FrancophonIA/ELRC3.0 huggingface dataset:
English: BindRen should not be used in children and adolescents.
Danish: BindRen må ikke anvendes til børn og unge.
English: BindRen is not absorbed and is not systemically available.
Danish: BindRen absorberes ikke og er ikke systemisk tilgængeligt.
English: No direct effects of BindRen are thus anticipated.
Danish: Der forventes således ingen direkte effekt af BindRen.
English: ATC code: not yet assigned.
Danish: ATC-kode: endnu ikke tildelt
English: These measures will help to protect the environment and to prevent accidental access by children.
Danish: Dette vil hjælpe med at beskytte miljøet og til at forhindre at børn får fat i det.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg apotekspersonalet hvordan du bortskaffer lægemidler, der ikke længere skal anvendes.
English: There are no known antidotes to BindRen.
Danish: Der er ingen kendte antidoter til BindRen.
English: Hyperparathyroidism BindRen alone is not indicated for the control of hyperparathyroidism.
Danish: Hyperparathyroidisme BindRen alene er ikke indiceret til kontrol af hyperparathyroidisme.
English: Do not throw away any medicine via wastewater or household waste.
Danish: Bortskaf ikke lægemidler via spildevand eller husholdningsaffald.
English: The reductions in LDL-cholesterol are also reflected in significant falls in total cholesterol.
Danish: Reduktionen i LDL-cholesterol afspejles også i signifikante fald i total-cholesterol.
English: Interaction studies have been conducted in healthy volunteers.
Danish: Der er udført interaktionsundersøgelser med sunde, frivillige forsøgspersoner.
English: No data are available.
Danish: Der foreligger ingen data herom.
English: BindRen alone cannot treat this condition and other medicines should be prescribed for you.
Danish: BindRen alene kan ikke behandle dette, og der bør ordineres anden medicin til dig.
English: Your doctor may decide to increase this up to a total dose of 15 g per day depending on the level of phosphorus in your blood.
Danish: Lægen kan beslutte at øge dette op til en samlet dosis på 15 g dagligt, afhængig af dit fosforniveau i blodet.
English: However, even though you are taking BindRen, you must also follow the special diet recommended by your doctor.
Danish: Selvom du tager BindRen, skal du også følge den specielle diæt, der anbefales af din læge.
English: For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Systemic ion balance
Danish: Systemisk ionbalance
English: However, if you cannot swallow the contents of a whole sachet at once you can divide the contents of the sachet dose into smaller portions.
Danish: Hvis du ikke kan synke indholdet af et helt brev på en gang, kan du dele brevets indholdsdosis i mindre portioner.
English: Pharmacotherapeutic group: not yet assigned.
Danish: Farmakoterapeutisk klassifikation: endnu ikke tildelt.
English: Elemental calcium should be given as a supplement in case of hypocalcaemia.
Danish: Calcium bør gives som supplement i tilfælde af hypokalcæmi.
English: Tel/Tel./ Teл./Tlf/Tél/Sími/Τηλ: +44 (0) 20 7382 9000 medinfo@mt-pharma-eu.com
Danish: Tlf./Tel./ Teл./Tlf/Tél/Sími/Τηλ: +44 (0) 20 7382 9000 medinfo@mt-pharma-eu.com
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 January 2013
Danish: Dato for første markedsføringstilladelse: 21 januar 2013
English: The results of in vitro testing suggest that medicinal products with anionic and/or lipophilic characteristics have a higher potential to bind to BindRen.
Danish: Resultater af in vitro-afprøvning antyder at lægemidler med anioniske og/eller lipofile egenskaber har et højere potentiale til at binde til BindRen.
English: The safety and efficacy of BindRen has not been studied in patients with:
Danish: Sikkerhed og virkning af BindRen er endnu ikke undersøgt hos patienter med:
English: You have also been advised to follow a special diet to reduce the amount of phosphorus that your body takes from food.
Danish: Det er også blevet anbefalet, at du følger en speciel diæt for at nedbringe mængden af fosfor, som du får fra fødevarer.
English: Two long-term, open-label, flexible-dose studies demonstrated that serum phosphorus reduction was maintained for up to one year.
Danish: To længerevarende undersøgelser med open label, fleksible doser viste, at reduktion af fosfat i serum var opretholdt i op til et år.
English: Haemorrhage and increased clotting parameters (PT and aPTT) were evident in rats following repeat administration.
Danish: Blødning og øgede koagulationsparametre (PT og aPTT) var evident i rotter efter gentagen administration.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold flasken tæt tillukket for at beskytte mod fugt.
English: - you have abnormally low levels of calcium in your blood.
Danish: - du har unormalt lavt calsiumindhold i blodet.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Colestilan is a non-absorbed, non-calcium, non-metallic phosphate-binding polymer.
Danish: Colestilan er en ikke-absorberet, calciumfri, ikke-metallisk, fosfatbindende polymer.
English: Email: info@mt-pharma-eu.com
Danish: E-mail: info@mt-pharma-eu.com
English: Interactions have not been studied at doses >9 g daily, and greater interaction effects at higher doses of BindRen cannot be excluded.
Danish: Der er ikke udført interaktionsundersøgelser for doser på > 9 g dagligt, og større interaktionseffekt af større doser af BindRen kan ikke udelukkes.
English: Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia.
Danish: Nogle gange er dialyse og diæt ikke tilstrækkeligt til at forhindre, at fosfor i dit blod stiger til høje niveauer, en tilstand, som din læge betegner som hyperfosfatæmi.
English: It is important that you continue taking BindRen for as long as your doctor prescribes the medicine and to keep to your diet.
Danish: Det er vigtigt, at du fortsætter med at tage BindRen, så længe din læge har ordineret det, og at du holder din diæt.
English: Your doctor may consider measuring blood levels of the other medicines you are taking.
Danish: Lægen kan beslutte at måle blodniveauerne for anden medicin, du tager.
English: The frequency of adverse reactions increased with dose.
Danish: Hyppighed af bivirkninger steg med dosis.
English: However, reproductive toxicity studies were not conducted at doses higher than 2.5 times the human clinical dose, and the possible reproductive effects related to coagulation and bleeding have not been assessed.
Danish: Undersøgelse af reproduktionstoksicitet blev ikke udført i større doser end 2,5 gange human klinisk dosis, og de mulige reproduktive effekter, der er relateret til koagulation og blødning er ikke vurderet.
English: Granules.
Danish: Granulat.
English: The following side effects have also been seen in patients taking BindRen:
Danish: Følgende bivirkninger er set hos patienter, der tager BindRen:
English: SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed in order to protect from moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Hold flasken tæt tillukket for at beskytte mod fugt.
English: BindRen granules are white cylindrical granules.
Danish: BindRen granulater er hvide, cylindriske granulater.
English: A majority of patients received 12 or 15 g/day of colestilan in the long-term studies.
Danish: Størstedelen af patienter modtog 12 eller 15 g/dagligt af colestilan i de længerevarende undersøgelser.
English: It is recommended that you take the tablets whole with meals and with a small amount of water.
Danish: Det anbefales, at du sluger tabletterne hele sammen med måltider og med lidt vand.
English: Fertility No data are available to assess the potential influence of BindRen on fertility.
Danish: Fertilitet Der foreligger ingen data til vurdering af potentiel påvirkning fra BindRen på fertiliteten.
English: What BindRen contains
Danish: Hvad BindRen indeholder
English: Single dose interaction studies demonstrated that the bioavailability of ciprofloxacin, warfarin and enalapril were not affected when co-administered with BindRen (6-9 g/day).
Danish: Interaktionsundersøgelser af enkeltdoser viste, at optageligheden af ciprofloxacin, warfarin og enalapril ikke blev påvirket, når de blev administreret sammen med BindRen (6-9 g/dagligt).
English: Film-coating Ethylcellulose Hypromellose Macrogol 8000
Danish: Filmovertræk Ethylcellulose Hypromellose Macrogol 8000
English: These were considered to result from a deficiency of vitamin K following a reduction in the absorption of fat-soluble vitamins (see section 4.4).
Danish: Det blev betragtet som en følge af vitamin K-mangel som følge af reduktion i absorption af fedtopløselige vitaminer (se pkt.
English: BindRen does not contain calcium and your doctor may prescribe additional calcium tablets.
Danish: BindRen indeholder ikke calcium, og din læge kan ordinere ekstra calcium-tabletter.
English: Serum calcium concentrations should be monitored as a normal follow-up of a dialysis patient.
Danish: Serum-calciumkoncentrationer skal kontrolleres som led i normal opfølgning af dialysepatienter.
English: Serum phosphorus concentrations should be monitored.
Danish: Serum-fosfatkoncentrationer skal kontrolleres.
English: The safety and efficacy of BindRen in children and adolescents aged under 18 years has not yet been established.
Danish: Sikkerhed og virkning af BindRen hos børn og unge under 18 år er endnu ikke klarlagt.
English: BindRen has been given to dialysis patients in doses up to 15 g/day for up to one year continuously with no cases of overdose.
Danish: BindRen har været givet til dialysepatienter i doser op til 15 g/dagligt uafbrudt i op til et år uden tilfælde af overdosis.
English: However, intestinal folate absorption may be impaired during long-term treatment of BindRen.
Danish: Intestinal optagelse af folat kan imidlertid svækkes ved langvarig behandling med BindRen.
English: Flexible-dose studies:
Danish: Undersøgelser med fleksibel dosis:
English: Patients should be encouraged to adhere to their prescribed low phosphate diets.
Danish: Patienter bør opfordres til at overholde deres ordinerede diæt med lavt fosfatindhold.
English: - you have been told that you have a disorder that decreases the intestines ability to absorb nutrients (malabsorption syndrome) or if you are treated with so called coumarin anticoagulants (e.g. warfarin), since your doctor may want to monitor your blood and possibly ask you to start taking vitamin supplements.
Danish: - du har fået oplyst, at du har en sygdom der sænker den intestinale evne til at absorbere næringsstoffer (malabsorptionssyndom), eller hvis du er i behandling med såkaldte coumarinantikoagulanter (f.eks. warfarin), da lægen måske vil kontrollere dit blod og muligvis anmode dig om at begynde at tage vitamintilskud.
English: Therefore, the use of BindRen is not recommended in patients with these disorders.
Danish: Derfor anbefales BindRen ikke til patienter med disse sygdomme.
English: • Recent history of peritonitis in peritoneal dialysis patients
Danish: • Nylig peritonit hos patienter i peritonealdialyse
English: The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population.
Danish: Fase II- og III- kliniske undersøgelser der involverede 1.410 patienter med KNS i stadium 5 i dialyse, behandlet med BindRen i op til et år, udgør sikkerhedspopulationen.
English: However, decreased blood concentrations have been reported for medicinal products with a similar mechanism of action to BindRen.
Danish: Der er imidlertid rapporteret om nedsat blodkoncentration efter lægemidler med lignende virkningsmekanisme som BindRen.
English: No in vivo data are available on the possible interaction of BindRen on the absorption of the immunosuppressant medicinal products mycophenolate mofetil, ciclosporin or tacrolimus.
Danish: Der foreligger ingen in vivo-data om mulig interaktion mellem BindRen og absorption af de immunosupprimerende lægemidler mycophenolate mofetil, ciclosporin eller tacrolimus.
English: About high blood phosphorus levels (hyperphosphataemia) If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys.
Danish: Om for højt indhold af fosfor i blodet (hyperfosfatæmi) Hvis nyrerne ikke længere fungerer korrekt, så kan du komme i dialyse, hvilket erstatter mange af dine nyrefunktioner.
English: No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years).
Danish: Der foreligger ingen data om sikkerhed og virkning af BindRen hos børn og unge (under 18 år).
English: Three Phase III studies and two long term follow-up studies have been performed in patients with CKD Stage 5 on dialysis, in order to investigate efficacy and safety in this population.
Danish: Tre fase III-undersøgelser og to længerevarende opfølgende undersøgelser hos patienter med KNS i stadium 5 i dialyse er gennemført for at undersøge virkning og sikkerhed i denne population.
English: This may show as either fresh or altered blood in your vomit, or when from the lower bowel, as a black stool or with blood mixed in your stool.
Danish: Det kan vise sig som enten frisk eller ændret blod i dit opkast, eller fra den nedre tarm, som sort afføring eller med blod blandet i afføringen.
English: Treatment of high blood phosphorus levels is usually required for a long period of time.
Danish: Behandling af høje blodfosforniveauer kræves normalt i længere tid.
English: Constipation is common and if you suffer from persistent or worsening constipation please tell your doctor or pharmacist as this may be the first sign of blockage of your intestines.
Danish: Forstoppelse er almindelig, og hvis du lider af vedvarende eller forværring af forstoppelse, så fortæl det til din læge eller apotekspersonalet, da det kan være det første tegn på blokering i tarmene.
English: The binding sites become partially protonated in the stomach and interact through ionic and hydrogen bonding with both dietary phosphate anions and bile acids in the duodenum.
Danish: Bindingsstederne bliver delvist protonerede i maven og interagerer via ionisk- og hydrogen-binding med både diætetiske fosfatanioner og galdesyrer i duodenum.
English: In most clinical studies, colestilan decreased serum PTH compared to baseline, and was statistically significant against placebo.
Danish: I de fleste kliniske undersøgelser sænkede colestilan PTH i serum sammenlignet med baseline og denne effekt var statistisk signifikant i forhold til placebo.
English: Changes in systemic ion balance with an increase in chloride and decrease in bicarbonate are therefore possible.
Danish: Ændringer i systemisk ionbalance med stigning i chlorid og en sænkning i bicarbonat kan forekomme.
English: BindRen is not absorbed from the gastrointestinal tract of healthy volunteers following oral administration of 14C-radiolabelled colestilan.
Danish: BindRen blev ikke absorberet fra mave-tarm-kanalen hos sunde frivillige efter oral administration af 14C-røntgenmærket colestilan.
English: Aluminium/polychlorotrifluoroethylene/PVC blister.
Danish: Aluminium/polychlorotrifluoroethylen/PVC-blister.
English: Keeping the phosphorus level in your blood low is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.
Danish: Det er vigtigt at holde fosforniveauet i dit blod lavt for at opretholde sunde knogler og blodkar og for at forhindre hudkløe, røde øjne, smerter i knoglerne eller brud på knoglerne.
English: In patients who develop severe constipation or other severe gastrointestinal symptoms, alternative treatment may need to be considered.
Danish: Hos patienter, der udvikler svær obstipation eller andre svære mave-tarm-symptomer, kan det blive nødvendigt at overveje alternativ behandling.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: BindRen binds phosphate and bile acid, with the release of chloride which is available for systemic absorption.
Danish: BindRen binder fosfat og galdesyre med frigivelse af chlorid som er tilgængelig for systemisk absorption.
English: - you have abnormally high levels of calcium in your blood due to overactivity of the parathyroid glands.
Danish: - du har unormalt højt calciumindhold i blodet på grund af overaktivitet af parathyroideaekirtler.
English: Your doctor may advise you to take calcium, vitamin D supplements and other vitamins or other medicines in addition to BindRen.
Danish: Lægen kan anbefale dig at tage calcium, vitamin D-tilskud eller anden medicin sammen med BindRen.
English: White, cylindrical, film-coated granules, each approximately 3.5 mm in length and 3 mm in diameter.
Danish: Hvidt cylinderformet, filmovertrukket granulat, hver ca. 3,5 mm lang og 3 mm i diameter.
English: Triethyl citrate Titanium dioxide Talc
Danish: Triethyl citrat Titanium dioxid Talkum
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Danish: Bivirkningerne er inden for hver enkelt hyppighedsgruppe opstillet i rækkefølge efter faldende alvorlighed.
English: Indigo carmine aluminium lake (E 132) Carnauba wax
Danish: Indigo carmine aluminium lake (E132) Carnaubavoks
English: In these patients, monitoring serum folate status and supplementation with folic acid should be considered.
Danish: Hos disse patienter bør kontrol af folatstatus i serum og supplement med folsyre overvejes.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with BindRen.
Danish: I meget sjældne tilfælde er der set tarmobstruktion og ileus/subileus hos patienter, mens de var i behandling med BindRen.
English: When administering any medicinal product where a reduction in the bioavailability could have a clinically relevant effect on safety or efficacy, the medicinal product should be administered at least 1 hour before, or 3 hours after taking BindRen.
Danish: Ved administration af lægemidler, hvor en nedsat optagelighed kan have en klinisk relevant virkning på sikkerhed eller virkning, skal lægemidlet administreres mindste en time før eller tre timer efter indtagelse af BindRen.
English: If you have to take other medicines your doctor will tell you if you can take the other medicines at the same time as BindRen or if you need to take the other medicines 1 hour before or 3 hours after taking BindRen.
Danish: Hvis du skal tage anden medicin, fortæller lægen dig, om du kan tage anden medicin samtidigt med BindRen, eller om du skal tage anden medicin 1 time før eller 3 timer, efter du har taget BindRen.
English: Two similar 12-week, open-label, flexible-dose studies followed by a 4-week double-blind withdrawal period (comparison to placebo) were performed.
Danish: Der blev udført to ens 12-ugers undersøgelser med open label, fleksibel dosis efterfulgt af en 4-ugers dobbeltblindet afvænningsperiode (sammenligning med placebo).
English: Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia.
Danish: Patienter med nyreinsufficiens kan udvikle hypokalcæmi eller hyperkalcæmi.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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, før du tager dette lægemiddel.
English: Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Danish: Colestilan binder til fosfor fra føden i din fordøjelseskanal for at forhindre, at den absorberes i dit blod.
English: This is because your doctor may want to monitor your health, change the dose of BindRen or the other medicine you are taking or tell you to not take BindRen and the other medicine at the same time.
Danish: Der er fordi din læge måske vil kontrollere dit helbred, ændre dosis af BindRen eller anden medicin, du tager eller anmode dig om ikke at tage BindRen samtidigt.
English: Granules should be taken whole as one dose from the sachet.
Danish: Granulater skal tages hele som en dosis fra brevet.
English: Intestinal obstruction and ileus/subileus
Danish: Tarmobstruktion og ileus/subileus
English: Manufacturer allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Danish: Fremstiller allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
English: BindRen is not absorbed from the gastrointestinal tract but may affect the bioavailability or absorption rate of other medicinal products.
Danish: BindRen absorberes ikke fra mave-tarm-kanalen, men kan påvirke biotilgængeligheden eller absorptionen af andre lægemidler.
English: If you do become pregnant or you are breast-feeding, and your doctor decides that you should continue your treatment with BindRen, your doctor may ask you to also take vitamin supplements.
Danish: Hvis du bliver gravid, eller hvis du ammer, og din læge beslutter, at du skal fortsætte din behandling med BindRen, kan din læge også bede dig om at tage vitamintilskud.
English: Patients received doses of up to 15 g per day, in three divided doses of 5 g.
Danish: Patienterne modtog doser af op til 15 g pr. dag i tre opdelte doser a 5 g.
English: They are supplied in blisters or bottles in cartons of 45, 99, 198, 270 or 297 tablets.
Danish: De leveres i blisterpakninger eller flasker i æsker med 45, 99, 198, 270 eller 297 tabletter.
English: They are supplied in 2 g or 3 g sachets in cartons of 30, 60 or 90 sachets.
Danish: De leveres i breve med 2 g eller 3 g i æsker med 30, 60 eller 90 breve.
English: No data are available to assess the safety and efficacy in pregnant women.
Danish: Der foreligger ingen data til vurdering af sikkerhed og virkning hos gravide kvinder.
English: Colestilan reduced calcium-phosphorus ion product by 0.90 mmol2/L2 after one year.
Danish: Colestilan reducerede calcium-fosfat-ionproduktet med 0,90 mmol2/l2 efter et år.
English: Non-clinical data reveal no direct special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, genotoxicity, carcinogenic potential or toxicity to reproduction and development.
Danish: Prækliniske data viser ingen direkte speciel risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter enkeltdoser og gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you: - you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).
Danish: Tal med lægen eller apotekspersonalet hvis du under din behandling med BindRen oplever følgende: - oplever forstoppelse, da din læge kan ønske at kontrollere din tarmfunktion for at registrere mulige bivirkninger (se pkt.