| Product Description: | Clinimix 5/15无硫酸盐（15％葡萄糖中的5％氨基酸），2000毫升清晰双室容器袋，仅Rx。DIST：Baxter Healthcare Corporation，一个Baxter Parkway，Deerfield，IL60015。NDC：0338-1099-04。 |
|---|---|
| Status: | Ongoing |
| City: | Deerfield |
| State: | il |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | 信 |
| Distribution Pattern: | US Nationwide |
| 分类: | Class I |
| Product Quantity: | 7,388 bags |
| 召回的原因： | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. |
| Recall Initiation Date: | 20131118 |
| Report Date: | 20140326 |
Clinimix
加载...Clinimix Recall
获取警报召回时。
Questions & Answers
副作用和不良反应
添加剂可能不兼容，包括脂肪乳液。如果有的话，请咨询药剂师。引入添加剂时，请使用无菌技术。彻底混合。
Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
这些无硫酸亚硫酸盐（葡萄糖中的氨基酸），must be在输液之前混合。对于混合说明，请参阅使用塑料容器的说明。
The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis. After mixing, strongly hypertonic nutrient injections should only be administered through an indwelling intravenous catheter with the tip located in a large central vein, such as the superior vena cava.
Proper administration of these admixed amino acid/dextrose injections requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration。研究应包括血糖，血清蛋白，肾脏和肝功能测试，电解质，具有差异，二氧化碳结合功率或含量的全血细胞计数，血清渗透压，血液培养和血液氨水水平。
对肝功能不全的患者施用氨基酸溶液可能会导致血清氨基酸失衡，高症血症，昏迷和昏迷。
Hyperammonemia is ofspecial significance in infants。该反应似乎与遗传或产物起源的尿素周期氨基酸的缺乏有关。至关重要的是，在婴儿中经常测量血液。
这些混合氨基酸/葡萄糖注射的保守剂量应给已知或怀疑的肝功能障碍的患者。如果出现高氨血症的症状，应停用给药，并重新评估患者的临床状况。
在肾功能受损的情况下，氨基酸溶液的给药提出了与电解质保留相关的特殊问题。
These admixed injections should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
在非常低的出生体重婴儿中，右旋糖注射过多或快速给药可能导致血清渗透压增加和可能的脑出血。
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.
研究表明，肾脏功能受损的患者，包括过早的新生儿，他们在4至5 mcg/kg/day的肠胃脂水平以与中枢神经系统和骨骼毒性相关的水平上积累了铝。组织负荷可能以更低的给药速率发生。
法律问题
There is currently no legal information available for this drug.
FDA安全警报
目前没有FDA安全警报for this drug.
Manufacturer Warnings
目前还没有生产informa的警告tion available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
肠胃外营养方案中的无硫酸硫酸盐（葡萄糖中的氨基酸）注射是一种热量成分，是抵消氮损失或治疗患者负氮平衡负氮的蛋白质（氮）来源。
- the alimentary tract cannot or should not be used,
- gastrointestinal absorption of protein is impaired, or
- metabolic requirements for protein are substantially increased, as with extensive burns.
Central vein infusion should be used when amino acid solutions are admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.
For patients in whom the central vein route is not indicated, amino acid solutions diluted with low dextrose concentrations may be infused by peripheral vein.
History
There is currently no drug history available for this drug.
Other Information
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are sterile, nonpyrogenic, hypertonic solutions in a CLARITY Dual Chamber Container.
出口端口腔中的无硫酸氨基酸注射是必需氨基酸和非必需氨基酸的溶液。
The Dextrose Injections, USP in the injection port chamber are solutions for fluid replenishment and caloric supply.
After opening the seal between the chambers and mixing thoroughly, the admixed product is intended for intravenous use. See Table 1 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product.
The CLARITY Dual Chamber Container is a lipid-compatible plastic container (PL 2401 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
来源
Clinimix制造商
-
百特医疗公司
![Clinimix (Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose) Injection [Baxter Healthcare Corporation]](//www.lbxkm.com/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clinimix | Baxter Healthcare Corporation
If a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition should be considered.
The total daily dose of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.
Recommended Dietary Allowances 1 of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants up to three months of age. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.
为了初次治疗创伤或蛋白质卡路里营养不良，必须使用相应量的碳水化合物的蛋白质来促进足够的患者对治疗的反应。治疗疾病的严重程度是确定适当剂量水平的主要考虑因素。如此较高的剂量，尤其是在婴儿中，必须伴随着更频繁的实验室评估。
Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to these admixed injections, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.
Patients receiving CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections without electrolytes should be monitored frequently and their electrolyte requirements individualized.
Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.
Maintenance vitamins, additional electrolytes, and trace elements should be administered as required.
In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
Fat emulsion administration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN.
Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per mL (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid/dextrose injections in the CLARITY Container to supplement caloric intake.
根据患者的临床状况，每24小时可进行大约3升溶液。术后使用时，该疗法应在术后第一天从1000 mL开始。此后，剂量可以增加到每天3000毫升。
Do not administer unless seal between chambers is opened, other seals are intact, and solution is clear and thoroughly mixed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
轻微的黄色不会改变该产品的质量和功效。
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.
请勿存储含有添加剂的解决方案。混合后，这些带有电解质/葡萄糖带有钙注射的氨基酸应立即使用。任何具有添加剂的存储都应在制冷范围内，并限于短时间内，不到24小时。
1Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989).
儿科用途：在儿科患者中注射的clinimix无硫酸盐（葡萄糖中的氨基酸）的使用受到相同的考虑，这些因素会影响小儿使用任何氨基酸溶液的使用。施用的量是根据氨基酸/千克体重/天的克剂量给予的。对于足够卡路里的婴儿来说，两到3 g/kg的体重通常足以满足蛋白质需求并促进氮平衡。通过周围静脉施用溶液不得超过两倍的正常血清渗透压（718 MOSMOL/L）。
中央静脉管理：Hypertonic mixtures of amino acid/dextrose injections may be administered safely by continuous infusion through a central vein catheter with the tip located in the vena cava. In addition to meeting nitrogen needs, the administration rate is governed, especially during the first few days of therapy, by the patient’s tolerance to dextrose, as indicated by frequent determinations of urine and blood sugar levels. Daily intake of amino acids in dextrose should be increased gradually to the maximum required dose.
Sudden cessation in administration of these admixed injections may result in insulin reaction due to continued endogenous insulin production. Parenteral nutrition mixtures should be withdrawn slowly.
Peripheral Vein Administration:For patients requiring parenteral nutrition in whom the central vein route is not indicated, low concentration amino acid/dextrose injections may be administered by peripheral vein. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Login To Your Free Account