American Regent Introduces Sodium Phosphates Injection, USP; FDA-Approved and "AP" Rated1
American Regent Introduces Sodium Phosphates Injection, USP; FDA-Approved and "AP" Rated1
SHIRLEY, N.Y., July 2, 2024 /PRNewswire/ -- American Regent announces the launch and availability of Sodium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Sodium Phosphates.1 Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
2024年7月2日，美國睿吉公司宣佈推出並提供美國食品藥品監督管理局批准的等效於磷酸鈉的注射液，USP。.1磷酸鈉注射液 USP 3 mM P/mL 可用作補充靜脈大容量液的磷源，以預防或糾正限制或無口服攝入患者的低磷血癥。當患者的需要無法通過標準電解質或營養液滿足時，它還有用於製備特定的腸外營養液配方。
The concomitant amount of sodium
(Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
在製備這類溶液的總電解質劑量中，應計入同時攝入的鈉離子（Na+）的量。
（Na+ 4 mEq/mL）+鈉磷酸鹽在高磷或低鈣水平可能出現的疾病以及高鈉血癥患者中禁忌使用。
Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
在存在高磷或低鈣水平的疾病以及高鈉血癥的患者中，磷酸鈉禁忌使用。
"An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Sodium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc.
睿吉公司首席商務官兼副總裁Joann Gioia表示:“我們公司的使命之一是在可能的情況下，協助減輕藥品短缺問題，確保關鍵藥品的供應。爲此，我們很高興將磷酸鈉注射液 USP 添加到我們堅實流暢的產品線中，這些產品均在我們的美國製造工廠裏製備，灌裝和完成。”
This product is available for immediate shipment. Customers can order Sodium Phosphates Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.
該產品可立即發貨。客戶可以通過其批發商/經銷商或聯繫我們的客戶支持組1-800-645-1706訂購磷酸鈉注射液 USP。磷酸鈉注射液 USP顧客可以通過其批發商/經銷商訂購磷酸鈉注射液 USP,或聯繫我們的客戶支持組1-800-645-1706。.
Sodium Phosphates Injection, USP is supplied as follows:
磷酸鈉注射液 USP如下：
|
NDC# |
Strength Pack |
Supplied as |
Shelf pack |
|
0517-7305-25 |
15 mM P/5 mL (3 mM P/mL) |
5 mL |
25 |
|
0517-7315-25 |
45 mM P/15 mL (3 mM P/mL) |
15 mL |
25 |
|
0517-7350-25 |
150 mM P/50 mL (3 mM P/mL) |
50 mL |
25 |
|
NDC# |
Strength Pack |
集裝量 |
貨架包裝 |
|
0517-7305-25 |
15 mM P/5 mL (3 mM P/mL)，含20 mEq Na+/5 mL (4 mEq/mL) |
5毫升 |
25 |
|
0517-7315-25 |
每15毫升45毫摩爾磷(每毫升3毫摩爾磷) |
15毫升 |
25 |
|
0517-7350-25 |
每50毫升150毫摩爾磷(每毫升3毫摩爾磷) |
50毫升 |
25 |
See the following Important Safety Information, in addition to the product's Full Prescribing Information.
For additional information, please visit
請注意下面的重要安全信息，除了產品的完整處方信息。
獲取更多信息，請訪問
FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS
僅適用於在靜脈輸液液體中稀釋後添加使用
INDICATIONS AND USAGE
Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
LINZESS（linaclotide）適用於治療成人腸易激綜合徵伴便秘（IBS-C）和慢性特發性便秘（CIC），以及6至17歲兒童和青少年的便秘功能障礙（FC）。不知道LINZESS在年齡小於6歲的FC兒童或IBS-C小於18歲的患者中是否安全和有效。
美國藥典鈉磷酸鹽注射液，每毫升3毫摩爾磷，適用於大劑量靜脈注射液中添加磷，以預防或糾正攝入受限或無法口服的低磷血癥患者。當標準電解質或營養液溶液無法滿足患者需要時，此藥可作爲添加劑使用。
The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
這些配好的溶液的總電解質劑量必須考慮鈉(每毫升4毫當量)的同時加入量。+鈉磷酸鹽在高磷或低鈣水平可能出現的疾病以及高鈉血癥患者中禁忌使用。
IMPORTANT SAFETY INFORMATION
重要安全信息
CONTRAINDICATIONS
Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
禁忌症
在存在高磷或低鈣水平的疾病以及高鈉血癥的患者中，磷酸鈉禁忌使用。
WARNINGS
Sodium Phosphates Injection, USP 3 mM P/mL must be diluted and thoroughly mixed before use.
警告
使用前必須將USP 3 mM P/mL磷酸鈉注射液稀釋並充分混合。
To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored.
爲避免磷中毒，含有磷酸鈉的溶液應緩慢注入。注入高濃度磷可能會降低血清鈣和導致低鈣性驚厥症狀。應監測鈣水平。
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
如有必要，在擁有水腫和鈉滯留症狀的患者中，應極度小心或儘量避免使用含鈉離子的溶液。
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
對於腎功能減退的患者，使用含鈉離子的溶液可能導致滯留鈉離子。
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
警告：本產品含有可能具有毒性的鋁。如果腎功能受損，則鋁在長期靜脈注射後可能達到有害水平。早產兒特別容易患上鋁中毒，因爲他們的腎臟未發育完全，需要大量含鋁的鈣磷溶液。
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
研究表明，腎功能受損的患者，包括早產兒，接受每天大於4到5微克/千克的靜脈注射鋁，會導致與中樞神經系統和骨骼毒性相關的鋁積聚。即使在更低的注射速率下也可能發生組織負荷。
PRECAUTIONS
Do not administer unless solution is clear and seal is intact. Discard unused portion.
注意事項
僅當溶液清晰無顆粒並且密封完好才能使用，未用部分需丟棄。
Phosphorus replacement therapy with sodium phosphate should be guided primarily by the serum phosphorus level and the limits imposed by the accompanying sodium (Na+) ion.
鈣（Ca）離子會影響磷（P）離子，應以血清磷水平爲主導，考慮鈉離子（Na）。+與腎功能不全、肝硬化、心力衰竭以及其他腫脹或滯留鈉的情況下患者使用時需謹慎。
Use with caution in patients with renal impairment, cirrhosis, cardiac failure, and other edematous or sodium-retaining states.
愛的所有板塊懷疑心患者，腎功能損害患者，肝硬化患者和處於腫脹或鈉瀦留狀態患者的情況下使用含鈉離子的溶液應小心使用。
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
靜脈注射液，尤其是含鈉離子的液體，注射給正在接受皮質類固醇或促腎上腺皮質激素的患者時應小心使用。
Pregnancy: Animal reproduction studies have not been conducted with sodium phosphate. It is also not known whether sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium phosphate should be given to a pregnant woman only if clearly needed.
有關使用BIKTARVY治療妊娠期間的人類數據不足。與另一種整合酶抑制劑多烯伏格雷相關的有神經管缺陷的報道。討論在懷孕和受孕期間使用BIKTARVY的效益風險。已建立抗逆轉錄病毒妊娠登記表。從FTC的APR獲得的可用數據顯示，先前未描述的畸形有與美國參考人群相比毫無差異的出生缺陷率。未進行磷酸鈉的動物繁殖研究。還不知道磷酸鈉是否會對孕婦造成胎兒損害或影響生殖能力。除非確實需要，否則不應給孕婦使用磷酸鈉。
Pediatric Use: The safety and effectiveness of sodium phosphate has been established in pediatric patients (neonates, infants, children, and adolescents).
小兒用量：磷酸鈉的安全性和有效性已在嬰兒、兒童和青少年患者中得到證明。小兒用量：磷酸鈉的安全性和有效性已在嬰兒、兒童和青少年患者中得到證明。
Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
老年用藥：對當前文獻的評估未發現老年患者反應與年輕患者之間的差異。一般而言，應小心給老年患者選擇劑量，通常在劑量範圍的低端開始，反映出肝臟、腎功能或心功能的降低頻率更高以及合併疾病或其他藥物治療的情況。鑑於鈉離子和磷離子經腎臟大量排泄，因此，腎功能受損患者風險高，對該藥物的毒性反應可能更大。由於老年患者腎功能受損的概率更高，因此在劑量選擇方面應謹慎，並且可能有助於監測腎功能。
Sodium ions and phosphorus are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
未發現與磷酸鈉有關的常見不良反應。
ADVERSE REACTIONS
Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany.
不良反應
不良反應包括可能引起的磷中毒。磷中毒導致血清鈣減少，症狀爲低鈣性驚厥。
OVERDOSAGE
In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
過量劑量：如果過量劑量，則應立即停止含磷酸鈉溶液的注入，並採取糾正療法以恢復降低的血清鈣和降低的血清鈉水平。請參閱警告、注意事項和不良反應。
如出現超劑量，則應立即停止含磷酸鈉的輸液，並採取糾正療法以恢復血清鈣的降低以及降低血清鈉水平的達到正常水平。請參閱警告、注意事項和不良反應。
For additional safety information, please see Full Prescribing Information.
有關更多安全信息，請查看 完整處方信息.
You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236, or to the FDA by visiting or by calling 1-800-FDA-1088.
我們鼓勵您向美國公司American Regent Inc.報告藥品不良事件，電話是1-800-734-9236，或通過訪問 或撥打1-800-FDA-1088進行舉報。
You are encouraged to report adverse drug events (ADEs) to American Regent:
T 1.800.734.9236; E [email protected]; F 1.610.650.0170
我們鼓勵您向美國公司American Regent報告藥品不良事件：
T1.800.734.9236; E [email protected]; F1.610.650.0170
ADEs may also be reported to the FDA:
1.800.FDA.1088
or
藥品不良事件也可以向FDA舉報：
1.800.FDA.1088
或
Medical Information:
T 1.888.354.4855
(9:00 am–5:00 pm Eastern Time, Monday–Friday)
醫療信息：
電話：1.888.354.4855
（東部時間 上午9點至下午5點，週一至週五）
For medical information outside of normal business hours
that cannot wait until the next business day, please call 1.877.845.6371
若有醫療信息需詢問，需在正常工作時間外，請撥打電話1.877.845.6371 。
如有緊急情況，請致電1.877.845.6371。
About American Regent
American Regent, Inc., a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy.
關於美國公司American Regent
美國公司American Regent，Inc.是大正製藥集團（Daiichi Sankyo Group）的一家領先製劑製造商。 自50多年以來，美國公司American Regent一直在開發，製造和供應高質量的非專利和品牌主打的製劑製劑以回饋醫療保健工作者，包括近20年的靜脈鐵療法領域。作爲戴維三共集團公司的一員，美國再生已成爲行業領先的注射劑生產商。超過50年來，美國再生一直致力於開發、製造和供應高質量的通用和品牌注射劑，服務於醫療保健提供商。20多年來，我們一直是IV鐵療法的領導者。
American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future.
美國公司American Regent致力於在美國製造。 因此，在過去幾年中，我們在俄亥俄州和紐約州的製造設施擴大和現代化方面進行了重大投資。 這次擴張將使我們的產能增加近一倍，並使我們能夠更好地爲現在和未來的客戶提供服務。
Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.
速度至關重要。 靈活性很重要。 可靠性和質量是最重要的。 因爲患者不應該等待他們所需的藥物。
For more information, please visit .
有關更多信息，請訪問。
About Daiichi Sankyo Group
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society."
關於大正製藥集團
戴養三共致力於利用我們的世界一流科學技術創造新的形式和創新藥品，以實現我們的目標“爲全球生活質量的提高做出貢獻”。除了我們當前的腫瘤和心血管疾病藥品組合外，戴養三共主要致力於開發新的治療方案，針對患有高度未滿足的醫療需求的癌症患者以及其他疾病。戴養三共擁有100多年的科學專業知識並在20多個國家設有分支機構，全球16000多名員工借力於豐富的創新遺產，實現我們的2030年願景成爲“一個爲可持續發展做出貢獻的創新全球醫療保健公司。”
For more information, please visit: .
欲了解更多信息，請訪問:
All trademarks are the property of their respective owners.
所有商標均爲其各自所有者的財產。
Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. Accessed April 12, 2024 .
參考資料: 1. Orange book: 獲得治療等效性評估的批准藥物。美國食品和藥物管理局。2024年4月12日查閱。
SOURCE American Regent Inc
來源美國攝影劑公司。
譯文內容由第三人軟體翻譯。