Instruction for use: Eralfon

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Dosage form: Solution for intravenous and subcutaneous administration

Active substance: Epoetinum alfa

ATX

B03XA Other anemia drugs

Pharmacological group:

Stimulators of hemopoiesis

The nosological classification (ICD-10)

B23.2 HIV disease, with manifestations of hematologic and immunological disorders, not elsewhere classified: Anemia in HIV-infected patients; Neutropenia in patients with AIDS

C80 Malignant neoplasm without specification of localization: Malignant tumor; Malignant neoplasm; Malignant neoplasms of different localization; Malignant tumors; Eton-Lambert syndrome; Locally prevalent forms of malignant neoplasms; Metastatic ascites; Metastatic ascites; Cerebellar degeneration in tumors; Hereditary cancers; Metastatic tumors; Cancer ascites; Solid tumors

C85.9 Non-Hodgkin lymphoma of unspecified type: Non-Hodgkin's lymphoma; Non-Hodgkin's Lymphomas; Non-Hodgkin's Malignant Lymphoma

C91 Lymphoid leukemia [lymphatic leukemia]: Lymphatic leukemia; Lymphoproliferative diseases; Neuroleukemia; Refractory acute lymphoblastic leukemia; Refractory lymphoblastic leukemia; Transformation of preleukemias; Chronic lymphocytic leukemia; Lymphoproliferative disorders

C92.9 Myeloid leukemia, unspecified: Anemia in patients with myeloma; Myeloid aplasia of the bone marrow

D63.0 Anemia in neoplasm: Anemia in chronic diseases; Anemia due to radiation damage; Radiation anemia; Anemia in patients with solid tumors; Pernicious anemia

D63.8 Anemia in other chronic diseases classified elsewhere: Anemia in chronic diseases; Anemia in immunological disorders; Anemia in peptic ulcer; Anemia in kidney diseases; Anemia with HIV treatment; Anemia in the background of chronic renal failure; Anemia in patients with myeloma; Symptomatic anemia; Symptomatic anemia of renal genesis; Anemia in HIV-infected patients; Renal anemia

N18 Chronic Renal Failure: Congestive Renal Failure; Renal failure chronic; Chronic Renal Failure; CRF; Chronic kidney failure in children

P61.2 Anemia of prematurity: Anemia in preterm infants; Anemia of physiological preterm infants

Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction

Z49.1 Aids that include extracorporeal dialysis: hemodialysis; Chronic hemodialysis; Extracorporeal circulation; Thrombosis of hemodialysis shunt

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Composition

Solution for intravenous and subcutaneous injection 1 amp. (1 ml)

active substance: Epoetin alfa (recombinant human erythropoietin) 1000 IU; 2000 IU; 4000 IU; 10,000 IU

Excipients: Albumin solution in terms of dry albumin - 2.5 / 2.5 / 2.5 / 2.5 mg; Sodium citrate pentasecylhydrate 5.8 / 5.8 / 5.8 / 5.8 mg or sodium citrate dihydrate 4.776 (4.776) 4.766 (4.776 mg; Sodium chloride - 5.84 / 5.84 / 5.84 / 5.84 mg; Citric acid monohydrate 0.057 / 0.057 / 0.057 / 0.057 mg; Water for injection - up to 1 ml

Solution for intravenous and subcutaneous administration 1 syringe (0.3 ml)

active substance: Epoetin alfa (recombinant human erythropoietin) 1000 IU; 2000 IU

Excipients: Albumin solution in terms of dry albumin - 0.75 / 0.75 mg; Sodium citrate pentasecylhydrate - 1.74 / 1.74 mg or sodium citrate dihydrate - 1.4328 / 1.4328 mg; Sodium chloride - 1,752 / 1,752 mg; Citric acid monohydrate - 0.0171 / 0.0171 mg; Water for injection - up to 0.3 ml

Solution for intravenous and subcutaneous administration 1 syringe (0.5 ml)

active substance: Epoetin alfa (recombinant human erythropoietin) 2000 IU

Excipients: albumin solution in terms of dry albumin - 1.25 mg; Sodium citrate pentasecylhydrate - 2.9 mg or sodium citrate dihydrate - 2.388 mg; Sodium chloride - 2.92 mg; Citric acid monohydrate - 0.0285 mg; Water for injection - up to 0.5 ml

Solution for intravenous and subcutaneous administration 1 syringe (0.4 ml)

active substance: Epoetin alfa (recombinant human erythropoietin) 4000 IU

Excipients: albumin solution in terms of dry albumin - 1 mg; Sodium citrate pentasecovihydrate - 2.32 mg or sodium citrate dihydrate - 1.9104 mg; Sodium chloride - 2,336 mg; Citric acid monohydrate - 0.0228 mg; Water for injection - up to 0.4 ml

Solution for intravenous and subcutaneous administration 1 syringe (0.6 ml)

active substance: Epoetin alfa (recombinant human erythropoietin) 10,000 IU

Excipients: Albumin solution in terms of dry albumin - 1.5 mg; Sodium citrate pentasecovihydrate - 3,48 mg or sodium citrate dihydrate - 2,8656 mg; Sodium chloride - 3.504 mg; Citric acid monohydrate - 0.0342 mg; Water for injection - up to 0.6 ml

Solution for intravenous and subcutaneous administration 1 syringe (1 ml)

active substance: Epoetin alfa (recombinant human erythropoietin) 10000 IU

Excipients: Albumin solution in terms of dry albumin - 2.5 mg; Sodium citrate pentasecvhydrate - 5.8 mg or sodium citrate dihydrate - 4.776 mg; Sodium chloride - 5.84 mg; Citric acid monohydrate - 0.057 mg; Water for injection - up to 1 ml

Solution for intravenous and subcutaneous administration 1 syringe (0.3 ml)

active substance: Epoetin alfa (human recombinant erythropoietin) 3000 IU; 5000 IU

Solution for intravenous and subcutaneous administration 1 syringe (0.5 or 0.6 ml)

active substance: Epoetin alfa (human recombinant erythropoietin) 20000 IU

Excipients: Albumin solution in terms of dry albumin - 1.25 / 1.5 mg; Sodium citrate pentasecylhydrate 2,9 / 3,48 mg or sodium citrate dihydrate 2,388 / 2,8656 mg; Sodium chloride - 2.92 / 3.504 mg; Citric acid monohydrate - 0.0285 / 0.0342 mg; Water for injection - up to 0.5 / 0.6 ml

Solution for intravenous and subcutaneous administration 1 syringe (1 ml)

active substance: Epoetin alfa (human recombinant erythropoietin) 40,000 IU

Description of dosage form

Clear colorless solution.

Pharmachologic effect

Mode of action - Erythropoietic.

Pharmacodynamics

Epoetin alfa-glycoprotein, specifically stimulating erythropoiesis, activates the mitosis and maturation of erythrocytes from the progenitor cells of the erythrocyte series. Recombinant epoetin alfa is synthesized in mammalian cells in which a gene encoding human erythropoietin is inserted. In its composition, biological and immunological properties, epoetin alfa is identical to natural human erythropoietin. The introduction of epoetin alfa leads to increased levels of Hb and hematocrit, improved blood supply to the tissues and the work of the heart. The most pronounced effect from the use of epoetin alfa is observed in anemias caused by CRF. In very rare cases, with the prolonged use of erythropoietin for the therapy of anemic conditions, the formation of neutralizing antibodies to erythropoietin may be observed with the development of partial red cell aplasia or without it.

Pharmacokinetics

With intravenous administration of epoetin alfa in healthy individuals and patients with uremia T1 / 2 is 5-6 hours. With the administration of epoetin alfa, its concentration in the blood increases slowly and reaches a maximum in the period from 12 to 18 hours after administration, T1 / 2 is 16-24 hours. Bioavailability of epoetin alfa with SC introduction is 25-40%. Does not cumulate.

Indications Eralfon

Common

Prevention and treatment of anemia in patients with solid tumors, whose anemia was the result of antitumor therapy;

Prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas, chronic lymphocytic leukemia;

In the context of the pre-op program before extensive surgical intervention in patients with a hematocrit level of 33-39% to facilitate the collection of autologous blood and reduce the risk associated with the use of allogeneic blood transfusions if the expected need for transfused blood exceeds the amount that can be obtained by autologous collection Without the use of epoetin alfa;

Before carrying out extensive surgery with the expected blood loss of 900-1800 ml in adult patients without anemia or with mild to moderate anemia (Hb concentration 100-130 g / l) to reduce the need for allogeneic blood transfusions and facilitate the recovery of erythropoiesis.

In addition to the solution for intravenous and subcutaneous administration, 1000, 2000, 3000, 4000, 5000, 10000, 20000 ME

Anemia in patients with chronic renal failure, incl. Who are on hemodialysis;

Prevention and treatment of anemia in patients infected with HIV caused by zidovudine, with an endogenous erythropoietin level of less than 500 IU / ml.

In addition for the solution for intravenous and subcutaneous administration 1000, 2000, 4000, 10000 ME

Treatment and prevention of anemia in premature infants born with a low body weight of up to 1.5 kg.

Contraindications

Hypersensitivity to the drug or its components;

Partial red cell aplasia after previous therapy with an erythropoietin;

Uncontrolled arterial hypertension;

Impossibility of conducting adequate anticoagulant therapy;

Severe occlusive diseases of the coronary, carotid, cerebral and peripheral arteries and their consequences, including acute and recently suffered myocardial infarction and acute impairment of cerebral circulation (as part of the pre-op program to collect blood before surgical operations).

With caution: malignant neoplasms; Epileptic syndrome (including if there is an anamnesis); Thrombocytosis; Thrombosis (in the anamnesis); Sickle-cell anemia; Iron, B12 or folic acid deficiency; Porphyria; Chronic hepatic insufficiency.

Side effects

At the beginning of treatment, flu-like symptoms can be noted: dizziness, drowsiness, fever, headache, myalgia, arthralgia.

On the part of the CAS: a dose-dependent increase in blood pressure, worsening of the course of arterial hypertension (most often in patients with CRF), in some cases - hypertensive crisis, a sharp increase in blood pressure with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic convulsions.

From the hematopoiesis: thrombocytosis, in some cases - thrombosis shunt or arteriovenous fistula (including in patients on hemodialysis with a tendency to arterial hypotension or aneurysm, stenosis), aplasia of erythrocyte sprout.

Allergic reactions: skin rash (mild or moderate), eczema, hives, itching, angioedema.

Local reactions: hyperemia, burning, mild or moderate soreness at the site of injection (often occur with SC the introduction).

On the part of laboratory indicators: a decrease in serum ferritin concentration, with uremia - hyperkalemia, hyperphosphataemia.

Other: complications associated with respiratory failure or with a decrease in blood pressure, immune reactions (induction of antibody formation), exacerbation of porphyria.

Interaction

Reduces the concentration of cyclosporine due to an increase in the degree of its binding to erythrocytes (there may be a need for correction of the dose of cyclosporine). Pharmaceutically incompatible with solutions of other drugs.

Dosing and Administration

IV, SC.

Treatment of anemia in patients with chronic renal failure

Adults who are on hemodialysis. Eralfon� is injected with SC or IV in the end of the dialysis session. When the method of administration is changed, the drug is used in the previous dose, then the dose is corrected if necessary (in the case of the method for administering the drug to achieve the same therapeutic effect, a dose of 20-30% less than for IV administration is required). Treatment with the drug includes two stages.

1. Correction stage: with the initial administration of the drug, the initial single dose is 30 IU / kg 3 times a week. With iv administration of the drug, the initial single dose is 50 IU / kg 3 times a week. The correction period lasts until the optimal level of Hb is reached (100-120 g / L in adults and 95-110 g / L in children) and hematocrit (30-35%). These indicators need to be monitored weekly.

The following situations are possible:

- the hematocrit rises from 0.5 to 1% per week. In this case, the dose is not changed until the optimal parameters are reached;

- the rate of growth of the hematocrit is less than 0.5% per week. In this case it is necessary to increase the single dose by 1.5 times;

- rate of increase more than 1% per week. In this case, it is necessary to reduce the single dose of the drug by 1.5 times;

- the hematocrit remains low or decreases. It is necessary to analyze the causes of resistance before increasing the dose of the drug.

The effectiveness of therapy depends on a properly selected individual treatment regimen.

2. The stage of maintenance therapy: to maintain hematocrit at 30-35%, the dose of the drug used in the correction phase should be reduced by 1.5 times. Then the maintenance dose of the drug is selected individually, taking into account the dynamics of hematocrit and Hb levels.

Children who are on hemodialysis. The initial dose is 50 units / kg 3 times a week. If necessary, a single dose is increased 1 time per 4 weeks by 25 units / kg until the optimal concentration of Hb is achieved. The maintenance dose for children weighing less than 10 kg is 75-150 units / kg (average 100 units / kg) 3 times a week; 10-30 kg - 60-150 units / kg (average 75 units / kg) 3 times a week; More than 30 kg - 30-100 units / kg (an average of 33 units / kg) 3 times a week.

Adult pre-dialysis patients. The initial dose is injected w / c or IV three times at 50 units / kg / week. If necessary, a single dose is increased 1 time per 4 weeks by 25 units / kg until the optimal concentration of Hb is achieved. The maintenance dose is 17-33 U / kg 3 times a week.

Prevention and treatment of anemia in patients with solid tumors

Before the start of treatment it is recommended to carry out a determination of the level of endogenous erythropoietin. When the serum erythropoietin concentration is less than 200 IU / ml, the initial dose of the drug is 150 mg / kg 3 times a week for IV administration. If, after 4 weeks of treatment, the Hb level rises to at least 10 g / L or the number of reticulocytes increases by more than 40,000 cells / μl from the baseline, the dose remains the same (150 IU / kg 3 times a week).

If after 4 weeks of treatment the increase in Hb is less than 10 g / L and the increase in the number of reticulocytes is less than 40,000 cells / μl compared to baseline, then during the next 4 weeks the dose is increased to 300 IU / kg 3 times a week. If after an additional 4 weeks of treatment with a dose of 300 IU / kg the Hb level rises and is not less than 10 g / l or the amount of reticulocytes increases by more than 40,000 cells / μl, then maintain the existing dose of the drug (300 IU / kg 3 times a week ). If, after 4 weeks of treatment at a dose of 300 IU / kg, the Hb level rises by less than 10 g / l and the increase in the number of reticulocytes is less than 40,000 cells / μl compared to baseline, treatment should be discontinued. If the Hb level rises by more than 20 g / L during the month, the dose of the drug should be reduced by 25%. If the Hb level exceeds 140 g / L, the treatment should be suspended until the Hb level falls below 120 g / L and then continue to inject the drug at a dose 25% below the original level.

The drug should be continued for 1 month after the end of chemotherapy.

The serum ferritin level (or serum iron level) should be determined in all patients before and during drug treatment. If necessary, an additional iron intake is prescribed.

Prevention and treatment of anemia in patients with HIV infection

It is recommended to determine the initial level of endogenous erythropoietin in the blood serum before starting treatment with Eralfon�. The conducted studies show that at an erythropoietin level of more than 500 IU / ml, the effect of drug therapy is unlikely.

Treatment with the drug includes 2 stages.

1. Correction phase: the drug is given in a dose of 100 IU / kg 3 times a week, sc, or IV for 8 weeks. If after 8 weeks of therapy failed to achieve a satisfactory effect (for example, reduce the need for blood transfusions or to increase the level of Hb), the dose can gradually increase (not more often than once per 4 weeks) by 50-100 IU / kg 3 times a week. If the satisfactory effect of Eralfon� therapy at a dose of 300 IU / kg is not achieved 3 times a week, then the response to further therapy at higher doses is unlikely.

2. The stage of maintenance therapy: after achieving a satisfactory effect in the phase of correction of anemia, the maintenance dose should provide a hematocrit level within the range of 30-35%, depending on the dose change of zidovudine, the presence of concomitant infectious or inflammatory diseases. With a hematocrit more than 40%, the drug should be discontinued until the hematocrit is reduced to 36%. When resuming therapy, the dose of epoetin alfa should be reduced by 25%, with subsequent adjustment to maintain the required level of hematocrit. The serum ferritin level (or serum iron level) should be determined in all patients before and during drug treatment. If necessary, an additional iron intake is prescribed.

Prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas and chronic lymphocytic leukemia

In these patients, the feasibility of epoetin alfa treatment is due to an inadequate synthesis of endogenous erythropoietin against the background of anemia. At a level of Hb below 100 g / L and serum erythropoietin below 100 IU / mL, Eralfon� is administered SC at a starting dose of 100 IU / kg 3 times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose of the drug is adjusted toward increase or decrease every 3-4 weeks. If no increase in Hb is observed when a weekly dose of 600 IU / kg is reached, further use of epoetin alfa should be discontinued as ineffective.

Prevention and treatment of anemia in patients with rheumatoid arthritis

In patients with rheumatoid arthritis, the synthesis of endogenous erythropoietin is suppressed under the influence of an increased concentration of pro-inflammatory cytokines. Treatment of anemia in these patients is carried out with the drug with p / to the introduction of a dose of 50-75 IU / kg 3 times a week. If the Hb level is increased by less than 10 g / L after 4 weeks of treatment, the dose of the drug is increased to 150-200 IU / kg 3 times a week. Further increase in the dose seems inappropriate.

Treatment and prevention of anemia in preterm infants born with low body weight

Eralfon� is administered SC at a dose of 200 IU / kg 3 times a week starting from the 6th day of life until the target levels of Hb and hematocrit are reached, but no more than 6 weeks.

Adult patients participating in the autologous blood collection program before surgical interventions

It is recommended to use iv injection route. Epoetin alfa should be administered at the end of the blood collection procedure.

Before prescribing the drug, all contraindications to collection of autologous blood should be taken into account. Before surgery, Eralfon� should be administered 2 times a week for 3 weeks. At each visit to the doctor, the patient receives a blood sample (if hematocrit ≥33% and / or Hb ≥110 g / l) and is stored for autologous transfusion. The recommended dose of Eralfon� is 600 IU / kg iv twice a week.

The serum ferritin level (or serum iron level) should be determined in all patients before and during drug treatment. If necessary, an additional iron intake is prescribed.

In the presence of anemia, its cause should be established before the initiation of epoetin alfa therapy. It is necessary to provide an adequate intake of iron into the body as soon as possible, by administering an iron preparation orally at a dose of 200 mg / day (based on ferrous iron), and to maintain the intake of iron at this level throughout the course of therapy.

Patients in the pre- and postoperative period who do not participate in the autologous blood collection program

It is recommended to use the sc administration of the drug at a dose of 600 IU / kg per week for 3 weeks preceding the operation (21, 14 and 7 days before the operation) and on the day of the operation. If necessary, when the preoperative period should be reduced for medical reasons, Eralfon� can be administered daily at a dose of 300 IU / kg for 10 days before surgery, on the day of surgery and for 4 days after surgery. If the level of Hb in the preoperative period reaches 150 g / l and above, the use of epoetin alfa should be discontinued. Prior to the initiation of epoetin alfa therapy, it must be ensured that there is no iron deficiency in patients.

All patients should receive an adequate amount of iron (orally 200 mg / day based on ferrous iron) throughout the course of treatment. If possible, additional oral ingestion of iron should be provided prior to the initiation of epoetin alfa therapy to ensure an adequate iron depot in the patient's body.

The device and the procedure for working with a syringe with an automatic needle protection device

Before injection.

After injection.

Components:

1. Stock.

2. Clamps.

3. Protective cover.

4. Protective cap.

5. The needle.

After completion of the injection, the needle and syringe will move back to the protective device.

Attention! Avoid contact with the clamps during syringe preparation! The device is activated by pressing the rod to the terminals.

Carefully inspect the pre-filled glass syringe with the protective device. Remove the protective cap from the needle.

Carry out the injection according to the standard procedure.

Press the rod with your thumb and hold until the entire dose of the drug has been injected. The protective device is not activated until the entire dose of the drug has been injected.

Remove the needle, release the stem, allow the protective casing to move forward until the needle is fully protected and locked in place.

The procedure for working with a syringe with a non-automatic needle protector

Carry out the injection according to the standard procedure. Attention! When carrying out the injection, it is necessary to keep the fingers on the protective cover to prevent premature activation of the protective device.

After the injection, move the protective device along the needle. An audible click will indicate the correctness of the action. During the entire procedure, the fingers should be behind the needle.

Overdose

Symptoms: increased side effects.

Treatment: symptomatic. At a high level of Hb - bloodletting.

Special instructions

During treatment, it is necessary to monitor BP weekly and conduct a general blood test (including platelets, hematocrit, ferritin). In the pre- and postoperative period, the concentration of Hb should be monitored more often if the initial concentration is less than 140 g / l. It must be remembered that epoetin alfa in the treatment of anemia does not replace blood transfusion, but reduces the need for its repeated application.

Patients with controlled arterial hypertension or thrombotic complications in the history may need to increase the dose of antihypertensive drugs and / or anticoagulants, respectively.

When appointing patients with hepatic insufficiency, it is possible to slow the metabolism of epoetin alfa and a marked increase in erythropoiesis. The safety of the drug in this category of patients is not established.

Although the drug stimulates erythropoiesis, one cannot completely exclude the possibility of the effect of epoetin alfa on the growth of certain types of tumors, incl. Bone marrow.

One should take into account the possibility that preoperative increase in Hb level may serve as a predisposing factor to the development of thrombotic complications. Before the planned surgical intervention, patients should receive adequate preventive antiplatelet therapy. In the pre and postoperative period, the drug is not recommended to appoint patients with a baseline Hb level of more than 150 g / l.

In adult patients with CRF, clinically expressed CHD or CHF, the concentration of Hb should not exceed 100-120 g / l.

Before starting treatment, the possible causes of inadequate reaction to the drug should be excluded (iron deficiency, folic acid, cyanocobalamin, severe aluminum salt poisoning, concomitant infections, inflammatory processes and trauma, latent bleeding, hemolysis, bone marrow fibrosis of various etiologies) and, if necessary, adjust the treatment.

Before the start of treatment should assess the iron stores in the body. In most patients with CRF, cancer and HIV-infected patients, the concentration of ferritin in the plasma decreases simultaneously with an increase in hematocrit. The concentration of ferritin should be determined throughout the course of treatment. If it is less than 100 ng / ml, substitution therapy with iron for oral administration is recommended at the rate of 200-300 mg / day (100-200 mg / day for children). For preterm infants, oral iron therapy at a dose of 2 mg / day should be given as soon as possible. Patients who take autologous blood and are in the pre- or postoperative period should also receive an adequate amount of iron inside at a dose of 200 mg / day.

In patients with CRF, correction of anemia can cause an improvement in appetite and an increase in absorption of potassium and proteins. Periodic correction of dialysis parameters may be required to maintain the urea, creatinine and potassium concentrations within normal limits.

In patients with CRF, it is necessary to monitor the level of electrolytes in the blood serum.

According to available data, the use of epoetin alfa in pre-dialysis patients does not accelerate the progression of CRF. Because of the increase in hematocrit, it is often necessary to increase the dose of heparin during hemodialysis. With inadequate heparinization, blockage of the dialysis system, thrombosis of vascular access, especially in patients with a tendency to hypotension or complications of arteriovenous fistula (including stenosis, aneurysm) is possible. In such patients, prevention of thrombosis is recommended.

When used in women of reproductive age with anemia in the presence of chronic renal failure, menstruation may resume. The patient should be warned about the possibility of pregnancy and the need for reliable methods of contraception before the start of therapy. In experimental studies on rats and rabbits, no teratogenic effect was observed with IV administration at doses up to 500 U / kg / day; In higher doses, a weak, statistically insignificant decrease in fertility was noted.

Given the possible more pronounced effect of the drug, its dose should not exceed the dose of recombinant erythropoietin used in the previous course of treatment. During the first 2 weeks, the dose is not changed, the dose / response ratio is evaluated. After that, the dose may be decreased or increased (see "Method of administration and dose").

Impact on the performance of potentially hazardous activities requiring special attention and speed of reactions. During the treatment, before the optimal maintenance dose is established, patients with CRF should be careful when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions (increased risk of BP increase at the beginning of therapy).

Release form

Solution for intravenous and subcutaneous administration, 1000 ME, 2000 ME, 4000 ME or 10000 ME. 1 ml in ampoules of colorless neutral glass with a color fracture ring or a colored dot and a notch. The ampoules additionally bear 1, 2 or 3 color rings and / or a two-dimensional barcode, and / or alphanumeric coding, or without additional rings, a two-dimensional barcode, alphanumeric coding.

At 5 amp. In contour acrylic packing from PVC film and foil of aluminum lacquered or multilayer film, or without foil and film. 1 or 2 contour squares in a pack of cardboard.

The bundle is glued on both sides by stickers of self-adhesive material to control the opening.

For 0.3 ml 1000 ME, 0.4 ml 4000 ME in a sterile glass graduated syringe with a needle, protective cap, with an additional automatic or non-automatic device to protect the needle after using the syringe or without it.

By 1, 2 or 3 syringes in a contour squeeze of PVC or PET film and a multilayer or polypropylene or PE film, or a polymer-wrapped packaging paper, or paper for packaging medical products, or aluminum lacquered foil. 1 or 2 contour squares in a pack of cardboard.

The pack is glued on both sides with stickers of self-adhesive material to control the opening.

For 0.3 ml of 2000 ME, 0.5 ml of 2000 ME, 0.6 ml of 10000 ME, 1 ml of 10,000 IU in a sterile glass sterilized syringe with needle, protective cap, with an additional automatic or non-automatic device to protect the needle after using the syringe Or without it.

1, 2 or 3 syringes in a contour squeeze of PVC or PET film and a multilayer or polypropylene or PE film or a polymer-coated packaging paper, or a paper for packaging medical products, or an aluminum lacquered foil. 1 or 2 contour squares in a pack of cardboard. 5 contour cell packs of 2 syringes without a device to protect the needle in a pack of cardboard.

The pack is glued on both sides with stickers of self-adhesive material to control the opening.

A solution of 10,000 IU / ml in 0.25 ml (2500 IU); 0.6 ml (6000 IU); 0.8 ml (8000 ME) in a sterile glass syringe with a needle, protective cap, with an additional automatic or non-automatic device to protect the needle after using the syringe or without it.

3 syringes in a contour squeeze of PVC or PET film and a multilayer or polypropylene or PE film or a polymer-wrapped packaging paper, or paper for packaging medical products, or aluminum lacquered foil. 1 or 2 contour squares in a pack of cardboard.

The bundle is glued on both sides by stickers of self-adhesive material to control the opening.

Solution for intravenous and subcutaneous administration, 3000 ME, 5000 ME, 20000 ME. For 0.3 ml 3000 ME; 0,3 ml of 5000 ME; 0.5 ml or 0.6 ml 20000 ME in width with an additional automatic or non-automatic device to protect the needle after using the syringe or without it.

1 or 3 syringes are placed in a contoured, cellular package with a coating. 1 or 2 contour squares in a pack of cardboard.

The bundle is glued on both sides by stickers of self-adhesive material to control the opening.

Solution for intravenous and subcutaneous administration, 40000 ME. For 0.3 ml (12000 ME) and 1 ml (40,000 ME) in a syringe with an additional automatic or non-automatic device to protect the needle after using the syringe or without it.

For 1, 2 or 3 syringes in a contoured, coated cell. 1 contour cell package for 1, 2 or 3 syringes or 2 contour packs for 2 or 3 syringes in a pack of cardboard.

The bundle is glued on both sides by stickers of self-adhesive material to control the opening.

Manufacturer

CJSC "PharmFirma" Sotex ". 141345, Russia, Moscow Region

The owner of the registration certificate: ZAO "FarmSirma" Soteks ".

Complaints of consumers should be addressed to the manufacturer's address.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Eralfon

At a temperature of 2-8 � C.

Keep out of the reach of children.

Shelf life of the drug Eralfon

Solution for intravenous and subcutaneous administration of 1000 IU - 3 years.

Solution for intravenous and subcutaneous administration of 2000 IU - 3 years.

Solution for intravenous and subcutaneous administration of 3000 IU - 3 years.

Solution for intravenous and subcutaneous administration of 4000 IU - 3 years.

Solution for intravenous and subcutaneous injection of 5000 IU - 3 years.

Solution for intravenous and subcutaneous administration 10,000 IU - 3 years.

Solution for intravenous and subcutaneous administration of 10,000 IU / ml - 3 years.

Solution for intravenous and subcutaneous administration 20,000 IU - 3 years.

Solution for intravenous and subcutaneous administration of 40,000 IU - 3 years.

Solution for intravenous and subcutaneous administration of 40,000 IU / ml - 3 years.

Do not use after the expiry date printed on the package.

Instructions

Instruction for use: Eralfon

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