FrancophonIA/ELRC3.0 huggingface dataset:
English: For information regarding concomitant use with CYP3A4 inhibitors, see sections 4.2, 4.3 and 4.5.
Danish: For oplysninger vedrørende samtidig brug af CYP3A4-hæmmere: se pkt.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Piramal Healthcare UK Limited
English: The 25 mg dose in the LIR subgroup increased mean days per week compared with placebo with at least 1 complete spontaneous bowel movement (CSBM) in both studies (Kodiac 4 p=0.002, Kodiac 5 p<0.001).
Danish: 25 mg-dosen i undergruppen med utilstrækkeligt respons på laksantia øgede det gennemsnitlige antal dage om ugen med mindst 1 fuldstændig spontan afføring i forhold til placebo i begge studier (Kodiac 4 p=0,002, Kodiac 5 p<0,001).
English: Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters.
Danish: Pakningsstørrelser med 30 x 1 og 90 x 1 filmovertrukne tabletter i perforerede enkeltdosisblistre.
English: A potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed in 1 volunteer in the 250 mg group and 1 volunteer in the 1,000 mg group.
Danish: Der blev observeret en potentiel CNS-virkning (reversering af opioidforårsaget pupilforsnævring, målt ved pupillometri) hos 1 rask forsøgsperson i gruppen, der fik 250 mg, og hos 1 rask forsøgsperson i gruppen, der fik 1.000 mg. I et klinisk studie med patienter med opioidinduceret obstipation var den daglige dosis på 50 mg forbundet med en øget forekomst af uudholdelige gastrointestinale virkninger (primært mavesmerter).
English: Moventig 12.5 mg tablets naloxegol
Danish: Moventig 12,5 mg tabletter naloxegolum
English: Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.
Danish: Moventig 12,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder naloxegoloxalat svarende til 12,5 mg naloxegol.
English: − Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate.
Danish: Hver Moventig 25 mg filmovertrukken tablet (tablet) indeholder 25 mg naloxegol som naloxegoloxalat.
English: 25 mg film-coated tablets
Danish: 25 mg filmovertrukne tabletter
English: Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.
Danish: Moventig 25 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder naloxegoloxalat svarende til 25 mg naloxegol.
English: 12.5 mg film-coated tablets
Danish: 12,5 mg filmovertrukne tabletter
English: Moventig 25 mg tablets naloxegol
Danish: Moventig 25 mg tabletter naloxegolum
English: − Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as naloxegol oxalate.
Danish: Hver Moventig 12,5 mg filmovertrukken tablet (tablet) indeholder 12,5 mg naloxegol som naloxegoloxalat.
English: Interaction with moderate CYP3A4 inhibitors
Danish: Interaktion med moderate CYP3A4-hæmmere
English: Moventig 25 mg film-coated tablets naloxegol
Danish: Moventig 25 mg filmovertrukne tabletter naloxegolum
English: The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet can be crushed to a powder and mixed with water (120 ml).
Danish: I sådanne tilfælde kan tabletten knuses til et pulver og blandes med vand (120 ml).
English: The time to first SBM in the LIR subgroup after taking the first dose was shorter for the 25 mg dose as compared to placebo in Kodiac 4 (p<0.001) and Kodiac 5 (p=0.002).
Danish: I undergruppen med utilstrækkeligt respons på laksantia var tiden til første spontane afføring efter indtagelse af første dosis kortere med 25 mg-dosen end med placebo i Kodiac 4 (p<0,001) og Kodiac 5 (p=0,002).
English: Interaction with CYP3A4 inhibitors and inducers
Danish: Interaktion med CYP3A4-hæmmere og -induktorer
English: • if you take diltiazem or verapamil (for high blood pressure or angina) Your doctor may tell you to increase the dose to 25 mg depending on how you respond to the medicine.
Danish: • hvis du tager diltiazem eller verapamil (mod forhøjet blodtryk eller brystsmerter (angina)).
English: Patient assessment of constipation symptoms (PAC-SYM) questionnaire Naloxegol 25 mg dose in the LIR subgroup resulted in a greater improvement (change from baseline) of patient assessment of constipation symptoms (PAC-SYM) total scores compared with placebo in both studies at 12 weeks (Kodiac 4 p=0.023, Kodiac 5 p=0.002).
Danish: Spørgeskema til patientvurdering af obstipationssymptomer (PAC-SYM) I undergruppen med utilstrækkeligt respons på laksantia resulterede naloxegol 25 mg-dosen i en større forbedring (ændring i forhold til baseline) end placebo i patienternes totalscore ifm.
English: The 12.5 mg dose in the LIR subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 (p=0.002) and Kodiac 5 (p<0.001).
Danish: Der blev også påvist en kortere tid til første spontane afføring efter dosering med 12,5 mgdosen i undergruppen med utilstrækkeligt respons på laksantia i forhold til placebo i Kodiac 4 (p=0,002) og Kodiac 5 (p<0,001).
English: • passing wind
Danish: • luftafgang fra tarmen
English: The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p<0.001).
Danish: Forbedring af symptomer på opioidinduceret obstipation 25 mg-dosen i undergruppen med utilstrækkeligt respons på laksantia forbedrede den rektale anstrengelse (Kodiac 4 p=0,043, Kodiac 5 p<0,001).
English: What Moventig looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Moventig 12.5 mg film-coated tablets naloxegol
Danish: Moventig 12,5 mg filmovertrukne tabletter naloxegolum
English: Each film-coated tablet contains 12.5 mg naloxegol (as naloxegol oxalate).
Danish: Hver filmovertrukken tablet indeholder 12,5 mg naloxegol (som naloxegoloxalat).
English: In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol (≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence.
Danish: I de samlede data fra kliniske studier er de hyppigst indberettede bivirkninger med naloxegol (≥5 %):
English: Interaction with strong CYP3A4 inhibitors
Danish: Interaktion med stærke CYP3A4-hæmmere
English: For dose recommendations for patients with moderate or severe renal insufficiency, see section 4.2.
Danish: 4.2 vedrørende doseringsanbefalinger hos patienter med moderat eller svær nyreinsufficiens.
English: What Moventig is and what it is used for What you need to know before you take Moventig How to take Moventig
Danish: Det skal du vide, før du begynder at tage Moventig Sådan skal du tage Moventig Bivirkninger
English: Strong CYP3A4 inhibitors
Danish: Stærke CYP3A4-hæmmere
English: For definition of inadequate response to laxative(s), see section 5.1.
Danish: Se definitionen af utilstrækkeligt respons på laksantia i pkt.
English: It is available as white tablets (625 mg).
Danish: Det fås som hvide tabletter (625 mg).
English: The tablets need to be taken with food and drink.
Danish: Tabletterne skal tages sammen med mad og drikke.
English: This document is a summary of the European Public Assessment Report (EPAR) for Cholestagel.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cholestagel.
English: They can either be taken all at once, or split into two doses during the day.
Danish: De kan enten tages alle på samme tid eller fordeles på to doser i løbet af dagen.
English: Cholestagel was equally effective when it was taken in the morning, in the evening, or twice a day.
Danish: Cholestagel var lige effektivt ved indtagelse om morgenen, om aftenen eller to gange dagligt.
English: Cholestagel is used in the following ways:
Danish: Cholestagel anvendes på følgende måder:
English: ‘Primary' means that there is no disease causing the high cholesterol levels.
Danish: ‘Primær' betyder, at det ikke er nogen sygdom, der forårsager de høje kolesteroltal.
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 Cholestagel.
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 Cholestagel.
English: Blood cholesterol levels should also be measured before and during treatment to check the patient's response.
Danish: Koncentrationen af kolesterol i blodet skal også måles inden og under behandlingen for at kontrollere patientens reaktion.
English: Other information about Cholestagel:
Danish: Andre oplysninger om Cholestagel:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cholestagel to Genzyme Europe B.V. on 10 March 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cholestagel til Genzyme Europe B.V.
English: The CHMP concluded that Cholestagel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Cholestagel opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: • together with ezetimibe (another cholesterol-lowering medicine), with or without a statin.
Danish: • sammen med ezetimibe (et andet kolesterolsænkende lægemiddel) med eller uden et statin.
English: Cholestagel is a medicine that contains the active substance colesevelam.
Danish: Cholestagel er et lægemiddel, der indeholder det aktive stof colesevelam.
English: The full EPAR for Cholestagel can be found here.
Danish: Den fuldstændige EPAR for Cholestagel findes her.
English: Lowering cholesterol, especially LDL cholesterol, can reduce the risk of heart disease.
Danish: En sænkning af kolesterolkoncentrationen, især LDL-kolesterol, reducerer risikoen for hjertesygdomme.
English: This combination can also be used in patients who have familial hypercholesterolaemia (primary hypercholesterolaemia that runs in the family).
Danish: Denne kombination kan også anvendes til patienter, som har en familiær hyperkolesterolæmi (primær hyperkolesterolæmi, som ligger til familien).
English: Because the bile acids are prevented from being absorbed into the bloodstream, the liver is forced to make more bile acids.
Danish: Da galdesyrerne forhindres i at blive absorberet i blodbanen, er leveren nødt til at fremstille mere galdesyre.
English: For more information about treatment with Cholestagel, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med Cholestagel fremgår af indlægssedlen (også en del af denne EPAR).
English: The maximum dose is seven tablets a day when it is taken on its own, and six tablets a day when it is taken with other medicines.
Danish: Den maksimale dosis er syv tabletter dagligt, når lægemidlet tages alene, og seks tabletter dagligt, når det tages sammen med andre lægemidler.
English: Cholestagel should not be used in people who may be hypersensitive (allergic) to colesevelam or any of the other ingredients.
Danish: Cholestagel bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for colesevelam eller andre af indholdsstofferne.
English: What is the risk associated with Cholestagel?
Danish: Hvilken risiko er der forbundet med Cholestagel?
English: Three of these studies looked at Cholestagel taken in combination with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients, two looked at Cholestagel taken on its own in 592 patients, and one looked at Cholestagel in combination with ezetimibe in 86 patients.
Danish: I tre af disse undersøgelser så man nærmere på Cholestagel taget i kombination med et statin (lovastatin, simvastatin eller atorvastatin) hos 491 patienter, i to andre så man på Cholestagel taget alene hos 592 patienter, og i en undersøgelse så man nærmere på Cholestagel i kombination med ezetimibe hos 86 patienter.
English: For the full list of all side effects reported with Cholestagel, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Cholestagel fremgår af indlægssedlen.
English: • as an add-on to a statin (another cholesterol-lowering medicine) and a cholesterol-lowering diet, to further reduce ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol levels in patients who are not adequately controlled with a statin alone;
Danish: • som tillægsbehandling til et statin (et andet kolesterolsænkende lægemiddel) og en kolesterolsænkende kost for yderligere at nedbringe ‘lav-densitetslipoprotein-' (LDL eller ‘det dårlige') kolesteroltal hos patienter, som ikke er under tilstrækkelig kontrol med et statin alene,
English: • as an add-on to a cholesterol-lowering diet, to reduce total-cholesterol and LDL-cholesterol levels in patients who cannot take statins;
Danish: • som tillægsbehandling til en kolesterolsænkende kost for at nedbringe det samlede kolesteroltal og LDL-kolesteroltallet hos patienter, som ikke kan tage statiner,
English: Cholestagel has been compared with placebo (a dummy treatment) in seven main studies involving adults with primary hypercholesterolaemia.
Danish: Cholestagel er blevet sammenlignet med placebo (en virkningsløs behandling) i syv hovedundersøgelser, som omfattede voksne med primær hyperkolesterolæmi.
English: The combination of Cholestagel and ezetimibe was more effective than ezetimibe taken with placebo: there was a fall of 32% in LDL-cholesterol levels in the patients taking Cholestagel and a fall of 21% in those taking placebo.
Danish: Kombinationen af Cholestagel og ezetimibe var mere effektiv end ezetimibe taget sammen med placebo: Der var et fald på 32 % i LDL-kolesteroltallet hos patienter, der fik Cholestagel, og et fald på 21 % hos dem, der fik placebo.
English: Why has Cholestagel been approved?
Danish: Hvorfor blev Cholestagel godkendt?
English: The final study looked at Cholestagel as an add-on to ezetimibe and a statin in 86 adults with familial hypercholesterolaemia.
Danish: I den sidste undersøgelse blev Cholestagel undersøgt som en tillægsbehandling til ezetimibe og et statin hos 86 voksne med familiær hyperkolesterolæmi.
English: The recommended dose of Cholestagel is six tablets a day when it is taken on its own, and four to six tablets a day when it is taken in combination with other medicines.
Danish: Den anbefalede dosis Cholestagel er seks tabletter dagligt, når det tages alene, og fire til seks tabletter dagligt, når det tages i kombination med andre lægemidler.
English: The main measure of effectiveness was the decrease in LDL-cholesterol levels after four to six weeks, except for one of the studies looking at Cholestagel taken on its own, which measured the cholesterol levels after six months.
Danish: Det primære effektmål var faldet i LDLkolesteroltallet efter fire til seks uger, bortset fra en af undersøgelserne, hvor man så nærmere på Cholestagel taget alene, og hvor man målte kolesteroltallet efter seks måneder.
English: In studies, the most common side effects with Cholestagel (seen in more than 1 patient in 10) were flatulence (gas) and constipation.
Danish: I undersøgelserne var de hyppigste bivirkninger ved Cholestagel (som optræder hos flere end 1 ud af 10 patienter) flatulens (luft i maven) og forstoppelse.
English: What is Cholestagel?
Danish: Hvad er Cholestagel?
English: There was a 16% reduction with 3.8 g Cholestagel (about six tablets).
Danish: Der blev opnået en sænkning på 16 % med 3,8 g Cholestagel (ca. seks tabletter).
English: Cholestagel is used to lower cholesterol levels in adults with primary hypercholesterolaemia (high blood cholesterol levels).
Danish: Cholestagel anvendes til at sænke kolesteroltallet hos voksne med primær hyperkolesterolæmi (forhøjet koncentration af kolesterol i blodet).
English: In the studies looking at Cholestagel taken on its own, more than half of the patients receiving 3.8 or 4.5 g Cholestagel (about six to seven tablets) had a decrease in LDL-cholesterol level of 15 to 18% after six weeks.
Danish: I undersøgelserne af Cholestagel anvendt alene opnåede mere end halvdelen af de patienter, der fik 3,8 eller 4,5 g Cholestagel (ca. seks-syv tabletter), et fald på 15 til 18 % i LDL-kolesteroltallet efter seks uger.
English: As the liver uses cholesterol to make bile acids, this reduces cholesterol levels in the blood.
Danish: Når leveren anvender kolesterol til at fremstille galdesyrer, falder koncentrationen af kolesterol i blodet.
English: When added to ezetimibe and a statin, Cholestagel caused a reduction of 11% in LDL-cholesterol levels after six weeks in patients with familial hypercholesterolaemia, compared with a rise of 7% when adding placebo.
Danish: Når Cholestagel blev anvendt som tillægsbehandling til ezetimibe og et statin, bevirkede det et fald på 11 % i LDL-kolesteroltallet efter seks uger hos patienter med familiær hyperkolesterolæmi sammenlignet med en stigning på 7 %, når der blev anvendt placebo som tillægsbehandling.
English: Patients should start a cholesterol-lowering diet before treatment and continue it throughout treatment.
Danish: Før der indledes behandling med Cholestagel, skal patienterne sættes på en kolesterolsænkende diæt, og under behandlingen skal denne diæt fortsætte.
English: Looking at the results of the three studies in which Cholestagel was used with a statin, there was an 8% reduction in LDL-cholesterol levels with 2.3 g Cholestagel (about four tablets) after six weeks, as compared to placebo.
Danish: Resultaterne af de tre undersøgelser, hvor Cholestagel blev anvendt sammen med et statin, viser, at der blev opnået en yderligere sænkning på 8 % af LDL-kolesteroltallet med 2,3 g Cholestagel (ca. fire tabletter) efter seks uger sammenlignet med placebo.
English: In comparison, the patients taking placebo had no changes in LDL-cholesterol levels.
Danish: Til sammenligning var LDLkolesteroltallet uændret hos patienter, der fik placebo.
English: In the longer study, the decrease seen at six weeks with 3.8 g Cholestagel (about six tablets) was maintained for six months.
Danish: I den længerevarende undersøgelsen blev sænkningen, som kunne iagttages efter seks uger med 3,8 g Cholestagel (ca. seks tabletter), fastholdt i seks måneder.
English: How has Cholestagel been studied?
Danish: Hvordan blev Cholestagel undersøgt?
English: What benefit has Cholestagel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cholestagel?
English: What is Cholestagel used for?
Danish: Hvad anvendes Cholestagel til?
English: It must not be used in patients whose gut or bile duct is blocked.
Danish: Cholestagel må ikke gives til patienter med tarm- eller galdevejsobstruktion.
English: How is Cholestagel used?
Danish: Hvordan anvendes Cholestagel?
English: The active substance in Cholestagel, colesevelam, is not absorbed by the body, but stays in the gut, where it attaches to substances called bile acids and carries them out of the body in the faeces.
Danish: Det aktive stof i Cholestagel, colesevelam, absorberes ikke af kroppen.
English: How does Cholestagel work?
Danish: Hvordan virker Cholestagel?
English: Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: The company who applied for a marketing authorisation is Bayer HealthCare AG.
Danish: Firmaet, der har indgivet ansøgning om markedsføringstilladelse, er Bayer HealthCare AG.
English: The CVMP considered that the company had not been able to identify a dose that was effective whilst at the same time providing an adequate margin of safety.
Danish: CVMP fandt, at firmaet ikke havde været i stand til at fastsætte en dosis, der var effektiv, og som på samme tid gav en tilstrækkelig sikkerhedsmargen.
English: For this reason the Committee concluded that the safety of pradofloxacin had not been conclusively proven.
Danish: Af denne grund konkluderede udvalget, at sikkerheden af pradofloxacin ikke var blevet endegyldigt påvist.
English: They noted that the genotoxicity data (the potential for the substance to damage genes) showed differences from that for other antibiotics in the same class, and that the reasons for these differences were unclear.
Danish: Udvalget bemærkede, at dataene vedrørende genotoksicitet (stoffets potentiale til at beskadige gener) viste, at der var forskelle i forhold til data for andre antibiotika i samme klasse, og at grundene til disse forskelle var uklare.
English: QUESTIONS AND ANSWERS ON THE RECOMMENDATION FOR REFUSAL OF A MARKETING AUTHORISATION APPLICATION for VERAFLOX
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VERAFLOX
English: International Non-proprietary Name (INN): pradofloxacin
Danish: Internationalt fællesnavn (INN): pradofloxacin
English: What documentation did the Company present to support its application to the CVMP?
Danish: Hvilken dokumentation har firmaet fremlagt til støtte for ansøgningen til CVMP?
English: This results in the bacteria dying and so the infection is cured.
Danish: Dette medfører, at bakterierne dør, hvorved infektionen kureres.
English: The CVMP was therefore of the opinion that Veraflox's benefits had not been shown to be greater than its risks.
Danish: derfor af den opfattelse, at fordelene ved Veraflox ikke havde vist sig at være større end risiciene.
English: After having considered the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the recommendation of the refusal of the marketing authorisation application on 14 September 2006.
Danish: Efter at have drøftet begrundelserne for denne anmodning tog CVMP udtalelsen op til fornyet overvejelse og bekræftede anbefalingen om at afslå ansøgningen om markedsføringstilladelse den 14. september 2006.
English: On 17 May 2006 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Veraflox 15 mg, 60 mg & 120 mg Tablets for Cats and Dogs, and Veraflox 25 mg/ml Oral Suspension for Cats.
Danish: Den 17. maj 2006 vedtog Udvalget for Veterinærlægemidler (CVMP) en negativ udtalelse, hvori det anbefalede at give afslag på ansøgningen om markedsføringstilladelse for lægemidlet Veraflox 15 mg, 60 mg & 120 mg tabletter til katte og hunde, og Veraflox 25 mg/ml oral suspension til katte.
English: Like other antibiotics, pradofloxacin is not effective against every type of bacteria.
Danish: Som det gælder for andre antibiotika, er pradofloxacin ikke effektivt mod alle typer bakterier.
English: Veraflox is an antibiotic.
Danish: Veraflox er et antibiotikum.
English: All these fluoroquinolones, including pradofloxacin, kill bacteria by interacting with some of the enzymes in bacteria responsible for major DNA functions.
Danish: Alle disse fluoroquinoloner, herunder pradofloxacin, dræber bakterierne ved at interagere med nogle af de enzymer i bakterierne, der er ansvarlige for vigtige DNA-funktioner.
English: The active substance in Veraflox, pradofloxacin, belongs to a class of antibiotics called third generation fluoroquinolones.
Danish: Det aktive stof i Veraflox, pradofloxacin, tilhører en klasse af antibiotika, der kaldes tredje generations fluoroquinoloner.
English: Veraflox Oral Suspension contains 25 mg/ml pradofloxacin.
Danish: Veraflox oral suspension indeholder 25 mg/ml pradofloxacin.
English: How is Veraflox expected to work?
Danish: Hvordan forventes Veraflox at virke?