Nutriflex Peri Solution For Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutriflex peri Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amounts of active substances in both the 1000 ml and 2000 ml sizes of the product before and after mixing of the two chambers are given below.
|
Composition |
Before Lower Compartment 600 ml |
Mixing Upper Compartment 400 ml |
After Mixing 1000 ml |
Before Lower Compartment 1200 ml |
Mixing Upper Compartment 800 ml |
After Mixing 2000 ml |
|
Isoleucine |
2.34 g |
2.34 g |
4.68 g |
4.68 g | ||
|
Leucine |
3.13 g |
3.13 g |
6.26 g |
6.26 g | ||
|
Lysine hydrochloride (equivalent to lysine:) |
2.84 g (2.27 g) |
2.84 g (2.27 g) |
5.68 g (4.54 g) |
5.68 g (4.54 g) | ||
|
Methionine |
1.96 g |
1.96 g |
3.92 g |
3.92 g | ||
|
Phenylalanine |
3.51 g |
3.51 g |
7.02 g |
7.02 g | ||
|
Threonine |
1.82 g |
1.82 g |
3.64 g |
3.64 g | ||
|
Tryptophan |
0.57 g |
0.57 g |
1.14 g |
1.14 g | ||
|
Valine |
2.60 g |
2.60 g |
5.20 g |
5.20 g | ||
|
Arginine monoglutamate (equivalent to arginine:) (equivalent to glutamic acid:) |
4.98 g (2.70 g) (2.28 g) |
4.98 g (2.70 g) (2.28 g) |
9.96 g (5.40 g) (4.56 g) |
9.96 g (5.40 g) (4.56 g) | ||
|
Histidine hydrochloride monohydrate (equivalent to histidine:) |
1.69 g (1.25 g) |
1.69 g (1.25 g) |
3.38 g (2.50 g) |
3.38 g (2.50 g) | ||
|
Alanine |
4.85 g |
4.85 g |
9.70 g |
9.70 g | ||
|
Aspartic acid |
1.50 g |
1.50 g |
3.00 g |
3.00 g | ||
|
Glutamic acid |
1.22 g |
1.22 g |
2.44 g |
2.44 g | ||
|
Glycine |
1.65 g |
1.65 g |
3.30 g |
3.30 g | ||
|
Proline |
3.40 g |
3.40 g |
6.80 g |
6.80 g | ||
|
Serine |
3.00 g |
3.00 g |
6.00 g |
6.00 g | ||
|
Magnesium acetate tetrahydrate |
0.86 g |
0.86 g |
1.72 g |
1.72 g | ||
|
Sodium acetate trihydrate |
1.56 g |
1.56 g |
3.12 g |
3.12 g | ||
|
Potassium dihydrogen phosphate |
0.78 g |
0.78 g |
1.56 g |
1.56 g | ||
|
Potassium hydroxide |
0.52 g |
0.52 g |
1.04 g |
1.04 g | ||
|
Sodium hydroxide |
0.50 g |
0.50 g |
1.00 g |
1.00 g | ||
|
Glucose monohydrate (equivalent to glucose:) |
88.0 g (80.0 g) |
88.0 g (80.0 g) |
176.0 g (160.0 g) |
176.0 g (160.0 g) | ||
|
Sodium chloride |
0.17 g |
0.17 g |
0.34 g |
0.34 g | ||
|
Calcium chloride dihydrate |
0.37 g |
0.37 g |
0.74 g |
0.74 g |
|
Electrolytes: | ||||||
|
Sodium |
3.0 mmol |
24.0 mmol |
27.0 mmol |
6.0 mmol |
48.0 mmol |
54.0 mmol |
|
Potassium |
15.0 mmol |
15.0 mmol |
30.0 mmol |
30.0 mmol | ||
|
Calcium |
2.5 mmol |
2.5 mmol |
5.0 mmol |
5.0 mmol | ||
|
Magnesium |
4.0 mmol |
4.0 mmol |
8.0 mmol |
8.0 mmol | ||
|
Chloride |
8.0 mmol |
23.6 mmol |
31.6 mmol |
16.0 mmol |
47.2 mmol |
63.2 mmol |
|
Phosphate |
5.7 mmol |
5.7 mmol |
11.4 mmol |
11.4 mmol | ||
|
Acetate |
19.5 mmol |
19.5 mmol |
39.0 mmol |
39.0 mmol |
|
Amino acid content |
40 g |
40 g |
80 g |
80 g | ||
|
Nitrogen content |
5.7 g |
5.7 g |
11.4 g |
11.4 g | ||
|
Carbohydrate content |
80 g |
80 g |
160 g |
160 g |
Excipients
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Infusion bag with two compartments
Amino acids and glucose solutions: clear, colourless or slightly yellowish aqueous solution
|
1000 ml |
2000 ml | |
|
Non-protein energy [kJ (kcal)] |
1340 (320) |
2680 (640) |
|
Total energy [kJ (kcal)] |
2010 (480) |
4020 (960) |
|
Osmolarity |
900 mOsm/l |
900 mOsm/l |
|
pH |
4.8 - 6.0 |
4.8 - 6.0 |
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Parenteral nutrition with Nutriflex Peri is indicated when short term nutritional supplementation is required and enteral nutrition is inadequate or impossible. Such situations may occur following surgery, trauma or burns, or when gastrointestinal absorption of nutrients is impaired.
Nutriflex Peri is also indicated in cases where a central venous catheter is contraindicated because of a high risk of infection.
Nutriflex Peri contains a balanced mixture of essential and non essential amino acids, together with electrolytes and glucose. The glucose provides 56 kcal/g nitrogen.
4.2. Posology and method of administration
The dosage must be adjusted according to individual patient needs but 1000 ml - 2000 ml Nutriflex Peri per day is regarded as a normal dose, sufficient for the majority of circumstances providing 0.6-1.2 g amino acids per kg body weight per day. However, in liver failure it might be necessary to reduce these dosages.
Nutriflex Peri should be administered by continuous infusion at a maximum rate of 2 ml (= 40 drops) per kg BW per hour up to a maximum dosage of 40 ml per kg BW per day.
Nutriflex Peri has an osmolarity of about 900 mOsm/l and as such can be given via a peripheral vein.
Trace elements and vitamin levels should be assessed, particularly in the critically ill or those patients receiving prolonged nutrition, and supplementation may be required on an individual basis.
In order to provide an appropriate input of calories a lipid emulsion may be administered.
4.3. Contraindications
Parenteral nutrition is contraindicated in the case of
- Acute shock
- Inborn errors of amino acid metabolism
- Irreversible hepatic failure
- Severe renal insufficiency without renal replacement therapy
- Babies and infants up to the age of 24 months because of their different nutritional requirements.
4.4. Special warnings and precautions for use
As with all large volume infusion fluids, Nutriflex Peri should be administered with caution to patients with cardiac or renal dysfunction. Care should be exercised in the administration of parenteral nutrition solutions containing amino acids to patients with altered amino acid metabolism, or with hepatic dysfunction.
As with other solutions containing glucose, administration of Nutriflex Peri may lead to hyperglycaemia. Blood glucose levels should be monitored and the rate of infusion adjusted or insulin administered if hyperglycaemia occurs.
Fluid, electrolyte and acid-base balance should be monitored Administration of amino-acid solutions may cause acute folate deficiency and supplementary folic acid should be administered. Vitamin B12 status should be monitored and supplementation given if necessary.
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.
The infusion site should be changed at regular intervals.
4.5. Interactions with other medicinal products and other forms of interaction
Because of the potassium content the efficacy of cardiac glycosides can be reduced.
4.6. Pregnancy and lactation
Category C
Controlled studies in man and animals are not available. For this reason Nutriflex solutions should only be prescribed when the potential benefits outweigh the potential risks to the foetus.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
Nausea may occasionally occur. If the recommended infusion rate is exceeded, vomiting, sweating and flushing may occur. Abnormal results of liver function tests and cholestasis have been reported in some patients receiving parenteral nutrition.
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 at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Signs or overdosage
A osmotic diuresis with a simultaneous loss of amino acids, together with dizziness and nausea.
Treatment
The infusion should be stopped. In severe cases peritoneal dialysis or haemodialysis should be used.
5.1. Pharmacodynamic Properties
Nutriflex Peri 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 aminoacids play a prominent role, being the building blocks for protein synthesis.
In order to ensure a specific utilisation of the aminoacids, 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 two chambers Nutriflex Peri solution can provide the body with the substances required for parenteral nutrition in an appropriate fashion.
Nutriflex Pen solution contains in 1 litre:
• 40 g amino acids (15 different laevoratory amino acids and glycine equivalent to 5.7 g nitrogen.
• 80g glucose, amounting to 1340 carbohydrate kJ (320 kcal). This gives a ratio of 56 kcal/g nitrogen.
• 5.7 mmol of immediately utilisable phosphate.
• electrolytes.
Following intravenous infusion, the constituents of Nutriflex solutions are immediately available for metabolism. A portion of the arninoacids 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..
5.3. Preclinical Safety Data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid monohydrate Water for injections
6.2 Incompatibilities
No additive or other component should be added to the medicinal product unless compatibility has been proven in advance. See also section 6.6.
6.3 Shelf life
Unopened
2 years
After first opening the container
The product should be administered immediately after connecting to infusion set. Partially used containers must not be stored for later use.
After mixing of the contents
Ideally after mixing the two solutions, Nutriflex peri should be administered immediately but it can in special circumstances be stored for up to 7 days at room
temperature and up to 14 days if stored in a refrigerator (including administration time).
6.4 Special precautions for storage
Do not store above 25 °C.
Keep bag in the outer carton in order to protect from light.
6.5 Nature and contents of container
Flexible plastic bag made of a dual-layer film consisting of polyamide (external layer) and polypropylene (internal layer). The container is divided into two compartments, separated by an internal peel seam, of either 400 ml and 600 ml or 800 ml and 1200 ml. Opening the peel seam results in an aseptic mixing of the two solutions.
Each bag is packed in a protective plastic bag.
Nutriflex peri is supplied in two-chamber plastic bags containing:
- 1000 ml (400 ml of amino acids solution + 600 ml of glucose solution)
- 2000 ml (800 ml of amino acids solution + 1200 ml of glucose solution)
Pack sizes: 5 x 1000 ml, 5 x 2000 ml Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements are needed for disposal of container, overwrap and oxygen absorber.
The design of the dual chamber bag permits aseptic mixing of amino acids, glucose and optional fat in the lower chamber. The addition of further electrolytes is possible if required.
Immediately before use the internal peel seam between the two compartments must be opened allowing the respective contents to be aseptically mixed.
Remove the bag from its protective bag and proceed as follows:
- Open out the bag and lay on a solid surface
- Open the peel seam by using pressure with both hands
- Briefly mix the contents of the bag together
An additive port is provided for admixing of supplements to Nutriflex peri.
Only mixtures of known compatibility should be prepared. Information on compatibility of specified mixtures is available from the manufacturer.
When admixing other solutions or fat emulsions to Nutriflex peri, aseptic precautions must be strictly observed. Fat emulsions can be easily admixed by means of a special transfer set.
After infusion, any remaining solution should never be stored for later use. Only completely clear solutions from undamaged containers are to be used.
7. MARKETING AUTHORISATION HOLDER
B Braun Melsungen AG Carl-Braun-Strasse 1 D-34212 Melsungen Germany
8. MARKETING AUTHORISATION NUMBER
PL 03551/0021
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
15th November 1995
10 DATE OF REVISION OF THE TEXT
03/09/2014