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Presentation
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- Prothrombinex®-VF is supplied as a 500 IU vial containing 500 IU of factor IX, 500 IU of factor II and 500 IU of factor X. Each single pack contains one vial of product, one 20 mL vial of Water for Injections and one Mix2Vial filter transfer set.
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ABO Compatibility
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- Compatibility is not relevant for manufactured (fractionated)
plasma product transfusion
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Warfarin reversal apps
An app for reversing warfarin and guiding your perioperative anticoagulation now available in the Apple iTunes and Android Play stores (free). Scan or click on the QR code.
Rivaroxaban (Xarelto©) management apps
An app for rivaroxaban management, including managing the bleeding patient, is available in the Apple iTunes and Android Play stores (free). Scan or click on the QR code.
Dabigatran (Pradaxa©) management apps
An app for dabigatran management, including managing the bleeding patient, is available in the Apple iTunes and Android Play stores (free). Scan or click on the QR code.
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Storage and Infusion
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- See the Mix2Vial System for intructions on reconsitution of the vial (may take up to ten minutes to reconstitute).
- Allow the vials to reach room temperature (between 20°C and 30°C) before reconstituting. Infuse promptly.
- Do not refrigerate Prothrombinex®-VF once it has been reconstituted.
- Multiple vials of the same product may be pooled together.
- Draw up into a syringe and administer via a syringe pump or by IV bolus.
- Note! Administering Prothrombinex®-VF to patients who are not warfarinised substantially increases the risk of thromboembolism
- See the Mix2Vial page for instructions on spiking the bottle
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Precautions
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- Read manufacturer's instructions carefully.
- Always observe for turbidity / particulate material
(floaters).
- Pumps use is acceptable.
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Rate
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- Prothrombinex®-VF should be given as an infusion or slow IV push at 3 mL/min (180mL/hour) or 7 minutes a vial.
- IV infusion should be completed within 3 hours of reconstituting
bottle
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Dose
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- Prothrombinex®-VF for reversal of warfarin: 25-50 IU/kg in the following situations:
- INR is >10.0 and the patient is at high risk of bleeding
- INR is ≥ 2.0 and there is clinically significant bleeding
- INR is ≥ 1.5 with life threatening (critical organ) bleeding
- a pre-op patient where surgery is urgent, INR > 1.5 due to warfarin
- Note: INR reductions occur within 10 - 15 minutes post-infusion and the effect on INR persists for approximately 12 - 24 hours.
- ASTH warfarin reversal guidelines (2013)
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Dabigatran guidance
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Monitoring
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- Recipients should remain under observation for 20 minutes following administration in case they experience an immediate adverse event requiring treatment.
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DO NOT
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- DO NOT add medications to blood products.
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Calculators
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These calculators will calculate the number of vials of Prothrombinex®-VF your patient may need in different situations.
| Risk group |
Atrial Fibrillation |
Venous Thromboembolism |
Mechanical Heart Valves |
Moderate
or High |
Recent stroke or TIA (<3 months previously)
Rheumatic valvular heart disease
CHADS2 score: 3-6 |
Recent VTE (< 3 months previously)
Recurrent VTE
VTE within last 3-12 months
High risk thrombophilia (Deficiency of antithrombin, protein C or protein S, antiphospholipid syndrome, or homozygous or double-heterozygous factor V Leiden and prothrombin
variant) |
Any mechanical mitral valve or older aortic heart valves (eg, caged-call)
Recent stroke or TIA (<3 months previously)
Bileaflet aortic valve prosthesis with one or
more risk factors (atrial fibrillation, cardiac failure, hypertension, age ≥75 years, diabetes, prior stroke or TIA) |
| Low |
CHADS2 score: 0-2 (no previous TIA or stroke) |
VTE > 12 months previously |
Bileaflet aortic heart valve without any risk factors |
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| CHADS2 scoring: congestive heart failure, hypertension, age ≥75 years, diabetes, 1 point each; prior stroke or transient ischaemic attack, 2 points. |
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More Info
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