Privacy policy
Veltassa®
Report adverse events:
Adverse events should be reported to the Vifor Pharma group.
safety@viforpharma.com
Privacy policy
Key takeaways
- What personal data we collect when you use our website
- What we do with your personal data How long we store your personal data and why
- Who may have access to your personal data
- Your rights around your personal data
- This privacy policy explains what information we collect during your visit to our website, how we may use it, how we protect it and your rights regarding data privacy
What personal data do we collect and why?
If you send us a question or other communication to the email addresses specified as contact points, we use that information to respond to your request, If you send us an adverse event report, we record, process and forward the information in accordance with our legal obligations.
We use aggregated data collected through this website for statistical purposes to help us to understand the use of our website and how we can improve it.
We use a website analytics service to track the use of the website using cookies. This service involves the collection and use of the IP (internet protocol) address of your computer or device. For more information see our cookie policy. The IP address will only be used to identify you in exceptional circumstances, such as for legal proceedings or criminal investigations.
The legal basis for the collection and use of your personal data is our legitimate interest in having a website which allows users to send queries and other communications. In relation to personal data concerning health received via this website, such as safety information, the legal basis is public interest.
With whom do we share your personal data?
If you send us a request through this website, we may share it internally or with other companies of the Vifor Pharma Group, to collect the information required to respond to your request. You can see the location of entities of the Vifor Pharma Group at: http://www.viforpharma.com/en/about-vifor-pharma/global-presence.
We work with third-party service providers who help us to collect and process safety information and/or who provide other services such as technical support or data hosting. These service providers may have access to your personal data in order to provide the services.
We may also disclose your personal data to:
Official authorities where applicable by law (e.g. reporting adverse events for pharmacovigilance), court order or other legal proceeding, our legal and other expert advisors, distributors, license partners or other companies with whom we collaborate for the purposes specified in this privacy notice. These service providers and collaboration partners are legally bound to keep all personal information confidential and to use it only to perform the services for which we engaged them or to comply with legal pharmacovigilance obligations.
Some of the above-noted parties who receive your personal data as per this privacy policy may be located outside your country of domicile, including in countries whose data protection laws are not regarded by the competent authorities as providing an adequate level of protection for personal data. In such cases, we ensure that appropriate safeguards are in place to protect your personal data, such as EU standard contractual clauses or Privacy Shield Framework certification (www.privacyshield.gov) except in case of disclosures to official authorities. A copy of the EU standard contractual clauses may be obtained from our Data Protection Officer (GroupDPO@viforpharma.com).
How long do we store your personal data?
If you send us a question or other communication to the email addresses specified as contact points, we use that information to respond to your request, If you send us an adverse event report, we record, process and forward the information in accordance with our legal obligations.
We use aggregated data collected through this website for statistical purposes to help us to understand the use of our website and how we can improve it.
We store your personal data for as long as required to fulfill the purposes outlined in this privacy policy, unless a longer or shorter retention period is required or permitted by law. By law we must store your personal data relating to safety information for at least 10 years after the medicinal product is no longer available. The legal basis for the collection and use of your personal data is our legitimate interest in having a website which allows users to send queries and other communications. In relation to personal data concerning health received via this website, such as safety information, the legal basis is public interest.
What are your rights regarding your personal data?
You are entitled at any time to access your personal data that we have. To the extent legally permissible, you can request that your data be deleted, that errors be corrected or that processing of your personal data be restricted. You can also object to our processing your personal data.
If you would like to exercise your rights, please contact us as described in the section “How to contact us” below. Please note that applicable laws may prevent us from complying with requests to delete safety information or to restrict our processing of it.
You are entitled to lodge a complaint with the supervisory authority.
Links to other sites
We may provide links to other websites that we believe are useful and meet our high standards for information accuracy and utility. However, we cannot guarantee the standards or privacy policies of the websites to which we link. We are not responsible for the content of any website which is not owned by a Vifor Pharma Group company.
Personal data of children
This website is intended for adult use only, i.e. anyone 16 years of age or older. We do not knowingly collect personal data from anyone under the age of 16 through this website. We assume that any person who provides their personal data through this website is 16 years of age or older. If you would like to contact us about personal data that your child (under 16 years old) may have provided without your consent, please see the “How to contact us” section below. If we learn that we have collected any personal data from a child under the age of 16, we will take steps to delete such information promptly.
Updates to this privacy policy
We may periodically update this privacy policy. In this case, we will post updated versions on this page. If we make significant changes to our privacy policy, we will display a prominent notice of the change on this website so that users are aware of the change. A revised privacy policy will apply only to personal data collected after its effective date (see below).
How to contact us
Please contact us if you have any questions, comments, or concerns about this privacy policy or if you wish to exercise your privacy rights to your personal data.
Vifor Fresenius Medical Care Renal Pharma Ltd.
Rechenstrasse 37
CH-9014 St. Gallen
Switzerland
(This is the “Controller” of the personal data)
+ 41 (0) 58 851 8000
GroupDPO@viforpharma.com
safety@viforpharma.com
Effective date: 02 May 2019
Contact a Vifor medical representative
To learn more about hyperkalaemia management with Veltassa®, please contact us.
Address
Vifor Pharma Nordiska AB
Gustav III:s Boulevard 46,
169 73 Solna,
Sweden
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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