Source: Health Products and Food Branch (CA) Revision Year: 2020
OCTAPLASMA – Solvent Detergent (S/D) Treated Human Plasma.
OCTAPLASMA is solvent detergent (S/D) treated human plasma (45-70 mg/mL human plasma proteins). During the manufacturing process, OCTAPLASMA is treated with a combination of 1% Tri(n-butyl)-phosphate (TNBP) and 1% Octoxynol. These S/D reagents are removed by castor oil extraction (TNBP) and subsequent solid phase extraction (Octoxynol) before sterile filtration. After sterile filtration, 200 mL OCTAPLASMA is filled into sterile, plasticised polyvinyl chloride (PVC) blood bags that are over-wrapped with a polyamide/polyethylene film. The coagulation activity values are close to the corresponding values for normal human singledonor fresh-frozen plasma (FFP) and a minimum of 0.5 IU/mL is obtained for all clotting factors. However, as a result of the S/D treatment and purification, the content of lipids and lipoproteins is reduced. This is of no relevance for the indications for OCTAPLASMA. OCTAPLASMA has similar pharmacokinetic properties as normal FFP.
Precautions against viral transmission include: selection of plasma donors, screening of donations and plasma pool, as well as quality control measurements of the final product. As with any blood product, a potential problem is the transmission of blood borne pathogens including those of hitherto unknown origin. When medicinal products prepared from human blood or plasma are given to a patient, the transmission of infectious agents cannot be totally excluded. This applies also to hitherto unknown pathogens. This product is prepared from large pools of human plasma, which may contain the causative agents of hepatitis and other viral diseases (see WARNINGS AND PRECAUTIONS section).
| Route of Administration | Dosage Form/Strength | Clinically Relevant Nonmedicinal Ingredients |
|---|---|---|
| Injection | Solvent Detergent (S/D) Treated Human Plasma Per 200 mL: Human plasma proteins 9.0-14.0 g (45-70 mg/mL) | For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING section. |
OCTAPLASMA (Solvent Detergent (S/D) Treated Human Plasma) is supplied frozen in bags of 200 mL containing 45-70 mg/mL Human Plasma Proteins.
Each 200 mL of OCTAPLASMA (Solvent Detergent (S/D) Treated Human Plasma) contains Human plasma proteins (9.0-14.0 g), Sodium citrate dihydrate (0.88-1.48 g), Sodium dihydrogenphosphate dihydrate (0.06-0.24 g), Glycine (0.80-1.20 g), TNBP (<2.0 mcg/mL), Octoxynol (<5.0 mcg/mL).
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Manufactured by: Octapharma Pharmazeutika Produktionsges m.b.H., Oberlaaer Strasse 235, A-1100 Vienna, Austria and Octapharma AB, Lars Forssells gata 23, SE-112 75, Stockholm, Sweden Manufactured for: Octapharma Canada, Inc., 308-214 King St. W, Toronto, ON M5H 3S6, Canada 228252 |
Date of approval:
August 11, 2005 |
| Drug | Countries | |
|---|---|---|
| OCTAPLASMA | Canada, Lithuania |
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