Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
sodium chloride, Quantity: 6.43 g/L; potassium chloride, Quantity: 1.19 g/L; magnesium chloride hexahydrate, Quantity: 3.25 g/L; calcium chloride dihydrate, Quantity: 0.176 g/L
Baxter Healthcare Pty Ltd
calcium chloride dihydrate,magnesium chloride hexahydrate,potassium chloride,Sodium chloride
Solution
Excipient Ingredients: water for injections; hydrochloric acid
Intracardial
1000mL
Not scheduled. Not considered by committee
OTHER CONDITIONS: The pH of the Solution must be adjusted to 7.4 to 7. 8 with 10mL of Sodium Bicarbonate 8.4% w/v Injection BP (not supplied) BEFORE USE. INDICATIONS: Following pH adjustment with 10mL of Sodium Bicarbonate 8.4% w/v Injection BP, Cardioplegia "A" Solution is used in combination with ischaemia and hypothermia to induce cardiac arrest during open heart surgery and to preserve the myocardium during asystole.
Visual Identification: Clear, colourless solution.; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1996-07-10
CARDIOPLEGIA “A” SOLUTION FOR CARDIAC PERFUSION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? PAGE What Cardioplegia “A” Solution is used for? 1 Before Cardioplegia “A” Solution is used on you 1 Using Cardioplegia “A” Solution 1 _When is Cardioplegia “A” Solution used? _ _ _ 1 _Amount of Cardioplegia “A” Solution used _ _ _ 1 _Inadequate Dosage _ _ _ 1 _Overdosage _ _ _ 1 Side Effects 2 What Cardioplegia “A” Solution looks like 2 Ingredients 2 Manufacturer 2 This leaflet does not contain all of the available information about Cardioplegia “A” Solution. It does not take the place of talking to your Doctor. WHAT CARDIOPLEGIA “A” SOLUTION IS USED FOR Cardioplegia “A” Solution is used in Open-Heart Surgery to stop the heart and to protect the heart muscle during your operation. BEFORE CARDIOPLEGIA “A” SOLUTION IS USED ON YOU 1. Ask your Doctor about the risks and benefits of using Cardioplegia “A” Solution while you are pregnant. 2. Inform your Doctor if you are breast feeding. It is not recommended to use Cardioplegia “A” Solution if you are breast feeding. Your baby can absorb Cardioplegia “A” Solution from breast milk if you are breastfeeding. USING CARDIOPLEGIA “A” SOLUTION _When is Cardioplegia “A” Solution used? _ _ _ Cardioplegia “A” Solution is used, by your surgeon, during Open-Heart surgery by pouring the solution through your heart. _Amount of Cardioplegia “A” Solution used: _ _ _ The volume of Cardioplegia “A” Solution used is dependent on your weight, height and body surface area. It is also dependent on the duration of the surgery and type of Open-Heart surgery. Cardioplegia “A” Solution may be re-introduced every 20-30 minutes or sooner depending on the temperature of your body (which must be between 15-20 degrees Celsius) and whether your heart starts to beat again during surgery. _Inadequate Dosage: _ _ _ Inadequate dosage of Cardioplegia “A” Solution may result in uneven cooling of your heart and may not sto Læs hele dokumentet
BAXTER CARDIOPLEGIA SOLUTION A Version 1.1 1 of 7 AUSTRALIAN PRODUCT INFORMATION – BAXTER CARDIOPLEGIA SOLUTION A (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE) 1 NAME OF THE MEDICINE Sodium chloride, potassium chloride, calcium chloride dihydrate and magnesium chloride hexahydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baxter Cardioplegia Solution A is a sterile, non-pyrogenic solution in a VIAFLEX bag. It is used to induce cardiac stasis and to protect the myocardium during open-heart surgery. Baxter Cardioplegia Solution A is an isotonic crystalloid solution based on extracellular fluid ionic concentrations. Approximate osmolality is 275 mOsm/kg and approximate pH is 3.7. Each 1000 mL contains: ACTIVE INGREDIENT QUANTITY Sodium chloride 6.43 g Potassium chloride 1.19 g Magnesium chloride hexahydrate 3.25 g Calcium chloride dihydrate 176 mg The mixture contains the following ions in 1000 mL: Sodium 110 mmol Chloride 160 mmol Potassium 16 mmol Magnesium 16 mmol Calcium 1.2 mmol For the full list of excipients, see section 6.1 List of Excipients. BAXTER CARDIOPLEGIA SOLUTION A REQUIRES THE ASEPTIC ADDITION OF 10 ML OF SODIUM BICARBONATE 8.4% W/V INJECTION PRIOR TO USE TO ADJUST THE PH TO 7.4 - 7.8. FOLLOWING PH ADJUSTMENT THE TOTAL SODIUM IONIC CONCENTRATION IS 120 MMOL/L. 3 PHARMACEUTICAL FORM Sterile aqueous solution (for cardiac perfusion). BAXTER CARDIOPLEGIA SOLUTION A Version 1.1 2 of 7 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Following pH adjustment with 10 mL of Sodium Bicarbonate 8.4% w/v Injection, Baxter Cardioplegia Solution A is used in combination with ischaemia and hypothermia to induce cardiac arrest during open heart surgery and to preserve the myocardium during asystole. 4.2 DOSE AND METHOD OF ADMINISTRATION It is important that an appropriate dose of Baxter Cardioplegia Solution A is used to ensure that all areas of the myocardium are cooled evenly, especially those areas distal to arterial obstruction in patients with coronary Læs hele dokumentet