Octaplex® Reconstitution Instructions

Reconstitution & Use InstructionsProthrombin Complex ConcentratePrepare at room temperature and on a stable surface.Please readall steps thoroughlybefore proceeding.1 2 3WaterPowderDisinfect the rubber stoppers.Remove Mix2Vial cover.Firmly press blue end onto water vial.4567Remove plastic packaging.Holding the octaplex ® vial on a flatsurface, firmly press the transparentend onto the octaplex ® powder vial.MAINTAIN PRESSURE until there isa complete transfer of water into thepowder vial.With both vials still attached, slowlyswirl (to prevent formation of bubbles)the octaplex ® vial to ensure the productis fully dissolved to a clear or slightlyopalescent solution.8 9 10 11After dilution, UNSCREW THE TWOPARTS of the Mix2Vial by holdingthe blue and transparent parts.The transparent part must stay on theoctaplex ® vial, as it contains theFILTER (15µ).Attach a plastic sterile disposable20 mL syringe to the transparent partof Mix2Vial .Invert the system and draw thereconstituted octaplex ® into the syringe.Administration InstructionsAdministrationRate of administrationIncompatibilityVital signs• octaplex ® should be administered intravenously.• Ideally, a new, clean IV line should be used. Otherwise, the IV line must first be ‘cleaned’ of other productsby flushing it with a saline or dextrose 5% solution. octaplex ® should not be mixed with any otherproduct (including saline or dextrose 5% solution) in the IV line.• Must be administered immediately after reconstitution.• The infusion should start at a speed of 1 mL per minute (60mL/hour), followed by 2-3 mL per minute(120-180mL/hour), using aseptic technique.• octaplex ® should not be mixed with other medication in the same infusion set.• The patient’s pulse rate should be measured before and during the injection. If a marked increase inthe pulse rate occurs, the injection speed must be reduced or the administration must be interrupted.This instruction sheet is inspired from a document created by Mrs. Suzanne Deschênes-Dion, Charged Clinical Transfusion Medicine Security Officer at Hôpital du Sacré-Cœur de Montréal, Montréal, Québec.© 2011 Octapharma Canada Inc. octaplex ® is a registered trademark of Octapharma Canada Inc. Mix2Vial ® is a registered trademark of Medimop Medical Projects Ltd. May 2011

What the medication is used for:• Treatment of bleeding and perioperativeprophylaxis of bleeding in acquireddeficiency of the prothrombin complexcoagulation factors, such as deficiencycaused by treatment with vitamin Kantagonists, or in case of overdoseof vitamin K antagonists, when rapidcorrection of the deficiency is required.NotesWhat it does:• The administration of octaplex ® cantemporarily stop bleeding in patientswith deficiency of one or several of thecoagulation factors II, VII, IX and X,which are commonly called theProthrombin Complex. octaplex ® willstart working immediately upon injection.octaplex ® should only be used whenrapid correction of major bleeding oremergency surgery is warranted.When it should not be used:• If reduction of the dose of the vitaminK antagonist and/or administration ofvitamin K is sufficient.• octaplex ® is not for patients who arehypersensitive to this drug or to anyingredient in the formulation, such asheparin, or component of the container.• octaplex ® should not be used in patientswith a recent heart attack, with a highrisk of blood clots, or with coronaryartery disease, or chronic liver disease.What the medicinal ingredients are:• Human Coagulation Factor II, VII, IXand X, and Proteins C and S.What the important non-medicinalingredients are:• Heparin, sodium citrate, solvent(Water for Injection).