8/28/2014
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`DIPRIVAN (r)-Common Clinical Questions
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`http://diprivan.com/faq/faq.html
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`DEC A.UG OCT
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`2000 2001 2002
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`Com"!on Clinical
`DIPR/VANf!
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`Questions
`INJECTABLE +. I
`EMULSION propo,o
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`I.Does DJPRIV AN� contain Sulfite?
`2.Does DIPRIV AN contain Latex?
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`3.What is the phosphorus content of the DIPRTVAN formulation?
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`4. What components of the DJPRIV AN formulation contribute to the caloric load?
`P/80
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`provided with the DIPRIV AN vial?5.ls it necessary to use the vents.pike
`6.How often must the tubin� be chan�ed when administerini: DIPRTV AN?
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`infusion devices does it fit?
`Current Issues o ill Anesthesia
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`7.What re the manufacturing specifications of the DlPRl VAN pre-filled syringe. and which
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`l.Does DIPRIV AN? contain sulfite?
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`Curret11 Issues
`in ICU Seoarion
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`Common Clinic.al
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`No, it does not. As noted in the prescribing information for DIPRIV AN, propofo1 is very slightly
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`soluble in water and, thus, is formulated in a white, oil-in-water emulsion. In addition to the active
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`component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5
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`mg/mL), egg lecithin (12 mg/mL); and disodium edetate (0.005%); with sodium hydroxide to
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`adjust pH. The DIPRIVAN emulsion is isotonic and has a pH of7-8.5.
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`2.Does DIPRIV AN contain Latex?
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`The rubber plun2:er in the syringes
`and the bung of the vials is an elastomeric formulation of l 00%
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`bromobutyl rubber, a synthetic rubber. No form of natural rubber latex is used in the manufacture
`of these packaging components.
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`3.What is the phosphorus content of the DIPRIV AN formulation?
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`The emulsion vehicle used in the formulation of DIPRlV AN contains 15 millimoles of phosphorus
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`(bound in the lipid phase) per liter.
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`4.What components of the DIPRIV AN formulation contribute to the caloric load?
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`of the DIP RIV AN formulation is identical to that found in Intralipid l 0%
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`The emulsion portion
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`described in the labeling, it contains and egg lecithin (Clint,ec Nutrition). In addition to the glycerol
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`of neutral triglycerides of a mixture
`I 0% soybean oil which is composed
`of predominantly
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`unsaturated fatty acids. The major component fatty acids are linoleic (50%), oleic (26%), palmitic
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`(I 0%), linolenic (9%) and stearic (3.5%). Linoleic acid is an Omega-6 fatty acid, linolenic acid is
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`an Omega-3 fatty acid, and oleic acid is an Omega-9 fatty acid. This formulation contains, on
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`average, 3% w/v cholesterol and provides I. l kilocalories and 0.1 g of fat per mL. Triglycerides
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`account for slightly less than 85% of the total calories, while glycerol contributes about 9%, and
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`the phospholipid portion about 7%.
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`Bass and Spangenberg
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`https://web.archive.org/web/2001080317 5340/http:/diprivan.com/faq/faq.html
`Fresenius Kabi USA, LLC
`U.S. Patent No. 8,476,010
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`Exhibit 1008
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`v.
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`1/3
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`Exh. 1008
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`812812014
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`DIPRIVAN (r}- Common Clinical Questions
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`5. Is it necessary to use the vent spike provided with the DIPRIV AN vial?
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`The vent spike is provided as a "value added" item with the 50 mL vial and a stopcock is provided
`with the 100 mL vial as added value. It is not mandatory that either of these items be used during
`administration from the vials, but venting of the vial must be achieved through some means to
`allow proper flow ofDIPRIVAN. When DIPRIVAN is admiinistered directly from the vial, tihe vial
`rubber stopper should be disinfected using 70% isopropyl alcohol. A sterile giving set or a
`combination of a vent spike and sterile tubing must be used. Administration should commence
`promptly and must be completed within 12 hours after the vial has been spiked. The dedicated
`giving set and any unused portions of D IPRI VAN must be discarded after 12 hours.
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`6. How often must the tubing be changed when administering DIPRIV AN?
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`Strict aseptic technique must always be maintained during handling. DIPRIV AN injectable
`emulsion is a single-use parenteral product that contains 0.005% disodium edetate to retard the rate
`of growth of microorganisms in the event of accidental extrinsic contamination. However,
`DIPRIV AN injectable emulsion can still support the growth of microorganisms as it is not an
`antimicrobially preserved product under USP standards. Therefore, time limitations for the
`administration of DIPRIV AN from any one specific container have been established. These
`limitations pertain only to the specific components (vial, syrilnge, tubing, etc . .) dedicated solely to
`the administration ofDIPRIVAN. They do not apply to devices or tubing which are in place to
`facilitate the administration of two or more solutions, includilng DIPRIVAN, which may then be
`admixed. When DIPRIV AN is administered directly from the vial, the vial rubber stopper should
`be disinfected using 70% isopropyl alcohol. A sterile vent spike and sterile tubing must be used.
`Administration should commence promptly and must be completed within 12 hours after the vial
`has been spiked. The dedicated tubing and any unused portions of DIPRIV AN must be discarded
`after 12 hours. If withdrawing D IPRIV AN from a vial with a syringe, the vial rubber stopper
`should be disinfected using 70% isopropyl alcohol. DIPRIV AN injection should be prepared for
`SINGLE PATIENT USE ONLY. Administration should begin promptly. Any unused portion of
`DIPRIV AN, its container, dedicated tubing and/or solutions containing DIPRIV AN must be
`discarded within 6 hours after withdrawing DIPRIV AN from the vial.
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`7. What are the manufacturing specifications of the DIPRIV AN pre-filled syringe, and which
`infusion devices does it fit?
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`In mid-1996, a DIPRIVAN 50 mL pre-filled glass syringe was introduced which is suitable for
`providing continuous infusion when placed in an appropriate infusion pump. To maximize the
`number of infusion pump designs in which this syringe would be compatible, the outside barrel
`diameter was made equal to that of the standard Becton- D ickinson 60 cc syringe.
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`J:iQm.e 1 prescrjbjog I oformatjoo 1 product Informatjoo 1 Cqrrent Issues jo Anesthesia 1
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`prjyacv Statement
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`Legal Informatjon
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`This product information is intended for US Health Care professionals only.
`201135 01/0 1 Copyright © 200 1 Astra7eneca I P All rights reserved.
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`AstraZeneca ~
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`LIS Corporate Sjte
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`https://web.archive.org/web/2001 08031 75340/http:/diprivan.com/faq/faq. html
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`213
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`Exh. 1008
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`

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`812812014
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`DIPRIVAN (r}- Common Clinical Questions
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`https://web.archive.org/web/2001 08031 75340/http:/diprivan.com/faq/faq. html
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`3/3
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`Exh. 1008