HUE034288T2 - Afliberceptet, folsavat, 5-fluoracilt (5-fu) és irinotekánt (folfiri) tartalmazó készítmény - Google Patents

Afliberceptet, folsavat, 5-fluoracilt (5-fu) és irinotekánt (folfiri) tartalmazó készítmény Download PDF

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HUE034288T2
HUE034288T2 HUE12717129A HUE12717129A HUE034288T2 HU E034288 T2 HUE034288 T2 HU E034288T2 HU E12717129 A HUE12717129 A HU E12717129A HU E12717129 A HUE12717129 A HU E12717129A HU E034288 T2 HUE034288 T2 HU E034288T2
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aflibercept
combination
dose
patient
administered
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HUE12717129A
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Remi Castan
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Sanofi Sa
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/178—Lectin superfamily, e.g. selectins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Claims (6)

  1. Szabadalmi fénypontok lx Aibbot'ecpnit. fotsavat, 5-fluoryraciit Í5-FU) és smotekám tedfíSsaa·ifesäto® -mesmyíáégekben tartalmazó kombináció kdoreksàbs, rák (OC) vagy kofoíektális rák (CRC) való alkalma- zásrs ilyen kezelési igénylő betegnél, &amp;:M· 1 . i#»ypom szerinti alkgâS^Îakkkpnïbëàçiô,. :WS^^0R!C.-^-Ääri3t^ tarnst miss«. S<te !. vágj 2. igénypont saeriMi alkalmaKSspaitömbinlglé, tfftrJntfíitiHt 'kemoisráp»« val> sogórferapiával vagy rnététtel. •4, Az I - 3. igénypontok hátwdsike szerinti a&amp;^lteám.kíntfetnáetö, aboi a betegét már kezdték oxttliplatifKm vagy bevakiztimabon slap-do terápiával. ®< Az:.1.., vagy 2. igénypont szarints alkalmasára kombioacíó, ahol a beteget sikertelenül kezeitek kemoterápiával* Síigáncrápíáva] vagy műtéttel. A, Aæ 1 - 5: tgdnyj^g#i:;|#S%to smioO alksltnazaant .kg^ggÉ^rtiÉ 'W@m kelőre ktális fák ( MCRC).
  2. 7, Az ) - 6. igénypontok bàrindvîke szerinti alkaisnazásra kombináció, ahol az aflíbercept, fökäv, 5-fluorurae.it (54'üt és irinotekánegymár «tátikerülnek beadásra. 8« At 1 - C fénypontok báróiéivá« skorinti alkalmazásra komöinádö, ahoi m éiihercggk íb!sav? '«tököméit í$-FU) és tr»notekÂ.'ifÿ''4Â-Â3Mtko» feeM kerülnek bsa$te 6gy>. 'S^iikomybÄÄxi-tsába batékonysags legyen elérhető. ló Az i - 8. igéitYpontók bármelyike szerinti alksbtt&amp;zásra kombináció, Él « betepok a folsav 2ÜÖ mg/nk és 6ÖÖ ipg/sbí feítAitts sfeisban, m 5-fiuoraradt ÇS-FÜV 3008 mgtnrri és 4e0$.fgAnï;i»«i döÄan, az irmotokén iOÖ mwnr és 300 mgAr közötti dózisban és az aOibercept I mg/kg és 10 mg/fcg közötti dózisban kerül beadásra, »0. Az I - o. b»t^dytk8>s^nö;'®ikato^^Mtenbte^i» :aboio§;;^p^,«;;feto -tmá- egy -Hid mg/nri dózisbaoj az S^llisornriteii {5Ä) mintegy 2800 mg/m5 dózisban. a?, irsnotekán mimegy 100 mg/m* dómban és az ailbét®bpt;mmtegy 4 mg% dózisban kerül bsadésrá.
  3. 11, Az. t . 10. igéaypontok'btedyá« szerinti alkalmazásra kombináció, aböl á fblsav intravénásán snimegy 400 mg/osd dózisban, az S-%«tmdÍ|Myü|:intravénásaa mintegy 2800 trsg/t# dózisban, m Mnotekáti intravénásán mrnlegy 180 mg/m"’ dózisban és ita sd!ibereap! intravénásán mintegy 4 Sagdíg dózisban kerül beadásra. es altos a kombináció kéthetenként kerül beadásra,
  4. 12, Az 3 - kL IgénypötWbk bármelyiké szerinti alkalmazásra kombiÂtë, abol a föl-sáv, az IriftóteMü és az sOíbereept ititi-avénásáüíkéíbeiesikéíO kerülbéádásra 9 és 18 bét közötti időszakost át
  5. 13, Aa 1 - 12, igénypontok bármelyike szeritni alkaimazásra komfeinádőii^ölkf foJsalil¾tf4Ä^á¾¾k "«libèrc·«^; beadása Klán mnmal kerül beadásra, ίί&amp;,&amp;χ d ·· t3. igénypontok bármelyike éritől alkaimaa&amp;sra kombtnáció./iál^fásilba^ in^litiiSb 'M ádsbsrcept beadása után azonnal mintegy 2 óráv időtartamon lseiül kerül beadásra. IS,.á:z I - 14. igénypontokbármelyike szerinti:.áik&amp;lmazásra kombináció: óból.^irlnóidcánslak’avéstifem az: adiborcgjsi:.böttdasa mán azötmal kerül beadásra. Nk Aï 1 ' IS, !g'-;sy|X;r!!ok bármelyike szeümi alkalmazásra kombináció, ahol st amdeké» imravérsásan beadása tófe azerarai 'mintegy 90 perces Mfbtrísmon beMksÄkeaiäsra« FA Az l * S 6. Igénypontok b&amp;nnelyike seeond alkabnazàxra kombináció, ahol az SAluoruracil (S-FIA Imravénàsan az allbsrcepi beadte usée azomuil kerül beadásra, IA> Az 1 -· í?. igénypoaMsk bármelyik«?· sxermti alkalmazásra k«mibiná<á&amp; .«böJ" #-%ofü?áCÍt egy felső msRoyisiSgs aferafefePäsa« az afliherefept beadásé mán azonnal és az S-FU egy második morrnyiségs ínA iávéhásao az első mgroiyiség alán folyamatos ndáxiókéxu kend beadásra. I-Ss-Äz I ' 18, Igéőypoatok bármelyike $m$M: 4$fcab5öá&amp;áára kombináeífo ahol az fofokírtkácd CS-folíi rbmiegy 4$ö;.f0g/n|* menáylségéinlravéaásün az aftibercepl beadása1 olás 2 - 4 pstees lifoiartáíáOb bélül és az foFlí 24öö mgdn1 mennyiség# Imiavénásap a 400 mgő#®ern!ysség beadása «fon csaknem 4b érán a·: folyamío fos: lakkfo árjánkéul beadásra,
  6. 20. Az I ~ IS. igéoypoxsíok bármslftlfemmfíá ai&amp;alxoagáars lombmáeid, ahol a betegnél nsájfodéisk: vannak. £1< Az i ~ 6, sgényponfoii bármelyike szerinti aiMIsnszásm kombfetáeii, shoí az sílibercfeffo Sbbavs y iluoraraeil (S-FU) és Mnofokán egykfeiöieg kerülnek beadásra.
HUE12717129A 2011-04-26 2012-04-25 Afliberceptet, folsavat, 5-fluoracilt (5-fu) és irinotekánt (folfiri) tartalmazó készítmény HUE034288T2 (hu)

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EP11305490 2011-04-26
EP11306154 2011-09-15

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US (1) US11033606B2 (hu)
EP (2) EP2701724B1 (hu)
JP (1) JP6114257B2 (hu)
KR (2) KR102002653B1 (hu)
CN (1) CN103608029A (hu)
AR (1) AR086051A1 (hu)
AU (1) AU2012247530B2 (hu)
BR (1) BR112013027356A2 (hu)
CA (1) CA2833592A1 (hu)
CL (1) CL2013003082A1 (hu)
CO (1) CO6811861A2 (hu)
CR (1) CR20130547A (hu)
CY (1) CY1120382T1 (hu)
DK (1) DK2701724T3 (hu)
DO (1) DOP2013000248A (hu)
EA (1) EA025182B1 (hu)
EC (1) ECSP13013044A (hu)
ES (1) ES2637074T3 (hu)
GT (1) GT201300260A (hu)
HR (1) HRP20171216T1 (hu)
HU (1) HUE034288T2 (hu)
IL (2) IL228947B (hu)
JO (1) JO3283B1 (hu)
LT (1) LT2701724T (hu)
MA (1) MA35130B1 (hu)
MX (1) MX341348B (hu)
NI (1) NI201300112A (hu)
PE (2) PE20171516A1 (hu)
PL (1) PL2701724T3 (hu)
PT (1) PT2701724T (hu)
RS (1) RS56177B1 (hu)
SG (2) SG194613A1 (hu)
SI (1) SI2701724T1 (hu)
TW (1) TWI599369B (hu)
UA (1) UA114708C2 (hu)
UY (1) UY34036A (hu)
WO (1) WO2012146610A1 (hu)
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