País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
monosodium aspartate, Quantity: 1.4 mmol/mL
The Royal Children's Hospital
Monosodium aspartate
Injection, concentrated
Excipient Ingredients: water for injections
Intravenous
10mL ampoule x 5
Not scheduled. Not considered by committee
Substrate for organ perfusion.
Visual Identification: Clear, colourless solution.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1995-12-12
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 Llegiu el document complet
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 Llegiu el document complet