Instructions Ferinject solution for injection 50 mg/ml 10 ml No. 1
Composition
active ingredient: iron in the form of iron carboxymaltose;
1 ml of solution contains 180 mg of iron carboxymaltose, which is equivalent to 50 mg of iron;
Excipients: sodium hydroxide and hydrochloric acid (for pH adjustment), water for injections.
Dosage form
Solution for injection and infusion.
Main physicochemical properties: opaque aqueous solution of dark brown color.
Pharmacotherapeutic group
Antianemic agents. Iron preparations. Iron preparations for parenteral administration. ATC code B0ZA C.
Pharmacological properties
Mechanism of action
After intravenous administration, iron carboxymaltose complex is mainly absorbed by the reticuloendothelial system of the liver, bone marrow and spleen. Iron is used mainly for the synthesis of hemoglobin, as well as myoglobin and iron-containing enzymes, and iron is also stored in the liver as a deposit.
Pharmacodynamics
Ferinject® solution contains iron in a stable state - in an iron (III) complex consisting of a polynuclear iron (III) hydroxide core with a carbohydrate polymer that supplies iron, is suitable for use and transport of iron in the body, and iron-depositing proteins (transferrin and ferritin). In a study with 59Fe- and 52Fe-labeled Ferinject® in 6 patients with iron deficiency anemia or renal anemia, 61–99% of iron was absorbed by erythrocytes 24 days after administration. In patients with iron deficiency anemia, absorption was 91–99%, and in patients with renal anemia - 61–84%.
Children aged 1–17 years
In a prospective phase 2 pharmacokinetic/pharmacodynamic study (1VIT13036), 35 children in sequential dose groups were treated with single intravenous doses of Ferinject® 7.5 mg iron/kg (n = 16) and Ferinject® 15 mg iron/kg (n = 19) (maximum dose 750 mg iron). At day 35 post-injection, the mean (standard deviation [SD]) increase in hemoglobin was 1.9 (1.38) g/dL for 7.5 mg iron/kg and 2.8 (1.15) g/dL for 15 mg iron/kg. Ferritin and transferrin saturation also increased in a dose-dependent manner.
The efficacy and safety of intravenous Ferinject® was compared with oral iron therapy in a prospective, open-label, parallel-group, phase 3 study (1VIT17044). Forty children with iron deficiency anemia of various etiologies received 2 doses of Ferinject® at 15 mg iron/kg each, 7 days apart (maximum single dose 750 mg), and 39 children received oral ferrous sulfate for 28 days. Seven children who did not respond adequately to oral iron therapy also received 2 doses of Ferinject® in a single-arm extension study (1VIT18045).
In the main study, clinically meaningful increases in haemoglobin were observed in both treatment groups. The mean increase in haemoglobin (least squares) was 2.22 g/dl (95% CI: 1.69-2.75) after Ferinject® and 1.92 g/dl (95% CI: 1.43-2.41) after oral iron therapy, with no statistically significant difference between treatment groups. The primary endpoint of the study was therefore not met. The increases in secondary endpoints (ferritin and transferrin saturation) were greater with Ferinject® than with oral iron therapy. In the extension study, the mean [SD] increase in haemoglobin from the end of the main study was 0.7 (1.19) g/dl.
Pharmacokinetics
Distribution
After administration of a single dose of Ferinject® containing 100 to 1000 mg of iron to patients with iron deficiency anemia, peak serum total iron levels of 37 to 333 μg/mL were achieved within 15 minutes and 1.21 hours, respectively. The volume of distribution of the central compartment was similar to plasma volume (approximately 3 L).
Positron emission tomography showed that the iron of the radiolabeled drug Ferinject® is removed from the blood, enters the bone marrow and the reticuloendothelial system of the liver and spleen.
Metabolism
Carboxymaltose iron is mainly absorbed by the reticuloendothelial system of the liver, bone marrow and to a lesser extent the spleen and is broken down into iron hydroxide and carbohydrates, with the iron bound to form ferritin. The iron becomes available for erythropoiesis via transferrin if necessary. The carbohydrate breakdown products are maltotetraose, maltotriose, maltose and glucose.
Elimination
Plasma clearance of administered iron is rapid, with a terminal half-life of 7 to 12 hours and a mean drug retention time of 11 to 18 hours. Renal excretion of iron was negligible.
Kinetics in special patient groups
The pharmacokinetics of intravenous iron carboxymaltose were studied in children aged 1 year and older with iron deficiency anemia in a single-dose phase 2 pharmacokinetic/pharmacodynamic study 1VIT13036, which was supplemented by a population pharmacokinetic analysis that included additional pharmacokinetic samples from the phase 3 clinical study 1VIT17044. The pharmacokinetic properties at a dose level of 15 mg iron/kg (maximum single dose is 750 mg) were similar to those in adult iron-deficient patients receiving the recommended adult dose. Serum iron levels increased in a dose-proportional manner with single doses of 7.5 mg iron/kg and 15 mg iron/kg. After administration of a single dose of Ferinject® 15 mg iron/kg body weight (maximum dose 750 mg), the mean maximum serum total iron level of 310 μg/ml was determined after 1.12 hours. The terminal half-life was 9.8 hours and the volume of distribution calculated from population pharmacokinetic analysis ranged from 0.42 to 3.14 l.
Liver dysfunction
Studies in patients with hepatic impairment have not been conducted.
Indication
The use of the drug is indicated for patients in case of insufficient effectiveness, ineffectiveness or impossibility of oral iron preparations, for example, due to intolerance to oral iron preparations or in the presence of gastrointestinal diseases (such as ulcerative colitis), when oral iron preparations may provoke an exacerbation of the disease, or in case of iron deficiency resistant to therapy, when there is a suspicion that iron preparations are not being used properly.
Contraindication
Hypersensitivity to the active substance or other components of the drug;
anemia without confirmed iron deficiency;
the presence of signs of iron overload;
The first trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
The drug should not be used simultaneously with oral iron-containing agents, since the absorption of iron administered orally is reduced (see section "Special instructions").
Application features
Ferinject® should only be used when the diagnosis of iron deficiency is established and confirmed by appropriate laboratory tests (e.g. determination of plasma ferritin levels, transferrin saturation (TSAT), hemoglobin (Hb), hematocrit, red blood cell count, mean corpuscular volume (MCV) and mean corpuscular hemoglobin content (MCH)).
Hypersensitivity reactions
Intravenous administration of iron preparations may cause immediate-type hypersensitivity reactions (anaphylactic reactions), which can be fatal.
Such reactions have been reported even in cases where previous use of parenteral iron preparations was without complications. There have been reports of hypersensitivity reactions that may progress to Kounis syndrome (acute allergic spasm of the coronary arteries, which can lead to myocardial infarction, see section "Adverse reactions"). Treatment with Ferinject® should be prescribed by the attending physician only after a precise determination of the indication.
Ferinject® should only be administered when medical personnel trained in the assessment and treatment of anaphylactic reactions are available and in a facility with adequate resuscitation facilities. Before each administration of Ferinject®, the patient should be questioned about any previous adverse reactions associated with intravenous iron.
Typical symptoms of acute hypersensitivity reactions are a decrease in blood pressure, tachycardia (even anaphylactic shock), respiratory symptoms (including bronchospasm, laryngeal edema and pharyngeal edema), gastrointestinal symptoms (including abdominal cramps, vomiting) or skin symptoms (including urticaria, erythema, pruritus).
Each patient should be closely monitored for any signs of hypersensitivity reactions during administration and for at least 30 minutes after each parenteral administration of iron preparations. If any allergic reactions or signs of intolerance occur during administration of the drug, treatment should be discontinued immediately.
For emergency treatment of acute anaphylactic reactions, adrenaline is recommended first, according to current emergency care guidelines and the drug manufacturer's information, and only then antihistamines and/or corticosteroids (which have a later onset of action).
Fever or delayed allergic reactions (with a delay of several hours or even days) have been rarely observed.
Hypophosphatemia/hypophosphatemic osteomalacia
The use of parenteral iron preparations may cause hypophosphatemia, which in most cases is transient and occurs without clinical symptoms. Isolated cases of hypophosphatemia requiring medical attention have been reported, mainly in patients with risk factors and after prolonged use of higher doses.
Cases of hypophosphatemia with clinical manifestations, leading to hypophosphatemic osteomalacia and fractures requiring clinical intervention, including surgery, have been reported in the post-marketing setting. Patients should be advised to seek medical attention if they experience arthralgia or bone pain.
Patients receiving multiple increased doses as part of long-term treatment and who have risk factors (e.g. vitamin D deficiency, calcium and phosphate malabsorption, secondary hyperparathyroidism, hereditary hemorrhagic telangiectasia, inflammatory bowel disease and osteoporosis) should be monitored for the development of hypophosphatemic osteomalacia, including monitoring of serum phosphate levels. In case of persistent hypophosphatemia, treatment with Ferinject® should be reconsidered.
Liver or kidney failure
In patients with impaired liver function, parenteral iron preparations should be used after careful assessment of the benefit/risk ratio.
Parenteral iron administration should be avoided in patients with impaired liver function due to iron overload, especially in cases of porphyria cutanea tarda, and in any acute liver disorder.
Iron levels should be carefully monitored to avoid iron overload.
Infections
Parenteral iron should be used with caution in patients with acute or chronic infection, bronchial asthma, eczema or atopic allergy. It is recommended to discontinue Ferinject® treatment in patients with ongoing bacteremia.
Extravasation
Paravenous leakage should be avoided. This may cause skin irritation and long-term brown discoloration of the injection/infusion site. In the event of paravenous leakage of Ferinject®, the administration should be discontinued immediately.
Other components
1 ml of Ferinject® may contain up to 5.5 mg (0.24 mmol) of sodium. This should be taken into consideration by patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Pregnancy. There are currently limited data from controlled clinical trials on the use of Ferinject® in pregnant women. Animal studies have shown reproductive toxicity. The risk/benefit ratio should be assessed before use during pregnancy, as hypersensitivity reactions may carry a special risk for the mother and child (see section "Special warnings and precautions for use").
Ferinject® is contraindicated in the first trimester of pregnancy (see section "Contraindications"). The drug may be used in the second and third trimesters of pregnancy only strictly according to indications. When using the drug in the second and third trimesters of pregnancy, body weight data before pregnancy should be taken into account to calculate the required amount of iron in order to avoid overdose. When used during pregnancy, special attention should be paid to detecting signs of hypersensitivity reactions.
After parenteral iron administration, fetal bradycardia may occur, which is usually transient and is a consequence of a hypersensitivity reaction in the mother. During intravenous administration of parenteral iron, pregnant women should carefully monitor the condition of the unborn child.
Breastfeeding. There is limited clinical experience with the use of the drug during breastfeeding. A clinical study showed that the excretion of iron from Ferinject® into breast milk is very low (≤ 1%). Therefore, it is unlikely that the use of Ferinject® will pose a risk to the breastfed child.
Fertility: There are no clinical data on the effect of Ferinject® on fertility. Animal studies have not shown any effect of Ferinject® on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no relevant studies. The effect on the reaction speed when driving vehicles or other mechanisms is unlikely.
Method of administration and doses
Patients should be monitored for signs and symptoms of hypersensitivity reactions during and after each administration of Ferinject®.
Ferinject® should only be administered when medical personnel experienced in the evaluation and treatment of anaphylactic reactions are available for immediate response and in a facility adequately equipped for cardiopulmonary resuscitation. Patients should be observed for adverse reactions for at least 30 minutes after each administration of Ferinject® (see section 4.4).
Adults
Ferinject® dosing is performed in several stages: [1] determination of individual iron requirements, [2] calculation and administration of iron doses, and [3] checking iron stores after supplementation.
Step 1. Calculating the required amount of iron
The individual amount of iron required for iron replacement with Ferinject® can be determined based on the patient's body weight and hemoglobin (Hb) level. The iron requirement should be determined using the Ganzoni formula (see Table 1) or the simplified dosing regimen (see Table 2).
The use of the Ganzoni formula is recommended for patients who require a dose adapted to their individual needs, such as patients with anorexia nervosa, cachexia, obesity or pregnant women. Iron deficiency must be confirmed by laboratory tests (see section "Special instructions").
Table 1
Determination of iron requirements using the Ganzoni formula
| Body weight | Hb (g/dl) |
| [kg] | 6 | 7.5 | 9 | 10.5 |
| 30 | 18 ml (900 mg) | 16 ml (800 mg) | 14 ml (700 mg) | 12 ml (600 mg) |
| 35 | 24 ml (1200 mg) | 22 ml (1100 mg) | 20 ml (1000 mg) | 16 ml (800 mg) |
| 40 | 26 ml (1300 mg) | 24 ml (1200 mg) | 20 ml (1000 mg) | 18 ml (900 mg) |
| 45 | 28 ml (1400 mg) | 26 ml (1300 mg) | 22 ml (1100 mg) | 18 ml (900 mg) |
| 50 | 30 ml (1500 mg) | 28 ml (1400 mg) | 24 ml (1200 mg) | 20 ml (1000 mg) |
| 55 | 32 ml (1600 mg) | 28 ml (1400 mg) | 24 ml (1200 mg) | 20 ml (1000 mg) |
| 60 | 34 ml (1700 mg) | 30 ml (1500 mg) | 26 ml (1300 mg) | 22 ml (1100 mg) |
| 65 | 38 ml (1900 mg) | 32 ml (1600 mg) | 28 ml (1400 mg) | 24 ml (1200 mg) |
| 70 | 42 ml (2100 mg) | 36 ml (1800 mg) | 32 ml (1600 mg) | 26 ml (1300 mg) |
| 75 | 44 ml (2200 mg) | 38 ml (1900 mg) | 32 ml (1600 mg) | 28 ml (1400 mg) |
| 80 | 46 ml (2300 mg) | 40 ml (2000 mg) | 34 ml (1700 mg) | 28 ml (1400 mg) |
| 85 | 48 ml (2400 mg) | 42 ml (2100 mg) | 36 ml (1800 mg) | 30 ml (1500 mg) |
| 90 | 50 ml (2500 mg) | 44 ml (2200 mg) | 36 ml (1800 mg) | 30 ml (1500 mg) |
Hb – hemoglobin
For body weight ≤ 66 kg, the calculated total cumulative dose should be rounded down to the nearest 100 mg of iron.
For body weight > 66 kg, the calculated total cumulative dose should be rounded up to the nearest 100 mg of iron.
Ganzoni formula:
Total iron deficiency [mg] = total cumulative dose [mg] = Body weight(A) [kg] × (target Hb level(B) – actual Hb level)(C) [g/dl] × 2.4(D) + stored iron(E) [mg]. |
(A) For overweight patients, it is recommended to use ideal body weight, and for pregnant women, pre-pregnancy body weight. There are various ways to determine ideal body weight, such as calculating the body weight corresponding to a body mass index (BMI) of 25: ideal body weight = 25*(height in meters)2.
(B) The standard hemoglobin target for the Ganzoni formula is 15 g/dL. In special cases, such as pregnant women, a lower hemoglobin target should be set.
The effectiveness of treatment should be monitored by blood tests. Adjustment of the cumulative iron dose may be necessary to achieve the target hemoglobin level.
(C) To convert hemoglobin in mmol/L to g/dL, multiply the hemoglobin in mmol/L by the factor 1.61145.
(D) Factor 2.4 = 0.0034 × 0.07 × 10,000.
0.0034: the iron content in hemoglobin is 0.34%.
0.07: blood volume 70 ml/kg body weight ≈ 7% of body weight.
10,000: factor for converting "g/dL" to "mg/d" (1 g/dL = 10,000 mg/L).
(E) For patients weighing > 35 kg, the amount of iron stored is 500 mg or more. A value of 500 mg of iron stored corresponds to the lower limit of normal for women with low anthropometric characteristics (“petite women”). Some manuals recommend determining iron stored at the rate of 10–15 mg iron/kg body weight.
Table 2
Determination of iron requirements using a simplified dosing regimen
| Hb | Patient body weight |
| g/dl | mmol/l | < 35 kg | 35 kg – < 70 kg | ≥ 70 kg |
| < 10 | < 6.2 | 500 mg | 1500 mg | 2000 mg |
| 10 – < 14 | 6.2 – < 8.7 | 500 mg | 1000 mg | 1500 mg |
| ≥ 14 | ≥ 8.7 | 500 mg | 500 mg | 500 mg |
Step 2. Calculation and administration of the maximum dose of iron
Ferinject® should be administered in appropriate doses depending on the determined iron requirement. Use as described below.
A single dose of Ferinject® should not exceed the following values:
15 mg iron/kg body weight (when administered by intravenous injection) or
20 mg iron/kg body weight (when administered by intravenous infusion), or
1000 mg of iron (20 ml of Ferinject®).
The maximum recommended cumulative dose of Ferinject® is 1000 mg iron (20 ml of Ferinject®) per week. If the cumulative iron dose exceeds 20 mg iron/kg body weight or 1000 mg iron in Ferinject®, the dose should be divided into two administrations with an interval of at least 1 week.
Depending on the condition of the individual patient, the physician should perform repeated examinations (including blood tests). The hemoglobin level should be re-determined no earlier than 4 weeks after the last administration of Ferinject® to allow sufficient time for erythropoiesis and iron utilization. If the patient requires further iron supplementation, the iron requirement should be calculated using the Ganzoni formula or a simplified dosing regimen.
Method of administration
Ferinject® is administered exclusively intravenously:
by injection or
by infusion, or
undiluted by injection directly into the venous part of the dialyzer during the hemodialysis procedure.
Ferinject® should not be administered intramuscularly or subcutaneously.
Patients should be observed for signs of hypersensitivity during and after administration of Ferinject® and appropriate emergency treatment should be provided (see section 4.4).
Intravenous injection
Ferinject® can be administered by intravenous injection of undiluted solution. The maximum permissible single dose is 15 mg iron/kg body weight and should not exceed 1000 mg iron. For the rate of administration, see Table 3.
Table 3
Administration rate for intravenous injection of Ferinject®
| Required volume of Ferinject® | Equivalent dose of iron | Input speed/minimum input time |
| 2 | to | 4 ml | 100 | to | 200 mg | No minimum input time requirement |
| > 4 | to | 10 ml | > 200 | to | 500 mg | 100 mg iron/minute |
| > 10 | to | 20 ml | > 500 | to | 1000 mg | 15 minutes |
Intravenous infusion
Ferinject® can be administered by intravenous infusion, in which case it must be diluted. The maximum permissible single dose is 20 mg iron/kg body weight and should not exceed 1000 mg iron. For infusions, Ferinject® should only be diluted with sterile 0.9% (w/v) sodium chloride solution as shown in Table 4. Note: To ensure stability, Ferinject® should not be diluted to a concentration of less than 2 mg iron/ml (excluding the volume of ferric carboxymaltose solution in the vial). For further information on the dilution of this medicinal product before administration, see “Handling instructions” below.
Table 4
Ferinject® dilution plan for intravenous infusion
| Required volume of Ferinject® | Equivalent dose of iron | Maximum volume of sterile 0.9% (w/v) sodium chloride solution | Minimum input time |
| 2 | to | 4 ml | 100 | to | 200 mg | 50 ml | No minimum input time requirement |
| > 4 | to | 10 ml | > 200 | to | 500 mg | 100 ml | 6 minutes |
| > 10 | to | 20 ml | > 500 | to | 1000 mg | 250 ml | 15 minutes |
Handling instructions
The vials are intended for single use only.
Before using the drug, the vials should be visually inspected for visible particles and damage.
Only vials with a homogeneous solution without visible particles should be used.
Ferinject® should only be mixed with sterile 0.9% (w/v) sodium chloride solution. Other intravenous diluents and medicinal products should not be used due to the risk of precipitation and/or interaction.
Special patient groups
Children under 1 year old
The efficacy and safety of Ferinject® in children under 1 year of age have not been studied, therefore it is not recommended to use the drug in children of this age group.
Children aged ≥ 1 year
Ferinject® is not approved for use in children aged 1 to 18 years due to limited data.
No dosage recommendations can be made. Currently available data on use in children are described in sections 5.1 and 5.2.
Patients with chronic kidney disease requiring hemodialysis
For patients with chronic kidney disease requiring hemodialysis, the maximum dose administered should not exceed 200 mg of iron once daily.
The efficacy and safety of Ferinject® in children with chronic kidney disease requiring hemodialysis have not been studied. Therefore, Ferinject® is not recommended for use in children with chronic kidney disease requiring hemodialysis.
Patients with liver disorders
There is no experience with the use of Ferinject® in patients with impaired liver function.
Children
The efficacy and safety of Ferinject® in children have not been studied and therefore it is not recommended for use in this age group. The currently available data on use in children are described in the sections “Pharmacological properties” and “Adverse reactions”.
Overdose
Accidental excess of the total cumulative dose required to correct a patient's iron deficiency may lead to iron accumulation in the patient's stores and ultimately to hemosiderosis in such patients. This can be prevented by prophylactic monitoring of iron parameters - serum ferritin and transferrin saturation. Unwanted iron accumulation should be treated according to standard medical practice.
Side effects
The following adverse reactions have been reported in clinical trials involving 9456 adult patients and 82 children ≥ 1 year of age treated with Ferinject®, as well as during post-marketing use.
Adverse reactions are classified according to frequency using the following categories: common (< 1/10 — ≥ 1/100), uncommon (< 1/100 — ≥ 1/1000), rare (< 1/1000 — ≥ 1/10,000) and unknown (cannot be estimated from the available data). The most common adverse reactions include nausea, injection/infusion site reactions, hypophosphatemia, headache, facial flushing, dizziness, and hypertension.
The most important serious adverse reactions associated with the use of Ferinject® include hypersensitivity reactions, which are uncommon (see immune system reactions below).
The most serious adverse reactions were anaphylactic reactions (rare): fatalities have been reported.
In clinical studies, patients with decreased serum phosphate levels achieved nadirs after approximately 2 weeks. In most cases, levels returned to baseline within 12 weeks of treatment with Ferinject®.
The safety profile in children aged 1–17 years was studied in the following studies.
In a prospective phase 2 pharmacokinetic/pharmacodynamic study (1VIT13036), 35 children in sequential dose groups were treated with single intravenous doses of Ferinject® 7.5 mg iron/kg (n = 16) and Ferinject® 15 mg iron/kg (n = 19) (maximum dose 750 mg iron). No unexpected adverse drug reactions were observed compared to adults. The most common adverse reactions were 2 cases each of pyrexia and rash with Ferinject® 7.5 mg iron/kg and 3 cases each of rhinorrhea and urticaria, and 2 cases each of pyrexia and upper respiratory tract infection with Ferinject® 15 mg iron/kg.
In a prospective, open-label, parallel-group phase 3 study (1VIT17044), 40 children received 2 doses of Ferinject® at 15 mg iron/kg each, 7 days apart (maximum single dose 750 mg). No unexpected adverse drug reactions were observed compared to adults. The most common adverse reactions following intravenous Ferinject® therapy were hypophosphatemia/decreased serum phosphate (n = 5), vomiting (n = 2), headache (n = 2) and urticaria (n = 2).
Laboratory biochemical studies revealed potentially clinically significant hypophosphatemia in 8 patients receiving Ferinject® (including 4 of the reported adverse reactions). Nadir phosphate levels were usually achieved 2 weeks after initiation of therapy and generally normalized by day 35 after initiation of treatment. All cases of hypophosphatemia were asymptomatic.
See also the section "Application features".
On the part of the immune system
Uncommon: Immediate hypersensitivity reactions (anaphylactic reaction) may be fatal (see section 4.4). Symptoms of anaphylactic reactions include circulatory collapse, hypotension, tachycardia, respiratory symptoms (bronchospasm, laryngeal edema, pharyngeal edema), gastrointestinal symptoms (abdominal cramps, vomiting), skin symptoms (urticaria, erythema, pruritus).
Metabolism and eating disorders
Common: hypophosphatemia (based on laboratory data).
From the psyche
Rare: feeling anxious.
From the nervous system
Common: headache, dizziness.
Uncommon: taste perversion (dysgeusia), paraesthesia.
Not known: loss of consciousness.
From the heart
Uncommon: tachycardia.
From the vascular system
Common: hypertension, hot flashes.
Uncommon: hypotension.
Rare: dizziness, loss of consciousness, phlebitis.
Respiratory, thoracic and mediastinal disorders
Uncommon: dyspnoea.
Rare: bronchospasm.
From the digestive system
Common: nausea.
Uncommon: abdominal pain, vomiting, constipation, diarrhoea, dyspepsia.
Rare: flatulence.
Liver and gallbladder
Uncommon: increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased gamma-glutamyltransferase (γ-GT), increased alkaline phosphatase (ALP), increased lactate dehydrogenase (LDH).
Skin and subcutaneous tissue disorders
Uncommon: rash (including the following reactions: erythematous, generalized, macular, maculopapular, pruritic rash), pruritus, urticaria, erythema.
Rare: angioedema, remote skin discoloration, pallor.
Not known: dermatitis, facial edema.
Uncommon: arthralgia, myalgia, pain in extremity, back pain, muscle spasms.
Not known: hypophosphatemic osteomalacia.
General disorders and administration site conditions
Common: injection/infusion site reactions (including symptoms such as pain, haematoma, discolouration (potentially permanent), extravasation, irritation, phlebitis and paraesthesia at the injection/infusion site).
Uncommon: pyrexia, fatigue, chills, chest pain, peripheral oedema, pain, malaise.
Rare: flu-like illness (onset within a few hours to a few days).
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 30 ° C. Do not freeze. Keep out of the reach of children!
Incompatibility
Ferinject® can only be mixed with sterile 0.9% sodium chloride solution. Compatibility with containers made of materials other than polyethylene and glass has not been studied.
Packaging
2 ml or 10 ml in a vial. 1 or 5 vials in a cardboard box.
Vacation category
According to the recipe.
Producer
Vifor (International) Inc., Switzerland.
Location of the manufacturer and address of its place of business.
Rechenstrasse 37, 9014 St. Gallen, Switzerland/Rechenstrasse 37, 9014 St. Gallen, Switzerland.
