1 ABPICQMPENDIUM OF DATA SHEETS" *
`
`;
`
`
`
`
`‘ SUMMARIES 0F PRODUCT CHARACTERISTICS
`'
`N
`'
`1999—2000
`
`With ThaCode of Practice for the
`-
`Pharmaceutical lnduStry
`
`.-:..::
`,
`
`,.7,.:.7%‘§w.” .
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`:7.;-.7:51‘_,7,,-
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`_
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`WIZ , Datapharm PubiiCatiQns Limited
`I 1,2white'han; London' swmzn'v’
`
`- C
`
`IPLA LTD. EXHIBIT 2027 PAGE 1
`
`’
`
`
`
`
`
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`CIPLA LTD. EXHIBIT 2027 PAGE 1
`
`

`

`ALLEN 8t HANBURYS
`
`43
`
`Treatment with inhaled beclomethasonedipropionate
`should be continued at a dose sufficient to control
`asthma.
`Pharmaceutical precautions To keep the Rotacaps
`
`capsules i good condition it is important that they
`are stored ini'aTdry place below 30'C where they will
`not ba—fiaxposed-jto extremes of temperature. A
`convenien supply may be carried in the special
`container-'forr'the- Rotahaler device. The Rotacaps
`capsules should be inserted into the Rotahaler
`immediately prior to use to avoid softening. Failure to
`observe this instruction may affect the delivery of the
`drug. The Rotacaps must only be used in the
`Flotahaler.
`Legal category POM.
`100
`Rotacaps
`Beootide
`Package
`quantities
`micrograms, 200 micrograms and 400 micrograms
`are supplied in packs of 112.
`Further information Nil.‘
`Product licence numbers
`Becotido Rotacaps 100 micrograms 1094910061
`Becotide Flotacaps 200 micrograms 10949/0062
`Becotide Rotaceps 400 micrograms 1094910063
`
`FLIXONASE* AQUEOUS NASAL
`SPRAY
`
`occur after relatively high systemic exposure; direct
`intranasai application ensures minimal
`systemic
`exposure.
`-
`As with other drugs the use of Flixonase Aqueous
`Nasal Spray during human pregnancy requires that
`the possible benefits. of the drug be weighedagainst
`
`the possible hazards.
`'
`'
`Lactation: The secretion of'fiuticasone propionate in
`human breast milk has not beeninvestigated. Subcu—
`taneous administration of fluticasone-propionate to
`lactatinglaboratory rats produced measurable plasma
`levels and evidence of fluticasone propionate in the
`milk. However, following intranasal administration to
`' primates, no drug was detected in the plasma, and it
`is therefore unlikelythatthe drug would be detectable
`in milk. When fiuticasone propionate is used in breast
`feeding mothers the therapeutic benefits must be
`weighed against the potential hazards to mother and
`baby.
`Side—effects: Extremely rare cases of nasal septal
`perforation have been reported following the use of
`intranasal corticosteroids, usually in patients who
`have had previous nasal surgery.
`As with other nasal sprays, dryness and irritati'. -
`the nose and throat, unpleasant taste and smeli ~
`epistaxis have been reported.
`i
`Hypersensitivity reactions including skin rasli
`oedema ofthe face or tongue have been reporter
`There have also been rare reports of anaphy}.
`anaphyiactoid reactions and bronchospasm.
`i
`Overdosage:There are no data available on the ef
`‘of acute or chronic overdosage with Flixd
`Aqueous Nasal Spray. lntranasal administratii
`‘
`2 mg fluticasone propionate twice daily for s]
`days to healthy human volunteers had no effeé," x
`hypothalamic—pituitary—adrenal (HPA) axis funi
`-
`.
`inhalation or oral administration of high dost
`
`corticosteroids over a long period may lea“-
`suppression of HPA function.
`'
`‘
`Pharmaceutical precautions Shake gently befori
`Flixonase Aqueous Nasal Spray should he s:
`belowBO'C.
`'
`:
`Legal category POM.
`Package quantities Flixonase Aqueous Nasal Spray is
`supplied in an amber glass bottle fitted with a
`metering. atomising pump, nasal adaptor and a dust
`cover. Each bottle provides approximately 120
`metered sprays. when used as recommended.
`Furtherinformation Nil.
`_
`Product licence number 1094910036
`
`.
`
`-
`
`.
`
`.
`,,
`
`._
`,
`
`iili .
`
`than weekly intervals. For maintenance doses of
`prednisolone, orits equivalent, of“) mg daily or less,
`the decrements in dose should not be greater than
`1 mg per day, at not less than weekly intervals. For
`. maintenance doses of prednisolone in excess of
`'10 mg daily, it may be appropriate to employ cau—r
`....tiously larger decrements in dose at weekly intervals. .
`Some patients feel unwell in a nonspecific way
`'- --during the withdrawal phase despite maintenance or
`even improvement of the respiratory function. They
`should be encouragedto persevere with the Hotahaier
`and withdrawal of systemic steroid continued. unless
`there are objective signs of adrenal insufficiency.
`Patients weaned off oral steroids whose adreno-
`cortical function is impaired should carry a steroid
`warning card indicating that
`they may need
`supplementary systemic steroid during periods of
`stress, e.g. worsening asthma attacks, chest .infec—
`tions, major intercurrent illness, surgery, trauma, etc.
`Replacement of systemic steroid treatment with
`inhaled therapy sometimes unmasks allergies such
`as allergic rhinitis or eczema previously controlled by
`the systemic drug. These allergies
`should be
`symptomatically treated with antihistamine and/or
`topical preparations. including topical steroids.
`Treatment with Becotide'Fiotacaps should not be
`stopped abruptly.
`'
`As with all inhaled corticosteroids, special care is
`necessary in patients with active or quiescent pulmo-
`narytuberculosis.
`Pregnancy: There is inadequate evidence of safety in
`human pregnancy. Administration of corticosteroids
`to pregnant animals can cause abnormalities of fetal
`development including cleft palate and intra-uterine
`growth retardation. There may therefore be a very
`small risk of such effects in the human fetus. it should
`be noted, however, that the fetal changes in animals
`occur after relatively high systemicexposure. Because
`beclomethasone dipropionate is delivered directly to
`the lungs by the inhaled route it avoids the high level
`of exposure that occurs when corticosteroids are
`given by systemic routes.
`The use of beclomethasone dipropionate in preg~
`nancy requires that the possible benefits of the drug
`be weighed against the possible hazards. It should be
`noted that the drug has been in widespread use for
`many years without apparent ill consequence.
`Lactation: No
`specific
`studies
`examining the
`transference of beclomethasone dipropionate into the
`milk of lactating animals have been performed. It is
`reasonable to assume that beclomethasone dipro-
`pionate is secreted in milk, but at the dosages used
`for direct inhalation there is low potential for signifi~
`cant levels in breast milk.
`Theuseofbeclomethasonedipropionatein mothers
`breastfeeding their babies requires that the therapeu—
`tic benefits of the drug be weighed against the
`potential hazards to the mother and baby.
`Side-effects: Systemic effects of inhaled corticoste-
`roids may occur, particularly at high doses prescribed
`for prolonged periods. These may include adrenal
`suppression, growth retardation in children and ado-
`lescents, decrease in bone mineral density, cataract
`and glaucoma.'
`‘
`Candidiasis ofthe mouth and throat (thrush) occurs
`n some patients, the incidence increases with doses
`greater than 400 micrograms beciomethasone dipro-
`pionate per day. Patients with high blood levels of
`Candida precipitins, indicating a previous infection,
`are more likely to develop this complication. Some-
`patients may find it helpful to rinse their mouth
`thoroughly with water after using the Rotahaler.
`Symptomatic candidiasis can. be treated with topical
`anti-fungal therapy whilst still continuing with the
`treatment.
`,
`,_,
`_
`In some patients inhaled beclomothasone dipro—
`pionate may cause hoarseness'Or throat irritation; It
`may be helpful to rinse the mouth out with water
`immediately afterinhalation.
`.‘_
`4
`As with other inhalatioriiligggapv. paradoxical bron-
`chospasm may occur witiifan'ir‘nrnediate increase-ing
`wheezing after dosing. This-responds to a fast—acting
`inhaled bronchodilator. The preparation should be-
`dlscontinued immediately, the patient assessed and,
`if necessary, alternative therapy instituted.
`.L
`Hypersensitivity
`reactions
`including
`rashes;
`urticaria, pruritus and erythema, and oedema of the
`eyes, face, lips and th roat, have been reported.
`Overdosage:Acute. Inhalation ofthe drug in doses in
`excess of those recommended may lead to temporary
`suppression of adrenal function. This does not neces- .
`dilate emergency action being taken. In these patients
`treatment" With beclomethasone dipropionate by ,
`inhalation should be continued ata dose sufficient to
`control asthma; adrenal function recovers in a few
`' do a and can be'yerified byrneasu ring plasma cortisol.
`hronic. Use of inhaled beclomethas‘one dipropion_-
`ate in daily doses in excess of 1,500 micrograms over
`periods may lead to adrenal suppression.
`mailings
`onltorlng of adrenal. reserve may be indicated: -
`
`
`
`
` iil i i
`
`Presentation Flixonase Aqueous Nasal Spray is an
`aqueous suspension of microfine fiuticasone propio-
`nate (0.05% why) for topical administration to the
`nasal mucosa by means of a metering, atomising
`spray pump. Each 100 mg of spray'dalivered by the
`nasal adaptor contains 50 micrograms of fluticasone
`propionate.
`cellulose,
`Other
`ingredients: Microcrystalline
`sodiumcarboxymethylcellulose,dextrose,polysorbate
`80, purified water, benzalkonium chloride and
`phenylethylalcohol.
`Uses Flixonase Aqueous Nasal Spray is indicated
`for the prophylaxis and treatment of seasonal allergic
`rhinitis including hayfever, and perennial rhinitis.
`Fluticasone propionate‘ has potent anti-inflammatory
`activity but when used topically on the nasal mucos
`J‘,
`has no detectable systemic activity.
`5 "
`Dosage and administration
`Flixonase Aqueous
`Nasal Spray is for administration by the intranasai .
`route only.
`Adults and children over 12 years of age: For‘tha
`prophylaxis and treatment of seasonal allergic rhinitis
`and perennial rhinitis: two sprays into each nostril
`once a day, preferably in the morning. In some cases
`two sprays into each nostril
`twice daily may be
`required. The maximum daily dose should not exceed
`four sprays into each nostril.
`Elderly:The normal adult dosage is applicable.
`Children under 12 years of age: For the prophylaxis
`and treatment of seasonal allergic rhinitis and
`perennial rhinitis in children aged 4 to 11 years a dose
`of one spray into each nostril once daily is
`recommended. in some cases one spray into each
`nostril twice daily may be required. The maximum
`daily dose should not exceed two spray's into each
`nostril.
`?
`therapeutic benefit
`full
`For
`regular- usage is
`essential. The absence of an immediate effect should,
`be explained to the patient as maximum reliefmay
`not be obtained until after 3 to 4 days of treatment.
`Contra-indications, warnings, etc .
`._
`Contra-indications:Flixonase Aqueous Nasal Spray is "
`contraindicated in patients with hypersensitivity to
`any of its ingredients.
`'
`"
`Precautionsflnfections of the nasal ainNays should be
`appropriately treated but do not constitute a specific
`
`contraindication
`to
`treatment with ' _Flixonas'e
`Aqueous Nasal Spray.
`'
`,
`
`The full benefit of Fiixonase Aqueous Nasal 5
`
`may not be achieved until treatment has been ad
`
`istered for. several days.
`'
`-
`'
`Care must be taken while transferring patients from '
`systemic steroid treatment to Flixonase Aqueous
`Nasal Spray if there is any reason to suppose that
`their adrenal function is impaired.
`Although Flixonase Aqueous Nasal Spray will
`control seasonal allergic rhinitis in most cases, an
`abnormally heavy challenge of summer allergens
`may in certain instances necessitate appropriate
`additional
`therapy. particularly to control
`eye
`symptoms.
`_
`‘
`'
`Pregnancy: There is inadequate, evidenceofsafetyin
`human pregnancy. Administration of corticosteroids.
`to pregnant animals can cause abnormalities of fetal
`development, including cleft palate and intrauterine
`growth retardation. There may therefore be a very
`small risk of such effects in the human fetus. it should
`be noted, however, that the fetal changes in animals
`
`‘
`
`FLIXOTIDE* ACCUHALER*
`Qualitative and quantitative composition Flixotide
`Accuhalar is a moulded plastic device containing a
`foil stripwith 60 regularly placed blisters each contain-
`ing a mixture of microfine fluticasone propionate
`(50 micrograms. 100 micrograms,250 micrograms or
`500 micrograms) and larger particle size lactose.
`Pharmaceutical
`form Muiti-dose
`dry
`powder
`inhalation device.
`
`Clinical particulars
`Therapeutic indications:Fluticasone propionate given .
`by inhalation offers preventative treatment
`,for
`asthma. At recommended doses it has a potent
`glucocorticoid anti-inflammatory action within the
`lungs, with a lower incidence and severity of adverse
`effects than those observed when corticosteroids are
`administered systemically. in the majority of patients
`it has no effect on adrenal function or reserve at
`recommended doses.
`_
`'Ao'ults: Prophylactic management in:
`intermittent
`Mild
`asthma: Patients
`requiring
`symptomatic bronchodilator asthma medication on a
`regular daily basis.
`Moderate asthma: Patients with unstable or
`worsening asthma despite prophylactic therapy or
`bronchodilatoralone.
`_
`Severe asthma: Patients with severe'chronicasthma
`and those who are dependent on systemic cortico-
`steroids for adequate control of symptoms. 0n
`introduction of inhaled fiuticasone propionate many
`of these patients maybe able to reduce significantly,
`or to.eliminate, their requirement for oral cortico-
`steroids.
`.
`Children: Any child who requires prophylactic
`medication, including patients not controlled on our-
`rentiyavailable prophylactic medication.
`Posology and method of administration: Flixotide
`Accuhalar is for oral inhalation use.only. -Flixoti_de
`Accuhalar is suitable for many patients,., including
`those who. cannot- use a metered-dose inhaler
`successfully.
`Patients should be made aware of the prophylactic
`nature of therapy with Flixotide Accuheler and that it
`should be taken regularly even when they are
`
`CIPLA LTD. EXHIBIT 2027 PAGE 2
`
`CIPLA LTD. EXHIBIT 2027 PAGE 2
`
`

`

`"1362
`
`INDEX
`
`Ethyl Alcohoimenatiirewa is
`ionax* 456.-
`354"
`21.15
`
`Ethyl Nicotinate
`
`"
`Transvasin' 1567.
`
`Ethynodiol
`::
`I
`Femulen 1524:
`
`Ethyoi injea’eiong 24992
`Etidronal'e disodiunI-x“
`
`Didronal
`1263
`Etodoiac
`Lodine 929
`Etomidate
`Hypnomidate 642
`
`Etopophosinjection 250
`Etoposide
`Etopophos 250
`
`Vepesld 245 I‘
`Eucardic
`1311
`i
`
`11f"
`EudemineTablets 844
`
`E}-‘.'.LI'
`Euglucon 568
`
`Eugynon30 1437
`5‘.
`EumovatoCream 489.11.:
`
`EumovateOintm‘ent" .4891
`Eumeream 958
`In:
`
`EuraxLotion 958
`Eurax—Hydrocortisone "
`Evista 739
`
`
`
`
`
`.
`
`
`
`
`
`
`
`
`
`.
`
`9
`'
`iao'a'
`EvoreiPak 632
`Evorel 25 Patch,Evor'eim;'Eviorel1I If;
`Patch, Evorel 100 Patch 6532mm
`Exametazime
`“WI:3
`
`"’""""" Ceretec
`1071
`.‘I
`'
`aion 984
`'
`
`bsurf Neonatal
`1692‘III:
`.4 A‘330’)
`E
`terol 332
`
`
`."
`031119510 I
`'
`4."
`prorlX
`‘
`AlphaNino E475,-
`-
`
`0i!
`btor Vlll
`
`Alphanate 54£=..\ainiau --
`pIar Vill HS, heafitreatedé
`
`4-
`HaemateP 292
`:mr Vlll Inhibitor Bypassirag
`.
`-
`Fraction
`
`;
`IEIBA 600
`-
`
`btor Vlll:C, Porcineg:
`
`Hyatezc 613-:
`Wilding.-
`
`’epcid 908
`
`""'I.-aI"Isidar 1313
`
`Fareston 1106.
`Farlutal
`1194
`Fasigyn 1150
`Faverin 1620 .534:-
`FEIBA lmmuno 600
`Felblnac
`I It.
`Traxam 1759
`I381
`Feidene 1150 "
`Foldene Gel
`1152.59
`
`‘- Feloo‘ipine
`Plendii
`129
`
`.ng i;
`Felypressin
`
`Citanest with Octapreasin?‘
`11,18
`Femapak40 1621'"
`330:
`FemapakSO 1622
`
`Eemara 985
`1'033'
`Fematrix 1623
`
`-
`Femodene
`1439
`-
`FemodeneED 14402"r
`
`
`-
`Femoston 1625
`'
`FemSeven 100 86‘
`
`
`Fe'mSeverISO 862
`FemSeven 75 862
`"
`Femulen 1524
`
`‘
`Fenbufen
`
`I Lederfen 1733'
`.
`Fenofibrate
`I
`LipantiEMicro 446
`
`'
`Fenoprofen
`
`. Fenopron 1053-.
`Fenopron300 1053
`
`Fenopron600 1064‘:-
`' Eenorerolhydrobmmfde
`
`'Zr‘I'I
`Berotec
`191
`Duovent* 197
`"
`
`_.
`.Fentanyl
`" injection (Fandihg)' 40
`InjectioniMartindalei- 81
`
`' Sublimaze 665 "-'
`
`Fentanyl Citrate in13
`ion
`1
`. microgramsiml B17 '
`Fonranyl transder'mdliésystemIII}
`
`. Durogasic IGQSI-“I‘d- '
`‘i- ‘l\":.:'.'I
`' Eenticonazole Nitrate
`
`. Lomexin Pessary' 351v
`Ferristene
`.Abdoscan 1071
`Ferrograd 7
`FerrograciFolic 7
`
`
`FerrousFumaratoj-v
`'
`iI-uIG
`
`Pregaday* 853
`-
`Ferrous Sulphate
`Ferrograd 7.
`
`1026114?
`Slow-Fe
`FerrogradFolic* 743’
`
`Pharmaton* 2243i
`-
`
`Slow-Fe Folic“ 1025'
`60'
`:
`Feltira! 568
`2126'
`Fexofenadr'ne hydrochlo 6'6
`
`Telfast 597
`m6
`
`
`FibrogamminP II29L1
`
`
`Fibrov‘ein
`1663., .I..I .I
`FIlaIrForte Inhaler 30
`
`Filair100lnhaler 808:.‘
`
`FIlaIr50 inhaler 807
`FI'lgrastim
`
`Neupogen 84
`Finasterr‘de
`a:
`
`Proscar 911
`Flagyi
`549
`
`Flagleompak 550
`
`Fiagyliniection 1284
`Flagyi-SSuspension-'5
`‘Ii-‘i-U-Ji
`
`FiagyiSuppasitories 550
`
`Flamazinecream 1517196
`
`Flavoxate Hydrooiziorido
`
`Urispas
`1577
`M231
`Flecalnide
`
`
`1.14:1
`Tambocor 812
`Fleet MIcroEnemaaaBBI‘i:In
`
`Fleet Phosphzotsodamfiagi
`
`Fletchers’ EnemofltemI252I
`
`Fletchers Phosphate-Enema
`Flexin-25 Continua"Tabi’ots 0-937
`Flexin-50 Continus Tablfits (-9326-
`
`
`
`
`FlIxonaseAqueousNasaIIS'pray
`FIixotidaAccuh’aj
`FlixotideDiskhai'e
`.
`
`Flixotideiinhalarit 345m
`Flixotide NebElieVs
`r416
`
`Fiolan
`1693
`Flomax* MR 1770
`
`Fiorinef 1642
`Floxapen 159
`
`Fiuanxoitableté 79-
`FiuarixVaccine 1598
`Flucioxacillin
`_
`Floxapen 1597
`Magnapen* 511694
`Fluconazole
`.
`Diflucan
`Flucytosine
`..
`'Aicobon 604
`
`inn—>3
`Fludara
`1442.52.52:
`:9
`Fludarablne Phosphafm '
`
`
`FlLIdara
`14'423.‘
`III-"r.
`-
`FludroconisonoAceratéi .
`Florinef
`164-2
`“""
`Flumazem'i
`'
`{
`Anexate
`1300
`
`Flumerhasoneei'I 5
`Locorten-Vioforrni“
`
`Flunisollde
`'
`. PI“1
`Syntaris
`1366:5-
`
`Flunitrazepam
`Fiunitrazepam 1363‘?
`FlucieortoloneiiE-xonoa'taI-
`- Ultraianum Cne'al'm 5:146
`
`Uitralanum Ointmen
`-
`Ultraproct* 14703
`FiuoresceiiIi'lDilawere; -1
`
`Pancreoiauryl Test.
`A
`Fluorescein Sodium
`Minims Fluo‘ro‘sceinSodIum- 300rJ
`Minims Lignociiineiand'
`Fiuorescein* 301
`‘37
`
`Minims Proxymetao‘a'irie and-
`
`Fluorescein* 304
`“=1
`Pancreolauryl T4511F 116
`
`Fluorets 296
`
`Fluorouracil
`'-
`.Ampouies (Cambridge)
`"
`:aEfudix 604
`-'I
`-
`Injection iFauidIng) 407"
`
`luoihane "1.-784
`"=
`
`Elyoxetine
`Prozac 348
`
`325.":
`Flupenthixoi
`DepixolConc 794:
`Depixol tablets 7'96"
`
`Dapixoi 794 9“."
`Fluanxoi 797'
`
`Fluphenazine .:-"
`Injection (Fauidi'fig): ' 409"
`Modecate
`1408
`Moditen 141.0
`
`
`
`
`,
`1'21"
`
`:
`
`1146
`
`
`
`Furamide 684
`Ivar-:-
`i-TltL‘i'L‘iifiM
`
`Fusafungine
`INF Ina-mi"
`Locabiotai 1552
`38!" msIIII‘II'r
`
`\"01' A; .IIIII‘mi
`FusldicAcI'd
`15:) I18 mosl
`Fucibet* 1’23
`I
`‘
`
`Fucidin* 7 1‘
`
`Fybozest 1274
`
`
`
`.mm-I-W5""-'
`
`iI
`
`
`
`
`
`
`
`".I-
`
`262m.- .
`«
`
`‘
`
`'.
`
`"
`
`-
`
`
`
`_
`
`"
`
`
`
`
`Motipress“ 1413
`Motival*
`1413
`Flurandrenolone
`Haeian
`1054
`Flurbiprofen 5:21"!
`FIoanSH 684
`Froben 583
`Flutamide
`1475
`_Drogenil
`Fluticasone Proplonate
`Cutivate- 476-
`.5552,
`Flixonase 43
`-
`
`Flixotide
`43
`2‘65:
`Fluvastatin
`
`
`Lescol 9901‘
`(Surface Antigen) PhE-uri‘" 844
`Fluvoxamlne
`‘11:
`Faverin 1620-
`Fluzone
`1 135
`_ Folic Acid
`Ferrograd Foiic* 57‘! :
`
`_ Ketovite"
`12111
`Pregaday” 353;
`.Siow—Fe Foiic* .. 1026
`.
`Follitropin Alpha
`. GonaI-F 154.1
`Foradii 986 -
`Formaldehyde
`VeraourGel.
`157-9
`
`Formesrane
`a-‘I
`
`Lentaron 9.89
`
`Formoterol Fumaraie 977in
`Oxis 127.1159! "
`Fortagesic 1400
`1:169
`
`Fortovaso 1314
`<‘.
`Fortum for [niectio'fis‘MSD
`
`FosamaxT-Iabiet
`18939“
`
`Foscamet .1191 I-
`Foscavir 114
`
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`Gastrografin 1444
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`Gastromax 11.52-_
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`Gastrorniro 8'63"'
`
`lomeron 864
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`loparniffol‘‘86.;3-‘ '1
`Gaviscon Advjanpe
`27-
`
`'
`Ga'viscon'lnffint'
`'
`GavisconTabietsf'1275
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`
`Gelcotar 1269'
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`Gelcotar' L-ifIUid‘="~-1-269
`GelTears 297
`
`Gemcitabins Hydrochlorido
`
`Gemzar" 741
`"1""-
`Gemflbrozii
`=
`Lopid" 1026"“"13'
`Gemzar 741
`
`
`Genotropin ”1199“
`Gantal'rilém "43
`.Cidomycin 563
`
`Gentioin 1316
`
`Genti's'o -e '-" 43-17"
`
`Injection-iFIi'IJidi-fig
`- MinimsGantam‘icin
`
`Ge'nticin 0316 '
`Genti‘sbhe"r'1317' 7‘
`
`Geref 1540
`
`
`Minulet'"
`1.741%
`
`TIIad'eIrf'ei‘ .1467
`TrirMinuIét*"-1'7 '
`Gestbhé-“435 -"
`,
`Gestrinone
`. Dimerrioss 441.
`.
`
`Gestrfinol Hexanoét'é' ' ' "1 *
`
`(Cambridge) 272
`
`GHRH Ferring 435
`Glnse'n'g‘
`'- "'
`.
`_ Pharmaton” 22
`
`Glibenclamide
`‘Dh'b-iiil
`'567
`Euglucon 568:
`
`I"?
`Sémi-Daon'ii ' "567
`Glibenese 1153
`
`Gliclazida
`155
`.
`Diamicron
`
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`560
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`"
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`Minodiab"1_213"
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`'j
`
`Glurenorm 1403 "1"
`.
`
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`
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`'
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`
`
`
`CIPLA LTD'TEXHIBIT2027PAGE3 '
`
`'
`
`'
`
`CIPLA LTD. EXHIBIT 2027 PAGE 3
`
`

`

`
`
`
`
`Direct tel
`Direct fax
`
`+44(0) 1438 76 4024
`+44 (0)20 8047 6894
`
`Corporate Intellectual Property
`
`By EPOline ONLY
`
`European Patent Office
`D-80298 Miinchen
`
`Germany
`
`14th January 2010
`
`Our ref: JLM/OPP10171
`
`Dear Sirs,
`
`European Patent No: 1 519 73131
`Proprietor: CIPLA Ltd.
`
`This is an opposition to European Patent No. EP 1 519 731 B1, in the name of CIPLA Ltd. The
`Opponent is Glaxo Group Limited. We attach the following Documents:
`
`(i)
`(ii)
`
`Statement of Grounds of Opposition; and
`Documents D1-D3 as listed in the Statement of Grounds of Opposition.
`
`Instructions for the deduction of the Opposition Fee from Account No. 28050015 in the name of
`GlaxoSmithKline are included with the online submission via Epoline. Please deduct the correct
`amount if the indicated amount is incorrect.
`
`In the event that the Opposition is deemed inadmissible, or that the EPO considers that the
`Patent should be maintained, Oral Proceedings under A116 are hereby requested.
`
`Yours faithfully,
`
`Dr Jen L Le Miere
`Patent Counsel
`
`Enc:
`
`Statement of Grounds of Opposition
`D1, EP 0 780127 A1
`D2, Dykewicz journal article
`D3, ABPI datasheet, Flixonase
`
`
`
`CIPLA LTD. EXHIBIT 2027 PAGE 4
`
`CIPLA LTD. EXHIBIT 2027 PAGE 4
`
`

`

`
`
`Diagnosis and Management of Rhinitis:
`Complete Guidelines of the Joint Task Force
`on Practice Parameters in Allergy, Asthma
`and Immunology
`Mark S Dykewicz, MD,i Stanley F ineman, MD, MBA,§ Editors
`
`David P Skoner, MDfll Chair, Workgroup on Rhinitis
`
`Richard NicklaS, MDII; Rufus Lee, MD; Joann Blessing-Moore, MDfll; James T Li, MD, PhD**;
`I Leonard Bernstein, MDTT; William Berger, MD, MBAii; Sheldon Spector, MD§§; and
`Diane Schuller, MD,|||| Associate Editors
`
`This document contains complete guidelines for diagnosis and management of
`rhinitis developed by the Joint Task Force on Practice Parameters in Allergy,
`Asthma and Immunology, representing the American Academy of Allergy, Asthma
`and Immunology, the American College of Allergy, Asthma and Immunology and
`the Joint Council on Allergy, Asthma and Immunology. The guidelines are com-
`prehensive and begin with statements on clinical characteristics and diagnosis of
`different forms of rhinitis (allergic, non-allergic, occupational rhinitis, hormonal
`rhinitis [pregnancy and hypothyroidism], drug-induced rhinitis, rhinitis from food
`ingestion), and other conditions that may be confused with rhinitis. Recommenda-
`tions on patient evaluation discuss appropriate use of history, physical examination,
`and diagnostic testing, as well as unproven or inappropriate techniques that should
`not be used. Parameters on management include use of environmental control
`measures, pharmacologic therapy including recently introduced therapies and aller-
`gen immunotherapy. Because of the risks to patients and society from sedation and
`performance impairment caused by first generation antihistamines, second genera-
`tion antihistamines that reduce or eliminate these side effects should usually be
`considered before first generation antihistamines for the treatment of allergic rhi-
`nitis. The document emphasizes the importance of rhinitis management for co-
`morbid conditions (asthma, sinusitis, otitis media). Guidelines are also presented on
`special considerations in patients subsets (children, the elderly, pregnancy, athletes
`and patients with rhinitis medicamentosa); and when consultation with an allergist—
`immunologist should be considered.
`
`Ann Allergy Asthma Immunol 1998;81:478—518.
`
`CONTRIBUTORS: DonaldWAaronson, MD;
`Allen D Adinoff, MD; James N Baraniuk, MD;
`Robert
`J Dockhorn, MD; William Dolen,
`MD; Howard M Druce, MD; Marianne Frieri,
`MD, PhD; Morton P Galina, MD; Leon Greos, MD;
`Alfredo A Jalowayski, PhD; Craig F La Force,
`MD; Eli O Meltzer, MD; Robert M Naclerio,
`MD; Keith M Phillips, l\/[D; Gordon Raphael, MD;
`Michael Schatz, MD; Michael J Schumacher,
`MBBS; Howard J Schwartz, MD; Tommy C
`Sim, MD; Chester '1‘ Stafford, MD; William W
`Storms, MD; Michael J Tronolone, MD; Mi-
`chael J VVelch, MD; Chester C Wood, MD; and
`Robert S Zeiger, MD, PhD
`
`PRINCIPAL REVIEWERS: Jean A Chap-
`man, MD; Robert A Nathan, MD; John Santilli,
`Jr, MD; Michael Schatz, MD; and Betty B Wray,
`MD
`This document was developed by the Joint
`Task Force on Practice Parameters in Allergy,
`Asthma and Immunology,
`representing the
`American Academy of Allergy, Asthma and Im-
`munology (AAAAI), the American College of
`Allergy, Asthma and Immunology (ACAAI) and
`the Joint Council on Allergy, Asthma and Im-
`munology. The AAAAI and the AACAAI have
`jointly accepted responsibility for establishing
`these practice parameters. Because this docu-
`
`ment incorporated the efforts of many partici-
`pants, no single individual, including those who
`served on the Joint Task Force, is authorized to
`provide an official interpretation of this docu-
`ment by the AAAAI or ACAAI. Any request for
`information about or an inteipretation of this
`document by the AAAAI or ACAAI should be
`directed to the Executive Offices of the AAAAI,
`ACAAI and the Joint Council on Allergy,
`Asthma and Immunology.
`* This parameter was developed with Dr.
`Nicklas in his private capacity and not in his
`capacity as a medical officer with the Food and
`Drug Administration. No official support or en-
`dorsement by the Food and Drug Administration
`is intended or should be inferred.
`I Division of Allergy and Immunology, De-
`partment of Internal Medicine, Saint Louis
`University School of Medicine, St. Louis, Mis-
`souri; § Department of Pediatrics, Emory Uni—
`versity School of Medicine, Atlanta, Georgia;
`W Departments of Pediatrics & Otolaryngology,
`Children’s Hospital of Pittsburgh, University
`of Pittsburgh School of Medicine, Pittsburgh,
`Pennsylvania;
`H Department
`of Medicine,
`George Washington Medical Center, Washing-
`ton, DC; fl Departments of Medicine & Pediat-
`rics, Stanford University Medical Center, Palo
`Alto, California; ** Department of Medicine,
`Mayo Clinic & Medical School, Rochester, Min-
`nesota; H Departments of Medicine & Environ-
`mental Health, University of Cincinnati College
`of Medicine, Cincinnati, Ohio; 11 Department of
`Pediatrics, Division of Allergy and Immunology,
`University of California College of Medicine,
`Irvine, California; §§ Department of Medicine,
`University of California-Los Angeles, Los An-
`geles, California;
`”H Department of Pediatrics,
`Pennsylvania State University, Milton S. Her-
`shey Medical College, Hershey, Pennsylvania.
`The Joint Task Force has made an intense
`effort to appropriately acknowledge all contrib-
`utors to this parameter. If any contributors are
`inadvertently excluded, the Task Force Will in-
`sure that appropriate recognition of such contri-
`butions is subsequently made.
`
`
`478
`ANNALS OF ALLERGY, ASTHMA, & IMMUNOLOGY
`
`CIPLA LTD. EXHIBIT 2027 PAGE 5
`
`CIPLA LTD. EXHIBIT 2027 PAGE 5
`
`

`

`
`
`Summary
`
` Contents and Organization of this Document Statement Page
`
`INTRODUCTION ....................................................................
`480
`
`DEFINITION OF RHINITIS .............................................................
`DIFFERENTIAL DIAGNOSIS OF RHINITIS ..................................................
`
`1
`2
`
`Allergic Rhinitis ...................................................................
`
`3—1 2
`
`Non-Allergic rhinitis ................................................................
`Infectious rhinitis ..................................................................
`
`Non-Allergic rhinitis without eosinophilia .................................................
`
`Non-Allergic rhinitis with eosinophilia syndrome ............................................
`
`Occupational rhinitis ...............................................................
`
`Hormonal rhinitis (pregnancy and hypothyroidism) ..........................................
`Drug-induced rhinitis ...............................................................
`
`Rhinitis from food ingestion ..........................................................
`
`Other conditions that may be confused with rhinitis .........................................
`
`Nasal polyps .....................................................................
`EVALUATION OF RHINITIS ............................................................
`
`13
`14
`
`15
`
`16
`
`17
`
`18
`19
`
`20
`
`21
`
`22
`
`History .........................................................................
`
`23—24
`
`Physical examination ...............................................................
`
`Testing for specific IgE .............................................................
`
`Special diagnostic techniques ........................................................
`
`Nasal cytology ...................................................................
`
`Total serum IgE, blood eosinophil counts ................................................
`
`Unproven or inappropriate testing .....................................................
`MANAGEMENT OF RHINITIS ..........................................................
`Environmental control measures .......................................................
`
`25
`
`26
`
`27
`
`28
`
`29
`
`30
`
`31
`
`Pharmacologic therapy .............................................................
`Antihistamines ..................................................................
`
`32
`33—35
`
`Issues with sedation/performance impairment ..........................................
`Cardiac effects of some antihistamines ..............................................
`
`lntranasal antihistamines ..........................................................
`
`Oral and nasal decongestants .......................................................
`Nasal corticosteroids .............................................................
`
`Oral and parenteral corticosteroids ...................................................
`
`lntranasal cromolyn ..............................................................
`
`lntranasal anti-cholinergics .........................................................
`
`Oral anti-Ieukotriene agents ........................................................
`
`Allergen immunotherapy ............................................................
`
`Surgical approaches for co—morbid conditions .............................................
`
`Important considerations in management ................................................
`
`Education of patient and caregivers ....................................................
`Importance of rhinitis management for concomitant asthma, sinusitis, and otitis media ................
`
`Special considerations in children, the elderly, pregnancy, athletes, and rhinitis medicamentosa .........
`
`Consultation with an allergist-immunologist ...............................................
`
`34
`35
`
`36
`
`37
`38
`
`39
`
`40
`
`41
`
`42
`
`43
`
`44
`
`45
`
`46
`47
`
`48
`
`49
`
`480
`480
`
`480
`
`484
`485
`
`485
`
`486
`
`486
`
`487
`487
`
`487
`
`488