Olimel N12-640 emulsion for intravenous infusion bag.

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Olive Oil, Quantity: 140 g/L; Soya Oil, Quantity: 35 g/L

Dostupno od:

Baxter Healthcare Pty Ltd

Farmaceutski oblik:

Injection

Sastav:

Excipient Ingredients: egg lecithin; glycerol; sodium oleate; sodium hydroxide; nitrogen; water for injections

Administracija rute:

Intravenous Infusion

Jedinice u paketu:

1500 mL, 2000 mL, 650 mL, 1000 mL

Tip recepta:

Not scheduled. Not considered by committee

Terapijske indikacije:

OLIMEL is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

Proizvod sažetak:

Visual Identification: Homogenous, milky white liquid; Container Type: Multiple containers; Container Material: Composite plastic laminate; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2019-07-01

Svojstava lijeka

Olimel/PeriOlimel
Version 1.4
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
OLIMEL
®
/PERIOLIMEL
®
Emulsion for Intravenous Infusion
1.
NAME OF THE MEDICINE
OLIMEL/PeriOLIMEL with Electrolytes
Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine,
isoleucine, leucine, lysine acetate,
methionine, phenylalanine, proline, serine, threonine, tryptophan,
tyrosine, valine, sodium acetate
trihydrate, sodium glycerophosphate hydrate, potassium chloride,
magnesium chloride hexahydrate,
calcium chloride dihydrate, glucose monohydrate, olive oil and soya
oil.
OLIMEL without Electrolytes
Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine,
isoleucine, leucine, lysine acetate,
methionine, phenylalanine, proline, serine, threonine, tryptophan,
tyrosine, valine, glucose
monohydrate, olive oil and soya oil.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLIMEL/PeriOLIMEL is presented in the form of a 3-compartment bag. The
individual compartments
contain a glucose solution, a lipid emulsion and an amino acid
solution (with/without electrolytes).
In products containing electrolytes, calcium is included in the
glucose solution compartment and
other electrolytes are in the amino acid solution compartment. There
are 7 different formulations
of OLIMEL (4 with electrolytes and 3 without electrolytes) and one
formulation of PeriOLIMEL.
The general composition of the formulations are summarised below:
WITH
ELECTROLYTES (E)
WITHOUT
ELECTROLYTES
NITROGEN
1
AMINO
ACID
SOLUTION
2
GLUCOSE
SOLUTION
3
LIPID
EMULSION
4
PeriOLIMEL
N4-600E
_-_
_ _
4.0g/L
6.3%
18.75%
15%
OLIMEL
N5-860E
_-_
_ _
5.2g/L
8.2%
28.75%
20%
OLIMEL
N7-960E
OLIMEL
N7-960
7.0g/L
11.1%
35%
20%
OLIMEL
N9-840E
OLIMEL
N9-840
9.0g/L
14.2%
27.5%
20%
OLIMEL
N12-640E
OLIMEL
N12-640
12g/L
14.2 %
27.5 %
17.5 %
1
prefixes N4, N5, N7, N9 refer to approx nitrogen content in g/L
2
contains 17 amino acids (and electrolytes if present)
3
contains calcium if present
4
contains refined olive oil (80%) and refined soya oil (20%)
OLIMEL/PeriOLIMEL contains egg lecithi