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`| EDITION
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`1999
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`AstraZeneca Exhibit 2046 p. 7
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`

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`
`FOREWORDTOTHE FIFTY-THIRD EDITION _
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`‘given the sameemphasis in:PDR. «<0 gsc: a0
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`enhancements,include.
`the complet contents, of, 7)
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`_ontheInternetat www.me
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`more information on these or, anyothe members,.0
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`uct description has been preparedby the manufacturer, _
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`“the: growing.family of PDRproducts, please call,
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`department,‘medical director, and/o¥'medicalconsul" Lene y
`tant. In organizingand presenting’thematerial in’
`Physicians’,Desk Referenceis, published.by Medical.~
`' Economics.Company.in cooperation;wit participating~
`“Desk Réfererice,'the‘publisher“does not
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`‘Physicians’
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`manufacturers...
`Each full-lengthentry provides.you wit .
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`guarantee:
`any ofthe productsdéscribed, or
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`“warrant or guarantee:
`anexactcopy, ofthe, product'sFDA-approved,
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`‘Under the federal Food, Drug and Co
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`
`anyof. the! product* information “goritained herein. |
`
`Physicians” DeskReferencedoes not assume, ‘and’
`Act, a drug approved for marketing may be labeled, pro- 2
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`“moted, and-advertised by’thé ‘manufacturer fororily® ©
`“expressly “d
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`isclaims, “anyobligation to. obtaln and:
`those useéfor ‘which'the' drug's ‘safety ‘andeffective
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`- nesshave been established. "The’ Codé“of: Federal”
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`dthat bymake 9°
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`Regulations: 201.100(d)(1) pertaining. to Jabeling for...
`ing this material .available, the. publisher.is not.advores.
`prescription products requires..that for. PDR.content... «
`cating the use:of any: product..described herein, noriS oe.
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`“indications, effects, dosages, routes,
`ods,.and-:. :
`the publisher.responsibleformisuse-ofaproductdue be ERE
`on-and any rele:
`frequency and duration of administratio
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`to: typographical,error.-- Additional
`information: on any cg
`vant warnings, hazards,
`contraindications,...side:
`~productmay.be obtained.from themanufacturer.
`9 20 oo:
`effects, and: precautions” must be “same-injanguage ..
`
`
`
`
`
`
`AstraZeneca Exhibit 2046 p. 9
`
`

`

`
`
`CONTENTS
`
`
`
`
`
`
` 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 éach manufacturer’‘Ss
`
`products and.the page number of 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
`Section 3
`Lists. all fully described products by prescribing category. An overview ofthe. headings .
`appearson pages 201 and 202.
`
`Product IdentificationGuide(ayrcey) =S=S*s*=~<CS~*~<“<Ss*t‘ts~*«*«
`Section 4
`Presents full-color,actual-size photos oftabléts and capsules, pluspictures ofa variety ofother
`dosage.forms andpackages. Arranged alphabetically by manufacturer.
` Product Information(White Pages) ne 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 varietyofcommon1 diagnostic agents. Arranged.alphabetically bymanufacturer.
`DrugInformation Centerspheaeeeanesanesevnesveneetielecseeners"seadasueveesevercsecessbencccusthesssussedessuevsssceusecseseeressnensieesVeneer220
`a.)national directoryofinstitutions that answer.queries regarding drugs. Arranged alphabeticallybystate and7 ety.
`,
`Key to Controlled.Substances Categories..........ccscscsssesessesseetedecesueesetenatennnets,betes pueenensderenanees Leeserssueeevenegeee4 ”
`_ Gives the definition of each category and the prescribing limitations that apply.
`a
`: oo
`:
`Keyto FDA Use-in-PregnancyRatings ................cccececdeeeeeeeeeeceeeendeeneipeegenessasenaueveeenanduaeeeeeneeeeaeseenseevee OAT
`| Provides the exact interpretation of each risk/benefit rating...
`.
`re
`U.S. Food and Drug Administration TelephoneDirectory.....:..0.c..ccccccecsesesseesssiseeserseneeesasseseestananeenenens 1.348)
`Gives numbers of key reporting programs. and, information services.
`..
`ae
`Poison Control Centers... ceeececesesesestetneteeerereeenrenenneeesspetesenenevenedesipaanseddacesueanacateaneseeaseasseseseesesess3478
`A nationalv directory arranged alphabetically by state and city.
`
`. Section 6
`
`.
`
`-
`
`.
`
`/
`;
`
`;
`
`,
`
`.
`
`:
`
`:
`
`ee,
`
`7
`
`vO
`
`.
`
`.
`
`:
`
`AstraZeneca Exhibit 2046 p. 10
`
`

`

`“NOVARTIS:PHARMACEUTICALS/2025
`
`women need estrogen replaceniétit therapy’for ‘no loiger
`
`ning ofthe bones makes the bones weakerarid’ morelikely
`to ‘break,; often.leading.-to fractures.of the spine,: hip, and
`wrist. Taking estrogens after the:menopause.slows,down:or
`halts bone loss and may. prevent. bones from. breaking.
`I Rapidloss of bone may begin soon after.estrogen therapy is
`discontinued;, Eatingfoods that are high in calcium(such as
`milk products).or taking calcium: supplements ;and-certain
`
`types of.exercise-may also help prevent. osteoporosis.Before
`you change your calcium intake-orexercise habits,.it. is
`importantto discuss,theselife-style changes:swith your doc-
`tor.to find out.if they.are-safe for you,|Since estrogen use is
`associated with some risk, its use in,the. prevention) of
`
`osteoporosis should beconfined to women ho appear to be
`c
`susceptible to this condition. The following ‘characteristics
`are often:h presentjin’‘worne’
`‘who'aré likely to developoste-
`
`
` PRODUCTANFORMATIONi::
`
`
`
`“Mark the2:‘day |
`
`
`
`“Smallao‘of theve atarallyicuir
` through the‘skin fiom the Bstr
`
`
`than 6 months, ThePrevention ofosteoporosis mayrequire
`
`:
`
`.
`
`oils
`
`
`Women who’‘hadtheir menopause2 bi‘thé surgi
`théir‘oviries at a‘relatively youtig'age:nay be:‘good candi-
`. ardiind thea‘ari epurethritis‘(whic
`the
`cause difficultyor.burning¢on urination).
` During pregnancy. Although:the’“possibility fairly.small,
`there-is‘a-greaterrisk‘ofhaving: a child-born witha birth
`defect'ifyou take estrogens 'during*pregnancy. A male child
`may have an increasedrisk of developing abnormalitiesof
`the urinary system‘and sex organs. Afemale ‘child may. have
`an increased risk.of:developing’cancer ofthe vagina or’cer-
`vix in her teens or twenties. Estrogen is not-effectivein pre-"
`venting miscarriage (abortion). In addition; estrogen-should
`not be used.afterchildbirth‘to: prevent the breast‘from fill
`ing with milk, or while breast-feeding." .:"-
`
`Ifyou have alagnese? vaginal.bi
`
`
`
`
`e: heard;that.‘takingestrogens for.aioe
`periods (years) after menopause will keep yourskin soft and
`suppleand:keep.youfeeling young. Thereis no evidence for
`these claims, and suchlong:term treatment may carry seri-
`- ous risks. ««:
`
`
`DANGERS OF
`TROGENS
`Cancer.iof;the, uterus; The. risk of.canecer.,‘of theauterus
`increases. the longer estrogéns ‘are used and. when:larger
`doses are-taken: One study. showed that. whenestrogens-are
`discontinued, this increasedrisk. of cancer seems to falloff
`quickly. Three other studies Showed that the risk for uterine
`cancer stayedhigh. for 8. to, more than .15years, afterstop-
`ping estrogen. treatment.:Becauseofthis risk, it is impor-
`tant to take thelowest dose ofestrogen that will control your
`symptoms,andto. take it-only:aslong as you-need.it: Using
`progestin therapy. together withestrogen therapy may re-
`duce the higher: risk of uterine-cancer related to estrogen
`
`use (see OTHER INFORMATION).
`;
`
`If you have‘had your uterus removed(total hysti
`there is no dangerof developing cancer of theuterus.« own
`
`‘Cancer of the breast. The majority of studies Have"
`no association between the usual doses used for estrogen
`replacementtherapyandbreast cancer.Some stindies have
`suggested a possible incréased incidenceof breast cancérin
`those women taking-estrogens for prolongedperiods“oftime
`
`and especially if higher doses are used.
`«5
`.
`Regular breast.examinations by a:healthprofessional‘and
`monthly: self;examination: are: recommiended: for women
`receiving estrogen.therapy, as they-are-for.all women.:;:
`Gallbladder disease. Women-who'use.estrogens after meno-
`pause are morelikely to develop gallbladder disease:need-
`ing surgery than:women who.donot use:estrogens
`i
`
`- Continued on next‘page.
`~Consult:1999:PDR® supplements’and future editions. for revisions
`
`AstraZeneca Exhibit 2046 p. 11
`
`HOWSUPPLIED:
`Estradert‘estradiol transdermal system 0:05mg/day — |
`each 10 cm? system’contains 4 mgofestradiol USPfor noni:
`|
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`Patient Calendar Pack
`Of 8 Systems 0.0...sessceecntenegene‘1 NDC’‘0088-2310-08
`Carton of 6 Patient Calendar Packs:
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`of 8 Systems.
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`Cartonof 1 Pat en
`:
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`
`of24 Systenis..!
`Estradefni ‘estFadiol transdermal system0.1 mg/day Seach |
`20cm?‘systemcontains 8'mgof éstradiol USP’‘for norinal*
`
`delivery‘o