Octaplex
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Octaplex
Quick facts
- Dosing
1500 IU if IBW < 60kg and 2000 IU if IBW ≥ 60kg for acquired deficiency
- Administration
IV, ~15 mL/min, max 20 mL/min for acquired deficiency
- 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.
- 2
The treatment of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as deficiency that occurs during cardiac surgery.
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Contraindications
Contraindications
- 1
Contraindicated for patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
- 2
Contraindicated for patients suffering from heparin-induced thrombocytopenia type II or with known allergies to heparin.
- 3
Contraindicated in those rare cases where an individual has an immunoglobulin A (IgA) deficiency, with known antibodies against IgA.
- 4
Contraindicated in patients with recent myocardial infarction, with a high risk of thrombosis, or with angina pectoris with the exception of life-threatening bleeds due to overdose of oral anticoagulants, or when an emergency surgical procedure is indicated in patients on vitamin K antagonists and an international normalized ratio (INR) >3.
- 5
The administration of Octaplex is principally not recommended in patients suffering from disseminated intravascular coagulation (DIC) because of the pro-coagulant capacity of the product.
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Dosing
For Bleeding and perioperative prophylaxis of bleeding during VKA reversal
- 1
Pre-treatment INR
2 - <4
4 - 6
>6
Dose of Octaplex/kg body weight
25
35
50
Maximum dose
2,500
3,500
5,000
For bleeding in acquired deficiencies
- 1
For patients weighing more than 60 kg, the recommended Octaplex dose is 2,000 IU; those weighing 60 kg or less should receive 1,500 IU. If required, the dose may be repeated once.
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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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