Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
ALBUMIN HUMAN; PLASMA PROTEIN FRACTION
DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL
B05AA01
SOLUTION FOR INFUSION
ALBUMIN HUMAN 50 G / 1000 ML; PLASMA PROTEIN FRACTION 96 %
I.V
Required
OCTAPHARMA AG, SWITZERLAND
ALBUMIN
ALBUMIN
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 the official recommendations
2018-06-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Albunorm 5% _, _ 50 g/l, _ _ solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albunorm 5% is a solution containing 50 g/l of total protein of which at least 96% is human albumin. A bottle of 100 ml contains 5 g of human albumin. A bottle of 250 ml contains 12.5 g of human albumin. A bottle of 500 ml contains 25 g of human albumin. Excipients: Sodium (144-160 mmol/l) Albunorm 5% is a mildly hypooncotic solution. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The solution is a clear, slightly viscous liquid; it is 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 - urine output - electrolyte - haematocrit/haemoglobin Method of administration Human albumin can be directly administered by the intravenous route. The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange the infusion-rate should be adjusted to the rate of removal. 4.3 CONTRAINDICATIONS Hypersensitivity to albumin Izlasiet visu dokumentu