FrancophonIA/ELRC3.0 huggingface dataset:
English: For Grade 4 diarrhoea or colitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 4 diarré eller colitis skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is completeb
Danish: Dosis/doser udsættes, indtil symptomerne forsvinder, og behandling med kortikosteroider er afsluttetb
English: Two patients in the 10
Danish: Alle behandlede patienter
English: Ipilimumab can cause inflammation of the endocrine system organs, manifesting as hypophysitis, hypopituitarism, adrenal insufficiency, and hypothyroidism (see section 4.8), and patients may present with nonspecific symptoms, which may resemble other causes such as brain metastasis or underlying disease.
Danish: Ipilimumab kan forårsage inflammation i de endokrine organer, som manifesterer sig som hypophysitis, hypopituitarisme, binyrebarkinsufficiens og hypotyroidisme (se pkt.
English: Uncommon hyponatremia, alkalosis, hypophosphatemia, tumour lysis syndrome, hypocalcaemiad Psychiatric disorders
Danish: Almindelig dehydrering, hypokaliæmi Ikke almindelig hyponatriæmi, alkalose, hypophosphatæmi, tumorlysesyndrom, hypocalcæmid
English: Musculoskeletal and connective tissue disorders Common arthralgia, myalgia, musculoskeletal painf, muscle spasms Uncommon polymyalgia rheumatica, myositisd, arthritis, muscular weaknessd Rare polymyositisd Renal and urinary disorders Uncommon renal failureb, glomerulonephritisc, autoimmune nephritisd, renal tubular acidosis, haematuriad
Danish: Sjælden polymyositisd Nyrer og urinveje Ikke almindelig nyresvigtb, glomerulonephritisc, autoimmun nefritisd, renal tubulær acidose, hæmaturid
English: Baseline characteristics were well balanced across groups.
Danish: Ved behandlingsstart var karakteristika velbalancerede på tværs af grupperne.
English: In the Phase 3 study MDX010-20, (see section 5.1), patients received a median of 4 doses (range 1-4).
Danish: I fase 3‑studiet MDX010-20, (se pkt.
English: Ipilimumab as monotherapy (see section 4.2)
Danish: Ipilimumab som monoterapi (se pkt.
English: What YERVOY contains The active substance is ipilimumab.
Danish: Aktivt stof: Ipilimumab.
English: Uncommon paraneoplastic syndrome Blood and lymphatic system disorders Common anaemia, lymphopenia
Danish: Ikke almindelig paraneoplastisk syndrom Blod og lymfesystem Almindelig anæmi, lymfopeni Ikke almindelig hæmolytisk anæmib, trombocytopeni, eosinofili, neutropeni
English: Grade 3 diarrhoea or colitis observed with ipilimumab in combination with nivolumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 diarré eller colitis, som observeres med ipilimumab i kombination med nivolumab, skal behandlingen seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
English: Solid organ transplant rejection
Danish: Ikke almindelig sarkoidose Ikke kendt afstødning af transplanterede solide organerh
English: Each vial contains 200 mg ipilimumab.
Danish: 1 hætteglas indeholder 200 mg ipilimumab.
English: For Grade 4 serum creatinine elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 4 stigning i serumkreatinin skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider bør initieres med en dosis ækvivalent med methylprednisolon 12 mg/kg/dag.
English: Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely.
Danish: 4.8), bør patienter, som har brug for samtidig behandling med antikoagulantia, monitoreres tæt.
English: Uncommon pleural effusion Gastrointestinal disorders Very common colitisa, diarrhoea, vomiting, nausea,
Danish: Ikke almindelig pleuraeffusion Mave-tarm-kanalen Meget almindelig colitisa, diarré, opkastning, kvalme, abdominalsmerter diarre, opkastning, kvalme
English: if you have any history of inflammation of the lungs
Danish: du tidligere har haft en betændelseslignende reaktion (inflammation) i lungerne.
English: For Grade 3 or 4 transaminase or total bilirubin elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 eller 4 forhøjelse af aminotransferase eller total-bilirubin seponeres ipilimumab i kombination med nivolumab permanent, og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
English: Ipilimumab must be permanently discontinued in patients with a very severe (Grade 4) rash or severe (Grade 3) pruritus (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Danish: Ipilimumab skal seponeres permanent hos patienter med meget svær (Grad 4) udslæt eller svær (Grad 3) pruritus (se pkt.
English: Concurrent administration with vemurafenib
Danish: Samtidig administration af vemurafenib
English: Severe rash has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Danish: Der er observeret alvorligt udslæt med ipilimumab i kombination med nivolumab (se pkt.
English: For patients with Grade 3 or 4 transaminase or total bilirubin elevation, treatment must be permanently discontinued (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg daily or equivalent) should be initiated immediately.
Danish: 4.2), og intravenøs behandling med systemisk højdosis kortikosteroid (f.eks. methylprednisolon 2 mg/kg dagligt eller tilsvarende) bør straks initieres.
English: Common (may affect up to 1 in 10 people) serious lung infection (pneumonia), infections of the upper respiratory tract, inflammation of the eye (conjunctivitis) increase of eosinophils (type of white blood cells) allergic reaction, reactions related to the infusion of the medicine decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes dehydration inflammation of the liver inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), dizziness inflammation of the eye which causes redness or pain, blurred vision rapid heart beat high blood pressure (hypertension) inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), blood clots, fluid around the lungs, cough mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy, bumpy rash)
Danish: øget antal eosinofiler (en bestemt type af hvide blodlegemer) allergisk reaktion, reaktioner i forbindelse med infusion af medicinen nedsat udskillelse af de hormoner, der dannes i binyrerne (kirtler placeret over nyrerne), nedsat funktion (hypopituitarisme) af hypofysen eller betændelseslignende reaktion (hypofysitis) i hypofysen (sidder nederst i hjernen), hævelse af skjoldbruskkirtlen, sukkersyge (diabetes) dehydrering betændelseslignende reaktion i leveren betændelseslignende reaktion i nerverne (som medfører følelsesløshed, svaghed, snurrende fornemmelse eller brændende smerter i arme og ben), svimmelhed øjenbetændelse (med rødme og smerter), sløret syn hurtig hjerterytme (puls) forhøjet blodtryk (hypertension) betændelseslignende reaktion i lungerne (pneumonitis, med hoste og vejrtrækningsbesvær), blodpropper, væske omkring lungerne, hoste mundsår og forkølelsessår (stomatitis), betændelseslignende reaktion i bugspytkirtlen (pancreatitis), forstoppelse, mundtørhed pletvise farveændringer af huden (vitiligo), tør hud, hudrødme, unormalt hårtab eller udtynding af håret, nældefeber (kløende, hævet udslæt) en betændelseslignende reaktion (inflammation) i led (artritis), muskelkramper, muskelsvaghed nyresvigt (inklusive pludseligt tab af nyrefunktion) væskeansamlinger (hævelse), smerter, brystsmerter, kulderystelser
English: These include:
Danish: YERVOY indeholder:
English: When to withhold dose of YERVOY as monotherapy Withhold YERVOY dosea in patients with the following immune-related adverse reactions.
Danish: YERVOY-dosisa udsættes hos patienter med følgende bivirkninger.
English: Patients in the combination arm received nivolumab 1 mg/kg over 60 minutes and ipilimumab 3 mg/kg over
Danish: Patienterne i kombinationsarmen fik nivolumab 1 mg/kg i.v.
English: For additional information on warnings and precautions associated with nivolumab treatment, please refer to the nivolumab SmPC.
Danish: Se produktresuméet for nivolumab for at få yderligere oplysninger om advarsler og forsigtighedsregler forbundet med behandling med nivolumab.
English: Immune-related skin adverse reactions
Danish: Immunrelaterede hudbivirkninger
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea
Danish: Sjælden temporal arteritisd Luftveje, thorax og mediastinum
English: Further data on the long-term safety of the medicine will be collected post-marketing.
Danish: Yderligere data om lægemidlets sikkerhed på lang sigt vil blive indsamlet efter markedsføringen.
English: If no side effects are experienced during the initial treatment, the injections can be repeated after at least 3 months.
Danish: Hvis der ikke opstår bivirkninger i løbet af det første behandlingsforløb, kan indsprøjtningerne gentages, når der er gået minimum tre måneder.
English: Other information about Nuceiva
Danish: Andre oplysninger om Nuceiva
English: Further information on Nuceiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nuceiva.
Danish: Yderligere information om Nuceiva findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/nuceiva.
English: As for all medicines, data on the use of Nuceiva are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Nuceiva løbende overvåget.
English: The medicine is injected in 5 different places above and between the eyebrows.
Danish: Lægemidlet indsprøjtes på fem forskellige steder over og mellem øjenbrynene.
English: Thirty days after treatment, 87% (205 out of 235) of adults who received Nuceiva had either mild or no vertical lines between the eyebrows, compared with 83% (202 out of 244) of patients who received another medicine containing botulinum toxin type A and 4% (2 out of 48) of patients who were given placebo.
Danish: 30 dage efter behandlingen havde 87 % (205 ud af 235) af de voksne, der fik Nuceiva, enten lette eller ingen lodrette rynker mellem øjenbrynene sammenlignet med 83 % (202 ud af 244) af de patienter, der fik et andet lægemiddel indeholdende botulinumtoksin type A, og 4 % (2 ud af 48) af de patienter, der fik placebo.
English: The European Medicines Agency decided that Nuceiva's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Nuceiva opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Nuceiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nuceiva?
English: Serious side effects include drooping eyelids, immune responses (when the body's defence system produces antibodies against the botulinum toxin which stop the medicine from working), spread of the toxin to other parts of the body (which may lead to muscle weakness, difficulty breathing or swallowing, and constipation), development or worsening of disorders affecting the muscles and nerves, and hypersensitivity (allergic) reactions.
Danish: Alvorlige bivirkninger omfatter hængende øjenlåg, immunreaktioner (når kroppens forsvarssystem danner antistoffer mod botulinumtoksin, som forhindrer lægemidlet i at virke), spredning af toksinet til andre dele af kroppen (hvilket kan medføre muskelsvaghed, vejrtræknings- eller synkebesvær og forstoppelse), udvikling eller forværring af lidelser, der påvirker musklerne og nerverne, og overfølsomhedsreaktioner (allergiske reaktioner).
English: Side effects reported with Nuceiva are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Nuceiva vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The side effects seen with Nuceiva are as expected from this type of medicine and do not raise any major concerns.
Danish: Bivirkningerne ved Nuceiva er som forventet af denne type lægemiddel og giver ikke anledning til større betænkeligheder.
English: An overview of Nuceiva and why it is authorised in the EU
Danish: En oversigt over Nuceiva, og hvorfor det er godkendt i EU
English: The toxin reduces the release of acetylcholine, a chemical messenger that causes muscle contraction.
Danish: Toksinet reducerer frigivelsen af acetylkolin, som er et kemisk signalstof, der medfører muskelsammentrækning.
English: The most common side effects with Nuceiva (which may affect up to 1 in 10 people) include headache and drooping eyelids.
Danish: De hyppigste bivirkninger ved Nuceiva (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine og hængende øjenlåg.
English: What is Nuceiva and what is it used for?
Danish: Hvad er Nuceiva, og hvad anvendes det til?
English: Nuceiva (botulinum toxin type A) EMA/249428/2019
Danish: Nuceiva (botulinumtoksin type A)EMA/249428/2019
English: The medicine can only be obtained with a prescription and must be given by a doctor with expertise in the treatment of vertical lines between the eyebrows and the use of the required equipment.
Danish: Lægemidlet fås kun på recept og skal gives af en læge med ekspertise i behandling lodrette rynker mellem øjenbrynene og anvendelse af det relevante udstyr.
English: For more information about using Nuceiva, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Nuceiva, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Why is Nuceiva authorised in the EU?
Danish: Hvorfor er Nuceiva godkendt i EU?
English: Nuceiva must not be used in people with diseases affecting the muscles, such as myasthenia gravis or Eaton-Lambert syndrome, and those who have an infection or inflammation at the planned site of injection.
Danish: Nuceiva må ikke anvendes til personer med sygdomme, der påvirker musklerne, såsom myasthenia gravis eller Eaton Lambert-syndrom, og personer, der har en infektion eller betændelse på det planlagte injektionssted.
English: What are the risks associated with Nuceiva?
Danish: Hvilke risici er der forbundet med Nuceiva?
English: Nuceiva has been shown to make the vertical lines between the eyebrows less noticeable in a main study involving 540 adults with moderate or severe vertical lines that affected their mood or caused symptoms of anxiety or depression.
Danish: Nuceiva er påvist at gøre de lodrette rynker mellem øjenbrynene mindre synlige i et hovedstudie, som omfattede 540 voksne med moderate til svære lodrette rynker, som påvirkede deres humør eller medførte symptomer på angst eller depression.
English: It is used in adults less than 65 years of age who have moderate to severe facial lines and in whom those lines are having a significant psychological impact.
Danish: Det anvendes hos voksne personer på under 65 år med moderate til svære ansigtsrynker, og som er stærkt psykisk påvirket af disse rynker.
English: The effectiveness of treatment was measured using a standard 4-point scale, called glabellar line scale (GLS), where 0 = no lines, 1 = mild, 2 =moderate and 3 = severe.
Danish: punktsskala, kaldet glabellalinjeskalaen (GLS), hvor 0 = ingen rynker, 1 = let, 2 = moderat og 3 = svær.
English: The active substance in Nuceiva, botulinum toxin type A, is produced by the bacterium Clostridium botulinum.
Danish: Det aktive stof i Nuceiva, botulinumtoksin type A, produceres af bakterien Clostridium botulinum.
English: Nuceiva is at least as effective as another medicine containing botulinum toxin type A and more effective than placebo in adults with moderate to severe vertical lines between the eyebrows.
Danish: Nuceiva er mindst lige så effektivt som et andet lægemiddel indeholdende botulinumtoksin type A og mere effektivt end placebo hos voksne med moderate til svære lodrette rynker mellem øjenbrynene.
English: Nuceiva is a medicine used to temporarily improve the appearance of vertical frown lines between the eyebrows.
Danish: Nuceiva er et lægemiddel, som anvendes til midlertidigt at forbedre udseendet af lodrette rynker mellem øjenbrynene.
English: When Nuceiva is injected directly into the muscles above and between the eyebrows, it causes the muscles to relax, helping to make the vertical lines less noticeable.
Danish: Når Nuceiva indsprøjtes direkte i musklerne over og mellem øjenbryderne, får det musklerne til at slappe af, hvilket gør de lodrette rynker mindre synlige.
English: Nuceiva (botulinum toxin type A)
Danish: Nuceiva (botulinumtoksin type A)
English: For the full list of side effects of Nuceiva, see the package leaflet.
Danish: Den fuldstændige liste over bivirkningerne ved Nuceiva fremgår af indlægssedlen.
English: In the study, Nuceiva was compared with another medicine containing botulinum toxin type A and placebo (a dummy treatment).
Danish: Nuceiva blev i studiet sammenlignet med et andet lægemiddel indeholdende botulinumtoksin type A og placebo (en uvirksom behandling).
English: How is Nuceiva used?
Danish: Hvordan anvendes Nuceiva?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuceiva have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nuceiva.
English: What benefits of Nuceiva have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nuceiva?
English: Nuceiva contains the active substance botulinum toxin type A.
Danish: Nuceiva indeholder det aktive stof botulinumtoksin type A.
English: How does Nuceiva work?
Danish: Hvordan virker Nuceiva?
English: Nuceiva is given by injection into the muscles in the forehead whose contractions cause the vertical lines between the eyebrows.
Danish: Nuceiva indsprøjtes i de pandemuskler, der, når de trækker sig sammen, danner de lodrette rynker mellem øjenbrynene.
English: Invented name Strength Pharmaceutical form Route of administration Immediate Packaging
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: This summary was last updated in 09/2013.
Danish: Dette sammendrag blev sidst ajourført i 09-2013.
English: EMA/CHMP/472738/2013 EMEA/H/C/002679
Danish: EMA/472738/2013 EMEA/H/C/002679
English: The full EPAR for Ultibro Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ultibro Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ultibro Breezhaler on 19 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ultibro Breezhaler den 19. september 2013.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend the use for reducing exacerbations.
Danish: CHMP fandt imidlertid, at dets virkning i form af nedsættelse af andelen af tilbagefald var for lille til, at det bør anbefales til reduktion af tilbagefald.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ultibro Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Ultibro Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This is a summary of the European public assessment report (EPAR) for Ultibro Breezhaler.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ultibro Breezhaler.
English: Ultibro Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Danish: Ultibro Breezhaler var genstand for to hovedundersøgelser, hvori der i alt deltog 2 667 patienter med KOL.
English: A risk management plan has been developed to ensure that Ultibro Breezhaler is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ultibro Breezhaler anvendes så sikkert som muligt.
English: Ultibro Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Danish: Ultibro Breezhaler er et lægemiddel, der indeholder to aktive stoffer, nemlig indacaterol (85 mikrogram) og glycopyrronium (43 mikrogram).
English: The most common side effects with Ultibro Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Danish: De hyppigste bivirkninger ved Ultibro Breezhaler (som kan forekomme hos flere end 1 ud af 10 patienter) er infektioner i de øvre luftveje (forkølelse).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ultibro Breezhaler, 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 Ultibro Breezhaler, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: What measures are being taken to ensure the safe and effective use of Ultibro Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ultibro Breezhaler?
English: In patients with severely reduced kidney function Ultibro Breezhaler should only be used after a careful benefit-risk assessment.
Danish: Hos patienter med stærkt nedsat nyrefunktion bør Ultibro Breezhaler kun anvendes efter nøje afvejning af fordelene i forhold til risiciene.
English: Ultibro Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml more than glycopyrronium alone.
Danish: Ultibro Breezhaler øgede desuden FEV1 med 70 ml mere end indacaterol alene og 90 ml mere end glycopyrronium alene.
English: The effects of Ultibro Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Danish: Virkningerne af Ultibro Breezhaler til lindring af symptomerne på KOL havde klinisk betydning.
English: For more information about treatment with Ultibro Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ultibro Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The first study showed that treatment with Ultibro Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Danish: Den første undersøgelse viste, at Ultibro Breezhaler var mere effektivt end placebo og i gennemsnit øgede FEV1 med 200 ml mere.