Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALBUMIN HUMAN
GERMAX SDN. BHD.
ALBUMIN HUMAN
250ml mL; 500 ml mL; 100 ml mL; 50 ml mL
BIO PRODUCTS LABORATORY LIMITED
GPS Limited Tel: 020 8863 9700 Job No: 18552 Text Sizes: Main Body Text 7pt Line Spacing 8pt Fonts used: Helvetica Neue 55 Roman 75 Bold Project Name: Zenalb 4.5 PIL Malaysia ADMY5 Contact: Laura Ambrose Client Order No. P53744 Date: 26/06/2020 Proof No. 4 Operator: Hema Joshi Doc. Size: 200 x 280mm PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB 4.5 HUMAN ALBUMIN 4.5% SOLUTION ADMY5 1. NAME OF THE MEDICINAL PRODUCT Zenalb 4.5, Human Albumin 45 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zenalb 4.5 is a solution containing 45 g/l (4.5%) of total protein of which at least 95% is human albumin. A vial of 100 ml contains 4.5 g of human albumin. Zenalb 4.5 has a mildly hypooncotic effect. Excipient with known effect: Zenalb 4.5 contains approximately 100-160 mmol/l sodium. For the 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 Zenalb 4.5 is indicated in all patients for the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. 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 ra Baca dokumen lengkap