Octaplex
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Octaplex
Quick facts
- Dosing
1500 IU if IBW < 60kg and 2000 IU if IBW ≥ 60kg
- Administration
IV, Initial rate of 1 mL per minute, followed by 2-3 mL per minute
- Storage:
Store the product between 2°C to 25°C for up to 3 years
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Indications
Indications
- 1
The treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
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Contraindications
Contraindications
- 1
Hypersensitivity to components, including heparin, IgA deficiency with antibodies against IgA
- 2
Monitor for thrombosis/ DIC/ MI in at-risk patients.
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Dosing
For Bleeding and perioperative prophylaxis of bleeding during VKA reversal
- 1
Initial INR
2 – 2.5
2.5 – 3
3 – 3.5
> 3.5
Approximate dose (mL Octaplex/kg body
0.9 –1.3
1.3 – 1.6
1.6 – 1.9
> 1.9
For other acquired deficiencies
- 1
Dosing should be individualized and preferably be accompanied by laboratory analysis of global and single coagulation parameters
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Preparation and handling
For Blood Bank
- 1
The reconstituted solution can be stored for up to 8 hours at room temperature (20°C to 25°C).
- 2
Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light
For Clinicians
- 1
Octaplex® is for single use only. Do not re-use any of the components.
- 2
Inspect all components for physical integrity prior to use. Do not use products or components that appear damaged or broken.
- 3
The product reconstitutes quickly (1 to 5 minutes) at room temperature (20°C to 25°C).
- 4
The solution should be administered immediately after reconstitution, or within 8 hours, provided sterility is maintained.
- 5
The reconstituted solution should be clear, colorless or slightly blue.
- 6
Inspect the solution visually for particulate matter and discoloration prior to administration.
- 7
Do not use solutions that are cloudy or have deposits.
- 8
Do not mix with other medicinal products.
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Safety
Safety measures
- 1
Risk of infectious agents with products made from human plasma.
- 2
Risk of allergic reaction.
- 3
Patients should be monitored for risk of thrombosis.
- 4
Safety has not been established for use in human pregnancy.
- 5
Benefits and risks to pregnant women should be carefully weighed.
- 6
Safety has not been established for use in nursing women. Should be given with caution.
- 7
In case of major surgical interventions, precise monitoring of the substitution therapy by means of coagulation assays is essential (specific coagulation factor assays and/or global tests for prothrombin complex levels).
- 8
Octaplex® does not contain AT. However, especially in patients treated for coagulation disorders because of chronic liver disease or because of liver transplantation, AT levels should be monitored and an AT concentrate should be given concomitantly if an AT deficiency is present.
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