Composition: One litre contains: Active ingredient: plasma proteins (at least 96% human albumin) 50 g or 200 g. Excipients for 50 g / 200 g respectively: Sodium: 144–160 mmol / 144–160 mmol. Potassium: ≤2.5 mmol / ≤10 mmol. N-acetyl-DL-tryptophan: 3.2–4.8 mmol / 12.8–19.2 mmol. Caprylic acid: 3.2–4.8 mmol / 12.8–19.2 mmol. Water for injections: up to 1.0 l / up to 1.0 l.
Form: Solution for infusion 20%.
Indications: Hypoalbuminemia, shock, nephrotic syndrome, severe burns, ascites, acute liver injury, cerebral edema, ARDS, hemolytic disease of the newborn, therapy during plasmapheresis and hemodialysis.
Contraindications: • Individual intolerance to albumin, including a history of hypersensitivity. • Severe anaemia. • Hypervolaemia. • Grade II–III chronic heart failure. • Pulmonary oedema. • Thrombosis. • Arterial hypertension. • Ongoing internal bleeding. • Haemorrhagic diathesis. • Renal and postrenal anuria. • Oesophageal varices.
Dosage: Intravenously via drip or bolus. Adults: up to 100 ml of 20% solution at a time. Children: 1–3 ml/kg. Administration rate — no more than 1–2 ml/min. Administered only in hospital settings.
Side effects: Rare: anaphylaxis, hypotension. Very rare: urticaria, tachycardia, dyspnea, fever, confusion, rash.
Interactions: No specific drug interactions described. Do not mix with other medications, whole blood, protein hydrolysates, amino acids, or alcohol-containing solutions.
Warnings: Do not use if solution is cloudy or vial integrity is compromised. Monitor electrolyte and fluid balance. Reactions may occur in sensitized patients.
Age restrictions: For adults and children as indicated
Pregnancy: Safety not established, but no harmful effects on fetus or newborn expected. Use if necessary.
Country of origin: Austria
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H
Storage conditions: Store at 2°C to 25°C in a light-protected place. Do not freeze.
