Intralipid

General characteristics. Structure:

Active ingredient: 100 g or 200 g of oil of soy cleared.

Osmolality 300 ¼Äß¼/kg H2O, energy value of 1100 kcal/l (4600 kJ/l), pH 7.5-8.5.

Excipients: phospholipids of an egg yolk, глицерол (anhydrous), sodium hydroxide - q.s. to pH 8 (for correction pH), water for injections.

Pharmacological properties:

Pharmacodynamics. Intralipid - an energy source and irreplaceable fatty acids, contains the purified soy oil emulsified with the purified phospholipids of an egg yolk. Soy oil consists of mix of triglycerides preferential of polyunsaturated fatty acids. Phospholipids are emitted from an egg yolk. The size lipidic глобул and biological properties of Intralipid are identical to that for chylomicrons.

Indications to use:

— Parenteral food (as an energy source and irreplaceable fatty acids). Intralipid is especially necessary at the states connected with a hyper catabolism: sepsis, polyinjury, heavy burns and др;

— Insufficiency of essential fatty acids. (For patients with the deficit of irreplaceable fatty acids not capable to independent completion of normal balance of essential fatty acids by peroral consumption).

Route of administration and doses:

Parenteral food. The dose and a way of introduction have to be defined by ability to Intralipid's elimination. Adults. The recommended maximum dose - 3 g of triglycerides/kg/days that corresponds to 30 ml/kg/days (Intralipid of 10%) or 15 ml/kg/days (Intralipid of 20%). Intralipid can cover up to 70% of energy demands. Speed of infusion of Intralipid of 10% and 20% should not exceed 500 ml in 5 hours.

Newborns and children of early age. The recommended dose can vary from 0,5 to 4 g of triglycerides/kg/days that corresponds to 5-40 ml/kg/days (Intralipid of 10%) or 2,5-20 ml/kg/days (Intralipid of 20%).

Speed of infusion should not exceed 0,17 g of triglycerides/kg/h (4 g/kg / 24 hour). At premature and at the children born with low body weight it is desirable to carry out Intralipid's infusion continuously within a day. The initial dose making 0,5-1 g/kg/days can be increased by 0,5-1 g/kg/days to a dose of 2 g/kg/days. Only at strict control of concentration of triglycerides of serum, hepatic tests and saturation of blood further increase in a dose up to 4 g/kg/days can be made by oxygen. It is not necessary to make attempts of exceeding of this level for the purpose of compensation of the dose passed before.

Insufficiency of essential fatty acids: For prevention or correction of insufficiency of unsaturated fatty acids Intralipid's introduction providing receipt of enough linoleic and linolenic acids and 4 - 8% of nonprotein energy is recommended. At a stressful state in combination with insufficiency of essential fatty acids it is necessary to increase the number of the entered Intralipid. Way of introduction: Intralipid it is possible to enter via the Y-shaped connector or in parallel into the same central or peripheral vein into which solution of carbohydrates and/or amino acids is entered.

Intralipid can also in aseptic conditions be added to the plastic (polymeric) capacity which is not containing phthalate as a part of the general mix "In total in One" consisting also of carbohydrates, amino acids, microelements and vitamins and Dipeptiven. In this case control of physical stability of mix is necessary.

Elimination of lipids is estimated by definition of concentration of triglycerides in serum.

Features of use:

Use at pregnancy and feeding by a breast. Use during pregnancy and a lactation is effective and safe.

Use at abnormal liver functions. With care to use at a heavy liver failure.

Use at renal failures. With care to use at a heavy renal failure.

Special instructions. At Intralipid's use control of triglycerides in blood serum is necessary. Special attention when using Intralipid's at newborn and premature children with a hyperbilirubinemia is necessary, and also at suspicion of pulmonary hypertensia. At newborns, especially premature, at long carrying out parenteral food control of number of thrombocytes, hepatic tests is necessary.

Intralipid can exert impact on results of certain laboratory parameters (bilirubin, a lactate dehydrogenase, blood saturation by oxygen, hemoglobin, etc.). Thereof it is desirable to conduct the specified researches 5-6 hours later after completion of infusions of drug. Any remains of drug from an open container have to be destroyed.

Side effects:

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

Data on other side reactions connected with Intralipid's introduction are extremely rare, less than 1 on 1 million infusions.

Immediate, or early, side reactions: allergic reactions (anaphylactic reactions, rash and urticaria on skin), disorders of breath (tachypnea) and circulator disturbances (decrease or increase in arterial pressure), hemolysis, a reticulocytosis, a headache, abdominal pains, increased fatigue, a priapism (frequency <0, 0001%).

The delayed side reactions: at prolonged use of Intralipid at newborns - thrombocytopenia. Perhaps temporary increase in hepatic tests against the background of long use of Intralipid (frequency <0,0001%). All symptoms are usually reversible at the termination of infusions of Intralipid.

Interaction with other medicines:

Joint introduction with Intralipid of the following drugs is allowed:

1. Vitalipid adult and Vitalipid children's,

2. Soluvit.

Mixing of solutions has to be carried out in aseptic conditions. Heparin causes tranzitorny increase in a lipolysis in plasma that leads to temporary decrease in clearance of triglycerides owing to oppression of a lipoprotein lipase. Insulin can influence activity of a lipase too, but data on adverse influence of this factor on the therapeutic value of drug are absent.

Contraindications:

— acute stage of shock;

— hypersensitivity to drug components;

— the expressed disturbances of lipidic exchange, for example, at a pathological lipidemia.

With care: the diseases causing lipid metabolism disturbance: a heavy renal and/or liver failure, a dekompensirovanny diabetes mellitus, pancreatitis, a hypothyroidism (at the accompanying gipertriglitseridemiya); an allergy to soy protein (only after carrying out allergy tests).

Overdose:

Symptoms: can lead disturbance of elimination of Intralipid to development of a syndrome of excessive fatty loading which, in turn, can entail a renal failure or developing of an infection. The syndrome of excessive fatty loading is characterized by a lipidemia, fever, fatty infiltration, dysfunction of various bodies and a coma.

Treatment: the termination of infusions of Intralipid leads to disappearance of all symptoms.

Storage conditions:

To store in protected from light at a temperature not above 25 °C. Not to freeze! To store in the place, unavailable to children. Period of validity 2 years. Not to use after the term specified on packaging.

Issue conditions:

According to the recipe

Packaging:

100 ml - bottles of colourless glass (10) - a box cardboard.
100 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.
100 ml - bottles of colourless glass (12) - a box cardboard.
100 ml - bottles of colourless glass with holders plastic (12) - boxes cardboard.
250 ml - bottles of colourless glass (10) - a box cardboard.
250 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.
250 ml - bottles of colourless glass (12) - a box cardboard.
250 ml - bottles of colourless glass with holders plastic (12) - boxes cardboard.
500 ml - bottles of colourless glass (10) - a box cardboard.
500 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.
500 ml - bottles of colourless glass (12) - a box cardboard.
500 ml - bottles of colourless glass with holders plastic (12) - boxes cardboard.