought. The doctor will decide whether the patient should receive the medicine.

During breastfeeding, seek medical advice before taking Ferrinemia.

Driving and operating machinery

After administration of Ferrinemia, symptoms such as dizziness, disorientation or feeling faint may occur. In such cases, the patient should not drive or operate machinery until these symptoms have subsided. If in doubt, consult a doctor.

Ferrinemia contains sodium

Ferrinemia contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How Ferrinemia is administered

Your doctor will decide the dose of Ferrinemia to be administered. The doctor will also determine how often and for how long the medicine should be given. To adjust the dose, your doctor will perform blood tests.
Ferrinemia will be administered by your doctor or nurse in one of the following ways:

• slow intravenous injection – 1 to 3 times per week;
• as an intravenous infusion (drip) – 1 to 3 times per week;
• during dialysis – the medicine will be given into the venous line of the dialysis machine.

Ferrinemia may only be administered in facilities equipped to provide rapid and appropriate medical assistance in case of hypersensitivity reactions. After each administration, the patient should remain under the supervision of a doctor or nurse for at least 30 minutes to monitor for adverse reactions.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly reported adverse reactions in clinical studies were: taste disturbances,
such as a metallic taste, low or high blood pressure, and reactions at the
injection/infusion site, nausea.
Allergic reactions (may occur in up to 1 in 100 people)
If a patient experiences an allergic reaction, a doctor should be informed immediately. Symptoms
may include:

• Low blood pressure (dizziness, feeling faint, fainting).
• Facial swelling.
• Breathing difficulties.
• Chest pain, which may be a symptom of a sometimes severe allergic reaction called Kounis syndrome. If a patient suspects an allergic reaction, they should immediately inform their doctor or nurse.

Other adverse reactions:
Common (may occur in up to 1 in 10 people)

• Taste disturbances, such as a metallic taste. This symptom usually does not last for a long time.
• Low or high blood pressure.
• Nausea.
• Reactions at the injection/infusion site, such as pain, irritation, itching, bruising, or skin discolouration due to extravasation of the medicine.

Uncommon (may occur in up to 1 in 100 people)

• Headache or dizziness.
• Abdominal pain or diarrhoea.
• Vomiting.
• Wheezing, difficulty breathing.
• Itching, rash.
• Muscle spasms, cramps, or muscle pain.
• Tingling or numbness.
• Reduced sense of touch.
• Phlebitis (inflammation of veins).
• Flushing, burning sensation.
• Constipation.
• Joint pain.
• Limb pain.
• Back pain.
• Chills.
• Weakness, fatigue.
• Swelling of hands and feet.
• Pain.
• Increased liver enzyme activity (AlAT, AspAT, GGT) in blood.
• Increased serum ferritin concentration.

Rare (may occur in up to 1 in 1,000 people)

• Fainting.
• Drowsiness or somnolence.
• Palpitations.
• Change in urine colour.
• Chest pain.
• Excessive sweating.
• Fever.
• Increased lactate dehydrogenase activity in blood.

Other adverse reactions occurring with unknown frequency include: feeling of reduced
concentration, feeling disoriented; loss of consciousness; anxiety; tremor or shaking; swelling of the face, lips,
tongue or throat, which may cause breathing difficulties; slow heart rate; fast heart rate; circulatory collapse;
phlebitis leading to blood clots; acute bronchoconstriction; itching, urticaria, rash or redness of the skin; cold sweat; general malaise; pallor; sudden, life-threatening allergic reactions (shock).
Influenza-like symptoms may occur within a few hours to several days after injection; typical
symptoms include: high body temperature and muscle and joint pain.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to: Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ferrinemia

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not freeze.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Ferrinemia contains
1 ml of solution contains 20 mg of iron as iron(III) hydroxide complexed with sucrose.
1 ampoule (5 ml) contains 100 mg of iron.
Excipients: sodium hydroxide (for pH adjustment), water for injections.

What Ferrinemia looks like and contents of the pack
Ferrinemia is a sterile, dark brown, opaque aqueous solution intended for intravenous use only, either as an injection or intravenous infusion (after dilution), containing iron(III) hydroxide complexed with sucrose. The solution also contains sodium hydroxide and water for injections.
Ferrinemia is available in 5 ml glass ampoules, each containing 100 mg of iron.
Ampoules are packed in cardboard boxes, each containing 5 ampoules.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Propius Single Member P.C., Georgiou Gennimata 124, 16561 Glifada, Greece

Manufacturer:
Help ABEE, Valaoritou 10, Metamorfosi, Attica, Greece

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Greece, the country of export: 11823/21-07-2017
Parallel Import Licence Number: 39/24

Information intended exclusively for medical professionals:

Administration
Patients must be carefully monitored for subjective and objective signs of hypersensitivity reactions during and after each administration of Ferrinemia.
Ferrinemia must be administered only under the direct supervision of medical personnel trained in the assessment and treatment of anaphylactic reactions, and in a setting fully equipped with resuscitation equipment. The patient should be monitored for adverse reactions for at least 30 minutes after each administration of Ferrinemia.

Dosage
The cumulative dose of Ferrinemia must be calculated for each patient and must not be exceeded.

Dose calculation:
The total cumulative dose of Ferrinemia, equivalent to the total iron deficit (mg), is determined based on hemoglobin concentration and body weight. The dose of Ferrinemia must be individually calculated for each patient according to the total iron deficit, using the Ganzoni formula, for example:
Total iron deficit [mg] = body weight [kg] x (target hemoglobin concentration – current hemoglobin concentration) [g/dL] x 2.4* + tissue iron stores [mg]

* Coefficient 2.4 = 0.0034 (iron content in hemoglobin = 0.34%) x 0.07 (blood volume = 7% of body weight) x 1000 (conversion factor from [g] to [mg]) x 10

Total amount of Ferrinemia drug (ml) to be administered depending on the patient's body weight,
current Hb concentration, and target Hb concentration*.

To convert hemoglobin concentration from mM to g/dl, multiply the value by 1.6.
If the total required dose exceeds the maximum allowable single dose, administration should be
divided over time. If no improvement in hematological parameters is observed after 1–2 weeks,
the initial diagnosis should be reconsidered.
Calculation of iron dose in cases of iron deficiency due to blood loss and as a supportive measure
in autologous transfusion
The dose of Ferrinemia required to correct iron deficiency can be calculated using the following
formulas:
If the volume of blood lost is known: administration of 200 mg iron (10 ml of Ferrinemia) should
result in an increase in hemoglobin concentration approximately equivalent to transfusion of 1
unit of blood (400 ml with hemoglobin concentration = 15 g/dl).

If hemoglobin concentration is lower than expected: the formula used assumes that there is no need
to replenish tissue iron stores. Required iron amount [mg] = body weight [kg] x 2.4
(target hemoglobin concentration – current hemoglobin concentration) [g/dl]

Intravenous infusion solution
Ferrinemia must be diluted in sterile 0.9% m/v sodium chloride (NaCl) solution. The medicinal product
should be diluted immediately before infusion and prepared according to the following instructions:

Intravenous injection
The Ferrinemia medicinal product may be administered by slow intravenous injection at a rate of 1 ml
of undiluted solution per minute, not exceeding a volume of 10 ml (200 mg of iron) per
injection.
Injection into the venous line of a dialysis machine
The Ferrinemia medicinal product may be administered during hemodialysis directly into the venous line of the
dialysis machine, in accordance with recommendations for intravenous injection.
Pharmaceutical incompatibilities
Do not mix the medicinal product with other medicinal products, except with sterile 0.9% sodium chloride solution for dilution.
Precipitation and/or interactions may occur when mixed with other solutions or medicinal products. Compatibility with containers other than glass, polyethylene, or PVC is unknown.
Special precautions for preparation of the medicinal product for administration
Before use, visually inspect the ampoules for presence of precipitate and for any damage. Use only ampoules containing a clear, homogeneous solution free from precipitate.
Stability and compatibility
Shelf-life after first opening of the container:
From a microbiological point of view, the medicinal product should be used immediately.
Shelf-life after dilution of the medicinal product in 0.9% m/V sodium chloride (NaCl) solution:
Chemical and physical stability of the solution is maintained at room temperature for up to 12 hours after preparation.
From a microbiological point of view, the product should be used immediately after dilution in 0.9% sodium chloride solution. If the solution is not used immediately, the person deciding on subsequent administration is responsible for determining the storage duration and conditions. This period should not exceed 3 hours at room temperature, unless the dilution was carried out under controlled aseptic conditions.