Ferrum-lek

Leaflet attached to the packaging: patient information

Ferrum Lek, 50 mg iron(III) ions/ml, solution for injection

Ferri hydroxidum dextranum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ferrum Lek and what is it used for
• 2. Important information before using Ferrum Lek
• 3. How to use Ferrum Lek
• 4. Possible side effects
• 5. How to store Ferrum Lek
• 6. Contents of the packaging and other information

1 What is Ferrum Lek and what is it used for
Ferrum Lek in the form of a solution for injection contains iron. Iron is used, among other things, in the bone marrow to produce hemoglobin (Hb).
Ferrum Lek is used to treat cases of iron deficiency that require rapid replenishment. The medicine is used especially:
in significant iron deficiency after blood loss;
in active inflammatory bowel disease, where the use of oral iron preparations is ineffective;
in cases of poor tolerance to oral preparations or lack of improvement after using oral preparations.

2. Important information before using Ferrum Lek

When not to use Ferrum Lek

if you are allergic (hypersensitive) to iron or any of the other ingredients of this medicine (listed in section 6);
if you have been diagnosed with severe hypersensitivity to other parenterally administered iron preparations;
if you have anemia caused by other factors than iron deficiency;
if you have been diagnosed with excessive iron stores in the body or disorders of its use by the body;
if you have been diagnosed with disorders of iron incorporation into the hemoglobin structure (e.g. due to lead poisoning);
if you have severe coagulation disorders caused by a developing hematoma;
if you are in the first trimester of pregnancy.

Warnings and precautions

Parenterally administered iron may cause allergic reactions or pseudoanaphylactic reactions, which can be fatal.
The risk of an allergic reaction is increased in patients with diagnosed allergies, including drug allergies, including patients with severe asthma, eczema, or other atopic allergies. The risk of allergic reactions to other parenterally administered iron preparations is also increased in patients with Crohn's disease and advanced chronic polyarthritis, systemic lupus erythematosus, rheumatoid arthritis, and in patients with reduced iron binding capacity and (or) folic acid deficiency.
Procedure in case of a severe allergic reaction or pseudoanaphylactic reaction - see information for medical professionals at the end of the leaflet.
Patients with renal or hepatic impairment will receive Ferrum Lek under close medical supervision..
In patients with heart failure and cardiovascular disease, treatment with iron preparations may cause complications from the cardiovascular system.
Please inform your doctor if the above warnings apply to your current or past situation.

Children and adolescents

The use of Ferrum Lek is not recommended in children under 4 months of age.

Ferrum Lek and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is especially true for:

• angiotensin-converting enzyme inhibitors (medicines used to treat high blood pressure, e.g. enalapril), as they enhance the effect of parenterally administered iron;
• oral iron preparations, as Ferrum Lek may weaken their absorption. Treatment with oral iron preparations can be started after at least 5 days from the last iron injection.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of the medicine during pregnancy is possible only if necessary, if in the doctor's opinion the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
It is not known whether the medicine passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

The effect of Ferrum Lek on driving and using machines is not known.

Ferrum Lek contains sodium

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

3. How to use Ferrum Lek

Ferrum Lek should always be used as directed by your doctor. If you are unsure, consult your doctor.
Your doctor will determine the dose of Ferrum Lek individually for each patient. Additional information for medical staff can be found at the end of the leaflet.
Usual dosing
Adults and the elderly
1 to 2 ampoules per day every other day (corresponding to 100 to 200 mg of iron), depending on the hemoglobin concentration.
Maximum 4 ml (2 ampoules), corresponding to 200 mg of iron.
Children
0.06 ml/kg body weight per day every other day (corresponding to 3 mg of iron/kg body weight per day). Maximum
0.14 ml/kg body weight per day (corresponding to 7 mg of iron/kg body weight per day).

Method of administration

Ferrum Lek is administered every other day exclusively intramuscularly (not intravenously), injecting deeply, alternately into the left and right buttock muscle.
After administering the medicine, the patient will be observed for about 30 minutes to see if they experience any symptoms of an allergic reaction.

Using a higher dose of Ferrum Lek than recommended

If you suspect that you have received a dose of the medicine higher than recommended, consult your doctor.
There is currently no information on overdose of iron administered by injection in the form of an iron(III) hydroxide complex with dextran.
Excessive doses of iron can cause acute complications and hemosiderosis (increased iron deposition in the body).

Missing a dose of Ferrum Lek

Do not take a double dose to make up for a missed dose.

Stopping the use of Ferrum Lek

Do not stop treatment without consulting your doctor first.
If you have any further questions about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
often (may occur in less than 1 in 10 people)
uncommonly (may occur in less than 1 in 100 people)
rarely (may occur in less than 1 in 1000 people)
very rarely (may occur in less than 1 in 10,000 people)
frequency not known (cannot be estimated from available data)
Uncommonly: blurred vision, numbness, collapse, hot flashes, bronchospasm, dyspnea, nausea, vomiting, abdominal pain, itching, urticaria, rash, eruptions, redness, muscle spasms, feeling of heat,
Rarely: pseudoanaphylactic reactions, with dyspnea, urticaria, rash, itching, nausea, chills, peripheral edema, fatigue, weakness, malaise, seizures, dizziness, anxiety (mainly motor), tremors, arrhythmias, tachycardia, chest pain and tightness, hypotension, collapse, diarrhea, angioedema, sweating, pain and discoloration of the skin at the injection site, muscle pain, altered mental status, anaphylactic reactions (which rarely include joint pain), fatigue, general malaise.
Very rarely: hemolysis, lymphadenopathy, severe pseudoanaphylactic reactions (sudden respiratory and (or) cardiovascular disorders), also fatal, headache, paresthesia, transient deafness, fetal bradycardia, palpitations, hypertension.
Frequency not known: leukocytosis, hypersensitivity reactions (including delayed reactions with joint pain, muscle pain, fever, sometimes severe), transient taste disorders (especially metallic taste in the mouth), loss of consciousness, fainting, seizures, hypoesthesia, drowsiness, impaired consciousness, confusion, anxiety, bradycardia, Kounis syndrome, sudden flushing of the skin, especially the face, phlebitis, cardiovascular collapse, thrombophlebitis, respiratory arrest, constipation, petechiae, excessive sweating, joint pain, arthritis, limb pain, back pain, change in urine color, confusion, injection site reactions (irritation, skin discoloration, itching, bleeding, formation of sterile abscesses, tissue necrosis or atrophy, pain), cold sweats, weakness, peripheral edema, malaise, pallor, fever, chills, changes in blood test results, increased activity of enzymes AlAT, AspAT, GGT, LDH, increased ferritin levels, flu-like symptoms, which may occur within a few hours to a few days after injection (typical symptoms are: high body temperature and muscle and joint pain).
Allergic reactions
Please inform your doctor immediately if you experience any of the following symptoms that may indicate a severe allergic reaction, including: dyspnea, urticaria, rash, itching, peripheral edema, sudden breathing difficulties, cardiovascular collapse, joint pain, muscle pain, fever, and chest pain, which may be a sign of a sometimes severe allergic reaction called Kounis syndrome.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ferrum Lek

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25 ° C. Do not freeze. Store in the original packaging.
The medicine should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ferrum Lek contains

1 ampoule (2 ml solution for injection) contains 100 mg of iron in the form of an iron(III) hydroxide complex with dextran.
1 ml solution for injection contains 50 mg of iron in the form of an iron(III) hydroxide complex with dextran.
The other ingredients are sodium hydroxide and hydrochloric acid (to adjust the pH), water for injections.

What Ferrum Lek looks like and contents of the packaging

Brown, opaque solution.
50 ampoules of 2 ml each

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Sandoz logo

Date of last revision of the leaflet: --------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals:

Instructions for the use of Ferrum Lek

Improper storage of ampoules may cause precipitation. Before administration, the contents of the ampoule should be inspected. Only ampoules without precipitate, containing a homogeneous solution, can be used. Ampoules with visible precipitate or after the expiry date should be destroyed.
The contents of the ampoule should be used immediately after opening.
Ferrum Lek should not be mixed with other medicinal products.
To avoid pain and skin discoloration, Ferrum Lek should be administered carefully and in the correct manner: the medicine is injected intramuscularly with a 5-6 cm needle (in the upper outer quadrant of the buttock muscle). Before injection, the skin should be cleaned and the subcutaneous tissue should be pressed firmly to a depth of 2 cm to minimize potential leakage of the administered medicine. After administration of the preparation, the injection site should be pressed for one minute.
Calculating the dose of the medicine to be administered to the patient:
Dose determination
The doctor determines the dose of Ferrum Lek individually for each patient, using the following formula:
Total amount of iron that the patient should receive (total iron deficiency) [mg]=
body weight [kg] x (target Hb concentration [g/l] - actual Hb concentration [g/l]) x 0,24 + tissue iron stores [mg].

Total iron deficiency [mg]
Number of Ferrum Lek ampoules =
100 mg
Table 1.
Number of Ferrum Lek ampoules to be administered depending on the patient's current hemoglobin concentration and body weight.
If the calculated number of ampoules is higher than the recommended maximum daily dose, the doctor will precisely determine the duration of treatment.

Total dose in case of iron deficiency caused by blood loss:

If the amount of lost blood is known:
Administration of 200 mg of iron (2 ampoules) results in an increase in Hb concentration corresponding to the transfusion of 1 unit of blood.
Total amount of iron to be administered [mg] = number of lost blood units x 200
Number of Ferrum Lek ampoules = number of lost blood units x 2
If the Hb deficiency is known (assuming that tissue stores do not need to be replenished):
Total amount of iron to be administered [mg] =
body weight [kg] x (target Hb concentration [g/l] - actual Hb concentration [g/l]) x 0,24

Anaphylactic/pseudoanaphylactic reactions

Ferrum Lek should be administered only under the direct supervision of medical personnel trained in the assessment and treatment of anaphylactic reactions, in a fully equipped resuscitation facility. Patient observation should last at least 30 minutes after each administration of the medicinal product. If hypersensitivity reactions or intolerance symptoms occur during treatment, treatment should be discontinued immediately. Resuscitation equipment and equipment for the treatment of acute anaphylactic or pseudoanaphylactic reactions (including adrenaline injection solution at a concentration of 1:1000) should be available. If necessary, antihistamines and (or) corticosteroids should also be used.

Administration of a higher dose of Ferrum Lek than recommended

If the patient has received too high a dose of Ferrum Lek, supportive treatment is used, and if necessary, a chelating agent (e.g. deferoxamine in a maximum dose of 15 mg/kg body weight/hour) is administered.

15 mg/kg body weight/hour).

Stability and compatibility

Ferrum Lek should not be mixed with other medicinal products.