AMINOVEN amino acid 10% solution for infusion 1000 mL bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

alanine, Quantity: 14 g/L; arginine, Quantity: 12 g/L; glycine, Quantity: 11 g/L; histidine, Quantity: 3 g/L; isoleucine, Quantity: 5 g/L; leucine, Quantity: 7.4 g/L; lysine acetate, Quantity: 9.31 g/L (Equivalent: lysine, Qty 6.6 g/L); methionine, Quantity: 4.3 g/L; phenylalanine, Quantity: 5.1 g/L; proline, Quantity: 11.2 g/L; serine, Quantity: 6.5 g/L; taurine, Quantity: 1 g/L; threonine, Quantity: 4.4 g/L; tryptophan, Quantity: 2 g/L; tyrosine, Quantity: 400 mg/L; valine, Quantity: 6.2 g/L

Tilgængelig fra:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Alanine,Arginine,Glycine,Histidine,Isoleucine,Leucine,Lysine acetate,Methionine,Phenylalanine,Proline,Serine,Taurine,Threonine,T

Lægemiddelform:

Injection, solution

Sammensætning:

Excipient Ingredients: glacial acetic acid; water for injections

Indgivelsesvej:

Intravenous

Enheder i pakken:

1000mL

Recept type:

Not scheduled. Not considered by committee

Terapeutiske indikationer:

To supply amino acids as part of a composite admixture of total parenteral nutrition.

Produkt oversigt:

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

Autorisation status:

Registered

Autorisation dato:

2007-10-22

Indlægsseddel

Page 1 of 2
AMINOVEN
®
Amino Acids Solution
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
question
about
Aminoven. 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
being
given
Aminoven 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
AMINOVEN
IS
USED FOR
Aminoven
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.
Aminoven is usually given together
with
carbohydrates,
fats,
salts,
trace
elements
and
vitamins
to
provide
a
complete
intravenous
diet.
Your doctor may have prescribed
Aminoven for another reason. Ask
your
doctor
if
you
have
any
questions
about
why
Aminoven
has been prescribed for you.
BEFORE
YOU
ARE
GIVEN
AMINOVEN
_WHEN SHOULD YOU NOT BE GIVEN _
_AMINOVEN? _
You
should
NOT
be
given
Aminoven if

You
have
an
allergy
to
Aminoven
or
any
of
the
ingredients
listed
at
the
end of this leaflet.

You
have
an
inability
to
break down amino acids.

You
have
severe
liver
failure.

You
have
severe
kidney
failure (if dialysis facilities
are not available).

You have too much fluid in
your body.

You have too much acid in
your
blood,
also
called
metabolic acidosis.

There
is
not
enough
oxygen being supplied to
your cells.

You
are
experiencing
a
sudden decrease in b

Produktets egenskaber

Australian Product Information –
Aminoven 10% (amino acids) solution for infusion
Page 1 of 19
1
NAME OF THE MEDICINE
Alanine, arginine, glycine, histidine, isoleucine, leucine, lysine
acetate, methionine, phenylalanine,
proline, serine, taurine, threonine, tryptophan, tyrosine, valine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMINOVEN is a clear, colourless to slightly yellow solution. Each
litre contains:
Aminoven
10%
Alanine (g)
14.0
Arginine (g)
12.0
Glycine (g)
11.0
Histidine (g)
3.0
Isoleucine (g)
5.0
Leucine (g)
7.4
Lysine (g)
6.6
Methionine (g)
4.3
Phenylalanine (g)
5.1
Proline (g)
11.2
Serine (g)
6.5
Taurine (g)
1.0
Threonine (g)
4.4
Tryptophan (g)
2.0
Tyrosine (g)
0.4
Valine (g)
6.2
•
Total amino acids (g)
100
•
Total Nitrogen (g)
16.2
•
Total energy (kJ) (kcal)
1680 (400)
•
•
pH
5.5
–
6.3
•
Titratable acidity (mmol NaOH/L)
22
Osmolality (mOsm/kg water)
1070
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection, intravenous infusion.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
To supply amino acids as part of a composite admixture of total
parenteral nutrition.
4.2
Dose and method of administration
Dosage depends on the severity of the catabolic state and amino acid
requirement. A daily dose of
1.0
–
1.5 g amino acids/kg body weight/day is commonly used but
recommendations from current
professional nutritional guidelines should be consulted.
Page 2 of 19
Clinical trial data on duration of therapy are limited to up to 7 days
of administration in post-operative
patients.
Adults
_Dosage _
10
–
20 mL of Aminoven 10% per kg body weight (equivalent to 1.0
–
2.0 g amino acids per kg body
weight/day), e.g. corresponding to 700
–
1400 mL Aminoven 10% at 70 kg body weight/day.
_Maximum infusion rate _
1.0 mL of Aminoven 10% per kg body weight per hour (equivalent to 0.1
g amino acids per kg body
weight an hour).
_Maximum daily dose _
20 mL of Aminoven 10% per kg body weight (equivalent to 2.0 g amino
acids per kg body weight/day)
corr