FrancophonIA/ELRC3.0 huggingface dataset:
English: The vast majority of these gastrointestinal disorders occurred early during treatment and abated with time with continued dosing.
Danish: Langt størstedelen af disse gastrointestinale lidelser opstod tidligt i behandlingen og aftog med tiden ved fortsat dosering.
English: One phase 3 clinical study has been performed in patients with CKD on dialysis to investigate the efficacy and safety of Velphoro in this population.
Danish: Et klinisk fase 3-studie er udført hos patienter med CKD i dialyse for at undersøge virkningen og sikkerheden af Velphoro i denne population.
English: This is thought to be most likely an adaptive response to the pharmacological effect of the drug, and not clinically relevant.
Danish: Dette menes med stor sandsynlighed at skyldes en adaptiv respons på den farmakologiske virkning af lægemidlet og menes derfor ikke at være klinisk relevant.
English: If one or more doses are missed, the normal dose of the medicinal product should be resumed with the next meal.
Danish: Hvis en eller flere doser ikke tages, skal den normale dosis lægemiddel tages i forbindelse med næste måltid.
English: If you are pregnant or breastfeeding, or you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Due to the insolubility and degradation characteristics of Velphoro, no classical pharmacokinetic studies can be carried out, e.g., determination of the distribution volume, area under the curve, mean residence time, etc.
Danish: Pga. uopløseligheden og egenskaberne for degradering af Velphoro kan der ikke udføres klassiske farmakokinetiske studier, f.eks. bestemmelse af fordelingsvolumen, areal under kurven, gennemsnitlig residenstid osv.
English: In the 55 weeks long term studies, the majority of these diarrhoea adverse reactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients.
Danish: I studierne på 55 uger var størstedelen af tilfældene af diarré forbigående, opstod tidligt under behandlingsstarten og medførte seponering af behandling hos 3,1 % af patienterne.
English: Effects seen in the rabbit embryo-foetal development toxicity study (skeletal variations and incomplete ossificaton) are related to exaggerated pharmacology, and likely not relevant for patients.
Danish: Virkninger, set i studiet af embryo-føtal udviklingstoksicitet hos kaniner (knoglevariationer og ufuldstændig ossifikation), er relateret til overdreven farmakologi og er sandsynligvis ikke relevante for patienter.
English: The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received Velphoro treatment of up to 55 weeks.
Danish: Velphoros aktuelle sikkerhedsprofil er baseret på i alt 778 patienter i hæmodialyse og 57 patienter i peritonealdialyse, der modtog Velphoro-behandling i op til 55 uger.
English: In vitro studies with the following active substances did not show any relevant interaction: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone and quinidine.
Danish: In vitro-studier med følgende aktive stoffer viste ingen relevant interaktion: acetylsalicylsyre, cefalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazid, metformin, metoprolol, nifedipin, pioglitazon og quinidin.
English: 4.7 Effects on ability to drive and use machines Velphoro has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Velphoro påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 2D-stregkode med den entydige identifikator inkluderet.
English: Tablets must be chewed and not swallowed whole; tablets may be crushed.
Danish: Tabletterne skal tygges og må ikke sluges hele.
English: In patients, absorbed iron is expected to be also distributed to the target organs, i.e. liver, spleen and bone marrow, and utilized by incorporation into red blood cells.
Danish: Hos patienter forventes det også, at absorberet jern fordeles til målorganerne, dvs. lever, milt og knoglemarv, og udnyttes ved at blive inkorporeret i de røde blodlegemer.
English: In order to maximise the adsorption of dietary phosphate, the total daily dose should be divided across the meals of the day.
Danish: For at maksimere optagelsen af fosfat i kosten skal den samlede daglige dosis fordeles mellem alle dagens måltider.
English: If you have missed a dose, just take the next dose at the usual time with a meal.
Danish: Hvis du har glemt at tage en dosis, skal du tage næste dosis på det sædvanlige tidspunkt i forbindelse med et måltid.
English: Tablets have a 20 mm diameter and a thickness of 6.5 mm.
Danish: Tabletterne har en diameter på 20 mm og en tykkelse på 6,5 mm.
English: The distribution studies in humans were not performed.
Danish: Der blev ikke udført fordelingsstudier hos mennesker.
English: Do not take Velphoro:
Danish: Tag ikke Velphoro:
English: If you have accidentally taken too many tablets, do not take any more and talk to your doctor or pharmacist immediately.
Danish: Hvis du ved en fejl kommer til at tage for mange tabletter, må du ikke tage flere, og du skal øjeblikkeligt kontakte din læge eller apotekspersonalet.
English: Non-clinical studies in several species (rats and dogs) showed that pn-FeOOH is distributed from the plasma to the liver, spleen and bone marrow, and utilized by incorporation into red blood cells.
Danish: Prækliniske studier i flere arter (rotter og hunde) viste, at pn-FeOOH fordeles fra plasma til lever, milt og knoglemarv og udnyttes ved at blive inkorporeret i de røde blodlegemer.
English: In vitro data suggest that the sucrose and starch components of the drug substance can be digested to glucose and fructose, and maltose and glucose, respectively.
Danish: In vitro-data antyder, at saccharose- og stivelseskomponenter i lægemiddelstoffet kan fordøjes til henholdsvis glucose og fructose og maltose og glucose.
English: In these clinical trials, approximately 43% of patients experienced at least one adverse reaction during Velphoro treatment, which were reported as serious adverse reactions in 0.36%.
Danish: I disse kliniske forsøg oplevede ca. 43 % af patienterne mindst én bivirkning under Velphorobehandlingen, og af disse bivirkninger blev 0,36 % indberettet som alvorlige bivirkninger.
English: 92042 Paris la Défense Cedex France
Danish: 92042 Paris la Défense Cedex Frankrig
English: Your doctor may adjust the dose during the treatment course depending on the phosphorus level in your blood.
Danish: Din læge kan justere dosis under behandlingsforløbet i forhold til mængden af fosfor i blodet.
English: Neohesperidin-dihydrochalcone Magnesium stearate
Danish: Neohesperidin-dihydrochalcon Magnesiumstearat
English: - When taking Velphoro you should adhere to your recommended diet and treatments prescribed by your doctor such as calcium supplements, vitamin D3 or calcimimetics.
Danish: - Når du tager Velphoro, skal du følge den anbefalede kostplan og de behandlinger, der er ordineret af din læge, såsom calciumtilskud, D3-vitamin eller calcimimetika.
English: Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.
Danish: Eventuelle tilfælde af overdosering af Velphoro (f.eks. hypofosfatæmi) skal håndteres i henhold til standard klinisk praksis.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia; ATC code: V03AE05
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af hyperkaliæmi og hyperfosfatæmi, ATC-kode: V03AE05
English: If you are not sure, talk to your doctor before taking this medicine.
Danish: Hvis du er i tvivl, skal du kontakte din læge, inden du tager dette lægemiddel.
English: Patients with severe hepatic impairment were excluded from participating in clinical studies with Velphoro.
Danish: Patienter med svær leverinsufficiens blev udelukket fra at deltage i kliniske studier med Velphoro.
English: Your doctor will advise you whether Velphoro should be used during pregnancy, based on benefit and risk assessment for use during pregnancy.
Danish: Lægen vil rådgive dig om, hvorvidt du bør bruge Velphoro under graviditet baseret på en vurdering af fordele og risici ved brug under graviditet.
English: The response rates, defined as the proportion of subjects achieving serum phosphorus levels within the KDOQI (Kidney Disease Outcomes Quality Initiative) recommended range were 45.3% and 59.1% at week 12 and 51.9% and 55.2% at week 52, for Velphoro and sevelamer carbonate, respectively.
Danish: Responsraterne, defineret som andelen af forsøgspersoner, der opnår serumfosfatniveauer inden for det anbefalede niveau fra KDOQI (Kidney Disease Outcomes Quality Initiative), var henholdsvis 45,3 % og 59,1 % ved uge 12 og 51,9 % og 55,2 % ved uge 52 for Velphoro og sevelamer-karbonat.
English: Too much phosphorus in the blood can lead to calcium being deposited in tissues (calcification).
Danish: For meget fosfat i blodet kan medføre, at der aflejres kalk i vævet (forkalkning).
English: Velphoro should only be used in these patients following careful assessment of benefit/risk.
Danish: Velphoro bør kun anvendes til disse patienter efter en udførlig vurdering af fordele/risici.
English: Velphoro may be harmful to the teeth.
Danish: Velphoro kan skade tænderne.
English: Only for the blister packs: - Separate the blister pack at perforations.
Danish: Gælder kun blisterkort: - Adskil blisterkortet ved perforeringerne.
English: Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract.
Danish: Bindingen af fosfat foregår ved ligandudveksling mellem hydroxylgrupper og/eller vand og fosfationer over hele det fysiologiske pH-område i mave-tarm-kanalen.
English: It may also lead to calcium deposits in soft tissues and bone causing effects such as red eyes, itchy skin and bone pain.
Danish: Det kan også medføre kalkaflejringer i bløddele og knogler, hvilket kan give symptomer, som f.eks. røde øjne, kløende hud og smerter i knoglerne.
English: Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg af reproduktions- og udviklingstoksicitet viste ingen skadelige virkninger hvad angår graviditet, embryonal/føtal udvikling, parturitio- eller postnatal udvikling (se pkt.
English: EU/1/14/943/002 90 chewable tablets
Danish: EU/1/14/943/002 90 tyggetabletter
English: Any potential bleeding from your digestive tract (stomach and gut) may be hidden by these black stools.
Danish: Enhver form for potentiel blødning fra fordøjelseskanalen (mave og tarm) kan skjules af sort afføring.
English: Each tablet also contains 750 mg sucrose and 700 mg starches.
Danish: Hver tablet indeholder også 750 mg saccharose og 700 mg stivelse.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 August 2014
Danish: Dato for første markedsføringstilladelse: 26. august 2014 Dato for seneste fornyelse:
English: The majority of the adverse reactions reported from trials were gastrointestinal disorders, with the most frequently reported adverse reactions being diarrhoea and discoloured faeces (very common).
Danish: Størstedelen af de indberettede bivirkninger fra forsøg var gastrointestinale lidelser, og de hyppigst indberettede bivirkninger var diarré og misfarvet afføring (meget almindelig).
English: INFORMATION IN BRAILLE velphoro
Danish: INFORMATION I BRAILLE-SKRIFT velphoro
English: Velphoro is available in packs containing 30 or 90 chewable tablets.
Danish: Velphoro fås i pakker med 30 eller 90 tyggetabletter.
English: In rats, there was a slightly increased incidence of benign C-cell adenoma in the thyroid of male rats given the highest dose of sucroferric oxyhydroxide.
Danish: Hos rotter var der en lille stigning i forekomsten af benign C-celleadenom i thyroidea hos hanrotter, der fik den højeste dosis af sucroferrioxyhydroxid.
English: The active moiety of Velphoro, pn-FeOOH, is practically insoluble and therefore not absorbed.
Danish: Den aktive substans for Velphoro, pn-FeOOH, er praktisk talt uopløselig og absorberes derfor ikke.
English: In animal studies with rats and dogs administered 59Fe-Velphoro drug substance orally, radiolabelled iron was recovered in the faeces but not the urine.
Danish: I dyrestudier med rotter og hunde, som fik lægemiddelstoffet 59Fe-Velphoro oralt, blev der fundet radioaktivt mærket jern i afføring, men ikke i urin.
English: Information about sucrose and starches (carbohydrates) Velphoro contains sucrose.
Danish: Oplysninger om saccharose og stivelse (kulhydrater) Velphoro indeholder saccharose.
English: Velphoro should only be used by pregnant women if clearly needed following careful assessment of benefit/risk.
Danish: Velphoro bør udelukkende bruges til gravide kvinder, hvis det findes strengt nødvendigt, efter udførlig vurdering af fordele/risici.
English: This medicine has no significant effect on your ability to drive or to use tools or machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Shelf-life after first opening the bottle: 90 days Opening date:
Danish: Opbevaring efter anbrud af flasken: 90 dage Dato for åbning:
English: In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 - 2,000 mg iron per day (3 to 4 tablets).
Danish: I klinisk praksis vil behandling være baseret på behovet for kontrol af serumfosfatniveauet, selvom patienter, der responderer på Velphoro, typisk opnår optimale serumfosfatniveauer ved doser på 1.500-2.000 mg jern dagligt (3 til 4 tabletter).
English: Other reproduction toxicity studies showed no adverse effects.
Danish: I yderligere studier af reproduktionstoksicitet sås ingen bivirkninger.
English: Velphoro works by binding phosphate in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy.
Danish: Velphoro fungerer ved binding af fosfat i mave-tarm-kanalen, og serumkoncentrationen er derfor ikke relevant for dets virkning.
English: Brown, circular tablets embossed with PA500 on one side.
Danish: Brune, runde tabletter præget med PA500 på den ene side.
English: This reduces the amount of phosphorus that can be absorbed into the bloodstream and thus lowers phosphorus levels in your blood.
Danish: På den måde reduceres den mængde fosfat, der kan optages i blodbanen, og dermed også mængden af fosfat i blodet.
English: In addition, post-hoc analyses from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral Vitamin D analogues.
Danish: Desuden viste post hoc analyser fra kliniske studier, at Velphoro ikke har nogen indvirkning på den iPTH-sænkende effekt af orale vitamin D-analoger.
English: • Haemochromatosis and any other iron accumulation disorders.
Danish: • Hæmokromatose og alle andre sygdomme i forbindelse med ophobning af jern.
English: Hypercalcaemia Hypocalcaemia
Danish: Hyperkalcæmi Hypokalcæmi
English: Its degradation product, mononuclear iron species, can however be released from the surface of pnFeOOH and be absorbed.
Danish: Dets degraderingsprodukt, mononukleære jernarter, kan dog frigives fra overfladen af pn-FeOOH og absorberes.
English: The active moiety of Velphoro, pn-FeOOH, is not metabolised.
Danish: Den aktive substans for Velphoro, pn-FeOOH, metaboliseres ikke.
English: There are no data on the effect of Velphoro on fertility in humans.
Danish: Der er ingen data fra virkningen af Velphoro på fertiliteten hos mennesker.
English: Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Danish: Velphoro bør anvendes i forbindelse med flere andre behandlinger, der kan omfatte calciumsupplement, 1,25-dihydroxyvitamin D3 eller et af dettes analoge stoffer eller calcimimetika til kontrol af udviklingen af renal knoglesygdom.
English: The mean daily dose of Velphoro over 55 weeks of treatment was 1,650 mg iron and the mean daily dose of sevelamer carbonate was 6,960 mg.
Danish: Den gennemsnitlige daglige dosis af Velphoro i løbet af 55 ugers behandling var 1.650 mg jern, og den gennemsnitlige daglige dosis af sevelamer-karbonat var 6.960 mg.
English: Uncommon (may affect up to 1 in 100 people): bloating (abdominal distension), inflammation of the stomach, abdominal discomfort, difficulty swallowing, acid coming back up from the stomach (gastrooesophageal reflux disease), tongue discolouration, low or high calcium levels in the blood seen in tests, tiredness, itch, rash, headache, shortness of breath.
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 personer): oppustethed (abdominal udspiling), betændelse i maven, mavebesvær, synkebesvær, tilbageløb af syre fra mavesækken til spiserøret (gastroøsofageal reflukssygdom), misfarvning af tungen, lave eller høje calciumniveauer i blodet påvist ved prøver, træthed, kløe, udslæt, hovedpine, åndenød.
English: Adverse reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3,000 mg iron/day in these patients (n=835) are listed in Table 1.
Danish: Bivirkninger, som er rapporteret fra brugen af Velphoro ved doser fra 250 mg jern/dag til 3.000 mg jern/dag hos disse patienter (n = 835), er angivet i tabel 1.
English: Velphoro contains sucrose and starches (carbohydrates) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Velphoro indeholder saccharose og stivelse (kulhydrater) Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: After first opening of the bottle the chewable tablets can be used for 90 days.
Danish: Når flasken er blevet åbnet, har tyggetabletterne en holdbarhed på 90 dage.
English: If you are taking any other medicine that is known to be affected by iron (for example medicines containing the active substance alendronate (used to treat certain bone disorders) or doxycycline (an antibiotic)) or has the potential to be affected by iron (for example medicines containing the active substance levothyroxine (used to treat thyroid function disorder)), make sure that you take this medicine at least one hour before taking Velphoro or at least two hours after taking Velphoro.
Danish: Hvis du tager anden medicin, som bliver påvirket af jern (f.eks. medicin, der indeholder det aktive stof alendronat (bruges til at behandle visse knoglesygdomme) eller doxycyclin (et antibiotikum)), eller hvis du tager anden medicin, som kan blive påvirket af jern (f.eks. medicin, der indeholder det aktive stof levothyroxin (bruges til at behandle sygdomme i skjoldbruskkirtlen)), skal du sørge for at tage dette lægemiddel mindst en time før, du tager Velphoro, eller mindst to timer efter du har taget Velphoro.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Velphoro in one or more subsets of the paediatric population in the treatment of hyperphosphataemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Velphoro i en eller flere undergrupper af den pædiatriske population til behandling af hyperfosfatæmi (se pkt.
English: In healthy subjects, the median uptake of radiolabelled iron in the blood was estimated to be 0.43% (range 0.16 - 1.25%) on Day 21, in pre-dialysis patients 0.06% (range 0.008 - 0.44%) and in haemodialysis patients 0.02% (range 0 - 0.04%).
Danish: Hos raske forsøgspersoner blev den gennemsnitlige optagelse af radioaktivt mærket jern i blodet estimeret til at være 0,43 % (område: 0,16-1,25 %) på dag 21, hos patienter inden dialyse 0,06 % (område: 0,008-0,44 %) og hos hæmodialysepatienter 0,02 % (i et område fra 0-0,04 %).
English: The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch) per tablet.
Danish: Det aktive stof sucroferrioxyhydroxid indeholder 750 mg saccharose og 700 mg stivelse (kartoffelstivelse og pregelatineret majsstivelse) pr. tablet.
English: No dose-dependent trends were observed in the adverse reaction profile of Velphoro.
Danish: Der blev ikke observeret dosisafhængige tendenser i Velphoros bivirkningsprofil.
English: When administering any medicinal product that is already known to interact with iron (like alendronate and doxycycline) or has the potential to interact with Velphoro based only on in vitro studies like levothyroxine, the medicinal product should be administered at least one hour before or two hours after Velphoro.
Danish: Når der administreres et hvilket som helst lægemiddel, der allerede har en dokumenteret interaktion med jern (såsom alendronat og doxycyclin) eller muligvis kan interagere med Velphoro på baggrund af in vitro-studier med levothyroxin, skal det administreres mindst en time før eller to timer efter Velphoro.
English: 90 chewable tablets
Danish: 90 tyggetabletter
English: Serum phosphorus levels and calcium-phosphorus product levels were reduced as a consequence of the reduced dietary phosphate absorption.
Danish: Serumfosfatniveauerne og calcium-fosfatproduktniveauerne blev reduceret som en følgevirkning af den reducerede absorption af fosfat i kosten.
English: The iron uptake from radiolabelled Velphoro drug substance, 2,000 mg iron in 1 day was investigated in 16 CKD patients (8 pre-dialysis and 8 haemodialysis patients) and 8 healthy volunteers with low iron stores (serum ferritin <100 mcg/L).
Danish: Optagelsen af jern fra radioaktivt mærket Velphoro-lægemiddelstof, 2.000 mg jern på 1 dag, blev undersøgt hos 16 CKD-patienter (8 patienter inden dialyse og 8 hæmodialysepatienter) og 8 raske frivillige med lave jerndepoter (serumferritin < 100 mikrog/l).
English: Peritonitis, gastric and hepatic disorders and gastrointestinal surgery Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic disorders and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Peritonitis, gastriske eller hepatiske lidelser og gastrointestinale indgreb Patienter med en anamnese (inden for de sidste 3 måneder) med peritonitis, betydelige gastriske eller hepatiske lidelser og patienter med større gastrointestinale indgreb har ikke deltaget i kliniske studier med Velphoro.
English: If you have diabetes you should take notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
Danish: Hvis du har diabetes, skal du være opmærksom på, at én tablet Velphoro svarer til cirka 1,4 g kulhydrater (svarende til 0,116 brødenheder).
English: There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.
Danish: Der er ingen kliniske data fra anvendelse af sucroferrioxyhydroxid til gravide kvinder.
English: Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin).
Danish: Data fra kliniske studier har vist, at Velphoro ikke påvirker den lipidsænkende effekt af HMG-CoAreduktasehæmmere (f.eks. atorvastatin og simvastatin).