Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
SOYBEAN OIL; EGG PHOSPHOLIPIDS; SAFFLOWER OIL
HOSPIRA HEALTHCARE ULC
B05BA02
FAT EMULSIONS
5%; 0.9%; 5%
EMULSION
SOYBEAN OIL 5%; EGG PHOSPHOLIPIDS 0.9%; SAFFLOWER OIL 5%
INTRAVENOUS
500ML
Ethical
CALORIC AGENTS
Active ingredient group (AIG) number: 0318894002; AHFS:
CANCELLED POST MARKET
2014-08-01
PRODUCT MONOGRAPH LIPOSYN® II 10% Injection LIPOSYN® II 20% Injection Intravenous Fat Emulsion 10% and 20% Intravenous Nutrient Supplement Hospira Healthcare Corporation DATE OF PREPARATION: 5400 Côte-de-Liesse January 13, 2005 Town of Mount Royal (QC) CANADA H4P 1A5 Control # 096408 - 2 - NAMES OF DRUG LIPOSYN® II 10% Injection LIPOSYN® II 20% Injection Intravenous Fat Emulsion 10% and 20% THERAPEUTIC CLASSIFICATION Intravenous Nutrient Supplement ACTION LIPOSYN® II Injection (Intravenous Fat Emulsion 10% and 20%) provides the patient requiring parenteral nutrition with a source of calories and the essential fatty acids normally obtained from a nutritionally complete oral diet. The supplemental polyunsaturated fat prevents biochemical changes of essential fatty acid deficiency (EFAD) and prevents and reverses EFAD clinical manifestations (scaliness of skin, growth retardation, poor wound healing, sparse hair growth). The infused fat particles are cleared from the bloodstream in a manner thought to be similar to the clearing of chylomicrons. INDICATIONS AND CLINICAL USE LIPOSYN® II Injection (Intravenous Fat Emulsion 10% and 20%) is indicated as a source of calories for patients requiring parenteral nutrition. This includes pre- and post-operative nutritional disorders and nutritive disorders resulting from decreased or inhibited intestinal absorption, as with tumours of the digestive tract, or in ulcerative colitis and terminal ileitis. LIPOSYN® II Injection is also indicated in burn cases, where nitrogen loss can be excessive, in prolonged states of unconsciousness if tube feeding is inadvisable and in cachexia due to serious diseases other than of the alimentary tract. Where such nutrition is required for extended periods of time (more than five days), LIPOSYN® II Injection is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ratio) and the clinical manifestations of EFAD. CONTRAINDICATIONS Přečtěte si celý dokument