INSTRUCTIONS FOR MEDICAL USE
Trade name of the drug: FERRAT-C®
Active substance (INN): polymaltose complex of iron (III) hydroxide.
Dosage form: solution for injection 100 mg/2 ml
2 ml of the solution (1 ampoule) contains:
Active ingredient: iron (III) hydroxide polymaltose complex – 322.5 mg (in terms of elemental iron 100 mg)
Excipients: sodium chloride, sodium hydroxide, water for injection.
Description: red-brown colored solution.
Pharmacotherapeutic group: agents stimulating erythropoiesis.
ATX code: B03AC.
Anti-anemic drug. After intramuscular (I/m) administration, iron from polymaltose complex of iron (III) hydroxide as an active ingredient is mainly accumulated in liver. There it is included in hemoglobin, myoglobin and iron-containing enzymes, as well as stored in the body as ferritin. The blood count response with parenteral administration of iron is not faster than with oral administration of iron salts in patients in whom they are effective. Like other iron preparations, it has no effect on erythropoiesis and is ineffective in anemia not associated with iron deficiency.
After intravenous administration, the complex enters the bloodstream via the lymphatic system (15% of the dose after 15 minutes, 44% after 30 minutes). Maximum concentration (Cmax) of iron is reached approximately 24 hours after injection. From plasma, the macromolecular complex enters the reticulo-endothelial system, where it splits into iron hydroxide and polymaltose. In the bloodstream, iron binds with transferrin and is stored in tissues as ferritin. In the bone marrow it is incorporated into hemoglobin and used in the process of erythropoiesis. Half-life (T1/2) is 3-4 days. Only small amounts of iron are excreted from the body. Polymaltose is metabolized by oxidation and excreted by the kidneys.
There are no data on pharmacokinetics of the drug in patients with iron deficiency anemia. It is well known that iron incorporation into protoporphyrin depends on the severity of iron deficiency anemia. It is more intensive in case of a low hemoglobin level and decreases with the normalization of the hemoglobin level.
Indications for use
The product is used for the treatment of iron deficiency in cases of blood loss, inefficiency or impossibility of oral administration of iron-containing drugs (e.g: In persons who cannot tolerate or do not respond to oral iron therapy, in patients suffering from malabsorption or who do not agree to take oral iron preparations on a long-term and regular basis, in patients with gastrointestinal diseases (e.g. ulcerative colitis), in whom oral iron preparations may provoke an exacerbation of the disease.)
Dosage and administration
The solution is administered only v/m! Before the first therapeutic dose of the drug, a test in m/m should be carried out. Adults shall be administered from 1/4 to 1/2 dose (25 to 50 mg of iron), children – half of the daily dose. If there are no adverse reactions within 15 minutes of administration, the remainder of the initial dose can be administered. Emergency treatment for anaphylactic shock should be available.
The dose of the drug is calculated individually and adjusted according to total iron deficiency using the following formula:
Total iron deficiency (mg) = body weight (kg) × (normal Hb level – patient’s Hb level) (g/l × 0.24* + iron reserves (mg).
For body weight less than 35 kg: normal Hb = 130 g/l, which corresponds to iron stores = 15 mg/kg body weight.
At body weight above 35 kg: normal Hb = 150 g/L, corresponding to iron stores = 500 mg.
- Factor 0.24 = 0.0034×0.07×1000 (Hb iron content = 0.34%, blood volume =7% of body weight, factor 1000 = conversion from g to mg)
- Total number of ampoules to administer = total iron deficiency (mg) 100 mg
Table for calculating the total number of ampoules for one patient depending on body weight and Hb level
|Body weight, kg||Total number of ampoules per course of treatment|
If the required dose exceeds the maximum daily dose, the drug should be administered in fractions.
Adults: 1 ampoule daily (2.0 ml = 100 mg of iron)
Children: The dosage is determined according to the body weight.
Maximum permissible daily doses:
|Children up to 5 kg:||1/4 ampoules(0.5 ml = 25 mg of iron)|
|Children weighing from 5 to 10 kg:||1/2 ampoules(1.0 ml= 50 mg of iron)|
|Adults:||2 ampoules(4.0 ml= 200 mg of iron)|
If there is no response from hematologic parameters after 1-2 weeks (e.g., an increase in Hb levels of about 0.1 g/dL per day), the initial diagnosis should be reconsidered. The total dose of drug per course of treatment should not exceed the calculated number of ampoules.
The injection technique is critical. Incorrect injection technique can result in pain and staining of the skin at the injection site. The ventro-gluteal injection technique described below is recommended instead of the commonly used – in the upper outer quadrant of the greater gluteal muscle:
Needle length should be at least 5 – 6 cm. Needle lumen should not be too wide. For children, as well as for adults with low body weight, needles should be shorter and thinner.
According to Hochstetter recommendations, the place of injection is determined as follows: along the line of the spinal column at the level corresponding to the lumbosacral junction, fix point A. If the patient is lying on the right side, place the middle finger of the left hand at point A. Place the index finger away from the middle finger so that it is below the iliac crest line at point B. The triangle located between the proximal phalanges, middle and index fingers is the injection site.
Instruments are disinfected in the usual manner
Before inserting the needle, move the skin about 2 cm in order to close the puncture channel well after removing the needle. This prevents the injected solution from penetrating the subcutaneous tissues and staining the skin.
Position the needle vertically in relation to the skin surface, at a greater angle to the point of the iliac joint than to the point of the femoral joint.
After the injection, slowly remove the needle and press the area of skin adjacent to the injection site with your finger for about 5 minutes. After the injection, the patient needs to move around.
Digestive system: nausea, vomiting.
Central nervous system: headache, dizziness. Fever
Local reactions: skin staining, pain and inflammatory reaction at the injection site may occur if the technique of injection is inappropriate.
Other: arterial hypotension, arthralgia, enlarged lymph nodes. malaise: extremely rare – allergic or anaphylactic reactions.
Anemia not related to iron deficiency (e.g., hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency, disorders of erythropoiesis, bone marrow hypoplasia); excess iron (i.e. Hemochromatosis, hemosiderosis); impaired iron utilization (e.g., sideroachrestic anemia, thalassemia, lead anemia, late skin porphyria); Osler-Randu-Weber syndrome; chronic polyarthritis; bronchial asthma; acute stage of infectious kidney disease; uncontrolled hyperparathyroidism; decompensated cirrhosis of the liver; infectious hepatitis; pregnancy (first trimester), use for intravenous (IV) injection, hypersensitivity to components of the drug.
As all other parenteral iron drugs, this drug should not be used concomitantly with oral iron-containing drugs, because the absorption of the latter from the gastrointestinal tract is reduced. Therefore, treatment with oral iron-containing drugs should not be started earlier than 1 week after the last injection.
Simultaneous use of ACE inhibitors (e.g., Enalapril) may increase the systemic effects of parenteral iron preparations.
The drug is administered only when iron deficiency has been confirmed by appropriate tests (e.g. by measuring serum ferritin, hemoglobin, hematocrit or erythrocyte count as well as their parameters – average erythrocyte volume, average Hb content in an erythrocyte or average Hb concentration in an erythrocyte). Administration in children under 4 months of age is not recommended due to lack of experience.
The drug is used in patients with clear indications for administration of the drug, with obligatory determination of plasma ferritin level and erythrocyte count in peripheral blood. In case of suspected iron absorption disorders, an iron absorption test should be performed.
Before use, ampoules should be inspected for sediment and damage. Only ampoules without precipitate and damage may be used. After opening the ampoule, the drug should be administered immediately. The drug should not be mixed with other drugs. In case of moderately pronounced allergic reactions, antihistamines should be prescribed; if a severe anaphylactic reaction develops, adrenaline should be administered immediately. Cardiopulmonary resuscitation must be available. Caution should be exercised when administering the drug to patients with allergies, as well as those with hepatic and renal insufficiency.
Side effects occurring in patients with cardiovascular diseases may aggravate the course of the underlying disease.
Patients with bronchial asthma or those with low serum iron-binding capacity and/or folic acid deficiency are at high risk of allergic or anaphylactic reactions.
In children, parenteral iron preparations may adversely affect the course of the infectious process.
In II and III trimesters of pregnancy the preparation is prescribed only on vital indications, if the expected effect of application exceeds possible risk for a fetus. As the complex of iron hydroxide (III) with polymaltose is excreted unchanged in small amounts with the milk, caution is necessary when prescribing during lactation.
Protect from excessive heating and do not freeze.
Improper storage of the drug may lead to formation of visible precipitate.
Symptoms: overdose of iron preparations may lead to acute overload and hemosiderosis.
Treatment: symptomatic. Specific antidote for iron is deferoxamine.
Form of production
Solution for injection 100 ml/2 ml in 2 ml ampoules #3, #3 (1×3)
Store in a dry, dark place at temperatures not exceeding 25°C. Keep out of the reach of children!
2 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released by a doctor’s prescription.