FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration with strong CYP3A4 inhibitors is not recommended and caution is warranted, these interactions are described in the interaction table below (e.g. indinavir, azole antifungals like clotrimazole).
Danish: Disse interaktioner er beskrevet i nedenstående interaktionstabel (f.eks. indinavir, azolantimykotika som clotrimazol).
English: For patients with renal or hepatic impairment colchicine with PREZISTA co-administered with low dose ritonavir is contraindicated (see sections 4.3 and 4.4).
Danish: Colchicin sammen med PREZISTA administreret sammen med lavdosis ritonavir er kontraindiceret til patienter med nedsat nyre- eller leverfunktion (se pkt.
English: The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
Danish: Måltidets sammensætning påvirker ikke eksponeringen for darunavir (se pkt.
English: Darunavir is metabolised by the hepatic system.
Danish: Darunavir metaboliseres i leveren.
English: With baseline CD4+ cell count ≥ 200 median
Danish: Med hivRNA ≥ 100.000 ved baseline Med CD4+celletal < 200 ved baseline Med CD4+celletal ≥ 200 ved baseline
English: PREZISTA is also available as 75 milligram, 150 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Danish: PREZISTA fås også som 75 mg, 150 mg, 400 mg, 600 mg og 800 mg filmovertrukne tabletter og som 100 mg pr. ml oral suspension.
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Danish: PREZISTA fås også som 75 mg, 150 mg, 300 mg, 600 mg og 800 mg filmovertrukne tabletter og som 100 mg pr. ml oral suspension.
English: Boosted PREZISTA is expected to increase these β-blocker plasma concentrations.
Danish: Boostet PREZISTA forventes at øge plasmakoncentrationen af disse betablokkere.
English: Each tablet contains 150 milligram of darunavir (as ethanolate).
Danish: Hver tablet indeholder 150 mg darunavir som ethanolat.
English: Recommended dose for treatment-experienced paediatric patients (3 to 17 years) with PREZISTA and ritonavir
Danish: Anbefalet dosis af PREZISTA og ritonavir a til behandlingserfarne pædiatriske patienter (3 til 17 år)
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram and 600 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Danish: PREZISTA fås også som 75 mg, 150 mg, 300 mg, 400 mg og 600 mg filmovertrukne tabletter og som 100 mg/ml oral suspension.
English: For patients with renal or hepatic impairment colchicine with boosted PREZISTA is contraindicated (see sections 4.3 and 4.4).
Danish: Colchicin sammen med boostet PREZISTA er kontraindiceret til patienter med nedsat nyre- eller leverfunktion (se pkt.
English: Each tablet contains 300 milligram of darunavir (as ethanolate).
Danish: Hver tablet indeholder 300 mg darunavir som ethanolat.
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Danish: PREZISTA fås også som 75 mg, 150 mg, 300 mg, 400 mg og 800 mg filmovertrukne tabletter og som 100 mg/ml oral suspension.
English: Press on the plunger of the pipette towards the mouth, then swallow.
Danish: Tryk sprøjtens stempel og synk dosen.
English: PREZISTA is expected to increase these β-blocker plasma concentrations.
Danish: PREZISTA forventes at øge plasmakoncentrationen af disse betablokkere.
English: PREZISTA should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Danish: Ved symptomer på alvorlige hudreaktioner skal PREZISTA straks seponeres.
English: Recommended dose for treatment-naïve paediatric patients (3 to 17 years) with PREZISTA and ritonavir
Danish: Anbefalet dosis af PREZISTA og ritonavir a til behandlingsnaive pædiatriske patienter (3 til 17 år)
English: CD4+ cell count mean change from baseline
Danish: CD4+-celletal - gennemsnitlig ændring fra baseline
English: Each tablet contains 600 milligram of darunavir (as ethanolate).
Danish: Hver tablet indeholder 600 mg darunavir som ethanolat.
English: The full EPAR for Riprazo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Riprazo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Riprazo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Riprazo.
English: It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Riprazo.
Danish: Den skal tages sammen med et let måltid, helst på samme tid hver dag, men der må ikke indtages grapefrugtjuice sammen med Riprazo.
English: The recommended dose of Riprazo is 150 mg once a day.
Danish: Den anbefalede dosis af Riprazo er 150 mg én gang dagligt.
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
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 Riprazo.
English: The CHMP therefore decided that the benefits of Riprazo are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget afgjorde derfor, at fordelene ved Riprazo overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The dose of Riprazo may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Danish: Dosis af Riprazo kan øges til 300 mg én gang dagligt hos patienter, hvis blodtryk ikke er tilstrækkeligt reguleret.
English: It is available as tablets (150 and
Danish: Det fås som tabletter (150 og 300 mg).
English: In five of the studies, the effects of Riprazo taken alone were compared with those of placebo (a dummy treatment).
Danish: I fem af undersøgelserne blev virkningerne af Riprazo anvendt alene sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: Riprazo has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Danish: Riprazo er blevet anvendt i 14 hovedundersøgelser, hvori der deltog 10 000 patienter med essentiel hypertension.
English: For more information about treatment with Riprazo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Riprazo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Riprazo is a medicine that contains the active substance aliskiren.
Danish: Riprazo er et lægemiddel, der indeholder det aktive stof aliskiren.
English: Riprazo is used to treat essential hypertension (high blood pressure) in adults.
Danish: Riprazo anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, or in women who are more than three months pregnant.
Danish: Det må ikke anvendes hos patienter, som har haft angioødem (hævelse under huden) med aliskiren, arveligt angioødem eller angioødem uden kendt årsag eller hos kvinder, som er mere end tre måneder henne i graviditeten.
English: Riprazo also reduced blood pressure in patients with diabetes and patients who were overweight.
Danish: Riprazo nedsatte også blodtrykket hos patienter med sukkersyge og hos overvægtige patienter.
English: The CHMP noted that Riprazo is effective in reducing blood pressure when used alone or in combination.
Danish: CHMP konstaterede, at Riprazo er effektivt til at nedsætte blodtrykket, hvad enten det anvendes alene eller i kombination.
English: For the full list of all side effects reported with Riprazo, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Riprazo fremgår af indlægssedlen.
English: What is the risk associated with Riprazo?
Danish: Hvilken risiko er der forbundet med Riprazo?
English: This may reduce the risks associated with high blood pressure, such as having a stroke.
Danish: Dette kan nedsætte de risici, der er forbundet med forhøjet blodtryk såsom slagtilfælde.
English: Why has Riprazo been approved?
Danish: Hvorfor blev Riprazo godkendt?
English: The active substance in Riprazo, aliskiren, is a renin inhibitor.
Danish: Det aktive stof i Riprazo, aliskiren, er en reninhæmmer.
English: Riprazo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Danish: Når Riprazo blev anvendt alene, var det mere effektivt end placebo og lige så effektivt som sammenligningslægemidlerne til at nedsætte blodtrykket.
English: When the results of the five studies comparing Riprazo taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Riprazo, from an average of 99.4 mmHg at the start of the study.
Danish: I de fem undersøgelser, hvor Riprazo blev anvendt alene og sammenlignet med placebo, fik patienter under 65 år i gennemsnit mindsket det diastoliske blodtryk med 9,0 mmHg efter otte ugers behandling med Riprazo, 150 mg.
English: Combination studies looked at Riprazo used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Danish: I kombinationsundersøgelserne blev Riprazo anvendt sammen med en ACE-hæmmer, ramipril, en ARB (valsartan), en betablokker (atenolol), en kalciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
English: This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients
Danish: Til sammenligning fik patienterne på placebo et fald på 5,8 mmHg fra en startværdi på 99,3 mmHg.
English: Riprazo must not be used by people who are hypersensitive (allergic) to aliskiren or any of the other ingredients.
Danish: Riprazo må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for aliskiren eller andre af indholdsstofferne.
English: The most common side effects with Riprazo (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Danish: De almindeligste bivirkninger ved Riprazo (som optræder hos mellem 1 og 10 patienter ud af 100) er svimmelhed, diarré, artralgi (ledsmerter) og hyperkalæmi (for højt kaliumindhold i blodet).
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Riprazoden 22. august 2007.
English: However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Riprazo should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Danish: Efter gennemgang af undersøgelsen ALTITUDE anbefalede CHMP imidlertid i februar 2012, at Riprazo ikke bør anvendes sammen med en ACEhæmmere eller en ARB hos patienter med sukkersyge eller moderat til svær nyrefunktionsnedsættelse.
English: Riprazo may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Danish: Riprazo kan anvendes alene eller sammen med et andet lægemiddel mod for højt blodtryk, bortset fra “angiotensinkonvertasehæmmere” (“ACEhæmmere”) eller “angiotensinreceptorantagonister” (ARB) hos patienter med sukkersyge eller moderat til svært nedsat nyrefunktion.
English: Riprazo in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: Riprazo kombineret med en ACE-hæmmer eller en ARB må ikke anvendes til patienter med sukkersyge eller moderat til svær nyrefunktionsnedsættelse.
English: What benefit has Riprazo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Riprazo?
English: Riprazo must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Danish: Riprazo må heller ikke tages sammen med ciclosporin, itraconazol eller andre lægemidler af typen “potente P
English: The studies with Riprazo in combination with other medicines showed additional decreases in blood pressure compared with the decreases produced by these medicines alone.
Danish: Undersøgelserne viste, at når Riprazo blev anvendt sammen med andre lægemidler, mindskedes blodtrykket mere, end når disse lægemidler anvendes alene.
English: How does Riprazo work?
Danish: Hvordan virker Riprazo?
English: Riprazo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Danish: Riprazo blev dels taget alene, dels i kombination med andre lægemidler og blev sammenlignet med andre lægemidler mod for højt blodtryk.
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Riprazo.
Danish: Hos patienter over 65 år og hos dem, der fik Riprazo i større doser, blev blodtrykket sænket yderligere.
English: The European Commission granted a marketing authorisation valid throughout the EU for Tevagrastim to Teva Generics GmbH on 15 September 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tevagrastim til Teva Generics GmbH den 15. september 2008.
English: This means that Tevagrastim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Danish: Det betyder, at Tevagrastim svarer til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kendt som "referencelægemidlet").
English: How it is given, the dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Danish: Hvordan lægemidlet gives, doseres og hvor længe behandlingen skal vare, afhænger af, hvorfor lægemidlet anvendes, hvor meget patienten vejer, og hvordan patienten reagerer på behandlingen.
English: (cancer treatment) that is cytotoxic (cell-killing);
Danish: (cancerbehandling), som er cytotoksisk (celledræbende)
English: Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Danish: Filgrastim produceres via en metode, der er kendt som ‘rekombinant DNA-teknologi': Det produceres af en bakterie, der har modtaget et gen (DNA), som gør den i stand til at producere filgrastim.
English: The active substance in Tevagrastim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Tevagrastim, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G-CSF).
English: Tevagrastim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Danish: Tevagrastim kan også anvendes til patienter, der skal donere blodstamceller til transplantation, for at bidrage til at frigøre disse celler fra knoglemarven.
English: The study looked at the duration of severe neutropenia during the patients' first cycle of cytotoxic chemotherapy.
Danish: Undersøgelsen så på varigheden af svær neutropeni i løbet af patienternes første cytotoksiske kemoterapicyklus.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TEVAGRASTIM EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TEVAGRASTIM EPAR - Sammendrag for offentligheden
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Tevagrastim is being used for.
Danish: Andre bivirkninger kan optræde hos flere end 1 ud af 10 patienter, afhængig af den tilstand, som Tevagrastim anvendes til behandling af.
English: Tevagrastim is used to stimulate the production of white blood cells in the following situations:
Danish: Tevagrastim anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde:
English: The most common side effect with Tevagrastim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Danish: Den hyppigste bivirkning ved Tevagrastim (som ses hos mere end 1 ud af hver 10 patienter) er muskelsmerter (smerter i muskler og knogler).
English: The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Danish: Det kunstigt fremstillede middel virker på samme måde som det naturligt fremstillede G-CSF ved at tilskynde knoglemarven til at producere flere hvide blodlegemer.
English: Tevagrastim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Danish: Tevagrastim bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for filgrastim eller andre af indholdsstofferne.
English: During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Danish: I løbet af deres første kemoterapicyklus på 21 dage havde patienter behandlet med Tevagrastim eller Neupogen svær neutropeni i gennemsnitligt 1,1 dag sammenlignet med 3,8 dage hos dem, der fik placebo.
English: Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Danish: Tevagrastim blev sammenlignet med Neupogen og placebo (en virkningsløs behandling) i en hovedundersøgelse af 348 patienter med brystcancer.
English: To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Danish: For at undersøge sikkerheden af Tevagrastim blev der gennemført to undersøgelser af patienter med lungecancer og non-Hodgkin's lymfom (en form for lymfekræft).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Tevagrastim i overensstemmelse med EU's krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
English: Other information about Tevagrastim:
Danish: Andre oplysninger om Tevagrastim:
English: The Committee recommended that Tevagrastim be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Tevagrastim.
English: Tevagrastim is a ‘biosimilar' medicine.
Danish: Tevagrastim er et ‘biosimilært' lægemiddel.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy
Danish: • til at reducere varigheden af neutropeni (lavt antal af neutrofiler, en type hvide blodlegemer) og forekomsten af febril neutropeni (neutropeni med feber) hos patienter, der får kemoterapi
English: The full EPAR for Tevagrastim can be found here.
Danish: Den fuldstændige EPAR for Tevagrastim findes her.
English: The reference medicine for Tevagrastim is Neupogen.
Danish: Referencelægemidlet for Tevagrastim er Neupogen.
English: Tevagrastim is given by injection under the skin or infusion into a vein.
Danish: Tevagrastim gives ved injektion under huden eller ved infusion i en vene.
English: Tevagrastim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Danish: Tevagrastim gives sædvanligvis på et specialiseret behandlingscenter, selvom de patienter, der får lægemidlet gennem injektion under huden,
English: Tevagrastim is a solution for injection or for infusion (drip into a vein).
Danish: Tevagrastim er en opløsning til injektion eller infusion (drop i en vene).
English: What is the risk associated with Tevagrastim?
Danish: Hvilken risiko er der forbundet med Tevagrastim?
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
Danish: • til at reducere varigheden af neutropeni hos patienter, der er under behandling, for at tilintetgøre knoglemarvsceller inden en knoglemarvstransplantation (som for eksempel hos visse patienter med leukæmi), hvis der er risiko for, at de får langvarig svær neutropeni
English: Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen.
Danish: Tevagrastim blev undersøgt for at påvise, at det er sammenligneligt med referencelægemidlet Neupogen.
English: For the full list of all side effects reported with Tevagrastim, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tevagrastim fremgår af indlægssedlen.
English: Why has Tevagrastim been approved?
Danish: Hvorfor blev Tevagrastim godkendt?
English: Therefore, the effectiveness of Tevagrastim was shown to be equivalent to that of Neupogen.
Danish: Virkningen af Tevagrastim viste sig derfor at svare til virkningen af Neupogen.
English: Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe neutropenia.
Danish: Behandling med Tevagrastim mindskede varigheden af svær neutropeni på tilsvarende måde som Neupogen.
English: What is Tevagrastim?
Danish: Hvad er Tevagrastim?
English: What benefit has Tevagrastim shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tevagrastim?
English: How has Tevagrastim been studied?
Danish: Hvordan blev Tevagrastim undersøgt?
English: What is Tevagrastim used for?
Danish: Hvad anvendes Tevagrastim til?
English: How is Tevagrastim used?
Danish: Hvordan anvendes Tevagrastim?
English: How does Tevagrastim work?
Danish: Hvordan virker Tevagrastim?
English: It has few side effects.
Danish: Det har få bivirkninger.
English: Tremfya received a marketing authorisation valid throughout the EU on 10 November 2017.
Danish: Tremfya fik en markedsføringstilladelse med gyldighed i hele EU den 10. november 2017.
English: The recommended dose is 100 mg as a single dose, followed by a further dose after 4 weeks and then 100 mg every 8 weeks.
Danish: Den anbefalede dosis er 100 mg som en enkelt dosis, der efterfølges af endnu en dosis efter 4 uger og derefter 100 mg hver 8. uge.
English: Further information on Tremfya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Tremfya findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: As for all medicines, data on the use of Tremfya are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Tremfya løbende overvåget.