Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Soya Oil, Quantity: 12.36 g; Olive Oil, Quantity: 10.3 g; medium chain triglycerides, Quantity: 10.3 g; Fish oil - rich in Omega-3 acids, Quantity: 8.24 g
Baxter Healthcare Pty Ltd
Injection, emulsion
Excipient Ingredients: egg lecithin; glycerol; sodium oleate; dl-alpha-tocopherol; sodium hydroxide; water for injections
Intravenous Infusion
1085 mL (551 mL AAS, 328 mL GS, 206 mL LE)
Not Scheduled after consideration by Committee
Finomel is indicated for parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.
Visual Identification: Homogenous, milky white liquid; Container Type: Bag; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2019-06-28
FINOMEL (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium sulfate heptahydrate, sodium glycerophosphate hydrate, zinc sulfate heptahydrate, glucose monohydrate, soya oil, olive oil, medium chain triglycerides and fish oil-rich omega-3 acids) Version 3.0 1 of 23 AUSTRALIAN PRODUCT INFORMATION – FINOMEL EMULSION FOR INTRAVENOUS INFUSION (ALANINE, ARGININE, GLYCINE, HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE HYDROCHLORIDE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, THREONINE, TRYPTOPHAN, TYROSINE, VALINE, SODIUM ACETATE TRIHYDRATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM SULFATE HEPTAHYDRATE, SODIUM GLYCEROPHOSPHATE HYDRATE, ZINC SULFATE HEPTAHYDRATE, GLUCOSE MONOHYDRATE, SOYA OIL, OLIVE OIL, MEDIUM CHAIN TRIGLYCERIDES AND FISH OIL-RICH OMEGA-3 ACIDS) 1 NAME OF THE MEDICINE Alanine, arginine, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium sulfate heptahydrate, sodium glycerophosphate hydrate, zinc sulfate heptahydrate, glucose monohydrate, soya oil, olive oil, medium chain triglycerides and fish oil-rich omega-3 acids. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FINOMEL emulsion for infusion is presented in a 3-compartment plastic bag. Each bag contains a sterile non-pyrogenic combination of a 10% amino acid solution with electrolytes, a 20% lipid emulsion and 42% glucose solution for FINOMEL. The general compositions of the reconstituted formulations are summarised below: FINOMEL 1085ML 1435ML 1820ML Nitrogen (g) 9.1 12.0 15.3 Amino acids (g) 55 73 92 Glucose (g) 138 182 231 Lipids (g) 41 55 69 Total electrolytes (g) 7.6 10.1 12.8 ATTACHMENT 2B FINOMEL (alanine, arginine, glycine, histidine, isoleucine, leucine, lysin Lugege kogu dokumenti