FrancophonIA/ELRC3.0 huggingface dataset:
English: Always use this medicine exactly as described in this leaflet and as your doctor has told you.
Danish: Brug altid Rivastigmine 3M Health Care Ltd. depotplastre nøjagtigt som beskrevet i denne indlægsseddel, eller efter lægens anvisning.
English: Baseline 264 34.4 268 34.9
Danish: Gennemsnitsbaseline  SD 27,0  10,3 27,9  9,4 28,6  9,9 Gennemsnitsændring ved uge
English: Uncommon (may affect up to 1 in 100 people) - Problems with your heartbeat such as slow heartbeat - Seeing things that are not really there (hallucinations) - Stomach ulcer - Dehydration (losing too much fluid) - Hyperactivity (high level of activity, restlessness) - Aggression
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) Problemer med hjerterytmen, såsom langsom hjerterytme (puls) Ser ting, der ikke er der i virkeligheden (hallucinationer) Mavesår
English: Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
Danish: Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster rivastigmin
English: - A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to
Danish: • En patient, som får en stabil og veltolereret dosis på 9 mg/dag oral rivastigmin, kan skiftes til 9,5 mg/24 timer depotplastre.
English: Drug-in-adhesive (DIA) matrix
Danish: DIA-matrix: - Acrylatcopolymerklæbemiddel - Isopropylmyristat
English: Tear the pouch open where indicated and remove the patch from the pouch.
Danish: Riv brevet op som vist, og tag plastret ud af brevet.
English: IMPORTANT: - Take off the previous patch before putting ONE new patch on. - Only one patch per day.
Danish: VIGTIGT: - Fjern det gamle plaster, før du påsætter ÉT nyt plaster.
English: Take off the previous patch before putting ONE new patch on.
Danish: Det gamle plaster skal tages af før ET nyt plaster påsættes.
English: Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. transdermal patches as follows: - A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Danish: 5.2), kan patienter, som behandles med rivastigmin kapsler eller oral opløsning, skiftes til Rivastigmine 3M Health Care Ltd. depotplastre, som følger:
English: Otherwise treatment should be re-initiated with 4.6 mg/24 h.
Danish: Er afbrydelsen af længere varighed, genoptages behandlingen med 4,6 mg/24 timer.
English: How to use Rivastigmine 3M Health Care Ltd.
Danish: Sådan skal du bruge Rivastigmine 3M Health Care Ltd.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch
Danish: LÆGEMIDLETS NAVN Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch
Danish: LÆGEMIDLETS NAVN Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster
English: Dose escalation
Danish: Rivastig min
English: Renal impairment
Danish: Nyrer og urinveje
English: - if you have, or have ever had, seizures.
Danish: - hvis du har eller har haft krampeanfald.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Danish: Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster rivastigmin
English: Rivastigmine 13.3 mg/24 h*
Danish: Rivastigmin 4,6 mg/24 timer Rivastigmin 9,5 mg/24 timer Rivastigmin 13,3 mg/24 timer*
English: If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.
Danish: Næste dag udskifter du depotplasteret med et nyt til sædvanlig tid.
English: Very rare (may affect up to 1 in 10,000 people) - High blood pressure - Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting) - Bleeding in the gut - shows as blood in stools or when being sick - Seeing things that are not there (hallucinations) - Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)
Danish: Blødning i tarmen - viser sig ved blod i afføringen eller ved opkastning Ser ting, der ikke er der i virkeligheden (hallunicationer) Nogle mennesker, der har haft voldsom opkastning, har fået hul (ruptur) i spiserøret
English: Mean change at week 24  SD -0.6  6.4 p-value versus placebo
Danish: 24  SD p-værdi versus placebo
English: Renal and urinary disorders Common General disorders and administration site conditions Common
Danish: Almene symptomer og reaktioner på administrationsstedet
English: - Do not use this medicine if you see that the patch is damaged or shows signs of tampering.
Danish: - Brug ikke Rivastigmine 3M Health Care Ltd., hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den. - Når depotplasteret er taget af, folder du det sammen på midten med den klæbende side indad.
English: • Summary of Product Characteristics
Danish: • Produktresumé
English: Treatment
Danish: Administration
English: This summary was last updated in 04-2016.
Danish: Dette sammendrag blev sidst ajourført i 04-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bonviva den 23. februar 2004.
English: This is a summary of the European public assessment report (EPAR) for Bonviva.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bonviva.
English: The full EPAR for Bonviva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bonviva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.)
Danish: (i områder med hårdt vand, hvor postevandet indeholder en del opløst calcium, kan flaskevand med lavt mineralindhold anvendes).
English: Other information about Bonviva
Danish: Andre oplysninger om Bonviva
English: A risk management plan has been developed to ensure that Bonviva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Bonviva anvendes så sikkert som muligt.
English: What measures are being taken to ensure the safe and effective use of Bonviva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bonviva?
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour.
Danish: Tabletterne må ikke anvendes hos patienter, som har abnormiteter i spiserøret, eller som ikke kan sidde eller stå op i mindst en time.
English: Bonviva has been studied in three main studies involving women with osteoporosis.
Danish: Bonviva blev undersøgt i tre hovedundersøgelser, der omfattede kvinder med osteoporose.
English: The 2.5-mg once-daily tablets used in the studies are no longer authorised.
Danish: De daglige 2,5 mg-tabletter, der blev anvendt i undersøgelserne, er ikke længere tilladte.
English: If the tablet is used, the dose is one tablet every month, preferably on the same date each month.
Danish: Bruger man tabletterne er doseringen én tablet en gang om måneden, helst samme dato hver måned.
English: Bonviva can be given either as a tablet or as an injection into a vein.
Danish: Bonviva kan enten indgives som tabletter eller ved injektion i en vene.
English: The dose by injection is 3 mg once every three months.
Danish: Ved injektion gives én dosis på 3 mg hver tredje måned.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bonviva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Bonviva skal anvendes.
English: The CHMP decided that Bonviva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Bonviva opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: The studies looked at the change in the density of the bones in the spine and the hip over two years.
Danish: Der blev i undersøgelserne set nærmere på ændringen i knogletætheden i rygsøjlen og hoften over en periode på to år.
English: For more information about treatment with Bonviva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bonviva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Bonviva is a medicine that contains the active substance ibandronic acid.
Danish: Bonviva er et lægemiddel, der indeholder det aktive stof ibandronsyre.
English: Bonviva ibandronic acid
Danish: Bonviva ibandronsyre
English: It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
Danish: Det fås som tabletter (150 mg) og som injektionsvæske i en fyldt sprøjte (3 mg).
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Danish: Osteoporose opstår, når der ikke dannes tilstrækkelig knoglemasse til at erstatte den knoglemasse, som naturligt nedbrydes.
English: The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Danish: Det aktive stof i Bonviva, ibandronsyre, er et bisphosphonat.
English: Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
Danish: Patienter, der får Bonviva, bør desuden tage et tilskud af vitamin D og calcium, hvis dette ikke dækkes gennem deres kostplan.
English: Gradually, the bones become thin and fragile, and more likely to break.
Danish: Knoglerne bliver gradvis tynde og skøre, og sandsynligheden for brud øges.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bonviva, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Bonviva, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels).
Danish: Det må ikke gives til patienter med hypocalcæmi (lavt calciumindhold i blodet).
English: The most serious side effects with Bonviva are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut) irritation and eye inflammation.
Danish: De alvorligste bivirkninger ved Bonviva er en anafylaktisk reaktion (svær overfølsomhedsreaktion), atypiske frakturer i femur (lårbenet), osteonekrose (henfald af knoglevævet i kæben, som kan forårsage smerter, bylder i munden eller tandudfald), mave-tarm-irritation og øjenbetændelse.
English: In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Danish: Virksomheden, som markedsfører Bonviva, vil desuden udarbejde et patientkort med oplysninger om risikoen for osteonekrose i kæben og en instruks til patienter om at kontakte deres læge, hvis de oplever symptomer.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Danish: Osteoporose er mest almindeligt hos kvinder efter overgangsalderen, når mængden af det kvindelige kønshormon østrogen falder, eftersom østrogen er med til at holde knoglerne sunde.
English: The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Danish: De hyppigste bivirkninger ved Bonviva (som optræder hos mellem 1 og 10 patienter ud af 100) er arthralgi (ledsmerter) og influenzalignende symptomer.
English: What is the risk associated with Bonviva?
Danish: Hvilken risiko er der forbundet med Bonviva?
English: Blocking the action of these cells leads to less bone loss.
Danish: Blokering af disse celler nedsætter knogletabet.
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Danish: Det blokerer virkningen af osteoklasterne, som er de celler, der medvirker til at nedbryde knoglevævet.
English: The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets.
Danish: I de to øvrige undersøgelser blev de månedlige 150 mg-tabletter (1 609 patienter) og injektionerne (1 395 patienter) sammenlignet med de daglige 2,5 mg-tabletter.
English: Why has Bonviva been approved?
Danish: Hvorfor blev Bonviva godkendt?
English: The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip.
Danish: De to andre undersøgelser viste, at de månedlige 150 mg-tabletter og injektionerne var mere effektive end de daglige 2,5 mg-tabletter til at øge knogletætheden i rygsøjlen og hoften.
English: In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
Danish: I den første undersøgelse resulterede daglig behandling med Bonviva-tabletter, 2,5 mg, i 62 % lavere risiko for nye brud på rygsøjlen end placebo.
English: Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
Danish: Efter to år blev knogletætheden i rygsøjlen forbedret med 7 % med de månedlige tabletter og med 6 % med injektionerne i forhold til 5 % med de daglige tabletter.
English: The first study compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
Danish: I den første undersøgelse sammenlignedes 2,5 mg Bonviva-tabletter, der blev taget én gang dagligt, med placebo (en virkningsløs behandling) hos ca. 3 000 kvinder, og man så nærmere på, hvor mange nye brud på rygsøjlen, der optrådte hos patienterne i løbet af tre år.
English: Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Danish: Bonviva anvendes til behandling af osteoporose (en sygdom, der gør knoglerne skøre) hos kvinder, der har været gennem overgangsalderen, og som har forhøjet risiko for knoglebrud.
English: In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
Danish: Knogletætheden i hoften blev forbedret med 4 % med de månedlige tabletter og med 3 % med injektionerne i forhold til 2 % med de daglige tabletter.
English: The patient should not lie down for one hour after taking the tablet.
Danish: Efter at patienten har taget tabletten, må denne ikke ligge ned i en time.
English: What is Bonviva?
Danish: Hvad er Bonviva?
English: Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
Danish: Undersøgelser har vist, at det mindsker risikoen for brud på rygsøjlen, hvorimod det ikke er påvist, at det nedsætter risikoen for lårbensbrud.
English: For the full list of restrictions with Bonviva, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Bonviva fremgår af indlægssedlen.
English: What is Bonviva used for?
Danish: Hvad anvendes Bonviva til?
English: For the full list of all side effects reported with Bonviva, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Bonviva fremgår af indlægssedlen.
English: How has Bonviva been studied?
Danish: Hvordan blev Bonviva undersøgt?
English: What benefit has Bonviva shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Bonviva?
English: How is Bonviva used?
Danish: Hvordan anvendes Bonviva?
English: How does Bonviva work?
Danish: Hvordan virker Bonviva?
English: EMA would like to express its warmest gratitude to all those who have contributed to this public hearing.
Danish: EMA vil gerne udtrykke sin varme tak til alle, der har bidraget til denne offentlige høring.
English: Public hearing held on 13 June 2018
Danish: Afholdt den 13. juni 2018
English: As time permitted, the Chair invited additional comments from the floor.
Danish: Da tiden tillod det, opfordrede formanden til supplerende kommentarer fra salen.
English: Public hearings are conducted according to the rules of procedure for public hearings.
Danish: Offentlige høringer gennemføres i henhold til procedurereglerne for offentlige høringer.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Danish: Det sidste trin i gennemgangen er Europa-Kommissionens vedtagelse af en retligt bindende afgørelse med gyldighed i alle EU's medlemsstater.
English: • Patients were not given information about risks.
Danish: • Patienterne blev ikke oplyst om risiciene.
English: Patients should also have to give informed consent before treatment.
Danish: Patienterne burde desuden skulle give informeret samtykke før behandling.
English: Next steps
Danish: Næste trin
English: Nigel Stacey provided comments after the video recording had been stopped.
Danish: Nigel Stacey fremsatte kommentarer efter at videooptagelsen var ophørt.
English: In closing the discussions, Dr Raine praised the courageous testimonies from patients and other participants.
Danish: Som slutning på diskussionerne roste Dr. Raine de modige vidnesbyrd fra patienter og andre deltagere.
English: The hearing was broadcast live and a recording is available on EMA's website.
Danish: Høringen blev udsendt live, og en optagelse af den er tilgængelig på EMA's websted.
English: Many other members of the public who could not attend sent submissions in writing, which will all be taken into account during the review.
Danish: Mange andre medlemmer af offentligheden, som ikke selv kunne være til stede, indsendte skriftlige indlæg, der alle vil blive taget i betragtning under gennemgangen.
English: They also stressed the importance of microbial testing to make sure the medicines are only used when necessary.
Danish: De understregede desuden vigtigheden af mikrobiel testning for at sikre, at lægemidlerne kun anvendes, når det er nødvendigt.
English: European Medicines Agency
Danish: Det Europæiske Lægemiddelagentur
English: General public (patient representatives, carers, families) Speaker 1:
Danish: Offentligheden (patientrepræsentanter, omsorgsgivere, familier) Taler 1:
English: More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu
Danish: Flere oplysninger om arbejdet i Det Europæiske Lægemiddelagentur findes på agenturets websted: www.ema.europa.eu
English: He spoke of the need for improvements in package leaflets to take account of those who may not be able to understand the text.
Danish: Han talte om behovet for forbedringer i indlægssedlerne for at tage hensyn til dem, der måske har svært ved at forstå teksten.
English: The legal basis for public hearings is Article 107j of Directive 2001/83/EC of the pharmacovigilance legislation, which gives the PRAC the possibility to hold public hearings for safety reviews conducted by the Committee under Article 20 of Regulation (EC) No 726/2004, and Articles 31 or 107i of Directive 2001/83/EC.
Danish: Retsgrundlaget for offentlige høringer er artikel 107j i direktiv 2001/83/EF om lægemiddelovervågning, som giver PRAC mulighed for at afholde offentlige høringer med henblik på en sikkerhedsmæssig gennemgang, der foretages af udvalget i medfør af artikel 20 i forordning (EF) nr. 726/2004 og artikel 31 eller 107i i direktiv 2001/83/EF.
English: The recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion.
Danish: Henstillingerne vil derefter blive overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vil vedtage agenturets indstilling.
English: The PRAC will now reflect on all the views expressed at the hearing, including written submissions, and will take them into account as it considers its recommendations on the use of these antibiotics.
Danish: PRAC vil nu gennemgå alle synspunkter, der blev udtrykt under høringen, herunder skriftlige indlæg, og vil tage dem i betragtning i vurderingen af sine henstillinger om brugen af disse antibiotika.
English: List of Speakers
Danish: Liste over talere
English: Proposals
Danish: Forslag
English: Another issue raised was the reaction to foods, which patients said should be further investigated.
Danish: Endnu et spørgsmål, der blev bragt op, var reaktionen på fødevarer, som patienterne udtalte burde undersøges nærmere.
English: Questions addressed to participants
Danish: Spørgsmål, der blev stillet til deltagerne
English: There was minority support for an outright ban of these medicines, and some patients supported restricting use to hospitals.
Danish: Et mindretal gik ind for et direkte forbud mod disse lægemidler, og nogle patienter støttede begrænsning af anvendelsen til hospitaler.
English: • Encourage research on how the medicines cause side effects, including genetic research.
Danish: • Tilskynd til forskning i, hvordan lægemidlerne forårsager bivirkninger, herunder genetisk forskning.
English: In the absence of answers from healthcare professionals, patients have had to rely on information on the Internet to understand the symptoms they were experiencing.
Danish: I mangel af svar fra sundhedspersonerne har patienterne måttet forlade sig på oplysninger på internettet for at forstå de symptomer, de oplevede.
English: Given the seriousness of the side effects, Melanie Carr, Head of EMA's Stakeholders and Communication Division remarked in her welcome address that this public hearing was “particularly important because it allows us to consider your views on the risk associated with these medicines and consider options for regulatory action in a wider public health context”.
Danish: På baggrund af bivirkningernes alvorlighed bemærkede Melanie Carr, leder af EMA's afdeling for berørte parter og kommunikation, i sin velkomsttale, at denne offentlige høring var "særlig vigtig, fordi den giver os mulighed for at tage jeres synspunkter om risikoen ved disse lægemidler i betragtning og overveje muligheder for regulerende indgreb i en bredere sundhedssammenhæng".