Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Albumin, Quantity: 40 g/L
CSL Behring Australia Pty Ltd
Injection, solution
Excipient Ingredients: chloride; water for injections; sodium; octanoate
Intravenous
1 X 250mL vial
Not scheduled. Not considered by committee
INDICATIONS AS AT 27 JANUARY 2000 : Hypovolaemia/shock: Preservation of an adequate circulating blood volume should be the primary aim of therapy. The initial resuscitating fluid should not be a human blood product, but rather an alternative plasma volume expander should be used as a first-line replacement. Albumex 4 may, however, be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25g/Litre), or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. Albumex 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome. Cardiopulmonary bypass: Albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long bypass time, anaemia or repeat surgery. For post-operative hypovolaemia Albumex 4 may be used if further colloid is required after a moderate amount of synthetic colloid (1-2L) has been given, or there is ongoing bleeding or anaemia, until cross-matched blood is available. Plasma exchange: Albumex 4 is indicated as a replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20mL/Kg body weight. In patients with thrombotic thrombocytopenic purpura, fresh frozen plasma may be a preferred replacement.,Albumex 4 is a plasma volume expander for restoration and maintenance of circulating blood volume. Albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery. Albumex 4 is indicated as a replacement solution in plasma exchange procedures.
Visual Identification: A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.; Container Type: Vial; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2000-03-09
Albumex 4 AU CMI 10.00 Page 1 of 3 ALBUMEX ® 4 Human albumin, solution for intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Albumex ® 4. It does not contain all the available information about Albumex ® 4. It does not take the place of talking to your doctor. All medicines have benefits and risks. Your doctor has weighed the benefits that Albumex ® 4 will have for you against the risks. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR. FOLLOW YOUR DOCTOR’S ADVICE EVEN IF IT IS DIFFERENT FROM WHAT THIS LEAFLET SAYS. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT FOR FUTURE REFERENCE. The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated. WHAT ALBUMEX ® 4 IS USED FOR Albumex ® 4 may be used: • when the blood volume is low (hypovolaemia) • during heart-lung bypass surgery • in procedures where the patient’s plasma is replaced (plasma exchange). Acute loss of blood or plasma (plasma is the non-cellular part of the blood) may occur due to trauma, after heart-lung bypass surgery, and in patients with multiple organ failure or leaky small blood vessels. The main functions of Albumex ® 4 are to replace and retain fluid in the blood vessels, and to carry other chemicals through the blood stream. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALBUMEX ® 4 HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU ARE GIVEN ALBUMEX ® 4 WHEN YOU MUST NOT TAKE IT DO NOT TAKE ALBUMEX ® 4 IF YOU ARE ALLERGIC TO: • human albumin • any of the ingredients listed at the end of this leaflet. BEFORE YOU ARE GIVEN IT TELL YOUR DOCTOR IF YOU: • are allergic to any other food or medicine • have any other medical conditions such as a history of heart or kidney disease, low blood pressure, breathing difficulties, decreased number of red blood cells (anaemia) or a tendency to bleed or bruise easily Aqra d-dokument sħiħ
Albumex 4 AU PI 10.00 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION ALBUMEX ® 4 (HUMAN ALBUMIN) – SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Human albumin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin 4% (40 g/L) It is a sterile, preservative-free 4% w/v human albumin solution which is iso-oncotic with human serum. It has a nominal osmolality of 260 mOsm/kg, is approximately isotonic and the pH is 6.7 to 7.3. Albumex ® 4 is manufactured from human plasma collected by Australian Red Cross Lifeblood. It is prepared using predominantly chromatographic techniques. The nominal composition of Albumex ® 4 is as follows: Human Albumin 40 g/L Sodium 140 mmol/L Chloride 128 mmol/L Octanoate 6.4 mmol/L Albumex ® 4 also contains Water for Injections. 3 PHARMACEUTICAL FORM Solution for intravenous infusion. Albumex ® 4 is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS HYPOVOLAEMIA/SHOCK Preservation of an adequate circulating blood volume should be the primary aim of therapy. The initial resuscitating fluid should not be a human blood product, but rather an alternative plasma volume expander should be used as first-line replacement. Albumex ® 4 may, however, be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25 g/L), or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. _ _ Albumex 4 AU PI 10.00 Page 2 of 12 Albumex ® 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome. CARDIOPULMONARY BYPASS Albumex ® 4 may be used for priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long Aqra d-dokument sħiħ