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  药店国别: 德国药房
产地国家: 德国
所属类别: 泌尿生殖系统及泌乳药物->治疗肾病药物
处方药:处方药
包装规格: 800毫克/片 180片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
健赞
生产厂家英文名:
Genzyme GmbH
该药品相关信息网址1:
http://www.renvela.com/hcp/about/rv_hcp_about.asp
该药品相关信息网址2:
http://www.renvela.com/patients/about-renvela.aspx
原产地英文商品名:
RENVELA 800mg/tablet 180tablets/bottle
原产地英文药品名:
sevelamer carbonate
中文参考商品译名:
RENVELA 800毫克/片 180片/瓶
中文参考药品译名:
碳酸司维拉姆
原产地国家批准上市年份:
2007/10/19
英文适应病症1:
Treatment of chronic kidney disease
英文适应病症2:
control of serum phosphorus levels in vivo
临床试验期:
完成
中文适应病症参考翻译1:
治疗慢性肾病
中文适应病症参考翻译2:
控制体内血清磷水平
药品信息:

友情提示:RENVELA 400mg已停产。

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 详细处方信息以本药内容附件PDF文件(20104105402828.pdf)的“原文Priscribing Information”为准
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部分中文sevelamer carbonate 处方资料(仅供参考)

    美国Genzyme生物制药公司药品Renvela用于慢性肾病(CKD)患者,以控制他们体内血清磷水平,这为专业医师提供了一种治疗高磷酸盐血症的全新选择。

    值得指出的是,欧盟同时批准了该药的片剂和粉剂两种剂型。其中粉剂是该公司另一种磷酸盐粘结剂Renagel的下一代产品,可用于未接受过透析治疗,且体内血清磷水平≤1.78 mmol/L的患者。

    导致高磷酸盐血症的原因是患者肾脏发生病变,难以将体内的磷滤除并排除体外,而血清磷含量的升高会导致身体组织钙化,从而进一步增加发生心脏病的风险。若对这种情况不加以治疗,还有可能出现骨痛、骨骼畸形和骨折等,因此,将血清磷含量维持在一个理想的水平对CKD患者来说是一种重要的治疗途径。

    目前,Renvela和Renagel是唯独不含钙和任何金属成分的磷酸盐粘结剂。它们通过批准的依据均是多项临床实验的喜人结果——患者用药后体内的磷含量可以维持在正常的范围。

    enzyme公司肾病药事业部负责人表示,Renvela能获准进入欧洲市场意味着在CKD治疗领域又前进了一步。该药是第一种在欧洲集中审批程序下获准,可用于治疗从未进行过透析CKD患者的产品,也为医师提供了一种可尽早治疗,控制病情的新药


About Renvela
Generic Name:
sevelamer (se VEL a mer)
Brand Names: Renvela tablets and powder

Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on dialysis. Renvela contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the dietary tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum.

Renvela has the same polymeric structure as Renagel® (sevelamer hydrochloride)1 with a salt change.
Treatment with Renvela improves serum bicarbonate levels compared to Renagel.

Renvela contains no calcium or metal and does not accumulate in the body, either in plasma or tissues.
Calcium-based binders have been associated with calcification, even at doses below the KDOQI-recommended maximum.

Hypercalcemia has been found to be prevalent in 50% of dialysis patients (serum calcium >9.5 mg/dL).
Lanthanum has been shown in human studies to accumulate in bone and in animal studies to accumulate in the GI tract, liver and other tissues.

Aluminum-containing agents have been associated with acute aluminum neurotoxicity, dialysis encephalopathy, aluminum bone disease, microcytic anemia and other complications

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Important Treatment Considerations
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis

Renvela is contraindicated in patients with bowel obstruction

Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery

Uncommon cases of bowel obstruction and perforation have been reported

Serum bicarbonate and chloride levels should be monitored

Vitamins D, E, K (coagulation parameters), and folic acid levels should be monitored
The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting

In a short-term study of sevelamer carbonate powder dosed three times daily, adverse events were similar to those reported for sevelamer carbonate tablets

In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation

Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported

Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela

Patients should be informed to take Renvela with meals and to adhere to their prescribed diets.

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What is Renvela?
Renvela (sevelamer) is a phosphate binder. Sevelamer helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.

Renvela is used to reduce blood levels of phosphorus in people with chronic kidney disease who are on dialysis.

envela may also be used for other purposes not listed in this medication guide.

Important information about Renvela:You should not take Renvela if you are allergic to Renvela, or if you have a low blood level of phosphorus (hypophosphatemia), or a blockage in your intestines.

Before taking Renvela, tell your doctor if you have trouble swallowing, severe constipation, a digestive disorder of your stomach or intestines, or if you have recently had stomach or intestinal surgery.

Avoid taking any other medicines within 1 hour before or 3 hours after you take Renvela. Sevelamer can bind to other medications and make them less effective.

Before taking Renvela, tell your doctor if you are taking ciprofloxacin (Cipro), a heart rhythm medication, or a seizure medication.

Do not take calcium or other mineral supplements without your doctor's advice. Use only the specific type of calcium or mineral supplement your doctor recommends.

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Before taking Renvela
You should not take Renvela if you are allergic to sevelamer, or if you have:a low blood level of phosphorus (hypophosphatemia); or a blockage in your intestines.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Renvela:trouble swallowing;severe constipation;a digestive disorder of your stomach or intestines; orif you have recently had stomach or intestinal surgery.

FDA pregnancy category C. It is not known whether Renvela is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sevelamer passes into breast milk or if it could harm a nursing baby. Do not use Renvela without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings in more detail

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How should I take Renvela?
Take Renvela exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take Renvela with meals. Do not crush, chew, or break the Renvela tablet. Swallow the pill whole.

Renvela tablets expand when they are wet, and breaking or crushing the pill may make it harder to swallow.

Renvela powder must be dissolved in water before you take it. The 0.8-gram packet should be mixed with at least 1 ounce (2 tablespoons) of water. The 2.4-gram packet should be mixed with at least 2 ounces (4 tablespoons) of water.

Stir the Renvela powder in water until it is completely dissolved. Drink all of this mixture right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Renvela may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store Renvela tablets and powder at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Since Renvela is not absorbed by the body, an overdose of this medication is not likely to cause life-threatening symptoms.

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What should I avoid while taking Renvela?
Avoid taking any other medicines within 1 hour before or 3 hours after you take Renvela. Sevelamer can bind to other medications and make them less effective.

Do not take calcium or other mineral supplements without your doctor's advice. Use only the specific type of calcium or mineral supplement your doctor recommends.

Renvela side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Renvela: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:severe stomach pain or constipation; orfever, chills, body aches, flu symptoms.

Less serious Renvela side effects may include:upset stomach;stomach pain, gas;nausea, vomiting;diarrhea; or constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Renvela side effects in more detail

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What other drugs will affect Renvela?
The following drugs can interact with Renvela. Tell your doctor if you are taking any of these:ciprofloxacin (Cipro);levothyroxine (Synthroid, Levothroid, Levoxyl);a heart rhythm medication; ora seizure medication.

This list is not complete and there may be other drugs that can interact with Renvela. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Renvela.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Renvela only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.


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 详细处方信息以本药内容附件PDF文件(20104105402828.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-05-26
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