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.

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.

Nutriflex Peri/Nutriflex Plus also contains citric acid as excipient.

Indications/Uses
Nutriflex Peri: Patients who need parenteral nutrition only for a short period of time.
where a central venous catheter is contraindicated because of a high risk of infection.
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

Nutriflex Plus: Hypercatabolic patients who need PN and EN is contraindicated.

trauma, severe burns, 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.

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).
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.

Contraindications

Clinimix and Clinimix E Injections are contraindicated in patients with known hypersensitivity

to one or more amino acids or dextrose; in patients with inborn errors of amino acid metabolism
due to risk of severe metabolic and neurologic complications; and in patients with pulmonary
edema or acidosis due to low cardiac output. In addition, Clinimix E is contraindicated in
neonates (less than 28 days of age) receiving concomitant treatment with ceftriaxone, even if
separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in
the neonate’s bloodstream.

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.

Warnings, Precautions and Adverse Reactions

Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have
been reported in patients receiving parenteral nutrition. Excess addition of calcium and
phosphate increases the risk of the formation of calcium phosphate precipitates. The solution
should be inspected for precipitates before admixing, after admixing, and again before
administration. If signs of pulmonary distress occur, stop the infusion and initiate a medical
evaluation. Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed
with Clinimix E, in the same intravenous administration line. Do not administer ceftriaxone
simultaneously with Clinimix E via a Y-site. Stop infusion immediately and treat patient
accordingly if signs or symptoms of a hypersensitivity reaction develop. Monitor for signs and
symptoms of early infections. Refeeding severely undernourished patients may result in
refeeding syndrome. Thiamine deficiency and fluid retention may also develop. Monitor severely
undernourished patients and slowly increase nutrient intakes. Clinimix and Clinimix E solutions
containing more than 5% dextrose have an osmolarity of ≥ 900 mOsm/L and must be infused
through a central catheter. Clinimix and Clinimix E contain no more than 25 mcg/L of
aluminum which may reach toxic levels with prolonged administration in patients with renal
impairment. Preterm infants are at greater risk because their kidneys are immature, and they
require large amounts of calcium and phosphate solutions which contain aluminum. Patients with
renal impairment, including preterm infants, who receive parenteral levels of aluminum at
greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous
system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who
receive parenteral nutrition for extended periods of time, especially preterm infants.
If Clinimix and Clinimix E treated patients develop liver test abnormalities, consider
discontinuation or dosage reduction. Use Clinimix and Clinimix E with caution in patients with
cardiac insufficiency or renal impairment due to increased risk of electrolyte and fluid volume
imbalance. Monitor renal and liver function parameters, ammonia levels, fluid and electrolyte
status, serum osmolarity, blood glucose, blood count and coagulation parameters throughout
treatment. In situations of severely elevated electrolyte levels, stop Clinimix and Clinimix
E until levels have been corrected. Adverse reactions include diuresis, extravasation, glycosuria,
hyperglycemia, and hyperosmolar coma.

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.
Presentation/Packing
Nutriflex Peri: Infusion 1 L x 5's. Nutriflex Plus: Infusion 1 L x 5's.