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福沙匹坦二甲葡胺冻干粉注射剂(EMEND IV INJ 115MG)

药店国别:

产地国家:英国

处方药:

所属类别:115毫克/瓶 3瓶/盒

包装规格: 115毫克/瓶 3瓶/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Merck

原产地英文商品名:EMEND IV INJ 115mg/vial 3vials/box

原产地英文药品名:FOSAPREPITANT DIMEGLUMINE

中文参考商品译名:EMEND IV注射剂 115毫克/瓶 3瓶/盒

中文参考药品译名:福沙吡坦二甲葡胺

简介

部份中文福沙匹坦二甲葡胺处方资料(仅供参考)

药品名称:福沙匹坦二甲葡胺粉针

英文名称:Fosaprepitantdimeglumine

商品名称:Emend[美国] Ivemend[欧洲]

分子量:1004.83CAS号:265121-04-8

剂 型:冻干粉针

规格:115mg、150mg/10ml

适应症:本品与其他止吐药联用适用于防治中等和大剂量催吐抗癌化疗药( 包括大剂量顺铂)初始和反复用药等引起的急性和迟后期恶心和呕吐。

用法用量:本品的推荐剂量为115 mg,给药方法为静脉注射(15分钟)。

药理作用

本品是阿瑞吡坦(aprepitant) 的前体药物,注射后在体内迅速转化成阿瑞吡坦。本品与阿瑞吡坦属人P 物质/ 神经激肽1(NK-1)选择性高亲和性受体阻断剂,主要通过阻断大脑恶心和呕吐信号发挥作用。在动物模型上,阿瑞吡坦通过中枢神经作用抑制诸如顺铂等细胞毒化疗药物诱导的呕吐。动物和人正电子发射断层成像术(PET)研究表明,阿瑞吡坦可透过血脑屏障并占据了脑部NK-1受体作用。

动物和临床研究显示,阿瑞吡坦增大5-HT3受体阻断剂昂丹司琼和糖皮质激素地塞米松的止吐作用,抑制顺铂诱导的急性期和迟后期呕吐。健康志愿者单剂量静脉注射(15分钟)本品后,阿瑞吡坦的平均AUC0-∞为31.7 (±14.3) μg·h/mL,阿瑞吡坦平均Cmax为3.27(±1.16)μg/mL。患者静脉注射本品115mg 后24小时阿瑞吡坦平均血药浓度和口服阿瑞吡坦125mg相当。

产品特点:

福沙吡坦2008年1月25日获得上市许可,规格为115mg和150mg,其中115mg用10ml西林瓶包装,剂型为注射用粉针,商品名为EMEND,与阿瑞匹坦的商品名相同。也在瑞典、捷克、葡萄牙和英国上市,商品名为IVEMEND,本品尚未在日本上市。福沙匹坦Base含3个手性中心,每个葡甲胺另外含4个手性中心,福沙匹坦二甲葡胺为无定形。

福沙匹坦二甲葡胺是阿瑞匹坦口服制剂的前体药物,静脉注射后迅速转化为阿瑞匹坦。115mg福沙匹坦(相当于188mg福沙匹坦二甲葡胺)在15分钟内静脉输注至人体内,输液结束后30分钟内,福沙匹坦的血药浓度即降至或低于定量限浓度10ng/ml,福沙匹坦几乎完全转化为阿瑞匹坦。

健康志愿者静脉输注115mg福沙匹坦15分钟或口服125mg阿瑞匹坦,给药后4~5小时,前者血浆中阿瑞匹坦浓度较后者高,但之后两者浓度相近。静脉输注115mg福沙匹坦二甲葡胺可取代口服125mg阿瑞匹坦胶囊。临床研究显示,本品115mg
注射与口服阿瑞吡坦125mg呈生物等效性。

英文版说明书

Emend Injection DosageGeneric name: FOSAPREPITANT DIMEGLUMINE 115mg in 5mLDosage form: injection, powder, lyophilized, for solutionWhat EMEND I.V. is used forChemotherapy Induced Nausea and VomitingEMEND I.V., in combination with other medicines, is used to prevent•nausea (feeling sick) and vomiting associated with cancer chemotherapy.EMEND I.V. belongs to a group of medicines called neurokinin 1 (NK1) receptor antagonists. It works by blocking the actions of substances in your brain, called substance P neurokinins, that cause nausea and vomiting.Your doctor may have prescribed EMEND I.V. for another reason. Ask your doctor if you have any questions about why EMEND I.V. has been prescribed for you.The safety and effectiveness of EMEND I.V. in children and teenagers under the age of 18 years have not been established.EMEND I.V. is not addictive.Before you are given EMEND I.V.When you must not be given itDo not use EMEND I.V. if you have an allergy to EMEND I.V., aprepitant or any of the ingredients listed at the end of this leaflet.Do not use EMEND I.V. if you are taking:•cisapride, used to treat stomach reflux•pimozide, used to treat psychotic conditions•terfenadine (Teldane#) and astemizole (Hismanal#), antihistamines used for allergic conditions, including hayfever# not available in Australia•St John’s Wort – a herb used to treat depressionUsing EMEND I.V. with these medicines may cause serious or life-threatening reactions.Do not use EMEND I.V. if you are breast-feeding or plan to breast-feed.It is not known if EMEND I.V. passes into breast milk. You and your doctor should discuss whether you should stop breast-feeding or not be given EMEND I.V..Do not use EMEND I.V. if:the packaging is torn or shows signs of tamperingthe expiry date on the pack has passed.If you use this medicine after the expiry date has passed, it may not work.If you are not sure whether you should start using EMEND I.V., talk to your doctor.Before you are given itTell your doctor if:1. you have or have had any medical conditions2. you are pregnant or intend to become pregnantEMEND I.V. has not been studied in pregnant women. EMEND I.V. should be used during pregnancy only if clearly needed.3. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.If you have not told your doctor about any of the above, tell them before you are given any EMEND I.V.Taking other medicinesTell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.Some medicines should not be taken with EMEND I.V.. These include:•cisapride, used to treat stomach reflux•pimozide, used to treat psychotic conditions•terfenadine (Teldane#) and astemizole (Hismanal#), antihistamines used for allergic conditions, including hayfevernot available in Australia•St John’s Wort – a herb used to treat depressionUsing EMEND I.V. with these medicines may cause serious or life-threatening reactions.Some medicines and EMEND I.V. may interfere with each other. These include:•warfarin, used to prevent blood clots. Your doctor may order additional blood tests to check the effect of warfarin after you have been given EMEND I.V..•rifampicin, an antibiotic used to treat tuberculosis and other infections•ketoconazole, used to treat fungal infections•oral contraceptive pills (also known as the pill). Alternative or “back-up” measures of contraception should be used during treatment with EMEND I.V. and for one month following the last dose of EMEND I.V.•paroxetine, used to treat depression, and obsessive compulsive and panic disorders•diltiazem, used to treat angina and high blood pressure•midazolam, triazolam, or alprazolam, used as sedatives or to treat anxiety or panic disorder•dexamethasone or methyprednisolone, steroid medicines used for a variety of conditions•certain cancer chemotherapy agents, including etoposide, vinorelbine, paclitaxel•tolbutamide, used to treat diabetes•phenytoin, used to treat epilepsyThese medicines may be affected by EMEND I.V. or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.Your doctor or pharmacist has more information on medicines to be careful with or avoid while using EMEND I.V..How EMEND I.V. is givenHow much to useEMEND I.V. is to be given intravenously by your doctor and it contains 150 mg or 115 mg of fosaprepitant as the active ingredient.EMEND I.V. must only be administered by your doctor or nurse.EMEND I.V. may be given to you in one of two ways.1. EMEND I.V. 150 mg given on Day 1 only.Day 1 (Day of chemotherapy) -EMEND I.V. 150 mg may be given to you as an infusion over 20-30 minutes approximately 30 minutes before you start your chemotherapy treatment.OR2. EMEND I.V. 115 mg given along with capsules of EMEND.Day 1 (Day of chemotherapy)EMEND I.V. 115 mg may be given to you as an infusion over 15 minutes approximately 30 minutes before you start your chemotherapy treatment.Day 2 and Day 3 (the two days after chemotherapy)Take one 80-mg capsule of EMEND (aprepitant) each morning for the 2 days following your chemotherapy treatment.Follow all directions given to you by your doctor carefully.They may differ from the information contained in this leaflet.How long to use itChemotherapy Induced Nausea and VomitingEMEND I.V. 150 mg is given only on the day of chemotherapy.EMEND I.V. 115 mg is only given on Day 1 of a 3 day regimen, with EMEND capsules taken on day 2 and 3.While you are using EMEND I.V.Things you must doWomen taking oral contraceptive pills for birth control should also use other methods of contraception during treatment with EMEND I.V. and for one month following the last dose of EMEND I.V.This is because oral contraceptive pills may not work as well when using EMEND I.V..If you become pregnant while using EMEND I.V., tell your doctor immediately.If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using EMEND I.V..Things to be careful ofBe careful driving or operating machinery until you know how EMEND I.V. affects you.EMEND I.V. generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many medicines, it may cause certain side effects in some people, including tiredness and dizziness. Make sure you know how you react to EMEND I.V. before you drive a car or operate machinery.Things that may be helpful to manage your chemotherapy induced nausea and vomitingSmall, frequent meals or eating a snack before your chemotherapy treatment may help you to tolerate it better.Talk to your doctor, pharmacist or nurse for more information.Side EffectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are being given EMEND I.V..EMEND I.V. helps most people with nausea and vomiting associated with cancer chemotherapy, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor if you notice or have any of the following and they worry you:•tiredness•generally feeling unwell•muscle weakness•headache, dizziness•constipation, diarrhoea•indigestion, heartburn, loss of appetite•gas from the stomach or bowel, wind•hiccups/hiccoughs•vomiting•disorientation•chills•hot flushes•bloating•pain on urination•changes to your walking pattern•acne•injection site pain•hardening at the injection site•redness and/or itching at infusion siteMost of these are the more common side effects of EMEND I.V.. For the most part these have been mild.Tell your doctor immediately if you notice any of the following:•slow, fast or irregular heart beat•severe upper stomach pain•symptoms of severe sunburn, such as redness, itching, pain, swelling or blistering•signs of anaemia such as, being short of breath when exercising, looking pale•frequent signs of infections such as fever, severe chills, sore throat or mouth ulcersThese may be serious side effects. You may need urgent medical attention. These side effects are rare.If any of the following happen, tell your doctor immediately or go to accident and emergency at your nearest hospital:•swelling of the face, lips, mouth, throat or tongue which may cause difficulty in breathing or swallowing•pinkish, itchy swellings on the skin, also called hives or nettlerash•severe skin reactions, including the inside of the nose or mouthThese may be serious side effects. If you have them, you may be having a serious allergic reaction to EMEND I.V.. You may need urgent medical attention. These side effects are rare.Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.Do not be alarmed by this list of possible side effects. You may not experience any of them.After using EMEND I.V.StorageEMEND I.V will be stored in the pharmacy or on the ward.It is kept in a refrigerator where the temperature stays between 2-8°C.Product descriptionWhat it looks likeEMEND comes as a white to off-white powder in a glass vial.IngredientsActive ingredient:Each vial of EMEND I.V. 115 mg contains fosaprepitant dimeglumine equivalent to 115 mg of fosaprepitant free acid.Each vial of EMEND I.V. 150 mg contains fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant free acid.Inactive ingredients:•edetate disodium•polysorbate 80•lactose anhydrous•sodium hydroxide or hydrochloric acidEMEND I.V. does not contain gluten, sucrose, tartrazine or any other azo dyes.

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