TRIOMEL 7 GL NITROGEN 1140 KcalL

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ALANINE; ARGININE; ASPARTIC ACID; GLUCOSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; SOYA OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE

Inapatikana kutoka:

REMEDIX CARE LTD

Dawa fomu:

EMULSION FOR INFUSION

Tungo:

ALANINE 16.02 G / 1 L; ARGININE 10.85 G / 1 L; ASPARTIC ACID 3.20 G / 1 L; GLUTAMIC ACID 5.53 G / 1 L; GLYCINE 7.67 G / 1 L; HISTIDINE 6.61 G / 1 L; ISOLEUCINE 5.53 G / 1 L; LEUCINE 7.67 G / 1 L; LYSINE 8.71 G / 1 L; METHIONINE 5.53 G / 1 L; PHENYLALANINE 7.67 G / 1 L; PROLINE 6.61 G / 1 L; SERINE 4.37 G / 1 L; THREONINE 5.53 G / 1 L; TRYPTOPHAN 1.84 G / 1 L; TYROSINE 0.28 G / 1 L; VALINE 7.08 G / 1 L; SOYA OIL 200 G / 1 L; GLUCOSE MONOHYDRATE 385 G / 1 L

Njia ya uendeshaji:

I.V

Dawa ya aina:

Required

Viwandani na:

BAXTER HEALTHCARE LTD. U.K.

Matibabu dalili:

Triomel is indicated for parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Idhini ya tarehe:

2018-03-31

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion is presented
in the form of a 3-
compartment bag.
Each bag contains a glucose solution, a lipid emulsion and an amino
acid solution.
CONTENTS PER BAG
1500 ML
35 % Glucose solution
(corresponding to 35 g/100 ml)
600 ml
11.1 % Amino acid solution
(corresponding to 11.1 g/100 ml)
600 ml
20 % Lipid emulsion
(corresponding to 20 g/100 ml)
300 ml
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
ACTIVE SUBSTANCES
1500 ML
Refined olive oil+ refined soya-bean oil
a
60.00 g
Alanine
9.61 g
Arginine
6.51 g
Aspartic acid
1.92 g
Glutamic acid
3.32 g
Glycine
4.60 g
Histidine
3.97 g
Isoleucine
3.32 g
Leucine
4.60 g
Lysine
(equivalent to lysine acetate)
5.23 g
(7.31 g)
Methionine
3.32 g
Phenylalanine
4.60 g
Proline
3.97 g
Serine
2.62 g
Threonine
3.32 g
Tryptophan
1.10 g
Tyrosine
0.17 g
Valine
4.25 g
Glucose anhydrous
(equivalent to glucose monohydrate)
210.00 g
(231.00 g)
a: Mixture of refined olive oil (approximately 80%) and refined
soya-bean oil (approximately
20%) corresponding to a ratio essential fatty acids / total fatty
acids of 20%.
For a full list of excipients, see section 6.1.
Nutritional intakes of reconstituted emulsion for each of the bag
sizes:
1500 ML
Lipids
60 g
Amino acids
66.4 g
Nitrogen
10.5 g
Glucose
210.0 g
Energy:
Total calories approx.
1710 kcal
Non-protein calories
1440 kcal
Glucose calories
840 kcal
Lipid calories
a
600 kcal
Non-protein calories / nitrogen ratio
137 kcal/g
Glucose / lipid calories ratio
58/42
Lipid / total calories
35%
Electrolytes:
Phosphate
b
4.5 mmol
Acetate
46 mmol
pH
6.4
Osmolarity
1220 mosm/l
a: Includes calories from purified egg phospholipids
b:Includes phosphate provided by the lipid emulsion
3.
PHARMACEUTICAL FORM
After reconstitution:
Emulsion for infusion.
Appearance prior to reconstitution:
-
The amino acids