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  药店国别: 意大利药房
产地国家: 意大利
所属类别: 影响血液及造血系统药物->抗贫血药物
处方药:处方药
包装规格: 15毫升 40毫克 10瓶
计价单位:
   
生产厂家英文名:
ITALFARMACO SpA
该药品相关信息网址1:
http://www.vademecum.es/medicamento-ferplex+40_1544
原产地英文商品名:
Ferplex oral solution 15ml 40mg 10 vials
原产地英文药品名:
Ferriprotinato
中文参考商品译名:
Ferplex 15毫升 40毫克 10瓶
中文参考药品译名:
Ferriprotinato
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Iron deficiency anemia
临床试验期:
完成
中文适应病症参考翻译1:
缺铁性贫血
药品信息:
【药品名称】 通用名称: 蛋白琥珀酸铁口服溶液 成份】本品主要成份为蛋白琥珀酸铁800毫克(相当于三价铁40毫克) 【性状】本品为深红色液体;气芬香,味甜。 【适应症】 绝对和相对缺铁性贫血的治疗,由于铁摄入量不足或吸收障碍、急性或慢性失血以及各种年龄患者的感染所引起的隐性或显性缺铁性贫血的治疗,妊娠与哺乳期贫血的治疗。 【规格】15ml:40mg(以铁计) 【用法用量】 本品均由口服。 成人:每天1-2瓶(相当于三价铁40-80毫克),遵医嘱分两次在饭前口服。 儿童:每天按体重1.5毫升/公斤(相当于每天三价铁4毫克/公斤体重),应遵医嘱分两次于饭前口服。 【不良反应】 偶有发生。尤其用药过量时易发生胃肠功能紊乱(如腹泻、结肠痉挛、恶心、呕吐、上腹部疼痛),在减量或停药后可消失。 【禁忌】 对本药品过敏者以及含铁血黄素沉着、血色素沉着、再生障碍性贫血、溶血性贫血、铁利用障碍性贫血、慢性胰腺炎和肝硬化患者禁用。 【注意事项】 在开始治疗前,应先找出产生贫血的原因。本品尤其适用于妊娠与哺乳期妇女贫血的治疗。 本品不会影响病人的反应(驾驶及机器的操作)。本品不会引起成瘾性,除了持续性出血、月经过多及怀孕外,不应服用本品超过六个月。 【孕妇及哺乳期妇女用药】 本品适用于妊娠与哺乳期妇女贫血的治疗。 【儿童用药】 儿童每天按体重1.5毫升/公斤(相当于每天三价铁4毫升/公斤体重),应遵医嘱分两次于饭前口服。 【老年用药】 本品未进行老年用药相关试验研究,但预计不存在限制本品在老年使用的特殊问题。 【药物相互作用】 铁衍生物可影响四环素类药品的吸收,应避免与其同时服用。服用超过200毫克维生素C可增加铁质的吸收,而跟制酸剂一起服用可降低铁质的吸收,氯霉素可延迟病人对本品的反应。H2受体拮抗剂跟本品没有药物相互作用。 【药物过量】 服用大量补铁药物后6至8小时会产生上腹部疼痛、恶心、呕吐、腹泻及呕血,亦可产生嗜睡、面色苍白、青黑斑、休克甚至昏迷。可立即服用催吐药后再洗胃以作治疗。 【药理毒理】 本品中的铁与乳剂琥珀酸蛋白结合,形成铁-蛋白络合物,用以治疗各种缺铁性贫血症。 【药代动力学】 本品是一种有机铁化合物,它在酸碱度PH值小于4时能呈沉淀物,而在酸碱度PH较高时(PH7.5-8)又重新变为可溶性物质。此外,该制剂不被胃蛋白酶消化,却在中性PH值时可被胰蛋白酶水解。 由于蛋白琥珀酸铁的这些性质,本药品所含的铁受蛋白酶的保护而不同胃液中盐酸和胃蛋白酶发生反应,因此该制剂不会造成胃粘膜损伤。本品中的铁在十二指肠内开始释放,特别应在空肠中释放,因为正常PH值的升高使得这种化合物重新变得可溶,并且使蛋白膜为胰蛋白酶所消化。 这样的铁非常有利于机体的生理吸收,却又不会形成太高的吸收峰;事实上,它呈现一种恒定的吸收趋势,在机体的各个部位逐渐达到吸收与贮存的最佳平稳状态。因此,本品一般不会产生胃肠的耐受性问题。 【贮藏】密封保存,本药品应存放在孩子不能触及之地方。 【包装】白色胶瓶。每支装15毫升,每盒10瓶。 【有效期】24个月 【执行标准】进口药品注册标准JX20000298 【批准文号】进口药品注册证号H20040821 【生产企业】 企业名称:意大泛马克大药厂 ITAFARMACO, S.A. [Drug Name] Common name: iron protein succinate oral solution Ingredient of the main ingredients of iron protein succinate 800 mg (equivalent to 40 mg of ferric) [Traits] crimson liquid; air fragrant, sweet. Indications Implicit or explicit treatment of iron deficiency anemia in absolute and relative treatment of iron deficiency anemia due to insufficient iron intake or malabsorption, acute or chronic blood loss in patients of all ages as well as infections caused by pregnancy and lactation anemia treatment. [Specification] 15ml: 40mg (total iron) Dosage The goods are taken orally. Adults: 1-2 bottles (the equivalent of ferric 40-80 mg) daily, prescribed orally twice before meals. Children: daily according to body weight 1.5 ml / kg (equivalent to ferric 4 mg / kg body weight), should be prescribed orally twice before meals. Adverse reactions Occasionally occur. Especially when overdose prone to gastrointestinal disorders (such as diarrhea, spastic colon, nausea, vomiting, abdominal pain), after reduction or withdrawal may disappear. Taboo Those who are allergic to the drugs and hemosiderosis, hemochromatosis, aplastic anemia, hemolytic anemia, iron utilization anemia, chronic pancreatitis and liver cirrhosis disabled. [Note] Before starting treatment, you should first find out the cause of anemia. This product is especially suitable for pregnant and lactating women in the treatment of anemia. This product does not affect the patient's response (driving and operation of the machine). This product does not cause addiction, in addition to persistent bleeding, menorrhagia and pregnancy, but should not be taking this more than six months. Pregnant and lactating women drug] This product is suitable for pregnant and lactating women in the treatment of anemia. Pediatric Use Children's daily according to body weight 1.5 ml / kg (equivalent to a daily ferric 4 ml / kg body weight), should be prescribed orally twice before meals. Geriatric Use This product is not related to the elderly pilot study medication, there is no limit but is expected to issue a special use of this product in the elderly. Drug interactions Iron tetracycline derivatives can affect the absorption of drugs should be avoided while taking his. Taking more than 200 milligrams of vitamin C increases the absorption of iron, which taken together with antacids can reduce the absorption of iron, chloramphenicol can delay the patient's response to this product. H2 receptor antagonists with this product is no drug interactions. [Drug Overdose After taking a lot of iron medication 6-8 hours will produce abdominal pain, nausea, vomiting, diarrhea and vomiting, may produce drowsiness, pale green spots, shock or even coma. Immediately after taking the drug can induce vomiting, gastric lavage for treatment. Pharmacology and Toxicology The product of the iron and protein binding of succinic acid emulsion to form iron - protein complexes for the treatment of a variety of iron-deficiency anemia. Pharmacokinetics] This product is an organic iron compound, which in PH pH value of less than 4:00 was able to precipitate, and PH is high in pH (PH7.5-8) again becomes soluble substances. Furthermore, the formulation is not digested by pepsin, but at neutral PH value may be trypsin hydrolysis. Because of these properties of the protein acid iron, the iron contained in the drug protected by different proteases hydrochloric acid and pepsin in gastric juice to react the formulation and therefore does not cause gastric damage. The product of the iron in the duodenum began to release, especially in the jejunum should be released, because the normal PH value increased so that this compound again become soluble and membrane protein tryptic make the digestion. Such physiological absorption of iron is very beneficial to the body, but not too high peaks form; fact, it presents a constant absorption trends in various parts of the body gradually achieve optimal steady state absorption and storage. Therefore, the product generally does not produce gastrointestinal tolerability issues. [Storage] sealed, this drug should be stored in place of the child can not reach. [Packaging] white plastic bottles. Each installed 15 ml, pack of 10 bottles. [Validity] 24 months 【Standard】 imported drug registration standards JX20000298 【Approval number】 imported drug registration No H20040821 [Manufacturers] Company Name: Pan-mark Italy's Pharmaceutical ITAFARMACO, SA
更新日期: 2014-05-11
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