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  药店国别: 澳大利亚药房
产地国家: 澳大利亚
所属类别: 维生素类及微量元素药物->氨基酸
处方药:处方药
包装规格: 250毫升 10支
计价单位:
   
生产厂家英文名:
Fresenius Kabi
该药品相关信息网址1:
https://www.diagnosia.com/at/medikamente/padamin-infusionslosung/
原产地英文商品名:
PAEDAMIN / Pädamin 250ML 10 INFUSION VIALS
中文参考商品译名:
PAEDAMIN输液 250毫升 10支
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Undernutrition
临床试验期:
完成
中文适应病症参考翻译1:
营养不足
药品信息:
它是什么和如何使用它? Pädamin是一种氨基酸溶液作为人造蛋白质置换早产婴儿和新生儿,婴幼儿的人工营养的所有应用程序。 在Pädamin还蛋白成分包括牛磺酸,因为它可能会导致在某些情况下早产儿和新生儿长期taurinfreier人工喂养脑发育损伤或失明。 Pädamin基于早产和新生婴儿的氨基酸流动率的氨基酸模式,因此具有对蛋白质代谢的有利作用。 显示Pädamin时,在饮食或管饲不可能的一个进气口和替代药物的氨基酸势在必行。 2你需要使用它之前要考虑什么? Pädamin不应该被使用, 如果你的孩子是过敏这种药的活性成分之一, 如果你的孩子是从氨基酸代谢紊乱, 如果您的孩子患有晚期肝功能衰竭, 如果您的孩子有血液酸中毒, 如果您的孩子患有未经治疗的休克, 如果您的孩子患有严重的心脏衰竭的病人, 一般禁忌输液治疗,如:无法控制的心脏衰竭,肺或脑肿胀积液,严重肾功能不全(尿量减少)和überwässerungszuständen 。 警告和注意事项 请谈谈你的医生或保健专业人士之前Pädamin应用当你的孩子 减少钠的血液中的水平, 钾降低血液中的水平, 其他疾病或过敏 受到影响。 928815_F_GI_12 - 09- 03_PädInflsg 请将安排你的医生检查是必须的。 控制水平衡, Serumionogramms和酸碱平衡和血清尿素氮和血氨水平是必需的。 任何故障必须在治疗前予以纠正。 由于该解决方案不包含碳水化合物或电解质,它们必须根据需要加入。 对于长期使用L-色氨酸含产品,血嗜酸性粒细胞白血细胞在嗜酸粒细胞增多 - 肌痛综合征( EMS )来控制的背景下强劲增长。 Pädamin与其他药物的应用 告知您的医生必须或医疗保健专业人士,如果你的孩子正在服用任何其他药物/应用,最近已采取/使用的任何其他药物或打算采取/使用其他药物。 Pädamin与其他药品的相互作用是已知的。 怀孕和哺乳 不适用。 驾驶和使用机器 不适用。 3如何使用它? Pädamin是由医生或其他保健专业人士给予你的孩子。您的医生会决定你的孩子需要多大的,当它被管理。请与您的医生或保健专业人士检查,如果您不能确定。 如果Pädamin和其它营养液一起给出的,应当注入到一个中央静脉,它是由本身给出,它也可以被注入外周静脉。 建议在人工饲料与0,5 - 1克氨基酸开始( 7-13毫升Pädamin )每公斤体重每天和之后各氨基酸需要量逐渐增加。 每日最大剂量: 将2.5g氨基酸( 33毫升Pädamin )每公斤体重。 最大输注速率: 0.15g的氨基酸( 2毫升Pädamin )每公斤体重和小时。 标准值: 0.08 ~0.12 g氨酸( 1 - 1.6毫升Pädamin ) /千克体重每小时。 与另外的药物,不育性,必须是安全的,以确保彻底混合是很重要的。 Pädamin应该只与其中的相容性是确保溶液混合。 Pädamin的混合物,如:葡萄糖5 % “费森尤斯” - 输液,脂肪乳20 % - 乳液输液, Omegaven “费森尤斯” - 乳液输液, SMOFlipid 200毫克/毫升乳液输液,氯化钠“费森尤斯” 1molar输液特 - 安瓿钙“费森尤斯” - 氯化钾针剂“费森尤斯” 1molar输液特 - 安瓿瓶,维他脂质 - 维生素浓缩为孩子输液制剂, Soluvit - 粉输液制剂, Peditrace - 输液此外,葡萄糖-1 - 磷酸盐“费森尤斯” 1molar输液特 - 安瓿,力肽 - 200毫克/毫升的浓缩输注和L -肉碱“费森尤斯” 1克解决方案 - 小瓶检查兼容性。 兼容性仅用于混合比率来定义。对混合比例的信息都要求在上市许可持有人(见第6节)可用。 928815_F_GI_12 - 09- 03_PädInflsg 的兼容性,应至少肉眼检查(不可见的化学或治疗不兼容性仍然是可能的) 。 混合溶液的输液应在24小时内完成。 治疗时间 Pädamin可以,只要是需要的人工饲料被应用。 如果推荐Pädamin的管理作为一个更大的量 告知你的医生或保健专业人士,如果您担心您的孩子接受Pädamin过量。 由于用药过量或标志过快输液速度可以不耐受症状,如恶心,呕吐,寒战,发热,潮红,增加氨基酸浓度在血液中,增加氨基酸的损失在尿液,血液和血液酸中毒增加氨浓度可能会发生。 如果Pädamin的申请被遗忘 告知你的医生或保健专业人士,如果您担心,脱漏。 如果您对使用该药的任何问题,请联系您的医生或医疗保健专业人员。 4什么是可能的副作用? 像所有的药物,这种药物可引起副作用,虽然不是每个人都得到他们。 如果您发现副作用,请联系您的医生或医疗保健专业人员。这也适用于在本说明书中未列出的任何副作用。 长期管理到外周静脉可导致静脉发炎。 5应该如何储存? 请将本药放在儿童接触不到的地方。 勿储存在高于25 ℃,商店。 保持容器的外箱避光。 表示在纸箱和容器届满日期后,请不要使用此药。到期日是指该月的最后一天。 如果您发现该解决方案不明确和/或无色至浅黄色和/或容器损坏您可能不能使用这种药物。 Pädamin必须先后立即打开容器中使用。残留物应该被丢弃。 从一个微生物学点需要的解决方案是不受控制的和未经验证的条件下混合会立即应用。对于重组方案的存储时间/条件的责任是与用户。 的量,兼容性得到保证,在无菌条件下制备的控制和验证的条件下搅拌混合物24小时,在室温下,应在时间输注后是稳定的。 仅供一次性使用。 What is it and how is it used? Pädamin is an amino acid solution as an artificial protein replacement in premature infants and neonates, infants and toddlers for all applications of artificial nutrition. In Pädamin also the protein component is included taurine, as it may lead to impairment of brain development or blindness in long-term taurinfreier artificial feeding of premature and newborn infants under certain circumstances. The amino acid pattern of Pädamin based on the amino acid turnover rates of premature and newborn infants, and therefore has a favorable effect on the protein metabolism of. Pädamin is displayed when a intake in the diet or by gavage not possible and a replacement drug amino acids is imperative. 2 What you need to consider before using it? Pädamin should not be used, if your child is allergic to one of the active ingredients of this medicine, if your child is suffering from a disorder of amino acid metabolism, if your child suffers from advanced liver failure, if your child has a blood acidosis, if your child suffers from an untreated shock, if your child is suffering from severe heart failure, in general contraindications to infusion therapy such as: uncontrollable heart failure, fluid accumulation in the lungs or brain swelling, severe renal impairment (decreased urine output) and überwässerungszuständen. Warnings and Precautions Please talk to your doctor or health care professional before Pädamin is applied when your child decreased levels of sodium in the blood, lowered levels of potassium in the blood, other diseases or allergy suffers. 928815_F_GI_12-09-03_PädInflsg Keep the arranged by your doctor check-ups a must. Controls the water balance, the Serumionogramms and the acid-base balance and serum urea nitrogen and blood ammonia levels are required. Any faults must be corrected before therapy. Since the solution does not contain carbohydrates or electrolytes, they must be fed according to need. For long-term use of L-tryptophan-containing products, the blood is strong increase of the eosinophil white blood cells in the context of an eosinophilia-myalgia syndrome (EMS) to control. Application of Pädamin with other medicines Inform your doctor must or health care professional if your child is taking any other medicines / apply, has recently taken / used any other medicines or intends to take / use other drugs. Interactions of Pädamin with other medicinal products are known. Pregnancy and lactation Not applicable. Driving and using machines Not applicable. 3 How is it used? Pädamin is administered to your child by a doctor or other healthcare professional. Your doctor will decide how much your child needs and when it is administered. Please check with your doctor or health care professional if you are not sure. If Pädamin given together with other nutrient solutions, it should be infused into a central vein, it is given by itself, it can also be infused into a peripheral vein. It is recommended that the artificial diet with 0,5 - 1 g amino acids to begin (7-13 ml Pädamin) per kg body weight per day and gradually increase after each amino acid requirement. Maximum daily dose: 2.5 g of amino acid (33 ml Pädamin) per kg body weight. Maximum infusion rate: 0.15 g of amino acids (2 ml Pädamin) per kg body weight and hour. Standard value: 0.08 to 0.12 g amino acids (1 - 1.6 ml Pädamin) / kg body weight per hour. With the addition of drugs, sterility must be secure and it is important to ensure thorough mixing. Pädamin should only be mixed with solutions for which compatibility is ensured. Mixtures of Pädamin with eg glucose 5% "Fresenius" - infusion, Intralipid 20% - emulsion for infusion, Omegaven "Fresenius" - emulsion for infusion, SMOFlipid 200 mg / ml emulsion for infusion, sodium chloride "Fresenius" 1molar infusion Extra - ampoules, Calcium "Fresenius" - ampoules of potassium chloride "Fresenius" 1molar infusion Extra - ampoules, Vita lipid - Vitamin concentrate for infusion preparation for children, Soluvit - Powder for infusion preparation, Peditrace - Infusion addition, glucose-1-phosphate "Fresenius" 1molar infusion Extra - ampoules, Dipeptiven - 200 mg / ml concentrate for solution for infusion and L-carnitine "Fresenius" 1 g - vials were checked for compatibility. Compatibility is defined only for mixing ratios. Information on the mixing ratios are on request at the Marketing Authorisation Holder (see section 6) available. 928815_F_GI_12-09-03_PädInflsg The compatibility should be checked at least visually (not visible chemical or therapeutic incompatibilities are still possible). The infusion of the mixed solution should be completed within 24 hours. Duration of treatment Pädamin can be applied as long as an artificial diet is needed. If a greater amount of Pädamin administered as recommended Inform your doctor or health care professional if you are concerned that your child has received an excessive amount of Pädamin. As a sign of overdosage or too rapid infusion rate can intolerance symptoms such as nausea, vomiting, chills, fever, flushing, increased amino acid concentrations in the blood, increased amino acid losses in the urine, increased ammonia concentration in the blood and blood acidosis may occur. If the application of Pädamin was forgotten Inform your doctor or health care professional if you are concerned, a dose is missed. If you have any further questions on the use of this medicine, contact your doctor or health care professional. 4 What are the possible side effects? Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice side effects, contact your doctor or health care professional. This also applies to any side effects not listed in this leaflet. Prolonged administration into a peripheral vein can lead to venous irritation. 5 How should it be stored? Keep this medicine out of the reach of children. Do not store above 25 ° C. Store. Keep the container in the outer carton to protect from light. Do not use this medicine after the expiry date stated on the carton and the container. The expiry date refers to the last day of that month. You may not use this medicine if you notice that the solution is not clear and / or colorless to pale yellow and / or the container is damaged. Pädamin must be used after first opening the container immediately. Residues should be discarded. From a microbiological point of view need solutions were mixed under uncontrolled and unvalidated conditions are applied immediately. The responsibility for the storage time / conditions of the reconstituted solution is with the user. Mixtures for which the compatibility is ensured and prepared aseptically controlled and validated conditions are stable after mixing for 24 hours at room temperature and should be infused in the time. For single use only.
更新日期: 2014-04-17
附件:
201451818395211.pdf    

 
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