VAMIN 18 ELECTROLYTE FREE 1000mL injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tryptophan, Quantity: 1.9 g/L; arginine, Quantity: 11.3 g/L; phenylalanine, Quantity: 7.9 g/L; cysteine, Quantity: 0.56 g/L; tyrosine, Quantity: 0.23 g/L; glycine, Quantity: 7.9 g/L; threonine, Quantity: 5.6 g/L; methionine, Quantity: 5.6 g/L; leucine, Quantity: 7.9 g/L; alanine, Quantity: 16 g/L; isoleucine, Quantity: 5.6 g/L; aspartic acid, Quantity: 3.4 g/L; lysine acetate, Quantity: 12.7 g/L (Equivalent: lysine, Qty 9 g/L); serine, Quantity: 4.5 g/L; histidine, Quantity: 6.8 g/L; proline, Quantity: 6.8

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: glacial acetic acid; water for injections

Administration route:

Intravenous

Units in package:

6 x 1000mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Intravenous supply of amino acids specially to patients with highly increased requirement who are unable to receive sufficient amounts of protein enterally. Vamin 18 is also indicated where there is a need to control the total amount of fluid being given to a patient.

Product summary:

Visual Identification: Clear, colourless to slightly yellow solution; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-03-08

Patient Information leaflet

2016
CMI FOR VAMIN 14, 14EF, 18EF
Filename: Vamin Clean
Page 1 of 2
VAMIN
®
14, 14EF, 18EF
Amino Acids Solution
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common questions about Vamin.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
given
Vamin
against the benefits this medicine
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
_KEEP THIS LEAFLET_. You may need
to read it again.
WHAT VAMIN IS USED FOR
Vamin contains amino acids and is
an intravenous infusion, which is
given
as
a
part
of
intravenous
nutritional
therapy.
When
the
intake of nutrients or food into the
mouth or directly into the gut is not
possible
or
it
is
not
enough
to
supply
the
body’s
needs
then
intravenous nutrients or foods can
be
given.
This
is
especially
important for people whose bodies
are
under
physical
stress
from
illness or recent surgery. During
illness or after surgery the body
requires nutrition or food. Amino
acids are the building blocks used
by
the
body
to
make
proteins.
Vamin
is
usually
given
together
with
carbohydrates,
fats,
salts,
trace
elements
and
vitamins
to
provide
a
complete
intravenous
diet.
Your doctor may have prescribed
Vamin for
another reason.
Ask
your
doctor
if
you
have
any
questions
about
why
Vamin
has
been prescribed for you.
BEFORE
YOU
ARE
GIVEN
VAMIN
_WHEN SHOULD YOU NOT BE GIVEN _
_VAMIN ? _
You should NOT be given Vamin if

You
have
severe
liver
damage.

You
have
an
allergy
to
Vamin
or
any
of
the
ingredients listed at the end
of this leaflet.

You
have
an
inability
to
break down amino acids.

You
have
severe
kidney
disease or impaired kidney
function.

You have too much fluid in
your body.

You
have
too
much
potassium
in
your
blood,
also called hyperkalaemia.

You
have
multi
system
organ
failure
or
severe
sepsis.
If you are not sure whether any of

Summary of Product characteristics

Australian Product Information –
Vamin
®
14, Vamin
®
14
Electrolyte Free, Vamin
®
18 Electrolyte Free
(amino acids) solution for infusion
Page 1 of 8
1
NAME OF THE MEDICINE
Vamin 14
–
Alanine, arginine, aspartic acid, cysteine hydrochloride monohydrate,
glutamic acid,
glycine, histidine, isoleucine, leucine, lysine hydrochloride,
methionine, phenylalanine, proline, serine,
threonine, tryptophan, tyrosine, valine, calcium gluconate
monohydrate, magnesium
sulfate heptahydrate, potassium chloride, sodium acetate trihydrate.
Vamin 14 Electrolyte Free & Vamin 18 Electrolyte Free
–
Alanine, arginine, aspartic acid, cysteine,
glutamic acid, glycine, histidine, isoleucine, leucine, lysine
acetate, methionine, phenylalanine, proline,
serine, threonine, tryptophan, tyrosine, valine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, colourless to slightly yellow solution.
Table 1.
Vamin 14
Vamin 14
Electrolyte Free
Vamin 18
Electrolyte Free
g/L
% of total
amino acids
g/L
% of total
amino acids
g/L
% of total
amino acids
Isoleucine
4.2
4.92
4.2
4.92
5.6
4.92
Leucine
5.9
6.92
5.9
6.92
7.9
6.94
Valine
5.5
6.45
5.5
6.45
7.3
6.41
Phenylalanine
5.9
6.92
5.9
6.92
7.9
6.94
Methionine
4.2
4.92
4.2
4.92
5.6
4.92
Lysine
6.8
1
7.97
6.8
2
7.97
9.0
2
7.90
Threonine
4.2
4.92
4.2
4.92
5.6
4.92
Tryptophan
1.4
1.64
1.4
1.64
1.9
1.67
Cysteine
0.42
3
0.49
0.42
0.49
0.56
0.49
Histidine
5.1
5.98
5.1
5.98
6.8
5.97
Tyrosine
0.17
0.20
0.17
0.20
0.23
0.17
Alanine
12.0
14.06
12.0
14.06
16.0
14.05
Arginine
8.4
9.85
8.4
9.85
11.3
9.92
Aspartic acid
2.5
2.93
2.5
2.93
3.4
2.99
Glutamic acid
4.2
4.92
4.2
4.92
5.6
4.92
Glycine
5.9
6.92
5.9
6.92
7.9
6.94
Proline
5.1
5.98
5.1
5.98
6.8
6.97
Serine
3.4
3.99
3.4
3.99
4.5
3.95
Total Nitrogen
13.5
13.5
18.0
Amino acid
concentration
(% by weight)
8.5
8.5
11.4
1
as hydrochloride
2
as acetate
3
as hydrochloride monohydrate
Page 2 of 8
Table 2.
Vamin 14
Vamin 14
Electrolyte Free
Vamin 18
Electrolyte Free
Calcium Gluconate H
2
O
2.24 g/L
Potassium chloride
3.73 g/L
Sodium acetate 3H
2
O
13.6 g/L
Magnesium sul