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    LifePearl Loading Instructions Irino 3

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    rasfahan
    This document provides instructions for loading Irinotecan chemotherapy drug into LifePearl microspheres. It details the drug preparation, syringe preparation, drug aspiration into the syringe, loading times, expelling supernatant, adding contrast and sterile water, and agitating prior to use. The loading process must be done aseptically and carefully to avoid introducing air bubbles.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    LifePearl Loading Instructions Irino 3

    Uploaded by

    rasfahan
    5 views2 pages
    This document provides instructions for loading Irinotecan chemotherapy drug into LifePearl microspheres. It details the drug preparation, syringe preparation, drug aspiration into the syringe, loading times, expelling supernatant, adding contrast and sterile water, and agitating prior to use. The loading process must be done aseptically and carefully to avoid introducing air bubbles.

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    Lifepear loading

    Original Title

    LifePearl loading instructions Irino 3

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    This document provides instructions for loading Irinotecan chemotherapy drug into LifePearl microspheres. It details the drug preparation, syringe preparation, drug aspiration into the syringe, loading times, expelling supernatant, adding contrast and sterile water, and agitating prior to use. The loading process must be done aseptically and carefully to avoid introducing air bubbles.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    5 views2 pages

    LifePearl Loading Instructions Irino 3

    Uploaded by

    rasfahan
    This document provides instructions for loading Irinotecan chemotherapy drug into LifePearl microspheres. It details the drug preparation, syringe preparation, drug aspiration into the syringe, loading times, expelling supernatant, adding contrast and sterile water, and agitating prior to use. The loading process must be done aseptically and carefully to avoid introducing air bubbles.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    LIFEPEARL® Microspheres

    INSTRUCTIONS FOR DRUG LOADING


    Irinotecan for Injection
    In order to minimize the risk of microbial
    Required Number of LIFEPEARL® Syringes
    contamination, loading and preparation of
    LifePearl® Microspheres must be carried out To give required dose No. of vials of Irinotecan No. of LIFEPEARL®
    using strict aseptic technique under controlled of Irinotecan Solution 100mg/5ml (20mg/ml) Syringes
    conditions. 100mg 1 1
    Throughout the loading process, avoid 200mg 2 2
    introduction of air bubbles into the system
    and eliminate any that occur.

    1 DRUG PREPARATION
    Use a total of 100mg of Irinotecan for Injection
    as received from the manufacturer.
    i.e. 5ml of 20mg/ml concentration

    2 SYRINGE PREPARATION
    Stand the syringe vertically for approximately 10 minutes
    on the plunger to allow the microspheres to settle.
    Use a 5 micron filter needle to expel most of the
    packaging media (PBS), leaving 3ml total contents in the 3ml
    syringe.
    NOTE: DO NOT compress the microspheres.

    3 ASPIRATE DRUG INTO SYRINGE


    Transfer 5ml (100mg) of Irinotecan solution from the
    vial into the syringe using a transfer device or needle.
    Moderately agitate syringe until contents are homo­
    geneous (approximately 1 min.).

    4 LOAD DEVICE
    Allow microspheres to load for the duration of the loading
    period.
    Refer to the table below for the required loading times.
    During the loading period, agitate the microspheres
    occasionally.

    NOTE: When loaded with 50mg Irinotecan per ml of


    microspheres, LifePearl shrinks up to 15% of their original size.

    Loading Times Per Syringe of LIFEPEARL® Microspheres Physical & Chemical Stability of LIFEPEARL® Microspheres
    Tolerance of ±3%*
    Irinotecan-loaded LIFEPEARL® Irinotecan-loaded LIFEPEARL®
    Irinotecan Uptake Microspheres (100mg/2ml) Microspheres mixed with non-ionic
    100±25µm 200±50µm 400±50µm
    (100mg/syringe) in supernatant contrast and sterile water
    98%* 30 min. 30 min. 30 min. 14 days (at 2-8° C) USE IMMEDIATELY

    These loading times are achieved for LifePearl® Microspheres and Irinotecan when the syringe is gently agitated every 30 minutes until loading time is complete.
    The use of the LifePearl® device in combination with drugs is not cleared or approved in the U.S.A. by the Food and Drug Administration.
    5 EXPEL SUPERNATANT
    Stand the syringe vertically for approximately 10 minutes
    on the plunger to allow the microspheres to settle.
    Use a 5 micron filter needle to expel the drug supernatant
    from the syringe.
    NOTE: DO NOT compress the microspheres.
    DO NOT store loaded microspheres dry- please use
    sterile water to store the microspheres, in an event, the
    supernatant is expelled.
    NOTE: After the required loading time, the solution in the syringe may retain some coloration. This is NOT an indication that
    the LifePearl® embolic has failed to load.

    6 ADD NON-IONIC CONTRAST &


    STERILE WATER SOLUTION
    To prepare the loaded syringe of embolic for injection, transfer all
    contents to a 50-60ml syringe.
    Add aminimum of 20ml of 50:50 non-ionic contrast and sterile
    water solution.
    NOTE: At this point, product must be used immediately – DO NOT
    store for later use.

    7 AGITATE AND SUSPEND


    PRIOR TO USE
    Use a 20ml syringe and a 3-way stopcock to expel all air
    and agitate contents between two syringes until homo­
    geneous suspension is achieved (approximately 2-3
    minutes).
    NOTE: DO NOT introduce air into the system.
    During the treatment procedure, the recommended
    solution delivery rate is 1ml per minute.

    ORDERING INFORMATION
    LifePearl Microspheres
    Volume of Microspheres (ml) Volume of PBS (ml) Product Codes Colour
    Sizes (µm)
    100 ± 25 2 4 8LP2S100 Black
    200 ± 50 2 4 8LP2S200 Yellow
    400 ± 50 2 4 8LP2S400 Blue

    The use of the LifePearl® device in combination with drugs is not cleared or approved in the U.S.A. by the Food and Drug Administration.
    IS614GB0516ITIII(1117)E

    INDICATIONS FOR USE: LifePearl® Microspheres are indicated for embolization of blood vessels supplying primary-hypervascular tumors or metastases in the liver.
    Note: LifePearl® Microspheres can be loaded with chemotherapeutic drugs. When used for drug loading, drug loading should be done under a physician’s direction,
    choice and responsibility, based on type and dose of drug most beneficial to the patient.

    1 . Please refer to IFU/loading instructions provided in LifePearl packaging when using the technical handout.

    Manufacturer Distributed by:


    MicroVention Europe Terumo Europe N.V.
    30 bis, rue du Vieil Abreuvoir Interleuvenlaan 40
    78100 Saint-Germain-en-Laye 3001 Louvain Belgique
    France Tel: +32 16 38 12 11
    Tel: +33(0)1 39 21 77 46  egistered Trademark
    ® RPublished
    www.terumo-europe.com Fax: +33(0)1 39 21 16 01 by Terumo Europe NV

    MICROVENTION is a registered trademark of MicroVention, Inc. LifePearl is a trademark of Terumo, Inc. Scientific and clinical data related to this document are on file at MicroVention, Inc.

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