Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
ALBUMIN (HUMAN)
EURO ASIA MEDICO PTE. LTD.
B05AA01
20% w/v
INJECTION
ALBUMIN (HUMAN) 20% w/v
INTRAVENOUS
Prescription Only
BIO PRODUCTS LABORATORY LIMITED
ACTIVE
1992-10-09
MyGPS Europe Limited Tel: 020 8863 9700 Job No: 1568 Project Name: Zenalb 20 Leaflet Dual Malaysia / Singapore Contact: Wioletta Nisiobedzka Client Order No. P5520 Date: 23/05/2014 Proof No. 5 Operator: Hema Joshi Doc. Size: 150 x 220mm PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB ® 20 HUMAN ALBUMIN 20% SOLUTION ABNMYSG1 1. NAME OF MEDICINAL PRODUCT ZENALB ® 20, Human Albumin 20% Solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENTS Human albumin. 2.2 QUANTITATIVE COMPOSITION ZENALB ® 20 is a clear, yellow to green, sterilised solution. It is a low salt solution containing 150-250g/L of plasma protein of which not less than 95% is albumin. The residual proteins are heat stable alpha- and beta- globulins. Zenalb ® 20 is free from plasma proteins associated with the blood clotting mechanism and blood group antibodies. 3. PHARMACEUTICAL FORM ZENALB ® 20 is a low salt solution of albumin for intravenous use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZENALB ® 20 is used for albumin replacement in patients with albumin and blood volume deficiency. ZENALB ® 20 is indicated in: i) the clinical management of hypovolaemic shock associated with blood loss, trauma and surgical procedures, ii) the clinical management of burn injuries. It should be used as part of a recognised method of resuscitation and, depending upon the particular regimen being followed, may be the principal component of the intravenous fluid therapy or given as an adjunct to crystalloid infusions, iii) albumin replacement in patients with severe hypoalbuminaemia, to restore physiological oncotic balance. ZENALB ® 20 has an aluminum content of not more than 200ug/L and is therefore suitable for premature infants and patients undergoing dialysis, in compliance with the European Pharmacopoeia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ZENALB ® 20 is given by intravenous infusion. 4.2.1 POSOLOGY ZE Lees het volledige document
Star Creative Tel: 07986 500108 Job No: 50131 Text. Sizes: Main Body Text 6pt Line Spacing 7pt Fonts used: Helvetica Neue LT Std 55 Roman Helvetica Neue LT Std 75 Bold Project Name: Zenalb 20 PIL Singapore ABSG5 Contact: Laura Ambrose Client Order No. P73814 Date: 10/07/2023 Proof No. 3 Operator: Hema Joshi Doc. Size: 170 x 220mm PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB 20 HUMAN ALBUMIN 20% SOLUTION ABSG5 COLOURS: PANTONE PROCESS BLACK 1. NAME OF THE MEDICINAL PRODUCT Zenalb 20 200 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zenalb 20 is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin. A vial of 100 ml contains 20 g of human albumin. Zenalb 20 has a mildly hyperoncotic effect. Excipient with known effect: Zenalb 20 contains approximately 50-120 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 20 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 ad Lees het volledige document