HRP20200445T1 - Metode liječenja ili prevencije tromboze u stentu - Google Patents

Metode liječenja ili prevencije tromboze u stentu Download PDF

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Publication number
HRP20200445T1
HRP20200445T1 HRP20200445TT HRP20200445T HRP20200445T1 HR P20200445 T1 HRP20200445 T1 HR P20200445T1 HR P20200445T T HRP20200445T T HR P20200445TT HR P20200445 T HRP20200445 T HR P20200445T HR P20200445 T1 HRP20200445 T1 HR P20200445T1
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Croatia
Prior art keywords
stent
use according
combination product
thrombosis
myocardial infarction
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HRP20200445TT
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English (en)
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Clive Arthur Arculus-Meanwell
Simona Skerjanec
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Chiesi Farmaceutici S.P.A.
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Application filed by Chiesi Farmaceutici S.P.A. filed Critical Chiesi Farmaceutici S.P.A.
Publication of HRP20200445T1 publication Critical patent/HRP20200445T1/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • 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
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • A61K38/58—Protease inhibitors from animals; from humans from leeches, e.g. hirudin, eglin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Surgery (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)

Claims (23)

1. Kombinacijski proizvod koji sadrži farmaceutski pripravak koji sadrži kangrelor i farmaceutski pripravak koji sadrži bivalirudin za upotrebu u liječenju ili prevenciji tromboze u stentu kod subjekta koji za tim ima potrebu, u redukciji mortaliteta kod subjekta koji podliježe implantaciji stenta, u liječenju ili prevenciji infarkta miokarda kod subjekta koji za tim ima potrebu, i/ili u redukciji mortaliteta kod subjekta koji je doživio infarkt miokarda.
2. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da je tromboza u stentu inducirana implantacijom čistog metalnog stenta ili stenta koji izlučuje lijek u subjekt.
3. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da tromboza u stentu jest intraproceduralna tromboza u stentu, akutna tromboza u stentu, subakutna tromboza u stentu, kasna tromboza u stentu ili vrlo kasna tromboza u stentu.
4. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da prevencija tromboze u stentu jest prevencija tijekom perkutane koronarne intervencije (PCI) ili druge vaskularne implantacije stenta.
5. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da je implantacija stenta tijekom perkutane koronarne intervencije (PCI) ili druge vaskularne implantacije stenta.
6. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da je infarkt miokarda izazvan implantacijom čistog metalnog stenta ili stenta koji izlučuje lijek u subjekt, ili je infarkt miokarda uzrokovan intraproceduralnom trombozom u stentu, akutnom trombozom u stentu, subakutnom trombozom u stentu, kasnom trombozom u stentu, vrlo kasnom trombozom u stentu, ili okluzijom koronarne arterije.
7. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da je mortalitet uzrokovan intraproceduralnom trombozom u stentu, akutnom trombozom u stentu, subakutnom trombozom u stentu, kasnom trombozom u stentu ili vrlo kasnom trombozom u stentu.
8. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da se infarkt miokarda dogodio tijekom perkutane kororarne intervencije (PCI) ili druge vaskularne implantacije stenta.
9. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da infarkt miokarda jest infarkt miokarda odabran iz skupine koju čine akutni infarkt miokarda, liječeni infarkt miokarda, izliječeni infarkt miokarda, akutni infarkt miokarda bez elevacije ST te akutni infarkt miokarda s elevacijom ST.
10. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da se subjekt podvrgava ili je podvrgnut vaskularnoj implantaciji stenta.
11. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da je stanje subjekta odabrano iz skupine koju čine infarkt miokarda s elevacijom ST-segmenta (STEMI), infarkt miokarda bez elevacije ST-segmenta (NSTEMI), stabilna angina, nestabilna angina, te akutni koronarni sindrom.
12. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da su kangrelor i bivalirudin u istom farmaceutskom pripravku.
13. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da su kangrelor i bivalirudin u različitim farmaceutskim pripravcima.
14. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 13, naznačeno time da su farmaceutski pripravak koji sadrži kangrelor i farmaceutski pripravak koji sadrži bivalirudin dani subjektu istodobno ili sekvencijalno, bilo kojim redom.
15. Kombinacijski proizvod za upotrebu prema patentnim zahtjevima 1-8 ili 10, naznačeno time da je farmaceutski pripravak koji sadrži kangrelor dan subjektu oralno, kao intravenozni bolus, kao kontinuirana intravenozna infuzija, ili kao intravenozni bolus nakon čega slijedi kontinuirana intravenozna infuzija u roku od oko 1 sat prije početka implantacije stenta, tijekom implantacije stenta, ili nakon završetka implantacije stenta.
16. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 15, naznačeno time da je intravenozni bolus dan u dozi od oko 30 µg/kg.
17. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 15, naznačeno time da je kontinuirana intravenozna infuzija dana na oko 4 µg/kg/min.
18. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 1, naznačeno time da je farmaceutski pripravak dan subjektu kao kontinuirana intravenozna infuzija u periodu od najmanje dva sata.
19. Kombinacijski proizvod za upotrebu prema patentnim zahtjevima 15-18, naznačeno time da farmaceutski pripravak koji sadrži kangrelor jest farmaceutski pripravak koji sadrži oko 1 mg/mL kangrelora, ili oko 5 mg/mL kangrelora.
20. Kombinacijski proizvod za upotrebu prema patentnim zahtjevima 1-8 ili 10, naznačeno time da je farmaceutski pripravak koji sadrži bivalirudin dan subjektu kao intravenozni bolus, kao kontinuirana intravenozna infuzija, ili kao intravenozni bolus nakon čega slijedi kontinuirana intravenozna infuzija.
21. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 20, naznačeno time da je intravenozni bolus dan u dozi od oko 0.75 mg/kg.
22. Kombinacijski proizvod za upotrebu prema patentnom zahtjevu 20, naznačeno time da je kontinuirana intravenozna infuzija dana na oko 1.75 mg/kg/h.
23. Kombinacijski proizvod za upotrebu prema patentnim zahtjevima 1-8, 10, 16 ili 20, naznačeno time da je implantacija stenta tijekom perkutane koroarne intervencije (PCI).
HRP20200445TT 2009-11-11 2010-11-10 Metode liječenja ili prevencije tromboze u stentu HRP20200445T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US26036109P 2009-11-11 2009-11-11
PCT/US2010/056225 WO2011060066A2 (en) 2009-11-11 2010-11-10 Methods of treating or preventing stent thrombosis
EP10830654.9A EP2498731B1 (en) 2009-11-11 2010-11-10 Methods of treating or preventing stent thrombosis

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HRP20200445T1 true HRP20200445T1 (hr) 2020-06-12

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US (5) US9925265B2 (hr)
EP (1) EP2498731B1 (hr)
AU (1) AU2010319612B2 (hr)
BR (1) BR112012011298B1 (hr)
CA (1) CA2778880C (hr)
DK (1) DK2498731T3 (hr)
EA (1) EA028885B1 (hr)
ES (1) ES2773040T3 (hr)
HR (1) HRP20200445T1 (hr)
PL (1) PL2498731T3 (hr)
PT (1) PT2498731T (hr)
SI (1) SI2498731T1 (hr)
WO (1) WO2011060066A2 (hr)

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MA49452A (fr) * 2017-06-23 2021-05-05 Chiesi Farm Spa Procédé de prévention de thrombose de shunt de l'artère systémique-pulmonaire

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