Vamin 14 with electrolytes

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Alanine 12 g/L;  ;  ;  ; Arginine 8.4 g/L (L-Arginine);  ;  ; Aspartic acid 2.5 g/L (L-Aspartic acid);  ;  ; Calcium gluconate monohydrate 2.24 g/L;  ; Cysteine 0.42 g/L (as L-Cysteine hydrochloride); Glutamic acid 4.2 g/L (L-Glutamic acid);  ;  ; Glycine 5.9 g/L (as aminoacetic acid);  ;  ; Histidine 5.1 g/L (L-Histidine);  ;  ; Isoleucine 4.2 g/L (L-Isoleucine);  ;  ;  ; Leucine 5.9 g/L (L-Leucine);  ;  ;  ; Lysine hydrochloride 6.8 g/L;  ;  ;  ; Magnesium sulfate heptahydrate 1.97 g/L; Methionine 4.2 g/L (L-Methionine);  ;  ; Phenylalanine 5.9 g/L (L-Phenylalanine);  ;  ;  ; Potassium chloride 3.73 g/L; Proline 5.1 g/L (L-Proline);  ; Serine 3.4 g/L (L-Serine);  ;  ;  ;  ; Sodium acetate trihydrate 13.6 g/L;  ;  ; Threonine 4.2 g/L (L-Threonine);  ;  ;  ; Tryptophan 1.4 g/L (L-Tryptophan);  ; Tyrosine 0.17 g/L (L-Tyrosine); Valine 5.5 g/L (L-Valine);  ;  

Tilgængelig fra:

Fresenius Kabi New Zealand Limited

INN (International Name):

Alanine 12 g/L

Lægemiddelform:

Solution for infusion

Sammensætning:

Active: Alanine 12 g/L       Arginine 8.4 g/L (L-Arginine)     Aspartic acid 2.5 g/L (L-Aspartic acid)     Calcium gluconate monohydrate 2.24 g/L   Cysteine 0.42 g/L (as L-Cysteine hydrochloride) Glutamic acid 4.2 g/L (L-Glutamic acid)     Glycine 5.9 g/L (as aminoacetic acid)     Histidine 5.1 g/L (L-Histidine)     Isoleucine 4.2 g/L (L-Isoleucine)       Leucine 5.9 g/L (L-Leucine)       Lysine hydrochloride 6.8 g/L       Magnesium sulfate heptahydrate 1.97 g/L Methionine 4.2 g/L (L-Methionine)     Phenylalanine 5.9 g/L (L-Phenylalanine)       Potassium chloride 3.73 g/L Proline 5.1 g/L (L-Proline)   Serine 3.4 g/L (L-Serine)         Sodium acetate trihydrate 13.6 g/L     Threonine 4.2 g/L (L-Threonine)       Tryptophan 1.4 g/L (L-Tryptophan)   Tyrosine 0.17 g/L (L-Tyrosine) Valine 5.5 g/L (L-Valine)     Excipient: Glacial acetic acid Water for injection

Enheder i pakken:

Bottle, glass, 500 mL

Klasse:

General sale

Recept type:

General sale

Fremstillet af:

Evonik Rexim Nanning Pharmaceuticals Co Ltd

Terapeutiske indikationer:

Intravenous supply of amino acids to patients with moderately increased requirements who are unable to receive sufficient amounts of protein enterally

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, glass, - 500 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 1000 mL - 24 months from date of manufacture stored at or below 25°C

Autorisation dato:

1986-07-31

Indlægsseddel

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
these apply to you, check with your
doctor.
_ YOU MUST T

Produktets egenskaber

NEW ZEALAND DATA SHEET
Page 1 of 8
1
PRODUCT NAME
Vamin 14 - Solution for Infusion
Vamin 14 Electrolyte Free - Solution for Infusion
Vamin 18 Electrolyte Free - Solution for Infusion
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
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 sulfate 7H
2
O
1.97 g/L
Page 2 of 8
Table 2.
Vamin 14
Vamin 14
Electrolyte Free
Vamin 18
Electrolyte Free
Osmolality mOsm/kg H
2
O
1145
810
1130
pH
5.4 – 5.8
5.4 – 5.8
5.4 – 5.8
Na
+
(mmol/1000 mL)
100
K
+
(mmol/1000 mL)
50
Ca
++
(mmol/1000 mL)
5
Mg
++
(mmol/1000 mL)
8
Cl
-
(mmol/1000 mL)
100
Acetate (mmol/1000 mL)
135
Sulfate (mmol/1000 mL)
8
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
Vamin 14, Vamin 14 Electrolyte Free
Intravenous supply of amino acids to patients with moderately