Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Albumin, Quantity: 0.2 g/mL
CSL Behring Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: water for injections; sodium; octanoate
Intravenous
INDICATIONS AS AT 27 JANUARY 2000: Hypoproteinaemia in the acutely ill patient: Albumex 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy. Shock: Albumex 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4-5% human albumin is preferred when available. Burns: Extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins, resulting in hypovolaemic shock and circulatory failure. Inititally (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. Large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of Albumex 20 are required to maintain adequate plasma volume and colloid osmotic pressure. Adult respiratory distress syndrome
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 at 2 to 8 degrees Celsius
Registered
1991-11-04
Albumex 20 AU CMI 13.00 Page 1 of 3 ALBUMEX ® 20 Human albumin, solution for intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Albumex ® 20. It does not contain all the available information about Albumex ® 20. 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 ® 20 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 ® 20 IS USED FOR Albumex ® 20 may be used: • in an acutely ill patient when the amount of protein in their blood is low (hypoproteinaemia) • to replace fluid in the blood vessels due to acute loss of blood or plasma (plasma is the non-cellular part of the blood) • to treat extensive burns • to treat a serious lung condition (respiratory distress syndrome) • in procedures where the patient’s blood is purified (haemodialysis) • in procedures where the patient’s plasma is replaced (plasma exchange). The main functions of Albumex ® 20 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 ® 20 HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU ARE GIVEN ALBUMEX ® 20 WHEN YOU MUST NOT TAKE IT DO NOT TAKE ALBUMEX ® 20 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 Baca dokumen lengkap
Albumex 20 AU PI 13.00 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION ALBUMEX ® 20 (HUMAN ALBUMIN) – SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Human albumin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin 20% (200 g/L) It is a sterile, preservative-free 20% w/v human albumin solution. It has a nominal osmolality of 130 mOsm/kg, is hypotonic and the pH is 6.7 to 7.3. It is hyperoncotic and hypo-osmotic compared to human serum. Albumex ® 20 is manufactured from human plasma collected by Australian Red Cross Lifeblood. It is prepared using predominantly chromatographic techniques. The composition of Albumex ® 20 is as follows: Human Albumin 200 g/L Sodium 48–100 mmol/L Octanoate 32 mmol/L Albumex ® 20 also contains Water for Injections. 3 PHARMACEUTICAL FORM Solution for intravenous infusion. Albumex ® 20 is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS HYPOPROTEINAEMIA IN THE ACUTELY ILL PATIENT Albumex ® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy. Albumex 20 AU PI 13.00 Page 2 of 14 SHOCK Albumex ® 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4–5% human albumin is preferred when available. BURNS Extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins, resulting in hypovolaemic shock and circulatory failure. Initially (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. Large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of Albumex ® 20 are required to maintain adequate plasma volume and colloid osmotic pressure. ADULT RESPIRATORY DISTRESS SYNDROME The clinical syndrome is characte Baca dokumen lengkap