Ivelip 20% is a sterile, non pyrogenic lipid emulsion.

Composition

Each one litre of Ivelip	20% contains
Soybean oil	200 g
Egg phosphatides	12 g
Glycerol	25 g
Sodium Oleate	0.3 g
Osmolarity (approx)	270 mOsm/l
Energy content (approx)	2000 Kcal/l

Indication
Ivelip 20% is indicated as a source of energy and essential fatty acids for patients requiring parenteral nutrition.

Contra Indication
The administration of Ivelip 20% is contra-indicated in patients demonstrating disturbances in normal fat metabolism such as pathologic hiperlipidemia, lipoid nephrosis and acute pancreatitis if accompanied by hyperlipaemia and severe hepatic insufficiency.

Warning
2. Warnings Caution should be exercised in administering Ivelip 20% to patients with severe liver damage, pulmonary disease, anaemia or blood coagulation disorders or when there is danger of fat embolism. Premature and small for gestational age infants have poor cleareance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to different administration of then the maximum recommended doses di these patients in order to decrease the likehood of intravenous fat overloaded. It is not known whether Ivelip 20% can cause total harm when administered to pregnant women or can affect reproductive capacity. This matter should be taken into consideration when this therapy is indicated in pregnant women 3. Precautions During long term parenteral nutrition with Ivelip 20% liver function tests should be performed. Should these tests indicate impaired liver function, the therapy should be done in neonatal patients receiving Ivelip 20%. Acute (immediate) reactions noted include allergic reactions, hyperlipaemia, nausea, vomiting, cyanosis, dyspnoea, sweating, headache, chest and back pain, flushing, sleepiness, hyperthermia, dizziness, thrombocytopneia (rarely in neonates), hypercoagulability, slight pressure over the eyes and irritation at the site of infusion. Chronic (delayed) reactions that have been noted with long term lipid emulsion therapies include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leucopenia, transient increases in liver function tests, and overloading syndrome (local seizures, fever, leukocytosis, splenomegaly and shock). The deposition of brown pigmentation (“intravenous fat pigment”) in the reticuloendothelial tissue of the liver has also been reported, although the cause and signification of this phenomenon is unknown.

Dosage
1. Dosage Adult patients: 1-3 g of lipids/kg/24 hours Pediatric patients: 0,5-4 g of lipids/kg/24 hours 2. Route of administration Ivelip 20% alone could be administered in a peripheral vein. Ivelip 20% in co-administration or as mixture should be administered in a peripheral or a central vein according to the final osmolarity of the solution infused.

Direction
Ivelip 20% is usually administered with a source of energy and protein appropriate for needs of the patient, either by co-administration or as a mixture. Ivelip 20% may be included in the composition of nutritive mixtures combining carbohydrates, proteins, electrolytes, trace elements and vitamins, when compabilitiy and stability are known.

Stability
Storage temperatures should not exceed 250C. Protect from freezing. Do not use if separation of the emulsion is observed. Filters should not be used for administration of Ivelip 20%. The 1 litre presentation of Ivelip 20% is a bulk source container for pharmacy use; it is not for direct intravenous infusion. Do not store partly-used containers. Discard all equipment after use.