VAMINOLACT INTRAVENOUS SOLUTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

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

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

B05BA01

Dosage:

6.3 g/1000 ml

Pharmaceutical form:

INJECTION

Composition:

ALANINE 6.3 g/1000 ml; ARGININE 4.1 g/1000 ml; ASPARTIC ACID 4.1 g/1000 ml; CYSTEINE 1 g/1000 ml; GLUTAMIC ACID 7.1 g/1000 ml; GLYCINE 2.1 g/1000 ml; HISTIDINE 2.1 g/1000 ml; ISOLEUCINE 3.1 g/1000 ml; LEUCINE 7 g/1000 ml; LYSINE 5.6 g/1000 ml; METHIONINE 1.3 g/1000 ml; PHENYLALANINE 2.7 g/1000 ml; PROLINE 5.6 g/1000 ml; SERINE 3.8 g/1000 ml; TAURINE 300 mg/1000 ml; THREONINE 3.6 g/1000 ml; TRYPTOPHAN 1.4 g/1000 ml; TYROSINE 500 mg/1000 ml; VALINE 3.6 g/1000 ml

Administration route:

INTRAVENOUS

Prescription type:

General Sale List

Manufactured by:

FRESENIUS KABI AUSTRIA GMBH

Authorization status:

ACTIVE

Authorization date:

1993-05-12

Patient Information leaflet

M088915/00 EXP
VAMINOLACT™
DESCRIPTION
Amino acid solution for intravenous nutrition.
Vaminolact™  is  an  electrolyte-free,  clear, 
colourless  to  slightly  yellow  solution  of  amino 
acids, for intravenous nutrition in infants and
children.
COMPOSITION
_Amino acids (g/l):_
Alanine 

6.3 
Arginine   

4.1  
Aspartic acid 

4.1  
Cysteine/cystine   
1.0  
Glutamic acid 

7.1  
Glycine (amino acetic acid)  2.1  
Histidine   

2.1  
Isoleucine   

3.1 

Leucine 

7.0  
Lysine 

5.6
Methionine 

1.3
Phenylalanine 

2.7
Proline 

5.6
Serine 

3.8
Taurine 

0.3
Threonine  

3.6
Tryptophan 

1.4
Tyrosine   

0.5
Valine 

3.6
Water for injections to 1000 ml.
_Total amount of amino acids: _65.3 g/l of which 
31.9 g, including cysteine, tyrosine and histidine, 
are essential.
_Nitrogen content: _9.3 g/l
_Electrolytes:_ None
_Antioxidant additives: _none
_Energy content:_ 1.0 MJ (240 kcal)
_pH:_ 5.2
_Osmolality:_ 510 mosmol per kg water
CLINICAL PHARMACOLOGY
The amino acid composition of Vaminolact is based 
on that of human milk. Vaminolact contains the 18 
essential  and  non-essential  amino  acids  needed 
for  synthesis  of  body  proteins.  Furthermore,  it 
contains  taurine,  an  aminosulfonic  acid  which  is 
also present in human milk.
The  intracellular  concentration  of  taurine  is 
normally  high,  particularly  in  the  mature  retina, 
in  muscle  and  in  developing  brain  tissue.  In 
children, long term intravenous nutrition without 
taurine has induced low taurine levels and altered 
electro-retinograms
which normalised after taurine supplementation.
Vaminolact has been shown to result in positive 
nitrogen balance in preterm and terms of infants. 
Vaminolact  does  not  contain  carbohydrates  and 
is  electro

Summary of Product characteristics

VAMINOLACT™
DESCRIPTION
Amino acid solution for intravenous nutrition.
Vaminolact™
is
an
electrolyte-free,
clear,
colourless to slightly yellow solution of amino
acids, for intravenous nutrition in infants and
children.
COMPOSITION
_Amino acids (g/l):_
Alanine
6.3
Arginine
4.1
Aspartic acid
4.1
Cysteine/cystine
1.0
Glutamic acid
7.1
Glycine (amino acetic acid) 2.1
Histidine
2.1
Isoleucine
3.1
Leucine
7.0
Lysine
5.6
Methionine
1.3
Phenylalanine
2.7
Proline
5.6
Serine
3.8
Taurine
0.3
Threonine
3.6
Tryptophan
1.4
Tyrosine
0.5
Valine
3.6
Water for injections to 1000 ml.
_Total amount of amino acids: _65.3 g/l of which
31.9 g, including cysteine, tyrosine and histidine,
are essential.
_Nitrogen content: _9.3 g/l
_Electrolytes: _None
_Antioxidant additives: _none
_Energy content: _1.0 MJ (240 kcal)
_pH: _5.2
_Osmolality: _510 mosmol per kg water
requirements of energy (given as carbohydrates
and fat), vitamins and trace elements should be
met.
Glucose
is
recommended
as
the
source
of
carbohydrates.
INDICATIONS
Vaminolact is indicated as a source of amino acids
for protein synthesis and of taurine in infants and
children requiring intravenous nutrition.
CONTRAINDICATIONS
Vaminolact
is contra-indicated in patients
with
inborn
errors
of
amino
acid
metabolism,
irreversible liver damage and in severe uremia
when dialysis facilities are not available.
CAUTION
Intravenous infusion
of
amino acids
may be
accompanied by increased urinary excretion of
the trace elements copper and, in particular zinc,
which should be taken into account in the dosing
of trace elements, particularly during long-term
intravenous nutrition
Light exposure of solutions for intravenous
parenteral nutrition, especially after admixture with
trace elements and/or vitamins, may have adverse
effects on clinical outcome in neonates, due to
generation of peroxides and other degradation
products. When used in neonates and children
below 2 years, Vaminolact should be protected from
ambient light until administration is completed
ADVERSE EVENTS
Nausea occurs r