Expiration date: 04/2026

The composition and form of issue: 

Kabiven peripheral

Emulsion for infusion in a three-chamber container, presented in four volumes 

composition see in table:

The volume of container, ml	2400	1920	1440
Each camera contains the following solutions, depending on volume of container, ml
Glucose, 11%	1475	1180	885
VAMIN 18 Novum	500	400	300
Intralipid, 20%	425	340	255
The composition after mixing the three cameras
Active ingredients:
soybean oil, g	85	68	51
glucose (dextrose) monohydrate (dextrose anhydrous), g	178 (162)	143 (130)	107 (97)
L-alanine, g	8	6,4	4,8
L-arginine, g	5,6	4,5	3,4
L-aspartic acid, g	1,7	1,4	1
L-valine, g	3,6	2,9	2,2
L-histidine, g	3,4	2,7	2
glycine (aminouxusna acid), g	4	3,2	2,4
L-glutamic acid, g	2,8	2,2	1,7
L-isoleucine, g	2,8	2,2	1,7
L-leucine, g	4	3,2	2,4
L-lysine hydrochloride (lysine), g	5,6 (4,5)	4,5 (3,6)	3,4 (2,7)
L-methionine, g	2,8	2,2	1,7
L-Proline, g	3,4	2,7	2
L-serine, g	2,2	1,8	1,4
L-tyrosine, g	0,12	0,092	0,069
L-threonine, g	2,8	2,2	1,7
L-tryptophan, g	0,95	0,76	0,57
L-phenylalanine, g	4	3,2	2,4
calcium chloride dihydrate (calcium chloride), g	0,49 (0,37)	0,39 (0,3)	0,29 (0,22)
sodium glycerophosphate (anhydrous), g	2,5	2	1,5
magnesium sulfate heptahydrate (magnesium sulfate), g	1,6 (0,8)	1,3 (0,64)	0,99 (0,48)
potassium chloride, g	3	2,4	1,8
sodium acetate trihydrate (sodium acetate), g	4,1 (2,4)	3,3 (2)	2,5 (1,5)
Auxiliary components:
phospholipids of egg yolk, g	5,1	4,1	3,1
glycerol (anhydrous), g	9,4	7,5	5,6
glacial acetic acid	q.s. for pH correction
sodium hydroxide	q.s. for pH correction
water for injection, ml	up to 2400	up to 1920	up to 1440
Contents:
amino acids, g	57	45	34
nitrogen, g	9	7,2	5,4
fats, g	85	68	51
carbohydrates (glucose anhydrous), g	162	130	97
Energy value, kcal	1700	1400	1000
The energy value of non-protein kcal	1500	1200	900
Electrolytes:
sodium, mmol	53	43	32
potassium, mmol	40	32	24
magnesium, mmol	6,7	5,3	4
calcium, mmol	3,3	2,7	2
phosphate, mmol	18	14	11
sulfate, mmol	6,7	5,3	4
chloride, mmol	78	62	47
acetate, mmol	65	52	39
Indicators:
The osmolality, mOsm/kg water	about 830
Osmolarity, mOsm/l	about 750

Pharmacological action

Pharmacological action — makes up for the deficiency of proteins, fats and carbohydrates.

Method of application and doses

Intravenous, drip.

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).

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).

Release form

Emulsion for infusion. In three-chambered plastic container "Biofin", each chamber of which contains one of the solutions: glucose solution, 11% (885, 1180 or 1475 ml, respectively), VAMIN 18 Novum (300, 400 or 500 ml, respectively), Intralipid, 20% (255, 340, or 425 ml, respectively), 1440, 1920 and 2400 ml. Each container along with the antioxidant in the outer plastic bag.

2, 3 or 4 bags in a cardboard box (for hospitals).