FrancophonIA/ELRC3.0 huggingface dataset:
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som lægemidl et er beregnet til
English: Packaging Content
Danish: Indgivelsesvej Emballage Indhold Pakningsst ørrelse
English: Horses Intraarticular use Vial (plastic)
Danish: Hætteglas (plastic)
English: 1 vial of stem cell suspension
Danish: 1 hætteglas med stamcellesus pension
English: Package size
Danish: Intraartikulær anvendelse
English: Target species
Danish: Heste
English: 483 mg/g Granules
Danish: 483 mg/g Granulat
English: EU (MA) Number
Danish: EU-nummer (Markedsføringstilla delse)
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administration Indre emballage
English: 1 bottle + 1 dosing spoon
Danish: Flaske (HDPE) 174 g 1 flaske + 1 måleske
English: Immediate Packaging
Danish: Indhold Pakningsst ørrelse
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imprida HCT to Novartis Europharm Limited on 15 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Imprida HCT til Novartis Europharm Limited den 15. oktober 2009.
English: Imprida HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Danish: Imprida HCT indtages gennem munden, og dosis er en tablet dagligt på samme tidspunkt hver dag og helst om morgenen.
English: Patients received either Imprida HCT or one of the three combinations containing only two of the active substances for eight weeks.
Danish: Patienterne fik enten Imprida HCT eller en af de tre kombinationer, som kun indeholdt to af de aktive stoffer, i otte uger.
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Danish: Det fås som tabletter indeholdende amlodipin, valsartan og hydrochlorthiazid i følgende mængder: 5/160/12,5 mg, 10/160/12,5 mg, 5/160/25 mg, 10/160/25 mg og 10/320/25 mg.
English: Other information about Imprida HCT:
Danish: Andre oplysninger om Imprida HCT:
English: The Committee recommended that Imprida HCT be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Imprida HCT.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Imprida HCT which combines the three substances in a single tablet.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at der var større sandsynlighed for, at patienter, der allerede fik de tre aktive stoffer, ville overholde behandlingen, hvis de fik ordineret Imprida HCT, hvor de tre stoffer er kombineret i en enkelt tablet.
English: The three active substances in Imprida HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Danish: De tre aktive stoffer i Imprida HCT er lægemidler mod forhøjet blodtryk, som allerede anvendes i Den Europæiske Union (EU).
English: The main study showed the benefit of the highest strength of Imprida HCT in lowering the blood pressure.
Danish: Hovedundersøgelsen påviste den gavnlige virkning af den højeste styrke af Imprida HCT til nedsættelse af blodtrykket.
English: The dose of Imprida HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Danish: Den dosis af Imprida HCT, som skal anvendes, er den samme som doserne af tre individuelt aktive stoffer, som patienten fik tidligere.
English: The full EPAR for Imprida HCT can be found here.
Danish: Den fuldstændige EPAR for Imprida HCT findes her.
English: Imprida HCT should not be used in people who may be hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Imprida HCT.
Danish: Imprida HCT må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for de aktive stoffer, andre sulfonamider, dihydropyridinderivater eller andre af indholdsstofferne i Imprida HCT.
English: Treatment with the highest strength of Imprida HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Danish: Behandling med den højeste styrke af Imprida HCT var mere effektiv til at behandle hypertension end tokombinationsbehandlinger, der hver indeholdt to aktive stoffer.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Imprida HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Danish: Den gennemsnitlige reduktion af blodtrykket var ca. 39,7/24,7 mmHg hos patienter, der fik Imprida HCT, sammenlignet med 32/19,7 mmHg, 33,5/21,5 mmHg og 31,5/19,5 mmHg hos patienter, der henholdsvis fik kombinationerne valsartan/hydrochlorthiazid, valsartan/amlodipin og hydrochlorthiazid/amlodipin.
English: Imprida HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Danish: Imprida HCT er et lægemiddel, der indeholder de tre aktive stoffer amlodipin, valsartan og hydrochlorthiazid.
English: The most common side effects with Imprida HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Danish: De hyppigste bivirkninger ved Imprida HCT (som optræder hos mellem 1 og 10 patienter ud af 100) er hypokaliæmi (lavt kaliumindhold i blodet)), svimmelhed, hovedpine, hypotension (for lavt blodtryk), dyspepsi (halsbrand), pollakisuri (hyppig vandladning), træthed og ødem (væskeansamling).
English: For all doses, Imprida HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Danish: Imprida HCT opfyldte endvidere i samtlige doser kravet om at dokumentere, at lægemidlet var sammenligneligt med kombinationerne af de individuelt aktive stoffer indtaget separat.
English: The daily dose of Imprida HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Danish: Den daglige dosis af Imprida HCT må ikke overskride 10 mg amlodipin, 320 mg valsartan og 25 mg hydrochlorthiazid.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Imprida HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Danish: Derudover blev der gennemført en hovedundersøgelse af 2 271 patienter med moderat til svær hypertension, som blev behandlet med den højeste styrke af Imprida HCT (320 mg valsartan, 10 mg amlodipin og 25 mg hydrochlorthiazid).
English: Finally, Imprida HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Danish: Endelig må Imprida HCT ikke anvendes hos patienter med hypokaliæmi (lavt kaliumindhold i blodet), hyponatriæmi (lavt saltindhold i blodet) og hypercalcæmi (forhøjet calciumniveau i blodet), som ikke reagerer på behandling, og hos patienter med hyperurikæmi (forhøjet urinsyre i blodet), der udløser symptomer.
English: The CHMP therefore decided that Imprida HCT's benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede derfor, at fordelene ved Imprida HCT er større end risiciene til behandling af essentiel hypertension hos voksne, hvis blodtryk allerede er tilstrækkeligt kontrolleret med en kombination af amlodipin, valsartan og hydrochlorthiazid.
English: What is the risk associated with Imprida HCT?
Danish: Hvilken risiko er der forbundet med Imprida HCT?
English: For the full list of all side effects reported with Imprida HCT, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Imprida HCT fremgår af indlægssedlen.
English: Imprida HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Danish: Imprida HCT anvendes til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne, hvis blodtryk allerede er tilstrækkeligt kontrolleret med en kombination af amlopidin, valsartan og hydrochlorthiazid.
English: Imprida HCT amlodipine, valsartan and hydrochlorothiazide EPAR summary for the public
Danish: Imprida HCT amlodipin, valsartan og hydrochlorthiazid
English: Why has Imprida HCT been approved?
Danish: Hvorfor blev Imprida HCT godkendt?
English: What is Imprida HCT?
Danish: Hvad er Imprida HCT?
English: How has Imprida HCT been studied?
Danish: Hvordan blev Imprida HCT undersøgt?
English: What benefit has Imprida HCT shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Imprida HCT?
English: What is Imprida HCT used for?
Danish: Hvad anvendes Imprida HCT til?
English: How is Imprida HCT used?
Danish: Hvordan anvendes Imprida HCT?
English: How does Imprida HCT work?
Danish: Hvordan virker Imprida HCT?
English: After 24 weeks, a 20% improvement in symptoms was seen in 74% of Hulio-treated patients (270 of 363) and 76% of Humira treated patients (271 of 358).
Danish: Efter 24 uger sås en symptombedring på 20 % hos 74 % af de Huliobehandlede patienter (270 ud af 363) og hos 76 % af de Humira-behandlede patienter (271 ud af
English: Further information on Hulio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Hulio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Hulio
Danish: Andre oplysninger om Hulio
English: These packs will include information on the safety of the medicine.
Danish: Informationsmaterialet skal indeholde oplysninger om lægemidlets sikkerhed.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight.
Danish: Dosen og injektionshyppigheden afhænger af den sygdom, der skal behandles, og dosen til et barn beregnes normalt ud fra barnets vægt.
English: As for all medicines, data on the use of Hulio are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Hulio løbende overvåget.
English: An overview of Hulio and why it is authorised in the EU
Danish: En oversigt over Hulio, og hvorfor det er godkendt i EU
English: The reference medicine for Hulio is Humira.
Danish: Referencelægemidlet for Hulio er Humira.
English: What measures are being taken to ensure the safe and effective use of Hulio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hulio?
English: This means that Hulio is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Hulio i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i
English: Side effects reported with Hulio are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Hulio vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Like other medicines of its class, Hulio may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Danish: Ligesom andre lægemidler i samme klasse kan Hulio påvirke immunsystemets evne til at bekæmpe infektioner og kræft, og der har været nogle tilfælde af alvorlige infektioner og blodkræft hos patienter, der får adalimumab.
English: After training, patients or their carers may inject Hulio if their doctor considers it appropriate.
Danish: Efter oplæring kan patienten eller dennes omsorgsperson selv foretage indsprøjtningen med Hulio, hvis lægen finder det hensigtsmæssigt.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Danish: Ved at binde til TNF blokerer adalimumab TNF's aktivitet og reducerer dermed inflammationen og andre symptomer på sygdommen.
English: Hulio must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Hulio må ikke anvendes hos patienter med aktiv tuberkulose eller andre svære infektioner eller hos patienter med moderat til svær hjerteinsufficiens (en tilstand, hvor hjertet ikke kan pumpe tilstrækkeligt blod rundt i kroppen).
English: An alert card will also be given to patients.
Danish: Derudover skal patienterne have udleveret et patientkort.
English: Hulio is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: Hulio er et lægemiddel, der virker på immunsystemet, og som anvendes til behandling af følgende sygdomme:
English: Hulio contains the active substance adalimumab and is a ‘biosimilar medicine'.
Danish: Hulio indeholder det aktive stof adalimumab og er et "biosimilært lægemiddel".
English: What is Hulio and what is it used for?
Danish: Hvad er Hulio, og hvad anvendes det til?
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.
Danish: Øjenlæger, der behandler uveitis, bør også rådføre sig med læger, der har erfaring i brug af adalimumab.
English: In addition, Hulio was as effective as Humira in a study involving 730 patients with rheumatoid arthritis that was not adequately controlled with the medicine methotrexate.
Danish: Hulio var desuden lige så effektivt som Humira i et studie med 730 patienter med leddegigt (rheumatoid artritis), der ikke havde opnået tilstrækkelig sygdomskontrol ved behandling med lægemidlet methotrexat.
English: Hulio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Hulio anvendes oftest til voksne, når deres tilstand er svær eller moderat svær, når tilstanden forværres, eller når de ikke kan få andre behandlinger.
English: Why is Hulio authorised in the EU?
Danish: Hvorfor blev Hulio godkendt i EU?
English: What are the risks associated with Hulio?
Danish: Hvilke risici er der forbundet med Hulio?
English: Because Hulio is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hulio.
Danish: Da Hulio er et biosimilært lægemiddel, behøver de studier af virkningen og sikkerheden ved adalimumab, der er udført for Humira, ikke at blive gentaget for Hulio.
English: The active substance in Hulio, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Hulio, adalimumab, er et monoklonalt antistof (en type protein), der er designet til at genkende og binde til et stof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hulio is used to treat.
Danish: TNF er en medvirkende årsag til inflammationstilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Hulio.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hulio has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Hulio har en struktur, renhed og biologisk aktivitet, der svarer til Humiras, og at det fordeles i kroppen på samme måde.
English: All these data were considered sufficient to conclude that Hulio will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Hulio vil have de samme egenskaber som Humira, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: Hulio can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hulio is used.
Danish: Hulio udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i håndtering af de sygdomme, der behandles med Hulio.
English: Therefore, the Agency's view was that, as for Humira, the benefit of Hulio outweighs the identified risk and it can be authorised.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Hulio opvejer de identificerede risici, som for Humira, og kan godkendes.
English: The company that markets Hulio must provide educational packs for doctors who prescribe the medicine.
Danish: Den virksomhed, der markedsfører Hulio, skal sørge for informationsmateriale til ordinerende læger.
English: For more information about using Hulio, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Hulio, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Danish: • polyartikulær juvenil idiopatisk artritis og aktiv enthesitis-relateret artritis (begge er sjældne sygdomme, der giver inflammation af leddene)
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Danish: • non-infektiøs uveitis (inflammation i øjets årehinde (hinden under det hvide i øjeæblet)).
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger ved adalimumab (der kan forekomme hos mere end 1 ud af 10 patienter) er infektioner (herunder i næsen, svælget og bihulerne), reaktioner på injektionsstedet (rødme, kløe, blødning, ømhed eller hævelse), hovedpine og muskel- og knoglesmerter.
English: For the full list of side effects and restrictions with Hulio, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Hulio fremgår af indlægssedlen.
English: Laboratory studies comparing Hulio with the reference medicine Humira have shown that the active substance in Hulio is highly similar to that in Humira in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Hulio med Humira, har vist, at det aktive stof i Hulio svarer til det aktive stof i Humira, hvad angår struktur, renhed og biologisk aktivitet.
English: Hulio is available as a solution for injection under the skin in a vial or pre-filled syringe or pen and is usually given every 2 weeks.
Danish: Hulio fås som injektionsvæske i hætteglas, fyldte sprøjter eller fyldte penne til injektion under huden og indgives typisk hver 2. uge.
English: For more information on the use of Hulio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brugen af Hulio ved de forskellige sygdomme, herunder hvornår Hulio kan anvendes til børn, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Studies have also shown that giving Hulio produces similar levels of the active substance in the body to giving Humira.
Danish: Studier har også vist, at indgivelse af Hulio giver samme mængde aktivt stof i kroppen som indgivelse af Humira.
English: In addition, a study in patients with rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Danish: Derudover har et studie med patienter med leddegigt vist, at Hulios virkning svarer til Humiras ved denne sygdom.
English: How is Hulio used?
Danish: Hvordan anvendes Hulio?
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Danish: • aksial spondyloartritis (inflammation i rygsøjlen, der medfører rygsmerter), herunder såkaldt ankyloserende spondylitis og sygdom uden røntgenforandringer, men med tydelige tegn på inflammation
English: What benefits of Hulio have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Hulio?
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Danish: Andre sjældne alvorlige bivirkninger (der kan forekomme hos op til 1 ud af 1 000 personer) omfatter svigtende produktion af blodceller i knoglemarven, nervelidelser, lupus og lupuslignende sygdomme (hvor immunsystemet angriber patientens eget væv og forårsager inflammation og organskader) og
English: • Crohn's disease (a disease causing inflammation of the gut);
Danish: • Crohns sygdom (en sygdom, der giver inflammation i tarmen)
English: How does Hulio work?
Danish: Hvordan virker Hulio?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hulio have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Hulio.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Danish: • colitis ulcerosa (en sygdom, der giver inflammation og sår i tarmslimhinden)
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Danish: • svedkirtelbetændelse (hidradenitis suppurativa/acne inversa; en kronisk hudsygdom, der giver knuder, bylder og ar i huden
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Danish: • leddegigt (reumatoid artritis, en sygdom, der giver inflammation i leddene)
English: • plaque psoriasis (a disease causing red, scaly patches on the skin);
Danish: • plaque-psoriasis (en sygdom, der giver røde, skællende hudområder)
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Danish: • psoriasisgigt (en sygdom, der giver røde, skællende hudområder og inflammation (betændelse) i leddene)
English: Therefore the risk of medication error was considered to be a potential serious risk to public health.
Danish: Risikoen for medicineringsfejl blev derfor anset for at være en potentiel alvorlig risiko for den offentlige sundhed.
English: Harmful for those suffering from alcoholism.
Danish: Skadeligt for personer med alkoholisme.