DK2222285T3 - Farmaceutiske sammensætninger - Google Patents

Farmaceutiske sammensætninger Download PDF

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DK2222285T3
DK2222285T3 DK08848615.4T DK08848615T DK2222285T3 DK 2222285 T3 DK2222285 T3 DK 2222285T3 DK 08848615 T DK08848615 T DK 08848615T DK 2222285 T3 DK2222285 T3 DK 2222285T3
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Erik Philipp
Ludwig Daniel Weibel
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Vifor (International) Ag
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009Sachets, pouches characterised by the material or function of the envelope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds

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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Zoology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Endocrinology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (25)

1. Farmaceutisk sammensætning omfattende jernoxid-hydroxid i høj koncentration på 10 til 80 % (vægt/vægt) udtrykt i forhold til den farmaceutiske sammensætnings samlede vægt, i en form der er egnet til oral indgivelse, hvor mængden af jernoxid-hydroxid pr. dosisform er > 300 mg.
2. Farmaceutisk sammensætning omfattende jernoxid-hydroxid i høj koncentration på 10 til 80 % (vægt/vægt) udtrykt i forhold til den farmaceutiske sammensætnings samlede vægt, i en form der er egnet til oral indgivelse som film-overtrukne dosisformer til intakt synkning eller som dosisformer der er i stand til at desintegrere i mundhulen, hvor mængden af jernoxid-hydroxid pr. dosisform er > 300 mg.
3. Sammensætning ifølge krav 1 eller 2, hvor sammensætningen indeholder mindst et kulhydrat og/eller huminsyre.
4. Sammensætning ifølge krav 3, hvor kulhydratet er valgt fra gruppen bestående af et mono-, di- eller polysaccharid, såsom agarose, dextran, dextrin, dextranderivater, cellulose og cellulosederivater, saccharose, maltose, og lactose, fortrinsvis saccharose, dextran, og stivelse.
5. Sammensætning ifølge et hvilket som helst af de foregående krav hvor jernoxid-hydroxidet indeholder beta jernoxid-hydroxid.
6. Sammensætning ifølge et hvilket som helst af de foregående krav hvor jernoxid-hydroxid er til stede i en mængde på 30 til 65 % (vægt/vægt), udtrykt i forhold til sammensætningens samlede vægt.
7. Sammensætning ifølge et hvilket som helst af de foregående krav hvor kulhydratet og/eller huminsyren er til stede i en samlet mængde på 1 til 50 % (vægt/vægt), fortrinsvis 5 til 30 % (vægt/vægt), udtrykt i forhold til sammensætningens samlede vægt.
8. Sammensætning ifølge et hvilket som helst af de foregående krav endvidere omfattende et eller flere aromastoffer, sødemidler, smagsfremmende midler, og/eller farvestoffer.
9. Sammensætning ifølge krav 8, hvor sødemidlet er naturligt eller ikke-naturligt sødemiddel valgt fra en sukker, en polyol, aspartam, sucralose, acesulfamin K, og/eller sakkarin og det smagsfremmende middel er valgt fra glycosider såsom neohesperidin-dihydrochalcon, glycyrrhizin, glutamat.
10. Sammensætning ifølge krav 8 eller 9, hvor sødemidlet er til stede i en mængde på 0,01 til 2,5 % (vægt/vægt), og det smagsfremmende middel i en mængde på 0,1 til 10 ppm, hver udtrykt i forhold til sammensætningens samlede vægt.
11. Sammensætning ifølge krav 8, hvor aromastoffet er til stede i en mængde på 0,01 til 10 % (vægt/vægt), fortrinsvis 0,1 til 5 % (vægt/vægt), mest fortrinsvis 0,1 til 1 % (vægt/vægt), udtrykt i forhold til sammensætningens samlede vægt.
12. Sammensætning ifølge et hvilket som helst af de foregående krav endvidere omfattende en eller flere excipienser, såsom super-desintegrationsmidler, glidemidler, antioxidanter.
13. Sammensætning ifølge krav 12, hvor super-desintegrationsmidlet er valgt fra gruppen bestående af tværbundne polyvinylpyrrolidoner, modificerede stivelser, og modificerede celluloser.
14. Sammensætning ifølge krav 12 eller 13, hvor super-desintegrationsmidlet er til stede i en mængde på 0,1 til 10% (vægt/vægt), fortrinsvis 0,5 til 8 % (vægt/vægt), mere fortrinsvis 2,5 til 6 % (vægt/vægt), udtrykt i forhold til sammensætningens samlede vægt.
15. Sammensætning ifølge krav 12, hvor glidemidlet er valgt fra gruppen bestående af magnesiumstearat, silikaderivater, såsom kolloid silika, pyrogen silika, hydreret natrium-aluminiumsilikat, kolloid siliciumdioxid, talkum og blandinger deraf, fortrinsvis magnesiumstearat, kolloid silika eller talkum.
16. Sammensætning ifølge krav 12 eller 15, hvor glidemidlet er til stede i en mængde på 0,01 til 10 % (vægt/vægt), fortrinsvis 0,1 til 5 % (vægt/vægt), udtrykt i forhold til sammensætningens samlede vægt.
17. Sammensætning ifølge et hvilket som helst af de foregående krav omfattende jernoxid-hydroxid i en mængde på 10 til 80 % (vægt/vægt), mindst et kulhydrat og/eller huminsyre i en samlet mængde på 1,0 til 50 % (vægt/vægt), eventuelt en eller flere excipienser i en samlet mængde på 1,0 til 50 % (vægt/vægt), et eller flere smagsfremmende midler i en samlet mængde på 0,1 til 10 ppm, og/eller et eller flere aromastoffer i en samlet mængde på 0,01 til 10 % (vægt/vægt), hver udtrykt i forhold til sammensætningens samlede vægt.
18. Sammensætning ifølge krav 17 omfattende et eller flere superdesintegrationsmidler i en samlet mængde på 0,1 til 10 vægtprocent (vægt/vægt).
19. Sammensætning ifølge et hvilket som helst af de foregående krav i form af en form til intakt synkning eller i en form der er i stand til hurtig at desintegrere såsom tyggetabletter eller piller, tørpulvere, granulater, kapsler eller små poser indeholdende disse granulater, oblater, eller pastiller.
20. Anvendelse af sammensætningerne ifølge et hvilket som helst af de foregående krav til fremstillingen af et medikament til behandlingen af hyperfosfatæmi.
21. Anvendelse af sammensætningerne ifølge et hvilket som helst af de foregående krav til fremstillingen af et medikament til behandlingen af patienter med kronisk nyreinsufficiens.
22. Fremgangsmåde til fremstilling af sammensætningen ifølge et hvilket som helst af de foregående krav i form af en tablet ved direkte komprimering eller tørgranulering.
23. Fremgangsmåde til fremstilling af sammensætningen ifølge et hvilket som helst af de foregående krav i form af en tablet, hvor en vandig suspension, omfattende mindst 90 % (vægt/vægt) af ingredienserne baseret på slutsammensætningens samlede vægt, fremstilles, som derefter underkastes sprøjtetørring for at opnå et flydbart pulver, som eventuelt blandes med de resterende ingredienser og efterfølgende komprimeres for at opnå en tablet.
24. Tablet, som er opnåelig med fremgangsmåden ifølge krav 23.
25. Tablet omfattende jernoxid-hydroxid i en mængde på 40 til 65 % (vægt/vægt), saccharose i en mængde på 5 til 30 % (vægt/vægt), og stivelse i en mængde på 5 til 30 % (vægt/vægt), udtrykt i forhold til tabletsammensætningens samlede vægt, eksklusiv vægten af en eventuelt tilstedeværende tablet-coating.
DK08848615.4T 2007-11-16 2008-11-13 Farmaceutiske sammensætninger DK2222285T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP07120837 2007-11-16
PCT/EP2008/065444 WO2009062993A1 (en) 2007-11-16 2008-11-13 Pharmaceutical compositions

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DK2222285T3 true DK2222285T3 (da) 2017-02-06

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Application Number Title Priority Date Filing Date
DK21176696.9T DK3895699T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid
DK16195982.0T DK3143992T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid
DK08848615.4T DK2222285T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger
DK18191458.1T DK3492069T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid

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DK21176696.9T DK3895699T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid
DK16195982.0T DK3143992T3 (da) 2007-11-16 2008-11-13 Farmaceutiske sammensætninger omfattende jern-oxy-hydroxid

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US (13) US9561251B2 (da)
EP (6) EP3143992B1 (da)
JP (7) JP5466164B2 (da)
KR (2) KR101590115B1 (da)
CN (7) CN112022796A (da)
AR (1) AR069312A1 (da)
AU (1) AU2008322963B2 (da)
BR (1) BRPI0820308B8 (da)
CA (1) CA2700444C (da)
CO (1) CO6280398A2 (da)
CY (3) CY1118496T1 (da)
DK (4) DK3895699T3 (da)
ES (5) ES2951457T3 (da)
FI (1) FI3895699T3 (da)
GT (1) GT201000144A (da)
HK (1) HK1207298A1 (da)
HR (4) HRP20220318T1 (da)
HU (2) HUE041429T2 (da)
IL (2) IL205726A (da)
LT (3) LT3492069T (da)
MA (1) MA31898B1 (da)
MX (1) MX2010005346A (da)
MY (2) MY156383A (da)
NZ (1) NZ585435A (da)
PH (1) PH12015500727B1 (da)
PL (4) PL3143992T3 (da)
PT (5) PT3895700T (da)
RU (2) RU2493831C3 (da)
SA (1) SA112340044B1 (da)
SG (1) SG188789A1 (da)
SI (4) SI2222285T1 (da)
TN (1) TN2010000152A1 (da)
TW (2) TWI468167B (da)
WO (1) WO2009062993A1 (da)
ZA (1) ZA201004256B (da)

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