国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
Albumin, Quantity: 12.5 g
CSL Behring Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: sodium acetyltryptophanate; sodium octanoate; water for injections; sodium chloride
Intravenous Infusion
250 mL
Not scheduled. Not considered by committee
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient.
Visual Identification: A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-07-07
Alburex 5 AU CMI 3.00 Page 1 of 4 ALBUREX ® 5 AU _Human albumin, solution for intravenous infusion. _ CONSUMER MEDICINE INFORMATION 250 ML AUST R 327950 500 ML AUST R 327951 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Alburex ® 5 AU. It does not contain all the available information about Alburex ® 5 AU. It does NOT take the place of talking to your doctor. All medicines have benefits and risks. Your doctor has weighed the benefits that Alburex ® 5 AU 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 with this medicine. WHAT ALBUREX ® 5 AU IS USED FOR Alburex ® 5 AU is used to restore and stabilise the circulating blood volume. It is normally used under intensive care situations, when your blood volume has decreased critically. This may be the case, for example: • due to severe loss of blood after an injury _or_ • due to a large surface burn. The choice of using Alburex ® 5 AU will be made by your doctor. It will depend on your individual clinical situation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALBUREX ® 5 AU HAS BEEN PRESCRIBED FOR YOU. HOW ALBUREX ® 5 AU WORKS Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicines and toxins. The albumin protein in Alburex ® 5 AU is isolated from human blood plasma. Therefore the albumin works exactly as if it was your own protein. BEFORE YOU ARE GIVEN ALBUREX ® 5 AU WHEN YOU MUST NOT RECEIVE IT DO NOT RECEIVE ALBUREX ® 5 AU 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 BEFORE TREATMENT IF YO 完全なドキュメントを読む
Alburex 5 AU PI 4.00 Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION ALBUREX ® 5 AU (HUMAN ALBUMIN) – SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Human albumin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin 5% (50 g/L) Alburex ® 5 AU is a solution containing 50 g/L of total protein of which at least 96% is human albumin. Alburex ® 5 AU is mildly hypooncotic to normal plasma. It has a nominal osmolality of 258 mOsm/kg, is isotonic and the pH is 6.7–7.3. Alburex ® 5 AU is manufactured from human plasma collected in Australia by Australian Red Cross Lifeblood. One litre of Alburex ® 5 AU also contains 4 mmol of sodium acetyltryptophanate and 4 mmol of sodium octanoate. Sodium chloride is added to give a sodium content of 140 mmol/L. Alburex ® 5 AU also contains Water for Injections. 3 PHARMACEUTICAL FORM Solution for intravenous infusion. Alburex ® 5 AU is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient. 4.2 D OSE AND METHOD OF ADMINISTRATION The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements. Alburex 5 AU PI 4.00 Page 2 of 9 DOSAGE The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. Infusion rate and volume need to be adapted according to clinical conditions, most notably in the elderly or in the paediatric population. _PAEDIATRIC POPULATION _ The dosage in children and adolescents (0–18 years) should be adjusted to the patient’s individual requirements. MONITORING 完全なドキュメントを読む