The package insert of the drug Recormon

the package insert of the medicine Recormon. Therapeutic class of Antianemicos.

what For?

RECORMON is indicated in the treatment of anemia associated with chronic renal failure in patients on dialysis Treatment of
anemia renal symptomatic patients with insuticiência chronic kidney that have not yet been subjected to dialysis RECORMON is also indicated for the treatment of anemia associated with cancer and chemotherapy (mielossupressora or nephrotoxic) and in the anemia of the carrier of AIDS and subjected to treatment with zidovudine RECORMON can be used to increase the yield of autologous blood from patients in a program of pre-donation, started, stop, avoid the use of homologous blood.

Contraindications

When should I not use?

RECORMON must not be used in cases of uncontrolled hypertension and known hypersensitivity to the drug. Studies in animals have shown that there is no teratogenic effects in therapeutic conditions. However, RECORMON must not be used during pregnancy and lactation because the experience to date is insufficient.

Dosage

How to use?

Sisfema cardiovascular – anemic Patients with chronic renal failure: The adverse reaction the most frequent during treatment with epoetin beta is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid increase of the hematocrit. A hypertensive crisis with similar symptoms to encephalopathy (eg, headache, confusion, sensory disturbances and motor – such as disturbances of speech, or of the march – until seizures tonic-clonic) may occur, even in patients with normal blood pressure or low. This requires the immediate attention of the physician and the medical care intensive care is taken particularly with headaches poignant sudden, similar to migraines, as a possible warning sign. Blood – anemic Patients with chronic renal failure: May occur only a moderate increase in dose-dependent in the platelet count within the normal range during treatment with epoetin beta, especially after intravenous administration. This increase subsides with continued treatment. The development of thrombocytosis is very rare. It is recommended that the platelet count be monitored regularly during the first 8 weeks of treatment. Often an increase in dose of heparin during hemodialysis may be necessary as a result of the increase in hematocrit (risk of occlusion of the dialysis system). Can occur thrombosis of the ‘main’, especially in patients who have a tendency to hypotension or whose arteriovenous fistula view complications (for example, stenosis, aneurysms) In the majority of cases, there is a fall in the values of ferritin along with an increase in hematocrit. Thus, it is recommended the replacement of oral iron with 200 to 300 mg of Fe2+ per day in all patients with serum values of ferritin below 100 ng/ml or saturation of transferrin below 20%. In isolated cases, can ocorree except in cases of hyperkalemia temporary and hyperphosphatemia. Other – In isolated cases, have been observed in reactions of the type anaphylactic

Side Effects

What are the evils that can cause me?

Sisfema cardiovascular – anemic Patients with chronic renal failure: The adverse reaction the most frequent during treatment with epoetin beta is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid increase of the hematocrit. A hypertensive crisis with similar symptoms to encephalopathy (eg, headache, confusion, sensory disturbances and motor – such as disturbances of speech, or of the march – until seizures tonic-clonic) may occur, even in patients with normal blood pressure or low. This requires the immediate attention of the physician and the medical care intensive care is taken particularly with headaches poignant sudden, similar to migraines, as a possible warning sign. Blood – anemic Patients with chronic renal failure: May occur only a moderate increase in dose-dependent in the platelet count within the normal range during treatment with epoetin beta, especially after intravenous administration. This increase subsides with continued treatment. The development of thrombocytosis is very rare. It is recommended that the platelet count be monitored regularly during the first 8 weeks of treatment. Often an increase in dose of heparin during hemodialysis may be necessary as a result of the increase in hematocrit (risk of occlusion of the dialysis system). Can occur thrombosis of the ‘main’, especially in patients who have a tendency to hypotension or whose arteriovenous fistula view complications (for example, stenosis, aneurysms) In the majority of cases, there is a fall in the values of ferritin along with an increase in hematocrit. Thus, it is recommended the replacement of oral iron with 200 to 300 mg of Fe2+ per day in all patients with serum values of ferritin below 100 ng/ml or saturation of transferrin below 20%. In isolated cases, can ocorree except in cases of hyperkalemia temporary and hyperphosphatemia. Other – In isolated cases, have been observed in reactions of the type anaphylactic

Warnings and Precautions

what should I know before using?

The misuse of RECORMON for healthy people (for example, for doping) can lead to an excessive increase in hematocrit. This product should be used only under the supervision of a hospital In isolated cases, have been observed in reactions of the type anaphylactic . In this way, it is recommended that the first dose be administered under medical supervision Epoetin beta should not be used in children under 2 years of age because the experience of the clinic is still insufficient. RECORMON should be used with caution in the presence of malignant tumors, epilepsy, thrombocytosis, and chronic renal failure Due to a possible increase in blood pressure or aggravation of existing hypertension, blood pressure should be monitored regularly, and also between the diálises (particularly at the beginning of the therapy), and possible increases treated if necessary Deficiencies of folic acid and vitamin B12 should be excluded because they reduce the effectiveness of RECORMON. Serious overload of aluminum due to the treatment of renal failure may compromise the effectiveness of RECORMON Recommended revisions to the early ‘shunts” and prophylaxis of thrombosis, for example, with aspirin, especially in patients with a tendency to hypotension or complications of fistula. The plasma levels of potassium and phosphate should be monitored regularly. Has been reported an elevation of potassium levels in some patients urêmicos. When RECORMON is used in a program of pre-donation autologous, guidelines, officials of the principles of blood donation must be considered, in particular: only patients with a hematocrit greater than or equal to 33% (hemoglobin greater than or equal to 11 g/dl) can donate: special care must be taken with patients below 50 kg body weight; the volume unit withdrawn may not exceed approximately 12% of the blood volume estimated for the patient.