Source: Health Products and Food Branch (CA) Revision Year: 2017
| Route of Administration | Dosage Form/Strength | Clinically Relevant Nonmedicinal Ingredients |
| Intravenous infusion | Solution for Infusion Each mL contains 250 mg protein, of which ≥96% is human albumin | Sodium, Potassium, N-acetyl-DL-tryptophan, Caprylic acid, Aluminium, Water for injections For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING section. |
Octalbin 25% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Octalbin 25% is obtained from collection centres that are inspected by national health authorities and audited by Octapharma. The product is manufactured by the cold ethanol fractionation process followed by ultra- and diafiltration. The manufacturing process includes final container pasteurisation and an additional bulk pasteurisation at 60 0.5°C for 10-11 hours. The Octalbin 25% manufacturing process provides a significant viral reduction in in vitro studies. These reductions are achieved through a combination of process steps including cold ethanol fractionation and final container pasteurisation.
Octalbin 25% contains no preservative. Octalbin 25% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green.
Octalbin 25% is human albumin from human plasma source.
Octalbin 25% is a hyperoncotic pasteurized solution for intravenous use. It is a clear or slightly opalescent solution containing 25% of protein of which at least 96% is human albumin. Each 100 ml contains 25g of human albumin.
1000 ml solution contain:
Sodium 142.5-157.5 mmol
Potassium max. 2.0 mmol
N-acetyl-DL-tryptophan max. 21 mmol
Caprylic acid max. 21 mmol
Aluminium max. 200 µg
Water for injections ad 1000 ml
Glass bottles are made of glass quality type II (Ph.Eur.) and are closed with bromobutyl rubber stoppers quality type I (Ph.Eur.).
Single pack:
1 infusion bottle with 50 ml
1 infusion bottle with 100 ml
Multiple pack:
10 × 1 infusion bottle with 50 ml
10 × 1 infusion bottle with 100 ml
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Octapharma Pharmazeutika Produktionsges m.b.H., Oberlaaer Strasse 235, A-1100 Vienna, Austria Manufactured for: Octapharma Canada, Inc., 308-214 King St W, Toronto, ON M5H 3S6, Canada 208685 |
Date of approval:
October 30, 2017 August 22, 2017 |
| Drug | Countries | |
|---|---|---|
| OCTALBIN | Brazil, Canada, New Zealand |
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