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CLINIMIX is a brand name for Methionine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CLINIMIX (Amino Acids without Electrolytes in Dextrose Injection) products are indicated as a source of amino acids and carbohydrate calories in clinical conditions where enteral nutritional supply is or is expected to be insufficient or impossible in order to offset or prevent nitrogen loss or negative nitrogen…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations CLINIMIX products contain dextrose and amino acids (Blend B) (see Table 1). 4 Administration). The solutions in the two chambers must be first mixed together (see Administration subsection below) prior to use (see Table 1 for the contents of the products in the resulting Admixed solution).
Do not infuse the solution packaged in a chamber without prior mixing. 4 Administration when including electrolytes and lipid emulsion. Do not add any additives including electrolytes and lipid emulsion until the solutions in the two chambers are thoroughly mixed to reduce the risk of instability of the resulting solution and formation of precipitates which may result in serious clinical outcomes (see 2 CONTRAINDICATIONS, Respiratory subsection of 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Additives must be added before lipid component to facilitate visual inspection for incompatibility. Discard any solution where precipitates, particulate matter, cloudiness, discoloration and/or other unusual appearance are observed.
4 Administration). During infusion, the infused solution, infusion set and catheter should periodically be checked for precipitates. If precipitates (particulate matter) are observed, the infusion must be stopped immediately and medical evaluation initiated.
If electrolytes are to be added to CLINIMIX products, the type and the amount of electrolytes should be dictated by the status of electrolyte balance, disease condition and related vital organ function of the patient. For single use only.
When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure after admixture through administration. It is recommended that after opening the bag, the contents should be used immediately, and should not be stored for a subsequent infusion.
Product Monograph Master Template Template Date:
September 2020 CLINIMIX (Blend B) Page 6 of 30 Table 1 - The Contents of the Admixed Solution* of CLINIMIX Amino Acids (Blend B) without Electrolytes in Dextrose Injection. 4 Dextrose (g/L) 50 100 166 200 Energy: Total energy from amino acids and dextrose approx.
(Kcal/L) 370 540 764 880 Energy from dextrose approx. 5 Osmolarity approx. , amino acids and dextrose) should be based on individual nutritional requirements and patient tolerance. The total daily dose of these solutions depends on the patient’s metabolic requirement and clinical response.
). Additives must be added before lipid component to facilitate visual inspection for incompatibility. Discard any solution where precipitates, particulate matter, cloudiness, discoloration and/or other unusual appearance are observed.
4 Administration). During infusion, the infused solution, infusion set and catheter should periodically be checked for precipitates. If precipitates (particulate matter) are observed, the infusion must be stopped immediately and medical evaluation initiated.
If electrolytes are to be added to CLINIMIX products, the type and the amount of electrolytes should be dictated by the status of electrolyte balance, disease condition and related vital organ function of the patient. For single use only.
When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure after admixture through administration. It is recommended that after opening the bag, the contents should be used immediately, and should not be stored for a subsequent infusion.
Product Monograph Master Template Template Date:
September 2020 CLINIMIX (Blend B) Page 6 of 30 Table 1 - The Contents of the Admixed Solution* of CLINIMIX Amino Acids (Blend B) without Electrolytes in Dextrose Injection. 4 Dextrose (g/L) 50 100 166 200 Energy: Total energy from amino acids and dextrose approx.
(Kcal/L) 370 540 764 880 Energy from dextrose approx. 5 Osmolarity approx. , amino acids and dextrose) should be based on individual nutritional requirements and patient tolerance. The total daily dose of these solutions 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. 8 g/kg of body weight for adults. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially.
The use of all formulations of CLINIMIX (Amino Acids without Electrolytes in Dextrose Injection) is contraindicated in the following populations / situations: Known hypersensitivity to any of the substances or component of the container.
For a complete listing, see Table 1 and text in the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Concomitant administration of ceftriaxone in newborns (≤ 28 days of age), even if separate infusion lines are used due to risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream.
, via Y-port/Y- site) in patients older than 28 days of age. If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. Known allergy to corn or corn products since the products contain corn-derived dextrose Patients with acute renal failure and without undergoing renal replacement therapy.
Patients with severe liver failure or hepatic coma Congenital abnormality of amino acid metabolism Severe hyperglycemia (glucose concentration greater than 180 mg/dL or 10 mmol/L)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The determination of nitrogen balance and accurate daily body weights (corrected for fluid balance), are probably the best means of assessing individual nitrogen requirements. 8 g/kg of body weight for adults. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially.
5 g/kg of body weight for adults and 2 to 3 g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate will be necessary to promote adequate patient response to therapy.
The severity of the illness being treated is the primary consideration in determining proper dose level. Higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.
Product Monograph Master Template Template Date:
September 2020 CLINIMIX (Blend B) Page 7 of 30 Care should be exercised to ensure the maintenance of proper levels of serum potassium. It may be necessary to add additional quantities of this electrolyte to the solution in order to meet the patient’ s potassium intake needs.
Potassium requirements in a parenteral nutrition (PN) formulation for generally healthy people with normal losses are 1-2 mmol/kg/day, but should be customized to meet individual patient needs. g. renal failure), acceptable total daily administration volumes are dependent upon the fluid balance requirements of the patient.
Extreme care should be given to prevent fluctuations of blood osmolarity and serum electrolyte concentrations. Frequent and careful monitoring is mandatory when fluid restricted patients are receiving intravenous nutrition. Electrolyte supplementation for CLINIMIX products may be indicated according to the clinical needs of the patient.
4 Administration). 4 Administration). 4 Administration Preparation of the Product for Administration: Prior to use, the […]
5 g/kg of body weight for adults and 2 to 3 g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate will be necessary to promote adequate patient response to therapy.
The severity of the illness being treated is the primary consideration in determining proper dose level. Higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.
Product Monograph Master Template Template Date:
September 2020 CLINIMIX (Blend B) Page 7 of 30 Care should be exercised to ensure the maintenance of proper levels of serum potassium. It may be necessary to add additional quantities of this electrolyte to the solution in order to meet the patient’ s potassium intake needs.
Potassium requirements in a parenteral nutrition (PN) formulation for generally healthy people with normal losses are 1-2 mmol/kg/day, but should be customized to meet individual patient needs. g. renal failure), acceptable total daily administration volumes are dependent upon the fluid balance requirements of the patient.
Extreme care should be given to prevent fluctuations of blood osmolarity and serum electrolyte concentrations. Frequent and careful monitoring is mandatory when fluid restricted patients are receiving intravenous nutrition. Electrolyte supplementation for CLINIMIX products may be indicated according to the clinical needs of the patient.
4 Administration). 4 Administration). 4 Administration Preparation of the Product for Administration: Prior to use, the solutions in the two chambers must be thoroughly mixed following the procedure described below. Any additives including electrolytes and lipid emulsion, if needed, should only be added to the mixed solution of the product.
For details on the product packaging, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Before Mixing: Do not open the overwrap until ready for use. The overwrap is not a sterility barrier. The inner bag maintains the sterility of the product.
Prior to use, tear the overwrap down side at strip and take out the dual-chamber solution container (see Step 1 and Step 2 in Figure 1). Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
Confirm that the content of the individual chambers is clear, colorless or slightly yellow. Otherwise, discard the solution and report to Baxter Corporation. e. solutions are contained in separate chambers. Check for minute leaks by separately squeezing each chamber.
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