Medicinal Products

PERIKABIVEN 1,700 KCAL

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, Sodium Glycerophosphate, Magnesium Sulphate (E518), Potassium Chloride (E508), Sodium Acetate
laboratory: Fresenius Kabi France

Injectable emulsion for IV infusion
Box of 3 Pockets with three compartments (Polyp-co-Ethylene) of 2400 ml
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 1 700 KCAL Injectable emulsion for infusion IV Box of 3 Pockets with three compartments (Polyp-co-Ethylene) 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

- Hypersensitivity to egg, soy or peanut proteins, or to any other active substance or excipient contained in the product.
- 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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