说明 / 使用说明：Buserelin-long FS

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ATX代码L02AE01 Buserelin

药理组

抗肿瘤药，促性腺激素释放激素类似物（GnRH）[下丘脑，脑垂体，促性腺激素及其拮抗剂的激素]

抗肿瘤药，促性腺激素释放激素类似物（GnRH）[抗肿瘤激素和激素拮抗剂]

香精分类（ICD-10）

C50乳腺恶性肿瘤

乳腺乳头和乳晕的癌症，乳腺癌，更年期妇女复发性乳腺癌的激素依赖型，激素依赖性乳腺癌，弥散性乳腺癌，弥漫性乳腺癌，恶性乳腺癌，乳腺恶性肿瘤，对侧乳腺癌，局部晚期或转移性乳腺癌，局部分布的乳腺癌，局部复发性乳腺癌，转移性乳腺癌，乳腺肿瘤转移，转移性乳腺癌，不能手术的乳腺癌，不相容的乳腺癌，转移性妇女的乳腺癌乳腺癌，男性乳腺癌，乳腺癌，远处转移性乳腺癌，绝经后妇女乳腺癌，乳腺癌激素依赖型乳腺癌，局部转移性乳腺癌，乳腺癌转移灶，乳腺癌与区域转移，乳腺癌转移，常见激素依赖形式的乳腺癌 呃，普通乳腺癌，复发性乳腺癌，乳腺肿瘤复发，乳腺癌，雌激素依赖性乳腺癌，雌激素依赖性乳腺癌，HER2过表达的弥散性乳腺癌，乳腺肿瘤

C61前列腺恶性肿瘤

前列腺腺癌，激素依赖性前列腺癌，激素前列腺癌，前列腺恶性肿瘤，前列腺恶性肿瘤，前列腺癌，局部分布的非转移性前列腺癌，局部晚期前列腺癌，局部扩散前列腺癌转移性前列腺癌，转移性前列腺癌，转移性激素抵抗性前列腺癌，非转移性前列腺癌，不相容性前列腺癌，前列腺癌，前列腺癌，常见前列腺癌，睾丸激素前列腺癌

D25子宫肌瘤

子宫肌瘤

D26子宫的其他良性肿瘤

子宫纤维瘤，子宫肌瘤，子宫肌瘤，纤维瘤，子宫肌瘤，Fibrrios，Meigs综合征，子宫肿瘤

E28.0过量的雌激素

低过激症，绝对低钠血症，低过敏症

E34.8其他指定的内分泌失调

Progeria，一个空的土耳其马鞍综合征

N80子宫内膜异位症

子宫内膜异位子宫内膜异位症

N85.0子宫内膜腺增生

子宫内膜增生过程，子宫内膜囊性腺体增生

N85.1腺瘤内膜增生

N97女性不育症

女性不育症无排卵，高泌乳素不孕症，不孕不育高泌乳素血症，内分泌不育症，下丘脑 - 垂体功能障碍不孕不育，不孕不育，不孕不育，高泌乳素血症不孕不育，功能不育，婚姻不育，卵巢发育不孕，单个卵泡的生长

组成

用于制备用于肌内给药延长作用的悬浮液的氯化铝

醋酸布列瑞利3.93mg

布列瑞林 - 3.75毫克

辅助物质：dl-乳酸和乙醇酸共聚物 - 200mg; D-甘露醇85mg; 卡梅洛尔钠 - 30mg; 聚山梨酯-80-2mg

溶剂：甘露醇，0.8％溶液（1ml：d-甘露糖醇8.0mg，注射用水至1.0ml）

剂型说明

活性物质：冻干粉末（脆性冻干物）或压缩成片状多孔质量白色或白色，稍有淡黄色的色泽。

溶剂：透明无色液体。

减少的悬浮液：当加入溶剂并搅拌时，形成白色或白色均匀的具有弱黄色色调的悬浮液; 静置时，悬浮液沉淀，但容易通过摇动重悬; 悬挂液必须通过针号0840通过注射器。

药理作用

药理作用 - 抗雄激素，抗原性，抗雌激素。

药效学

内源GnRH的合成类似物。 布列瑞林竞争性地结合垂体前叶细胞的受体，导致血浆中性激素水平的短期增加，进一步导致垂体的促性腺激素功能的完全可逆阻断，从而抑制LH的释放和FSH。 结果，抑制性腺中性激素的合成，这表现在血浆中雌二醇浓度降低到妇女绝经后的价值，睾酮含量下降男性的发育水平。 布列瑞林在第21天首次注射男性后，睾丸激素的浓度下降到后期水平（睾丸状态的特征），即称为药理性阉割。 而在女性中，雌二醇的浓度降低到与卵巢切除术或绝经后相当的水平。

在整个治疗期间，睾酮和雌二醇的浓度在每28天进行一次，这导致抑制生长和激素依赖性肿瘤的反向发展。 停止治疗后，恢复激素的生理分泌。

药代动力学

生物利用度高。 血浆中的C max在/ m施用后大约2-3小时实现，并保持在足以抑制垂体腺中促性腺激素合成至少4周的水平。

适应症

激素依赖性前列腺癌;

乳腺癌

子宫内膜异位症（术前和术后）;

子宫肌瘤;

子宫内膜增生过程;

治疗不孕症（进行体外受精方案（IVF）时）。

禁忌症

对药物组分的过敏反应;

怀孕;

哺乳期

怀孕和哺乳期

禁止怀孕。

副作用

过敏反应：荨麻疹，皮肤充血，很少血管性水肿。

从中枢神经系统的一侧：心情的频繁变化，睡眠障碍，抑郁症，头痛。

从肌肉骨骼系统：长期使用 - 具有骨质疏松症风险的骨骼脱矿质。

妇女 - 头痛，抑郁，出汗和性欲改变，阴道粘膜干燥，下腹部疼痛，很少月经如出血（治疗前一周）。

在男性中，治疗前列腺癌 - 在首次注射后2-3周内，布舍瑞林可引起潜在疾病的加重和进展（分别与促性腺激素和睾酮的合成刺激相关），男子乳腺发育，可能出现血液潮红，出汗增加，效力下降（很少需要戒断治疗），血液中雄激素浓度暂时升高，排尿延迟，肾肿大，脸部，眼睑，双腿肿胀; 下肢肌肉无力。 在开始治疗前列腺癌患者时，骨骼暂时性疼痛可能暂时发生; 在这种情况下，应进行症状治疗。 记录输尿管阻塞发展和脊髓压迫的个别情况。

其他：单因素（因果关系未明确确定） - 肺栓塞，消化不良障碍。

相互作用

使用Bucerelin-long同时使用含有性激素的制剂（例如，在诱导排卵）可能有助于卵巢过度刺激综合征的出现。

同时使用布舍瑞林长期FS可能会降低降血糖药物的有效性。

给药和管理

在/ m。

在乳腺癌和激素依赖性前列腺癌中，布舍瑞林长的FS每4周以3.75mg（1次注射）的剂量施用。 长期在医生的监督下。

在子宫内膜异位症的治疗中，增生子宫内膜过程中，药物以3.75mg IM的剂量每4周施用一次。 治疗应从月经周期的头5天开始。 治疗时间 - 4-6个月。

在子宫肌瘤的治疗中，布列瑞林长的FS以3.75mg IM的剂量每4周施用一次。 治疗应从月经周期的头5天开始。 手术前的治疗时间为3个月，其余6例。

在通过IVF治疗不育症中，布列瑞林长期FS在3.75mg（1次注射）IM剂量下一次在卵泡发生（月经周期的第2天）或黄体期中期21-24天）的月经周期，以前的刺激。 在垂体功能的封锁之后，通过血清雌激素水平的降低证实，不少于基线的50％（通常在布列瑞林长期注射后12-15天确定），没有卵巢囊肿（根据超声数据），子宫内膜厚度不超过5毫米，超声监测和血清雌二醇水平控制下，促性腺激素的超排卵刺激开始。

暂停药物管理规定

药物只能肌内注射。

借助于所提供的溶剂，立即在给药前制备用于IM注射的悬浮液。

3.药物只能由经过专门培训的医务人员进行准备和管理。

具有Buserelin-long FS的瓶子应严格保持垂直。 轻松敲打小瓶，确保所有的冻干液都在小瓶的底部

5.打开注射器，连接1.2×50毫米的针头用于溶剂萃取。

6.用溶剂打开安瓿，将安瓿的所有内容物收集到注射器中，将注射器置于2ml

7.从包含冷冻干燥剂的小瓶中取出塑料盖。 用酒精棉签消毒小瓶的橡胶塞

8.将针头插入小瓶中，通过橡胶塞的中心冻干，并小心地将溶剂插入小瓶的内壁，而不用小瓶内容物接触针头。 从小瓶中取出注射器

9.小瓶应保持静止，直到溶剂完全饱和，并形成悬浮液（约3-5分钟）。 之后，不要转动小瓶，检查小瓶壁和底部是否存在干燥的冻干物质。 如果发现干燥残留的冷冻干燥物，请离开药瓶，直到其完全浸泡

在干燥冻干物质的残留物消失后，以圆周运动轻轻搅拌小瓶的内容物30-60秒，直到形成均匀的悬浮液。 请勿推翻或摇动小瓶

11.将针快速穿过橡胶塞进入小瓶。 然后将针切下来，以45°的角度倾斜小瓶，缓慢地将注射器与悬浮液完全填满

12.打字时请勿翻转小瓶。 少量的药物可以保留在小瓶的壁和底部。 考虑到残留物在墙壁和小瓶底部的消耗

13.拨打后立即取出针头。 更换为0.8×40 mm针头，轻轻转动注射器，并从注射器中取出空气

14.停药布列瑞林长期FS应在准备后立即给药。

15.使用酒精棉塞，消毒注射部位。 将针插入臀肌，然后稍微将注射器柱塞向后拉，以确保不会损坏血管。 缓慢地引入悬浮液，在注射器的柱塞上恒定压力。 当针头堵塞时，用相同直径的另一根针头更换针头。

16.重复注射后，左右两侧应交替使用。

过量

目前，没有报告过量的药物。

特别说明

在妇女中 药物治疗期间任何形式的抑郁症患者都应接受医疗监督。

引导排卵应在严格的医疗监督下进行。

在药物治疗的初期阶段，卵巢囊肿的发展是可能的。

在开始治疗之前，建议排除怀孕并停止服用荷尔蒙避孕药，然而，在使用该药物的头两个月内，有必要使用其他（非激素）避孕方法。

治疗停止后，恢复卵巢的功能。 3个月后第一次月经恢复。

在男人身上 为了有效地预防药物第一阶段可能发生的副作用，必须在首次注射布舍瑞林长期FS前2周使用抗雄激素，并在第一次注射后2周使用抗雄激素。

对驱动能力和其他机制的影响。 对于需要增加注意力和精神和运动反应速度的潜在危险活动的患者开药时，应谨慎行事。

问题形式

用于制备用于肌内给药延长作用的悬浮液的冻干物，含有3.75mg布舍瑞林。 在容量为10毫升的深色玻璃瓶中。 在中性玻璃安瓿中加入2ml溶剂（甘露醇，0.8％溶液）。

在轮廓网格包装中放置：1 fl。 用药; 1安培 用溶剂; 1只一次性注射器，容量为5ml; 1无菌注射针，0.8 mm×40 mm; 1无菌溶剂针，1.2 mm×50 mm; 1刀用于开启安瓿或1个清洁剂; 2酒精擦拭巾。

当您将溶剂包装到具有打开戒指或断点的进口安瓿瓶中时，安瓿扫帚机或打开安瓿瓶的开启器不放置。 该套件的1个电路板放置在纸板包装中。

药店的休假条款

处方。

储存条件

在干燥的阴暗处，温度不高于25℃。

放在儿童接触不到的地方。

保质期

2年。 溶剂 - 3年。

在包装上打印有效期后不要使用。

bue-se-REL-in

Available Dosage Forms:

· Injectable

· Implant

· Spray

Pharmacologic Class: Human Follicle Stimulating Hormone

Buserelin is used to treat cancer of the prostate gland.

It is similar to a hormone normally released from the hypothalamus gland. When given regularly, buserelin decreases testosterone levels. Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

Buserelin is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For buserelin, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to buserelin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of buserelin in the elderly to use in other age groups, it has been used mostly in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Buserelin comes with patient directions. Read these instructions carefully.

For patients using the injection form of buserelin:

· Use the syringes provided in the kit. Other syringes may not provide the correct dose. These disposable syringes and needles are already sterilized and designed to be used one time only and then discarded. If you have any questions about the use of disposable syringes, check with your health care professional.

· After use, dispose of the syringes and needles in a safe manner. If a special container is not provided, ask your health care professional about the best way to dispose of syringes and needles.

For patients using the nasal solution form of buserelin:

· Use the nebulizer (spray pump) provided. Directions about how to use it are included. If you have any questions about the use of the nebulizer, check with your health care professional.

Use buserelin only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much may increase the chance of side effects, while using too little may not improve your condition.

Buserelin sometimes causes unwanted effects such as hot flashes or decreased sexual ability. It may also cause a temporary increase in pain, trouble in urinating, or weakness in your legs when you begin to use it. However, it is very important that you continue to use the medicine, even after you begin to feel better. Do not stop using buserelin without first checking with your doctor.

The dose of buserelin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of buserelin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

· For prostate cancer:

o For nasal dosage forms:

o Adults: 200 micrograms (mcg) (2 sprays) into each nostril every eight hours.

o For injection dosage forms:

o Adults: In the beginning, 500 mcg (0.5 milligrams [mg]) injected under the skin every eight hours. After a time, your doctor may lower your dose to 200 mcg (0.2 mg) once a day.

If you miss a dose of buserelin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Dispose of used syringes properly in the container provided.

It is very important that your doctor check your progress at regular visits to make sure that buserelin is working properly and to check for unwanted effects.

Buserelin causes sterility which may be permanent. If you intend to have children, discuss this with your doctor before receiving buserelin.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

· Bone pain

· numbness or tingling of the hands or feet

· trouble with urinating

· weakness in the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

· Decrease in sexual desire

· impotence

· sudden sweating and feelings of warmth ("hot flashes")

Less common

· Burning, itching, redness, or swelling at the place of injection

· diarrhea

· dry or sore nose (with nasal solution)

· headache (with nasal solution)

· increased sweating (with nasal solution)

· loss of appetite

· nausea or vomiting

· swelling and increased tenderness of breasts

· swelling of the feet or lower legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.