Product Description

Product Name：Recombinant Human Erythropoietin(rh-EPO) Injection, Erythropoietin，EPO, Epoetin
Nombre del Producto: Eritropoyetina humana recombinante
Specification: ***0IU,***0IU,***0IU,***0IU,****0IU
Package: in vials,or in pre-filled syringe
Standard: CP
[Introduction]
A clear and colorless solution
 
[Indications]
Anaemia due to renal inadequacy, including peritoneal dialysis patients undergoing hemodialysis, peritoneal dialysis and non-dialysis treatment.
 
[Usage and Dosage]
This product should be used under the instructions of physicians. Before use dilute it with 1ml injection saline, and then perform subcutaneous or intravenous injection. Inject **3 times per week. The dosage depends on the anaemia degree, age and other relative factors.
In the treatment period: the starting dosage for hemodialysis patients is **0~**0IU/kg per week, for peritoneal dialysis and non-dialysis is *5~**0IU/kg per week. If the packed red blood cells is less than 0.5vol% per week, the dosage can be increased to be *5~*0IU/kg after four weeks. But the highest dosage should not overpass *0IU/kg/week. The packed red blood cells should be elevated to be *0~*3vol%, but should not be over *6vol%(*4vol%).
In the maintenance period: If the packed red blood cells is up to *0~*3vol% or/and packed red blood cells is up to **0~**0g/L, then it becomes the maintenance period. It is recommended to adjust the dosage to be 2/3 of the treatment dosage, and then check the packed red blood cells every **4 weeks to adjust the dosage, in order to avoid too rapid erythropoiesis, and to maintain the packed red blood cells and the hemoglobin at an appropriate level.
 
[Side effects]
1. Common reactions: in the beginning some individuals might have headache, low fever and hypodynamia, some might have muscle pains and joints pains. Most of these side effects can be cured after appropriate treatment. And theyll not affect continuous administration of this product. For very rare cases the administration should be stopped.
2. Allergic reactions: for rare cases after injection they might have allergic reactions such as rash or cnidosis, including allergic shock. Thus for the patients that is administered with this medicine for the first time, it is recommended to use small dosage at first. If there are no abnormal reactions full dosage can be used. If there is any side effect, administration should be stopped.
3. Cerebrovascular system: elevation of blood pressure, aggravation of high blood pressure and thus causes headache, conscious disturbance and spasm. Thus during treatment the blood pressure should be watched carefully. The dosage should be decreased or stopped if necessary.
4. Blood system: with the increase of the packed red blood cells, the blood viscosity also increases. Attention should be paid to prevent thrombopoiesis.
5. Liver: for rare cases there might be elevation of GOT and GPT.
6. Stomach and intestine: sometimes there might be nausea, vomit, poor appetite and diarrhea.
 
[Contraindications]
1. Serious high blood pressure patients beyond control
2. Patients allergic to this product or human serum protein
3. Patients with concurrent infection should not use this product until the infection is cured.
 
[Cautions]
1. The hematocrit should be controlled periodically during Erythropoietin therapy (once a week during the early phase of treatment, twice a week during the maintenance phase). Care needs to be taken to avoid red blood cell production at an excessive rate (the hematocrit should be confirmed below *4 vol%). If it is found that red blood cells produce too rapidly, Erythropoietin should be temporarily withheld.
2. This product can slightly increase the serum potassium thus the foods should be adjusted to avoid increase of serum potassium.
3. Patients should be cautious who have heart infarction, pulmonary infarction and allergic to this product.
4. Due to effective haematogenesis during treatment, the demand for iron will be increased thus the serum iron level will be slightly decreased. If the patients serum ferritin is lower than **0ng/ml, or the degree of saturation of TF is lower than *0%, iron should be supplemented each day.
 
[Pregnant and nursing women]
Since the safety to such patients has not been established yet, use it with caution. Only with the evidence that the benefit over-weights the potential risk to fetus, the drug can be used. Stop nursing before using the drug.
 
[Administration for children]
Safety not sure
 
[Administration for the aged]
In old patients administered by Erythropoietin, blood pressure and hematocrit should be monitored carefully and the dosage and administration times should be adjusted appropriately.
 
[Drug interactions]
Insufficient Folic Acid or Vitamin B*2 will decrease the effects of this product. Too excessive aluminium will also affect the results.

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