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`| EDITION
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`FOREWORDTOTHE FIFTY-THIRDEDITION
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`aPDR For Nofiprescription Drugs?"
`the latest“herb'du:jour,” PDR for Herbal:Medicinés:can’
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`¢ PDR For‘Ophthalmology®
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`which botariicalsto éncourage“and which to'avoid:"It /@PDR® forHerbal Medicines™
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`ciousclaims, warnsof conflicting conditions and drugs,
`PDR® Nurse's Handbook™
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`PDR® Nurse's Dictionary™
`relevant clinical literature on each medicinalplant.
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`PDR® Atlas of Anatomy™
`a truly indispensable reference in an era when more |
`PDR Supplements
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`AstraZeneca Exhibit 2046 p. 8
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`AstraZeneca Exhibit 2046 p. 9
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` and emphasis” as the approved labeling fo the prod-
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`PDRand its major companion vo mes are. also found
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`
` Manufacturers’ Index.(White© Pages) : | OO : . 4
`
`. Section 1 -
`.
`Lists all pharmaceutical manufacturers participating in PHYSICIANS' DESK REFERENCE.
`Includes addresses, phone numbers, and emergency contacts. Shows each manufacturer’‘Ss
`
`products and.the page numberof those described in PDR. .
`
`
`Brand and Generic Name Index(PinkPages). - 201 as
`Section 2:
`Gives the page number ofeachh product bybrand andgeneric|name.
` Product Category Index (BluePages) | ee 201
`Lists. all fully described products by prescribingcategory. An overview ofthe. headings .
`
`appearson pages 201 and 202. :
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`Product IdentificationGuide(cayracs) =S=S*=*~<CS~*é‘=~*«S
`Section 4
`Presents full-color,actual-size photos oftablets and capsules, pluspictures ofa variety ofother
`dosage.forms andpackages. Arranged alphabetically by manufacturer.
` Product Information(White Pages) re a 401 |
`Section 5
`The main section ofthe‘book; Includes entriesfor over 2,200 pharmaceuticals. Listings are
`
`arranged alphabetically by manufacturer. ‘
`
`DiagnosticProduct Information 7 a | 3467
`. Gives usage guidelines fora1 varietyofcommon diagnostic agents. Arranged.alphabetically bymanufacturer.
`DrugInformation Centerspheaeeeanesanesevnesveneecteleeeserens"suadasueveonseseucecusduenssvustaassusaudasdeatessessanseseesauensneteasVeneer220
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`a.)national directoryofinstitutions that answer.queries regarding drugs. Arranged alphabeticallybystate and7 ety.
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`Key to ControlledSubstances Categories.........ccesccssssiessessentedecerspescneeenicertenebetes pueenensderenanees Leeserssuecevaeegee 4” ;
`_ Gives the definition of each category and the prescribing limitations that apply.
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`Keyto FDA Use-in-PregnancyRatings ............c0..cccececdeeseeeeeeeeeeeenisveedpeegeessaseseeesceneesenereaeeerenesseenstere OAT
`| Provides the exact interpretation of each: risk/benefit rating...
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`U.S. Food and Drug Administration TelephoneDirectory.......0..6c.scccecssssessessetecenssesseneneeeseasseeiareneneseenes 1.348)
`Gives numbers of key reporting programs. and, information services.
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`A nationalv dlrectory arranged alphabetically by state and city.
`
`Section 3
`
`.. Section 6
`
`.
`
`-
`
`.
`
`
`
`CONTENTS
`
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`
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`7
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`
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`AstraZeneca Exhibit 2046 p. 10
`
`

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` PRODUCT-INFORMATIONI::
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`AstraZeneca Exhibit 2046 p. 11
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`“NOVARTIS:PHARMACEUTICALS/2025
`
`HOWSUPPLIED:
`women need estrogen replaceniétit therapy’for né loiger
`| A stiff protective liner covers the adhesive side of:the
`Estraderti‘SStradiol transdermal system 0:05mg/day — |
`system — the side that will be placed against your skin. This -
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`each 10 cm* system'contains 4 mg ofestradiol USPfor noni:
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`Patient Calendar Pack
`finger. Then hold the systemat one edge. Remove the
`Of 8 Systems oo...ccsceseeseessessteeegeaee‘1 NDC’‘0088-2310-08
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`Carton of 6 Patient Calendar Packs:
`ning of the bones makes the bones weakeranid‘ more Jikely
`adhesive.
`NDC 0083-2310-62
`to -break,; often. leading.-to fractures.of the spine,hip, and
`of 8 Systems’
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`wrist. Taking estrogens after the:menopause.slows,down:or
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`NDC: 0083-2310-24 -;
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`Estradefni‘estFadiol iranisdermal system0.1: mg}day each |
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`
`discontinued;, Eatingfoods that are high in calcium(such as
`20cm?‘systemcontains 8'mg oféstradiol USP’‘for norinal*
`milk products).or. taking calcium: supplements;and-certain
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`types of.exercise:may also help prevent. osteoporosis, Before
`Patient Calendar Pack|
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`you change your calcium intake-or exercise habits,..it. is
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`a NDC:0088:2820.24
`osteoporosis should beconfined to women ho appearto be
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`susceptible to this condition. The following ‘characteristics
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`Donot store ‘above 86°F (30°C).
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`1, ESTROGENS INCREASE THE RISK. OF.‘CANCER‘OF7
`>THE, UTERUS- IN--WOMEN. WHO: HAVE- HAD THEIR -
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`defectifyou take estrogens’ee‘pregnancy. A male child
`. MENOPAUSE.(”“CHANGE OFLIFE”),
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`Tf you.use, any: estrogen-containing: drug,-it
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`may have an increasedrisk of developing abnormalitiesof
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`the urinary system‘and sex organs. A’female child may have
`
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`an increased risk.of:developing’cancer of the vagina or’cer-
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`~ menopause -may:be.a warning:sign-of:-uterine cancer.
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`vix in her teens or twenties. Estrogenis not effective:in pre-"
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`Your doctor shouldevaluate:any-unustalvaginal:Bleed-:
`venting miscarriage (abortion). In addition; estrogenshould
`
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`.. unborn: child -has..a gredter than: usual: chance. of :
`
`having bitth: defects. Therisk of developing these. de=.;
`fects:is small;but.clearly. larger than the risk inchildren: |
`whose