EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Rising Pharma Holdings, Inc., d/b/a Rising Pharmaceuticals, Inc. (“Rising”) announced commercial availability of Edetate calcium disodium injection. Access to Rising’s product continues despite a commercial shortage of this product in the United States.

新泽西州东布伦瑞克（商业新闻短讯）--瑞星制药控股有限公司（Rising Pharma Holdings，Inc.），d/b/a瑞星制药有限公司（Rising Pharmaceuticals，Inc.）（“瑞星”）宣布了依地酸钙二钠注射液的商业可用性。尽管Rising的产品在美国商业上短缺，但仍然可以继续获得该产品。

Rising’s Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults.

瑞星的依地酸钙二钠注射液用于降低儿童和成人铅中毒（急性和慢性）和铅脑病的血液水平和铅储存量。

“Rising’s Edetate calcium disodium injection provides an available option for health care providers to treat patients exposed to lead poisoning,' said David Picard, Executive Vice President for Institutional Markets at Rising. 'This continued availability reflects our ongoing commitment to addressing product supply shortages to help ensure health care providers have access to products for patient care.”.

瑞星负责机构市场的执行副总裁大卫·皮卡德（DavidPicard）表示：“瑞星的依地酸钙二钠注射液为医疗保健提供者治疗铅中毒患者提供了一种可用的选择。这种持续的可用性反映了我们正在致力于解决产品供应短缺问题，以帮助确保医疗保健提供者能够获得用于患者护理的产品。”。

Edetate Calcium Disodium injection, USP

依地酸二钠钙注射液

5 mL single-dose vial containing 200 mg of

5毫升单剂量小瓶，含200毫克

edetate calcium disodium per mL (1000 mg per vial)

依地酸二钠钙/mL（每瓶1000mg）

Supplied in boxes containing 5 vials (NDC 64980-588-51)

装在装有5个小瓶的盒子中（NDC 64980-588-51）

Wholesale Item Numbers

批发商品编号

Cardinal

红衣主教

5855416

5855416

Cencora

5

10291753

10291753

Mckesson

麦凯松

2830826

2830826

Morris Dickson

莫里斯·迪克森

296285

296285

___________________________

___________________________

1 Full prescribing information and label available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22&type=display and provided below.

1完整的处方信息和标签可在https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22&type=显示器，如下所示。

About Rising Pharmaceuticals, Inc.

关于Rising Pharmaceuticals，Inc。

Rising Pharmaceuticals, Inc. is a leading provider of generic and specialty-branded pharmaceuticals in the U.S. Rising focuses on the development, regulatory, and commercial aspects of the product life cycle while outsourcing manufacturing to its network of strategic CMO and CDO partners.

Rising Pharmaceuticals，Inc.是美国通用和专业品牌药品的领先供应商。Rising专注于产品生命周期的开发、监管和商业方面，同时将制造外包给其战略CMO和CDO合作伙伴网络。

With over 182 commercialized generic medicines and over 620 active SKUs, Rising has one of the largest portfolios of any generic pharmaceutical company in the US market. Through an extensive global network of manufacturing facilities, Rising supplies almost 9 billion doses of generic medicine to the market annually..

瑞星拥有182多种商业化仿制药和620多种活跃SKU，是美国市场上所有仿制药公司中投资组合最大的公司之一。通过广泛的全球制造设施网络，Rising每年向市场供应近90亿剂仿制药。。

The Company is based in New Brunswick, New Jersey. For more information about the Company, please visit www.risingpharma.com.

该公司总部位于新泽西州新不伦瑞克。有关该公司的更多信息，请访问www.risingpharma.com。

Edetate Calcium Disodium Injection, USP

依地酸二钠钙注射液

Intravenous or Intramuscular Use

静脉注射或肌肉注射

Rx Only

WARNINGS

Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high. Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients.

依地酸钙二钠注射液能够产生致命的毒性作用。铅脑病在成人中相对罕见，但在儿科患者中更常见，因为这些患者可能是早期的，因此被忽视。儿科患者的死亡率一直很高。铅脑病和脑水肿患者在静脉输注后可能会出现致命的颅内压升高；这些患者首选肌内途径。

In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded..

如果需要静脉途径，避免快速输注。应遵循剂量表，任何时候都不得超过推荐的每日剂量。。

DESCRIPTION

描述

Edetate Calcium Disodium injection, USP is a sterile, injectable, chelating agent in concentrated solution for intravenous infusion or intramuscular injection. Each 5 mL single-dose vial contains 1000 mg of edetate calcium disodium (equivalent to 200 mg/mL) in water for injection and sodium hydroxide (as pH adjuster).

依地酸钙二钠注射液，USP是一种无菌、可注射的浓缩溶液中的螯合剂，用于静脉输注或肌内注射。每个5毫升单剂量小瓶在注射用水和氢氧化钠（作为pH调节剂）中含有1000毫克依地酸二钠钙（相当于200毫克/毫升）。

Chemically, this product is called [[N,N'-1,2-ethanediyl-bis[N-(carboxymethyl)-glycinato]](4-)-N,N',O,O',ON,ON']-, disodium, hydrate, (OC-6-21)-Calciate(2-)..

化学上，该产物称为[[N，N'-1,2-乙二酰基-双[N-（羧甲基）-甘氨酸]]（4-）-N，N'，O，O'，ON，ON']-，二钠，水合物，（OC-6-21）-方解石（2-）。。

CLINICAL PHARMACOLOGY

临床药理学

The pharmacologic effects of edetate calcium disodium are due to the formation of chelates with divalent and trivalent metals. A stable chelate will form with any metal that has the ability to displace calcium from the molecule, a feature shared by lead, zinc, cadmium, manganese, iron and mercury. The amounts of manganese and iron mobilized are not significant.

依地酸钙二钠的药理作用是由于与二价和三价金属形成螯合物。任何能够从分子中置换钙的金属都会形成稳定的螯合物，这是铅、锌、镉、锰、铁和汞共有的特征。锰和铁的动员量并不显着。

Copper1 is not mobilized and mercury is unavailable for chelation because it is too tightly bound to body ligands or it is stored in inaccessible body compartments. The excretion of calcium by the body is not increased following intravenous administration of edetate calcium disodium, but the excretion of zinc is considerably increased.1.

铜1没有被动员，汞不能用于螯合，因为它与身体配体的结合太紧，或者它被储存在不可接近的身体隔室中。静脉注射依地酸钙二钠后，体内钙的排泄量没有增加，但锌的排泄量显着增加。

Edetate calcium disodium is poorly absorbed from the gastrointestinal tract. In blood, all the drug is found in the plasma. Edetate calcium disodium does not appear to penetrate cells; it is distributed primarily in the extracellular fluid with only about 5% of the plasma concentration found in spinal fluid..

依地酸钙二钠从胃肠道吸收不良。在血液中，所有药物都存在于血浆中。依地酸钙二钠似乎不穿透细胞；它主要分布在细胞外液中，只有脊髓液中血浆浓度的约5%。。

The half life of edetate calcium disodium is 20 to 60 minutes. It is excreted primarily by the kidney, with about 50% excreted in one hour and over 95% within 24 hours.2 Almost none of the compound is metabolized.

依地酸钙二钠的半衰期为20至60分钟。。

The primary source of lead chelated by edetate calcium disodium is from bone; subsequently, soft-tissue lead is redistributed to bone when chelation is stopped.3,4 There is also some reduction in kidney lead levels following chelation therapy.

依地酸钙二钠螯合的铅的主要来源是骨骼；随后，当螯合停止时，软组织铅被重新分配到骨骼中。螯合治疗后肾铅水平也有所降低。

It has been shown in animals that following a single dose of edetate calcium disodium urinary lead output increases, blood lead concentration decreases, but brain lead is significantly increased due to internal redistribution of lead.5 (See WARNINGS.) These data are in agreement with the recent results of others in experimental animals showing that after a five day course of treatment there is no net reduction in brain lead.6.

在动物中已经表明，单剂量依地酸钙二钠尿铅输出增加后，血铅浓度降低，但由于铅的内部重新分布，脑铅显着增加。5（见警告）。这些数据与其他实验动物最近的结果一致，表明在五天的疗程后，脑铅没有净减少。

INDICATIONS AND USAGE

适应症和用法

Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults.

依地酸钙二钠注射液适用于降低儿科人群和成人铅中毒（急性和慢性）和铅脑病中铅的血液水平和储存量。

Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.

螯合疗法不应取代消除或减少铅进一步暴露的有效措施。

CONTRAINDICATIONS

禁忌症

Edetate calcium disodium injection should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.

依地酸钙二钠注射液不应在无尿期间使用，也不应用于活动性肾脏疾病或肝炎患者。

WARNINGS

警告

See boxed warning.

请参阅盒装警告。

PRECAUTIONS

注意事项

General Precautions

一般注意事项

Edetate calcium disodium may produce the same renal damage as lead poisoning, such as proteinuria and microscopic hematuria. Treatment-induced nephrotoxicity is dose-dependent and may be reduced by assuring adequate diuresis before therapy begins. Urine flow must be monitored throughout therapy which must be stopped if anuria or severe oliguria develop.

依地酸钙二钠可能产生与铅中毒相同的肾损伤，如蛋白尿和镜下血尿。治疗引起的肾毒性是剂量依赖性的，可以通过在治疗开始前确保充分的利尿来减少。在整个治疗过程中必须监测尿流，如果出现无尿或严重少尿，必须停止尿流。

The proximal tubule hydropic degeneration usually recovers upon cessation of therapy. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Patients should be monitored for cardiac rhythm irregularities and other ECG changes during intravenous therapy..

近端小管水肿变性通常在停止治疗后恢复。对于先前存在轻度肾脏疾病的患者，必须减少剂量使用依地酸钙二钠。静脉治疗期间应监测患者的心律失常和其他心电图变化。。

Information for patients

患者信息

Patients should be instructed to immediately inform their physician if urine output stops for a period of 12 hours.

如果尿量停止12小时，应指示患者立即通知医生。

Laboratory tests

实验室测试

Urinalysis and urine sediment, renal and hepatic function and serum electrolyte levels should be checked before each course of therapy and then be monitored daily during therapy in severe cases, and in less serious cases after the second and fifth day of therapy. Therapy must be discontinued at the first sign of renal toxicity.

在每个疗程之前应检查尿液分析和尿沉渣，肾功能和肝功能以及血清电解质水平，然后在严重病例的治疗期间每天监测，在治疗的第二天和第五天之后，在不太严重的病例中每天监测。在出现肾毒性的第一个迹象时，必须停止治疗。

The presence of large renal epithelial cells or increasing number of red blood cells in urinary sediment or greater proteinuria call for immediate stopping of edetate calcium disodium administration. Alkaline phosphatase values are frequently depressed (possibly due to decreased serum zinc levels), but return to normal within 48 hours after cessation of therapy.

尿沉渣中存在大量肾上皮细胞或红细胞数量增加或蛋白尿增多，需要立即停止依地酸钙二钠给药。碱性磷酸酶值经常降低（可能是由于血清锌水平降低），但在停止治疗后48小时内恢复正常。

Elevated erythrocyte protoporphyrin levels (> 35 mcg/dl of whole blood) indicate the need to perform a venous blood lead determination. If the whole blood lead concentration is between 25 to 55 mcg/dl a mobilization test can be considered.7,8 (See Diagnostic Test.) An elevation of urinary coproporphyrin (adults: > 250 mcg/day; pediatric patients under 80 lbs: > 75 mcg/day) and elevation of urinary delta aminolevulinic acid (ALA) (adults: > 4 mg/day; pediatric patients: > 3 mg/m2/day) are associated with blood lead levels > 40 mcg/dl.

红细胞原卟啉水平升高（全血>35 mcg/dl）表明需要进行静脉血铅测定。如果全血铅浓度在25至55微克/分升之间，可以考虑进行动员试验。7,8（见诊断试验）。尿粪卟啉升高（成人：>250微克/天；80磅以下的儿科患者：>75微克/天）和尿δ-氨基乙酰丙酸（ALA）升高（成人：>4毫克/天；儿科患者：>3毫克/平方米/天）与血铅水平>40微克/分升有关。

Urinary coproporphyrin may be falsely negative in terminal patients and in severely iron-depleted pediatric patients who are not regenerating heme.9 In growing pediatric patients long bone x-rays showing lead lines and abdominal x-rays showing radio-opaque material in the abdomen may be of help in estimating the level of exposure to lead..

尿粪卟啉在终末期患者和严重缺铁且未再生血红素的儿科患者中可能呈假阴性。9在生长中的儿科患者中，显示引线的长骨x射线和显示腹部不透光物质的腹部x射线可能有助于估计铅的暴露水平。。

Drug Interactions

药物相互作用

There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of edetate calcium disodium in animals.7 Edetate calcium disodium interferes with the action of zinc insulin preparations by chelating the zinc.7

没有已知的药物干扰标准临床实验室测试。类固醇增强了依地酸钙二钠对动物的肾毒性。7依地酸钙二钠通过螯合锌来干扰锌-胰岛素制剂的作用。7

Carcinogenesis, Mutagenesis, Impairment of Fertility

致癌、突变、生育能力受损

Long term animal studies have not been conducted with edetate calcium disodium to evaluate its carcinogenic potential, mutagenic potential or its effect on fertility.

尚未对依地酸钙二钠进行长期动物研究，以评估其致癌潜力，诱变潜力或对生育能力的影响。

Pregnancy

怀孕

Category B

B类

One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to edetate calcium disodium.10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to edetate calcium disodium, which were prevented by simultaneous supplementation of dietary zinc.11 There are, however, no adequate and well-controlled studies in pregnant women.

一项生殖研究是在大鼠中进行的，剂量高达人类剂量的13倍，没有发现由于依地酸钙二钠而导致生育能力受损或对胎儿造成伤害的证据.10另一项生殖研究在大鼠中进行，剂量高达人类剂量的25至40倍，揭示了依地酸钙二钠导致胎儿畸形的证据，这可以通过同时补充膳食锌来预防.11然而，在孕妇中没有足够且控制良好的研究。

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed..

由于动物繁殖研究并不总是能预测人类的反应，因此只有在明确需要的情况下才能在怀孕期间使用这种药物。。

Labor and Delivery

劳动力和交付

Edetate calcium disodium has no recognized use during labor and delivery, and its effects during these processes are unknown.

依地酸钙二钠在分娩和分娩过程中没有公认的用途，其在这些过程中的作用尚不清楚。

Nursing Mothers

哺乳期母亲

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when edetate calcium disodium is administered to a nursing woman.

目前尚不清楚这种药物是否在母乳中排泄。由于许多药物是从母乳中排出的，因此给哺乳期妇女服用依地酸二钠钙时应谨慎。

Pediatric Use

儿科使用

Since lead poisoning occurs in pediatric populations and adults but is frequently more severe in pediatric patients, edetate calcium disodium is used in patients of all ages. The intramuscular route is preferred by some for young pediatric patients. In cases where the intravenous route is necessary, avoid rapid infusion.

。一些年轻儿科患者首选肌内途径。如果需要静脉途径，避免快速输注。

(See WARNINGS.) Urine flow must be monitored throughout therapy; Edetate Calcium Disodium therapy must be stopped if anuria or severe oliguria develops. (See General Precautions.) At no time should the recommended daily dosage be exceeded. (See DOSAGE AND ADMINISTRATION.).

（见警告。）在整个治疗过程中必须监测尿流量；如果出现无尿或严重少尿，必须停止依地酸钙二钠治疗。。（参见剂量和给药）。

ADVERSE REACTIONS

不良反应

The following adverse effects have been associated with the use of edetate calcium disodium:

以下不良反应与使用依地酸钙二钠有关：

Body as a Whole: pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia.

全身：肌肉注射部位疼痛、发热、寒战、不适、疲劳、肌痛、关节痛。

Cardiovascular: hypotension, cardiac rhythm irregularities.

心血管疾病：低血压，心律失常。

Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli.

肾脏：近端小管急性坏死（可能导致致命性肾病），远端小管和肾小球罕见变化。

Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment.

尿：糖尿、蛋白尿、镜下血尿和尿沉渣中的大上皮细胞。

Nervous System: tremors, headache, numbness, tingling.

神经系统：震颤、头痛、麻木、刺痛。

Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst.

胃肠道：口臭、恶心、呕吐、厌食、口渴。

Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy.

肝脏：SGOT和SGPT轻度升高是常见的，并且在停止治疗后48小时内恢复正常。

Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash.

免疫原性：组胺样反应（打喷嚏，鼻塞，流泪），皮疹。

Hematopoietic: transient bone marrow depression, anemia.

造血：短暂性骨髓抑制，贫血。

Metabolic: zinc deficiency, hypercalcemia.

。

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告疑似不良反应，请联系Rising Pharma Holdings，Inc.，电话1-844-874-7464或FDA，电话1-800-FDA-1088或www.FDA.gov/medwatch。

OVERDOSAGE

过量服用

Symptoms

症状

Inadvertent administration of 5 times the recommended dose, infused intravenously over a 24 hour period, to an asymptomatic 16 month old patient with a blood lead content of 56 mcg/dl did not cause any ill effects. Edetate calcium disodium can aggravate the symptoms of severe lead poisoning, therefore, most toxic effects (cerebral edema, renal tubular necrosis) appear to be associated with lead poisoning.

对于血铅含量为56 mcg/dl的无症状16个月大的患者，在24小时内静脉输注，无意中给予推荐剂量的5倍，并未引起任何不良反应。依地酸钙二钠可加重严重铅中毒的症状，因此，大多数毒性作用（脑水肿，肾小管坏死）似乎与铅中毒有关。

Because of cerebral edema, a therapeutic dose may be lethal to an adult or a pediatric patient with lead encephalopathy. Higher dosage of edetate calcium disodium may produce a more severe zinc deficiency..

由于脑水肿，治疗剂量可能对成人或小儿铅脑病患者致命。较高剂量的依地酸钙二钠可能会导致更严重的缺锌。。

Treatment

治疗

Cerebral edema should be treated with repeated doses of mannitol. Steroids enhance the renal toxicity of edetate calcium disodium in animals and, therefore, are no longer recommended.7 Zinc levels must be monitored. Good urinary output must be maintained because diuresis will enhance drug elimination.

脑水肿应反复服用甘露醇。类固醇会增强依地酸钙二钠对动物的肾毒性，因此不再推荐使用。7必须监测锌水平。必须保持良好的尿量，因为利尿会增强药物的消除。

It is not known if edetate calcium disodium is dialyzable..

目前尚不清楚依地酸钙二钠是否可透析。。

DOSAGE AND ADMINISTRATION

剂量和给药

When a source for the lead intoxication has been identified, the patient should be removed from the source, if possible. The recommended dose of edetate calcium disodium for asymptomatic adults and pediatric patients whose blood lead level is < 70 mcg/dl but > 20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m2/day whether given intravenously or intramuscularly.

当确定铅中毒的来源时，如果可能的话，应将患者从来源中移除。对于血铅水平<70 mcg/dl但>20 mcg/dl（世界卫生组织推荐的允许上限）的无症状成人和儿科患者，无论是静脉注射还是肌肉注射，依地酸钙二钠的推荐剂量均为1000 mg/m2/天。

(See Surface Area Nomogram.).

（见表面积列线图）。

For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m2 every 24 hours for 5 days for patients with serum creatinine levels of 2 to 3 mg/dl, every 48 hours for 3 doses for patients with creatinine levels of 3 to 4 mg/dl, and once weekly for patients with creatinine levels above 4 mg/dl.

。

These regimens may be repeated at one month intervals.12.

这些方案可能每隔一个月重复一次。

Edetate calcium disodium, used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is > 70 mcg/dl or clinical symptoms consistent with lead poisoning are present, it is recommended that edetate calcium disodium be used in conjunction with BAL (dimercaprol).

单独使用依地酸钙二钠可能会加重血铅水平非常高的患者的症状。当血铅水平>70 mcg/dl或存在与铅中毒一致的临床症状时，建议将依地酸钙二钠与BAL（二巯基脯氨酸）联合使用。

Please consult published protocols and specialized references for dosage recommendations of combination therapy.14-18.

有关联合治疗的剂量建议，请参阅已发布的方案和专门参考文献14-18。

Therapy of lead poisoning in adults and pediatric patients with edetate calcium disodium is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug..

成人和小儿依地酸钙二钠铅中毒的治疗持续了五天。然后中断治疗2至4天，以使铅重新分布，并防止锌和其他必需金属的严重消耗。通常采用两个疗程；然而，这取决于铅毒性的严重程度和患者对药物的耐受性。。

Edetate calcium disodium is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients.

依地酸钙二钠无论是静脉注射还是肌肉注射都同样有效。肌内途径适用于所有明显铅性脑病患者，一些年轻儿科患者首选这种途径。

Acutely ill individuals may be dehydrated from vomiting. Since edetate calcium disodium is excreted almost exclusively in the urine, it is very important to establish urine flow with intravenous fluid administration before the first dose of the chelating agent is given; however, excessive fluid must be avoided in patients with encephalopathy.

急性病患者可能因呕吐而脱水。由于依地酸钙二钠几乎完全在尿液中排泄，因此在给予第一剂螯合剂之前，通过静脉内液体给药建立尿流是非常重要的；然而，脑病患者必须避免过量的液体。

Once urine flow is established, further intravenous fluid is restricted to basal water and electrolyte requirements. Administration of edetate calcium disodium should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease..

一旦尿流建立，进一步的静脉输液仅限于基础水和电解质需求。每当停止尿流时，应停止服用依地酸钙二钠，以避免药物的组织水平过高。对于先前存在轻度肾脏疾病的患者，必须减少剂量使用依地酸钙二钠。。

Intravenous Administration

静脉注射给药

Add the total daily dose of edetate calcium disodium (1000 mg/m2/day) to 250-500 mL of 5% dextrose or 0.9% sodium chloride injection. The total daily dose should be infused over a period of 8 to 12 hours. Discard unused portion. Edetate calcium disodium injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, one-sixth molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride..

将每日总剂量的依地酸钙二钠（1000毫克/平方米/天）加入250-500毫升的5%葡萄糖或0.9%氯化钠注射液中。每日总剂量应在8至12小时内输注。丢弃未使用的部分。依地酸钙二钠注射液与0.9%氯化钠中的10%葡萄糖、10%转化糖、乳酸林格、林格、六分之一摩尔乳酸钠注射液以及可注射两性霉素B和盐酸肼苯哒嗪不相容。。

Intramuscular Administration

肌内给药

The total daily dosage (1000 mg/m2/day) should be divided into equal doses spaced 8 to 12 hours apart. Discard unused portion. Lidocaine or procaine should be added to the edetate calcium disodium injection to minimize pain at the injection site. The final lidocaine or procaine concentration of 5 mg/mL (0.5%) can be obtained as follows: 0.25 mL of 10% lidocaine solution per 5 mL concentrated edetate calcium disodium; 1 mL of 1% lidocaine or procaine solution per mL of concentrated edetate calcium disodium.

每日总剂量（1000毫克/平方米/天）应分成相等的剂量，间隔8至12小时。丢弃未使用的部分。利多卡因或普鲁卡因应加入依地酸钙二钠注射液中，以尽量减少注射部位的疼痛。；每毫升浓缩依地酸钙二钠1毫升1%利多卡因或普鲁卡因溶液。

When used alone, regardless of method of administration, edetate calcium disodium should not be given at doses larger than those recommended..

单独使用时，无论使用何种给药方法，依地酸钙二钠的剂量均不应大于推荐剂量。。

Diagnostic Test

诊断测试

Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores.7, 9,12,13,18

已经描述了几种使用依地酸钙二钠进行铅动员试验以评估身体储存的方法。7、9、12、13、18

These procedures have advantages and disadvantages that should be reviewed in current references. Edetate calcium disodium mobilization tests should not be performed in symptomatic patients and in patients with blood lead levels above 55 mcg/dl for whom appropriate therapy is indicated.

这些程序有优点和缺点，应在当前参考文献中进行审查。对于有症状的患者和血铅水平高于55 mcg/dl且需要适当治疗的患者，不应进行依地酸钙二钠动员试验。

Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

只要溶液和容器允许，应在给药前目视检查肠胃外药物的颗粒物质和变色。

HOW SUPPLIED

供应方式

Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC 64980-588-05) containing 200 mg of edetate calcium disodium per mL (1000 mg per vial), in boxes containing 5 vials (NDC 64980-588-51).

依地酸钙二钠注射液，USP 5毫升单剂量小瓶（NDC 64980-588-05），每毫升含200毫克依地酸钙二钠（每瓶1000毫克），装在装有5瓶（NDC 64980-588-51）的盒子中。

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

储存于25°C（77°F）；。

Rx Only

仅接收

This product is non-returnable.

本产品不可退货。

REFERENCES

参考文献

1. Thomas DJ, Chisolm JJ. Lead, zinc and copper decorporation during calcium disodium ethylene diamine tetraacetate treatment of lead-poisoned children. J Pharmacol Exp Therapeu 1986; 239: 829–835.

托马斯DJ，Chisolm JJ。乙二胺四乙酸钙二钠治疗铅中毒儿童过程中铅、锌和铜的去除。J Pharmacol Exp Therapeu 1986；239:829-835。

2. The Pharmacological Basis of Therapeutics, 7th edition, Goodman and Gilman, editors. MacMillan Publishing Company, New York, 1985, pp. 1619–1622.

2、《治疗学的药理学基础》，第7版，古德曼和吉尔曼，编辑。麦克米伦出版公司，纽约，1985年，第1619-1622页。

3. Hammond PB, Aronson AL, Olson WC. The mechanism of mobilization of lead by ethylenediaminetetraacetate. J Pharmacol Exp Therapeu 1967; 157: 196–206.

3.Hammond PB，Aronson AL，Olson WC。乙二胺四乙酸动员铅的机制。J Pharmacol Exp Therapeu 1967；。

4. Van deVyver FL, D'Haese PC, Visser WJ, et al. Bone lead in dialysis patients. Kidney Intl 1988; 33: 601–607.

4.Van deVyver FL，D'Haese PC，Visser WJ等。透析患者的骨铅。肾脏国际1988；33:601-607。

5. Cory-Slecta DA, Weiss B, Cox C. Mobilization and redistribution of lead over the course of calcium disodium ethylene diamine tetraacetate chelation therapy. J Pharmacol Exp Therapeu 1987; 243: 804–813.

5.Cory Slecta DA，Weiss B，Cox C.乙二胺四乙酸钙二钠螯合疗法过程中铅的动员和重新分布。J Pharmacol Exp Therapeu 1987；243:804-813。

6. Chisolm JJ. Mobilization of lead by calcium disodium edetate. Am J Dis Child 1987;141: 1256–1257.

6、Chisolm JJ。依地酸二钠钙动员铅。Am J Dis Child 1987；141年：1256年至1257年。

7. Drug Evaluations, 6th Edition, American Medical Association, Saunders, Philadelphia, 1986, pp. 1637–1639.

7、《药物评估》，第6版，美国医学会，桑德斯，费城，1986年，第1637-1639页。

8. Centers for Disease Control: Preventing lead poisoning in young children. Atlanta, GA, Department of Health and Human Services, 1985 Jan.

疾病控制中心：预防幼儿铅中毒。佐治亚州亚特兰大，卫生与公众服务部，1985年1月。

9. Finberg L, Rajagopal V. Diagnosis and treatment of lead poisoning in children. J Family Med 1985 April: 3–12.

9.Finberg L，Rajagopal V.儿童铅中毒的诊断和治疗。J Family Med 1985年4月：3-12日。

10. Schardein JL, Sakowski R, Petrere J, et al. Teratogenesis studies with EDTA and its salts in rats. Toxicol Appl Pharmacol 1981; 61: 423–428.

10.Schardein JL，Sakowski R，Petrere J等。EDTA及其盐在大鼠体内的致畸作用研究。Toxicol Appl Pharmacol 1981；61:423–428。

11. Swenerton H, Hurley LS. Teratogenic effects of a chelating agent and their prevention by zinc. Science 1971; 173: 62–64.

。科学1971；173分：62-64分。

12. American Hospital Formulary Service, Drug Information, 1988, pp. 1695–1698.

12、《美国医院处方集服务》，药物信息，1988年，第1695-1698页。

13. Markowitz ME, Rosen JF. Assessment of lead stores in children: Validation of an 8-hour CaNa2EDTA (Edetate Calcium Disodium) provocative test. J Pediatrics 1984;104: 337–341.

13.Markowitz ME，Rosen JF。儿童铅储存评估：8小时CaNa2EDTA（依地酸钙二钠）激发试验的验证。J儿科1984；104:337-341。

14. Piomelli S, Rosen JF, Chisolm JJ, et al. Management of childhood lead poisoning. J Pediatrics 1984; 105: 523–532.

14.Piomelli S，Rosen JF，Chisolm JJ等。儿童铅中毒的管理。J儿科1984；105:523-532。

15. Sachs HK, Blanksma LA, Murray EF, et al. Ambulatory treatment of lead poisoning: Report of 1,155 cases. Pediatrics 1970; 46: 389.

Sachs HK，Blanksma LA，Murray EF等。铅中毒的动态治疗：1155例报告。；46分：389分。

16. Chisolm JJ. The use of chelating agents in the treatment of acute and chronic lead intoxication in childhood. J Pediatrics 1968; 73: 1.

16、Chisolm JJ。螯合剂在儿童急性和慢性铅中毒治疗中的应用。J儿科1968；73比1。

17. Coffin R, Phillips JL, Staples WI, et al. Treatment of lead encephalopathy in children. J Pediatrics 1966; 69: 198–206.

17.Coffin R，Phillips JL，Staples WI等。儿童铅脑病的治疗。儿科杂志1966；69:198-206。

18. Chisolm JJ. Increased lead absorption and acute lead poisoning. Current Pediatric Therapy 12, Gillis and Kagan, editors, WB Saunders, Philadelphia, 1986, pp. 667–671.

18、Chisolm JJ。铅吸收增加和急性铅中毒。《当前儿科治疗》12，Gillis和Kagan，编辑，WB Saunders，费城，1986年，第667-671页。

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Rising Pharma Holdings, Inc.

瑞星制药控股有限公司。

East Brunswick, NJ 08816.

新泽西州东布伦瑞克08816。

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