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CLINIMIX N12G20 is a brand name for Glucose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Parenteral nutrition when oral or enteral alimentation is impossible, insufficient or contraindicated. For patient undergoing long-term parenteral nutrition, the addition of a lipid emulsion to CLINIMIX in order to supply both calories and essential fatty acids is possible.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage should be individualised based on the patient’s nutritional/fluid requirements, energy expenditure, clinical status, body weight, and the ability to metabolise constituents of CLINIMIX, as well as additional energy or proteins given orally/enterally.
32 g of nitrogen/kg/d (approximately 2 g of amino acid/kg/d). 5 g of amino acid/kg/d). In adults and patients 12 to 18 year of age, calorie requirements range from 25 kcal/kg/d to 40 kcal/kg/d, depending on the nutritional status of the patient and the degree of catabolism.
Patients less than 12 years of age may have higher requirements. , amino acids and glucose) should be based on individual total nutritional requirements and patient tolerance. 5 ml/kg/hour or 150 ml/hour to 175 ml /hour (for a patient weighing 60 kg to 70 kg).
g. 2400 ml to 2800 ml (for a patient weighing 60 kg to 70 kg). Paediatric population The dosage should be individualised based on the patient’s nutritional/fluid requirements, energy expenditure, clinical status, body weight, and the ability to metabolise constituents of CLINIMIX, as well as additional energy or proteins given orally/enterally.
In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Clinical situations may exist where patients require amounts of nutrients varying from the composition of CLINIMIX. In this situation any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of CLINIMIX.
The infusion rate and volume should be determined by the consulting physician experienced in paediatric parenteral nutrition and intravenous fluid therapy. This product does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants.
This medicinal product is not recommended for preterm, and term neonates and for children below 2 years of age. For children 2 years old and above cysteine and taurine should be administered, if deemed needed, by the consulting physician experienced in paediatric parenteral nutrition and intravenous fluid therapy.
7 Rate Limiting Component Amino acids Amino acids Amino acids 1Maximum Recommended values from 2018 ESPGHAN/ESPEN Guidelines Method of administration For single use only. It is recommended that after opening the bag, the contents should be used immediately, and should not be stored for a subsequent infusion.
9). Post-marketing Adverse Reactions The following adverse reactions have been reported with CLINIMIX formulations in the post-marketing experience, listed by MedDRA System Organ Class (SOC) and by Preferred Term a: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100): rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
*Includes the following manifestations: Hypotension, Hypertension, Peripheral cyanosis, Tachycardia, Dyspnoea, Vomiting, Nausea, Urticaria, Rash, Pruritus, Erythema, Hyperhidrosis, Pyrexia, Chills Class Reactions Other adverse reactions reported with parenteral nutrition include: •Anaphylaxis •Pulmonary vascular precipitates •Hyperglycaemia; Hyperammonemia, Azotemia •Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Blood bilirubin increased, Hepatic enzyme increased •Cholecystitis, Cholelithiasis System Organ Class (SOC) Preferred MedDRA Term Frequencya Immune system disorders Hypersensitivity* Not known •Infusion site thrombophlebitis, Venous irritation (Infusion site phlebitis, Pain, Erythema, Warmth, Swelling, Induration) Glucose intolerance is a common metabolic complication in severely stressed patients.
With the infusion of the products, hyperglycaemia, glycosuria, and hyperosmolar syndrome may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard
WARNINGS
Hypersensitivity/infusion reactions including hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnoea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills have been reported with CLINIMIX formulations.
Anaphylaxis has been reported with other parenteral nutrition products. Special clinical monitoring is required at the beginning of any intravenous infusion. g. for hypersensitivity or infusion reaction, the infusion must be stopped immediately.
Solutions containing glucose should be used with caution, if at all, in patients with known allergy to corn or corn products. Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred.
Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation distal to the in- line filter and suspected in vivo precipitate formation have also been reported.
If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated. In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates. 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 hyperglycaemia, 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 hyperglycaemia can help recognize early infections.
1, or to the components of the container. Amino acid metabolism disorders Severe hyperglycaemia Metabolic acidosis, hyperlactataemia
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Administer the product only after breaking the seal and mixing the contents of both compartments. Appearance of the solution after mixing: clear and colourless or slightly yellow solution. 6. The osmolarity of a specific infusion solution must be taken into account when peripheral administration is considered.
4). 2). The flow rate should be increased gradually during the first hour. The rate of administration should be adjusted according to the dosage, the characteristics of the infused solution, the total volume intake per 24 hours and the duration of the infusion.
The infusion time should be higher than 8 hours. To reduce the risk of hypoglycaemia after discontinuation, a gradual decrease in flow rate in the last hour of administration should be considered. 6).
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 solutions may cause venous irritation if infused into a peripheral vein.
The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The general accepted limit for peripheral infusion is about 800 mOsm/l but it varies considerably with the age and the general condition of the patient and the characteristics of the peripheral veins.
Do not connect bags in series in order to avoid air embolism due to possible residual air contained in the primary bag. PRECAUTIONS Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
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.
Frequent clinical evaluation and laboratory determinations are necessary for correct monitoring during administration. These should include ionogram and kidney and liver function tests. The electrolyte requirements of patients receiving the solutions should be carefully determined and monitored especially for the electrolyte-free solutions.
CLINIMIX without electrolytes should not be used in cases of hypokalaemia and hyponatremia. Glucose intolerance is a common metabolic complication in severely stressed patients. With the infusion of the products, hyperglycaemia, glycosuria, and hyperosmolar syndrome may occur.
Blood and urine glucose should be monitored on a routine basis and for diabetics insulin dosage should be adapted, if necessary. Use with caution in patients with renal insufficiency, particularly if hyperkalaemia is present, because of the risk of developing or worsening metabolic acidosis and hyperazotemia if extra-renal waste removal is not being performed.
Fluid and electrolyte status should be closely monitored in these patients. In case of severe kidney failure, specially formulated amino acid solutions should be preferred. Caution should be exercised in administering CLINIMIX to patients with adrenal insufficiency.
Care should be taken to avoid circulatory overload particularly in patients with pulmonary oedema, cardiac insufficiency and/or failure. Fluid status should be closely monitored. In patients with pre-existing liver disease or hepatic insufficiency, apart from routine liver function tests, possible symptoms of hyperammonaemia should be controlled.
Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on parenteral nutrition.
The aetiology of these disorders is thought to be multifactorial and may differ between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
Increase in blood ammonia levels and hyperammonemia may occur in patients receiving amino acid solutions. 3) or hepatic insufficiency. Blood ammonia should be […]