PRIMENE 10% amino acids solution for injection Bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

threonine, Quantity: 3.7 mg/mL; proline, Quantity: 3 mg/mL; glycine, Quantity: 4 mg/mL; arginine, Quantity: 8.4 mg/mL; tyrosine, Quantity: 0.45 mg/mL; valine, Quantity: 7.6 mg/mL; leucine, Quantity: 10 mg/mL; serine, Quantity: 4 mg/mL; isoleucine, Quantity: 6.7 mg/mL; cysteine, Quantity: 1.89 mg/mL; taurine, Quantity: 0.6 mg/mL; lysine, Quantity: 11 mg/mL; ornithine monohydrochloride, Quantity: 3.18 mg/mL; histidine, Quantity: 3.8 mg/mL; alanine, Quantity: 8 mg/mL; aspartic acid, Quantity: 6 mg/mL; methionine, Quantity: 2.4 mg/mL; glutamic acid, Quantity: 10 mg/mL; tryptophan, Quantity: 2 mg/mL; phenylalanine, Quantity: 4.2 mg/mL

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: malic acid; water for injections

Administration route:

Intravenous

Units in package:

250mL, 100mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

PRIMENE 10% amino acid IV infusion is indicated in infants and neonates at term or premature, for short-term use, of normal or low birth-weight when oral or enteral nutrition is impossible, insufficient or contraindicated. It is used as an amino acid component in a composite admixture of total parenteral nutrition.

Product summary:

Visual Identification: A clear, colourless or practically colourless solution.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-04-23

Patient Information leaflet

PRIMENE 10%
Amino Acids Intravenous Infusion
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
PRIMENE 10% amino acids
IV infusion [PRIMENE 10%].
It does not contain all of the
available information. It does
not take the place of talking
to your doctor, pharmacist, or
other health professionals.
All medicines have risks and
benefits. Your doctor has
weighed the risks of your
baby being given PRIMENE
10% against the benefits
they expect it will have for
your baby.
IF YOU HAVE ANY CONCERNS
ABOUT THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may
need to read it again.
WHAT PRIMENE 10% IS
USED FOR
PRIMENE 10% is a mixture
of amino acids, a building
block of proteins. This
medicine contains a well-
balanced composition of
protein intended as a source
for nutritional support for
growth in premature babies
in particular. In the early life,
a rapid growth of tissues and
organs, such as the liver and
kidney requires essential
nutrients. Under a normal
condition these are provided
by breast milk. However,
premature babies, infants
who cannot be fed orally,
they should be fed by
infusion of a nutritional
supplement, such as
PRIMENE 10%.
BEFORE THE USE OF PRIMENE
10%
_ _
_PRIMENE 10% SHOULD NOT _
_BE GIVEN TO A BABY, INFANT, _
_PREMATURE INFANT IF: _
•
A baby has had an
allergic reaction to any
component of PRIMENE
10% listed at the end of
this leaflet or its
container components.
Some of the symptoms
of an allergic reaction
may include skin rash,
peeling of the skin,
swelling of the face, lips
or tongue, which may
cause difficulty
swallowing or shortness
of breath.
•
A baby is born with a
congenital abnormality
with metabolism of one
or more amino acids
listed in the Ingredients
section of this leaflet.
•
A baby suffering from
liver or kidney problems.
•
The expiry date printed
on the pack is overdue.
_ _
_TELL YOUR DOCTOR IF: _
•
Your baby is allergic to
anything
•
Your baby has any other
health problems
including infections.
HOW PRIME

Summary of Product characteristics

Primene 10% (
Lysine, glutamic acid, leucine, arginine, alanine, valine, isoleucine,
aspartic acid,
phenylalanine, glycine, serine, histidine, threonine, ornithine
monohydrochloride, proline, methionine,
tryptophan, cysteine, taurine and tyrosine)
Version 6.0
Page
1
of
20
AUSTRALIAN PRODUCT INFORMATION – PRIMENE
 10%
SOLUTION FOR INTRAVENOUS INFUSION
(LYSINE, GLUTAMIC ACID, LEUCINE, ARGININE, ALANINE,
VALINE, ISOLEUCINE, ASPARTIC ACID, PHENYLALANINE,
GLYCINE, SERINE, HISTIDINE, THREONINE, ORNITHINE
MONOHYDROCHLORIDE, PROLINE, METHIONINE,
TRYPTOPHAN, CYSTEINE, TAURINE AND TYROSINE)
1
NAME OF THE MEDICINE
Lysine, glutamic acid, leucine, arginine, alanine, valine, isoleucine,
aspartic acid, phenylalanine,
glycine, serine, histidine, threonine, ornithine monohydrochloride,
proline, methionine, tryptophan,
cysteine, taurine and tyrosine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Primene 10% amino acids IV infusion contains essential and
nonessential L-amino acids. The
composition and quantity of the L-amino acids in Primene 10% are shown
in the following table.
Table 1: each one litre of Primene 10% (w/v) contains
_Active constituents_:
Primene 10% (g)
Lysine
11.00
Glutamic acid
10.00
Leucine
10.00
Arginine
8.40
Alanine
8.00
Valine
7.60
Isoleucine
6.70
Aspartic acid
6.00
Phenylalanine
4.20
Glycine
4.00
Serine
4.00
Histidine
3.80
Threonine
3.70
Ornithine Monohydrochloride
3.18
_(2.49)*_
Proline
3.00
Methionine
2.40
Tryptophan
2.00
Cysteine
1.89
Taurine
0.60
Tyrosine
0.45
_Other constituents_
Malic acid q.s. to make pH 5.5 (range 5- 6.5)
≤ 3.2
Water for injections q.s. for
1000 mL
Osmolality (mOsmol/kg)
840 (780)
Note: under dilute conditions, osmolarity (mOsmol/L) is similar with
osmolality (mOsmol/kg). The values in the
brackets are osmolarity. Those amino acids are L-isomer form;
_* equivalent to ornithine base 2.49 g._
ATTACHMENT 2B
Primene 10% (
Lysine, glutamic acid, leucine, arginine, alanine, valine, isoleucine,
aspartic acid,
phenylalanine, glycine, serine, histidine, threonine, ornithine
monohydrochlor