Clinisol also known as Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine is a human prescription drug labeled by 'Baxter Healthcare Corporation'. National Drug Code (NDC) number for Clinisol is 0338-0502. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Clinisol drug includes Alanine - 2.17 g/100mL Arginine - 1.47 g/100mL Aspartic Acid - 434 mg/100mL Glutamic Acid - 749 mg/100mL Glycine - 1.04 g/100mL Histidine - 894 mg/100mL Isoleucine - 749 mg/100mL Leucine - 1.04 g/100mL Lysine Acetate - 1.18 g/100mL Methionine - 749 mg/100mL and more. The currest status of Clinisol drug is Active.

Clinisol lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, tyrosine lysine acetate lysine leucine leucine phenylalanine phenylalanine valine valine histidine histidine isoleucine isoleucine methionine methionine threonine threonine tryptophan tryptophan alanine alanine arginine arginine glycine glycine proline proline glutamic acid glutamic acid serine serine aspartic acid aspartic acid tyrosine tyrosine acetic acid water

Indications and usage 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Warnings additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic techniques. mix thoroughly. do not store. because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture. this injection is for compounding only, not for direct infusion. once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. after initial entry, maintain contents at room temperature (25ºc/77ºf). any admixture storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the pati Read more...

General in order for parenterally administered amino acids to be retained by the body and utilized for protein synthesis adequate calories must be administered concurrently. the administration of 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package as part of total parenteral nutrition (tpn) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia. during parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. early demonstration of this condition can only be accomplished by analysis of plasma lipids. the syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions. for complete nutritional support, tpn regimens must also include multiple vitamins and trace elements. potentially incompatible ions such as calcium and pho Read more...

Dosage and administration doses which achieve nitrogen equilibrium or positive balance are the most desirable. the dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia. fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (efad). pediatric use: use of 15% clinisol - sulfite-free (amino acid) injection 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 periphe Read more...

Contraindications hypersensitivity to one or more amino acids severe liver disease or hepatic coma anuria metabolic disorders involving impaired nitrogen utilization

Adverse reactions local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. in such cases the infusion site should be changed promptly to another vein. generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions. the following metabolic complications have been reported with administration of tpn: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death. sepsis has been reported following intravenous therapy, especially when using central venous catheters for prolonged periods. complications known to occur from the placement of central venous catheters are pneumotho Read more...

Pregnancy: teratogenic effects animal reproduction studies have not been conducted with 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package. it is also not known whether 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package should be given to a pregnant woman only if clearly needed.

Pediatric use: safety and effectiveness of 15% clinisol - sulfite-free (amino acid) injection in pediatric patients have not been established by adequate and well-controlled studies. however, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. see dosage and administration .

Description 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. a pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. the contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. the viaflex plastic container is fabricated from a specially formulated polyvinyl chloride (pl 146 plastic). exposure to temperatures above 25ºc/77ºf during transport and storage will lead to minor losses in moisture content. higher temperatures lead to greater losses. it is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (dehp), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to usp biological test for plastic containers as well as by tissue culture toxicity studies. each 100 ml of 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package contains: amino acids total nitrogen ph 15.0 g 2.37 g 6.0 (5.0 to 7.0) (ph adjusted with glacial acetic acid) essential amino acids lysine - (from lysine acetate) c 6 h 14 n 2 o 2 leucine - c 6 h 13 no 2 phenylalanine – c 9 h 11 no 2 valine - c 5 h 11 no 2 histidine - c 6 h 9 n 3 o 2 isoleucine - c 6 h 13 no 2 methionine - c 5 h 11 no 2 s threonine - c 4 h 9 no 3 tryptophan - c 11 h 12 n 2 o 2 nonessential amino acids alanine - c 3 h 7 no 2 arginine - c 6 h 14 n 4 o 2 glycine - c 2 h 5 no 2 proline - c 5 h 9 no 2 glutamic acid - c 5 h 9 no 4 serine – c 3 h 7 no 3 aspartic acid – c 4 h 7 no 4 tyrosine – c 9 h 11 no 3 anion profiles per liter* acetate from lysine acetate and glacial acetic acic *balanced by ions from amino acids osmolarity (calc.) 1.18 g 1.04 g 1.04 g 960 mg 894 mg 749 mg 749 mg 749 mg 250 mg 2.17 g 1.47 g 1.04 g 894 mg 749 mg 592 mg 434 mg 39 mg 127 meq 1357 mosmol/l

Clinical pharmacology 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package administered parenterally will provide biologically utilizable source material for protein synthesis when used with concentrated calorie sources, electrolytes, vitamins and minerals. central infusion 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package is intended for use in a pharmacy admixture program and as such is restricted to the preparation of admixtures for intravenous use. 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will meet the requirements for weight maintenance or weight gain. the energy component may be derived solely from dextrose or may be provided by a combination of dextrose and intravenous fat emulsion. peripheral infusion 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package, when diluted to an a Read more...

Carcinogenesis, mutagenesis, impairment of fertility: long term animal studies with 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility.

How supplied 15% clinisol - sulfite-free (amino acid) injection pharmacy bulk package is available in viaflex plastic containers as follows. 2b6187 500 ml ndc 0338-0502-03 2b6189 2000 ml ndc 0338-0502-06 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. it is recommended the product be stored at room temperature (25ºc/77ºf).

Principal display panel container label lot exp 2b6187 ndc 0338-0502-03 500ml 15% clinisol - sulfite-free (amino acid) injection 15% pharmacy bulk package not for direct infusion rx only each 100ml contains essential amino acids lysine (from lysine acetate) 1.18 g leucine 1.04 g phenylalanine 1.04 g valine 960 mg histidine 894 mg isoleucine 749 mg methionine 749 mg threonine 749 mg tryptophan 250 mg nonessential amino acids alanine 2.17 g arginine 1.47 g glycine 1.04 g proline 894 mg glutamic acid 749 mg serine 592 mg aspartic acid 434 mg tyrosine 39 mg ph adjusted with glacial acetic acid ph 6.0 (5.0 to 7.0) acetate 127 meq/l balanced by ions from amino acids hypertonic osmolarity 1357 mosmol/l (calc) sterile nonpyrogenic contains no more than 25µg/l of aluminum additives may be incompatible consult with pharmacist if available when compounding admixtures use aseptic techique mix thoroughly do not store dosage admix for intraveous administration as directed by a physician see accompanying directions for use once container closure has been penetrated withdrawal of contents should be completed within 4 hours affix accompanying label for date and time of entry caution do not use unless solution is clear a slight yellow color does not alter the quality and efficacy of the product baxter baxter healthcare corporation clintec nutrition division deerfield il 60015 usa made in the usa viaflex container pl 146 plastic baxter clinisol viaflex and pl 146 are trademarks of baxter international inc 1 2 3 4 clinisol representative container label ndc 0338-0502-03