RCH MONOSODIUM l-ASPARTATE 14mmol/10mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

monosodium aspartate, Quantity: 1.4 mmol/mL

Available from:

The Royal Children's Hospital

INN (International Name):

Monosodium aspartate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

10mL ampoule x 5

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Substrate for organ perfusion.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-12-12

Patient Information leaflet

RCH MSA SOLUTION CMI V1.3 October 2011
1
RCH MONOSODIUM L-ASPARTATE
Monosodium L-aspartate Solution
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common
questions about RCH Monosodium L-
aspartate Solution. 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
the
use
of
RCH
Monosodium
L-
aspartate Solution against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THE
USE OF THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT RCH
MONOSODIUM L-
ASPARTATE SOLUTION IS
USED FOR?
The name of your medicine is RCH
Monosodium
L-aspartate
Solution. It
contains
the
active
ingredient
monosodium aspartate.
This medicine is used in open heart
surgery
as
an
additive
to
solutions
which are used to bathe the heart to
stop it beating and minimise the energy
requirements
of
the
heart
during
surgery.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY IT IS BEING USED.
ASK YOUR DOCTOR OR PHARMACIST FOR A
COPY
OF
THE
CONSUMER
MEDICINE
INFORMATION
LEAFLET
WHICH
IS
AVAILABLE
FOR
THE
SOLUTIONS
WHICH
RCH
MONOSODIUM
L-ASPARTATE
SOLUTION IS ADDED TO PRIOR TO USE.
BEFORE RCH
MONOSODIUM L-
ASPARTATE SOLUTION IS
USED
_WHEN IT MUST NOT BE USED _
RCH
MONOSODIUM
L-ASPARTATE
SOLUTION MUST NOT BE USED IF YOU ARE
ALLERGIC TO:
- Monosodium aspartate
Signs
of
an
allergic
reaction
may
include itchy skin rash, shortness
of
breath,
wheezing
or
difficulty
breathing and swelling of the face, lips
or tongue.
Monosodium aspartate must be added
to cardioplegia solutions before use; it
must not be used alone.
THE MEDICINE SHOULD NOT BE USED IF:
•
the expiry date printed on the pack
has passed
•
the
packaging
is
torn
or
shows
signs of tampering.
_ _
_BEFORE IT IS USED _
TELL YOUR DOCTOR IF:
•
you
are
allergic
to
food,
dyes,
preservatives
or
any
other
medicines.
•
you
are
pregnant
or
plan
to
become
pregn

Summary of Product characteristics

RCH MSA Product Information: V1.3 13 October 2011
1
PRODUCT INFORMATION
_RCH MONOSODIUM L-ASPARTATE 14MMOL/10ML AMPOULE _
NAME OF THE MEDICINE
RCH Monosodium L-aspartate 14mmol in 10mL Concentrated Injection
DESCRIPTION
RCH
Monosodium
L-aspartate is a sterile, clear, colourless solution, containing
monosodium aspartate 14mmoL (added as the monohydrate) and water for
injections
to 10.0 mL. The pH of the solution is 7.3 to 7.6.
_SYNONYMS:_
L-aspartic
acid
sodium
salt
monohydrate,
asparaginic
acid
sodium,
asparaginic acid sodium salt
_CHEMICAL FORMULA: _ C
4
H
6
NNaO
4
.H
2
O
Molecular mass: 101.10 for monosodium aspartate monohydrate (98.09 for
anhydrous
monosodium aspartate)
_CHEMICAL STRUCTURE: _
_ _
[
]
Na+.H
2
O
_CAS:_ 3792-50-5 for monosodium aspartate monohydrate
_CAS:_ 56-84-8 for anhydrous monosodium aspartate
Monosodium aspartate monohydrate exists as a white crystalline powder.
It is soluble
in water.
PHARMACOLOGY
During cardiac surgery, the use of cardioplegia solution, usually in
combination with
cardiac
hypothermia,
produces
rapid
and
complete
diastolic
arrest.
Cardioplegia
solution is used to minimise myocardial energy requirements and
prevent ischaemic
damage which may be caused by the absence of coronary blood flow
during the arrest
phase. Cardioplegia solution also minimises or prevents reperfusion
injury when
coronary blood flow is restored.
Aspartate, when used as an additive to cardioplegia solution, may
protect myocytes
during ischaemia by increasing anaerobic energy production.
RCH Monosodium L-aspartate is added to cardioplegia solutions prior to
use in
cardiac surgery. It is not intended for use alone. (_See Dosage and
Administration_).
_ _
_ _
RCH MSA Product Information: V1.3 13 October 2011
2
_PHARMACOKINETICS: _
RCH Monosodium L-aspartate, as an additive to cardioplegia solutions,
should not be
absorbed
systemically
if
the
correct
procedures
are
followed.
However,
if
large
volumes of diluted cardioplegia solution are instilled and allowed to
return to the heart
lung machine without venti