| Product Description: | MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1. |
|---|---|
| Status: | 持续的 |
| 城市： | Lake Forest |
| 状态： | IL |
| Country: | 我们 |
| Voluntary/Mandated: | 自愿：公司发起 |
| 初始公司通知： | 新闻稿 |
| 分销模式： | 全国 |
| 分类： | I级 |
| 产品数量： | 181,704 bags |
| Reason For Recall: | Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection. |
| 记起Initiation Date: | 20150306 |
| Report Date: | 20150520 |
葡萄糖中的硫酸镁
loading ...葡萄糖中的硫酸镁记起
得到一个警报when a recall is issued.
问题和答案
Side Effects & Adverse Reactions
FETAL HARM: Continuous administration of magnesium sulfate beyond 5-7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5-7 days may cause fetal abnormalities.
肠外用途在肾功能不全的情况下可能导致镁中毒。
Legal Issues
目前没有可用于此药物的法律信息。
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
目前还没有生产informa的警告tion available for this drug.
FDA Labeling Changes
目前没有FDA标记可用于此药物的变化。
用途
硫酸镁在5％葡萄糖注射中，USP分别用于预防和控制预坦克西亚和葛兰普斯的癫痫发作。当明智地使用时，它有效地防止了并控制了异国普拉明裔的抽搐，而不会产生母亲或婴儿的中枢神经系统的有害抑制。但是，其他有效的药物可用于此目的。
History
There is currently no drug history available for this drug.
其他信息
Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection. Each 100 mL contains 1 or 2 g magnesium sulfate heptahydrate and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 1% and 2% concentrations. SeeHOW SUPPLIEDsection for the content and characteristics of available dosage forms and sizes.
硫酸镁，USP七水合物是化学指定的MgSO4• 7H2o，无色晶体或白色粉末可自由溶于水。
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6• H2O), a hexose sugar freely soluble in water. It has the following structural formula:
分子量198.17。
注射水，USP在化学上指定H.2O.
柔性塑料容器由特制配制的聚氯乙烯制成。水可以从容器内部渗透到外包装中，但不足以显着影响溶液的量。与塑料容器接触的溶液可以非常少量从塑料中渗出某些化学成分;然而，生物学测试支持塑料容器材料的安全性。在运输和储存过程中暴露于25℃/ 77°F以上的温度将导致水分含量的轻微损失。较高的温度导致更大的损失。这些轻微损失不太可能导致到期期内的临床显着变化。
Sources
葡萄糖制造商硫酸镁
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Hospira，Inc。
![葡萄糖中的硫酸镁（硫酸镁七水合物）注射，溶液[Hospira，Inc。]](//www.lbxkm.com/wp-content/themes/bootstrap/assets/img/loading2.gif)
葡萄糖中的硫酸镁| Hospira, Inc.
硫酸镁在5％葡萄糖注射中，USP仅用于静脉内使用。对于普通普拉明血症或异丙磷松的管理，通常与50％硫酸镁注射液，USP的颗粒注射液相同给予镁的稀释溶液（1％至8％）的静脉注入。因此，在下面引用的临床条件下，应酌情注意两种疗法。
Continuous maternal administration of magnesium sulfate in pregnancy beyond 5-7 days can cause fetal abnormalities.
In Eclampsia
In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g of Magnesium Sulfate in 5% Dextrose Injection, USP may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 7.5 mL of a 2% concentration (or its equivalent) per minute, except in severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% Magnesium Sulfate Injection, USP. After the initial I.V. dose, some clinicians administer 1-2 g/hour by constant I.V. infusion.
Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity. Therapy should continue until paroxysms cease.
对于对癫痫发作的控制，血清镁水平为6mg / 100ml。不应超过每日每天（24小时）剂量为30-40g硫酸镁。在存在严重的肾功能不全，必须获得频繁的血清镁浓度，并且每48小时硫酸镁的最大推荐剂量为20克。
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer unless solution is clear. Discard unused portion.
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