Expiration date: 03/2025
The composition and form of issue:
Kabiven Central
Emulsion for infusion in a three-chamber container, presented in four volumes
composition see table:
| The volume of container, ml | 2566 | 2053 | 1540 | 1026 |
| Each camera contains the following solutions, depending on volume of container, ml | ||||
| Glucose, 19% | 1316 | 1053 | 790 | 526 |
| VAMIN 18 Novum | 750 | 600 | 450 | 300 |
| Intralipid, 20% | 500 | 400 | 300 | 200 |
| The composition after mixing the three cameras | ||||
| Active ingredients: | ||||
| soybean oil, g | 100 | 80 | 60 | 40 |
| glucose (dextrose) monohydrate (dextrose anhydrous), g | 275 (250) | 220 (200) | 165 (150) | 110 (100) |
| L-alanine, g | 12 | 9,6 | 7,2 | 4,8 |
| L-arginine, g | 8,5 | 6,8 | 5,1 | 3,4 |
| L-aspartic acid, g | 2,6 | 2 | 1,5 | 1 |
| L-valine, g | 5,5 | 4,4 | 3,3 | 2,2 |
| L-histidine, g | 5,1 | 4,1 | 3,1 | 2 |
| glycine (aminouxusna acid), g | 5,9 | 4,7 | 3,6 | 2,4 |
| L-glutamic acid, g | 4,2 | 3,4 | 2,5 | 1,7 |
| L-isoleucine, g | 4,2 | 3,4 | 2,5 | 1,7 |
| L-leucine, g | 5,9 | 4,7 | 3,6 | 2,4 |
| L-lysine hydrochloride (lysine), g | 8,5 (6,8) | 6,8 (5,4) | 5,1 (4,1) | 3,4 (2,7) |
| L-methionine, g | 4,2 | 3,4 | 2,5 | 1,7 |
| L-Proline, g | 5,1 | 4,1 | 3,1 | 2 |
| L-serine, g | 3,4 | 2,7 | 2 | 1,4 |
| L-tyrosine, g | 0,17 | 0,14 | 0,1 | 0,07 |
| L-threonine, g | 4,2 | 3,4 | 2,5 | 1,7 |
| L-tryptophan, g | 1,4 | 1,1 | 0,86 | 0,57 |
| L-phenylalanine, g | 5,9 | 4,7 | 3,6 | 2,4 |
| calcium chloride dihydrate (calcium chloride), g | 0,74 (0,56) | 0,59 (0,44) | 0,44 (0,33) | 0,29 (0,22) |
| sodium glycerophosphate (anhydrous), g | 3,8 | 3 | 2,3 | 1,5 |
| magnesium sulfate heptahydrate (magnesium sulfate), g | 2,5 (1,2) | 2 (0,96) | 1,5 (0,72) | 0,99 (0,48) |
| potassium chloride, g | 4,5 | 3,6 | 2,7 | 1,8 |
| sodium acetate trihydrate (sodium acetate), g | 6,1 (3,7) | 4,9 (2,9) | 3,7 (2,2) | 2,5 (1,5) |
| Auxiliary components: | ||||
| phospholipids of egg yolk, g | 6 | 4,8 | 3,6 | 2,4 |
| glycerol (anhydrous), g | 11 | 8,8 | 6,6 | 4,4 |
| glacial acetic acid | q.s. for pH correction | |||
| sodium hydroxide | q.s. for pH correction | |||
| water for injection, ml | up to 2566 | up to 2053 | up to 1540 | up to 1026 |
| Contents: | ||||
| amino acids, g | 85 | 68 | 51 | 34 |
| nitrogen, g | 13,5 | 10,8 | 8,1 | 5,4 |
| fats, g | 100 | 80 | 60 | 40 |
| carbohydrates (glucose anhydrous), g | 250 | 200 | 150 | 100 |
| Energy value, kcal | 2300 | 1900 | 1400 | 900 |
| The energy value of non-protein kcal | 2000 | 1600 | 1200 | 800 |
| Electrolytes: | ||||
| sodium, mmol | 80 | 64 | 48 | 32 |
| potassium, mmol | 60 | 48 | 36 | 24 |
| magnesium, mmol | 10 | 8 | 6 | 4 |
| calcium, mmol | 5 | 4 | 3 | 2 |
| phosphate, mmol | 25 | 20 | 15 | 10 |
| sulfate, mmol | 10 | 8 | 6 | 4 |
| chloride, mmol | 116 | 93 | 70 | 46 |
| acetate, mmol | 97 | 78 | 58 | 39 |
| Indicators: | ||||
| The osmolality, mOsm/kg water | about 1230 | |||
| Osmolarity, mOsm/l | about 1060 | |||
Pharmacological action
Pharmacological action — makes up for the deficiency of proteins, fats and carbohydrates.
Method of application and doses
Intravenous, drip.
Only in the Central veins. Infusion can be continued as much time as required by the clinical condition of the patient, on the basis of daily requirement of glucose, lipids and amino acids.
The dosage and infusion rate are determined by the ability of the patient to excrete lipids and metabolize glucose.
Kabiven® Central is available in bags, 4 sizes (for patients with normal, moderately elevated or reduced need for nutrients). To conduct a full parenteral nutrition may need to add vitamins, electrolytes and trace elements.
The dose should be individualized and the choice of bag size to take into account the patient's condition, body weight and nutritional needs.
In obese patients the dose should be set based on ideal body weight.
In patients with moderate or severe catabolic stress in the presence or absence of malnutrition, the whey protein is 1-2 g/kg/day, which corresponds to the needs in nitrogen of 0.15–0.3 g/kg/day. It fits 27-40 ml/kg/day of the drug Kabiven® Central.
In patients without severe catabolic stress the need for amino acids is 0.7–1.3 g/kg/day, which corresponds to the needs in nitrogen of 0.1–0.2 g/kg/day. This corresponds to 19-38 ml/kg/day of the drug Kabiven® Central.
The maximum daily dose for adults is 40 ml/kg/day. This corresponds to one bag (largest size — 2566 ml) for a patient weighing 64 kg and ensures the supply of 1.3 g amino acids/kg/day (0.21 g/kg/day of nitrogen), 31 kcal/kg/day non-protein energy, 3.9 g/kg/day of glucose and 1.6 g/kg/day of lipids. The maximum daily dose depends on the clinical condition of the patient and may vary.
For children the dosage is determined by the ability of the patient to metabolise individual nutrients. Infusion, children (2 to 10 years) should begin with low doses (14-28 ml/kg/day), then the dose should be increased by 10-15 ml/kg/day, maximum 40 ml/kg/day. In children older than 10 years used the same dose as in adults.
The rate of infusion. The infusion rate of the drug Kabiven® Central should not exceed 2.6 ml/kg/h, which corresponds to the speed of infusion of glucose 0.25 g/kg/h, 0.09 g amino acids/kg/h and lipid 0.13 g/kg/h. the recommended duration of infusion of the drug Kabiven® Central is 12-24 hours.
Shelf life after mixing with additives
After opening the clips and mixing the three solutions to the mixture, you can add compatible additives through the port for the introduction of additives.
After the disclosure of locks chemical and physical stability of the mixed contents of the three chambers is maintained for 24 h at 25 °C.
To ensure the microbiological safety of the mixture should be used immediately after the introduction of additives. If the mixture is not used immediately, subject to the observance of asepsis during introduction of the additives, the mixture can be stored till 6 days at 2-8 °C, after which the mixture should be used within 24 h
Guidelines for the preparation of the container "Biofin" to use
The schema container "Biofin" (see Fig. 1).
In the peripheral or Central vein. Infusion can be continued as much time as required by the clinical condition of the patient, on the basis of daily requirement of glucose, lipids and amino acids.
The dosage and infusion rate are determined by the ability of the patient to excrete lipids and metabolize glucose.
Kabiven® peripheral is available in bags of 3 sizes (for patients with normal, moderately elevated or reduced need for nutrients). To conduct a full parenteral nutrition may need to add vitamins, electrolytes and trace elements.
The dose should be individualized and the choice of bag size to take into account the patient's condition, body weight and nutritional needs.
In obese patients the dose should be set based on ideal body weight.
In patients with moderate or severe catabolic stress in the presence or absence of malnutrition, the whey protein is 1-2 g/kg/day, which roughly corresponds to the needs in nitrogen of 0.15–0.3 g/kg/day. The energy demand of 30-50 kcal/kg/day.
In patients without catabolic stress the need for amino acids is 0.7–1 g/kg/day, which is approximately equal to the needs in nitrogen 0.1–0.15 g/kg/day. Energy demand is 20-30 kcal/kg/day. It fits 27-40 ml/kg/day of the drug Kabiven® peripheral.
The maximum daily dose for adults is 40 ml/kg/day. This corresponds to one bag (largest size — 2400 ml) for a patient weighing 64 kg and ensures the supply of 0.96 g/kg/day of amino acids (0.16 g/kg/day of nitrogen), 25 kcal/kg/day non-protein energy, 2.7 g/kg/day of glucose and 1.4 g/kg/day of lipids.
The dosage for children is determined by body's ability to metabolise individual nutrients. Infusion, children (2 to 10 years) should start with low doses of 14-28 ml/kg/day (corresponding to daily intake of lipids, amino acids and glucose 0,49–0,98 g/kg 0,34–0,67 g/kg and 0.95–1.9 g/kg, respectively), then the dose should be increased by 10-15 ml/kg/day, maximum 40 ml/kg/day. In children older than 10 years used the same dose as in adults.
The rate of infusion. The maximum infusion rate of glucose is 0.25 g/kg/h. Rate of administration of amino acids should not exceed 0.1 g/kg/h Intake of lipids should be no more than 0.15 g/kg/h.
The infusion rate of the drug Kabiven® peripheral should not exceed 3.7 ml/kg/h, which corresponds to the speed of infusion of glucose 0.25 g/kg/h, 0.09 g amino acids/kg/h and lipid 0.13 g/kg/h. the recommended duration of infusion of the drug Kabiven® peripheral is 12-24 hours.
Shelf life after mixing with additives
After opening the clips and mixing the three solutions to the mixture, you can add compatible additives through the port for the introduction of additives.
After the disclosure of locks chemical and physical stability of the mixed contents of the three chambers is maintained for 24 h at 25 °C.
To ensure the microbiological safety of the mixture should be used immediately after the introduction of additives. If the mixture is not used immediately, subject to the observance of asepsis during introduction of the additives, the mixture can be stored till 6 days at 2-8 °C, after which the mixture should be used within 24 h
Guidelines for the preparation of the container "Biofin" to use
The schema container "Biofin" (see Fig. 1).
1 — the incision at the external package; 2 — holder; 3 — hole for hanging the package; 4 — separating partition; 5 — the blind port (not used) 6 — port for introduction of the additives; 7 — port infusion system; 8 — oxygen scavenger (in an external package).
1. Removal of the outer package (see Fig. 2, 3).
To put the container on a horizontal surface. Break the external package in the notch by pulling along the edge (Fig. 2).
Remove the outer package, discard oxygen absorber (Fig. 3).
2. Mixing (see Fig. 4-7).
Put triple glazing on a horizontal surface. To minimize the package from the corner by the holder of the diagonal in the direction of the blind port (Fig. 4).
Then hold the folded part with one hand and keeping constant pressure inside the package, applying a force (pressure) with the other hand on the bag, while the vertical partitions is not revealed (Fig. 5).
Vertical partitions are revealed due to pressure generated contents of the package! Horizontal partition do not need to disclose — the contents of the chambers mixes easily after the disclosure only vertical walls (Fig. 6).
Mix the contents of chambers, turning the package 2-3 times (Fig. 7). Note: partitions can be opened to retrieve from the external package after external package can be removed.
3. Connect the infusion system (see Fig. 8-11).
If necessary, the introduction of additives (with confirmed compatibility include specific vitamins, minerals, Dipeptiven) remove (twist off) cap-arrow-from the port of white color immediately before the introduction of additives (Fig. 8).
Holding the base port for the introduction of additives, to enter fully through the center of the membrane the needle and adding a Supplement with confirmed compatibility (Fig. 9). Before the introduction of other additives to be mixed thoroughly by inverting the bag several times.
Connect the infusion system immediately before the needle is inserted to remove the cap from the port blue (Fig. 10).
supporting the bag with a port for the infusion system is up, insert the needle through the membrane, if necessary, turning and pushing her (Fig.11). Use a non-vented infusion system or prevent the access of air to the ventilated system. Note: the inner part of the port sterile.
4. Hanging on the infusion stand (see Fig. 12).
Hang bag on rack with holes on the holder (Fig. 12).
