Composition, form of production and packaging
The solution for intravenous and intravenous administration is colorless, transparent or slightly opalescent.
1 syringe tube
epoetin beta 1000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water.
0.3 ml - syringe tubes (3) complete with needles d / and (3 pcs.) - packings of cellular contour (2) - packs of cardboard.
The solution for intravenous and intravenous administration is colorless, transparent or slightly opalescent.
1 syringe tube
epoetin beta 2000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water.
0.3 ml - syringe tubes (3) complete with needles d / and (3 pcs.) - packings of cellular contour (2) - packs of cardboard.
The solution for intravenous and intravenous administration is colorless, transparent or slightly opalescent.
1 syringe tube
epoetin beta 10 000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water.
0.6 ml - syringe tubes (3) complete with needles d / and (3 pcs.) - packings of cellular contour (2) - packs of cardboard.
The solution for intravenous and intravenous administration is colorless, transparent or slightly opalescent.
1 syringe tube
epoetin beta 20,000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water.
0.6 ml - syringe tubes (3) complete with needles d / and (3 pcs.) - packings of cellular contour (2) - packs of cardboard.
The solution for intravenous and intravenous administration is colorless, transparent or slightly opalescent.
1 syringe tube
epoetin beta 30 000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water.
0.6 ml - syringe tubes (1) complete with needles d / and (1 pc.) - packings of cellular contour (1) - packs cardboard.
0.6 ml - syringe tubes (1) complete with needles d / and (1 pc.) - packings of cellular contour (4) - packs of cardboard.
Liofilizate for the preparation of a solution for administration in the form of a homogeneous powder or a porous mass of white or almost white color: solvent - colorless, clear liquid; the prepared solution is a colorless, clear or slightly opalescent liquid.
1 cartridge
epoetin beta 10 000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Solvent: benzyl alcohol, benzalkonium chloride, water d / u.
Cartridges two-section with lyophilizate in the first section and 1 ml of solvent in the second section (1) - packs cardboard.
Liofilizate for the preparation of a solution for administration in the form of a homogeneous powder or a porous mass of white or almost white color: solvent - colorless, clear liquid; the prepared solution is a colorless, clear or slightly opalescent liquid.
1 cartridge
epoetin beta 20,000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Solvent: benzyl alcohol, benzalkonium chloride, water d / and.
Cartridges two-section with lyophilizate in the first section and 1 ml of solvent in the second section (1) - packs cardboard.
Lyophilized powder for solution for injection homogeneous, white; solvent - colorless transparent liquid; the prepared solution is a colorless, clear or slightly opalescent liquid.
1 f.
epoetin beta 1000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Solvent: water d / u - 1 ml.
1000 IU - bottles (5) complete with a solvent (amp 5 pcs.) - plastic pallets (2) - cardboard packs.
Lyophilized powder for solution for injection homogeneous, white; solvent - colorless transparent liquid; the prepared solution is a colorless, clear or slightly opalescent liquid.
1 f.
epoetin beta 2000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Solvent: water d / u - 1 ml.
2000 ME - bottles (5) complete with a solvent (amp 5 pcs.) - plastic pallets (2) - cardboard packs.
Lyophilized powder for solution for injection homogeneous, white; solvent - colorless transparent liquid; the prepared solution is a colorless, clear or slightly opalescent liquid.
1 f.
epoetin beta 5000 IU
[PRING] urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Solvent: water d / u - 1 ml.
5000 IU - bottles (5) complete with a solvent (amp 5 pcs.) - plastic pallets (2) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Stimulator of hemopoiesis. Epoetin beta is a glycoprotein consisting of 165 amino acids, which, being a mitogenic factor and a differentiation hormone, promotes the formation of erythrocytes from partially determined progenitor cells of erythropoiesis.
Recombinant epoetin beta, obtained by genetic engineering, is identical in its amino acid and carbohydrate composition to human erythropoietin.
Epoetin beta after IV and SC administration increases the number of erythrocytes, reticulocytes and hemoglobin level, as well as the rate of iron incorporation ( 59 Fe) into cells, specifically stimulates erythropoiesis without affecting leukopoiesis. The cytotoxic effect of epoetin beta on the bone marrow or on human skin cells has not been revealed.
PHARMACOKINETICS
Suction
Bioavailability of epoetin beta with n / to the introduction of 23-42%. With the introduction of the drug to patients with uraemia, prolonged absorption provides a plateau of drug concentrations in the serum. T max - 12-28 h.
Distribution
V d is equal to bcc or 2 times greater than it.
Excretion
In patients with uremia and healthy volunteers, T 1/2 with iv administration is 4-12 hours T 1/2 of the terminal phase with a sc administration greater than after intravenous administration and averages 13-28 hours .
Pharmacokinetics in special clinical cases
The pharmacokinetics of epoetin beta in patients with hepatic insufficiency has not been studied.
INDICATIONS
- symptomatic anemia in chronic kidney disease in patients on dialysis;
- symptomatic anemia of renal genesis in patients not yet receiving dialysis;
- treatment of symptomatic anemia in adult patients with solid and hematological non-myeloid tumors receiving chemotherapy;
- for the purpose of increasing the volume of donor blood intended for subsequent autotransfusion (taking into account the registered risk of thromboembolic events and only for patients with moderate anemia (Hb 100-130 g / l or 6.21-8.07 mmol / l), without iron deficiency), if it is not possible to obtain a sufficient amount of preserved blood, and a planned large elective surgery may require a large amount of blood (? 4 units for women or? 5 units for men);
- prevention of anemia in premature newborns born with a body weight of 750-1500 g to 34 th week of pregnancy.
DOSING MODE
Treatment of anemia in patients with chronic kidney disease
Enter the SC or IV for 2 minutes. Patients on hemodialysis - through the arteriovenous shunt at the end of the dialysis session. Patients who do not receive hemodialysis, preferably enter the drug sc, to avoid puncture of peripheral veins.
The goal of the treatment is the hemoglobin (Hb) value of 100-120 g / l. Hb should not exceed 120 g / l. If the Hb is increased by more than 20 g / l (1.3 mmol / l), the dose of the drug should be reduced in 4 weeks. In patients with hypertension, cardiovascular and cerebrovascular diseases, weekly increase in hemoglobin and its targets should be determined individually, depending on the clinical picture. Careful observation of the patient should be carried out in order to select the minimum dose sufficient to ensure the maximum effect of the drug. Treatment Rekormon is carried out in 2 stages.
Correction stage. P / c, the initial dose is 20 IU / kg 3 times a week. If there is insufficient increase in Hb (less than 2.5 g / L per week), the dose can be increased every 4 weeks by 20 IU / kg 3 times a week. The total weekly dose of the drug can also be divided into daily injections.
In / in, the initial dose is 40 IU / kg 3 times a week. If there is an insufficient increase in Hb in a month, the dose can be increased to 80 IU / kg 3 times a week. If necessary, in the future, the dose should be increased by 20 IU / kg 3 times a week, with a monthly interval.
Regardless of the route of administration, the maximum dose should not exceed 720 IU / kg per week.
Supportive therapy. To maintain the target Hb (100-120 g / l), the dose should first be reduced by a factor of 2 from the previous dose. Subsequently, the maintenance dose is selected individually, with an interval of 2 or 4 weeks. With n / to the introduction of a weekly dose can be administered for 1 reception or divide by 3 or 7 administrations per week. When the condition is stabilized against the background of administration once a week, you can go to the administration once every 2 weeks, in which case an increase in the dose may be necessary.
Treatment Rekormon, as a rule, is long. If necessary, it can be interrupted at any time.
Treatment of symptomatic anemia in patients with solid and hematological non-myeloid tumors receiving chemotherapy
The drug is given SC, at an initial dose of 30,000 IU per week (450 MU / kg per week), once or divided a weekly dose into 3 or 7 injections.
Rekormon therapy is indicated for Hb ≥ 110 g / l (6.83 mmol / l). Index Hb should not exceed 130 g / l (8.07 mmol / l).
If Hb is increased by 10 g / l (0.62 mmol / L) after 4 weeks, therapy should continue at the same dose.
If Hb is increased by less than 10 g / L (0.62 mmol / L) after 4 weeks - the dose should be doubled.
In the absence of an increase in Hb by 10 g / l (0.62 mmol / l) after 8 weeks - treatment should be interrupted, t. response to therapy Rekormon unlikely.
Treatment should continue for 4 weeks after the end of chemotherapy.
The maximum dose should not exceed 60,000 IU per week.
When the target Hb for a particular patient is reached, the dose of the drug should be reduced by 25-50%.
To prevent an increase in Hb of more than 130 g / l, further dose reduction may be required.
When Hb increases by more than 20 g / L (1.3 mmol / L) per month, the dose of Rekormon should be reduced by 25-50%.
Preparation of patients for taking blood for subsequent autohemotransfusion
In / in (for 2 min) or sc, twice a week for 4 weeks. In those cases where the hematocrit indicator in a patient (≥33%) allows blood sampling, Recormon should be entered at the end of the procedure.
Throughout the course of treatment, the hematocrit should not exceed 48%.
The dose of the drug is determined by the transfusiologist and the surgeon individually, depending on how much blood is taken from the patient and from his erythrocyte reserve:
1. The amount of blood that will be taken from the patient depends on the estimated blood loss, the available methods of blood preservation and the general condition of the patient; it should be sufficient to avoid transfusion of blood from another donor.
2. The volume of blood that will be taken from the patient is expressed in units (1 unit is equivalent to 180 ml of erythrocytes).
3. The possibility of donation depends mainly on the volume of blood in this patient and the initial hematocrit. Both indices determine the endogenous red blood cell, which is calculated by the following formula:
Endogenous erythrocyte reserve = volume of blood [ml] x (hematocrit-33): 100
Women: blood volume [ml] = 41 [ml / kg] x body weight [kg] + 1200 [ml]
Men: blood volume [ml] = 44 [ml / kg] x body weight [kg] + 1600 [ml] (with a body weight of? 45 kg).
Indication for the use of Recormon and its single dose are determined from nomograms, based on the required volume of donor blood and the endogenous red blood cell. The maximum dose should not exceed 1600 IU / kg per week for IV administration and 1200 IU / kg per week for n / v introduction.
Prevention of anemia in premature newborns
The drug is used only in syringe tubes. Enter SC at a dose of 250 IU / kg 3 times a week, as early as possible, preferably from 3 days of life , for 6 weeks.
In children and adolescents, the dose of the drug depends on age: as a rule, the smaller the age, the higher the dose of Recormon is required. But since an individual response to a drug can not be predicted, it is advisable to start with a standard dosage regimen. When treating anemia associated with chronic kidney disease,Rekormon should not be prescribed to children under 2 years of age .
In clinical trials in elderly patients, the need for dose changes is not defined.
Terms of use
The syringe tube with the drug Recormon is ready for use. The solution contained in it is sterile and does not contain preservatives. Apply only light clear or slightly opalescent solution that does not contain visible inclusions. If after the injection in the syringe tube a certain amount of the drug remains, the repeated administration of it is unacceptable.
Instructions for the use of a syringe tube
Before injection, wash hands.
1. Remove one syringe from the package and make sure that the solution is clear, colorless and does not contain visible inclusions. Remove the cap from the syringe.
2. Remove one needle from the package, put it on the syringe and remove the protective cap from the needle.
3. Remove air from the syringe and needle, holding the syringe upright, gently pushing the piston upward. Press the plunger until the required dose of Recormon is left in the syringe.
4. Wipe the skin at the injection site with alcohol moistened with cotton wool. With a thumb and forefinger, take the skin into a crease. Holding the syringe body closer to the needle, insert the needle under the skin. Introduce the solution of Rekormon. Quickly remove the needle and squeeze the injection site with a sterile dry cotton wool.
Cartridge with Recormon for the pen-handle Reco-Pen is a two-section cartridge containing lyophilizate for the preparation of solution for the SC administration and a solvent with preservatives. The prepared solution is obtained by inserting the cartridge into the Reco-Pen syringe-pen in accordance with the instructions for Reco-Pen.
Cartridges with Recormon should only be used in the Reco Pen syringe pen. It is recommended to use needles for the Reco Pen syringe (for example, the Penfine needle). The solution prepared in the cartridge is stored for 1 month at a temperature of 2 В° to 8 В° C. After installing the cartridge, the Reco-Pen syringe pen is removed from the refrigerator only at the time of the injection.
SIDE EFFECT
From the cardiovascular system: often - the emergence or strengthening of an existing arterial hypertension (> 1%, <10%), especially in the case of a rapid increase in hematocrit; hypertensive crisis with the phenomena of encephalopathy (headaches and confusion, sensory and motor disorders - speech disorders, gait, up to tonic-clonic seizures), thromboembolic complications in cancer patients (> 0.1%, <1%) and in patients preparing for autotransfusion (there is no clear causal relationship with the drug).
From the side of the central nervous system: > 1%, <10% - headaches, incl. sudden migraine headaches.
On the part of the hematopoiesis system: a dose-dependent increase in the number of platelets (not exceeding the norm and disappearing with the continuation of therapy), especially after intravenous administration of the drug; <0.01% - thrombocytosis; > 0.01%, <0.1% - thrombosis of the shunts (possibly with inadequate heparinization), especially in patients with a tendency to reduce blood pressure or with complications of arteriovenous fistula (including stenosis, aneurysm).
Allergic reactions: rarely (from? 1/10 000 to? 1/1000) - skin rash, itching, urticaria; very rarely (? 1/10 000) - anaphylactoid reactions.
On the part of laboratory indicators: a decrease in serum ferritin concentration simultaneously with an increase in Hb, a decrease in serum iron metabolism; in patients with uremia - transient hyperkalemia (a clear causal relationship with the drug is not established), hyperphosphatemia. In premature newborns, a decrease in serum ferritin (> 10%), a slight increase in the number of platelets, especially up to the 12-14th day of life.
Other: reactions at the injection site; influenza-like symptoms (especially at the beginning of therapy, usually expressed mildly or moderately and disappear after a few hours or days), incl. fever, chills, headaches, pains in the extremities or bones, general malaise.
Postmarketing observation: in the case of Recormon therapy, isolated cases were recorded (0.107 cases per 10 000 patient-years with the use of Recormon for the treatment of anemia of renal genesis IV and S / I and 0.158 cases per 10 000 patient-years with the introduction of Rekormon for treatment of anemia of renal genesis) of partial red cell aplasia (PKAA) caused by the formation of neutralizing anti-erythropoietin antibodies.
CONTRAINDICATIONS
uncontrolled arterial hypertension;
- myocardial infarction or stroke during the previous month;
- unstable angina pectoris or an increased risk of deep vein thrombosis (venous thromboembolism) - the appointment to increase the volume of donor blood for autotransfusion;
- children up to 3 years (for cartridges lyophilisate for solution for s / c administration);
- hypersensitivity to Epoetin beta, or any of the components;
- increased sensitivity to benzoic acid - metabolite benzyl alcohol (when used for NeoRecormon pen Reco-Pen).
With cautionrefractory anemia when used in the presence blasttransformirovannyh cells thrombocytosis, epilepsy and chronic liver failure; body weight less than 50 kg for larger volume of donor blood for subsequent autotransfusion.
PREGNANCY AND LACTATION
Safety Information application NeoRecormon during pregnancy, childbirth and lactation (breastfeeding) is obtained by post-registration application.
During pregnancy or in childbirth Recormon should be used with caution, since the application of a sufficient experience of pregnancy and childbirth is not.
Endogenous erythropoietin is excreted in breast milk and is completely absorbed in the digestive tract of the newborn. The choice between the continuation or continuation of breastfeeding NeoRecormon therapy do with the need to care for the mother and the benefit of breastfeeding for the baby.
In experimental studies have shown that epoetin beta does not have teratogenic effects in animals.
APPLICATION FOR FUNCTIONS OF THE LIVER
The sharp increase in the aluminum content due to treatment of renal failure, can reduce the effectiveness of epoetin beta.
The decision on the use of NeoRecormon in patients with nephrosclerosis are not on dialysis, should be taken individually, as we can not completely exclude the possibility of a more rapid deterioration of renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With care use in patients with chronic liver failure.
APPLICATION FOR CHILDREN
For the prevention of anemia in preterm infants drug is used only in unit-dose syringes. Injected s / c in a dose of 250 IU / kg 3 times a week as soon as possible, preferably with 3 days of life , for 6 weeks.
In children and adolescents the dose depends on the age: as a rule, the lower the age, the higher the NeoRecormon doses required. But as an individual response to the drug can not be predicted, it is advisable to start with the standard dosing regimen. When the treatment of anemia associated with chronic kidney disease,Recormon В® should not be administered to children under 2 years .
Contraindications: children up to 3 years (for cartridges lyophilisate for solution for s / c administration).
APPLICATION IN ELDERLY PATIENTS
In clinical trials in elderly patients need to change the dose to be determined.
SPECIAL INSTRUCTIONS
Improper use of the drug by healthy people (for example, as a performance-enhancing drugs) can cause a sharp increase in the Hb, accompanied by life-threatening complications of the cardiovascular system.
Because in some cases, anaphylactoid reactions were observed, the first dose should be administered under the supervision of a physician.
Should regularly monitor the performance of platelets, hematocrit and Hb on the background of NeoRecormon therapy.
It should be used with caution Recormon in refractory anemia with the presence blasttransformirovannyh cells, epilepsy, thrombocytosis, and chronic liver failure. Prior to treatment should be deleted Recormon deficiency of vitamin B 12 and folic acid, as they reduce the effectiveness of the therapy.
Make sure to exclude iron deficiency Recormon before treatment and throughout the treatment period. If necessary, additional iron therapy can be administered according to clinical guidelines.
In the treatment of patients with severe forms of phenylketonuria should take into account the presence of phenylalanine as an adjuvant: In each syringe tube - 0.3 mg (dosages 1000 ME, 2000 ME) or 0.6 mg (10,000 ME, 20000 ME, 30 000 ME), each cartridge - up to 0.5 mg.
Lack of effect.The most frequent causes incomplete response to treatment by means of stimulating erythropoiesis are iron deficiency and inflammation (uremia or as a result of progressive metastatic cancer). The following states reduce the effectiveness of the treatment by means of stimulating erythropoiesis: chronic blood loss, bone marrow fibrosis, a sharp increase in aluminum concentration, caused by hemodialysis, folic acid deficiency and vitamin B 12, Hemolysis. If all of the state are excluded and the patient is a sudden reduction of Hb, reticulocytopenia and have antibodies to erythropoietin, it is necessary to conduct a study of the bone marrow to eliminate PKKA. With the development of PKKA therapy with NeoRecormon must be discontinued and patients should not be translated into therapy with other stimulants of erythropoiesis.
PKKA caused by neutralizing anti-erythropoietin antibody, it can be associated with therapy stimulators of erythropoiesis, including and therapy Recormon (0.107 cases per 10,000 person-years in the application of NeoRecormon for the treatment of anemia of renal origin in / and n / k; 0.158 cases per 10,000 person-years in the p / to introduction NeoRecormon for the treatment of anemia of renal origin). It is not recommended for patients translate Recormon therapy for suspected or confirmed the presence of the presence of erythropoietin neutralizing antibodies.
Effect on tumor growth.Epoetin are growth factors that primarily stimulate red blood cell production. Erythropoietin receptors may be present on the surface of various tumor cells. It is possible that agents that stimulate erythropoiesis, can stimulate the growth of any type of malignancy.
In clinical studies for the treatment of anemia in cancer patients with epoetin beta statistically significant deterioration in survival and tumor progression have been reported.
In patients with chronic kidney disease or malignancies receiving chemotherapy,there may be episodes of blood pressure increase and worsening of the existing flow of hypertension, particularly at sharp increase in the content Hb. The AD may be removed with medication, with no effect requires a temporary break in treatment Recormon. It is recommended to regularly monitor blood pressure (especially at the beginning of therapy), including between sessions of dialysis in patients with anemia of renal origin. For some patients with chronic kidney disease, hypertensive crisis can occur with symptoms of encephalopathy even at normal or low blood pressure. It requires immediate consultation of the therapist, and especially in the event of sudden acute migraine headaches.
During Recormon treatment it is recommended to periodically monitor the level of potassium in serum. In the event of hyperkalemia is necessary to temporarily cancel Recormon up to normalization of the potassium concentration.
Patients with chronic kidney disease requires increasing the dose of heparin during dialysis session due to higher content of Hb. Occlusion of the dialysis system is possible if heparinization inadequate. It recommended early shunt revision and timely prevention of thrombosis (e.g., acetylsalicylic acid).
Perhaps a moderate dose-dependent increase in the platelet count within the normal range, especially after the I / O assignment of NeoRecormon, followed by self-return to normal during continuation of therapy. During the first 8 weeks of treatment required weekly counting corpuscles and especially platelets.
If Recormon appoint front of the fence of autologous blood, should follow the recommendations of the donation procedure:
- Blood can be taken only in patients with hematocrit values? 33% (or hemoglobin of at least 110 g / l (6.83 mmol / L));
- special caution should be observed in patients weighing less than 50 kg;
- volume of blood picks up instantaneously, should not exceed 12% of the estimated blood volume of the patient.
Possible increase in the platelet count within the normal range in patients receiving Recormon front of the fence of autologous blood, so you should monitor the platelet count weekly. Treatment Recormon quenched with increasing platelet more than 150h10 9 / l or thrombocytosis.
Recormon treatment is indicated only for those patients who are most important to avoid homologous blood transfusion taking into consideration the risk-benefit for homologous transfusions.
Perhaps a slight increase in the number of platelets in the prevention of anemia in premature infants (up to 12-14 days), therefore it is recommended regular monitoring of platelets.
The decision on the use of NeoRecormon in patients with nephrosclerosis are not on dialysis, should be taken individually, as we can not completely exclude the possibility of a more rapid deterioration of renal function.
In most cases, simultaneously with increasing hemoglobin concentration decreases serum ferritin. Therefore all patients with anemia of renal origin, and with the concentration of serum ferritin below 100 mcg / L or the transferrin saturation of less than 20% is recommended oral iron supplements (Fe 2+ ) at a dose of 200-300 mg / day.
Patients with cancer and hematological diseases therapy with iron preparations performed according to the same principles, the patients with multiple myeloma, non-Hodgkin's lymphoma or chronic lymphocytic leukemia with transferrin saturation of less than 25% may be administered 100 mg Fe 3+ per week / in. Premature babies an oral iron therapy at a dose of 2 mg of Fe 2+ per day should be administered as early as possible (at the latest - on the 14th day of life). Correcting the dose of iron, depending on the level of serum ferritin. If it is firmly retained at a level below 100 pg / ml or have other symptoms of iron deficiency, the dose of iron preparations should be increased to 5-10 mg / day, and the therapy to relief of symptoms of iron deficiency.
Patients with moderate anemia before elective major surgery drug prescribed based on the benefits of epoetin beta, and an increased risk of thromboembolic complications.
Patients preparing for the donation of blood for subsequent autotransfusion, as they have indications of a temporary iron deficiency, oral iron therapy (of Fe 2+) At a dose of 300 mg / day should be started simultaneously with NeoRecormon therapy and continue until normalization of ferritin. If, despite oral iron substitution therapy, iron deficiency develops signs (ferritin levels? 20 mg / L or the transferrin saturation of less than 20%), it is necessary to consider additional on / in iron preparations. NeoRecormon solution cartridge contains as a preservative benzyl alcohol, capable of causing neonatal neurological and other complications that can sometimes fatal wearing character.
Impact on the ability to drive vehicles and manage mechanisms
Studies on the effect of the drug on the ability to road management and work with the mechanisms have not been conducted. Based on the mechanism of action and safety profile, Recormon has no such effect.
OVERDOSE
The therapeutic index of NeoRecormon is very wide, but should take into account an individual's response to therapy at the beginning of treatment. Possible excessive pharmacodynamic response, ie, excessive erythropoiesis with life-threatening cardiovascular complications.
At a high rate Hb necessary to temporarily interrupt treatment NeoRecormon. If necessary, it can be carried out phlebotomy.
DRUG INTERACTION
The obtained data so far did not reveal any interaction with other drugs NeoRecormon.
To avoid incompatibility or reducing the activity of a drug can not use another solvent and mixed preparation with other drugs or injectable solutions.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.
Injection pen Reco-Pen with the inserted cartridge can be stored for 1 month at 2-8 В° C.
