FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that Rasilez HCT'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 Rasilez HCT opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Rasilez HCT is a medicine used to treat essential hypertension (high blood pressure) in adults.
Danish: Rasilez HCT er et lægemiddel, der anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: It must not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Danish: Det må ikke tages sammen med ciclosporin, itraconazol eller andre lægemidler af typen "potente P-glykoproteinhæmmere" (som f.eks. quinidin).
English: The studies lasted for between 8 weeks and a year, and the main measure of effectiveness was the change in blood pressure either during the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).
Danish: Studierne varede mellem otte uger og et år, og det primære mål for virkningen var ændringen i blodtrykket, som enten var det diastoliske blodtryk (blodtrykket i hvilefasen mellem to hjerteslag) eller det systoliske blodtryk (blodtrykket i hjertekamrenes sammentrækningsfase).
English: An overview of Rasilez HCT and why it is authorised in the EU
Danish: En oversigt over Rasilez HCT, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Rasilez HCT?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rasilez HCT?
English: What is Rasilez HCT and what is it used for?
Danish: Hvad er Rasilez HCT, og hvad anvendes det til?
English: The medicine has been shown to reduce blood pressure more than each active substance alone.
Danish: Det er påvist, at lægemidlet reducerer blodtrykket mere end hvert enkelt stof alene.
English: Other common side effects (which may affect more than 1 in 10 patients) that have been observed with hydrochlorothiazide alone are hypokalaemia (low blood potassium levels) and increases in blood cholesterol and triglyceride (a type of fat) levels.
Danish: Andre hyppige bivirkninger (som kan forekomme hos flere end 1 ud af 10 patienter), der er observeret med hydrochlorthiazid alene, er lavt indhold af kalium i blodet (hypokaliæmi) og en forøgelse af indholdet af kolesterol og triglycerid (et fedtstof) i blodet.
English: By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Danish: Ved at nedsætte blodtrykket reduceres risikoen for skader på grund af højt blodtryk som f.eks. slagtilfælde.
English: The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
Danish: I studierne blev kombinationen af aliskiren og hydrochlorthiazid sammenlignet med placebo (ikke-aktivt stof), med aliskiren eller hydrochlorthiazid taget alene eller med andre lægemidler mod hypertension (valsartan, irbesartan, lisinopril eller amlodipin).
English: Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone.
Danish: Rasilez HCT anvendes hos patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret ved behandling med aliskiren eller hydrochlorthiazid anvendt alene.
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Danish: Det blokerer aktiviteten hos det humane enzym, renin, som er med til at producere et stof i kroppen, der kaldes angiotensin I. Angiotensin I omdannes til hormonet angiotensin
English: The medicine contains the active substances aliskiren and hydrochlorothiazide.
Danish: Lægemidlet indeholder de aktive stoffer aliskiren og hydrochlorthiazid.
English: Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Rasilez HCT.
Danish: Patienter, der tidligere kun har fået aliskiren eller hydrochlorthiazid, skal muligvis tage de to stoffer som separate tabletter og justere doserne, inden de skifter til Rasilez HCT.
English: It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
Danish: Det kan også anvendes til patienter, hvis blodtryk er tilstrækkeligt kontrolleret ved behandling med aliskiren og hydrochlorthiazid, taget som separate tabletter, for at erstatte de samme doser af de to aktive stoffer.
English: Why is Rasilez HCT authorised in the EU?
Danish: Hvorfor blev Rasilez HCT godkendt i EU?
English: In patients already adequately controlled with the two active substances, the dose of Rasilez HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking before.
Danish: Hos patienter, der allerede er tilstrækkeligt reguleret med de to aktive stoffer, skal dosis af Rasilez HCT indeholde de samme doser af aliskiren og hydrochlorthiazid, som patienten fik tidligere.
English: The dose depends on the doses of aliskiren or hydrochlorothiazide that the patient was taking before.
Danish: Dosen afhænger af de doser af aliskiren eller hydrochlorthiazid, som patienten tidligere fik.
English: The two active substances in Rasilez HCT, aliskiren and hydrochlorothiazide, work in different ways to reduce blood pressure.
Danish: De to aktive stoffer i Rasilez HCT, aliskiren og hydrochlorthiazid, sænker blodtrykket på hver sin måde.
English: Rasilez HCT must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, who have anuria (a condition in which a patient cannot make or pass urine), severe kidney or liver impairment, or whose blood potassium levels are too low or blood calcium levels are too high.
Danish: Rasilez HCT må ikke anvendes til patienter, der har fået angioødem (hævelse under huden) ved behandling med aliskiren, patienter med arveligt angioødem eller angioødem uden kendt årsag, der har anuri (en sygdom, hvor patienten har manglende urinproduktion eller evne til at tømme blæren), patienter med svær nyre- eller leverfunktionsnedsættelse eller patienter med for lavt kaliumindhold eller for højt kalciumindhold i blodet.
English: Rasilez HCT is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children.
Danish: Det må ikke anvendes hos børn under 2 år, og det anbefales ikke til ældre børn.
English: What are the risks associated with Rasilez HCT?
Danish: Hvilke risici er der forbundet med Rasilez HCT?
English: For the full list of all side effects reported with Rasilez HCT, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rasilez HCT fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rasilez HCT 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 Rasilez HCT.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: II, som er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: How is Rasilez HCT used?
Danish: Hvordan anvendes Rasilez HCT?
English: What benefits of Rasilez HCT have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rasilez HCT?
English: How does Rasilez HCT work?
Danish: Hvordan virker Rasilez HCT?
English: Rasilez HCT in combination with an ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) must not be used in patients with diabetes,
Danish: "angiotensinkonvertasehæmmere" ("ACE-hæmmere") eller "angiotensinreceptorantagonister" (ARB'er) må ikke anvendes hos patienter med sukkersyge eller moderat til svært nedsat nyrefunktion.
English: It is available as capsules (290 micrograms).
Danish: Det fås som kapsler (290 µg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Constella on 26 November 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Constella den 26. november 2012.
English: It has also been shown to have a beneficial impact on the quality of life of patients.
Danish: Det havde desuden vist gavnlig virkning på patienternes livskvalitet.
English: Other information about Constella
Danish: Andre oplysninger om Constella
English: The full EPAR for Constella can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Constella 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 Constella.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Constella.
English: The effects of Constella were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Constella blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The doctor should periodically assess the need of continued treatment.
Danish: Lægen bør med mellemrum vurdere behovet for fortsat behandling.
English: One of the studies also looked at the effects of Constella following 26 weeks of treatment.
Danish: En af undersøgelserne vedrørte desuden virkningerne af Constella efter 26 ugers behandling.
English: The recommended dose of Constella is one capsule once a day, taken at least 30 minutes before a meal.
Danish: Den anbefalede dosis af Constella er én tablet én gang dagligt, der indtages mindst 30 minutter før et måltid.
English: However, the Committee also noted that about half of the patients did not adequately benefit from treatment, and therefore recommended that the need for continued treatment should be reconsidered after four weeks.
Danish: Udvalget bemærkede dog også, at omkring halvdelen af patienterne ikke fik tilstrækkelig gavn af behandlingen, og anbefalede derfor, at behovet for fortsat behandling tages op til overvejelse efter fire uger.
English: If the patient has not experienced an improvement in symptoms after four weeks of treatment, the benefits and risks of continuing treatment should be reconsidered.
Danish: Hvis patienten ikke har mærket bedring i symptomerne efter fire ugers behandling, bør fordelene og risiciene ved fortsat behandling overvejes.
English: For more information about treatment with Constella, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Constella, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Regarding safety, the CHMP concluded that the side effects with Constella, mainly diarrhoea, are manageable.
Danish: Vedrørende sikkerheden konkluderede CHMP, at bivirkningerne med Constella, hovedsagelig diarré, er håndterbare.
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 Constella.
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 Constella.
English: EPAR summary for the public linaclotide
Danish: EPAR - sammendrag for offentligheden linaclotid
English: The CHMP therefore decided that Constella's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP afgjorde derfor, at fordelene ved Constella overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Constella.
English: Constella is a medicine that contains the active substance linaclotide.
Danish: Constella er et lægemiddel, der indeholder det aktive stof linaclotid.
English: Constella must not be used in people who are hypersensitive (allergic) to linaclotide or any of the other ingredients.
Danish: Constella må ikke anvendes hos personer, der er overfølsomme (allergiske) over for linaclotid eller andre af indholdsstofferne.
English: The most common side effect with Constella is diarrhoea, mainly mild to moderate, occurring in between 10 and 20 patients in 100.
Danish: Den hyppigste bivirkning med Constella er diarré, hovedsagelig let til moderat, der forekommer hos mellem 10 og 20 ud af 100 behandlede.
English: What is the risk associated with Constella?
Danish: Hvilken risiko er der forbundet med Constella?
English: In rare and more severe cases, diarrhoea may lead to dehydration, hypokalaemia (low blood potassium levels), decrease in blood bicarbonate, dizziness and orthostatic hypotension (low blood pressure on standing up).
Danish: I sjældne og mere alvorlige tilfælde kan diarré medføre dehydrering, hypokaliæmi (for lavt indhold af kalium i blodet), fald i bikarbonatindholdet i blodet, svimmelhed og ortostatisk hypotension (blodtryksfald når man rejser sig op).
English: The active substance in Constella, linaclotide, attaches to some receptors in the gut called guanylate cyclase C. By attaching to these receptors, it reduces pain and increases the secretion of fluid into the gut, thereby loosening the stools and increasing bowel movements.
Danish: Det aktive stof i Constella, linaclotid, bindes til nogle receptorer i tarmen, som kaldes guanylatcyklase C. Ved at bindes til disse receptorer mindsker stoffet smerterne og øger væskeudskillelsen i tarmen, hvorved afføringen bliver løsere, og tarmbevægelserne øges.
English: It must also not be used in patients with a known or suspected blockage in their stomach or gut.
Danish: Det må heller ikke anvendes hos patienter med kendt eller formodet maveeller tarmblokade.
English: Constella was shown to be more effective than placebo at improving the symptoms of IBS.
Danish: Constella var mere effektivt end placebo til at bedre symptomerne på irritabel tyktarm.
English: The CHMP noted that Constella has been shown to have clinically relevant, beneficial effects in patients with IBS with constipation in the long term (for up to six months).
Danish: CHMP bemærkede, at Constella havde vist klinisk relevant gavnlig virkning hos patienter med langvarig (op til seks måneder) irritabel tyktarm med forstoppelse.
English: Why has Constella been approved?
Danish: Hvorfor blev Constella godkendt?
English: Constella was investigated in two main studies involving a total of 1,608 patients with IBS with constipation, where it was compared with placebo (a dummy treatment).
Danish: Constella blev undersøgt i to hovedundersøgelser, der omfattede 1 608 patienter med irritabel tyktarm med forstoppelse.
English: Constella is used to treat the symptoms of moderate to severe irritable bowel syndrome (IBS) with constipation in adults.
Danish: Constella anvendes til behandling af symptomerne på irritabel tyktarm med forstoppelse hos voksne.
English: How has Constella been studied?
Danish: Hvordan blev Constella undersøgt?
English: What benefit has Constella shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Constella?
English: The results after 26 weeks of treatment showed an improvement in pain (for at least 13 weeks out of the 26 weeks) in 54% of patients taking Constella compared with 36% of patients taking placebo, as well as relief from symptoms for at least 13 weeks in 37% of Constella patients, compared with 17% of patients in the placebo group.
Danish: Efter 26-ugers behandling var der bedring i smerter (i mindst 13 uger ud af de 26 uger) hos 54 % af de patienter, der fik Constella, sammenholdt med 36 % af dem, der fik placebo, og lindring af symptomerne i mindst 13 uger hos 37 % af de patienter, der fik Constella, sammenholdt med 17 % af patienterne i placebogruppen.
English: In the first study, 55% of patients who received Constella experienced a 30% or higher improvement in their pain and discomfort for at least 6 out of the 12 weeks of treatment, compared with 42% of patients who received placebo.
Danish: I den første undersøgelse mærkede 55 % af de patienter, der fik Constella, en forbedring på 30 % eller derover med hensyn til smerter og ubehag i mindst 6 ud af de 12 ugers behandling, sammenholdt med 42 % af dem, der fik placebo.
English: IBS is a long-term disorder of the gut characterised by pain or discomfort in the abdomen and bloating together with altered bowel habit.
Danish: Irritabel tyktarm er en langvarig tarmsygdom med smerter eller ubehag i maven, oppustethed og ændrede afføringsvaner.
English: In addition, 37% of patients who received Constella were considerably or completely relieved from symptoms for at least 6 out of the 12 weeks of treatment, compared with 19% of patients who received placebo.
Danish: Desuden fik 37 % af de patienter, der fik Constella, væsentlig eller fuldstændig lindring af symptomerne i mindst 6 ud af de 12 ugers behandling, sammenholdt med 19 % af dem, der fik placebo.
English: The main measures of effectiveness were the number of patients who experienced at least a 30% improvement in their pain and discomfort and the number of patients who were considerably or completely relieved from all IBS symptoms for at least 6 out of the 12 weeks of treatment.
Danish: Virkningen blev hovedsagelig bedømt på det antal patienter, der mærkede mindst 30 % bedring i smerter og ubehag, og det antal patienter, der fik betydelig eller fuldstændig lindring af alle symptomerne på irritabel tyktarm i mindst 6 ud af de 12 ugers behandling.
English: What is Constella used for?
Danish: Hvad anvendes Constella til?
English: How is Constella used?
Danish: Hvordan anvendes Constella?
English: Similar results were obtained in the second study, with 54% of Constella patients experiencing an improvement in their pain and discomfort and 39% of them feeling considerably or completely relieved from symptoms for at least 6 out of the 12 weeks of treatment, compared with 39% and 17% of patients in the placebo group, respectively.
Danish: Den anden undersøgelse gav tilsvarende resultater: 54 % af patienterne på Constella fik bedring af smerter og ubehag, og 39 % fik væsentlig eller fuldstændig lindring af symptomerne i mindst 6 ud af de 12 ugers behandling, sammenholdt med henholdsvis 39 % og 17 % af patienterne i placebogruppen.
English: What is Constella?
Danish: Hvad er Constella?
English: How does Constella work?
Danish: Hvordan virker Constella ?
English: Melosus received a marketing authorisation valid throughout the EU on21 February 2011.
Danish: Melosus fik en markedsføringstilladelse med gyldighed i hele EU den 21. februar 2011.
English: Previously known as Melocam.
Danish: Tidligere kendt som Melocam.
English: Further information on Melosus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/melosus.
Danish: Yderligere information om Melosus findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/melosus.
English: Other information about Melosus
Danish: Andre oplysninger om Melosus
English: What are the benefits and risks of Melosus?
Danish: Hvilke fordele og risici er der forbundet med Melosus?
English: As for every medicine, the company provided studies on the quality of Melosus.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Melosus.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har også gennemført studier, der viste, at det er "bioækvivalent" med referencelægemidlet.
English: What is Melosus and what is it used for?
Danish: Hvad er Melosus, og hvad anvendes det til?
English: An overview of Melosus and why it is authorised in the EU
Danish: Oversigt over Melosus, og hvorfor det er godkendt i EU
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Metacam, and do not need to be repeated for Melosus.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Metacam, og det er ikke nødvendigt at gentage disse med Melosus.
English: This means that Melosus contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Danish: Det betyder, at Melosus indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU) og som hedder Metacam.
English: Melosus can only be obtained with a prescription.
Danish: Melosus udleveres kun efter recept.
English: Melosus is available as an oral (taken by mouth) suspension as 0.5 mg/ml for use in cats and guinea pigs and 1.5 mg/ml for use in dogs.
Danish: Melosus fås som en oral suspension (tages gennem munden) på 0,5 mg/ml til katte og marsvin og 1,5 mg/ml til hunde.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Melosus has been shown to have comparable quality and to be bioequivalent to Metacam.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Melosus er af sammenlignelig kvalitet og er bioækvivalent med Metacam.
English: Why is Melosus authorised in the EU?
Danish: Hvorfor blev Melosus godkendt i EU?
English: The precautions are the same as for the reference medicine since Melosus is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, da Melosus er et generisk lægemiddel.
English: Therefore, the Agency's view was that, as for Metacam, the benefit of Melosus outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Metacam opvejer de identificerede risici som for Melosus, og at det kan godkendes til anvendelse i EU.
English: Because Melosus is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Melosus er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Melosus is an anti-inflammatory medicine used in dogs, cats and guinea pigs.
Danish: Melosus er et antiinflammatorisk lægemiddel, der anvendes til hunde, katte og marsvin.
English: For further information about using Melosus, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Melosus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Melosus contains the active substance meloxicam and is a ‘generic medicine'.
Danish: Melosus indeholder det aktive stof meloxicam og er et "generisk lægemiddel".
English: Safety information has been included in the summary of product characteristics and the package leaflet for Melosus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Melosus, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.