醋酸亮丙瑞林注射剂(ELIGARD KIT 22.5MG 3-MONTH)

产地国家:美国

处方药:是

所属类别: 22.5毫克 3-MONTH/瓶/套

包装规格: 22.5毫克 3-MONTH/瓶/套

计价单位:套

生产厂家英文名:TOLMAR PHARMACEUTICALS IN

原产地英文商品名:ELIGARD KIT 22.5MG 3-MONTH 1

原产地英文药品名:LEUPROLIDE ACETATE

中文参考商品译名:ELIGARD 22.5毫克 3-MONTH/套

中文参考药品译名:醋酸亮丙瑞林

简介

药物名称: 醋酸亮丙瑞林

药物别名: LEUPROLIDE ACETATE、ELIGARD

英文名称: Leuprorelin acetate

注射液功用作用: 子宫内膜异位症;伴有月经过多、下腹痛、腰痛及贫血等的子宫肌瘤;绝经前乳腺癌,且雌激素受体阳性患者;前列腺癌;中枢性性早熟症。

用法用量: 皮下注射,成人3.75mg/次,1次/4周。子宫内膜异位症:通常,成人每4周1次,皮下注射醋酸亮丙瑞林3.75mg。当患者体重低于50kg时,可以使用1.88mg的制剂。初次给药应从月经周期的1~5日开始。子宫肌瘤:通常,成人每4周1次,皮下注射醋酸亮丙瑞林1.88mg。但对于体重过重或子宫明显肿大的患者,应注射3.75mg。初次给药应从月经周期的1~5日开始。前列腺癌、闭经前乳腺癌:通常,成人每4周1次,皮下注射醋酸亮丙瑞林3.75mg。中枢性性早熟症:通常,每4周1次,皮下注射醋酸亮丙瑞林30mg/kg,根据患者症状可增量至90mg/kg。

注意事项和不良反应

(1)内分泌系统:发热,颜面潮红,发汗,性欲减退,阳痿,男子女性化乳房,睾丸萎缩,会阴不适等现象。

(2)肌肉骨骼系统:可见骨疼痛,肩腰四肢疼痛。

(3)泌尿系统:可见排尿障碍,血尿等。

(4)循环系统:可见心电图异常,心胸比例增大等。

(5)消化系统:恶心,呕吐食欲不振等。

(6)过敏反应:可见皮疹搔痒等。注射局部疼痛,硬结,发红。

(7)其他:可见浮肿,胸部压迫感,发冷,疲倦,体重增加,知觉异常,听力衰退,耳鸣,头部多毛,尿酸,BUN,LDH,GOT,GPT上升等。由于雌激素降低作用而出现的更年期综合征样的精神抑郁状态。

(8)对本药成份、合成的LH-RH或LH-RH衍生物有过敏史者禁用。

(9)孕妇或有可能怀孕的妇女,或哺乳期妇女;有性质不明的、异常的阴道出血者[有可能为恶性疾病]禁用。

(10)皮下注射部位选上臂部、腹部、臀部,注射后不得揉搓注射部位。首次用药初期,由于高活性LH-RH衍生物对垂体-性腺系统的刺激作用,使血清睾丸素浓度上升,可见骨性疼痛暂时加重,尿储留或脊髓压迫症状,应对症处理。已存在由脊髓压迫或尿储留引起的肾功能障碍者或者是有重新发作可能性的患者及高龄者慎用。

(11)治疗时一定要确认患者未妊娠,且于月经周期的1-5天开始给药,在治疗期内应采用非激素性方法避孕。给药时应留心与类似疾患(恶性肿瘤等)鉴别,如给药过程中肿瘤增大,临床症状末见改善时应中止给药。由于雌激素降低可引起骨质的损失,故需长期给药或再次给药时,应尽可能检查骨密度,慎重用药。

(12)对含有明胶的药物或含有明胶的食物有过敏史者,例如休克、过敏性症状(荨麻疹、呼吸困难、口唇浮肿、喉头水肿等)应慎重用药;已有因使用本品引起血栓形成及肺栓塞症的报告。

英文版说明书

Important Safety Information for ELIGARDELIGARD should not be used by anyone who is allergic to any drug product in the same class of products, or who is allergic to any of the ingredients of Eligard, including leuprolide acetate.Life-threatening allergic reactions have been reported with the drugs in Eligard’s class .Eligard should not be used in women who are pregnant of may become pregnant. ELIGARD can cause pregnancy loss and harm to the fetus when used by a pregnant woman.Eligard, like other drugs in its class, causes a temporary increase in testosterone during the first and second weeks of treatment.Patients may experience worsening of symptoms or new symptoms during the first weeks of treatment, including bone pain, nerve damage, blood in the urine, pressure on the spine, or difficulty urinating.If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be fatal. You may require close medical attention during the first few weeks of therapy and you should notify your doctor if you develop any new or worsened symptoms after beginning treatment with Eligard.Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving the drugs in Eligard’s class.Your doctor will monitor your blood sugar levels. Increased risk of heart attack, sudden death due to heart attack, and stroke has also been reported in men with the use of the drugs in Eligard’s class.Your doctor will monitor you for heart disease.The most common injection site side effects are temporary burning and stinging, pain, bruising and redness. The most common systemic adverse events include mild to severe hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage and breast enlargement. For more information on these and other side effects, please talk to your doctor.IndicationELIGARD is a prescription drug, given by injection, for the management of advanced prostate cancer. However, there is no known cure for prostate cancer.

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