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Loading HepaSphere Microspheres with Lyophilized ... - Merit Medical

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Prepare in Biohazard HoodSteps 1 & 21 2Lift the cap from two<strong>HepaSphere</strong> <strong>Microspheres</strong>vials to the vertical positiontaking care NOT to removethe cap or the metalretaining ring from the vials.Roll the<strong>HepaSphere</strong><strong>Microspheres</strong>vials severaltimes to dispersemicrospheres.Step 33b3c10mL10mLWait 10 min.3a20mL25mg25mgVIAL 150mgD110mL10mLUsing a 30mL syringeand a 20G needle,reconstitute one 50mgdoxorubicin vial <strong>with</strong>20mL preservative-free0.9% sodium chloride.DO NOT USESTERILE WATER25mgUsing two new 20mLsyringes and new 20Gneedles, <strong>with</strong>draw 10mLof doxorubicin (from D1)into each of the two 20mLsyringes.25mgVIAL 2Using a new 20G needle on each 20mL syringe inject theentire contents of one syringe (10mL) into each of the<strong>HepaSphere</strong> <strong>Microspheres</strong> vials. This results in 25mg ofdoxorubicin in each of the 2 <strong>HepaSphere</strong> <strong>Microspheres</strong>vials. Note: There may be a vacuum in the <strong>HepaSphere</strong><strong>Microspheres</strong> vial.Rotate and invert the <strong>HepaSphere</strong> <strong>Microspheres</strong> vials backand forth so that the liquid contacts the gray stopper.Invert and shake every few minutes to continue to mixspheres <strong>with</strong> doxorubicin.


Supplies• 3 x doxorubicin 50mg powder vials• 2 x <strong>HepaSphere</strong> <strong>Microspheres</strong> vials• 11 x 20G needles or larger (18G preferred)• 2 x 20mL syringes or larger• 5 x 30mL syringes or larger• 6 x 10mL vials preservative-free0.9% sodium chloride for injection - DO NOT USE STERILE WATER• 2 x syringe caps150mgin twovialsStep 4Step 54a20mL4b20mLD2 +VIAL 130mLWait 60 min.4a50mgD220mL4b50mg20mLD3 +VIAL 275mg30mLRemove the needles andcap the syringes. Notethe time and wait 60minutes to optimize theuptake of the doxorubicininto the spheres. Agitateevery few minutes duringloading.50mgD350mg75mgUsing new 30mLsyringes and new 20Gneedles, reconstitute 2additional vials of 50mgof doxorubicin <strong>with</strong>20mL preservative-free0.9% sodium chloridein each vial.DO NOT USESTERILE WATERUsing two new 30mLsyringes and new 20Gneedles, <strong>with</strong>draw theentire contents from eachdoxorubicin vial into oneof the syringes. This resultsin 2 syringes containing50mg doxorubicin in 20mLof fluid in each.After the 10 minutes from Step 3c, usingnew 20G needles on each of these two 30mLsyringes, <strong>with</strong>draw the entire contents of oneof the <strong>HepaSphere</strong> <strong>Microspheres</strong> vials preparedin step 3 (vial1 and vial2) into each syringefrom Step 4 (D2 and D3).This results in two 30mL syringes, eachcontaining the contents of one <strong>HepaSphere</strong><strong>Microspheres</strong> vial <strong>with</strong> 75mg of doxorubicin in30mL of fluid.


www.merit.com<strong>Merit</strong> <strong>Medical</strong> Systems, Inc.1600 West <strong>Merit</strong> ParkwaySouth Jordan, UT 84095Tel: 1-801-253-1600Fax: 1-801-253-1652Customer Service: 1-800-35-MERiT<strong>Merit</strong> <strong>Medical</strong> Systems, Inc.EUROPE, MIDDLE EAST AND AFRICA (EMEA)amerikalaan 42,6199 aE Maastricht-airportThe netherlandsTel: +31 43 358 82 40BioSphere <strong>Medical</strong>, S.A.Parc des nations - Paris nord 2383 Rue de la Belle Etoile95700 Roissy en FranceFrance©2012 <strong>Merit</strong> <strong>Medical</strong> Systems, Inc. All rights reserved.MR11-106 Rev B 402279001/B ID 080112

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