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Erypro Safe 4000IU

Erypro Safe 4000IU (Erythropoietin)

Erypro safe 4000IU    (EPO) is a hormone included by the kidney which promotes thered blood cells formation by the bone marrow. The kidney cells which make Erypro safe 4000IU    are sensitive to low oxygen levels in the blood that travels through the kidney.

Feature
Brand name:
Erypro Safe
Active substance:
Erythropoietin 4000IU
Manufacturer:
Biocon Ltd
Packaging:
1 PFS
Product form:
Injection
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Active substance: Erythropoietin
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Description

DESCRIPTION

Erypro Safe     (EPO) is a hormone included by the kidney which promotes thered blood cells formation by the bone marrow. The kidney cells which make Erypro Safe     are sensitive to low oxygen levels in the blood that travels through the kidney.

These cells make and release Erypro Safe     when the oxygen level is too low. A low oxygen level may indicate a diminished number of red blood cells (Anemia), or haemoglobin molecules that carry oxygen through the body.

INDICATION

Erypro Safe     injection is Indicated in adult and paediatric Patients for the treatment of Anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. Patients for the treatment of Anemia due to zidovudine in patients with HIV-infection.

Patients for the treatment of Anemia because of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Patients for the reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

ADME PROPERTY

ABSORPTION

Duration to maximum plasma concentration of Erypro Safe     is 20 to 25 hours and bioavailability of SC injectable Erypro Safe     is much lesser than IV injection and is 20-24%. Adult and paediatric with CRF peak plasma level is 5 to 24 hours

DISTRIBUTION

Erypro Safe     has no plasma protein binding. Volume of distribution is range of 40-63.80 ml/kg

METABOLISM

Binding of erythropoietin and epoetin alfa to EPO-R leads to cellular internalization, which contains the degradation of the ligand. Erythropoietin and epoetin alfa may also be disgraced by the reticuloendothelial scavenging pathway or lymphatic system

ELIMINATION

Erypro Safe     injection are eliminated through uptake and degradation via the EPO-R-expressing cells and may also contain other cellular pathways in the interstitium. Only a less amount of unchanged epoetin alfa is found via urine. Half-life in adult is 4 hours and for children is approx. 6 hours Adult and paediatric with CRF the half-life is 4 to 13 hours

DOSAGE MANAGEMENT

DOSAGE AND ADMINISTRATION OF ERYPRO SAFE INJECTION


MOST NECESSARY DOSING INFORMATION FOR ERYPRO SAFE

Administer Evaluation of Iron Stores and Nutritional Factors Monitoring of Response to Therapy in Anemia Formulation Based Selection In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation)

PATIENTS WITH CHRONIC KIDNEY DISEASE
FOR ALL PATIENTS WITH CKD:

When starting or adjusting therapy, monitor haemoglobin levels at least weekly until stable, then monitor at least monthly. Avoid rises of the dose more frequently than once every 4 weeks. Reduces in dose can occur more frequently. Avoid frequent dose adjustments. If the haemoglobin increases rapidly, decrease the dose of Erypro safe by 25% or more as required to reduce fast responses.

FOR ADULT PATIENTS WITH CKD ON DIALYSIS

Start Erypro safe therapy when the haemoglobin level is less than 10 g/dL. If the haemoglobin level approaches or exceeds 11 g/dL, decrease the dose of Erypro safe. The usual starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC. The intravenous route is prescribed for patients on haemodialysis.

FOR PEDIATRIC PATIENTS WITH CKD

Start Erypro safe therapy only when the haemoglobin level is less than 10 g/dL.If the haemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Erypro safe. The usual starting dose for paediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly intravenously or subcutaneously.

ZIDOVUDINE-TREATED PATIENTS WITH HIV-INFECTION

The prescribed initial dose in adults is 100 Units/kg as an IV or SC injection 3 times per week. Discontinue Erypro safe if an increase in haemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

PATIENTS ON CANCER CHEMOTHERAPY

Start Erypro safe in patients on cancer chemotherapy only if the haemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. Use the less dose of ERYPRO SAFE needed to avoid RBC transfusions. Usually Starting Dose: For Adults administer the dose of 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 Units subcutaneously weekly until completion of a chemotherapy course. Paediatric Patients (5 to 18 years): 600 Units/kg intravenously weekly until completion of a chemotherapy course.

SURGERY PATIENTS

The prescribed Erypro safe injections are:300 Units/kg per day subcutaneously (SC) for 15 days total: given daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. And 600 Units/kg subcutaneously (SC) in 4 doses given the patients 21, 14, and 7 days before surgery and on the day of surgery.

OVERDOSE

Erypro Safe     overdose can cause by above the desired level of haemoglobin levels, which must be controlled with discontinuation or reduction of Erypro Safe     dosage with phlebotomy.

SIDE EFFECTS

SIDE EFFECTS CAUSED DUE TO ERYPRO SAFE     INJECTION

The injection Erypro Safe     has some serious side effects like Increase mortality, Myocardial infarction, stroke and thromboembolism Increased mortality/ risk of tumor progression or recurrence in patients. Hypertension, Seizures, PRCA, Serious allergic reactions, Severe cutaneous reaction

PRECAUTION

Patients go through surgery are at high risk for DVT; concomitant DVT prophylaxis is strongly recommended In Zidovudine-treated patients may have response only when zidovudine dosage <4200 mg/wk. and endogenous epoetin <500 U/mL In Dialysis patients having IV administration recommended to decrease red-cell aplasia risk; rises anticoagulation with heparin may be needed to prohibit clotting of extracorporeal circuit during haemodialysis Avoid increase dose more frequently than once monthly.

Patients Contains albumin; may carry extremely specific risk for transmission or viral diseases or Creutzfeldt-Jakob disease. In Cases of PRCA and of severe Anemia, with or without other cytopenia’s that appears following the growth of neutralizing antibodies to erythropoietin resulted in patients treated with epoetin alfa High incidence of death, myocardial infarction (MI), stroke, and thromboembolism: while Using ESAs to aim haemoglobin level of >11 g/dL rises risk of severe adverse cardiovascular reactions

Special caution usage in hypertension, iron deficiency, folate or B12 deficiency, congestive heart failure (CHF), coronary artery disease (CAD), seizure disorder, sickle-cell disease, haemolytic Anemia, porphyria, hematologic disorders Cancer patients will Increased tumor development rate when dosed to achieve haemoglobin level of >12 mg/ld. In Chronic renal failure patients at starting of treatment, transferrin saturation should be ≥20% and ferritin ≥100 ng/mL

DRUG INTERACTION

Interaction of dichlorphenamide and Erypro Safe     both decrease serum potassium use with caution and monitor

Erypro Safe     co administration with methyltestosterone will make high effects of epoetin alfa by pharmacodynamic synergism. Because of potential adverse effects of drug combination should be avoided

Concomitant use with danazol and fluoxymesterone, oxandrolone, oxymetholone will increase effects of epoetin alfa by pharmacodynamic synergism. Androgens used will reduce needed dose of epoetin alfa.

CONTRAINDICATION

The patients are contraindicated to Erypro Safe     injection as follows Uncontrolled high blood pressure, Pure red cell aplasia which initiated after therapy with Erypro safe 1000IU, severe allergic reactions by injection

PREGNANCY  & LACTATION

The limited available data on pregnancy women have insufficient to describe a drug associated risk of adverse development outcomes. Erypro Safe     from multiple dose which contains benzyl alcohol is contraindicated to pregnant women. If pregnant women needed treatment with Erypro Safe     then use benzyl alcohol free formulation to avoid harm to foetus.

LACTATION

Erypro Safe     from multiple dose which contains benzyl alcohol is contraindicated to lactating women. Advise the breast-feeding women not to feed for at least 2 weeks after the last dose. Possible similar harm to infants exposed to benzyl alcohol through human milk.

STORAGE

Store at 2°C to 8°C Do not freeze the injection Avoid using of shaken or frozen Erypro Safe     injection, do not shake Store the injection in original container until use to away from light

MISSED DOSE

If dose is failed to take by patients then immediately have the dose you remember before next dose otherwise skip the missed, if next dose time reached. Do not take extra dose at a time. Take advice of the doctor about missed dose

Feature
Brand name
Erypro Safe
Active substance
Erythropoietin 4000IU
Manufacturer
Biocon Ltd
Packaging
1 PFS
Product form
Injection
Strength
4000IU
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