盐酸表柔比星注射溶液Epirubicin(Epirubicin 10mg Vial)说明书

产地国家日本

处方药

所属类别 10毫克/瓶 5瓶/盒

包装规格 10毫克/瓶 5瓶/盒

计价单位

生产厂家英文名Nippon Pharmaceutical

原产地英文商品名Epirubicin(エピルビシン塩酸塩注射用「NK」)10mg/Vial 5Vial/box

原产地英文药品名Epirubicin Hydrochloride

中文参考商品译名Epirubicin(エピルビシン塩酸塩注射用「NK」)10毫克/瓶 5瓶/盒

中文参考药品译名盐酸表柔比星

简介:

部份中文表柔比星处方资料(仅供参考)

商品名Epirubicin

英文名:Epirubicin Hydrochloride

中文名:盐酸表柔比星

生产商:日本化薬エピルビシン塩酸塩注射用10mg「NK」/エピルビシン塩酸塩注射用50mg「NK」

药用类别名称:抗肿瘤抗生素制剂

批准日期:2008年6月

商标名:Epirubicin

一般名:エピルビシン塩酸塩(Epirubicin Hydrochloride)

化学名:(2S,4S)-4-(3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyloxy)-2,5,12-trihydroxy-2-hydroxyacetyl-7-methoxy-1,2,3,4-tetrahydrotetracene-6,11-dione monohydrochloride

分子式:C27H29NO11・HCl

分子量:579.98

对湿度, 6个月) 结果, 盐酸伊皮比星注射10毫克 “NK” 和盐酸伊皮比星注射50毫克 “NK” 估计在正常市场分布下稳定3年。

药用药理学:1. 通过形成肿性状:盐酸伊皮比星是一种细带黄红带褐变粉。它微溶于水或甲醇, 几乎不溶于乙醇 (95), 几乎不溶于乙腈。盐酸伊皮比星是吸湿的。操作注意事项1. 本剂粘附在眼睛或皮肤上时, 立即用水冲洗并进行适当的处理。2. 使用21G 或更薄的针头为该制剂。 使用较厚的针头更有可能导致橡胶塞子芯。 此外, 即使在同一地点多次刺伤, 橡胶塞芯也有可能发生。3. 稳定性测试加速测试使用最终包装产品 (40°c, 75% 相瘤细胞的 DNA 和复合物来抑制 DNA 聚合酶反应和 RNA 聚合酶反应, 通过抑制 DNA 和 RNA 的生物合成来发挥抗肿瘤作用。2. 对移植癌、白血病 L1210、白血病 P388、B-16 黑色素瘤、结肠38、P388 乳腺癌、肝癌 AH-13 等具有广泛的抗癌作用。

适应症:1. 下列疾病和其他症状的缓解急性白血病、恶性淋巴瘤、乳腺癌、卵巢癌、胃癌、肝细胞癌、尿路癌(膀胱癌、肾肾炎和输尿管肿瘤)。2. 以下恶性肿瘤的联合治疗乳腺癌 (手术病例中的术前或术后化疗)。

用法与用量

(1)急性白血病的情况下15毫克作为盐酸伊皮比星(滴度)/(体表面积) 溶解在白天站注水约20mL, 每天静脉注射三个星期, 每天5至7天。然后重复2-3 冷却, 如果有必要。

(2)在恶性淋巴瘤的情况下40 ~ 60毫克为盐酸伊皮比菌 (titer)/2(体表面积), 在日站注水约 20mL, 3 ~ 4周的药物静脉注射, 每天一次。然后通常有三四天重复。

(3)在乳腺癌、卵巢癌、胃癌、尿路癌 (膀胱癌、肾肾炎和输尿管肿瘤) 的情况下60毫克作为盐酸伊皮比星(滴度)/(体表面积)在日间站注水约20mL, 3至4周的药物静脉注射, 每天一次静脉注射一次。然后通常有三四天重复。

(4)在肝癌的情况下60毫克作为盐酸伊皮比星(titer)/min(身体表面积) 溶解在白天站注水约20mL, 从导管插入肝动脉, 给肝动脉服用一次, 每天3-4周的药物。然后通常有三四天重复。

(5)膀胱癌 (仅限于浅表膀胱癌)60mg 作为盐酸伊皮比星(滴度)溶解在白天站生理盐水30mL, 每天注射到膀胱腔 3天, 每天休息4天。 然后通常2-4天重复。注射过程中, 在Neranton导管内充分排空膀胱腔后, 从导管中注射盐酸伊皮比星溶液, 抓住1至2小时膀胱腔。注意剂量是年龄, 症状, 副作用, 增加或减少适当。

(6)乳腺癌联合抗肿瘤药物治疗(术前或术后化疗)结合环磷酰胺水合物, 剂量和给药的标准盐酸伊皮比星, 100毫克作为盐酸伊皮比星 (滴度)/分钟 (体表面积) 到约20毫升的日间站注水溶解, 给药后, 每天静脉注射一次, 通常4到6次重复。

(7)环磷酰胺水合物, 结合氟尿嘧啶, 剂量和给药的方法, 标准的盐酸伊皮比星, 100毫克作为盐酸伊皮比星 (滴度)/敏(身体表面积) 约20mL溶解在日间站注入水, 每天静脉注射一次后, 关闭20天。通常4到6次重复。剂量是年龄, 由症状情况。肝癌肝动脉化学栓塞治疗(TACE)以10mg(滴度)为盐酸伊皮比星, 以0.5至2mL的比例添加碘化罂粟油脂肪酸乙酯, 从插入肝动脉的导管中给肝动脉施用。剂的剂量, 1天60mg(滴度)/(体表面积), 并根据患者的病情增加或减少, 终止时, 乳状液充满肿瘤血管。

包装:注射液10毫克: 5瓶50毫克: 1小瓶

英文版说明书:

EpirubicinTrade names: EllenceTMChemocare.com uses generic drug names in all descriptions of drugs. Ellence is the trade name for epirubicin. In some cases, health care professionals may use the trade name ellence when referring to the generic drug name epirubicin.Drug type:Epirubicin is an anti-cancer(“antineoplastic” or “cytotoxic”)chemotherapy drug.This medication is classified as an “anthracyline antitumor antibiotic.” (For more detail, see “How this drug works” section below).What this drug is used for:•Epirubicin is used to treat breast cancer.It is used as adjuvant therapy in women who have had surgery and have lymph node involvement.•May be used in place of doxorubicin in some circumstances.Note:If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.How this drug is given:•Epirubicin is given by intravenous injection (IV).The syringe needle is placed directly into the tubing of a freely flowing IV solution into a vein or central line and the drug is given over several minutes.•Epirubicin is a vesicant.A vesicant is a chemical that causes extensive tissue damage and blistering if it escapes from the vein.The nurse or doctor who gives this drug must be carefully trained.If you notice redness or swelling at the IV site while you are receiving epirubicin, alert your health care professional immediately.•The amount of epirubicin that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.Side effects:Important things to remember about the side effects of epirubicin:•Most people do not experience all of the side effects listed.•Side effects are often predictable in terms of their onset and duration.•Side effects are almost always reversible and will go away after treatment is complete.•There are many options to help minimize or prevent side effects.•There is no relationship between the presence or severity of side effects and the effectiveness of the medication.•The side effects of epirubicin and their severity depend on how much of the drug is given.In other words, high doses may produce more severe side effects).•The following side effects are common (occurring in greater than 30%) for patients taking epirubicin:•Early: (within one week after treatment begins)◦Pain along the site where the medication was given◦Nausea or vomiting◦Urine will appear red for 1-2 days•Later: (within two weeks after treatment begins)◦Low blood counts. Your white and red blood cells and platelets may temporarily decrease.This can put you at increased risk for infection, anemia and/or bleeding.Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.Onset: none notedNadir: 8-14 daysRecovery: 21 days•Mouth sores•Hair loss on the scalp or elsewhere on the body(called alopecia). Most patients do lose some or all of their hair during their treatment.But your hair will grow back after treatment is completed.•Nausea and vomiting•Fatigue•Amenorrhea (loss of menstrual cycle-see menopause and chemotherapy)These side effects are less common side effects(occurring in about 10-29%)of patients receiving epirubicin:•Early:(within one week after treatment begins)◦Darkening of the skin where previous radiation treatment has been given. (radiation recall-see skin reactions).•Later:(within two weeks after treatment begins)◦Diarrhea◦Infection◦Darkening of the nail beds(see skin reaction)◦Conjunctivitis (see eye problems)◦Problems with fertility-ability to bear children.(occurs in about 10% of both men and women-this should be discussed with your doctor prior to therapy).•Delayed effects:◦A serious but uncommon side effect of epirubicin can be interference with the pumping action of the heart.You can receive only up to a certain amount of epirubicin during your lifetime.This “lifetime maximum dose” may be lower if you have heart disease risk factors such as radiation to the chest, advancing age, and use of other heart-toxic drugs.Your doctor will check your heart function before you may take any epirubicin and will monitor your heart closely during your treatment.Dose-related heart problems can occur as late as 7 or 8 years after treatments have ended.◦There is a slight risk of developing a blood cancer such as leukemia years after taking epirubicin.Talk to your doctor about this risk.Your fertility, meaning your ability to conceive or father a child, may be affected by epirubicin.Please discuss this issue with your health care provider.Not all side effects are listed above.Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.When to contact your doctor or health care provider:Contact your health care provider immediately, day or night,if you should experience any of the following symptoms:•Fever of 100.4°F (38°C), chills(possible signs of infection)•Blistering at the IV site•Shortness of breath, wheezing, difficulty breathing,closing up of the throat, swelling of facial features, hives(possible allergic reaction).The following symptoms require medical attention, but are not an emergency.Contact your health care provider within 24 hours of noticing any of the following:•Nausea(interferes with ability to eat and unrelieved with prescribed medication)•Vomiting (vomiting more than 4-5 times in a 24 hour period)•Mouth sores(painful redness, swelling or ulcers)•Diarrhea (4-6 episodes in a 24-hour period)•Fast or irregular heart beats•Unusual bleeding or bruising•Black or tarry stools, or blood in your stools or urine•Extreme fatigue (unable to carry on self-care activities)•Swelling of the feet or ankles•Redness, itchiness or pus in eyesAlways inform your health care provider if you experience any unusual symptoms.Precautions:•Before starting epirubicin treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc. Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.•Do not receive any kind of immunization or vaccination without your doctor’s approval while taking epirubicin.•Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment.Pregnancy category D (epirubicin may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).•For both men and women: Do not conceive a child(get pregnant) while taking epirubicin. Barrier methods of contraception, such as condoms, are recommended.Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.•Do not breast feed while taking this medication.•You may be more sensitive to sunlight, take extra care to avoid sun exposure.•People with congestive heart failure, those who have already had high doses of this drug or a similar drug, and those with permanent problems with blood counts(bone marrow suppression)cannot receive this drug.Self-care tips:•Apply ice if you have any pain, redness or swelling at the IV site, and notify your doctor.•You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.•Wash your hands often.•To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.•To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1teaspoon of baking soda and/or 1/2 to 1teaspoon of salt mixed with 8 ounces of water.•Use an electric razor and a soft toothbrush to minimize bleeding.•Avoid contact sports or activities that could cause injury.•Avoid sun exposure.Wear SPF 15(or higher) sunblock and protective clothing.•Drink two to three quarts of fluid every 24 hours, unless you are instructed otherwise.•Get plenty of rest.•Maintain good nutrition.•In general, drinking alcoholic beverages should be minimized or avoided.You should discuss this with your doctor.•If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.Monitoring and testing:A baseline heart eva luation is recommended before starting treatment, and a heart function test may be done and may be monitored periodically while you are receiving epirubicin. You will be checked regularly by your doctor while you are taking epirubicin, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.How this drug works:Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. “Normal” cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition.Cancerous cells lose this ability.Cancer cells no longer have the normal checks and balances in place that control and limit cell division.The process of cell division, whether normal or cancerous cells, is through the cell cycle.The cell cycle goes from the resting phase, through active growing phases, and then to mitosis(division).The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division.Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division.If the cells are unable to divide, they die.The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink.They also induce cell suicide (self-death or apoptosis).Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific.Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific. The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective.This is why chemotherapy is typically given in cycles.Chemotherapy is most effective at killing cells that are rapidly dividing.Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells.The “normal” cells will grow back and be healthy but in the meantime, side effects occur.The “normal” cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss.Different drugs may affect different parts of the body.Epirubicin is classified as an antitumor antibiotic.Antitumor antibiotics are made from natural products produced by species of the soil fungus Streptomyces.These drugs act during multiple phases of the cell cycle and are considered cell-cycle specific.There are several types of antitumor antibiotics:•Anthracyclines:Doxorubicin, Daunorubicin, Epirubicin, Mitoxantrone, and Idarubicin•Chromomycins:Dactinomycin and Plicamycin•Miscellaneous:Mitomycin and BleomycinNote:We strongly encourage you to talk with your health care professional about your specific medical condition and treatments.

 

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