Terms of use
Veltassa®
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PLEASE READ AND REVIEW THE FOLLOWING TERMS AND CONDITIONS OF USE CAREFULLY BEFORE USING THIS WEB SITE.
General.
Welcome to Veltassa.com (the "Website"). This Website is owned by Vifor Fresenius Medical Care Renal Pharma Ltd., with registered offices at Flughofstrasse 61, CH-8152 Glattbrugg, Switzerland ("Vifor Fresenius Medical Care Renal Pharma Ltd."). This Website is hosted in Germany and is governed by Swiss law without respect to its conflict of laws principles. Your access and use of the information contained herein is subject to the following terms and conditions of use and all applicable laws.
By accessing and browsing this Website, you accept, without limitation or qualification, these terms and conditions of use and acknowledge that (i) they constitute the entire agreement between you and Vifor Fresenius Medical Care Renal Pharma Ltd. with respect to the use of this Website and (ii) they supersede any other agreement between you and Vifor Fresenius Medical Care Renal Pharma Ltd.. You agree to indemnify Vifor Fresenius Medical Care Renal Pharma Ltd. for any claims or damages resulting from your failure to abide by these terms and conditions. If you do not agree to all of these Terms and Conditions of Use, please leave the Website.
The information on this Website was developed by Vifor Fresenius Medical Care Renal Pharma Ltd. as a resource for healthcare professionals (“HCPs”). The Website is not intended for use by US HCPs. If you are not a healthcare professional, please refrain from using this site.
Some information on this Website may relate to medical, health or fitness conditions, their prevention and treatment. Any references to products or services on the Website do not imply that Vifor Fresenius Medical Care Renal Pharma Ltd. offers or intends to offer these products or services in your country. Please always refer to local prescribing information before making any prescribing decisions. THE INFORMATION CONTAINED ON THIS WEBSITE IS NOT INTENDED TO PROVIDE OR REPLACE MEDICAL ADVICE. VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD. HEREBY PROHIBITS YOU FROM USING THE INFORMATION ON THIS WEBSITE FOR DIAGNOSING A HEALTH OR FITNESS PROBLEM OR DISEASE.
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Vifor Fresenius Medical Care Renal Pharma Ltd. will use reasonable efforts to include accurate, complete and up-to-date information on this Website. Information and related materials are subject to change without notice. This Website, and all information and related materials it contains, are provided "as is." Vifor Fresenius Medical Care Renal Pharma Ltd. makes no representation or warranty whatsoever regarding the completeness, accuracy, "up-to-dateness", or adequacy of, or the suitability, functionality, availability, or operation of this Website or the information or materials it contains. By using this Website, you assume the risk that the information and materials on this Website may be incomplete, inaccurate, out of date, or may not meet your needs and requirements. Vifor Fresenius Medical Care Renal Pharma Ltd. does not warrant that access to the Website will be available at all times or that the Website or the server that makes it available are free of viruses or other harmful components. Vifor Fresenius Medical Care Renal Pharma Ltd. specifically disclaims all warranties, express or implied, including without limitation, the warranties or merchantability, fitness for a particular purpose, and non-infringement with respect to this Website and information, graphics and materials contained herein.
Limitation of liability.
All users agree that access to this Website is at their own risk, and that neither Vifor Fresenius Medical Care Renal Pharma Ltd. nor any party involved in creating or delivering this Website shall be liable in any manner whatsoever for damages of any kind, including without limitation, any special, direct or indirect, incidental, or consequential or punitive damages (even if Vifor Fresenius Medical Care Renal Pharma Ltd. has been advised of the possibility of such damages) arising out of access to, reliance on, or (inability to) use of the information contained on this Website, or any errors or omissions, misprints, out-of-date information, technical or pricing inaccuracies, typographical or other errors appearing on this Website or from any interruption or discontinuation of any or all of the functionalities of the Website. This limitation includes damages to, or for any viruses that may infect your computer equipment. You, and not Vifor Fresenius Medical Care Renal Pharma Ltd., assume the entire cost of all necessary servicing, repair or corrections to your hardware, software or information whether or not caused by any virus or harmful component.
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You should assume that all logos and trademarks appearing on this Website are trademarks either owned by or licensed to Vifor Pharma or any of its affiliated companies. [The Website may also contain or reference patents, proprietary information, technologies, products, processes or other proprietary rights of Vifor Fresenius Medical Care Renal Pharma Ltd. and/or other parties.] No license to or right in any such trademarks, logos, [patents, domain names, technologies, products, processes and other proprietary information or rights] of Vifor Fresenius Medical Care Renal Pharma Ltd. and/or other parties is hereby granted to or conferred upon you.
Links to this Website.
No link to this Website may be included in any other website without the prior written consent of Vifor Fresenius Medical Care Renal Pharma Ltd. unless it only directs the web visitor to the home page of this Website, in a separate pop-up window, with the full Website domain name and an appropriate pop-up notification to the visitor that it is accessing a third-party website. Vifor Fresenius Medical Care Renal Pharma Ltd. does not have responsibility for, or control of, the contents, availability, operation or performance of other web sites from which this web site may be accessed.
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Revisions.
Vifor Fresenius Medical Care Renal Pharma Ltd. reserves the right to alter or delete material from this Website at any time. Vifor Fresenius Medical Care Renal Pharma Ltd. may, at any time, revise these terms and conditions of use by updating this posting. You are bound by any such revisions and should, therefore, periodically review these terms to review the then current Website terms of use.
If any provision herein is held to be unlawful, void, or for any reason unenforceable, then that provision shall be eliminated or limited to the minimum extent necessary and such elimination or limitation shall not affect the validity and enforceability of any remaining provisions.
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Submission of information to this Website.
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Date of last revision: 18.02.2021
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Forkortet produktinformation for Veltassa 8,4 g og 16,8 g pulver til oral suspension patiromer (som patiromersorbitexcalcium)
Denne produktinformation er omskrevet/forkortet i forhold til det af Det Europæiske Lægemiddelagentur godkendte produktresumé dateret 06. oktober 2022. Produktresumeet kan vederlagsfrit rekvireres fra indehaveren af markedsføringstilladelsen eller findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/ema/. LÆS PRODUKTRESUMÉET FØR ORDINATION, ISÆR MED HENSYN TIL DOSERING, BIVIRKNINGER, ADVARSLER OG KONTRAINDIKATIONER Indikationer: Behandling af hyperkaliæmi hos voksne. Dosering og administration: Den anbefalede startdosis er 8,4 g patiromer én gang dagligt. Den daglige dosis kan justeres i intervaller på en uge eller længere baseret på niveauet af serumkalium og det ønskede målinterval. For at opnå det ønskede målinterval kan den daglige dosis efter behov øges eller reduceres med 8,4 g, dog højst til en maksimumdosis på 25,2 g dagligt. Hvis serumkaliumniveauet falder under det ønskede målinterval, bør dosen reduceres, eller behandlingen ophøre. Hvis en dosis glemmes, skal den glemte dosis tages så hurtigt som muligt samme dag. Den glemte dosis bør ikke tages sammen med den næste dosis.Administration af Veltassa skal ske med 3 timers interval fra indtagelse af andre orale lægemidler. Virkningen af Veltassa indtræder inden for 4–7 timer efter administration. Veltassa bør ikke erstatte nødbehandling af livstruende hyperkaliæmi. Oral brug. Den fulde dosis skal hældes i et glas med ca. 40 ml vand og herefter omrøres. Yderligere ca. 40 ml vand tilføjes, og herefter skal suspensionen omrøres grundigt igen. Pulveret opløses ikke. Blandingen skal indtages inden for 1 time efter klargøring. Følgende væsker eller bløde fødevarer kan benyttes i stedet for vand: Æblejuice, tranebærjuice, ananasjuice, appelsinjuice, druesaft, pæresaft, abrikosnektar, ferskennektar, yoghurt, mælk, fortykningsmiddel, æblesauce, vanilje og chokoladebudding. Kaliumindholdet i væsker eller bløde fødevarer, der anvendes til fremstilling af blandingen, bør medregnes som en del af det anbefalede kaliumindtag for hver enkelt patient. Indtag af tranebærjuice bør generelt begrænses til moderate mængder (for eksempel mindre end 400 ml om dagen) på grund af den potentielle interaktion med andre lægemidler. Veltassa kan tages sammen med eller uden mad. Det må ikke opvarmes eller tilsættes opvarmede madvarer eller væsker. Det må ikke tages i dets tørre form. Kontraindikationer: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. Advarsler og forsigtighedsregler: Serummagnesium bør overvåges i mindst 1 måned efter påbegyndelse af behandlingen, og magnesiumtilskud bør overvejes til patienter, der udvikler lave niveauer af serummagnesium.
Fordele og risici ved at administrere Veltassa bør evalueres omhyggeligt før og under behandling af patienter, som har eller tidligere har haft alvorlige gastrointestinale lidelser. Ved ophør af behandling med Veltassa kan serumkaliumniveauerne stige, især hvis behandling med RAAS-inhibitor fortsættes. Patienter skal instrueres i ikke at ophøre med behandlingen uden at konsultere deres læge. Stigninger i serumkalium kan opstå så tidligt som 2 dage efter den sidste Veltassa-dosis. Serumkalium bør overvåges ved klinisk indikation, også efter der foretages medicinændringer, der påvirker serumkaliumkoncentrationen (f.eks. RAAS-inhibitorer eller diuretika), og efter Veltassa-dosis er titreret. Veltassa indeholder sorbitol. Bør ikke anvendes til patienter med hereditær fructoseintolerans. Veltassa indeholder calcium. Fordelene og risiciene ved administration af dette lægemiddel bør evalueres omhyggeligt hos patienter med risiko for hyperkalcæmi. Interaktioner: Patiromer har potentialet til at binde visse co-administrerede lægemidler, hvilket kan reducere deres absorption i mave-tarm-kanalen. Da patiromer ikke absorberes eller metaboliseres i kroppen, har det en begrænset indvirkning på virkningen af andre lægemidler. Som en sikkerhedsforanstaltning bør administration af patiromer ske mindst 3 timer før eller efter andre orale lægemidler. In vitro-studier har vist potentiel interaktion mellem patiromer og bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidin og telmisartan. Graviditet og amning: Som en sikkerhedsforanstaltning foretrækkes det at undgå brug af Veltassa under graviditet. Det skal besluttes, om amning skal ophøre eller behandling med patiromer seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. Bivirkninger: Almindelig (≥1/100 til <1/10): Hypomagnesæmi, forstoppelse, diarré, mavesmerter, luft i maven. Ikke almindelig (≥1/1.000 til <1/100): Kvalme, opkastning. Overdosering: Da overdrevne doser af Veltassa kan resultere i hypokaliæmi, bør niveauerne af serumkalium overvåges. Patiromer udskilles efter ca. 24 til 48 timer, baseret på den gennemsnitlige gastrointestinale transittid. Såfremt det besluttes, at lægelig behandling er nødvendig, kan relevante foranstaltninger til gendannelse af serumkalium overvejes. Pakningsstørrelser og priser: Æske med 30 breve. Se www.medicinpriser.dk for dagsaktuelle priser. Tilskud: Ej tilskudsberettiget. Udlevering: B. Indehaver af markedsføringstilladelsen: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, Frankrig. Representant: Vifor Pharma Nordiska AB, Gustav III:s Boulevard 46, SE-169 73, Solna, Sverige. Revisionsdato: 24.11.2022.
DK-PAT-23000001 2304