RCH Monosodium L-aspartate

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Monosodium aspartate

Available from:

The Royal Children's Hospital

Class:

Medicine Registered

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 pas
                                
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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 ar
                                
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