SYNTHAMIN 17 10% Amino Acid without Electrolytes 500mL injection bottle AHA6920

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

leucine, Quantity: 7.3 g/L; phenylalanine, Quantity: 5.6 g/L; methionine, Quantity: 4 g/L; lysine hydrochloride, Quantity: 7.24 g/L (Equivalent: lysine, Qty 5.8 g/L); isoleucine, Quantity: 6 g/L; valine, Quantity: 5.8 g/L; histidine, Quantity: 4.8 g/L; threonine, Quantity: 4.2 g/L; tryptophan, Quantity: 1.8 g/L; alanine, Quantity: 20.7 g/L; glycine, Quantity: 10.3 g/L; arginine, Quantity: 11.5 g/L; proline, Quantity: 6.8 g/L; tyrosine, Quantity: 400 mg/L; serine, Quantity: 5 g/L

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium metabisulfite; glacial acetic acid; water for injections

Administration route:

Intravenous

Units in package:

500mL x 1

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code)

Product summary:

Visual Identification: Clear solution; Container Type: Bottle; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

CMI April 2014
BAXTER
Page 1 of 4
SYNTHAMIN INTRAVENOUS INFUSION WITH _AND_
WITHOUT ELECTROLYTES
CONSUMER PRODUCT
INF
ORMA
TION
WHAT IS IN THIS LEAFLET?
This leaflet answers
some common
questions about
Synthamin Intravenous
Infusion, with or without
electrolytes
(SYNTHAMIN). It does
not contain all the
available information.
All medicines have risks
and benefits. Your
doctor has weighed the
risks of you being given
Synthamin against the
benefits he or she
expects it will have for
you.
It does not take the
place of talking to your
doctor, nurse or
pharmacist.
If you have any
concerns about being
given this medicine, ask
your doctor or
pharmacist.
KEEP THIS LEAFLET IN A
SAFE PLACE. You may
need to read it again.
WHAT SYNTHAMIN IS
USED FOR.
Synthamin Infusions are
sterile solutions
containing different
strengths of amino
acids, which are
building blocks your
body uses to make
proteins. Some of the
strengths of Synthamin
also contain
electrolytes, which are
nutrients your body
needs to work properly.
Synthamin is used as a
source of nutrition
whilst you cannot
consume enough food
by mouth. It is usually
given with other
nutrition solutions like
mineral and vitamins.
BEFORE YOU ARE GIVEN
SYNTHAMIN
SYNTHAMIN MUST NOT
BE GIVEN TO YOU IF YOU:
•
have had an allergic
reaction to any of the
ingredients of
Synthamin - some of
the symptoms of an
allergic reaction may
include skin rash,
aches and pains,
swelling of the face,
lips or tongue which
may cause difficulty
swallowing or
shortness of breath.
•
have severe liver
disease.
•
suffer from severe
kidney disease
and/or are not
producing any urine.
•
have too much
sodium, potassium,
magnesium and/or
phosphorus in your
blood that is not
being correct with
medication
● have an in-born
amino acid metabolic
disorder.
YOU SHOULD TELL YOUR
DOCTOR IF YOU:
•
suffer from liver
disease
•
suffer from heart
problems
•
have a build up of
fluid, particularly
around the the lungs
(pulmonary oedema),
ankles (peripheral
oedema) or any other
condition associated
with retaining

Summary of Product characteristics

SYNTHAMIN (AMINO ACIDS) INTRAVENOUS INFUSION WITH AND WITHOUT
ELECTROLYTES
__________________________________________________________________________________
Version 1.0
Page
1 of 12
AUSTRALIAN PRODUCT INFORMATION –
SYNTHAMIN (AMINO ACIDS) INTRAVENOUS INFUSION _WITH_ ELECTROLYTES; AND
SYNTHAMIN (AMINO ACIDS) INTRAVENOUS INFUSION _WITHOUT_ ELECTROLYTES
1
NAME OF THE MEDICINE
Alanine,
arginine,
glycine,
histidine,
isoleucine,
leucine,
lysine
hydrochloride,
methionine,
phenylalanine, proline, serine, threonine, tryptophan, tyrosine and
valine.
Synthamin
Intravenous
Infusion
with
electrolytes
also
includes
dibasic
potassium
phosphate,
magnesium chloride hexahydrate, sodium acetate and sodium chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Synthamin Intravenous Infusions are solutions of essential and
non-essential L-amino acids provided
with or without electrolytes, available in 5.5%, 8% and 10% strengths.
The excipients are sodium
metabisulfite, acetic acid and water for injections. Each strength has
a pH of approximately 6.0 and
each 500 mL unit contains amino acids and nitrogen in the following
quantities:
5.5%
8%
10%
Amino Acids
27.5 g
40 g
50 g
Nitrogen
4.5 g
6.6 g
8.3 g
Each 1000 mL of Synthamin Intravenous Infusions without electrolytes
contains:
L-Amino Acids
Total Nitrogen
Approximate pH
Protein Equivalents
5.5%
55 g
9.09 g
6.0
56.8 g
8%
80 g
13.2 g
6.0
82.7 g
10%
100 g
16.5 g
6.0
103 g
_ESSENTIAL AMINO ACIDS_
_ _
Leucine
5.5%
4.02 g
8%
5.84 g
10%
7.30 g
Phenylalanine
Methionine
Lysine (as the hydrochloride salt)
Isoleucine
Valine
Histidine
Threonine
Tryptophan
3.08 g
2.20 g
3.19 g
3.30 g
3.19 g
2.64 g
2.31 g
990 mg
4.48 g
3.20 g
4.64 g
4.80 g
4.64 g
3.84 g
3.36 g
1.44 g
5.60 g
4.00 g
5.80 g
6.00 g
5.80 g
4.80 g
4.20 g
1.80 g
_NONESSENTIAL AMINO ACIDS_
5.5%
8%
10%
Alanine
11.4 g
16.6 g
20.7 g
Glycine
5.66 g
8.24 g
10.3 g
Arginine
6.32 g
9.20 g
11.5 g
Proline
3.74 g
5.44 g
6.80 g
Tyrosine
220 mg
320 mg
400 mg
Serine
2.75 g
4.00 g
5.00 g
ATTACHMENT 2B
SYNTHAMIN (AMINO ACIDS) INTRAVENOUS INFUSION WITH AN