Properties
What is it?
Active substance: Each 5ml ampoule contains Iron (III) hydroxide sucrose complex, equivalent to 100mg (20mg/ml) of elemental iron. Excipient(s): Sodium hydroxide and water for injection. What is FERUMVAL and what is it used for? A preparation developed for intravenous administration in cases of iron deficiency anemia. Iron, the active substance of FERUMVAL, is an essential substance for oxygen transport in the blood. FERUMVAL is used: • If anemia has developed due to impaired iron absorption from the gastrointestinal tract, • If iron deficiency anemia has developed due to severe bleeding from the gastrointestinal tract; • If iron deficiency and anemia have developed due to the removal of all or part of the stomach, • In patients who have iron deficiency anemia and who cannot tolerate oral iron, • In patients who have developed iron deficiency anemia and whose oral iron is not sufficiently effective; • If your doctor has decided that your iron stores need to be replenished quickly and therefore iron is administered • Used in the presence of iron deficiency in patients with chronic renal failure who are not on dialysis (blood purification process), who are taking erythropoietin (EPO) (a hormone that stimulates blood production). FERUMVAL is not recommended in the first trimester. In the second and third trimesters, it should be used when the doctor deems 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 (hypersensitive) reactions to other injectable iron medicines, • Your body is overloaded with iron or if you have a problem with iron utilization, • If your anemia is not caused by iron deficiency. If any of the above apply to you, you should not take FERUMVAL. If you are unsure, talk to your doctor before taking FERUMVAL. Take special care with FERUMVAL in the following cases: Although rare, life-threatening allergic events such as collapse, low blood pressure, respiratory distress, and convulsions may occur after the use of FERUMVAL. Such events are observed with the intravenous administration of many iron-containing preparations. For this reason, the necessary equipment for emergency life support should be prepared with caution during the intravenous administration of FERUMVAL. Inform your doctor: • If you have a history of drug allergies, • If you have liver disease or have diseases such as infections, asthma, eczema, allergies, • If there is systemic lupus erythematosus (a connective tissue disease characterized by fever, weakness, fatigue, joint pain, and a widespread skin rash on the face, neck, and arms), • If you have rheumatoid arthritis (a disease characterized by widespread joint pain and damage to joint structure, especially affecting many joints in the hands and feet). In children, the intake of iron-containing products can cause fatal poisoning. Improper use of FERUMVAL can cause leakage of the product from the injection site, leading to skin irritation and potentially a long-lasting brown discoloration at the injection site. In such cases, administration into the body should be stopped immediately. In case any of these warnings apply to you, even in the past, please consult your doctor. Pregnancy: Consult your doctor or pharmacist before using the preparation. FERUMVAL has not been studied in women in the first trimester 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 to take this medicine. If you find out you are pregnant during treatment, consult your doctor immediately. Breastfeeding: Consult your doctor or pharmacist before using the preparation. There is no information about the excretion of FERUMVAL iron into human milk. Driving and operating machinery: Patients using FERUMVAL intravenously may experience symptoms of confusion or dizziness. Patients should not drive or operate machinery until the symptoms have stopped. Important information about some ingredients of FERUMVAL: This medicinal product contains less than 1 mmol (23 mg) of sodium per 5 ml; it is "sodium-free". Taking with other medicines: Since FERUMVAL can reduce the absorption of orally administered iron from the intestines, it should not be taken with oral iron preparations. Oral iron therapy should be carried out at least 5 days after the last dose of FERUMVAL. If you are taking or have recently taken any prescription or over-the-counter medicines, please inform your doctor or pharmacist. How to use FERUMVAL? Your doctor will decide how much FERUMVAL dose. He will also decide how often you need it and for how long. 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 a week. - As an infusion (drip) into your vein - 1 to 3 times a week. - During dialysis - it will be placed in the venous line of the dialysis machine. FERUMVAL will be given to you in an environment where appropriate management of allergic reactions can be provided. Route and method of administration: FERUMVAL is a preparation that should only be administered intravenously. Use in children: Parenteral administration of iron preparations in children is not recommended. Use in the elderly: Dose adjustment is not required in elderly patients. Special cases: Dose adjustment is not required in patients with renal failure. In case of liver failure, 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 take more FERUMVAL than you should: If you have more FERUMVAL than you need, consult your doctor or pharmacist. If you miss a dose of FERUMVAL: Do not take 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 nearest hospital emergency department: • Allergic reactions (low blood pressure (dizziness, lightheadedness, fainting), facial swelling, difficulty breathing, chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome). In some patients, these allergic reactions can 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 blood pressure 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 at the injection site. Uncommon • Itching and rash • Muscle spasms, painful cramps • Difficulty breathing, shortness of breath • Headache • Feeling dizzy • Tingling • Loss or decrease in sensitivity to touch (topagnosis) • Swelling of veins due to clot formation • Inflammation of blood vessels • Vomiting • Stomach pain • Redness with a burning sensation. • Constipation • Diarrhea • Joint pain • Hand and foot pain • Back pain • Feeling cold • Weakness and fatigue • Swelling in hands and ankles • Increase in liver enzymes (ALT, AST, GGT) in the blood • Increase in serum ferritin levels • Persistent muscle pain Rare • Dizziness • Insomnia or feeling sleepy • Palpitations • Change in urine color • Chest pain • Increased sweating • Fever • Increase in blood lactate dehydrogenase values (indication of tissue damage) Unknown • Feeling confused • Decreased concentration, suppressed concentration • Feeling of tension • Tremor • Swelling of the face, mouth, tongue or throat (angioedema), which may make breathing difficult • Slowing of heart rate • Increased heart rate • Circulatory arrest • Inflammation of veins, which may lead to blood clots • Sudden narrowing of the airways • Itching • Red blistering and itching of the skin, rash on the skin • Cold sweats • General feeling of illness • Pale skin • Sudden life-threatening allergic reactions • Kounis syndrome (allergic reactions with chest pain) • Flu-like symptoms (may occur from a few hours to a few days after taking the medicine and are characterized by muscle and joint pain with high fever.) How to store FERUMVAL? - Keep FERUMVAL out of reach of children and in its original packaging. - Store below 25°C and in its original packaging. Do not freeze. - Use according to the expiry date. Do not use FERUMVAL after the expiry date indicated on its packaging. - From a microbiological point of view, the product should be used immediately after opening. - Do not use FERUMVAL if you notice a defect in the product and/or packaging. Do not dispose of expired or unused medicines! Give them to the collection system determined by the Ministry of Environment, Urbanization and Climate Change. Instructions for use and handling: Before use, ampoules or vials should be visually inspected for precipitation and damage. Use only those that contain a non-precipitated and homogeneous solution. The diluted solution should be brown and transparent. Method of administration: - Extravasation should be avoided when using FERUMVAL. If extravasation occurs, there may be pain, inflammation, and brown discoloration. Intravenous drip infusion - FERUMVAL should only be diluted with sterile 0.9% sodium chloride (NaCl) solution. Dilution should be done immediately before infusion and the solution should be administered as follows: FERUMVAL injection dose (mg iron) - 50mg FERUMVAL injection dose (ml FERUMVAL injection) - 2.5ml Maximum dilution volume of sterile 0.9% w/v NaCl solution - 50ml Minimum infusion time - 8 minutes FERUMVAL injection dose (mg iron) - 100mg FERUMVAL injection dose (ml FERUMVAL injection) - 5ml Maximum dilution volume of sterile 0.9% w/v NaCl solution - 100ml Minimum infusion time - 15 minutes FERUMVAL injection dose (mg iron) - 200mg FERUMVAL injection dose (ml FERUMVAL injection) - 10ml Maximum dilution volume of sterile 0.9% w/v NaCl solution - 200ml Minimum infusion time - 30 minutes For stability reasons, dilution to reduce the concentration of FERUMVAL is not permitted. Incompatibility: FERUMVAL should not be mixed with any other medicinal products except sterile 0.9% w/v sodium chloride solution. There is a risk of precipitation and/or interaction if mixed with other solutions or medicinal products. Compatibility with containers other than glass, polyethylene, and PVC is unknown. Dispensing rule: Pharmaceutical product group II, dispensed with prescription form No. 3 Marketing authorization holder: VEM İlaç San. ve Tic. A.Ş. Maslak Mahallesi AOS 55. Sokakı42 Maslak A Blok Sit. No: 2/134 Sarıyer/İSTANBUL/TÜRKİYE Manufacturing site: VEM İlaç San. ve Tic. A.Ş. Çerkezköy Organize Sanayi Bölgesi Karaağaç Mah. Fatih Bulv.. No: 38 Kapaklı/TEKİRDAĞ/TÜRKİYE