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20% PROSOL is a brand name for Valine, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 20% ProSol (Amino Acid Injection 20% w/v) when administered with a source of energy is indicated as a source of amino acid in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used. (2) gastrointestinal absorption of amino acids is impaired, or (3) metabolic…
Verbatim from this product's HC label. Tap a section to expand.
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1 Adverse Reaction Overview Adverse reaction information is based on post-marketing experiences with parenteral amino acid products. 2 Post-Market Adverse Reactions Adverse reactions reported with parenteral amino acid products include: IMMUNE SYSTEM DISORDERS: Anaphylactic/anaphylactoid reactions, including skin, gastrointestinal and severe circulatory (shock) and respiratory manifestations as well as other hypersensitivity/infusion reactions, including pyrexia, chills, hypotension, hypertension, arthralgia, myalgia, urticaria/rash, pruritus, erythema, and headache METABOLISM AND NUTRITION DISORDERS: Hyperammonemia RENAL AND URINARY DISORDERS: Azotemia VASCULAR DISORDERS: Pulmonary vascular precipitates Adverse reactions reported with parenteral nutrition to which the amino acid component may play a causal or contributory role include: HEPATOBILIARY DISORDERS: Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Blood bilirubin increased, Hepatic enzyme increased; Cholecystitis, Cholelithiasis GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Infusion site thrombophlebitis; Venous irritation (infusion site phlebitis, pain, erythema, warmth, swelling, induration)
General The contents of the products are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Proper administration of a ProSol product requires a knowledge of fluid and electrolyte balance, nutritional status, nature of the disease, vital organ function as well as clinical expertise in prescribing PN regimens and recognition and treatment of the complications which may occur.
It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
Do not administer unless solution is clear. A slight yellow color does not alter the quality and efficacy of this product. Exercise caution to ensure that precipitates are not formed in any parenteral nutrient products since precipitates may result in life-threatening clinical outcomes (see Respiratory subsection and ADVERSE REACTIONS section).
If additional substances (other PN solution, additional electrolytes and/or other additives) are to be admixed with ProSol product, compatibility of the substances with the product must be evaluated to ensure that the final solution is stable and free of precipitates (see DOSAGE AND ADMINISTRATION section).
Product Monograph Template – Standard Template Date:
June 2017 Page 9 of 23 During infusion, the infusion set and catheter should also periodically be checked for precipitates. If precipitates (particular matters) are observed, infusion MUST be immediately stopped and medical evaluation is initiated.
Aseptic techniques are required when additives are added as nutrients in the products may support growth of microorganisms. The administration of 20% ProSol (Amino Acid Injection 20% w/v) 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.
The use of 20% ProSol (Amino Acid Injection 20% w/v) is contraindicated in the following populations/situations: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see Dosage Forms, Strengths, Composition and Packaging. Patients with severe liver failure or hepatic coma. Patients with acute renal failure and without undergoing renal replacement therapy. Congenital abnormality of amino acid metabolism.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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During prolonged parenteral nutrition with amino acid and dextrose 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 lipid emulsions. Administration of amino acid solutions and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure.
This includes attention to solution preparation, administration, and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team. Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral formulations, poor maintenance of catheters or contaminated solutions.
Immunosuppression and other factors such as hyperglycemia, malnutrition and/or their underlying disease state may predispose patients to infectious complications. Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycemia can help recognize early infections.
The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement, maintenance, as well as aseptic technique in nutritional formula preparation. Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic.
Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. Hypertonic infusion solutions may cause irritation of the vein when administered into a peripheral vein (see ADVERSE REACTIONS, Post-Marketing Adverse Reactions).
During protein sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administration of carbohydrates.
20% ProSol (Amino Acid Injection 20% w/v) must not be infused through the same tubing with blood or blood components unless there is documentation that it is safe.
Product Monograph Template – Standard Template Date:
June 2017 Page 10 of 23 Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Light exposure of solutions for intravenous parenteral nutrition, after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products.
When used in neonates and children below 2 years, 20% ProSol (Amino Acid Injection 20% w/v) should be protected from ambient light after admixture until administration is complete. Cardiovascular Use with caution in patients with pulmonary edema or heart failure.
Fluid status should be closely monitored. Endocrine and Metabolism Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given dietary component is not accurately assessed.
Adverse metabolic effects may arise from administration of inadequate or excessive nutrients or from inappropriate composition of an admixture for a particular patient's needs. When administered as component of parenteral nutrition, the following metabolic complications have been reported: metabolic acidosis, […]