Nutriflex Peri/Nutriflex Plus

Nutriflex Peri/Nutriflex Plus

Manufacturer:

B. Braun

Distributor:

DKSH
/
Four Star
Full Prescribing Info
Contents
Parenteral nutrition formula.
Description
Nutriflex Peri: Each litre contains amino acids (15 different laevorotatory amino acids and glycine) 40 g equivalent to nitrogen 5.7 g, glucose 80 g amounting to carbohydrate 1,340 kJ (320 kCal) this gives a ratio of 56 kCal/g nitrogen, 5.7 mmol of immediately utilisable phosphate and electrolytes. See Table 1.

Click on icon to see table/diagram/image

Nutriflex Plus: Each litre contains amino acids (15 different laevorotatory amino acids and glycine) 48 g equivalent to nitrogen 6.8 g, glucose 150 g amounting to carbohydrate 2,510 kJ (600 kCal) this gives a ratio of 88 kCal/g nitrogen, 20 mmol of immediately utilisable phosphate and electrolytes. See Table 2.

Click on icon to see table/diagram/image

Nutriflex Peri/Nutriflex Plus also contains citric acid as excipient.
Action
Pharmacology: Nutriflex Peri/Nutriflex Plus is a parenteral nutrition solution, intended for patients who cannot be fed either orally or through a nasogastric tube.
Parenteral nutrition must supply the body with all the components necessary for growth and tissue regeneration. The amino acids play a prominent role, being the building blocks for protein synthesis.
In order to ensure a specific utilisation of the amino acids, the administration of the following components is necessary: Energy Sources: Since glucose is employed directly as an energy source, it appears to be the best choice of carbohydrate.
Electrolytes: Magnesium, sodium, potassium, calcium, phosphate.
Magnesium is involved in numerous biological processes. Its role as enzyme activator is of considerable significance in lipid, phosphate and glucose metabolism.
Calcium also activates enzymes, and in the reduction of cell membrane permeability, it is of great importance.
Phosphate is involved in almost all energy transfer reactions.
The number of components to be infused and the known incompatibilities between particular substances pose numerous problems in the manufacture of parenteral nutrition solutions.
With the Twin-Flex system, a container divided into 2 chambers, Nutriflex Peri/Nutriflex Plus solution can provide the body with the substances required for parenteral nutrition in an appropriate manner.
Pharmacokinetics: Following IV infusion, the constituents of Nutriflex Peri/Nutriflex Plus solutions are immediately available for metabolism. A portion of the amino acids is used for protein synthesis, the rest being broken down as follows: The amino groups are separated by transamination and the carbon moiety is either oxidised to CO2 in the citric acid cycle or utilised in the liver as a substrate for gluconeogenesis. The amino groups resulting from protein breakdown in muscle tissue are transported to the liver, where urea is synthesised. As a matter of principle, the protein intake regarding nitrogen should exceed the urinary nitrogen excretion.
Indications/Uses
Nutriflex Peri: Nutriflex Peri is particularly appropriate for patients in state of satisfactory nutrition who need parenteral nutrition only for a short period especially in the postoperative phase or following trauma, e.g.: after surgical procedures; following injuries when catabolism is limited; after burns; in cases of sepsis (the treatment of sepsis should begin before the catheter is inserted).
In Medicine, e.g.: to calm intestinal activity for therapeutic or diagnostic purposes; malabsorption syndrome; exudative and inflammatory bowel disease; Whipple's disease, Crohn's disease, ulcerative colitis; severe diarrhoea or emesis; as addition to an oral diet; in cases of anorexia.
For patients with a higher requirement of energy the addition of a lipid emulsion is possible.
(For patients in a poor state of nutrition or with high energy requirements for a long period Nutriflex Plus or special solutions are indicated.)
Nutriflex Peri is also indicated in cases where a central venous catheter is contraindicated because of a high risk of infection.
Nutriflex Plus: Parenteral nutrition with Nutriflex plus is particularly appropriate for overcoming the intense catabolic processes in patients in the postoperative phase or following trauma, e.g.: after surgical procedures; following multiple injuries; after severe burns; in cases of sepsis (the treatment of sepsis should begin before the catheter is inserted).
In Medicine, e.g.: malabsorption syndrome; exudative and inflammatory bowel disease; Whipple's disease, Crohn's disease, ulcerative colitis; acute pancreatitis; severe diarrhoea or emesis.
For patients with a higher requirement of energy the addition of a lipid emulsion is possible.
Dosage/Direction for Use
Nutriflex Peri: Since the osmolarity of Nutriflex Peri is approximately 900 mOsmol/L, its administration is peripheral. It is recommended that Nutriflex Peri should be given as a continuous infusion over 24 hrs at a maximum rate of 40 drops/min. The duration of treatment is normally 3-7 days. The aseptic precautions necessary when administering amino acids should be closely observed.
The dosage must be adjusted according to the patient's individual needs but 2,000-3,000 mL Nutriflex Peri/day may be regarded as a normal dose, sufficient for the majority of circumstances. If there are no contraindications, the dose maybe in the range of 1.1-1.7 g amino acids/kg body weight/day. 3,000 mL Nutriflex Peri containing amino acids 120 g and glucose 240 g, may well be given if necessary. An individual adjustment of the dosage is necessary in liver insufficiency.
The time taken to infuse 1,000 mL Nutriflex Peri should not be <8 hrs (40 drops/min).
Nutriflex Plus: Since the osmolarity of Nutriflex Plus is approximately 1,400 mOsmol/L, it must be given via a central venous catheter. It is recommended that Nutriflex Plus should be given as a continuous infusion over 24 hrs. The aseptic precautions necessary when administering amino acids should be closely observed.
The dosage must be adjusted according to the patient's individual needs but 1,000-2,000 mL Nutriflex Plus per day may be regarded as a normal dose, and should suffice for the majority of circumstances. If there are no contraindications, the dose maybe in the range of 0.8-1.4 g amino acids/kg body weight/day. 2,000 mL Nutriflex Plus containing amino acids 96 g and glucose 300 g may well be given if necessary. However, in liver failure, these doses should be reduced.
The time taken to infuse 1,000 mL Nutriflex Plus should not be <10 hrs (33 drops/min).
Overdosage
A daily dose of 3,000 mL Nutriflex Peri or 2,000 mL of Nutriflex Plus should not be exceeded.
Symptoms: An osmotic diuresis with a simultaneous loss of amino acids, together with dizziness and nausea.
Treatment: Stop the infusion; in severe cases, peritoneal dialysis or haemodialysis.
Contraindications
Severe haemodynamic disturbances (shock, cardiac failure); metabolic acidosis; severe renal failure; advanced liver disease; overhydration; hyperkalemia; disorders of amino acid metabolism; untreated diabetes insipidus; complication of diabetes mellitus, with the exception of hypoglycaemia; treatment with high doses of cardiac glycosides.
Special Precautions
The state of the veins has to be taken into account before the administration of Nutriflex Peri: The addition of a lipid emulsion can improve the tolerance. It is recommended to change the vein every 48 hours.
Since Nutriflex Plus solution is hyperosmolar (1400 mosm/l), it must be infused via a central venous catheter.
Monitor electrolyte and blood glucose levels. If hyperglycemia occurs, adjust the infusion rate.
Only completely clear solutions from undamaged containers are to be used.
The contents of the two containers should be mixed immediately before use and administered thereafter. Previously opened containers should never be used. Any residual solution should be discarded.
Conventional aseptic precautions during the administration of amino acids must be strictly observed.
Use in children: Nutriflex Peri/Nutriflex Plus solutions are not indicated for babies and infants because of the balance of the ingredients.
Use In Pregnancy & Lactation
Controlled studies in man and animals are not available. For this reason Nutriflex Peri/Nutriflex Plus solutions should only be prescribed when the potential benefits outweigh the potential risks to the fetus.
Side Effects
Nausea and vomiting are possible during the infusion. Acidosis has been observed with the use of concentrated amino acids solutions.
As a result of the high osmolarity of Nutriflex Plus, an osmotic diuresis may ensue.
Drug Interactions
Because of the potassium content, the efficacy of cardiac glycosides can be reduced.
Caution For Usage
Nutriflex Peri/Nutriflex Plus should be administered immediately after mixing the two solutions (upper and lower chambers).
The mixture is stable for 24-48 hours.
Incompatibilities: Nutritional supplements such as fat emulsions and concentrated solutions of vitamins, trace elements or electrolytes (NaCl, KCl) may be added via the medication port provided for that purpose. Calcium, phosphate and bicarbonate should be added with caution as they may produce precipitations. The addition of insulin is possible. All additions should be made with the usual aseptic precautions, following the recommendations of the manufacturer.
Check the clarity of the solution following the addition.
Storage
Nutriflex should be stored below 25°C, in the original packaging, protected from light.
Shelf life: The shelf life is 2 years.
ATC Classification
B05BA10 - combinations ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Nutriflex Peri: Infusion 1 L x 5's. Nutriflex Plus: Infusion 1 L x 5's.
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