AMINOPLASMAL-15% INFUSION

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

ACETYLCYSTEINE EQV CYSTEINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE MONOHYDRATE EQV LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE

Commercializzato da:

B. BRAUN SINGAPORE PTE LTD

Codice ATC:

B05BA01

Dosaggio:

0.5 g/l

Forma farmaceutica:

INJECTION

Composizione:

ACETYLCYSTEINE EQV CYSTEINE 0.5 g/l; ALANINE 22.35 g/l; ARGININE 16.05 g/l; ASPARTIC ACID 7.95 g/l; GLUTAMIC ACID 16.2 g/l; GLYCINE 19.2 g/l; HISTIDINE 5.25 g/l; ISOLEUCINE 5.85 g/l; LEUCINE 11.4 g/l; LYSINE MONOHYDRATE EQV LYSINE 8.93 g/l; METHIONINE 5.7 g/l; PHENYLALANINE 5.7 g/l; PROLINE 7.35 g/l; SERINE 3 g/l; THREONINE 5.4 g/l; TRYPTOPHAN 2.1 g/l; TYROSINE 0.5 g/l; VALINE 7.2 g/l

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

General Sale List

Prodotto da:

B BRAUN MELSUNGEN AG

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

1995-09-14

Scheda tecnica

1
DIRECTIONS FOR USE
B. Braun Melsungen AG - 34209 Melsungen, Germany
1.
NAME OF THE MEDICINAL PRODUCT
Aminoplasmal 15% Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution for infusion contains
per 1 ml
per 500 ml
per 1000 ml
Isoleucine
5.850 mg
2.925 g
5.850 g
Leucine
11.400 mg
5.700 g
11.400 g
Lysine monohydrate
(equivalent to lysine)
8.930 mg
(7.950 mg)
4.465 g
3.975 g
8.930 g
(7.950 g)
Methionine
5.700 mg
2.850 g
5.700 g
Phenylalanine
5.700 mg
2.850 g
5.700 g
Threonine
5.400 mg
2.700 g
5.400 g
Tryptophan
2.100 mg
1.050 g
2.100 g
Valine
7.200 mg
3.600 g
7.200 g
Arginine
16.050 mg
8.025 g
16.050 g
Histidine
5.250 mg
2.625 g
5.250 g
Alanine
22.350 mg
11.175 g
22.350 g
Glycine
19.200 mg
9.600 g
19.200 g
Aspartic acid
7.950 mg
3.975 g
7.950 g
Glutamic acid
16.200 mg
8.100 g
16.200 g
Proline
7.350 mg
3.675 g
7.350 g
Serine
3.000 mg
1.500 g
3.000 g
Tyrosine
0.500 mg
0.250 g
0.500 g
Acetylcysteine
(equivalent to cysteine)
0.500 mg
(0.370 mg)
0.250 g
(0.185 g)
0.500 g
(0.370 g)
Electrolyte concentrations
Sodium
5.3
mmol/l
Total amino acids
150
g/l
Total nitrogen
24.0
g/l
Excipient with known effect:
This medicinal product contains 5.3 mmol sodium per 1000 ml. To be
taken into consideration in patients on
a controlled sodium diet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
ACTD Section: C
04811.0KM0420I16
Clear, colourless up to faintly straw-coloured aqueous solution
Energy [kJ/l (kcal/l)]
2505 (600)
Theoretical osmolarity [mOsm/l]
1290
Acidity (titration to pH 7.4) [mmol NaOH/l]
approx. 31
pH
5.7 – 6.3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supply of amino acids for parenteral nutrition, when oral or enteral
nutrition is impossible, insufficient or
contraindicated. For adults, adolescents and children over 2 years of
age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage has to be adjusted according to the individual need of
amino acids and fluid, depending on the
clinical condition of the patient (nutritional st