Download Nutriflex® Specific Product Information may differ from country to

Product Description
Lipoplus® 1 200 mg/ml
Composition
1000 ml of emulsion contains:
Medium-chain triglycerides:
100.0 g
Soybean oil, refined:
80.0 g
Omega-3-acid triglycerides:
20.0 g
Essential fatty acid content per liter:
Linoleic acid (omega-6):
48.0 - 58.0 g
Alpha-linolenic acid (omega-3):
5.0 - 11.0 g
Eicosa-pentaenoic acid and docosahexaenoic acid:
8.6 - 17.2 g
Caloric content per liter:
7,900 kJ ≈ 1,910 kcal
Osmolality:
approx. 410 mOsm/kg
Titration acidity or alkalinity (to pH 7.4): less than 0.5 mmol/l NaOH or HCl
pH:
6.5 - 8.5
Indications
Source of calories and essential omega-6 fatty acids and omega-3 fatty acids as a component of a parenteral nutrition regimen for adults.
Contraindications
Lipoplus® must not be used in any of the following conditions:
– Severe hyperlipidemia
– Serious blood clotting disorders
– Acidosis
– Intrahepatic cholestasis
– Severe liver failure
– Severe kidney failure
– Acute phase of myocardial infarction or stroke
– Acute thromboembolic disease, fat embolism
– Known hypersensitivity to egg, fish, or soybean protein
The following conditions are general contraindications to parenteral nutrition.
– Unstable hemodynamic status with compromised vital functions (conditions of collapse and shock)
– Fluid overload
– Acute pulmonary edema
Special warnings and precautions for use
Before infusing a fat emulsion together with other solutions via a Y connector or bypass set, the compatibility of these fluids should be checked, especially when co-administering carrier solutions to which drugs
have been added. Particular caution should be exercised when co-infusing solutions that contain divalent
electrolytes (such as calcium).
The emulsion should always be brought to room temperture prior to infusion.
If filters are used, these must be permeable to fat emulsions.
Serum triglycerides should be monitored during the infusion of Lipoplus®. In patients with suspected disorders of lipid metabolism, fasting lipemia should be ruled out before the start of the infusion.
Hypertriglyceridemia 12 hours after the administration of fat is also indicative of abnormal lipid metabolism.
Transient hypertriglyceridemia or elevated blood glucose levels may arise from the patient's metabolic
status. If the plasma triglyceride concentration rises to more than 3 mmol/l during administration of the
fat emulsion, it is recommended to reduce the infusion rate. If the plasma triglyceride concentration still
remains higher than 3 mmol/l, the infusion should be stopped until the plasma triglyceride concentration
normalizes.
Electrolytes, water balance or body weight, acid-base balance, blood glucose levels, and, during long-term
administration, blood counts, coagulation status, and liver function should be monitored.
There is as yet no clinical experience of the use of Lipoplus® in children, and there is only limited experience of its use in patients with diabetes mellitus or renal impairment.
There is as yet only limited experience of the use of Lipoplus® for periods longer than seven days.
Caution should be exercised in patients with conditions associated with impaired lipid metabolism, such
as renal insufficiency, uncontrolled diabetes mellitus, pancreatitis, hepatic insufficiency, hypothyroidism (in the presence of hypertriglyceridemia), and sepsis.
Lipids may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen
saturation) when the blood sample is taken before the lipids have been eliminated from the bloodstream.
In most patients this takes 5 to 6 hours beyond the end of the infusion.
The use of fat emulsions as the sole source of calories may give rise to metabolic acidosis. This may be
avoided by the concurrent infusion of carbohydrates. It is therefore recommended to infuse an adequate
quantity of intravenous carbohydrates or an amino acid solution containing carbohydrates along with the
fat emulsion.
Vitamin E can interfere with the effect of vitamin K in clotting factor synthesis. This should be borne in
mind in patients with blood clotting disorders or suspected vitamin K deficiency.
Subject to sale by pharmacists only.
B. Braun Melsungen AG
D-34209 Melsungen
1. Trade name in some countries: Lipidem®
Nutriflex®
Nutriflex®
Composition
Nutriflex® (mixed and ready for use 1000 ml)
Active ingredients
Nutriflex®
peri
(40/80)
L-isoleucine
2.34 g
L-leucine
3.13 g
L-lysine HCl
2.84 g
(equivalent to L-lysine)
2.27 g
L-methionine
1.96 g
L-phenylalanine
3.51 g
L-threonine
1.82 g
L-tryptophan
0.57 g
L-valine
2.60 g
Arginine glutamate
4.98 g
(equivalent to Arginine
2.70 g
and to Glutamic acid)
2.28 g
L-histidine · HCl · H2O
1.69 g
(equivalent to Histidine)
1.25 g
L-alanine
4.85 g
L-aspartic acid
1.50 g
L-(+)-glutamic acid
1.22 g
Amino acetic acid
1.65 g
L-proline
3.40 g
L-serine
3.00 g
Glucose · H2O
88.00 g
(equivalent to anhydrous glucose)
80.00 g
basal
(32/125)
1.88 g
2.50 g
2.27 g
1.82 g
1.56 g
2.81 g
1.45 g
0.46 g
2.08 g
3.98 g
2.16 g
1.82 g
1.35 g
1.00 g
3.88 g
1.20 g
0.98 g
1.32 g
2.72 g
2.40 g
137.50 g
125.00 g
plus
(48/150)
2.82 g
3.76 g
3.41 g
2.73 g
2.35 g
4.21 g
2.18 g
0.68 g
3.12 g
5.98 g
3.24 g
2.74 g
2.03 g
1.50 g
5.82 g
1.80 g
1.47 g
1.98 g
4.08 g
3.60 g
165.00 g
150.00 g
special
(70/240)
4.11 g
5.48 g
4.97 g
3.98 g
3.42 g
6.15 g
3.18 g
1.00 g
4.54 g
8.72 g
4.73 g
3.99 g
2.96 g
2.19 g
8.49 g
2.63 g
2.15 g
2.89 g
5.95 g
5.25 g
264.00 g
240.00 g
Sodium chloride
0.17 g
Calcium chloride · 2H2O
0.37 g
Magnesium acetate · 4H2O
0.86 g
Sodium dihydrogen phosphate · 2H2O
–
Potassium dihydrogen phosphate
0.78 g
Sodium acetate · 3H2O
1.56 g
Potassium hydroxide
0.52 g
Sodium hydroxide
0.50 g
Water for injections to
1000 ml
1.40 g
0.53 g
1.23 g
–
1.74 g
3.20 g
0.96 g
0.10 g
1000 ml
–
0.53 g
1.23 g
3.12 g
–
1.56 g
1.40 g
0.23 g
1000 ml
–
0.60 g
1.08 g
–
2.00 g
1.63 g
0.62 g
1.14 g
1000 ml
Total amino acids (g/l)
Total nitrogen (g/l)
Total carbohydrates (g/l)
Total energy kJ/l
(kcal/l)
Non-protein energy kJ/l
(kcal/l)
Osmolarity (mOsm/l)
Electrolytes:
+
Na
K+
++
Ca
Mg++
Cl–
H2PO4–
Acetate
basal
(32/125)
32
4.6
125
2640
(630)
2090
(500)
1140
plus
(48/150)
48
6.8
150
3310
(790)
2510
(600)
1400
special
(70/240)
70
10.0
240
5190
(1240)
4020
(960)
2100
mmol
mmol
mmol
mmol
27.0
15.0
2.5
4.0
31.6
5.7
19.5
49.9
30.0
3.6
5.7
50.0
12.8
35.0
37.2
25.0
3.6
5.7
35.5
20.0
22.9
40.5
25.7
4.1
5.0
49.5
14.7
22.0
Indication
Parenteral nutrition.
Contraindications
Nutriflex® is contraindicated in cases of hyperglycaemia, disorders of amino acid metabolism, manifest
congestive cardiac failure, untreated shock, overhydration, enhanced plasma potassium levels, acidosis. In
hepatic or renal insufficiency the dosage is to be individually adjusted. Because of the specific composition of the nutrients the use of Nutriflex® in newborns, infants and children up to the 2nd year of life is
not recommended.
Precautions
Serum ionogram, water balance, blood glucose levels and acid-base balance are to be monitored. Possible
intolerance reactions (nausea, vomiting, chills) and renal loss of glucose and amino acids with subsequent
amino acid imbalances are due to a too rapid infusion rate.
Adverse reactions
Adverse reactions are not to be expected, and besides have not been reported so far, if contraindications,
dosage recommendations, warnings and precautions are observed.
Subject to sale by pharmacists only.
B. Braun Melsungen AG
D-34209 Melsungen
Specific Product Information may differ from country to country
peri
(40/80)
40
5.7
80
2010
(480)
1340
(320)
900