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Ferromia Granules 8.3%.600bag×1.2g(柠檬酸亚铁钠颗粒)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 600包×1.2克 
包装规格 600包×1.2克 
计价单位: 盒 
生产厂家中文参考译名:
卫材有限公司
生产厂家英文名:
Eisai Co.Ltd.
该药品相关信息网址1:
https://www.info.pmda.go.jp/go/pack/3222013D1059_2_01/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Ferromia(フェロミア顆粒8.3%)600bag×1.2g
原产地英文药品名:
Sodium Ferrous Citrate
中文参考商品译名:
Ferromia(フェロミア顆粒8.3%)600bag×1.2克
中文参考药品译名:
柠檬酸亚铁钠
曾用名:
简介:

 

部份中文柠檬酸亚铁钠处方资料(仅供参考)
英文名:Sodium Ferrous Citrate
商标名:Ferromia Granules 8.3%
中文名:柠檬酸亚铁钠颗粒
生产商:卫材有限公司
フェロミア錠50mg/フェロミア顆粒8.3%
药用分类名称
可溶性非离子铁剂
批准日期:1986年11月
商標名
Ferromia
一般名
クエン酸第一鉄ナトリウム(Sodium Ferrous Citrate)
化学名
tetrasodium biscitrato iron(II)
分子式
C12H10FeNa4O14
分子量
526.01
構 造 式
物理化学的性状
柠檬酸铁钠是一种绿色白色至黄绿色白色结晶粉末。
本产品不易溶于水,几乎不溶于乙醇(95)。
本产品溶解在稀盐酸、稀硝酸或稀硫酸中。
本产品逐渐变成棕色,由光。
处理注意事项
1. 锁 PTP 包装在打开铝袋后,避免潮湿。
2. 锁玫瑰包装在开瓶后,避免潮湿。
3. 在打开铝袋后,避免潮湿。
4. 颗粒玫瑰包装在开瓶后,通过阻挡光线来储存,避免潮湿(颗粒可能因光线而变色,可能会因湿度而吸收)。
药效药理
1. 作用机制
吸收的铁与血浆转移蛋白结合,在体内循环。与转移蛋白结合的铁在骨髓中被结合到红细胞中,用于血红蛋白合成。
2. 增加血清铁而不受胃酸分泌的影响
在健康的大鼠和兔子以及贫血的兔子中,这种药物表现出与硫酸铁水合物或富马酸铁几乎相同的血清铁上升效应。 在狗中,该剂在餐后给药中表现出血清铁的上升。
此外,这种药物的血清铁上升效应在抑制胃酸分泌的大鼠中也观察到,相对不易受到胃酸的影响。
3. 通过恢复血红蛋白和储存铁改善贫血状况
在缺铁饮食中饲养的出血性贫血大鼠,在连续施用18天后,对30mg/kg/天进行这种药物30mg/kg/天,观察到明显的血红蛋白恢复效果。此外,与对照相比,肝脏和脾脏中的铁含量显著增加,观察到储存铁的补充效果。此外,血清铁和血清铁饱和度的降低和总铁结合能力的提高得到了提高。
适应症
缺铁性贫血
用法与用量
片剂 50mg
通常成人每天口服100-200mg(2-4片)作为铁,分1-2次口服。
此外,年龄,适当增加或减少症状。
颗粒 8.3%
通常成人每天口服100-200mg(1.2至2.4克)作为铁,分为1至2次。
此外,年龄,适当增加或减少症状。
临床结果
临床效果
在缺铁性贫血的一般临床试验中,贫血症状(疲劳、心绞痛、呼吸急促、头晕)的改善,以及外周血学发现(血红蛋白、血清铁、TIBC、血清铁蛋白、红细胞计数、血球蛋白值)的改善。
血红蛋白浓度的改善和有用程度,每天200mg给药组明显高于每天100mg给药组,在片剂和颗粒的比较中,血红蛋白浓度增加效应,对贫血症状的影响均无差异。
此外,该剂通过双盲试验获得有用性。
在如何进行药物使用结果调查的试点研究中,对545例孕妇和非孕妇的副作用表达频率进行了比较,发现无差异。
此外,对胎儿和新生儿进行跟踪调查,发现使用结果调查没有特别问题。
此外,还进行了试点研究,以比较老年人和非老年人的副作用表达频率。在受试者1,254例中,比较了60岁以上和60岁以下的副作用,两组按性别表达率的差异未观察到。然而,在性别方面,妇女的频率很高。
包装
片剂
50mg: 100片(PTP)、500片(PTP 瓶)、1000片(PTP)
颗粒 8.3%:
100g、500g、720g (1.2gx2x300)
制造分销商
Sannova Corporation
销售
卫材有限公司
注:以上中文资料不够完整,使用者以原处方资料为准。
完整资料附件:
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/331552_3222013D1059_2_01
Ferromia Granules 8.3%(Sodium ferrous citrate)
Brand name :Ferromia Granules 8.3%
 Active ingredient:
Sodium ferrous citrate
 Dosage form:
greenish white to green-yellowish white granule
 Print on wrapping:
(Face) フェロミア顆粒8.3%, 100mg(鉄として)/1包(1.2g)
(Back) Ferromia
Effects of this medicine
This medicine restores the low or depleted iron stores to the normal level and ameliorates the anemia. Iron absorbed in the intestine is bound by transferrin and circulated throughout the body in the transferrin-bound form. Iron is taken up by the erythroblasts and utilized for the synthesis of hemoglobin in the bone marrow.
It is usually used for treatment of iron deficiency anemia.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions(itch, rash, etc)to any medicines.
If you have gastric/duodenal ulcer, ulcerative colitis or Crohn's disease.
If your urine in the morning is dark reddish brown (paroxysmal nocturnal hemoglobinuria) .
If you are pregnant or breastfeeding.
If you are taking any other medicinal products(Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is((to be written by a healthcare professional))
In general, for adults, take 1.2 to 2.4 g granules(100 to 200 mg as iron) per day in one or two divided doses postprandially, to be adjusted depending on severity of symptoms or age. Strictly follow the instructions.
If you miss a dose, take the missed dose as soon as possible.If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
If you find your stool black after taking this medicine, take it as usual, because the blackish color is attributed to iron compounds. But if you have had abdominal pain before you find your stool black or tarry, as may be the symptoms of gastrointestinal bleeding, consult your doctor/pharmacist.
If you notice your teeth to be stained with dark brown, brush them with a small amount of baking soda.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, itchiness, photosensitivity, nausea, vomiting, upper abdominal discomfort, heartburn, diarrhea and dizziness. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep this medicine out of the reach of children and away from light, heat and moisture.
If you have leftover medicines, dispose of them appropriately and do not keep any unused medicine.
Internal
Revised: 3/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. 

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