DK3199172T3 - Doseringsregimen til multipel sklerose - Google Patents
Doseringsregimen til multipel sklerose Download PDFInfo
- Publication number
- DK3199172T3 DK3199172T3 DK17157735.6T DK17157735T DK3199172T3 DK 3199172 T3 DK3199172 T3 DK 3199172T3 DK 17157735 T DK17157735 T DK 17157735T DK 3199172 T3 DK3199172 T3 DK 3199172T3
- Authority
- DK
- Denmark
- Prior art keywords
- glatiramer acetate
- multiple sclerosis
- use according
- treatment
- human patient
- Prior art date
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Landscapes
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Magnetic Resonance Imaging Apparatus (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (12)
1. Glatirameracetat til anvendelse i behandling af en human patient der lider af en tilbagefaldsform af multipel sklerose eller som har gennemgaet en fprste klinisk episode og er i hpjrisiko for at udvikle klinisk varig multipel sklerose, omfattende administration til den humane patient af tre subkutane indsprpjtninger af 40 mg glatirameracetat hver syvende dag med mindst en dag imellem hver subkutan indsprpjtning, hvor glatirameracetatet er til stede i en farmaceutisk sammensaetning med en pH i omradet pa 5,5 til 7,0.
2. Glatirameracetat til anvendelse ifplge krav 1, hvor den humane patient lider af en tilbagefaldsform af multipel sklerose.
3. Glatirameracetat til anvendelse ifplge krav 1, hvor den humane patient har prpvet en fprste klinisk episode og er i hpjrisiko for at udvikle klinisk varig multipel sklerose.
4. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-3 til at nedsaette det kumulative antal forbedrende laesioner pa Ti-vaegtede billeder i den humane patient.
5. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-4 for at reducere antallet af nye T2-laesioner i hjernen pa den humane patient.
6. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-5 til at nedsaette frekvensen af tilbagefald i den humane patient.
7. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-6 i behandling af den humane patient sa effektivt som administration af 20 mg glatirameracetat s.c. dagligt.
8. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-7 til at pge tolerabiliteten af glatirameracetatbehandling i den humane patient.
9. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-7 til at nedsaette frekvensen af en umiddelbar efter-indsprpjtningsreaktion i forhold til daglig subkutan administration of 20 mg glatirameracetat.
10. Glatirameracetat til anvendelse ifplge krav 9, hvor den umiddelbare efter-indsprdjtningsreaktion omfatter palpitationer, varmefdlelse, rpdmen, hedeture, tachycardi, dyspnp, brystubehag, brystsmerte, ikke-kardial bryst, astheni, rygsmerte, bakterieinfektion, kuldegysninger, cyster, ansigts-0dem, feber, influenzasyndrom, infektion, halssmerte, smerte, migraene, besvimelse, tachycardi, vasodilatation, anorexi, diarre, gastroenteritis, gastrointestinale lidelser, kvalme, opkastning, blodudtraedning, perifer 0dem, arthralgi, agitation, angst, forvirring, dropfod, hypertoni, nervpsitet, nystagmus, taleforstyrrelser, tremor, vertigo, bronchitis, dyspnea, laryngismus, rhinitis, erythema, herpes simplex, pruritus, udslaet, transpiration, urticaria, prepine, pjenlidelser, dysmenorrheal, urin-trang, eller vaginal moniliasis.
11. Glatirameracetat til anvendelse ifplge et hvilket som heist af kravene 1-7 til at nedsaette frekvensen af en indsprpjtningsstedreaktion i forhold til daglig subkutan administration af 20 mg glatirameracetat.
12. Glatirameracetat til anvendelse ifplge krav 11, hvor indsprpjtningsstedreaktionen omfatter erythem, haemorrhag, induration, inflammation, masse, smerte, pruritus, udslaet, eller strimer der forekommer djeblikkeligt rundt om injektionsstedet.
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| EP13166080.5A EP2630962B1 (en) | 2009-08-20 | 2010-08-19 | Low Frequency Glatiramer Acetate Therapy |
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| DK17157735.6T DK3199172T3 (da) | 2009-08-20 | 2010-08-19 | Doseringsregimen til multipel sklerose |
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| DK201600003U DK201600003Y3 (da) | 2009-08-20 | 2016-01-06 | Lavfrekvent glatiramer-acetat-terapi |
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| USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
| US8759302B2 (en) | 2010-03-16 | 2014-06-24 | Teva Pharmaceutical Industries, Ltd. | Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis |
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| UY35790A (es) * | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
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| CN107550853B (zh) * | 2016-06-30 | 2020-06-12 | 深圳翰宇药业股份有限公司 | 一种醋酸格拉替雷注射液的制备方法 |
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