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PROCRIT(EPOETIN ALFA)注射液

2012-02-12 20:59:56  作者:新特药房  来源:中国新特药网天津分站  浏览次数:769  文字大小:【】【】【
简介: 英文名称:PROCRIT(EPOETIN ALFA) 中文名称:阿法依泊汀注射剂 品牌药生产企业:强生 药品介绍 促红细胞生成素(Epogen)实际上是一种生物制剂而不是药物,因为它最初是人体中自然产生的一种物质 ...

英文名称:PROCRIT(EPOETIN ALFA)

中文名称:阿法依泊汀注射剂

品牌药生产企业:强生

药品介绍

促红细胞生成素(Epogen)实际上是一种生物制剂而不是药物,因为它最初是人体中自然产生的一种物质——由肾制造的一种荷尔蒙,用于刺激红血球的再生。

药物名称:阿法依泊汀  
药物别名:重组人红细胞生成素,生血素,利血宝,促红素 Recombinant Human Erythropoietin,Epogen,Recormon 
英文名称:Epoetin Alfa 
粉针剂:1500IU、3000IU;倍他依泊汀[基](Epoetin Beta)粉针剂:1000IU、2000IU、5000IU或10000IU。
功用作用:肾病终末期病人的贫血、接受叠氮胸苷治疗的艾滋病毒感染病人的贫血以及癌症化疗引起的贫血。
用法用量:静注或皮下注射,一般开始剂量为50IU~150IU/kg,3次/周。如4周内,网状红细胞计数、细胞压积或血红蛋白水平未见明显增加,可小辐度增加剂量;如在2周内红细胞压积增加超过4%,应减少剂量。以红细胞压积达30%~33%或血红蛋白达100g~120g/L为指标,调节维持量,一般25IU/kg,3次/周。接受长期血透患者,应在每次透析结束时给予本品。腹腔内给药,剂量大于或等于静注剂量。 
注意事项:妊娠C类。治疗期间应监测血压、血管栓塞情况及血清铁量,必要时应补铁。皮下注射倍他依泊汀整体平均反应比阿法依泊汀高出12%(P<0.05)。

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GENERIC NAME: epoetin alfa
BRAND NAME: Epogen, Procrit
DRUG CLASS AND MECHANISM: Epoetin alfa is a man-made, injectable drug for treating anemia. Erythropoietin is a protein that normally is made in the body by the kidney. It causes the bone marrow to produce oxygen-carrying red blood cells. Under normal conditions, when the body senses a decrease in red blood cells or a deficiency in the supply of oxygen, more erythropoietin is produced, and this increases the number of red blood cells. When this natural mechanism is not working, it may become necessary to stimulate the bone marrow to produce red blood cells. The erythropoietin that is used for therapy, called epoetin alfa, is man-made. It is a product of the genetic engineering of ovarian cells of the Chinese hamster and is produced through recombinant DNA technology in bacteria. It does not cure the underlying cause of the anemia, and unless the underlying cause can be reversed, treatment with epoetin alfa must be continued indefinitely. Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. Other colony-stimulating factors include filigrastim (Neupogen) and sargramostim (Leukine). Epogen and Procrit are both epoetin alfa, but they are marketed by two different pharmaceutical companies.

PRESCRIPTION: Yes

PREPARATIONS: Epoetin alfa is available as a liquid for injection in vials containing from 2,000 to 40,000 units of epoetin alfa.
STORAGE: Epoetin alfa should be stored at 2-8°C (36-46°F). It should not be frozen. Multiple-use vials should be used within 21 days of the first use.
PRESCRIBED FOR: Epoetin alfa is used to treat anemia that is associated with chronic kidney failure in patients who are or will be receiving renal dialysis. It also is used to treat anemia in patients with HIV infection who are receiving zidovudine and in patients with cancer who are receiving chemotherapyand develop anemia. Epoetin alfa may be used to replace transfusions of red blood cells in patients who are anemic and undergoing surgery. Epoetin alfa has not been shown to improve fatigue or quality of life in patients with cancer.
DOSING: Epoetin alfa is administered intravenously or subcutaneously (under the skin) at 50-300 units per kilogram of weight, three times weekly. The dose is tailored to each patient based on targeted hemoglobin levels. Adult patients with cancer receiving chemotherapy may be treated with 40,000 to 60,000 units subcutaneously weekly. Epoetin alfa vials should not be shaken since the drug may be damaged, and bubbles may form that prevent some of the drug from being drawn up into the syringe during injection. Iron stores should be evaluated before therapy and supplemental iron should be administered if needed.
DRUG INTERACTIONS: No clinical studies have been done to demonstrate epoetin alfa drug interactions.
PREGNANCY: There are no studies of epoetin alfa use in pregnant women .
NURSING MOTHERS: It is not known if epoetin alfa is excreted into breast milk.
SIDE EFFECTS: Epoetin alfa is well-tolerated. The most common side effects in patients with kidney failure on dialysis are high blood pressure, headache, joint-pain and clotting at the injection site. Rare cases of stinging at the injection site, skin rash and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration. Allergic reactions, seizures and thrombotic events (e.g., heart attacks, strokes, and pulmonary embolism ) rarely occur.
In HIV-infected patients receiving zidovudine, the most common side effects with epoetin alfa are fever, headache, rash, and nasal or chest congestion. Rare cases of seizures or severe rash have occurred in these patients.
The most common side effects in patients undergoing surgery with anemia are fever, nausea, constipation, skin reactions, vomiting and headaches. Blood clots in veins, referred to as a deep venous thrombosis, also may occur.
Among patients with cancer receiving chemotherapy, the most common side effects of epoetin alfa are fever, diarrhea, tissue swelling, shortness of breath, paresthesia (abnormal sensations like burning or prickling that may occur anywhere in the body), and upper respiratory infection.
Treatment with epoetin alfa may increase the growth of several types of cancer and reduce survival, and, therefore, its use should be restricted to the conditions discussed previously.
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EPOETIN ALFA - INJECTION

Common brand name(s)
Epogen, Procrit
Warning
Discuss the risks and benefits of use for epoetin alfa with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots. It will be very important to keep all laboratory test appointments, as your doctor will need to carefully check your red blood cell tests (hemoglobin). The lowest effective dose of this medication should be used. When used to treat anemia related to cancer, this medication should be stopped after completing a treatment course of chemotherapy as directed by your doctor.
Uses
This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic renal failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for certain types of cancer (non-myeloid cancers). It may also be used in anemic patients to reduce the need for blood transfusions before certain planned surgeries that have a high risk of blood loss (usually combined with the "blood thinner" warfarin). Epoetin alfa helps to reverse anemia. It works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.
How to use
Read the Medication Guide and Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. If you have any questions, ask your doctor or pharmacist.This medication is given as an injection under the skin or into a vein, usually 1 to 3 times a week or as directed by your doctor. Hemodialysis patients should receive this medication by injection into a vein.Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you are injecting this medication under the skin, change the location of the injection site every time to avoid problem areas under the skin.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.The dosage is based on your medical condition, weight, and response to treatment. Blood tests should be performed frequently to check how well this medication is working and to determine the correct dose for you. Consult your doctor for more details.Do not increase your dose or use this medication more often than directed. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) of the week as directed. It may help to mark your calendar with a reminder.It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not improve or if they worsen.
Missed dose
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Precautions
Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (e.g., darbepoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (treated/controlled), blood disorders (e.g., sickle cell anemia, white blood cell or platelet problems, bone marrow problems), bleeding/clotting problems, blood vessel problems (e.g., stroke), heart problems (e.g., angina, heart failure), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.Some forms of this medication are made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. In some women of child-bearing age, menstrual periods have resumed with epoetin alfa treatment. Therefore, it may be possible to become pregnant while using this medication. Discuss the need for birth control with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Side effects
Headache, body aches, diarrhea, and irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Epoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your blood count (hemoglobin) tested regularly to reduce the chance of this side effect.Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, confusion, loss of consciousness.This medication may rarely cause blood clots. Seek immediate medical attention if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, coughing up blood, sudden vision changes, slurred speech, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, fainting, blood clots in your hemodialysis vascular access site.Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of epoetin alfa, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia return (e.g., increased tiredness, low energy, pale skin color, shortness of breath).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Drug interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: desmopressin.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
Notes
Do not share this medication with others.Laboratory and/or medical tests (e.g., complete blood count that includes hemoglobin and hematocrit, reticulocyte count) must be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.Blood tests for your iron levels will also be performed and you may be prescribed iron supplements to take. Your doctor may recommend that you eat a well-balanced diet rich in iron (e.g., raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.
Medical alert
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Storage
Store the medication in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. Let the medication come to room temperature before using. For the single-use vials, discard any unused medication immediately. For the multi-use vials, store opened vials in the refrigerator and discard any unused medication after 3 weeks. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
注:以下产品不同规格和不同价格,购买时请请以电话咨询为准!
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原产地英文商品名:
PROCRIT 10000U/ml 2mls/Vial 6Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 10000单位/毫升 2毫升/瓶 6瓶/盒
中文参考药品译名:
阿法依泊汀
中文参考化合物名称:
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson


---------------------------------------------------------------
原产地英文商品名:
PROCRIT 2000U/ml/Vial 6Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 2000单位/毫升/瓶 6瓶/盒
中文参考药品译名:
阿法依泊汀
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson


---------------------------------------------------------------
原产地英文商品名:
PROCRIT 3000U/ml/Vial 6Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 3000单位/毫升/瓶 6瓶/盒
中文参考药品译名:
阿法依泊汀
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson
---------------------------------------------------------------
原产地英文商品名:
PROCRIT 40000U/ml/Vial 4Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 40000单位/毫升/瓶 4瓶/盒
中文参考药品译名:
阿法依泊汀
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson


---------------------------------------------------------------
原产地英文商品名:
PROCRIT 10000U/ml/Vial 6Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 10000单位/毫升/瓶 6瓶/盒
中文参考药品译名:
阿法依泊汀
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson
---------------------------------------------------------------
原产地英文商品名:
PROCRIT 20000U/ml/Vial 4Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 20000单位/毫升/瓶 4瓶/盒
中文参考药品译名:
阿法依泊汀
中文参考化合物名称:
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson

 
---------------------------------------------------------------
原产地英文商品名:
PROCRIT 4000U/ml/Vial 6Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 4000单位/毫升/瓶 6瓶/盒
中文参考药品译名:
阿法依泊汀
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson

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