药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201232919252419.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Lantus处方资料(仅供参考)
新型胰岛素笔Lantus SoloStar在美上市 2007年4月30日,欧洲最大的制药商赛诺菲-安万特(NYSE: SNY)宣布FDA已批准其新型胰岛素笔Lantus SoloStar在美上市,用于I型和II型糖尿病的高血糖治疗。Lantus SoloStar是预先装填重组胰岛素Lantus的一次性注射装置,每天使用一次,剂量调整范围是1-80单位,使用非常方便。剂量精度和重复性由国际标准化协会IOS测定和认定。Lantus是全球处方量最大的重组胰岛素,也是唯一批准24小时使用一次的胰岛素。由于其突变特点,Lantus没有其他胰岛素制剂的作用峰值,24小时都是一个水平,安全性能高。Lantus SoloStar一般存放在2-8℃直至使用,一旦使用可在室温下保持28天。
美国食品药品管理局批准Lantus SoloStar®胰岛素笔 A New Prefilled Disposable Insulin Pen For Use With LANTUS® In People With Type 1 And Type 2 Diabetes 一种新的一次性预充,胰岛素笔,用于1型2型糖尿病人的Lantus SoloStar® When it comes to administering insulin, many people prefer an insulin pen over the standard syringe and vial because they find pens more convenient and more accurate. And pre-filled disposable pens are easiest of all, because you don’t have to install a new cartridge when the pen is empty¬–you just toss it out. 很多人源于用胰岛素避而不用注射器和小药瓶,因为它阿们发现笔更方便,更准确。一次性预充笔是最轻松的,因为,当笔管用空时,不需要装药管,甩掉就行了 Soon there’ll be a new player in the disposable pre-filled pen market: Sanofi-aventis’s SoloStar disposable pen comes pre-filled with Lantus, the long-acting insulin that’s injected once daily. The pen, which can administer doses from one to eighty units per injection, needs to be refrigerated until first use; after that, it’s fine at room temperature for up to 28 days. 在一次性预充笔的市场上,很快就有新的参与者。Sanofi-aventis’s SoloStar一次性笔,预先充满来得时Lantus ,该药为长效胰岛素,一天注射一次。这种笔,每次注射时,能处理1到80个单位的剂量,首次注射前,须放置在冰箱,启用以后,最好放于室温达28天 A recent study indicated that the SoloStar’s injection force is about thirty percent less than other popular disposable pens. Another study (sponsored by sanofi-aventis) pitted SoloStar against two other established pens. Most of the 510 patients in the study preferred the SoloStar with regard to design and esthetics. In addition, more of them were able to correctly prepar the pen and perform an injection when using SoloStar. Sanofi-aventis expects the SoloStar pen to hit pharmacies sometime this year. 最近一项调查指出SoloStar’s,笔,注射强度比其他普通一次性笔、大约轻30%(由sanofi-aventis 发起)的另一项调查,与其他两种已经制成的笔竞争。参加调查的510个人,绝大多数愿意用SoloStar’s 与笔的设计和美观,此外,当他们使用SoloStar’s时,多数人有能力正确地准备和进行注射 sanofi-aventis希望SoloStar笔,今年会在药业界取得成功 摘要 Sanofi-aventis’s SoloStar一次性笔,预先充满一天注射一次的长效胰岛素来得时Lantus ,注射强度比其他普通一次性笔、大约轻30% ,在一项510个人的调查中,绝大多数人,因SoloStar笔设计,美观,能正确掌握使用,愿意用SoloStar笔
Important Safety Information for Lantus® Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.
You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia may be serious and life threatening. It may cause harm to your heart or brain. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening.
Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to breast-feed.
Lantus® SoloSTAR® is a disposable prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.
LANTUS SOLOSTAR Sol. iny. 100UI/ml Datos generales de LANTUS SOLOSTAR Composición de LANTUS SOLOSTAR Principio Activo: Insulina glargina 100.0 U*/1 ml
Excipiente: Glicerol Y otros.
Clasif. Terapéutica de LANTUS SOLOSTAR Diabetes mellitus
Posología de LANTUS SOLOSTAR Ajuste individualizado de la dosis
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