Injection Recormon 4000iu/0.3ml F.Hoffmann-La Roche treat anemia (6 tubes x 0.3ml)

Dosage form Box of 6 tubes x 0.3ml
Specifications Epoetin beta

Ingredient

Thành phần cho 0.3ml

Composition informationContent
Epoetin beta4000iu

Uses

indications

Recormon is indicated in the following cases:

  • Treatment of chronic renal anemia shows symptoms in patients with kidney replacement. Being treated with chemotherapy. The treatment is only applicable to patients with anemia anemia (HB 10 - 13 g/dl [6.21 - 8.07 mmol/l], not short of iron) if the blood preservation process is not performed or insufficient while the program under the program requires a large amount of blood (from 4 or more blood units for women and 5 or more blood units for men). Learning

    The biological effect of Epoetin Beta has been shown after intravenous and subcutaneous in the various animal models in Vivo (normal mice and mice with hyperuremia, rats with polycythemia and dogs). After using Epoetin Beta, the number of red blood cells, hemoglobin and red blood cells as well as 59Fe mounted speed increased.

    It is found on in vitro with an increase in 3h - thymidine with red blood cells cells in the spleen (mouse spleen cells cultured) after incubation with Epoetin Beta.

    Researching the bone marrow cell culture sample in humans shows that Epoetin Beta stimulates red blood cells in a special way and does not affect the white blood cell creation. Epoetin Beta's cytotoxic effects are not found on bone marrow cells or human skin cells.

    It is found that after using a single dose of Epoetin Beta does not affect the behavior or exercise of the mouse and the circulating or respiratory function in the dog.

    Pharmacological properties

    Epoetin Beta's amino acid and carbohydrate components are like erythropoietin isolated from anemia patient.

    erythropoietin is a glycoprotein stimulating red blood cell formation from the precursors in the stem cell compartment. This substance acts as a factor that stimulates cell division and differentiate hormones.

    Mechanism of action

    erythropoietin is a glycoprotein, a growth factor with the main effect of stimulating the formation of red blood cells from the precursor cells. This substance acts as a factor that stimulates the process of cell division and differentiate hormones.

    pharmacokinetic

    absorption

    After Epoetin Beta's subcutaneous injection in patients with hyperur with blood urea, prolonged absorption leads to a stable serum level, with maximum concentration achieved after about 12 - 28 hours.

    The bioavailability of Epoetin Beta after subcutaneous injection is about 23 to 42% compared to intravenous injection.

    Distribution

    Mobile pharmacokinetic studies on healthy volunteers and patients with hyperuremia shows that the distribution volume corresponds to one or two plasma volumes.

    Elimination

    Mobile pharmacokinetic studies in healthy volunteers and patients with hyperuremia show that Epoetin Beta's waste time is inexplicable from 4 to 12 hours.

    After epidemic Epoetin beta for patients with hyperur with blood urea, the half -life is longer than after intravenous and average from 13 to 28 hours.

    • Before taking Injection Recormon 4000iu/0.3ml F.Hoffmann-La Roche treat anemia (6 tubes x 0.3ml)

    How to use

    Recormon drugs are used under skin or intravenous injection.

    The replacement by any other biological drugs require the consent of the prescribed doctor.

    Epoetin Beta's available syringes can be used immediately. Never reused injected pump in any situation; The drug is only used for one injection.

    Dosage

    Treatment of patients with chronic renal failure

  • The solution can be injected under the skin or intravenously. In the case of intravenous injection, it is necessary to inject the solution for 2 minutes, for example in patients with dialysis, should be injected through venous dynamic bridge when dialysis is done. Hemoglobin should not exceed 12 g/dl. If hemoglobin rises higher than 12 g/dl (1.3 mmol/l) for 4 weeks, it is necessary to consider reducing the dose accordingly. In case of previous hypertension or disease of cardiovascular disease, brain or peripheral vessels, the weekly increase in hemoglobin and the target hemoglobin level should be specifically identified for each patient according to clinical disease. Patients need to be closely monitored to ensure the full control of anemia symptoms with the lowest doses of Epoetin beta.

    is divided into 2 stages.

    Treatment phase

  • subcutaneous injection. Every 4 weeks may increase the dose of 3 x 20 IU/kg per week if hemoglobin is not enough ( To hold the target hemoglobin in the range of 10 - 12 g/dl, first reduce the dose to half of the dose is in use. Then, every two to four weeks, adjust the dose depending on the patient (maintenance dose). In case of use under the skin, the weekly dose may be injected once or divided into three times or seven times a week. Patients stabilizing at a dose once a week may switch to injection once every two weeks. In this case, the dose may be increased. However, if necessary, it can be stopped at any time. Data on the dose of treatment once a week has been established based on clinical studies with 24 -week treatment.
  • The solution used for subcutaneous injection. (6.83 mmol/l).
  • Hemoglobin level should not exceed 13g/dl (8.07 mmol/l). If the hemoglobin value does not increase at least 1 g/dl (0.62 mmol/l), think of a weekly increase of the dose doubled. If after 8 weeks of treatment, hemoglobin value does not increase at least 1 g/dl (0.62 mmol/l), it is difficult to respond and should stop treatment. 50% to maintain hemoglobin at the achieved level. If necessary, it is necessary to reduce the dose to ensure that the hemoglobin value does not exceed 13 g/dl.
  • The solution is intravenously in about 2 minutes or subcutaneously. In the case of a patient's hematocrite enough to give blood, for example, hematocrite ≥ 33%, epetin beta is used at the end of the blood. Each time is determined as above, 2 times/week and for 4 weeks. The maximum dose must not exceed 1600 IU/kg of body weight/week when intravenous injection or 1200 IU/kg of body weight/week when subcutaneous injection.
  • For this indication, only use the form of pre -closed syringe. Good treatment effects with children without blood transfusion.

    • 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? Overdose may cause excessive increasing signs of pharmacological impacts, for example, excessive red blood cell proliferation can cause life -threatening cardiovascular complications. If the concentration of hemoglobin increases too high, temporarily stop Recormon. If indicated, venous blood extraction can be proceeded.

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using Recormon, you may experience unwanted effects (ADR).

    Patients with chronic renal failure

    The most unwanted effects (common 1-10%), especially in the early stage of treatment with Recormon are manifestations of hypertension including increased blood pressure, hypertension with symptoms like brain pathology (eg headache and confusion, sensitivity disorders such as speech disorders or staggering to vibrating spasms) can occur. This phenomenon can be seen in patients with normal blood pressure or severe manifestations of hypertension before.

    Bloody thrombosis can occur, especially in patients who tend to lower blood pressure or venous dynamic detection location that appears complications (for example, narrow, aneurysm).

    or meet (ADR> 1%, ADR

  • Vascular disorders: Hypertension.
  • Nervous system disorders: headache.

    • Uncommon (ADR> 0.1%, ADR

    Vascular disorders: Hypertension.

    Rare (ADR> 0.01%, ADR

    Disorders of blood systems and lymph nodes: Blood thrombus connecting blood vessels.

    Very rare (ADR

  • Blood system disorders and lymph nodes: platelets.

    Common hypertension (1 - 10%), especially in the new stage of treatment.

    In some patients, there is a decrease in serum iron parameters.

    or meet (ADR> 1%, ADR

  • Vascular disorders: Hypertension.
  • Disorders of blood system and lymph nodes: Blood thrombosis.
  • Nervous system disorders: headache.

    • Patients in the program for self -blood for self -blood

    Patients in the program for blood self -blood may have a slight increase in the phenomenon of blood tolerance. However, it is unclear the cause and effect of using Recormon.

    There may be temporary iron deficiency.

    or meet (ADR> 1%, ADR

    Nervous disorders: headache.

    premature babies

    The phenomenon of decreased serum ferritin is very common (ADR> 10%).

    Unwanted effects for all indications

    Rare (≥ 1/10,000 to ≤ 1/1,000)

    Skin reactions such as rash, itching, urticaria or in the injection site.

    Very rare (≤ 1/10,000)

    Anaphylactic reaction is reported. However, in verified clinical studies, there is no increase in the ratio of hypersensitivity reactions.

    In some very rare cases (≤ 1/10,000)

    Special treatment, influenza syndrome such as fever, chills, headache, limb pain, fatigue and/or bone pain have also been recorded. These reactions are mild or medium and decrease after a few hours or days.

    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

    Recormon contraindications in the following cases:

  • Hypersensitivity is known in advance with the main active ingredient or any ingredient of the drug.
  • Hypertension is not well controlled.

    • In the indication of "increasing the amount of blood itself", not using Recormon for patients who have treated the previous month with myocardial infarction or a stroke, an unstable angina patient, or patients with a risk of deep vein thrombosis such as a history of venous thrombosis.

    Precautions when using

    General attention

    Recormon should be used carefully in the case of persistent anemia, there are many shifting, epilepsy, platelet increase, and chronic liver failure. Folic acid and vitamin B12 should be excluded because these conditions reduce the effect of Recormon.

    To ensure the effectiveness of the red blood cell generation, it is necessary to assess iron condition in the body before and during the treatment process and may need iron additional treatment according to the proposed treatment instructions.

    Recormon contains phenylalanine excipients. Therefore, it is important to pay attention to patients with severe physical ureter acid.

    Ineffective: The most common causes of response to erythrocyte hyperbears are iron deficiency and chronic inflammation (for example, increased blood urea or cancer metastasis). The following conditions can also affect the effectiveness of the treatment of erythrocytes stimulants: chronic blood loss, bone marrow fibrosis, severe aluminum overload due to kidney failure, folic acid deficiency or vitamin B12, and hemolysis.

    affect the development of tumors

    Recormon is a growth factor, stimulating the process of red blood cells. Erythropoietin receptors may be present on the surface of some different types of cancer cells. Like other growth factors, epetin can stimulate the growth of any malignant tumor.

    In patients with chronic renal failure and cancer patients using chemotherapy

    There may be hypertension (hypertension) or worsen hypertension, especially in the case of hemoglobin rapidly. It is possible to use hypertension medications for these cases.

    Heavy aluminum overload due to kidney failure can affect the effectiveness of Recormon treatment

    Patients with chronic renal failure often need to increase heparin dose when dialysis. Check the blood vessel bridge early and prevent thrombosis by taking some drugs such as acetylsalicylic acid, which should be considered in patients with chronic kidney failure at risk of blood vessels.

    For the use of Recormon in the program for self -blood, there may be a phenomenon of increased platelet quantity, mostly increased in the normal value range. Therefore, it is necessary to check the number of platelets at least a week in these patients. If the number of platelets increases> 150 × 109/l or if the number of platelets increases higher than normal, it is necessary to stop treating with Recormon.

    Abuse and depend on drugs

    Abuse of drugs because people without anemia can lead to excessive increase in hemoglobin. This situation can cause life -threatening cardiovascular complications.

    There is no report on drug dependence when using recormon.

    Testing

    Need to monitor the number of platelets and hematocrit/hemoglobin regularly in all patients.

    In patients with chronic kidney disease, serum hyperkalemia is recorded in patients using recormon, although the cause has not been identified. If the increased potassium should be considered to stop using Recormon until this value is adjusted.

    The ability to drive and operate machinery

    There has been no research on the impact on the ability to drive and operate machinery. However, no impact is expected based on the mechanism of action and the known safety characteristics of Recormon.

    Pregnancy

    Animal tests that do not record direct or indirect effects are harmful to pregnancy, embryo and fetal development, postpartum and postpartum development. However, due to the lack of clinical research data, it is necessary to be cautious when indicated for pregnant women.

    Breastfeeding period

    Experience in using drugs in breastfeeding is limited. Erythropoietin endogenous is excreted in milk and is quickly absorbed by the digestive tract of babies. The decision to continue or stop breastfeeding or continues or stops treating with Recormon should be considered based on the benefits of the baby when breastfeeding and the benefits of the mother.

    labor and childbirth

    However, due to lack of clinical research data, caution should be careful when indicated for pregnant women during labor.

    used for children

    Clinical trials for drug registration have been conducted in children and adolescents with anemia due to chronic kidney failure and in newborns to prevent premature anemia.

    In the indication for treatment of chronic renal anemia, do not use Recormon for young children (under 2 years old).

    With an anemia treatment in cancer patients using chemotherapy and treatment to mobilize blood sources itself, Recormon is not indicated for children.

    Hepatic failure

    There are currently no clinical trials conducted for patients with liver failure.

    Drug interaction

    There has been no research that conducted separately on drug interaction.

    Clinical results are so far not indicating any interaction between Recormon and other active ingredients.

    Using the same enzyme inhibitor may increase the risk of hyperkalemia, especially in people with kidney failure. In animal experimental studies, epetin does not increase the toxicity of bone marrow of cell proliferation drugs such as Etoposide, Cisplatin, Cyclophosphamide, and Fluorouracil.

    Storage

    Storage in the refrigerator (20C - 80C).

    Other drugs

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