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`Astrazeneca Ex
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`, that physicians can'?h’avea:A access to all
`ihformation
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`, moted, and ‘dv‘ertis‘e‘d' 'by"'~the ‘t:rhahura”cture‘r~ for’*"ohil‘yl~5 “ ~ iPh‘y‘siéians“ “Des
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`those uses‘ or w
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`=‘-Vind'clude any in
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`'*Th'e*Code*"‘of—"Fede’ra‘l31i
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`Regulations- 201.100(d)(1) pertaiiniflng,,_to,,—;labeling.,for-
`ing this majte.ria|,,availab|e., the. p,ublisher_,is ,not._ad\4o;.,.«:
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`prescription‘ products requires.-.f§h'<f:It,;1".‘or. PDR.-’content,f
`. V’ds.,..and’.',> .~ eating the.Ll.$_e:~.0f any.,product_.desc‘ribed her.ein,_ ,.no,r_i-st
`“indications, effects, dosages, routes,
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`frequency and duration of administration.-and _Aa_Mny,_:rfe'leéV
`at to..typographioal,error..» Additional
`information. .on._;.any
`yvant warnings, hazards,
`contraindications.,;_».A,_syide.
`effects, and precautions” must be =“sar,ne~.—in,,.Iangua,ge__ ~_=product“may...be—Qbtained,from the.man.uf,acturer.
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`Lists all pharmaceutical manufacturers participating in PHYSICIANS’ DESK REFERENCE.
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`Brand and "Generic Name Index (PinkAPagets).
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`Presents full—color, actua/-size photos of tablets and capsules, plus pictures of a_ variety of other
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`........ .. ..............................
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`lnbnrugn-Inforn1Aation Centers ........... .......
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`KeyAto FDA Use-in-Pregnancy Ratings....
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`M U'.S. Foodand Drug-AdministrationTelephone Directory....'......;.'............
`Gives numbers of key reporting programs. and information services.
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`Poison Control centers”;....; ...................
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`Astrazeneca EX. 2046 p. 10
`
`

`
`'
`PRODU.'CT‘~:INFORMAT|0Nif?
`‘NOVARTlS*:PHARMACEUTICALS/2025
`HOW'S‘UPP,LlED:~.
`‘
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`A stifl‘ protective liner covers the adhesive side of" the .
`women need estrogen replaceifiefit tligrapylfor :no‘ longer
`than 6 months. The prevention of osteoporosis may require
`system — the side that will be placed against your skin. This —‘
`Estraderrfi '€.§trq_dio_l
`transiiermdl system 0.-05‘_mg/day ——
`liner must be removed beforeapplying the system. Slide the ‘
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`each 10 cm” system’contains 4 mg of estradiol USP for noni"-
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`protective liner anddiscard it. fl‘ry_ to avoid touching the
`of 8 Systems .................................
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`the skin on the trunk of the body (including the buttocks '
`and abdomen).

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`e.r‘;azé.—40.: Seed
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`..
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`', vlomen b gin to lose lioné:mo‘\re
`devel p osteopo
`. This thin"-
`ning of the bones makes the bones weaker‘aniii’1nore;likély
`to. breek..vofie.n- leading-to fra.ct\Jres_.0f the spiI.1.e.~hip. and
`wrist.,Taking estrogens afier thegxnenopause.slows.down‘or
`halts bone loss and may prevent._b,o _es_ from. brgaking.
`. Rapidloss of bone may begin soon.s.fi;er-estrogen therapy is
`discontinued»;I1lat'ing~ foods that are high in calc_iun1_(suph as
`milk products or taking .calcium_ supplements .-a_nd;_c_ertain
`types oi‘-Je_xero1se;1__nay also help prevent. osteoporosis Before
`5'‘MU"-
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`youchange your calcium intake;
`'_
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`importantyto disou§s,_these_life;sty_le c anges_wi_th_ your doc-
`tor_ to find ontfif theypare-safe for you,;Since estrogen iise is
`associated with some risk, its use in .the_preyenti'_ong of
`osteoporosis should beconfined to women who agpeflrpto be
`susceptible to this cdiidi
`. The followin‘g"cha‘1‘act'e1istics
`are ofien present in-’women'whoia're‘1ikély' _to' dev'elop-o‘ste-
`' . .
`‘*$€e‘DES.$?R11‘TI0¥l3"
`oporosisz early menopaus‘
`‘
`'hite'or-Asian race;T‘a family
`Do not store ‘above “86°4F (3()"C).
`M ii
`history of osteoporosis in mother, sister, or- au‘nt;' slight
`Do not store unpouched. Apply immediatel
`build; cigarette ‘smoking ‘alcohol abuse; 0 sede‘ tax-y‘ life-
` style
`from the protective pouch.
`‘
`..
`,.
`
`
`_
`e " gical moval of
`_ Women‘who=hadtheir menopause
`their’-ovaries vat a'rela_tively' young
`may beigood’ candi-
`dates for Estraderin
`
`rapy'to help rev'e‘nt.oste‘oporosis.{=
`1l1“tr‘iéa't iztropfhic ‘zfagt
`5:-(‘1'_tcliing,?bui‘riing', "dr'y'ne‘s's_in"or
`around the -vagina) “art’d“tztr2';p‘h-zc‘ uréthritis "(vvhich‘ may
`cau e difliculty orbuming on urination).
`"
`'
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`'ty»is fairlyvsmall,
`During pregnancy. Althoughithepossi 7'
`there ‘st "a~’greater"'r1sk?of‘having‘ a child born with 4a birth
`defect‘~1f_you take estrogens'du1in"g'preg'nan'cy. A male child
`may have an increased risk of developing -abnormalities ‘of
`the urinary systemand ‘sex organs.»A‘female'child may have
`an increased risk ofdevelopiiigcancer of ‘the vagina or ‘cer-
`vix in her teens or twenties. Estrogen is not -‘efl'ectiv‘e -in pre-'
`venting miscarriage (abortion). In addition} estrogenlshould
`not be used after childbirth Ito? prevent the breast fiom_fill-
`ing with milk, or while breast-feeding.‘
`.::.-...:—‘~-
`v
`-»
`Unusualvaginal
`
`
`
`.
`
`
`
`nervous .symptoxns='or,depression during menopause. There
`‘is no-evidence that estrogensare eifective for such symp.
`toms. You may.gliayev heard; that ;taking estrogens for. long
`periods (years) after menopause will keep youriskin soil; and
`suppleand keep.you:feelingyoung. There is no evidence for
`these claims, and such long-term treatment may. carry seri-
`
`. ous riskao. ;; _
`
`V
`I
`DANGERS 0_F"E TRQGEN p
`Canc.e.nof ;th.e.'ztt,er.us: The.ri_s1<.. of «.caa<ser:. of the.-.ut.erUS
`increases the longer estrogens are -used and whendarger
`doses _are~taken. _Qne ,study—. showed that when jestrogensare
`discontinued, this increased’ riskv of cancer seems .to.-fa.1l;.ofl"
`quickly. Three other studies showed that the-risk for uterine
`cancerstayed high for ,8_.,to, more than 15, years,a_fter_stop,—
`ping estrogen treatment..Because of this risk, it is impor-
`tant to take tlw*¢lou_1._est dose ofestrogen that will control your
`symptoms, and to,ti1ke,i1! ozLly'~as_l9ng as you need;:it.‘.' Using
`progestin therapy together with estrogen therapy may re-
`duce the higher. risk of uterine cancer related to estrogen
`use (see OTHER INFORMATION).
`‘ "
`’3
`If you have‘-had your uterus removed (total hysterectomy),
`-" W11
`there is no danger of developing cancer of th_e'1‘.iteru
`‘Cancer of the breast. The majority of studies
`no‘ association between thevusual doses used_for estro

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