Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN
Baxter Healthcare Limited
HUMAN PLASMA PROTEIN
200 g/l
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FLEXBUMIN 200 G/L SOLUTION FOR INFUSION Human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Flexbumin 200 g/l is and what it is used for 2. Before you use Flexbumin 200 g/l 3. How to use Flexbumin 200 g/l 4. Possible side effects 5. How to store Flexbumin 200 g/l 6. Further information 1. WHAT FLEXBUMIN 200 G/L IS AND WHAT IT IS USED FOR This medicine is a solution of plasma protein and belongs to the pharmacotherapeutic group of plasma substitutes and plasma protein fractions. Plasma is the fluid in which blood cells are suspended. The medicine is used for restoration and maintenance of circulating blood volume when there is not enough blood volume. 2. BEFORE YOU USE FLEXBUMIN 200 G/L DO NOT USE FLEXBUMIN 200 G/L - if you are allergic (hypersensitive) to human albumin or any of the other ingredients of Flexbumin 200g/l. TAKE SPECIAL CARE WITH FLEXBUMIN 200 G/L - If you get headache, difficulties in breathing or feeling faint during the treatment please tell your doctor or nurse. It can be an allergic reaction. - If you have: – decompensated heart failure – high blood pressure – oesophageal varices (swelled veins in the oe সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flexbumin 200 g/l solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flexbumin 200 g/l is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin. A bag of 100 ml contains 20 g of human albumin. A bag of 50 ml contains 10 g of human albumin The solution is hyperoncotic Excipients: Sodium 130-160 mmol/l For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC 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, based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements. _Posology_ 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. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include: - arterial blood pressure and pulse rate - central venous pressure - pulmonary artery wedge pressure (PCW-pressure) - urine output - electrolyte - haematocrit/haemoglobin - clinical signs of cardiac/respiratory failure (e.g.dyspnoea) IRISH MEDICINES BOARD ___________________________________________________________________ সম্পূর্ণ নথি পড়ুন