OLICLINOMEL N7-1000 EMULSION FOR INFUSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

GLUCOSE (as GLUCOSE MONOHYDRATE) (In Compartment 3); GLYCINE (In Compartment 2); L-ALANINE (In Compartment 2); L-ARGININE (In Compartment 2); L-HISTIDINE (In Compartment 2); L-ISOLEUCINE (In Compartment 2); L-LEUCINE (In Compartment 2); L-LYSINE (as HCl) (In Compartment 2); L-METHIONINE (In Compartment 2); L-PHENYLALANINE (In Compartment 2); L-PROLINE (In Compartment 2); L-SERINE (In Compartment 2); L-THREONINE (In Compartment 2); L-TRYPTOPHAN (In Compartment 2); L-TYROSINE (In Compartment 2); L-VALINE (In

Available from:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC code:

B05BA10

Dosage:

176.00 g/l

Pharmaceutical form:

EMULSION

Composition:

GLUCOSE (as GLUCOSE MONOHYDRATE) (In Compartment 3) 176.00 g/l; GLYCINE (In Compartment 2) 4.12 g/l; L-ALANINE (In Compartment 2) 8.28 g/l; L-ARGININE (In Compartment 2) 4.60 g/l; L-HISTIDINE (In Compartment 2) 1.92 g/l; L-ISOLEUCINE (In Compartment 2) 2.40 g/l; L-LEUCINE (In Compartment 2) 2.92 g/l; L-LYSINE (as HCl) (In Compartment 2) 2.90 g/l; L-METHIONINE (In Compartment 2) 1.60 g/l; L-PHENYLALANINE (In Compartment 2) 2.24 g/l; L-PROLINE (In Compartment 2) 2.72 g/l; L-SERINE (In Compartment 2) 2.00 g/l; L-THREONINE (In Compartment 2) 1.68 g/l; L-TRYPTOPHAN (In Compartment 2) 0.72 g/l; L-TYROSINE (In Compartment 2) 0.16 g/l; L-VALINE (In Compartment 2) 2.32 g/l; REFINED SOYA BEAN OIL + REFINED OLIVE OIL (In Compartment 1) 40.00 g/l

Administration route:

INTRAVENOUS

Prescription type:

General Sale List

Manufactured by:

BAXTER SA

Authorization status:

ACTIVE

Authorization date:

2004-05-06

Summary of Product characteristics

1. SUMMARY OF PRODUCT CHARACTERISTICS
OliClinomel N7-1000, emulsion for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
This medicinal product is presented in the form of a 3‐compartment
bag. There are four presentations,
which have the following different volumes:
COMPARTMENT
1000 ML
1500 ML
2000 ML
2500 ML
Lipid emulsion
Amino acid solution
Glucose solution
200 ml
400 ml
400 ml
300 ml
600 ml
600 ml
400 ml
800 ml
800 ml
500 ml
1000 ml
1000 ml
Composition of a 1000ml bag:
_ _
_ _
_ _
ACTIVE SUBSTANCES
20% LIPID
EMULSION
COMPARTMENT
(CORRESPONDING TO
20G/100ML)
(200ML)
10% AMINO ACID
SOLUTION
COMPARTMENT
(CORRESPONDING TO
10G/100ML)
(400ML)
40% GLUCOSE
SOLUTION
COMPARTMENT
(CORRESPONDING TO
40G/100ML)
(400ML)
Refined olive oil
_ _
40.00 g
+ refined soya bean oil
*
Alanine
8.28 g
Arginine
4.60 g
Glycine
4.12 g
Histidine
1.92 g
Isoleucine
2.40 g
Leucine
2.92 g
Lysine
2.32 g
(As Lysine hydrochloride)
(2.90 g)
Methionine
1.60 g
Phenylalanine
2.24 g
Proline
2.72 g
Serine
2.00 g
Threonine
1.68 g
Tryptophan
0.72 g
Tyrosine
0.16 g
Valine
2.32 g
Glucose
160.00 g
(As Glucose monohydrate)
(176.00) g
* Mixture of refined olive oil (approximately 80%) and refined soya
bean oil (approximately 20%)
For full list of the excipients, see section 6.1
After the contents of the three compartments have been mixed, the
ternary mixture for each of the bag
Bar code
provides the
following:
PER BAG
1 LITRE
1.5 LITRE
2 LITRES
2.5 LITRES
Nitrogen (g)
6.6
9.9
13.2
16.5
Amino acids (g)
40
60
80
100
Glucose (g)
160
240
320
400
Lipids(g)
40
60
80
100
Total calories (kcal)
1200
1800
2400
3000
Non‐protein calories (kcal)
1040
1560
2080
2600
Glucose calories (kcal)
640
960
1280
1600
Lipid calories (kcal)
400
600
800
1000
Non‐protein calorie/nitrogen ratio
158
158
158
158
(kcal/g N)
Phosphate (mmol)**
3
4.5
6
7.5
Acetate (mmol)
37
56
74
93
Chloride (mmol)
16
24
32
40
pH
6
6
6
6
Osmolarity (mOsmol/l)
1400
1400
1400
1400
** Including phosphates provided by the lipid emulsion.
3. PHARMACEUTICAL FORM
After reconstitution:
Emulsion for infusion