Ferrinemia

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Ferrinemia

20 mg iron(III) ions/ml, solution for injection and infusion

Ferri hydroxidum saccharum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Ferrinemia and what is it used for
• 2. Important information before administering Ferrinemia to the patient
• 3. How to administer Ferrinemia
• 4. Possible side effects
• 5. How to store Ferrinemia
• 6. Contents of the pack and other information

1. What is Ferrinemia and what is it used for

Ferrinemia solution for intravenous injection replenishes the body's iron stores.
Iron is used in the bone marrow to produce hemoglobin (Hb).
Ferrinemia is used to treat iron deficiency cases that require supplementation. The medicine is used especially:

• if there is a clinical need for rapid replenishment of systemic iron stores,
• in patients who do not tolerate oral iron preparations or in whom such medicinal products cannot be administered,
• if 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 anemia that is not caused by iron deficiency;
• if the patient's iron level is too high or their body does not use iron properly;
• if the patient is allergic (hypersensitive) to the medicine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had severe allergic reactions (hypersensitivity) to other injectable iron preparations.

Do not administer Ferrinemia if any of the above points apply. In case of doubt before starting treatment with Ferrinemia, consult your doctor.

Warnings and precautions

Before starting treatment with Ferrinemia, discuss it with your doctor or nurse:

• if the patient has a history of drug allergy;
• 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.

In case of doubt, whether the above points apply, consult your doctor or pharmacist before starting treatment with Ferrinemia.

Ferrinemia and other medicines

Like all iron preparations for parenteral administration, Ferrinemia should not be used simultaneously with oral iron preparations, as the absorption of oral preparations is reduced in this case.

Pregnancy and breastfeeding

Ferrinemia has not been studied for use in the first three months of pregnancy. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or plan to have a baby.
If you become pregnant during treatment, consult your doctor.
Your doctor will decide whether you should receive Ferrinemia.
If you are breastfeeding, consult your doctor before taking Ferrinemia.

Driving and using machines

After administering Ferrinemia, symptoms such as dizziness, disorientation, or fainting may occur. In this case, the patient should not drive vehicles or operate machines until the symptoms have resolved. In case of doubt, consult your 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 to administer Ferrinemia

Your doctor will decide what dose of Ferrinemia you should receive. Your doctor will also decide how often and for how long you should receive the medicine. To adjust the dose, your doctor will perform blood tests.
Your doctor or nurse will administer Ferrinemia in one of the following ways:

• slow intravenous injection - 1 to 3 times a week;
• as an intravenous infusion - 1 to 3 times a week;
• during dialysis - the medicine will be administered into the venous line of the dialysis machine. Ferrinemia can only be administered in locations where immediate and appropriate medical care is available in case of an allergic reaction. After each administration of the medicine, the patient should be monitored by a doctor or nurse for at least 30 minutes to detect any side effects.

4. Possible side effects

Like all medicines, Ferrinemia can cause side effects, although not everybody gets them.
The most commonly reported side effects in clinical trials were: changes in taste, such as metallic taste, low or high blood pressure, reaction at the injection/infusion site, nausea.
Allergic reactions(may affect up to 1 in 100 people)
If the patient experiences an allergic reaction, they should immediately inform their doctor. Symptoms may include:

• Low blood pressure (dizziness, fainting, loss of consciousness).
• Facial swelling.
• Breathing difficulties.
• Chest pain, which can be a symptom of a sometimes severe allergic reaction called Kounis syndrome. If the patient thinks they have had an allergic reaction, they should immediately inform their doctor or nurse.

Other side effects:

Common(may affect up to 1 in 10 people)

• Changes in taste, such as 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, hematoma, or skin discoloration due to extravasation of the medicine.

Uncommon(may affect up to 1 in 100 people)

• Headache or dizziness.
• Abdominal pain or diarrhea.
• Vomiting.
• Wheezing, breathing difficulties.
• Itching, rash.
• Muscle spasms, cramps, or muscle pain.
• Numbness or tingling.
• Reduced sensation of touch.
• Phlebitis.
• Flushing, burning sensation.
• Constipation.
• Joint pain.
• Pain in limbs.
• Back pain.
• Chills.
• Weakness, fatigue.
• Swelling of hands and feet.
• Pain.
• Increased liver enzyme activity (AlAT, AspAT, GGT) in the blood.
• Increased ferritin levels in serum.

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

• Fainting.
• Somnolence or lethargy.
• Palpitations.
• Change in urine color.
• Chest pain.
• Excessive sweating.
• Fever.
• Increased lactate dehydrogenase activity in the blood.

Other side effects with unknown frequency include: feeling of decreased concentration, feeling of disorientation; loss of consciousness; anxiety; tremors or shaking; facial, lip, tongue, or throat swelling, which can cause breathing difficulties; slow heart rate; fast heart rate; circulatory collapse; phlebitis causing thrombosis; acute bronchospasm; itching, urticaria, rash, or skin redness; cold sweat; general malaise; pale skin; sudden, life-threatening allergic reactions (anaphylaxis). Flu-like symptoms may occur within a few hours to a few days after injection; typical symptoms are: high body temperature and muscle and joint pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to: Department of Adverse Reaction Monitoring 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 side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferrinemia

Keep the medicine out of the 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 month stated.
Do not store above 25°C. Do not freeze.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ferrinemia contains

1 ml of the solution contains 20 mg of iron in the form of an iron(III) hydroxide complex with sucrose.
1 ampoule (5 ml) contains 100 mg of iron.
Excipients: sodium hydroxide (to adjust pH), water for injections.

What Ferrinemia looks like and contents of the pack

Ferrinemia is a sterile, dark brown, non-transparent aqueous solution, intended for intravenous use only, in the form of injections or intravenous infusions (after dilution), containing an iron(III) hydroxide complex 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. The ampoules are packaged in cardboard boxes; each box contains 5 ampoules.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Greek marketing authorization number: 11823/21-07-2017

Parallel import authorization number: 39/24

Date of leaflet approval: 25.01.2024

__________________________________________________________________________

Information intended for healthcare professionals only:

Administration

Patients should be closely monitored to detect subjective and objective signs of hypersensitivity reactions during and after each administration of Ferrinemia.
Ferrinemia should be administered only under the direct supervision of medical personnel trained in the evaluation and treatment of anaphylactic reactions, in a location equipped with resuscitation equipment. The patient should be monitored for side effects 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 deficiency (mg), is determined based on hemoglobin concentration and body weight. The dose of Ferrinemia must be calculated for each patient based on the total iron deficiency, according to the Ganzoni formula, for example:

Total iron deficiency [mg] = body weight [kg] x (target hemoglobin concentration – current hemoglobin concentration) [g/dl] x 2.4* + tissue iron stores [mg]

* Factor 2.4 = 0.0034 (iron content in hemoglobin = 0.34%) x 0.07 (blood volume = 7% of body weight) x 1000 (conversion factor [g] to [mg]) x 10
The total amount of Ferrinemia (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 first value by 1.6.
If the total required dose exceeds the maximum allowed single dose, the dose should be divided over time. If after 1-2 weeks, no improvement in hematological parameters is observed, the correctness of the initial disease diagnosis should be reconsidered.
Calculating the iron dose in case of iron deficiency due to blood loss and as a supportive measure during autologous transfusion
The dose of Ferrinemia required to replenish iron deficiency can be calculated according to the following formulas:
If the volume of lost blood is known: administration of 200 mg of iron (10 ml of Ferrinemia) should result in an increase in hemoglobin concentration corresponding to approximately one unit of blood (400 ml with a hemoglobin concentration of 15 g/dl).
If the hemoglobin concentration is lower than expected: the applied formula 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
Ferrinemia must be diluted in a sterile 0.9% m/V sodium chloride (NaCl) solution. The medicine should be diluted immediately before infusion and prepared according to the following instructions:

Intravenous injection
Ferrinemia can 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
Ferrinemia can be administered during hemodialysis directly into the venous line of the dialysis machine, according to the instructions for intravenous injection.

Incompatibilities

Do not mix Ferrinemia with other medicines, except for a sterile 0.9% m/V sodium chloride solution for dilution.
There is a possibility of precipitation and/or interaction when mixed with other solutions or medicines. The compatibility of Ferrinemia with containers other than glass, polyethylene, or PCV is not known.

Special precautions for preparation and handling

Before use, visually inspect the ampoules for any precipitate and check for damage. Only use ampoules containing a clear, homogeneous solution.

Stability and compatibility

Shelf life after opening the container:
From a microbiological point of view, the medicine should be used immediately.
Shelf life after dilution in a 0.9% m/V sodium chloride (NaCl) solution:
The chemical and physical stability of the solution after preparation is maintained at room temperature for up to 12 hours.
From a microbiological point of view, the preparation should be used immediately after dilution in a 0.9% sodium chloride solution. Unless the solution is used immediately, the person who decided to administer the solution later is responsible for determining the storage time and conditions. This time should not exceed 3 hours at room temperature, unless the dilution of the medicine was performed under controlled aseptic conditions.