GLAMIN amino acids/dipeptides 500mL intravenous infusion injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

proline, Quantity: 6.8 g/L; isoleucine, Quantity: 5.6 g/L; methionine, Quantity: 5.6 g/L; lysine acetate, Quantity: 12.7 g/L (Equivalent: lysine, Qty 9 g; Equivalent: glycine, Qty 10.27 g); serine, Quantity: 4.5 g/L; glycylglutamine monohydrate, Quantity: 30.27 g/L (Equivalent: glycine, Qty 10.27 g; Equivalent: glutamine, Qty 20 g); alanine, Quantity: 16 g/L; histidine, Quantity: 6.8 g/L; glutamic acid, Quantity: 5.6 g/L; tryptophan, Quantity: 1.9 g/L; leucine, Quantity: 7.9 g/L; valine, Quantity: 7.3 g/L; aspartic acid, Quantity: 3.4 g/L; phenylalanine, Quantity: 5.85 g/L; glycyltyrosine dihydrate, Quantity: 3.45 g/L (Equivalent: tyrosine, Qty 2.28 g; Equivalent: glycine, Qty 0.94 g); arginine, Quantity: 11.3 g/L; threonine, Quantity: 5.6 g/L

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: citric acid; water for injections

Administration route:

Intravenous

Units in package:

500mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

GLAMIN provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate or severe catabolic status.

Product summary:

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

Authorization status:

Registered

Authorization date:

2002-05-29

Patient Information leaflet

Page 1 of 3
GLAMIN
®
Amino acid / Dipeptide 13.4% Solution
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
question about Glamin. 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 Glamin
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
GLAMIN
IS
USED
FOR
Glamin
is
a
13.4%
amino
acid/dipeptide 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.
Glamin
is
usually
given
together
with
carbohydrates,
fats,
salts,
trace
elements
and
vitamins
to
provide
a
complete
intravenous
diet.
Your doctor may have prescribed
Glamin for
another reason.
Ask
your
doctor
if
you
have
any
questions
about
why
Glamin
has
been prescribed for you.
BEFORE
YOU
ARE
GIVEN
GLAMIN
You should NOT be given Glamin if

You have an allergy to
Glamin
or
any
of
the
ingredients listed at the
end of this leaflet.

You have an inability to
break
down
amino
acids, for example an
inherited
condition
known
as
phenylketonuria.

You have severe liver
failure.

You
have
severe
kidney
failure
(if
dialysis facilities are not
available).

You are suffering from
a very serious problem
with
your
blood
circulation.

You
have
too
much
fluid in your body.

You
have
too
much
acid in your blood, also
called
metabolic
acidosis.

There
is
not
en

Summary of Product characteristics

Australian Product Information –
Glamin
®
(amino acids/dipeptides) solution for infusion
Page 1 of 8
1
NAME OF THE MEDICINE
Alanine, arginine, aspartic acid, glutamic acid, glycylglutamine
monohydrate, glycyltyrosine dihydrate,
histidine, isoleucine, leucine, lysine acetate, methionine,
phenylalanine, proline, serine, threonine,
tryptophan, valine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glamin is an amino acid/dipeptide 13.4% solution for intravenous
infusion.
Glamin is an electrolyte-free, clear and colourless to slightly yellow
amino acid solution which contains
glutamine and tyrosine as glycyl dipeptides for total parenteral
intravenous nutrition.
Content (per 1000 mL)
Active Ingredients
Alanine
16.00 g
Arginine
11.30 g
Aspartic acid
3.40 g
Glutamic acid
5.60 g
Glycylglutamine monohydrate
_ _
_(equivalent.to glycine 10.27 g & glutamine 20.0 g)_
30.27 g
Glycyltyrosine dihydrate
_ _
_(equivalent.to glycine 0.94 g & tyrosine 2.28 g)_
3.45 g
Histidine
6.80 g
Isoleucine
5.60 g
Leucine
7.90 g
Lysine acetate _(equivalent.to lysine 9.0 g)_
12.70 g
Methionine
5.60 g
Phenylalanine
5.85 g
Proline
6.80 g
Serine
4.50 g
Threonine
5.60 g
Tryptophan
1.90 g
Valine
7.30 g
1000 mL of Glamin supplies:
•
Amino acids and dipeptides
134 g
•
Total Nitrogen
22.4 g
•
Energy content
2300 kJ (540 kcal)
Theoretical osmolarity
1040 mOsm
Theoretical osmolality
1140 mOsm/kg water
Density
1.0414 g/cm
3
pH
approximately 5.8
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection, intravenous infusion.
Page 2 of 8
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Glamin provides amino acids as part of parenteral nutrition therapy,
when oral or enteral nutrition is
impossible, insufficient or contraindicated especially in patients
with a moderate to severe catabolic
status.
4.2
Dose and method of administration
Dosage
The dosage of Glamin will depend on the patient’s amino acid
requirements
. Generally, 1
–
2 g amino
acids/dipeptides (corresponding to 0.17
–
0.34 g N) per kg body w