| 产品描述： | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07 |
|---|---|
| 地位： | Ongoing |
| City: | Irvine |
| State: | CA |
| 国家： | 我们 |
| 自愿/要求： | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | Nationwide, Puerto Rico and Spain |
| Classification: | Class I |
| 产品数量： | 18,090个单位 |
| Reason For Recall: | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. |
| 记起Initiation Date: | 20131121 |
| 报告日期： | 20140507 |
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Questions & Answers
Side Effects & Adverse Reactions
该产品含有钾含钾，这是一种可能引起过敏反应的亚硫酸盐，包括过敏性症状和威胁生命或某些易感人士的哮喘发作。一般人群中亚硫酸盐敏感性的总体患病率尚不清楚，可能很低。在哮喘中，硫酸盐的敏感性比在非肢体人群中更频繁地看到。
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.
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.
Peripheral intravenous infusion of amino acids may cause a normal, modest rise in blood urea nitrogen (BUN) as a result of increased protein intake. The BUN may become elevated in patients with impaired renal or hepatic function. If the BUN levels exceed post-prandial limits and continue to rise, further use of ProcalAmine® should be reevaluated.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
如果出现高症血症的症状，应停止氨基酸给药，并重新评估患者的临床状况。
Undesirable side effects of glycerol reported in the literature include hemolysis, hemoglobinuria and renal damage. None of these side effects was observed in clinical trials with ProcalAmine®. The manifestation of these side effects is highly dependent on dose and route of administration as well as on formulation. In general, high concentrations of glycerol (up to 40%) are not hemolytic, provided solution is prepared with isotonic saline. Subcutaneous injection of low doses of glycerol alone,例如, 3% without other solutes, can cause hemolysis. Much higher doses, up to 20 times that of subcutaneous injection are required to obtain similar effects intravenously. Subcutaneous injection of glycerol at low doses can produce hemoglobinuria. Therefore, there should be frequent monitoring to ensure early detection of infiltrations.
在以下情况下，应极大谨慎地执行含有电解质的解决方案：
- Solutions containing sodium ions should be used with care in patients with congestive heart failure, renal insufficiency and in clinical states in which there exists edema with sodium retention.
- 含有钾离子的溶液应在患有高钾血症，肾功能不全以及存在钾保留率的情况下用于护理。
- 在代谢或呼吸碱中毒的患者中，应使用含有无机盐的乙酸离子的溶液。
- Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.
应注意避免循环超负荷，特别是在心脏不足患者中。
Blood sugar levels should be monitored frequently in diabetic patients.
Legal Issues
目前尚无该药物可用的法律信息。
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
目前尚无该药物可用的制造商警告信息。
FDA Labeling Changes
目前，该药物尚无FDA标签更改。
Uses
ProcalAmine® is indicated for peripheral administration in adults to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic patients who require short-term parenteral nutrition.
历史
There is currently no drug history available for this drug.
其他信息
procalamine®（3％氨基酸和3％用电解质注射3％）是一种无菌，非硫化，中度中度的高渗性静脉注射，含有结晶氨基酸，非蛋白质能底物和维持电解质。1000 mL单元总共提供29 g蛋白质等效的（4.6 g n）和130个非蛋白质卡路里。
All amino acids designated USP are the "L"-isomer with the exception of Glycine USP which does not have an isomer.
每100毫升包含：
Nonprotein energy source:
Glycerin USP (glycerol) .............................................................................. 3.0 g
必需的氨基酸
Isoleucine USP .......................................................................................... 0.21 g
亮氨酸USP ......................................。.....................................................................................。。。。0。27 g
Lysine ....................................................................................................... 0.22 g
（添加为乙酸赖氨酸USP ....................................................................................................................................................................... 0.31 g）
Methionine USP ........................................................................................ 0.16 g
Phenylalanine USP .................................................................................... 0.17 g
Threonine USP .......................................................................................... 0.12 g
Tryptophan USP ...................................................................................... 0.046 g
Valine USP ................................................................................................ 0.20 g
Nonessential amino acids
Alanine USP .............................................................................................. 0.21 g
Glycine USP .............................................................................................. 0.42 g
精氨酸USP……。.....................................................................................。。。。。。。。。............................ 0.29 g
组氨酸USP ..................................................................................................................................................................................................... 0.085 g
Proline USP ........................................................................................................................................................................................................................... 0.34 g
丝氨酸USP ................................................................................................................................................................................................................... 0.18克
半胱氨酸.........................................................................................................................................................................................................<0.014 g
（作为半胱氨酸HCl•H2O USP ...................................................................<0.020 g)
Sodium Acetate•3H2O USP........................................................................ 0.20 g
Magnesium Acetate•4H2o ......................................................................................................................................................................................................... 0.054 g
Calcium Acetate•H2O ............................................................................... 0.026 g
氯化钠USP ...................................................................................................................................................................................... 0.12 g
Potassium Chloride USP.............................................................................. 0.15 g
磷酸NF ........................................................................................................................................................................................ 0.041 g
Potassium Metabisulfite NF (as an antioxidant) ............................................<0.05 g
注入USP的水...............................................................................................................................................
pH adjusted with Glacial Acetic Acid USP
PH：6.8（6.5–7.0），计算出的渗透压：735 Mosmol/升
电解质的浓度（MEQ/L）：钠35;钾24.5;钙3
Magnesium 5; Chloride 41; Phosphate (HPO) 71; Acetate 472
- 1
- 3。5 mmole/liter; 10.9 mg% P
- 2
- 乙酸盐作为无机乙酸盐盐（23 meq/升），乙酸（9meq/升）和乙酸赖氨酸（15 mEq/升）。据认为，在肾脏营养的条件下，乙酸乙酸酯和乙酸在正常时不会影响净酸/碱平衡。临床经验似乎支持这种思维，尽管没有确认的实验证据。
Sources
原胺制造商
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B. Braun Medical Inc.
![促原胺(Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite) Injection [B. Braun Medical Inc.]](//www.lbxkm.com/wp-content/themes/bootstrap/assets/img/loading2.gif)
procalamine |B. Braun Medical Inc.
Procalamine®是为成年患者保存瘦体重，氨基酸，维护电解质和水的方便来源。
Determination of nitrogen balance and accurate daily body weights (corrected for fluid balance) are probably the best means of assessing individual protein requirements. Approximately three liters per day of ProcalAmine® will provide a total of 90 grams of amino acids, 390 nonprotein calories and the recommended daily intake of principal intra- and extracellular electrolytes for the stable patient. Therapy can begin with three liters of ProcalAmine® on the first day with close monitoring of the patient. As with all intravenous fluid therapy, the goal is to provide adequate water to compensate for insensible, urinary and other losses, and electrolytes for replacement and maintenance. These requirements should be determined frequently and appropriately administered. Additional electrolytes should be administered evenly throughout the day, and irritating medications should be injected at an alternate infusion site. Pediatric UseProcalAmine® is intended for use in adults. Use of ProcalAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
通过选择较大的外周静脉以及减慢输注速率，可以最大程度地减少输注部位的静脉刺激。在小儿患者中，最终溶液不应超过正常血清渗透压（718 MOSMOL/L）的两倍。肠胃外药物应在给药前，在溶液和容器允许的情况下，在给药前视觉检查颗粒物和变色。
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