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A medicinal product developed for intravenous administration in cases of anemia due to iron deficiency.
Active substance: each 5 ml ampoule contains iron (III) hydroxide sucrose complex equivalent to 100 mg (20 mg/ml) of elemental iron.
Excipients: sodium hydroxide and water for injection
What is FERUMVAL and what is it used for?
A medicinal product developed for intravenous administration in cases of anemia due to iron deficiency. Iron, the active substance of Ferumval, is an essential substance for the transport of oxygen in the blood.
FERUMVAL is used:
• if anemia has developed due to impaired absorption of iron from the gastrointestinal tract,
• if anemia due to iron deficiency has developed as a result of severe bleeding from the gastrointestinal tract;
• if iron deficiency and anemia have developed due to removal of all or part of the stomach,
• in patients who have anemia due to iron deficiency and cannot tolerate oral iron intake,
• in patients who have developed anemia due to iron deficiency and in whom oral iron does not have sufficient effect;
• if your doctor has decided that your iron stores need to be replenished rapidly and therefore iron is administered,
• in patients with iron deficiency who have chronic renal failure, whether or not they are dependent on dialysis (a blood purification process), and who are receiving erythropoietin (EPO) (a hormone that stimulates blood production).
Ferumval is not recommended during the first trimester. During the second and third trimesters it should be used when the doctor considers it necessary.
Do not use FERUMVAL if:
• you are allergic (hypersensitive) to Ferumval or any of its ingredients or excipients,
• you have ever had allergic (hypersensitivity) reactions to another injectable iron medicine,
• your body is overloaded with iron or you have a disorder of iron utilization,
• your anemia is not caused by iron deficiency.
If any of the above apply to you, you should not take FERUMVAL. If you are not sure, talk to your doctor before taking Ferumval.
Take special care with Ferumval in the following cases:
Although rare, life-threatening allergic events such as weakness, low blood pressure, respiratory distress, and convulsions may occur after the use of Ferumval. Such events are observed with intravenous administration of many iron-containing products. For this reason, during intravenous administration of FERUMVAL, the necessary equipment for emergency life support should be prepared as a precaution.
Inform your doctor:
• if you have a history of drug allergy,
• if you have liver disease or conditions such as infections, asthma, eczema, allergies,
• if you have systemic lupus erythematosus (a connective tissue disease characterized by fever, weakness, fatigue, joint pain, and widespread skin rash on the face, neck, and arms),
• if you have rheumatoid arthritis (a disease characterized by widespread joint pain and structural changes in joints, especially affecting many joints of the hands and feet).
In children, ingestion of iron-containing products may cause fatal poisoning.
Improper use of FERUMVAL may cause leakage of the product from the injection site, which can cause skin irritation and potentially long-lasting brown discoloration at the injection site. In such cases, administration should be stopped immediately.
If any of these warnings apply to you, even in the past, please consult your doctor.
Pregnancy: Consult your doctor or pharmacist before using this medicine. Ferumval has not been studied in women during the first three months of pregnancy. If you are pregnant or planning to become pregnant, it is important to share this information with your doctor. Your doctor will decide whether you should receive this medicine.
If you find out that you are pregnant during treatment, consult your doctor immediately.
Breast-feeding: Consult your doctor or pharmacist before using this medicine. There is no information on the excretion of Ferumval iron into human milk.
Driving and using machines:In patients receiving Ferumval intravenously, symptoms of confusion or dizziness may occur. Patients should not drive or use machines until the symptoms have resolved.
Important information about some of the ingredients of Ferumval:
This medicinal product contains less than 1 mmol (23 mg) of sodium per 5 ml; it is “sodium-free”.
Use with other medicines:
Since Ferumval may reduce the absorption of orally administered iron from the intestines, it should not be taken together with oral iron preparations. Oral iron therapy should be started at least 5 days after the final dose of Ferumval.
If you are using or have recently used any prescribed or non-prescribed medicines, please inform your doctor or pharmacist.
How to use FERUMVAL?
Your doctor will decide how much Ferumval you need. They will also decide how often and for how long you need it. Your doctor will perform blood tests to calculate the dose. Your doctor or nurse will administer Ferumval in one of the following ways:
Slow injection into your vein – 1 to 3 times per week.
As an infusion (drip) into a vein – 1 to 3 times per week.
During dialysis – it will be placed into the venous line of the dialysis machine.
Ferumval will be given to you in a setting where allergic reactions can be properly managed.
Route and method of administration: Ferumval is a medicinal product that should be administered only intravenously.
Use in children: Parenteral use of iron preparations in children is not recommended.
Use in the elderly: No dose adjustment is required in elderly patients.
Special cases:
No dose adjustment is required in patients with renal insufficiency.
In case of hepatic insufficiency, consult your doctor or pharmacist.
If you feel that the effect of Ferumval is too strong or too weak, consult your doctor or pharmacist.
If you use more FERUMVAL than you should: If you have received more Ferumval than required, consult your doctor or pharmacist.
If you miss a dose of Ferumval: Do not use a double dose to make up for a missed dose.
Possible side effects:
If you experience any of the following, stop using Ferumval and inform your doctor immediately or go to the emergency department of the nearest hospital:
• Allergic reactions (low blood pressure [dizziness, lightheadedness, weakness], swelling of the face, difficulty breathing, chest pain, which may be signs of a potentially serious allergic reaction called Kounis syndrome).
In some patients these allergic reactions may be serious and life-threatening (known as anaphylactoid or anaphylactic). If you think you have had an allergic reaction, inform your doctor or nurse immediately.
Other side effects include:
• Temporary taste disturbances
• Low or high blood pressure
• Feeling sick (nausea)
• Reactions at the injection/infusion site such as pain, irritation, itching, hematoma, or discoloration after leakage into the skin.
Uncommon
• Itching and rash
• Muscle spasms, painful cramps
• Difficulty breathing, shortness of breath
• Headache
• Feeling dizzy
• Tingling
• Loss or reduction of sensitivity to touch (topagnosia)
• Swelling of veins due to clot formation
• Inflammation of blood vessels
• Vomiting
• Stomach pain
• Redness, burning sensation
• Constipation
• Diarrhea
• Joint pain
• Pain in hands and feet
• Back pain
• Feeling cold
• Weakness and fatigue
• Swelling of hands and ankles
• Increase in liver enzymes (ALT, AST, GGT) in the blood
• Increase in serum ferritin levels
• Persistent muscle pain
Rare
• Fainting
• Insomnia or feeling sleepy
• Palpitations
• Change in urine color
• Chest pain
• Increased sweating
• Fever
• Increased blood lactate dehydrogenase values (an indicator of tissue damage)
Unknown
• Feeling confused
• Reduced concentration, impaired concentration
• Feeling of tension
• Tremor
• Swelling of the face, mouth, tongue, or throat (angioedema), which may make breathing difficult
• Decreased heart rate
• Increased heart rate
• Circulatory collapse
• Inflammation of veins, which may cause blood clotting
• Sudden narrowing of the airways
• Itching
• Red skin blisters and itching, skin rash
• Cold sweating
• General feeling of illness
• Pale skin
• Sudden life-threatening allergic reactions
• Kounis syndrome (allergic reactions with chest pain)
• Flu-like symptoms (may appear from several hours to several days after administration and are characterized by muscle and joint pain, especially with high fever).
How to store FERUMVAL?
Keep FERUMVAL out of the reach of children and in the original packaging.
Store below 25˚C and in the original packaging. Do not freeze.
Use according to the expiry date. Do not use FERUMVAL after the expiry date stated on the package.
From a microbiological point of view, the product should be used immediately after opening.
Do not use FERUMVAL if you notice defects in the product and/or packaging. Do not dispose of expired or unused medicines! Hand them over to the collection system defined by the Ministry of Environment, Urbanization and Climate Change.
Instructions for use and handling:
Before use, ampoules or vials should be visually inspected for sediment and damage. Use only those containing a clear and homogeneous solution without sediment.
The diluted solution should be brown and transparent.
Method of administration:
During use of Ferumval, paravenous leakage should be avoided. If paravenous leakage occurs, pain, inflammation, and brown discoloration may occur.
Intravenous drip infusion
Ferumval should be diluted only in sterile 0.9% sodium chloride (NaCl) solution. Dilution should be carried out immediately before infusion and the solution should be administered as follows:
Ferumval injection dose (mg iron) – 50 mg
Ferumval injection dose (ml Ferumval injection) – 2.5 ml
Maximum dilution volume of sterile 0.9% w/v NaCl solution – 50 ml
Minimum infusion time – 8 minutes
Ferumval injection dose (mg iron) – 100 mg
Ferumval injection dose (ml Ferumval injection) – 5 ml
Maximum dilution volume of sterile 0.9% w/v NaCl solution – 100 ml
Minimum infusion time – 15 minutes
Ferumval injection dose (mg iron) – 200 mg
Ferumval injection dose (ml Ferumval injection) – 10 ml
Maximum dilution volume of sterile 0.9% w/v NaCl solution – 200 ml
Minimum infusion time – 30 minutes
For stability reasons, dilution to reduce the concentration of Ferumval is not permitted.
Incompatibilities:
Ferumval must not be mixed with other medicinal products except sterile 0.9% w/v sodium chloride solution. Precipitation and/or interaction may occur when mixed with other solutions or medicinal products. Compatibility with containers other than glass, polyethylene, and PVC is unknown.
Mode of supply:Pharmaceutical product group II, supplied with prescription form No. 3
Marketing authorization holder:
VEM İlaç San. ve Tic. A.Ş.
Maslak Mahallesi AOS 55. Sokak
42 Maslak A Blok Sit. No: 2/134
Sarıyer/İSTANBUL/TÜRKİYE
Manufacturing site:
VEM İlaç San. ve Tic. A.Ş.
Çerkezköy Organized Industrial Zone
Karaağaç Mah. Fatih Bulv. No: 38
Kapaklı/TEKİRDAĞ/TÜRKİYE
