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  药店国别: 加拿大药房
产地国家: 加拿大
所属类别: 泌尿生殖系统及泌乳药物->前列腺疾病用药
处方药:处方药
包装规格: (0.5/0.4)毫克/胶囊 30胶囊/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
葛兰素史克
生产厂家英文名:
GLAXOSMITHKLINE
该药品相关信息网址1:
http://www.drugs.com/jalyn.html
该药品相关信息网址2:
http://www.rxlist.com/jalyn-drug.htm
原产地英文商品名:
JALYN (0.5/0.4)mg/cap 30caps/bottle
原产地英文药品名:
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE
中文参考商品译名:
JALYN (0.5/0.4)毫克/胶囊 30胶囊/瓶
中文参考药品译名:
度他雄胺/盐酸坦索罗辛
原产地国家批准上市年份:
2010/06/14
英文适应病症1:
Benign prostatic hyperplasia
临床试验期:
完成
中文适应病症参考翻译1:
良性前列腺增生症
药品信息:

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 详细处方信息以本药内容附件PDF文件(201011418301739.pdf)的“原文Priscribing Information”为准
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部分中文Jalyn处方资料(仅供参考)

    2010年6月14日,葛兰素史克公司宣布,美国食品药品管理局(FDA)已批准Jalyn——一种由度他雄胺(0.5 mg)与坦索罗辛(0.4 mg)构成的复方胶囊制剂——用于治疗有症状的良性前列腺增生症(BPH)。度他雄胺(商品名为Avodart)目前已获准用于治疗有症状的BPH、减少急性尿潴留风险及减少前列腺相关的手术风险。坦索罗辛(商品名为Flomax)是一种α受体阻滞剂,适用于BPH的对症治疗。
    FDA批准该复方药品是基于Avodart与Tamsulosin联合用药(CombAT)研究的2年结果。这项临床试验涉及4,844例患有BPH的男性,为国际性、多中心、随机、双盲、平行分组的研究。
    CombAT 研究者比较了接受度他雄胺配伍坦索罗辛治疗的男性与仅接受其中任一药治疗的男性在泌尿系统症状方面的改变,后者以有效的症状指数进行评估。研究结果显示,与单用任一药相比,两种药联用与BPH症状显著改善有关。
    临床试验中报告的不良事件与度他雄胺和坦索罗辛已知的安全性特征一致。接受联合治疗的男性中最常见的不良反应为阳痿、性欲减退、乳腺疾病(包括乳腺增大和压痛)、射精障碍及头晕。

Jalyn
Generic Name: dutasteride and tamsulosin hydrochloride
Date of Approval: June 14, 2010
Company: GlaxoSmithKline

Treatment for: Benign Prostatic Hyperplasia

The U.S. Food and Drug Administration (FDA) has approved Jalyn, a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Patient Information
Jalyn is for use by men only.

Read this patient information before you start taking this medicine and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Jalyn?
Jalyn is a prescription medicine that contains two medicines: dutasteride and tamsulosin. It is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

How does Jalyn work?
Jalyn contains two medications, dutasteride and tamsulosin. These two medications work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate and tamsulosin relaxes muscles in the prostate and neck of the bladder. These two medications, when used together, can improve symptoms of BPH better than either medication when used alone.

Who should not take Jalyn?
Do not take this medicine if you are:
pregnant or may become pregnant. It may harm your unborn baby. Pregnant women should not touch Jalyn Capsules. If a woman who is pregnant with a male baby gets enough active drug in her body by swallowing or touching the capsules, the male baby may be born with sex organs that are not normal.
a child or teenager.
allergic to dutasteride, tamsulosin, or any of the ingredients in Jalyn. See the end of this leaflet for a complete list of ingredients.
taking another medicine that contains an alpha-blocker.

What should I tell my doctor before taking Jalyn?
Before you take this medicine, tell your doctor if you:
have a history of low blood pressure
take medicines to treat high blood pressure
plan to have cataract surgery
have liver problems
are allergic to sulfa medications
have any other medical conditions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Jalyn and other medicines may affect each other, causing side effects. It may also affect the way other medicines work, and other medicines may affect how Jalyn works.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Jalyn?
Take this medicine exactly as your doctor tells you to take it.
Swallow capsules whole. Do not crush, chew, or open the capsules.
Take your Jalyn one time each day, about 30 minutes after the same meal every day. For example, you may take your dose 30 minutes after dinner every day.
If you miss a dose, you can take it later that same day, 30 minutes after a meal. Do not take two capsules in the same day. If you stop or
If you take too much Jalyn, call your doctor or go to the nearest hospital emergency room right away.
Your doctor may check you for other prostate problems, including prostate cancer before you start and while you take Jalyn. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. This medicine will reduce the amount of PSA measured in your blood. Your doctor is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels from their lowest point while on Jalyn (even if the PSA levels are in the normal range) should be evaluated by your doctor.

What should I avoid while taking Jalyn?
Avoid driving, operating machinery, or other dangerous activities when starting treatment until you know how Jalyn affects you. This medicine can cause a sudden drop in your blood pressure, especially at the start of treatment. A sudden drop in blood pressure may cause you to faint, feel dizzy or lightheaded.
You should not donate blood while taking Jalyn or for six months after you have stopped treatment. This is important to prevent pregnant women from receiving this drug through blood transfusions.

Jalyn side effects
This medicine may cause serious side effects, including:
Decreased blood pressure. Jalyn may cause a sudden drop in your blood pressure upon standing from a sitting or lying position, especially at the start of treatment. Symptoms of low blood pressure may include:
fainting
dizziness
feeling lightheaded
Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Jalyn in the past. If you need to have cataract surgery, tell your surgeon if you take or have taken Jalyn.
A painful erection that will not go away. Rarely, this medicine can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, there could be lasting damage to your penis, including not being able to have an erection.
Allergic reactions. Call your doctor if you get any signs of an allergic reaction while taking Jalyn, including:
itching
hives
rash
Rare and more serious allergic reactions may include:
swelling of your face, tongue, or throat
difficulty breathing
Get medical help right away if you have swelling of the face, tongue, or throat or difficulty breathing.

The most common side effects include:
ejaculation problems
trouble getting or keeping an erection (impotence)
a decrease in sex drive (libido)
decreased amount of semen released during sex
dizziness
enlarged or painful breast
runny nose

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Jalyn?
Store Jalyn Capsules at room temperature (59° to 86°F or 15° to 30°C).
Jalyn Capsules may become deformed and/or discolored if kept at high temperatures.
Do not use or touch Jalyn if your capsules are deformed, discolored, or leaking.
Safely throw away medicine that is no longer needed.

Keep Jalyn and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give this medicine to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Jalyn. If you like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for health professionals.

What are the ingredients in Jalyn?
Active ingredients: dutasteride and tamsulosin hydrochloride

Inactive ingredients: black ink, butylated hydroxytoluene, carrageenan, FD&C yellow 6, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, hypromellose, iron oxide red, methacrylic acid copolymer dispersion, microcrystalline cellulose, mono-di-glycerides of caprylic/capric acid, potassium chloride, talc, titanium dioxide, and triethyl citrate.

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 详细处方信息以本药内容附件PDF文件(201011418301739.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-09-04
附件:




201011418301739.pdf    

 
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