FrancophonIA/ELRC3.0 huggingface dataset:
English: - Joint pain, muscle pain, pain in arms and legs, sudden muscle contraction, pain in muscles and bones, stiffness of muscles and bones, joint stiffness, groin pain, feeling of heaviness, swelling in lower limbs
Danish: - Ledsmerter, muskelsmerter, smerter i arme og ben, muskeltrækninger, smerter i muskler og knogler, stivhed af muskler og knogler, ledstivhed, lyskesmerter, tyngdefornemmelse, hævede underben
English: Uncommon Hypoaesthesia oral Lip discolouration Tongue discoloration
Danish: Gingival misfarvning Oral hypæstesi Misfarvning af læber Misfarvning af tunge
English: - Hold the catheter at its base using a sterile technique, pinch and hold the skinfold cranial to, or overlying the patient's supra-iliac crest with two fingers.
Danish: - Tag fat i kateteret med steril teknink, klem hudfolden sammen, og hold hudfolden mellem to fingre kranialt for eller over crista iliaca superior.
English: - Chills, fever, flu, flu-like illness, blocked nose, blocked sinuses, inflamed nose and throat, nose inflammation
Danish: - Kulderystelser, feber, influenza, influenzalignende sygdom, tilstoppet næse, tilstoppede bihuler, næse- og halsinflammation, inflammation af næsen
English: Pain in extremity Muscle spasm Musculoskeletal pain Musculoskeletal stiffness Joint stiffness Groin pain
Danish: Ekstremitetssmerter Muskelspasmer Muskuloskeletale smerter Muskuloskeletal stivhed Ledstivhed
English: Menorrhagia Dysmenorrhoea Breast tenderness Menstruation irregular Vaginal discharge Libido decreased
Danish: Ømhed af bryster Uregelmæssig menstruation Vaginalt udflåd Øget libido
English: Fatigue Implant site discolouration Feeling hot
Danish: Misfarvning på implantationsstedet Varmefornemmelse
English: In most clinical studies afamelanotide plasma levels were below the limit of quantitation by day 10.
Danish: I de fleste kliniske undersøgelser var plasmaniveauet af afamelanotid under kvantificeringsgrænsen på dag 10. Implantatet absorberes af kroppen inden for 50 til 60 dage efter administration.
English: How to use SCENESSE
Danish: Sådan gives SCENESSE
English: Wound complication Open wound Fall
Danish: Sårkomplikationer Åbent sår
English: Abdominal distension Gingival pain
Danish: Abdominal distension Gingivale smerter Abdominalt ubehag Tandpine
English: - Inflamed lips, lip swelling, colouration on lip, gum pain, toothache, discoloured gums, reduced sense of touch in mouth, lip discolouration, tongue discolouration
Danish: - Inflammerede læber, hævede læber, farvede læber, ømme gummer, tandpine, misfarvede gummer, nedsat berøringssans i munden, misfarvede læber, misfarvet tunge
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The implant is inserted directly under the skin folds on your waist or abdomen in an area known as the supra-iliac crest.
Danish: Implantatet bliver indsat direkte under hudfolderne i maveskindet eller over hoftebenskammen.
English: - Increased hunger, nausea following implant insertion, indigestion, infection in stomach and intestines, inflamed stomach and intestines, heartburn, inflamed stomach, irregular bowel movements, wind, bloated tummy, tummy pain
Danish: - Øget sultfornemmelse, kvalme efter implantationen, fordøjelsesbesvær, mave-tarm-infektion, mave-tarminflammation, halsbrand, mavekatar, uregelmæssig afføring, tarmluft, oppustet mave, mavepine
English: Sensation of heaviness
Danish: Lyskesmerter Tyngdefornemmelse
English: • Periodic safety update reports (PSURs)
Danish: • Risikostyringsplan (RMP)
English: If you suffer from continued drowsiness, then you should speak to your doctor.
Danish: Hvis du er konstant døsig, skal du kontakte lægen.
English: synonyms: familial atypical mole-malignant melanoma syndrome, FAMMM; dysplastic naevus syndrome, DNS; B-K mole syndrome; CMM2 MIM #155601) and/or an - individual history of basal cell carcinoma, squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or premalignant skin lesions.
Danish: Særlig opmærksomhed kræves ved - patientanamnese eller familiær anamnese med melanom (herunder in situ-melanom, f.eks. lentigo maligna) eller formodet eller bekræftet tilbøjelighed til kutant melanom (CMM1, MIM #155600, synonymer: familiært atypisk mola-malignt melanomsyndrom (FAMMM), dysplastisk nævussyndrom (DNS), B-K mola syndrom; CMM2 MIM #155601)
English: - decreased appetite; - fatigue (tiredness), - dizziness, drowsiness and weakness; - hot flushes; - upper respiratory tract infections (colds).
Danish: - rygsmerter, - mavesmerter, - diarré og opkastning, - nedsat appetit, - træthed, - svimmelhed, døsighed og svaghed, - hedeture, - forkølelse (øvre luftvejsinfektioner).
English: Please inform your doctor about new or changing skin abnormalities.
Danish: Fortæl det til lægen, hvis der er nye hudforandringer eller ændringer i de forandringer, du allerede har.
English: What SCENESSE looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant
Danish: LÆGEMIDLETS NAVN SCENESSE, implantat, 16 mg
English: SCENESSE 16 mg implant afamelanotide
Danish: SCENESSE, implantat, 16 mg afamelanotid
English: - General changes to the skin including freckles and skin darkening; - migraine (a severe headache); - back pain; - abdominal (tummy) pain, - diarrhoea and vomiting,
Danish: - forandringer af hele huden med fregner og mørkfarvning, - svær hovedpine (migræne),
English: NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant afamelanotide
Danish: LÆGEMIDLETS NAVN SCENESSE, implantat, 16 mg afamelanotid
English: Gastroesophageal reflux disease
Danish: Hævede læber Gastroøsofagealt reflukssygdom Gastritis
English: For patients with renal or hepatic impairment see sections 4.3 and 5.2.
Danish: Vedrørende patienter med nedsat nyre- eller leverfunktion: se pkt.
English: Melanocytic naevus Pigmentation disorder Skin discolouration Skin hyperpigmentation Ephelides
Danish: Pigmentforstyrrelse Misfarvning af huden Hyperpigmentering af huden
English: Migraine Dizziness Lethargy Somnolence
Danish: Migræne Svimmelhed Letargi Somnolens
English: Lichen planus Rash vesicular Pruritus generalised Rash
Danish: Generaliseret pruritus Udslæt
English: Presbyopia
Danish: Hudbiopsi
English: - Remove the needle from within the catheter using a sterile technique.
Danish: - Tag kanylen sterilt ud af kateteret.
English: AUTHORISATION
Danish: Læbeødem
English: Uncommon unspecified (incl cysts and polyps) Blood and lymphatic system disorders
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Nausea
Danish: Hæmangiom
English: Rash erythematous Rash papular Rash pruritic Skin irritation Vitiligo
Danish: Erytematøst udslæt Papulært udslæt Pruritisk udslæt Hudirritation Vitiligo
English: Oedema peripheral Oedema mucosal Pain
Danish: Lichen planus Vesikulært udslæt
English: Nasopharyngitis
Danish: Dysmenorré
English: Very common (may affect more than 1 in 10 people): - Nausea (feeling sick), - headache; - reactions at the implant site including pain, redness, itching, bruising and changes to colour of overlying skin.
Danish: - kvalme, - hovedpine, - reaktioner på implantationsstedet med smerter, rødme, kløe, blå mærker og farveændring af den overliggende hud.
English: Implant site hypertrophy Implant site pruritus Device expulsion Application site discolouration Hangover
Danish: Kulderystelser Hæmatom på indstiksstedet Irritation på indstiksstedet Hypertrofi på implantationsstedet Pruritus på implantationsstedet Udstødning af anordningen Misfarvning på implantationsstedet Tømmermænd Influenzalignende sygdom
English: The European Commission granted a marketing authorisation valid throughout the European Union for BindRen on 21 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BindRen den 21. januar 2013.
English: The full EPAR for BindRen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for BindRen findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for BindRen.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for BindRen.
English: In clinical trials, around 3 in 10 patients experienced at least one side effect.
Danish: I de kliniske undersøgelser oplevede tre ud af ti patienter mindst én bivirkning.
English: The effects of BindRen were first tested in experimental models before being studied in humans.
Danish: Virkningerne af BindRen blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: All patients were on dialysis and received BindRen for three months.
Danish: Alle patienter var i dialyse og fik BindRen i tre måneder.
English: This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease.
Danish: Dette fører til hyperfosfatæmi, hvilket på lang sigt kan medføre komplikationer såsom hjerte- og knoglesygdom.
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 BindRen.
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 anvendelsesbetingelserne for BindRen.
English: It is available as tablets (1 g) and as granules (sachets containing 2 or 3 g).
Danish: Det fås som tabletter (1 g) og som granulat (breve indeholdende 2 eller 3 g).
English: There were no major safety concerns and the overall safety profile was similar to that of other phosphate binders, as the side effects affected mainly the gut and resolved by themselves.
Danish: Der var ingen væsentlige sikkerhedsproblemer, og den overordnede sikkerhedsprofil var den samme som for andre fosfatbindere, da bivirkningerne hovedsageligt vedrørte tarmen og forsvandt af sig selv.
English: For more information about treatment with BindRen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med BindRen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in BindRen, colestilan, is a phosphate binder.
Danish: Det aktive stof i BindRen, colestilan, er en fosfatbinder.
English: The recommended starting dose of BindRen is 6 to 9 g per day, taken in three equally divided doses together with or immediately after meals.
Danish: Den anbefalede startdosis af BindRen er 6 til 9 g pr. dag, som tages i tre lige store doser sammen med et måltid eller lige derefter.
English: The CHMP decided that BindRen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved BindRen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: When taken with meals, colestilan attaches to phosphate from food within the gut, preventing it from being absorbed into the body.
Danish: Når det tages i forbindelse med måltider, binder det sig til fosfatet i maden inde i tarmen og forhindrer, at det bliver absorberet i kroppen.
English: BindRen is a medicine that contains the active substance colestilan.
Danish: BindRen er et lægemiddel, der indeholder det aktive stof colestilan.
English: This helps to reduce the phosphate levels in the blood.
Danish: Dette medvirker til at nedsætte mængden af fosfat i blodet.
English: Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Danish: Patienter med svær nyresygdom kan ikke komme af med fosfaten i kroppen.
English: The third study also showed that BindRen was more effective than placebo when used at doses of 6, 9, 12 and 15 g/day: compared with placebo, the reduction in blood phosphate levels seen with BindRen was 0.16, 0.21, 0.19 and 0.37 mmol/l respectively.
Danish: Den tredje undersøgelse viste desuden, at BindRen var mere effektivt end placebo, når der blev anvendt doser på 6, 9, 12 og 15 g/dag: Sammenlignet med placebo var faldet i blodets fosfatindhold på henholdsvis 0,16, 0,21, 0,19 og 0,37 mmol/l med BindRen.
English: BindRen must not be used in people who are hypersensitive (allergic) to colestilan or any of the other ingredients.
Danish: BindRen må ikke anvendes til personer, som er overfølsomme (allergiske) over for colestilan eller andre af indholdsstofferne.
English: Patients should keep to their prescribed low phosphate diets.
Danish: Patienterne bør overholde den ordinerede fosfatfattige diæt.
English: What is the risk associated with BindRen?
Danish: Hvilken risiko er der forbundet med BindRen?
English: All studies looked at the change in the average amount of phosphate in the blood after three months.
Danish: Alle undersøgelserne så på ændringen af gennemsnitsindholdet af fosfat i blodet efter tre måneder.
English: Other information about BindRen
Danish: Andre oplysninger om BindRen:
English: A third main study involving 642 patients compared the effects of giving BindRen at various doses with placebo (a dummy treatment) for three months.
Danish: I en tredje undersøgelse med 642 patienter blev forskellige doser af BindRen sammenlignet med placebo (en uvirksom behandling) i tre måneder.
English: BindRen was investigated in two main studies involving 273 adults with long-term kidney disease and hyperphosphataemia.
Danish: BindRen blev undersøgt i to hovedundersøgelser, der omfattede 273 voksne med langvarig nyresygdom og hyperfosfatæmi.
English: The CHMP noted that treatment with BindRen has a beneficial effect in lowering phosphate levels.
Danish: CHMP bemærkede, at behandling med BindRen har en gavnlig virkning med hensyn til at sænke fosfatindholdet i blodet.
English: It is used in patients on haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Danish: Det anvendes til patienter, som er i hæmodialyse (hvor der anvendes et blodfiltreringsapparat) eller peritoneal dialyse (hvor der pumpes væske ind i bughulen, og en intern membran i kroppen filtrerer blodet).
English: The dose of BindRen should be adjusted every two to three weeks to a maximum of 15 g per day to reach an acceptable level of phosphate in the blood, which should then be monitored regularly.
Danish: Dosen af BindRen bør justeres hver anden til tredje uge til højst 15 g dagligt for at opnå et tilstrækkeligt indhold af fosfat i blodet.
English: Why has BindRen been approved?
Danish: Hvorfor blev BindRen godkendt?
English: For the full list of all side effects reported with BindRen, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved BindRen fremgår af indlægssedlen.
English: The most frequently reported side effects were nausea (feeling sick), dyspepsia (heartburn) and vomiting.
Danish: De hyppigst indberettede bivirkninger var kvalme, dyspepsi (halsbrand) og opkast.
English: The first two studies showed that BindRen was effective at controlling blood phosphate levels in patients with long-term kidney disease who were on dialysis.
Danish: De første to undersøgelser viste, at BindRen er effektivt til at kontrollere fosfatindholdet i blodet hos patienter med langvarig nyresygdom, og som er i dialyse.
English: What is BindRen?
Danish: Hvad er BindRen?
English: The most serious reported side effects with BindRen were gastrointestinal haemorrhage (bleeding in the stomach and gut) and constipation.
Danish: De mest alvorlige bivirkninger ved BindRen var gastrointestinale blødninger (blødninger i mave eller tarm) og forstoppelse.
English: BindRen is used to control hyperphosphataemia (high blood phosphate levels) in adults with long-term kidney disease who are on dialysis (a blood clearance technique).
Danish: BindRen anvendes til kontrol af hyperfosfatæmi (højt fosfatindhold i blodet) hos voksne med langvarig nyresygdom, som er i dialyse (en blodrensningsteknik).
English: In the first study, an average dose of 11.5 g of BindRen reduced the blood phosphate level by 0.36 mmol/l on average after three months.
Danish: I den første undersøgelse bevirkede en gennemsnitsdosis på 11,5 g BindRen et gennemsnitligt fald i fosfatindholdet i blodet på 0,36 mmol/l efter tre måneder.
English: What benefit has BindRen shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved BindRen?
English: How has BindRen been studied?
Danish: Hvordan blev BindRen undersøgt?
English: Similarly in the second study, an average dose of 13.1 g of BindRen resulted in a reduction of the blood phosphate level by 0.50 mmol/l on average after three months.
Danish: Ligeledes bevirkede en gennemsnitsdosis på 13,1 g BindRen i den anden undersøgelse et gennemsnitligt fald i blodets fosfatindhold på 0,50 mmol/l efter tre måneder.
English: What is BindRen used for?
Danish: Hvad anvendes BindRen til?
English: It must not be used in people with bowel obstruction (a blockage in the gut).
Danish: Det må ikke anvendes til patienter med tarmobstruktion (en blokering af tarmen).
English: How is BindRen used?
Danish: Hvordan anvendes BindRen?
English: How does BindRen work?
Danish: Hvordan virker BindRen?
English: The recommended dose is one tablet a day.
Danish: Den anbefalede dosis er én tablet én gang dagligt.
English: Side effects were similar to those of medicines of the same class.
Danish: Bivirkningerne var de samme som ved lægemidler af samme klasse.
English: Further information on Biktarvy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Biktarvy findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Biktarvy
Danish: Andre oplysninger om Biktarvy
English: Biktarvy contains three active substances which work in different ways against HIV:
Danish: Biktarvy indeholder tre aktive stoffer, der virker mod hiv på forskellige måder:
English: What measures are being taken to ensure the safe and effective use of Biktarvy?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Biktarvy?
English: As for all medicines, data on the use of Biktarvy are continuously monitored.
Danish: Som for alle lægemidler bliver oplysningerne vedrørende brugen af Biktarvy løbende overvåget.
English: It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Danish: Det blokerer enzymet integrase, som hiv-virus behøver for at danne nye kopier af sig selv i kroppen.
English: The European Medicines Agency therefore decided that Biktarvy's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Biktarvy opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For more information about using Biktarvy, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Biktarvy, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Biktarvy are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Biktarvy vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It is only used in patients where the virus has not developed resistance to a class of HIV medicines called integrase inhibitors, or to tenofovir or emtricitabine.
Danish: Det anvendes kun hos patienter, hvor virusset ikke har udviklet resistens over for en klasse af hiv-lægemidler, der hedder integrasehæmmere, eller over for tenofovir eller emtricitabin.
English: The benefits of Biktarvy in the treatment of HIV infection were investigated in four main studies.
Danish: Fordelene ved brug af Biktarvy til behandling af hiv-infektion er undersøgt i fire hovedstudier.
English: Biktarvy was shown to be as effective as comparator antiviral medicines.
Danish: Det er påvist, at Biktarvy er lige så effektivt som sammenlignelige antivirale lægemidler.
English: The most common side effects with Biktarvy (which may affect around 1 in 20 people) are headache, diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Biktarvy (som kan forekomme hos ca. 1 ud af 20 personer) er hovedpine, diarré og kvalme.
English: Biktarvy does not cure HIV-1 infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Biktarvy helbreder ikke hiv-1-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: An overview of Biktarvy and why it is authorised in the EU
Danish: En oversigt over Biktarvy, og hvorfor det er godkendt i EU
English: What is Biktarvy and what is it used for?
Danish: Hvad er Biktarvy, og hvad anvendes det til?
English: In the first study, Biktarvy was compared with another antiviral medicine containing abacavir, dolutegravir and lamivudine in 629 patients.
Danish: I det første studie blev Biktarvy sammenlignet med et andet antiviralt lægemiddel, der indeholder abacavir, dolutegravir og lamivudin hos 629 patienter.
English: Why is Biktarvy authorised in the EU?
Danish: Hvorfor blev Biktarvy godkendt i EU?
English: Biktarvy can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Biktarvy udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hiv-infektion.
English: Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide)
Danish: Biktarvy (bictegravir/emtricitabin/tenofoviralafenamid)
English: Biktarvy is an antiviral medicine used to treat adults infected with human immunodeficiency virus 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Biktarvy er et antiviralt lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI), which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
Danish: Tenofovir er en nukleotid revers transkriptase-hæmmer (NRTI), hvilket betyder, at det blokerer aktiviteten af revers transkriptase, der er et andet enzym, som virusset producerer for at formere sig.
English: • Emtricitabine is another type of NRTI (a nucleoside reverse transcriptase inhibitor) and it works in the same way as tenofovir.
Danish: • Emtricitabin er en anden type NRTI (nukleosid revers transkriptase-hæmmer), der virker på samme måde som tenofovir.
English: What are the risks associated with Biktarvy?
Danish: Hvilke risici er der forbundet med Biktarvy?
English: Biktarvy is available as tablets, each containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
Danish: Biktarvy fås som tabletter indeholdende 50 mg bictegravir, 200 mg emtricitabin og 25 mg tenofoviralafenamid.
English: Two other studies involved previously treated patients in whom the viral load was already lower than 50 copies per ml, and looked at whether it increased above this level 48 weeks after patients were switched from their previous HIV treatment to Biktarvy.
Danish: To andre studier omfattede tidligere behandlede patienter, hos hvem virusbelastningen allerede var lavere end 50 kopier pr. ml, og de så nærmere på, om dette tal steg 48 uger efter, at patienterne skiftede fra deres tidligere hiv-lægemiddel til Biktarvy.