FINOMEL 1085mL intravenous infusion bag (10% amino acid with electrolyte 42% glucose and 20% lipid emulsion)

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

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

Fáanlegur frá:

Baxter Healthcare Pty Ltd

Lyfjaform:

Injection, emulsion

Samsetning:

Excipient Ingredients: egg lecithin; glycerol; sodium oleate; dl-alpha-tocopherol; sodium hydroxide; water for injections

Stjórnsýsluleið:

Intravenous Infusion

Einingar í pakka:

1085 mL (551 mL AAS, 328 mL GS, 206 mL LE)

Gerð lyfseðils:

Not Scheduled after consideration by Committee

Ábendingar:

Finomel is indicated for parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.

Vörulýsing:

Visual Identification: Homogenous, milky white liquid; Container Type: Bag; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2019-06-28

Vara einkenni

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