Eprex Prefill 4000iu Janssen injection is anemia (6 tubes)
Dosage form 6 tube box
Specifications Epoetin Alfa
Ingredient
Thành phần cho 0.4ml
| Composition information | Content |
| Epoetin Alfa | 4000iu |
Uses
indications
Eprex drugs are indicated in the following cases:
Erythropoietin (EPO) is a glycoprotein hormone produced mainly by the kidneys to respond to tissue oxygen reduction, playing the main role in regulating red blood cells. EPO is related to all stages of red blood cell development, and has the main impact on the stage of red blood cell development. After connecting the receptors on the cell surface, EPO activates the signal transmission paths to the cell death process according to the programming (apoptosis) and stimulates the proliferation of red blood cells. The recombinant EPO (EPOETIN ALFA) is shown in Chinese Hamster mouse ovaries, including 165 amino acids with the same sequence as the urinary tract in humans; Both types of eppo cannot be distinguished based on functional analysis tests. The apparent molecular weight of Erythropoietin from 32000 to 40000 Dalton.
Pharmacological effectiveness
In the pharmacological response to Epoetin Alfa does not contain HSA (albumin of human serum), the change with the percentage of the ratio of red blood cells, hemoglobin, and the total number of red blood cells as well as the area under the curve (AUC) of these pharmacological parameters are similar between the two dose regimens (150 IU/kg under the skin three times a week to 40000 IU injected under the skin once a week).
Esas are the main growth factors that stimulate the formation of red blood cells. Erythropoietin receptors can be shown on the surface of many types of tumor cells.
Healthy volunteers
After using the single dose (2000 to 160000 IU injected subcutaneously) of Epoetin Alfa, observed the response depends on the dose of the pharmacological indicators studied including: mesh cells, the total number of red blood cells and hemoglobin. Data on time - concentration is determined with peak concentration and return to the initial concentration observed when the percentage of red blood cells changes. Determined data is observed for the number of red blood cells and hemoglobin. Overall, all pharmacological indicators increase linear at the dose and reach the maximum response at the highest dose.
A additional pharmacological studies have been conducted to explore the dose of 40000 IU/time/week compared to the dose of 150 IU/kg x 3 times/week. Despite the difference in time -concentration data, pharmacological response (measured by the change of percentage of red blood cells, hemoglobin and the total number of red blood cells) of these doses are similar. Additional studies compare the dosage mode of 40000 IU EPOETIN ALFA 1 time/week with the dosage mode every 2 weeks from 80000 to 120000 IU injected under the skin. Overall, based on the results of pharmacological research in healthy people, the dosage mode of 40000 IU/time/week seems to be effective in the production of red blood cells rather than the mode every 2 weeks, although the production of red blood cells in both modes once a week and every 2 weeks are observed as similar.
Chronic kidney failure
Epoetin Alfa has been shown to stimulate red blood cells in chronic renal failure subjects including subjects of fertilizer and fertilizer. The first evidence of response to Epoetin Alfa is an increase in the number of mesh red blood cells within 10 days, followed by increasing the number of red blood cells, hemoglobin and hematocrit, usually within 2 to 6 weeks. Hemoglobin meets different from objects and may be affected by iron reserves and the appearance of simultaneous medical problems.
Chemotherapy anemia
Epoetin Alfa is used 3 times/week or 1 time/week, showing an increase in hemoglobin and reducing blood transfusion demand after the first month of treatment in chemotherapy cancer patients.
In a study comparing the doses of 150 IU/kg x 3 times/week and 40000 IU/time/week in healthy subjects and anemia cancer subjects, time data changes percentage of red blood cells, hemoglobin and the total number of red blood cells are similar between two dosage modes in both healthy objects and anemic cancer subjects. The area under the curve (AUC) of the corresponding pharmacological parameters is similar between the doses of 150 IU/kg x 3 times/week and 40000 IU/time/week in both healthy subjects and anemia cancer object.
Patients with adult surgery in the self -donation program of self -donation
Epoetin Alfa is shown to stimulate the production of red blood cells to increase the collection of blood itself, and to limit the decline in hemoglobin in adult patients who have given large surgery programs that cannot be stored in advance for blood demand during their surgery.
Treatment for adult patients has been on a large orthopedic surgery program
In patients who have been given a large orthopedic surgery program that has been previously treated with hemoglobin> 10 and ≤ 13g/dl, Epoetin Alfa has shown a reduction in the risk of receiving blood transfusion and accelerating the recovery of red blood cells (increasing hemoglobin levels, hematocrite levels and number of mesh red blood cells).
pharmacokinetic pharmacokinetics
intravenously
Epoetin Alfa measurement after intravenous injection of 50 - 100 IU/kg has shown the half -life of about 4 hours in healthy people and longer selling time in patients with renal impairment, about 5 hours, after doses of 50, 100, 150 IU/kg. The selling time of about 6 hours is recorded in children's patients. With at least 4 days of dynamic blood sampling, the semi -cancellation estimates range from 20.1 to 33.0 hours have been observed in cancer patients taking the dose of Epoetin Alfa 667 and 1500 IU/kg intravenously.
Skin injection
Serum concentration when subcutaneously is lower than intravenously. Serum concentration increased slowly and peaked 12 - 18 hours after subcutaneous injection. The concentration of subcutaneous injection is always lower than intravenously (about 1/20 value).
There is no dosage: serum levels remain unchanged whether the data collected 24 hours after the first dose or 24 hours after the last dose. Data on concentration over time of erythropoietin at week 1 and week 4 is similar when using multiple doses of 600 IU/kg 1 time per week in healthy people.
Dynamic data on pharmacokinetics shows that there is no clear difference in the half -life between adult patients or under 65 years old.
Semi -cancellation time when using subcutaneous skin is about 24 hours. The average half -life values in healthy subjects are 19.4 ± 8.1 with many doses of 150 IU/kg three times a week and 15.0 ± 6.1 with 40000 IU doses per week.
Based on the comparison of the area under the curve (AUC), the relative bioavailability of Epoetin Alfa 40000 IU once a week compared to 150 IU/kg three times a week is 239%.
Epoetin Alfa's bioavailability in the skin after a dose of 120 IU/kg is lower than the bioavailability of the drug when intravenous injection: about 20%.
The pharmacokinetic parameters are evaluated when taking Epoetin Alfa containing HSA at a dose of 150 IU/kg three times a week or at a dose of 40000 IU/ml once a week at healthy research subjects and cancer patients with anemia being treated with cyclic chemotherapy.
Dynamic parameters in anemic cancer patients are different from the observed parameters found in healthy research subjects throughout the week 1 (when patients with chemotherapy is chemotherapy) but similar during week 3 (when patients with non -chemotherapy cancer are chemotherapy).
Epoetin alfa pharmacokinetic properties do not contain HSA in cancer patients with anemia and are being chemotherapy in the cycle that has been studied after taking the drug with the doses of 150 IU/kg three times a week and 40000 IU once a week. In general, pharmacokinetic parameters in patients with anemia cancer have a high level of variation.
Overall, the first pharmacokinetic data of Epoetin Alfa throughout the week 1 (when patients with chemotherapy is anemia) shows higher CMAX concentration, increasing the half -life, and lower clearance than the second kit of pharmacokinetics during week 3 or 4 (when patients with unpleasant anemic cancer).
Before taking Eprex Prefill 4000iu Janssen injection is anemia (6 tubes)
How to use
intravenously or subcutaneous injection. For patients with chronic renal failure including end -stage renal disease, intravenous use.
As well as other injection drugs, the injection solution must be tested for sub -stools and discoloration before injection. Do not shake, because shaking can denature glycoprotein inactivation.
Eprex is used in the form of one -time use without preservatives. Do not reuse the syringe. Unused part.
intravenous injection
Eprex should be injected for at least one minute to five minutes, depending on the total dose.
Should be injected slowly on patients reacting to the treatment of fake influenza.
In patients with hemolysis, it is advisable to inject once during the process of appraisal through the appropriate venous door on the dung. Or, can be injected with needles at the end of the fertilizer, then use 10 ml of isometric saline to wash the tube and make sure the drug is completely injected at the circulation.
Eprex is not indicated in intravenous or mixed with other drugs.
subcutaneous injection
The maximum volume at the injection site is 1 ml. Need to be injected more than one place if the volume of the injection is larger.
Should be injected in the limbs or abdominal walls first.
Products only used once.
The product should not be used and remove if:
frozen.
The non -used drugs or waste materials should be destroyed in accordance with local regulations.
If subcutaneous injection EPREX, one injection usually does not exceed 1 ml in an injection site.
Eprex is only used alone and is not mixed with other solutions for injection.
Do not shake the syringe containing Eprex. The strong and prolonged shake can damage the product.
Do not use if the product has been shaking vigorously.
How to inject with the pre -containing injection tube
Prelectable injection tubes are fitted with Protecs needle protective equipment to prevent the injury from stabbing needles after use. This information is recorded on the box.
Dosage
should only use intravenously for patients with chronic kidney disease.
The target hemoglobin concentration should be 10 - 12g/dl (6.2 - 7.5mmol/l) in adults and 9.5 - 11g/dl (5.9 - 6.8mmol/l) in children.
In patients with chronic renal failure, hemoglobin concentration should not exceed the upper limit of the hemoglobin level (see caution when using - '' patients with kidney failure ').
When changing the injection, it is advisable to start the same dose and then adjust to achieve hemoglobin concentration within the limited concentration range.
During the dose adjustment, the dose should be increased if hemoglobin does not increase at least 1g/dl (0.62mmol/l) per month.
Normally, the increase in hemoglobin is clinically significant after more than 2 weeks and can be up to 6-10 weeks in some patients.
When hemoglobin concentration is within the limit, a dose of 25 IU/kg/dose should be reduced to avoid exceeding the limit. The dose should be reduced when hemoglobin reaches 12g/dl.
may reduce the dose by ignoring one of the doses per week or by reducing the amount of drugs per dose.
Patients with dialysis adults
In patients with dialysis, only intravenous use.
The treatment is divided into two stages:
Adjustment phase
50 IU/kg three times per week.
When necessary, adjust the dose by increasing by 25 IU/kg three times per week for at least 4 weeks until reaching the hemoglobin concentration range (10 - 12g/dl [6.2 - 7.5mmol/l]).
Maintenance phase:
Adjust the dose to maintain hemoglobin values at the desired concentration: HB from 10 to 12g/dl (6.2 - 7.5mmol/l).
Maintenance dose should be individualized for each patient with chronic renal failure. The total weekly dose is proposed from 75 to 300 IU/kg.
Existing data shows that patients with initial hemoglobin ( 8g/dl or> 5mmol/l).
Pediatric patients who are dialysis
The treatment is divided into two stages:
Adjustment phase
50 IU/kg three times per week by intravenous line.
When necessary, adjust the dose by increasing by 25 IU/kg three times per week for at least 4 weeks until the concentration of hemoglobin (9.5 - 11g/dl [5.9 - 6.8mmol/l]).
Maintenance phase
Should adjust the appropriate dose to maintain hemoglobin concentration within the desired range between 9.5g/dl to 11g/dl (5.9 - 6.8mmol/l).
In general, children under 30 kg need to maintain a higher maintenance dose than children over 30 kg and adults. For example, the following maintenance dose has been observed in clinical trials after 6 months of treatment.
weight (kg)
Dose (IU/kg, 3 times/week)
Average Normal maintenance dose
100
75 - 150
10 - 30 75
60 - 150
30
33
30 - 100
[4.2mmol/l]).Patients with peritoneal jurors
In patients with peritoneal jurisdoms, intravenously.
The treatment is divided into two stages:
Adjustment phase
50 IU/kg twice per week.
When necessary, the dose adjustment should be increased by 25 IU/kg twice a week for a period of at least 4 weeks until the range of hemoglobin concentrations (10-12g/dl [6.2-7.5mmol/l]).
Maintenance phase
The usual dosage to maintain hemoglobin concentration (10 - 12g/dl [6.2 - 7.5mmol/l]) is from 25 to 50 IU/kg twice a week divided into two equal injections.
Pediatric patients with peritoneal fertilizer
The treatment is divided into two stages:
Adjustment phase
50 IU/kg three times per week by intravenously.
When necessary, adjust the dose by increasing by 25 IU/kg three times per week for at least 4 weeks until reaching the range of hemoglobin concentrations (9.5 - 11g/dl [5.90 - 6.83mol/l]).
Maintenance phase
In general, children 30 kg and adults. For example, observing the following maintenance dose in clinical trials after 6 months of treatment.
weight (kg)
Dose (IU/kg, 3 times/week)
Average Normal maintenance dose
100
75 - 150
10 - 30 75
60 - 150
30
33
30 - 100
Adult patients before dialysis (adult patients with end -stage renal failure)
In patients with renal impairment, only intravenous use. The treatment is divided into two stages:
Adjustment phase
50 IU/kg three times per week.
When necessary, the dose should be adjusted by increasing by 25 IU/kg, three times per week for at least 4 weeks until reaching the range of hemoglobin concentrations (10 - 12g/dl [6.2 - 7.5mmol/l]).
Maintenance phase
In the maintenance phase, EPREX is used 3 times a week, and in case of subcutaneous injection, once used once a week or 1 time every 2 weeks.
Adjust the appropriate dose and dose to maintain hemoglobin values at the desired concentration: HB from 10 to 12g/dl (6.2 - 7.5mmol/l). Expanding the dose range may require increasing dose.
The maximum dose must not exceed 150 IU/kg 3 times per week, 240 IU/kg (up to a maximum of 20,000 IU) once per week, or 480 IU/kg (up to maximum of 40000 IU) every 2 weeks.
Cancer patients
In adult cancer patients should use subcutaneous injections.
About HB concentration should be 10 to 12g/dl (7.5mmol/l) in men and women and should not exceed this range.
should continue to treat Eprex for another month after the end of chemotherapy. However, the demand for treatment continues EPREX should be re -evaluated periodically.
The starting dose of anemia should be 150 IU/kg 3 times per week.
Eprex can also be used at the starting dose of 40000 IU injected under the skin once a week.
If after 4 weeks of treatment at the starting dose, hemoglobin increases at least 1g/dl (0.6mmol/l) or red blood cells increasing ≥ 40000 cells/mCL compared to before treatment, treatment dose should be maintained.
If after 4 weeks of treatment at the starting dose, hemoglobin does not increase ≥ 1g/dl (0.6mmol/l) and red blood cells do not increase ≥ 40000 cells/mCL compared to before treatment, when not performing red blood cell transmission, should increase the dose up to 300 IU/kg, 3 times a week or 60000 IU per week.
If after 4 weeks of treatment at a dose of 300 IU/kg, 3 times per week or 60000 IU per week, hemoglobin increases ≥ 1g/dl (≥ 0.6mmol/l), or red blood cells increased ≥ 40000 cells/mCL, the dose should be maintained unchanged.
If after 4 more weeks of treatment with a dose of 300 IU/kg, 3 times per week or 60000 IU per week, hemoglobin increases
Avoid increasing hemoglobin per 1g/dl (0.6mmol/l) every 2 weeks or over 2g/dl (1.25mmol/l) per month or hemoglobin level> 12g/dl (> 8.1mmol/l). If hemoglobin is increasing> 1g/dl (0.6mmol/l) every 2 weeks or> 2g/dl (1.25mmol/l) per month or hemoglobin reaches about 12g/dl (7.5mmol/l), the Eprex should be reduced by 25-50% based on hemoglobin growth rate. If hemoglobin exceeds 12g/dl (7.5mmol/l), stop treatment until hemoglobin drops below 12g/dL (7.5mmol/l) and then starts with Eprex therapy at a lower dose than the previous dose of 25%.
HIV -infected patients, treated Zidovudine
Before starting eprex, the endogenous erythropoietin concentration should be determined before transmission. The existing data shows that the patient has endogenous erythropoietin levels in serum> 500 MU/ml will not respond to Eprex treatment.
Treatment is divided into 2 stages:
Adjustment phase
100 IU/kg x 3 times per week for 8 weeks by subcutaneous injection or intravenously.
If the response is not as expected (such as reducing the need for blood transfusion or increasing hemoglobin) after 8 weeks of treatment, EPREX dose can increase, Eprex can increase by 50 - 100 IU/kg x 3 times per week for at least 4 weeks. If the patient still does not respond to the desired Eprex at a dose of 300 IU/kg x 3 times per week, it is considered not to meet at a higher doses.
Maintenance phase
After achieving the desired response, the dose should be adjusted to maintain hematocrit between 30-35%, based on factors such as the change of zidovudine dose, the presence of recurrent infections or inflammatory stages. If Hematocrite exceeds 40%, it is advisable to suspend treatment until Hematocrit drops up to 36%. At the beginning of the treatment, it should be reduced by 25% and then adjust the dose to maintain the desired hematocrit level.
In patients with HIV infected with zidovudine, hemoglobin concentration should not exceed 12g/dl (7.5mmol/l).
Adult patients with surgery in the self -donation program of self -donation
Should be used by intravenously. Eprex should be used after completing each period of blood.
Patients with mild anemia (with hematocrit 33 - 39% and/or hemoglobin 10 - 13 g/dl (6.2 - 8.1 mmol/l) need to reserve ≥ 4 units of blood, the dose of Eprex used is 600 IU/kg, 2 times per week within 3 weeks before surgery.
For patients who need to stimulate hematopoiasis at a lesser level, the dose of 150 - 300 IU/kg, twice per week shows the effectiveness of self -donation of blood donation and reducing hematocrit decline.
Adult patients during the period of surgery (no blood donation)
Should be used by subcutaneous injection.
Eprex's recommended dosage mode is 600 IU/kg per week, for 3 weeks (on 21, 14 and 7) before surgery and on surgery.
In cases where the surgery is required to be reduced before three weeks, the recommended dosage mode is 300 IU/kg for 10 consecutive days before surgery, on surgery date and continue up to 4 days after surgery. Recommendations of 300 IU/kg/day if hemoglobin ≤ 13g/dl (8.1mmol/l). If the hemoglobin level reaches 15g/dl or higher, it is necessary to stop using Eprex and stop the next dose.
Patients with adults suffer from mild oral medulla syndrome or average risk 1
Should be used by subcutaneous injection.
Should use eprex for patients with mild medulla syndrome or average risk 1 accompanied by anemia [for example, hemoglobin concentration ≤ 10g/dl (6.2 mmol/l)].
The recommended starting dose is Eprex 450 IU/kg (the maximum total dose is 40000 IU), intravenous injection once a week.
Recommendation should be assessed at week 8. It is necessary to increase the dose from 450 IU/kg once a week to 1050 IU/kg once a week (maximum dose of 80000 IU per week), if not achieved red blood cells after 8 weeks according to IWG 2006 standard (see pharmacokological - '' clinical studies' '') and hemoglobin concentration The dose adjustment is need to maintain hemoglobin levels within the destination range of 10 g/dl to 12g/dl (6.2 to 7.5 mmol/l). See the diagram in Figure 2 for instructions to adjust the dose in step by step. Eprex should be stopped or the dose reduces when the concentration of hemoglobin exceeds 12 g/dl (7.5 mmol/l). When the dose is reduced, if the concentration of hemoglobin decreases ≥ 1 g/dl, the dose increases.
Should avoid Hemoglobin concentration maintained over 12 g/dl (7.5 mmol/l).
Special subjects
Children (≤ 17 years old)
Treatment for patients with chemotherapy anemia: The safety and effectiveness of Eprex when used for chemotherapy patients who are not established.
Treatment for patients with HIV infection is taking zidovudine
Safety and effectiveness of EPREX when used for patients with HIV infected with zidovudine has not been set up.
Treatment for patients with surgery in the self -donation program
Safety and effectiveness of EPREX when used for pediatric patients in the self -donating currency program has not been established.
Treatment for pediatric patients who have selected large orthopedic surgery program
The safety and effectiveness of EPREX when used for children who have been selected large orthopedic surgery programs have not been set up.
Elderly (≥ 65 years)
Selecting the dose and adjusting the dose for elderly patients should be conducted in individuals to achieve and maintain hemoglobin concentration.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? The overdose of Eprex can cause the effects of increasing pharmacological effects of hormones. Venous excerpts may be done if the concentration of hemoglobin is excessive.
Use other supportive measures when necessary.
What to do when forgetting 1 dose? If you remember in the same day with the next dose, skip the forgotten dose and continue to inject according to the normal course. Do not inject twice the dose.
Side Effects
When using Eprex, you may experience unwanted effects (ADR).
The adverse reactions are recorded after circulating the Epoetin Alfa with the frequency given in accordance with the following convention: Very common ≥ 1/10, common ≥ 1/100 and
Very common
Common
Vascular disorders: embolism and thrombosis, deep vein thrombosis, hypertension.
Less
Respiratory, chest and mediastinum disorders: Respiratory obstruction.
Slow erythrocytes (PRCA) after months to many years of Erythropoietin treatment have been recorded at a very rare rate (
Instructions on how to handle ADR
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Eprex drugs contraindicated in the following cases:
Hypersensitivity to active ingredients or any excipients.
Contraindicated Eprex for patients in the selective large orthopedic surgery program and are not participating in the self -donated program of blood donation but suffer from severe coronary artery disease, peripheral artery disease, carotid artery disease, or cerebrovascular disease, including patients with myocardial infarction or cerebrovascular accident recently. Patients with surgery are not fully prevented for any reason. Hypertension All patients using Eprex should be monitored and controlled strict blood pressure. In patients with non -treatment hypertension, incomplete treatment or poor control, it is necessary to be cautious when using EPREX. may be necessary to start or enhance the treatment of hypertension while using Eprex. If the blood pressure is not controlled, EPREX should be stopped. During the treatment period with Eprex in patients with normal or low blood pressure before, there has been a hypertension that comes with brain disease and seizures, which need to be examined and medical examination immediately. It is necessary to pay special attention to the throbbing pain and suddenly like migraine, which is considered as a potential warning signal (see unwanted effects). Red blood cells Soldly red blood cell property (PRCA) through antibody intermediaries have been recorded after subcutaneous injection treatment with Epoetin. These cases are also recorded rarely occurring when using the erythrocyte stimulants (ESAS) in patients with hepatitis C treated with Interferon and Ribavirin. ESA is not approved in the treatment of anemia accompanied by hepatitis c. In patients with chronic renal impairment, there is a sudden reduction in effectiveness, defined by a decrease in hemoglobin (1 to 2 g/dl per month) along with an increase in blood transfusion demand, need to count the number of red blood cells and need to evaluate the specific causes of non -response (for example, folate iron deficiency or vitamin B12, aluminum poisoning, bacteria or inflammation, blood loss, blood -free blood and blood loss, any blood -free blood, blood loss and blood loss, any blood -free blood and blood loss, any blood -free blood and blood loss. If the number of mesh red blood cells is suitable for anemia (for example, the red blood cell index) ( If the suspected suspected red blood cells are simply through the antibody -anti -antibody intermediaries, Eprex should be stopped immediately. Do not switch to other ESA treatment because of the risk of cross -reaction. Can be treated appropriately as blood transfusion when indicated. General Be cautious when using eprex for epilepsy patients, a history of convulsions, or medical conditions that can make patients susceptible to seizures such as central nervous system infection and brain metastasis. Eprex should be used cautiously in patients with chronic liver failure. Eprex's safety has not been shown in patients with liver dysfunction. Due to metabolic reduction, patients with liver dysfunction may have an increase in red blood cell synthesis when using Eprex. Observed the frequency of blood vessel thrombosis in patients who use red blood cell stimuli agents (Esas: Erythropoies-Stimulating Agents) (see unwanted effects). These events include thrombosis and artery and venous embolism (including some events with death outcome), such as deep vein thrombosis, pulmonary embolism, retinal thrombosis, and myocardial infarction. In addition, there are also reports of stroke (including cerebral infarction, cerebral hemorrhage and transient anemia). Be careful to consider between the risks of vascular thrombosis that has been reported with the benefits of treatment with Eprex, especially in patients with risk factors available. In all patients, hemoglobin concentration should be closely monitored due to the high risk of clogged thrombosis and the outcome may be fatal when the patient is treated at hemoglobin levels that exceed the scope of treatment.Eprex's safety and effectiveness is not shown in patients with blood (such as hemolytic anemia, sickle cell anemia, thalassemia). While treating Eprex may have a moderate increase in platelets depending on the dose, within normal limits. This situation will retreat during the therapy. In addition, the platelet creation has been recorded on normal limits. Should regularly monitor the number of platelets during the first 8 weeks of treatment. It is advisable to evaluate and treat other causes of anemia (iron deficiency, folate deficiency or vitamin B12, aluminum poisoning, bacterial or inflammation, blood loss, hemolytic and bone fibrosis due to any cause) before the beginning of treatment with Eprex and when deciding to increase the dose. In most cases, ferritin concentrations in serum decrease simultaneously with an increase in the rate of erythrocytes in the whole blood. To ensure optimal response to Eprex, you must ensure adequate iron reserves and should supplement iron if necessary: Very rare cases of porphyrin metabolism disorders shown from the beginning or play in patients treated with Eprex. Eprex should be used in patients with Porphyrin metabolic disorders. Skin peeling and blistering reactions include diverse roses and Stevens-Johnson syndrome (SJS)/Poisoned epidermal necrosis (Ten) has been reported in small quantities of patients treated with Eprex. Stopping Eprex immediately if suspected of having a serious skin reaction such as (SJS/Ten). The erythrocyte stimulants (ESA) are not necessarily similar. Therefore, it should be noted with patients who should only be transferred from this ESA drug (such as EPREX) to another ESA drug when the doctor's permission is allowed. Use in the elderly Of the 1051 patients putting into 5 clinical studies of Eprex to reduce body blood transfusion in patients under selective surgery, 745 patients use Eprex and 306 to use placebo. Of the 745 patients using Eprex, 432 patients (58%) at the age of ≥65, of which 175 patients (23%) at the age of ≥ 75. Overall there is no difference in safety or effectiveness observed between older patients and younger patients. Eprex's prescribed dose in older patients and younger patients in 4 studies are taking drugs under the program three times per week is similar. There is not enough patient to be selected in the study using the weekly dosage mode to determine whether the dosage needs are different for this treatment regime. Of the 882 patients who were included in 3 studies in patients with chronic dialysis, 757 patients using Eprex and 125 patients used placebo. Of the 757 patients using EPREX, 361 patients (47%) at age ≥ 65, of which 100 (13%) of patients at the age of ≥ 75. There is no difference in safety or effectiveness between older patients and younger patients. Choose and adjust the dose in older patients, depending on each person to achieve and maintain the limit of hemoglobin concentration (see dosage and usage). Inadequate number of patients age ≥ 65 is included in clinical studies in the treatment of anemia due to chronic renal failure before dialysis, chemotherapy in cancer, and the treatment of HIV infection with zidovudine to determine whether or not the difference between the elderly and the younger people. Patients with renal failure Treatment of symptomatic anemia in adult patients and children with chronic kidney failure: On some patients who extend the dose distance (larger than once a week) of Eprex may not maintain sufficient hemoglobin concentration (see pharmacokic) and may require increasing the dose of eprex. Hemoglobin concentration needs to be monitored regularly. Patients with chronic renal impairment and hemoglobin response are not enough when treating with ESA may even have a higher risk of cardiovascular events and mortality rates compared to other patients. Based on the information that is up to this point, the use of eprex does not increase the progression of kidney failure in patients with end -stage chronic kidney failure. There has been a pipe thrombosis in dialysis patients, especially in people who tend to lower blood pressure or those with venous leaks (such as narrow, aneurysm, etc.). Recommendations for early pipeline repair and thrombosis (eg with acetylsalicylic acid) in these patients. Observed a hyperkalemia in some individual cases, although it is not determined. The concentration of electrolytes should be monitored in patients with chronic renal impairment. If there is an increase in serum potassium concentration, besides the appropriate treatment for hyperkalemia, it is advisable to consider stopping eprex until the concentration of serum potassium has been adjusted. Due to the increase in red blood cell volume, patients with hemolysis therapeutic Eprex often need to increase the dose of heparin during the fertilizer. If the anticoagulant process is not optimal, the dialysis can occur. In some patients with chronic kidney failure, when using Eprex can cause menstruation, so it is necessary to discuss the possibility of pregnancy and assess the need for contraception. Cancer patients Eprex cancer patients should measure the level of hemoglobin periodically until the stability is reached and then continue monitoring. ESA are growth factors that mainly stimulate the formation of red blood cells. Erythropoietin receptors can be shown on the surface of many types of tumor cells. As with all growth factors, there is concern that ESA can stimulate the growth of tumors. In verified clinical trials, the use of Eprex and other ESA has shown: With the above information, the decision for treatment with recombinant erythropoietin should be based on assessment of benefits-mechanical benefits with the participation of each patient, and should pay attention to specialized clinical context. Factors for consideration when evaluation include: tumor type and fraction; anemia level; average life expectancy; patient treatment environment; And the patient's will (see pharmacies). In cancer patients in chemotherapy, it is necessary to take into account the delay of 2-3 weeks between the use of ESA and the appearance of red blood cells created by Erythropoietin to evaluate whether Eprex treatment is appropriate or not (especially in patients at risk of blood transfusion). HIV -infected patients Should consider and evaluate other causes of anemia such as iron deficiency anemia if the HIV -infected patient is poorly responded or maintained in response to EPREX. Patients with adult surgery in the self -donation program of self -donation All the special warnings and caution of the blood donation program itself, especially the replacement of the regular blood volume, should be followed by patients using EPREX. Adult patients during the period of surgery (no blood donation) Should regularly use good blood management practice during the surgery period. Patients who have been scheduled for large orthopedic surgery should be fully prevented from the prevention of thrombosis because thrombus and blood vessels may occur in surgical patients, especially for patients with cardiovascular disease. In addition, it is necessary to be particularly cautious in patients at risk of deep vein thrombosis. Moreover, in patients with initial hemoglobin> 13 g/dl (8.1 mmol/l), it is not possible to rule out the possibility of Eprex therapy may increase the risk of postoperative blood/thrombosis. Therefore, it should not be used for patients with initial hemoglobin> 13 g/dl (8.1 mmol/l). It is not recommended to use eprex in patients with initial hemoglobin> 13 g/dl (8.1 mmol/l). There has been no research on the effects of Eprex on the ability to operate machinery, train drivers, higher people working and other cases. In animal studies, with a weekly dose of 20 times the recommended dose weekly, EPOETIN ALFA reduces pregnancy weight, slows bone core and increases the death rate of death. These changes are explained as secondary to the mother's weight loss. There are no controlled and adequate studies in pregnant women. EPREX should only be used during pregnancy if the benefits may be superior to the potential risk to the fetus (see prime clinical safety - '' toxicity on reproductive ''). erythropoietin is present in human milk. However, it is not known whether Eprex will be distributed in human milk. Be cautious when using eprex for breastfeeding women. It is not recommended to use eprex in pregnant or breastfeeding patients to participate in the blood donation program. There is no evidence that Eprex is treated to change the metabolism of other drugs. Drugs that reduce red blood cells can reduce response to EPREX. Because cyclosporine is connected to erythrocytes, drug interactions may be interactive. If Eprex is used simultaneously with cyclosporine, the blood cyclosporine level should be monitored to adjust the dosage of cyclosporine when hematocrit increases. There is no evidence that there is an interaction between Eprex and G-CSF or GM-CSF when considering the differentiation of blood cells or the proliferation of tumor cells from in vitro biopsy samples. Eprex's effects may increase when treated simultaneously with a blood tonic, such as sulphate iron, when there is iron deficiency. In patients with metastatic breast cancer, Eprex 40000 IU injection at the same time with trastuzumab (6 mg/kg) has not affected the pharmacokinetics of trastuzumab. Precautions when using
The ability to drive and operate machinery
Pregnancy
breastfeeding period
Drug interaction
Storage
Store at a temperature of 20oC to 80 ° C in the refrigerator in the original packaging, not to prevent the ice. Do not freeze or shake.
Keep the syringe in the drug box to avoid light.
Eprex syringe is in use or intends to be kept at room temperature (no more than 250C) for a maximum of 7 days.
Other drugs
- BRUFEN TABLETS 200MG
- Buccolam
- CYCLO-PROGYNOVA 2MG
- DUSPATALIN 135MG TABLETS
- NOOTROPIL 800MG TABLETS
- Nimenrix
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions