Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Human Albumin (Human Plasma Protein containing at least 95% Albumin)
DUO MEDICAL PTE. LTD.
B05AA01
200 g/l
INFUSION, SOLUTION
Human Albumin (Human Plasma Protein containing at least 95% Albumin) 200 g/l
INTRAVENOUS
Prescription Only
Kedrion S.p.A.
ACTIVE
2011-11-03
_ _ _UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _ _ _ _Page 1 of 7 _ _SUMMARY OF PRODUCT CHARACTERISTICS _ _(CPMP/PhVWP/BPWG/2231/99 rev.2) _ 1 NAME OF THE MEDICINAL PRODUCT UMAN ALBUMIN 200 g/l Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION UMAN ALBUMIN 200 G/L Solution containing total plasma proteins to 20% of which human albumin at least to 95% a vial of 50 ml contains human albumin equal to 10 g a vial of 100 ml contains human albumin equal to 20 g The solution is hyperoncotic For excipients, see 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 infusion-rate should be adjusted to the patient’s individual requirements. _ _ _UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _ _ _ _Page 2 of 7 _ 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 pre Les hele dokumentet
_ _ _UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _ _ _ _Page 1 of 7 _ _SUMMARY OF PRODUCT CHARACTERISTICS _ _(CPMP/PhVWP/BPWG/2231/99 rev.2) _ 1 NAME OF THE MEDICINAL PRODUCT UMAN ALBUMIN 200 g/l Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION UMAN ALBUMIN 200 G/L Solution containing total plasma proteins to 20% of which human albumin at least to 95% a vial of 50 ml contains human albumin equal to 10 g a vial of 100 ml contains human albumin equal to 20 g The solution is hyperoncotic For excipients, see 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 infusion-rate should be adjusted to the patient’s individual requirements. _ _ _UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _ _ _ _Page 2 of 7 _ 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. UMAN ALBUMIN can be administered to premature infants and dialysis patients as the aluminium content of the finished product is not more than 200 g/l. METHOD OF ADMINISTRATION Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isoton Les hele dokumentet