OCTAPLAS Solution for infusion Ref.[27452] Active ingredients: Human plasma protein fraction

For intravenous use only

Administer Octaplas based on ABO-blood group compatibility.

2.1 Dose

Replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant:

• Initially infuse of 10 to 15 mL Octaplas per kilogram body weight. This should increase the patient’s plasma coagulation factor levels by approximately 15-25%. If hemostasis is not achieved, use higher doses.
• Adjust dose based on desired clinical response.
• Monitor response, including measurement of activated partial thromboplastin time (aPTT), prothrombin time (PT) and/or specific coagulation factors.
• Plasma exchange in patients with TTP:
• Completely replace plasma volume removed during plasmapheresis with Octaplas. Generally, 1 to 1.5 plasma volumes correspond to 40 to 60 milliliters per kg.[1,2]

2.2 Administration

Administer Octaplas after thawing using an infusion set with a filter.

Octaplas should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.

Avoid shaking.

Steps for Thawing:

• For water bath:
• Thaw in the outer wrapper in a circulating water bath at +30°C to +37°C (86°F to 98.6°F). An overwrap bag may be used to provide further protection of contents if appropriate.
• Prevent water from contaminating the entry port.
• The minimum thawing time is 30 minutes at 37°C (98.6°F). The thawing time depends on the number of bags in the water bath. If more than one plasma bag is thawed in the same water bath, then the thawing time can be prolonged, but should not exceed 60 minutes.
• For dry tempering system:
• Place the Octaplas bags between the heating plates according to the manufacturer’s instructions.
• Thaw plasma following manufacturer directions between +30°C to +37°C (86°F to 98.6°F). Remove the product when the thawing process is completed. The thawing process may be monitored and recorded using the thawing device printer or barcode scanner recommended by the device manufacturer.
• Monitor the thawing process and record using the thawing device printer or barcode scanner recommended by the device manufacturer.

Do not freeze Octaplas. Discard unused product.

Storage and Handling:

• Store at (-18°C (-0.4°F) for 3 years from the date of manufacture.
• Store protected from light.
• Thaw product according to instructions in section 2.2.
• Use thawed product within 24 hr. if stored at 1-6°C (33.8°F to 42.8°F) or within 8 hr. if stored at 20-25°C (68°F to 77°F).
• Do not refreeze thawed product.
• Do not use product that is cloudy or has deposits.
• Discard product after the expiration date printed on the container label.