Medicinal Products

PERIKABIVEN 1500 KCAL Emulsion for infusion Box of 2 Pockets with three compartments of 2400 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active Ingredients: Soybean Oil, Glucose, Alanine, Arginine, Aspartic Acid, Glutamic Acid (E620), Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine, Chloride calcium, glycerophosph
laboratory: Fresenius Kabi France

Injectable emulsion for IV infusion
All forms

Indication

Parenteral nutrition in adults and children over 2 years of age, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosage PERIKABIVEN 1500 KCAL Emulsion for infusion Box of 2 Pockets with three compartments of 2400 ml

Patients' ability to remove lipids and metabolize glucose will determine dosage and infusion rate, see warnings and precautions for use.
Dosage:
The dose administered should be individualized and the choice of pocket volume should be made according to the patient's clinical condition, body weight and nutritional requirements.
- In adults:
. Nitrogen requirements to maintain body protein mass depend on the clinical condition of the patient (eg, nutritional status and degree of stress catabolism). The requirement is 0.10-0.15 g Nitrogen / kg body weight / day for normal nutritional status. For patients in a state of moderate to high metabolic stress, with or without malnutrition, the requirements are in the range of 0.15-0.30 g of nitrogen per kg of body weight / day (1.0- 2.0 g of amino acids per kg of body weight / day). The usually estimated glucose and lipid requirements are 2.0-6.0 g for glucose and 1.0-2.0 g for lipids per pound of body weight / day.
. The total energy requirement depends on the clinical condition of the patient and is most often between 20-30 kcal / kg body weight / day. In obese patients the intakes should be based on the estimated ideal weight.
. PERIKABIVEN exists in three presentations for patients whose nutritional needs are moderately increased, baseline or low. As part of a total parenteral nutrition, it may be necessary to provide in addition to trace elements, vitamins and electrolytes.
. The dose of 0.10-0.20 g of nitrogen / kg of body weight / day (0.7-1.0 g of amino acids per kg of body weight / day) and a total energy intake of 20- 30 kcal / kg of body weight / day corresponds to approximately 27-40 ml of PERIKABIVEN per kg of body weight / day.
- In children:
The ability to metabolize nutrients must determine the dosage.
. Generally, for young children (2-10 years), infusion should start with a low dosage such as 14-28 ml / kg (corresponding to 0.49-0.98 g amino acids / kg / day). and 0.95-1.9 g glucose / kg / day) then will be increased in increments of 10-15 ml / kg / day to a maximum dosage of 40 ml / kg / day.
. For children over the age of 10, the adult dosage may be used.
- Infusion rate:
The maximum perfusion rate for glucose is 0.25 g / kg / hour.
Amino acid intake should not exceed 0.1 g / kg / hour.
The fat intake should not exceed 0.15 g / kg / hour.
The infusion rate of this emulsion should not exceed 3.7 ml / kg of body weight / hour (corresponding to 0.25 g of glucose, 0.09 g of amino acids and 0.13 g of lipids / kg of body weight).
The recommended infusion time of a PERIKABIVEN pouch is 12 to 24 hours.
- Maximum daily dosage:
. It is 40 ml / kg / day. This corresponds to the administration of a pocket (of the largest capacity) for a patient of 64 kg who will receive 0.96 g of amino acids / kg / day (0.16 g of nitrogen / kg / day) a non-protein caloric intake of 25 kcal / kg / day (2.7 g glucose / kg / day and 1.4 g lipid / kg / day).
. The maximum daily dosage varies depending on the clinical condition of the patient and can even be changed from one day to the next.
Mode and duration of administration:
PERFUSION BY CENTRAL OR PERIPHERAL VEIN.
- Administration may be continued as long as the clinical condition of the patient makes it necessary.
- To reduce the risk of thrombophlebitis (in the peripheral vein), it is advisable to change the infusion site daily.

Against indications

- Known hypersensitivity to egg or soy protein, or to any of the excipients.
- Hyperlipidemia important.
- Severe hepatic insufficiency.
- Severe disorders of blood coagulation.
- Congenital abnormalities of amino acid metabolism.
- Severe renal insufficiency without possibility of hemofiltration or dialysis.
- State of shock in the acute phase.
- Hyperglycemia requiring the administration of more than 6 insulin units / hour.
- High and pathological plasma levels of one of the electrolytes included in the product.
- Macrophage activation syndrome.
- General contraindications for infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure, and hypotonic dehydration.
- Unstable states, for example: severe post-traumatic state, decompensated diabetes, acute phase of myocardial infarction, metabolic acidosis, severe infection and hyperosmolar coma.
- Newborn and child under 2 years of age.

Perikabiven side effects

PERIKABIVEN infusion may result in increased body temperature (<3% incidence) and, less frequently, chills, chills, and nausea / vomiting (incidence <1%).
- Transient increases in liver enzymes under parenteral nutrition have also been reported.
As with any hypertonic solution, thrombophlebitis may occur in the case of peripheral vein administration.
- Other adverse effects attributable to the constituents of PERIKABIVEN are extremely rare.
- Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (eg tachypnea), effects on circulation (eg hypertension or hypotension) have been described.
- Haemolysis, reticulocytosis, abdominal pain, headache, nausea, vomiting, fatigue and priapism have also been described.
- Fat overload syndrome:
. A decrease in the lipid elimination capacity (contained in PERIKABIVEN) may lead to a "fat overload syndrome" which may be due to an overdose, but may also, at the recommended infusion rate, be associated with a sudden change the clinical condition of the patient, such as impaired renal or hepatic function.
. The occurrence of an overload syndrome is characterized by: hyperlipidemia, fever, hepatomegaly, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders and coma.
. All these symptoms are usually reversible if the infusion of the lipid emulsion is interrupted.

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