FrancophonIA/ELRC3.0 huggingface dataset:
English: In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients) and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Danish: Bivirkninger fra disse studier (299 patienter) og fra ukontrollerede kliniske studier (384 patienter) og fra spontane indberetninger post-marketing, er anført efter hyppighed i nedenstående tabel.
English: The safety and efficacy of this product have not been established in patients below the age of 18 years.
Danish: Pædiatrisk population Sikkerheden og virkningen af dette lægemiddel er ikke dokumenteret hos patienter under 18 år.
English: The safety of sevelamer hydrochloride has not been established in pregnant women.
Danish: Sikkerheden ved anvendelse af sevelamerhydrochlorid til gravide kvinder er ikke fastlagt.
English: Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and levothyroxine is recommended (see section 4.5).
Danish: Tættere monitorering af patienter med hypothyreose anbefales ved samtidig administration af sevelamerhydrochlorid og levotyroxin (se pkt.
English: What you need to know before you take Tasermity 3.
Danish: Det skal du vide, før du begynder at tage Tasermity
English: By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum.
Danish: Ved at binde phosphat i mave-tarm-kanalen nedsætter sevelamer phosphatkoncentrationen i serum.
English: Increased levels of serum phosphorus can lead to hard deposits in your body called calcification.
Danish: Et øget indhold af serumfosfat kan føre til hårde aflejringer i din krop.
English: During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine.
Danish: Der er efter markedsføring rapporteret meget sjældne tilfælde af øget niveau af thyreoidea stimulerende hormon (TSH) hos patienter, som har fået sevelamerhydrochlorid og levothyroxin samtidigt.
English: Tasermity may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Danish: Tasermity kan anvendes sammen med andre lægemidler, herunder calciumtilskud eller Dvitamintilskud, for at behandle udviklingen af renal knoglesygdom.
English: The safety and efficacy in children (below the age of 18 years) have not been studied.
Danish: Sikkerheden og virkningen af Tasermity er ikke fastlagt for børn (under 18 år).
English: Silica, colloidal anhydrous Stearic acid
Danish: Kolloid vandfri silica Stearinsyre
English: The safety of Tasermity has not been established in pregnant or breast-feeding women.
Danish: Sikkerheden ved anvendelse af Tasermity til gravide og ammende kvinder er ikke blevet fastlagt.
English: Also the medicinal product is not absorbed in the gastrointestinal tract.
Danish: Desuden absorberes lægemidlet ikke i mave-tarm-kanalen.
English: • Hypophosphataemia
Danish: • Hypophosphatæmi • Tarmobstruktion
English: In clinical trials, sevelamer hydrochloride has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Danish: I kliniske studier har sevelamerhydrochlorid vist sig at være effektiv i reduceringen af phosphor hos patienter, som var i hæmodialyse eller peritonealdialyse.
English: In preclinical studies in rats and dogs, sevelamer at a dose of 10 times the maximum human doses reduced absorption of fat soluble vitamins D, E and K, and folic acid.
Danish: I prækliniske studier på rotter og hunde nedsatte sevelamer optagelsen af de fedtopløselige vitaminer, D, E og K og folat i en dosis på 10 gange de maksimale humane doser.
English: Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Danish: Behandling med sevelamerhydrochlorid skal genvurderes for patienter, der udvikler svær obstipation eller andre alvorlige gastrointestinale symptomer.
English: Genzyme Europe B.V. Gooimeer 10
Danish: Genzyme Europe B.V.
English: Caution should be exercised when sevelamer hydrochloride is used in patients with difficulty swallowing.
Danish: Der skal udvises forsigtighed, når sevelamerhydrochlorid anvendes hos patienter, der har problemer med at synke.
English: Therefore caution should be exercised when sevelamer hydrochloride is used in patients with these disorders.
Danish: Der skal derfor udvises forsigtighed, når sevelamerhydrochlorid anvendes hos patienter med disse problemer.
English: Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust the dose of Tasermity when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
Danish: Lægen kan om nødvendigt ændre din dosis af Tasermity (mellem 1 og 5 tabletter på 800 mg pr. måltid) for at opnå den ønskede fosfatkoncentration i blodet.
English: • Hypersensitivity to sevelamer or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for sevelamer eller over for et eller flere af hjælpestofferne anført i punkt
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: C. ANDREFORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Danish: Tasermity er indiceret til kontrol af hyperphosphatæmi hos voksne patienter, der er i hæmodialyse eller peritonealdialyse.
English: In the event of a possible overdose you should contact your doctor immediately.
Danish: Hvis du har taget for mange Tasermity I tilfælde af en eventuel overdosis, skal du straks søge læge.
English: During post-marketing experience, very rare cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.
Danish: Efter markedsføring er der rapporteret om meget sjældne tilfælde af forhøjede fosfatniveauer hos patienter hvor protonpumpehæmmere og sevelamerhydrochlorid er administreret samtidig.
English: - If you have further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen.
English: Tasermity is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Danish: Tasermity anvendes til at kontrollere fosfatkoncentrationen i blodet hos voksne patienter med nyresvigt, som er i hæmodialyse eller peritonealdialyse.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor before taking Tasermity.
Danish: • Hvis du tager medicin mod problemer med hjerterytmen eller for epilepsi, skal du diskutere det
English: Tasermity 800 mg film-coated tablets sevelamer hydrochloride
Danish: Tasermity 800 mg filmovertrukne tabletter sevelamerhydrochlorid
English: In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Danish: Hos patienter med sekundær hyperparathyreose bør sevelamerhydrochlorid anvendes i forbindelse med flere andre behandlinger, der kan omfatte ekstra tilførsel af calcium, 1,25-dihydroxy-vitamin D3 eller et af dettes analoger for at sænke intakt parathyroideahormon-(iPTH)-niveauerne.
English: The safety of sevelamer hydrochloride has not been established in breast-feeding women.
Danish: Sikkerheden ved anvendelse af sevelamerhydrochlorid til ammende kvinder er ikke fastlagt.
English: He/she will base the dose on your serum phosphate level.
Danish: Lægen vil fastsætte din dosis ud fra indholdet af serumfosfat i dit blod.
English: In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels.
Danish: Hos patienter med sekundær hyperparathyreose bør sevelamerhydrochlorid anvendes i forbindelse med flere andre behandlinger, der kan omfatte calciumtilskud, 1,25-dihydroxy-vitamin D3 eller et af dettes analoge stoffer for at sænke niveauerne af iPTH.
English: Tasermity 800 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Tasermity 800 mg filmovertrukne tabletter
English: The effects on phosphate and calcium were proven to be maintained throughout a study with one year follow-up.
Danish: Det blev i et studie med opfølgning efter et år påvist, at virkningen på phosphat og kalium blev opretholdt.
English: Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Danish: Sevelamerhydrochlorid bør anvendes i forbindelse med flere andre behandlinger, der kan omfatte ekstra tilførsel af calcium, 1,25-dihydroxy-vitamin D3 eller et af dettes analoge stoffer til styring af udviklingen af renal knoglesygdom.
English: • if you have undergone major surgery on your stomach or bowel.
Danish: • Hvis du har gennemgået en større operation i mave-tarm-kanalen.
English: Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is important to inform your doctor or pharmacist of this symptom before or during the use of Tasermity.
Danish: Det er derfor vigtigt at informere din læge eller apotekspersonalet om dette symptom før eller under din behandling med Tasermity.
English: Zentiva Pharma GmbH Tel: +49 (0) 180 20 200 10
Danish: Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
English: Posology
Danish: Folatmangel
English: Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose
Danish: Dyrestudier har vist, at sevelamer ikke nedsætter fertiliteten hos hun- eller hanrotter ved udsættelse for en human dosis svarende til 2 gange den maksimale dosis i kliniske studier med 13 g/dag, baseret på en sammenligning af det relative legemsoverfladeareal .
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Danish: Særlige bemærkninger for patienter i peritonealdialyse Du kan udvikle peritonitis (bughindebetændelse) i forbindelse med peritonealdialysen.
English: How to store Tasermity
Danish: INFORMATION I BRAILLESKRIFT Tasermity
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Tasermity Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: C.
Danish: SN:
English: Therefore Tasermity is not recommended for use in this population.
Danish: Derfor anbefales Tasermity ikke til børn (under 18 år).
English: Package leaflet: Information for the user Tasermity 800 mg film-coated tablets sevelamer hydrochloride
Danish: LÆGEMIDLETS NAVN Tasermity 800 mg filmovertrukne tabletter sevelamerhydrochlorid
English: Name and address of the manufacturers responsible for batch release Genzyme Ireland Limited
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse
English: How to take Tasermity
Danish: Tag ikke Tasermity:
English: 180 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 180 filmovertrukne tabletter
English: The tablets must be swallowed whole.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tabletterne skal synkes hele.
English: Tabulated list of adverse reactions
Danish: Antiarytmika og antiepilektika
English: Uncommon reports of difficulty swallowing the sevelamer hydrochloride tablet have been reported.
Danish: Problemer med at sluge tabletterne eller med at få tabletterne galt i halsen Der er i ikke almindelige tilfælde rapporteret, at patienter har haft svært ved at sluge sevelamerhydrochlorid-tabletten.
English: Τηλ: +30 210 900 1600
Danish: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 1600
English: Nederland sanofi-aventis Netherlands B.V. Tel: +31 182 557 755
Danish: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
English: Τηλ: +357 22 871600
Danish: Tel: +31 182 557 755
English: 49 x 1 tablets (unit dose)
Danish: 196 (2 x 98) tabletter
English: Tradename Strength Pharmaceutical Form
Danish: Handelsnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til:
English: Withdrawal Period
Danish: Pakningsstørrelse Tilbageholdelsestid
English: Packaging
Danish: Hunde
English: London, 19 July 2007 Doc.
Danish: London, den 19. juli 2007 Ref.dok.
English: The main measure of effectiveness was how long the patients survived after the first operation.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede efter den første operation.
English: What is Cerepro?
Danish: Hvad er Cerepro?
English: The evaluation had finished and the CHMP had given a negative opinion.
Danish: Vurderingen var afsluttet, og CHMP ville have afgivet en negativ udtalelse.
English: The Committee also had concerns over the ways in which the study had been carried out, which made it difficult to interpret the results.
Danish: Desuden var der betænkelighed ved, at undersøgelsen var udført på en måde, der gjorde det vanskeligt at fortolke resultaterne.
English: The effects of Cerepro were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Cerepro blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for CEREPRO
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for CEREPRO
English: Ref. EMA/318692/2007
Danish: EMA/382249/2007
English: After removing as much of the brain tumour as possible, the surgeon would have made up to 70 small injections of Cerepro into the area from where the tumour was removed.
Danish: Efter at have fjernet så meget af hjernesvulsten som muligt skulle kirurgen foretage op til 70 små indsprøjtninger af Cerepro i det område, hvorfra svulsten var blevet fjernet.
English: Cerepro has also been studied in 36 patients with high-grade glioma.
Danish: Cerepro blev desuden undersøgt hos 36 patienter med high-grade gliom.
English: Cerepro was designated an orphan medicinal product on 6 February 2002.
Danish: Cerepro blev udpeget som lægemiddel til sjældne sygdomme den 6. februar 2002.
English: What are the consequences of the withdrawal for patients in clinical trials with Cerepro?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Cerepro?
English: The virus in Cerepro is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Danish: Viruset i Cerepro er et adenovirus, der er manipuleret, så det ikke kan lave kopier af sig selv og derfor ikke kan give infektion hos mennesker.
English: Cerepro would only have worked in combination with ganciclovir.
Danish: Cerepro ville kun have virket i kombination med ganciclovir.
English: Cerepro was intended for use during an operation.
Danish: Det var hensigten, at Cerepro skulle anvendes under operation.
English: When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites.
Danish: Når Cerepro indsprøjtes i hjernen, bliver det modificerede virus optaget af cellerne omkring indsprøjtningsstedet.
English: On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.
Danish: Den 13. juli 2007 meddelte Ark Therapeutics officielt til Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse for Cerepro til behandling af operabelt high-grade gliom tilbage.
English: Cerepro injection was to be followed by a two-week course of treatment with ganciclovir sodium, starting five days after the operation.
Danish: Indsprøjtningen af Cerepro skulle efterfølges af to ugers behandling med ganciclovirnatrium, begyndende fem dage efter operationen.
English: Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells).
Danish: Et gliom er en art hjernesvulst, der udgår fra gliacellerne (de celler, der omgiver og støtter nervecellerne).
English: The cells then start to produce the thymidine kinase enzyme.
Danish: Cellerne begynder derefter at producere enzymet thymidinkinase.
English: What was Cerepro expected to be used for?
Danish: Hvad forventedes Cerepro anvendt til?
English: The gene is carried within a ‘vector', a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body.
Danish: Genet overføres af en vektor, dvs. en virustype, der er ændret genetisk, så den kan overføre et gen (dna) til kroppens celler.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Cerepro.
Danish: Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Cerepro.
English: The study compared the effects of adding Cerepro and ganciclovir sodium to standard treatment with the effects of standard treatment alone.
Danish: I undersøgelsen blev virkningen af at supplere standardbehandling med Cerepro og ganciclovirnatrium sammenlignet med virkningerne af standardbehandling alene.
English: This enzyme helps to convert ganciclovir into a form which can kill cells that are dividing, including any cancerous cells that were not removed during the operation.
Danish: Enzymet omdanner ganciclovir til en form, hvor det dræber de celler, der formerer sig, bl.a. de kræftceller, der ikke blev fjernet ved oprationen.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål havde CHMP på tilbagetrækningstidspunktet afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Cerepro til behandling af operabelt high-grade gliom.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Cerepro had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Cerepro ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
English: Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene
Danish: Aktivt indholdsstof: adenovirus-medieret Herpes simplex virus gen for thymidinkinase
English: The CHMP had concerns that a benefit of Cerepro had not yet been shown.
Danish: CHMP havde betænkelighed ved, at fordelene ved Cerepro ikke var påvist.
English: How is Cerepro expected to work?
Danish: Hvordan forventedes Cerepro at virke?
English: Cerepro is a medicine containing a gene (a Herpes simplex virus thymidine kinase gene) carried by an adenovirus.
Danish: Cerepro er et lægemiddel, der indeholder et gen (et Herpes simplex virus gen for thymidinkinase), der overføres af et adenovirus.
English: It was concerned over the low number of patients included in the main study of Cerepro, which prevented a benefit of the medicine being demonstrated.
Danish: Der var betænkelighed ved, at hovedundersøgelsen af Cerepro omfattede så få patienter, at fordelen ved lægemidlet ikke kunne påvises.
English: Cerepro was to be used in combination with ganciclovir sodium to treat high-grade glioma in patients who are eligible for surgery.
Danish: Cerepro skulle i kombination med ganciclovirnatrium anvendes til behandling af high-grade (ondartet) gliom hos patienter, hos hvem operation er mulig.
English: It is made up into a solution that is injected directly into the brain during surgery.
Danish: Efter at være bragt i opløsning indsprøjtes lægemidlet direkte i hjernen under operation.
English: Cerepro contains the gene for the enzyme ‘thymidine kinase' from the herpes virus.
Danish: Cerepro indeholder genet for enzymet thymidinkinase fra herpesvirus.
English: In addition, the CHMP considered there to be insufficient information on the safety of Cerepro, and, since the benefits of the medicine had not been demonstrated, that its risks, when used in combination with ganciclovir, could be of concern.
Danish: Da dets fordele ikke er bevist, fandt udvalget grund til betænkelighed ved risiciene forbundet med anvendelse i kombination med ganciclovir.
English: Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010.
Danish: Nivestim fik en markedsføringstilladelse med gyldighed i hele EU den 8. juni 2010.
English: Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim.
Danish: Yderligere information om Nivestim findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/nivestim.
English: An overview of Nivestim and why it is authorised in the EU
Danish: En oversigt over Nivestim, og hvorfor det er godkendt i EU
English: Other side effects may be seen in more than 1 in 10 patients, depending on the condition that Nivestim is being used for.
Danish: Andre bivirkninger kan forekomme hos mere end 1 ud af 10 patienter, afhængigt af hvilken lidelse Nivestim anvendes for.
English: Other information about Nivestim
Danish: Andre oplysninger om Nivestim
English: This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Nivestim i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: What is Nivestim and what is it used for?
Danish: Hvad er Nivestim, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Nivestim?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nivestim?
English: Nivestim can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Danish: Nivestim fås kun på recept, og behandlingen bør ske i samarbejde med et center for kræftbehandling.
English: As for all medicines, data on the use of Nivestim are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Nivestim løbende overvåget.
English: Why is Nivestim approved?
Danish: Hvorfor er Nivestim godkendt?
English: Nivestim can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Danish: Nivestim kan også anvendes til personer, der skal donere blodstamceller til transplantation, for at medvirke til at frigøre disse celler fra knoglemarven.
English: Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Neutropeni er en almindelig bivirkning ved kræftbehandling og kan gøre patienterne sårbare over for infektioner.
English: Nivestim contains the active substance filgrastim.
Danish: Nivestim indeholder det aktive stof filgrastim.
English: Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Danish: Filgrastim virker på samme måde som naturligt produceret G-CSF ved at stimulere knoglemarven til at danne flere hvide blodlegemer.