HEMAPO

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    Komposisi:

    - Epoetin alfa 2000 IU.

    - Epoetin alfa 3000 IU.

    Bentuk sediaan:

    Pre-filled syringe.

    Farmakologi:

    Menstimulasi pembentukan sel darah merah.

    Indikasi:

    Terapi anemia pada pasien penyakit ginjal kronik yang menjalani dialisis / yang tidak menjalani dialisis.

    Kontraindikasi:

    Hipertensi yang tidak terkontrol, riwayat hipersensitivitas.

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    Dosis:

    Dosis awal : 100 - 150 IU/kg/minggu, terbagi 2-3 dosis.

    Dosis pemeliharaan : 50 - 150 IU/kg/minggu, terbagi 2-3 dosis.

    Peringatan dan Perhatian:

    - Tidak boleh diberikan pada orang sehat.

    - Perlu pemantauan pasca-pemberian.

    - Hati - hati pada pasien anemia refrakter dengan jumlah sel blast berlebih, epilepsi, trombositosis, dan penyakit hati kronik.

    - Perlu pemantauan kadar kalium dan fosfat serum; pasien hamil / menyusui.

    Efek Samping:

    Peningkatan tekanan darah, peningkatan jumlah trombosit dalam batas normal. Perlu peningkatan dosis heparin.

     

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    HEMAPO 2000 IU & 3000 IU

     

    Composition:

    Each mL of solution contains Epoetin alfa (recombinant human erythropoietin) 2000 IU and 3000 IU.

    Presentation:

    Box of 10 pre-filled syringes of 2000 IU/mL, 3000 IU/mL.

    Pharmacology:

    Erythropoietin is a hormone, which stimulates the terminal differentiation of erythroid progenitors to mature erythrocytes leading eventually to an increase in red cell mass. Erythropoietin not only induces differentitation of erythroid progenitors but also maintain their viability. Epoetin is used in the treatment of anaemia caused by a relative or absolute deficiency of the hormone, especially in chronic renal failure.

    Indications:

    Treatment of anaemia associated with chronic renal failure (renal anaemia) in patients on dialysis. Treatment of symptomatic renal anaemia in patients not yet undergoing dialysis.

    Contraindications:

    - Uncontrolled severe hypertension - Known hypersensitivity to mammalian cell-derived products - Known hypersensitivity to human albumin

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    Dosage:

    Treatment with Hemapo is divided into 2 stages: - Correction phase The initial dosage for the patients receiving haemodialysis is 100-150 IU/kg/week divided in 2-3 dosages. If hematocrit increase is not as expected (<0.5%/week), the dosage can be changed after 4 weeks of initial treatment to increas the dose 15-30 IU/kg/week, but not more than 30 IU/kg/week. Non dialysis patient: 100 IU/kg/week divided in 3 dosages. - Maintenance phase To maintain a hematocrit of between 30% and 35%, the dosage should be 50-150 IU/kg/week divided in 2-3 dosages (reduced to 2/3 of the previously administered amount). The hematocrit should be monitored once every 2-4 weeks so as to adjust the dosage to maintain hematocrit at the proper level as well as to avoid erythropoiesis to be formed too quickly.

    Warning and Precautions:

    Warnings Misuse by healthy persons (e.g., for doping) may lead to an excessive increase of hematocrit. This may be associated with life-threatening complications of the cardiovascular system. Precautions - Since anaphylactic reactions were observed in isolated cases, it is recommended that the 1st dose be administered under medical supervision. - Erythropoietin should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure. - Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of erythropoietin. - Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of erythropoietin. - The indication for erythropoietin treatment of nephrosclerotic patients not yet undergoing dialysis should be defined individually as a possible acceleration of progression of renal failure can not be ruled out with certainty. - Serum potassium and phosphate levels should be monitored regularly during erythropoietin therapy. - Use in pregnancy and lactation: animal studies revealed that no teratogenic effects occur under therapeutic conditions. There is no adequate experience in human pregnancy and lactation. Erythropoietin should only be used during pregnancy and lactation if the potential benefit justifies the potential risk.

    Adverse events:

    - Cardiovascular system: increase blood pressure or aggravation of existing hypertension, especially in cases of rapid PVC increase. - Blood: There may be a moderate, dose dependent rise in the platelet count within the normal range during treatment with erythropoietin especially after IV administration. Development of thrombocytosis is very rare. It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy. - Others: Rarely, skin reactions, e.g. rash, pruritus, urticaria, headache, arthralgias, nausea, edema, fatigue, diarrhea, vomiting or injection site reactions may occur.

    Drugs Interaction:

    There are no known clinically significant interactions, but the effect of erythropoietin may be potentiated by the simultaneous therapeutic administration of e haematinic agent such as ferrous suplphate when a deficiency state exists.

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