Intralipid - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

emulsion for infusions

Composition:

1 liter contains:

Intralipid 10% / Intralipid 20%

Active substances

Soybean oil refined 100 g / 200 g

Excipients

Phospholipids of egg yolk 12 g / 12 g

Glycerol (anhydrous) 22 g / 22 g

Sodium hydroxide q.s./q.s.

(for pH correction) to pH8.0 / to pH 8.0

Water for injection up to 1 l / up to 1 l

Osmolality (mOsm / kg water) 300/350

Power. value, kcal / l (kJ / l) 1100 (4600) / 2000 (8400)

pH 7.5-8.5

Description:Homogeneous emulsion of white or white with a cream shade of color.

Pharmacotherapeutic group:Parenteral nutrition

ATX: & nbsp

Fatty emulsions

Pharmacodynamics:

Intralipid - a source of energy and essential fatty acids, contains purified soybean oil, emulsified with purified egg yolk phospholipids.

Soybean oil consists of a mixture of triglycerides predominantly polyunsaturated fatty acids. Phospholipids are separated from the egg yolk. The size of lipid globules and the biological properties of Intralipid are identical to those of chylomicrons.

Indications:

- Parenteral nutrition (as a source of energy and essential fatty acids). Intralipid is especially necessary for conditions associated with hypercatabolism: sepsis, polytrauma, severe burns, etc.

- Lack of essential fatty acids. (For patients with deficiency of essential fatty acids,not capable of independently replenishing the normal balance of essential fatty acids by oral intake).

Contraindications:

Acute stage of shock, hypersensitivity to drug components, pronounced lipid metabolism disorders, for example, in pathological hyperlipidemia.

Carefully:

Diseases that cause lipid metabolism disorders: severe renal and / or hepatic insufficiency, decompensated diabetes mellitus, pancreatitis, hypothyroidism (with concomitant hypertriglyceridemia); allergy to soy protein (only after carrying out allergic tests).

Pregnancy and lactation:Use during pregnancy and lactation is effective and safe.

Dosing and Administration:

Parenteral nutrition.

The dose and route of administration should be determined by the ability to eliminate Intralipid. Elimination of lipids is assessed by determining the concentration of triglycerides in serum.

Method of administration.

Intralipid can be injected through a Y-shaped connector or parallel to the same central or peripheral vein into which a solution of carbohydrates and / or amino acids is introduced.

Intralipid can also be added under aseptic conditions to a plastic (polymeric) container that does not contain phthalate, as part of the "All in One" mixture, which also consists of carbohydrates, amino acids, trace elements, vitamins and dipeptivene. In this case, it is necessary to control the physical stability of the mixture.

Adults. The recommended maximum dose is 3 g of triglycerides / kg / day, which corresponds to 30 ml / kg / day (Intralipid 10%) or 15 ml / kg / day (Intralipid 20%). Intralipid can cover up to 70% of energy needs. The rate of infusion of Intralipid 10% and 20% should not exceed 500 ml in 5 hours.

Newborns and young children. The recommended dose can vary from 0.5 to 4 g triglycerides / kg / day, which corresponds to 5-40 ml / kg / day (Intralipid 10%) or 2.5 - 20 ml / kg / day (Intralipid 20%).

The infusion rate should not exceed 0.17 g of triglycerides / kg / h (4 g / kg / 24 hours). In premature infants and in infants born with low body weight, it is advisable to perform Intralipid infusion continuously throughout the day. The initial dose of 0.5-1 g / kg / day can be increased by 0.5-1 g / kg / day to a dose of 2 g / kg / day. Only with strict control of serum triglyceride concentrations,liver tests and oxygen saturation of blood can be further increased to 4 g / kg / day. Do not attempt to exceed this level in order to reimburse the previously missed dose.

Lack of essential fatty acids.

To prevent or correct the insufficiency of unsaturated fatty acids, the introduction of Intralipid is recommended, ensuring the intake of a sufficient amount of linoleic and linolenic acids and 4-8% of non-protein energy. In the stressful state in combination with the deficiency of essential fatty acids, it is necessary to increase the amount of Intralipid administered.

Precautions for use

When using Intralipid, control of triglycerides in blood serum is necessary. It is necessary to pay special attention to the use of Intralipid in newborns and premature babies with hyperbilirubinemia, as well as suspected pulmonary hypertension. In newborns, especially premature babies, long-term parenteral nutrition requires control of the number of platelets, liver samples.

Intralipid may affect the results of certain laboratory parameters (bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin, etc.).As a consequence, it is desirable to carry out these studies after 5-6 hours after completion of the drug infusion.

Any remnants of the drug from the open container must be destroyed.

Side effects:

Rarely, fever, nausea, or vomiting (frequency less than 1%).

Data on other adverse reactions associated with the administration of Intralipid are extremely rare, less than 1 to 1 million infusions.

Immediate, or early adverse reactions:

allergic reactions (anaphylactic reactions, rashes and urticaria on the skin), respiratory disorders (tachypnea) and circulatory disorders (decrease or increase in blood pressure), hemolysis, reticulocytosis, headache, abdominal pain, fatigue, priapism (frequency <0, 0001% ).

Delayed adverse reactions:

with prolonged use of Intralipida in newborns - thrombocytopenia. There may be a temporary increase in hepatic samples against the background of prolonged use of Intralipid (frequency <0.0001%). All symptoms are usually reversible upon discontinuation of Intralipid infusion.

Overdose:

Symptoms:

Violation of the elimination of Intralipid may lead to the development of the syndrome of excessive fat load, which, in turn, can lead to impaired renal function or the occurrence of infection.The syndrome of excessive fat load is characterized by hyperlipidemia, fever, fatty infiltration, impaired function of various organs and coma.

Treatment:

Discontinuation of Intralipid infusion leads to the disappearance of all symptoms.

Interaction:

A joint administration with Intralipid with the following preparations is allowed:

1. Vitalipid is an adult and Vitalipid is a child,

2. Solovit.

Mixing solutions should be carried out under aseptic conditions.

Heparin causes a transient increase in lipolysis in the plasma, which leads to a temporary decrease in the clearance of triglycerides due to the inhibition of lipoprotein lipase. Insulin can also affect the activity of lipase, but there is no evidence of an adverse effect of this factor on the therapeutic value of the drug.

Effect on the ability to drive transp. cf. and fur:It was not reported on the effect of the drug on the ability to drive and work with machinery.

Form release / dosage:

Emulsion for infusions of 10% and 20%.

Packaging:

For 100 ml, 250 ml or 500 ml in bottles of colorless glass, sealed with a butyl rubber stopper, run by an aluminum cap-control the first dissection.For 10 or 12 vials with or without plastic holders in a cardboard box with instructions for use.

Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:P N006504

Date of registration:14.11.2011 / 19.05.2017

Expiration Date:Unlimited

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS KABI DEUTSCHLAND, GmbH Germany

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp26.10.2017

Illustrated instructions

Instructions

Intralipid (Intralipid)