FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean plasma concentrations (Cmax) were 2% lower in the Child-Pugh Class A group and 30% lower in the Child-Pugh Class B group.
Danish: Child-Pugh-klasse), steg den gennemsnitlige systemiske eksponering (mindste kvadraters metode) (AUC) 64% i gruppen fra Child-Pugh-klasse A og 84% i gruppe fra Child Pugh-klasse B i forhold til 32 raske personer, der passede sammen aldersog vægtmæssigt, og som havde normal leverfunktion.
English: The concomitant administration of CRESEMBA and St John's wort is contraindicated.
Danish: Samtidig administration af CRESEMBA og Johannesurt er kontraindiceret.
English: (CYP3A4 inhibition)
Danish: (CYP3A4-hæmning)
English: CYP3A4/5 inhibitors
Danish: CYP3A4/5-hæmmere
English: No CRESEMBA dose adjustment necessary.
Danish: Justering af CRESEMBA-dosis ikke nødvendig.
English: Based on results with atorvastatin, no statin dose adjustment required.
Danish: Intet behov for justering af dosis af statinet, baseret på resultater med atorvastatin.
English: Adverse Drug Reactions Blood and lymphatic system disorders Uncommon Neutropenia; Thrombocytopenia^; Pancytopenia; Leukopenia^; Anaemia^ Immune system disorders Uncommon Hypersensitivity^ Metabolism and nutrition disorders Common Hypokalaemia; Decreased appetite Uncommon Hypomagnesaemia; Hypoglycaemia; Hypoalbuminaemia; Malnutrition^ Psychiatric disorders Common Delirium^ Uncommon Depression; Insomnia^ Nervous system disorders Common Headache; Somnolence Uncommon Convulsion^; Syncope; Dizziness ; Paraesthesia^; Encephalopathy; Presyncope; Neuropathy peripheral; Dysgeusia; Ear and labyrinth disorders Uncommon Vertigo Cardiac disorders Uncommon Atrial fibrillation; Tachycardia; Bradycardia^; Palpitations Atrial flutter; Electrocardiogram QT shortened; Supraventricular tachycardia; Ventricular extrasystoles ; Supraventricular extrasystoles
Danish: Atriefibrillering; takykardi; bradykardi^; palpitationer Atrieflagren; forkortet QT på elektrokardiogram; supraventrikulær takykardi; ventrikulære ekstrasystoler; supraventrikulære ekstrasystoler Vaskulære sygdomme Almindelig Thrombophlebitis^ Ikke almindelig
English: Anticoagulants Dabigatran etexilate (P-gp substrate)
Danish: Antikoagulantia Dabigatranetexilat (P-gp-substrat)
English: (mild CYP3A4/5 inducer)
Danish: (CYP3A4/5-induktion)
English: (CYP3A4/5 inhibition).
Danish: (CYP3A4/5-hæmning).
English: - efavirenz, etravirine, used for HIV, - nafcillin, used for bacterial infections.
Danish: - prednison, der bruges til behandling af leddegigt (rheumatoid arthritis) - pioglitazon, der bruges til behandling af diabetes
English: If a patient develops a severe cutaneous adverse reaction, CRESEMBA should be discontinued.
Danish: CRESEMBA skal seponeres, hvis patienten får en alvorlig kutan bivirkning.
English: Common Elevated liver chemistry tests^ Uncommon Hepatomegaly; Hepatitis Skin and subcutaneous tissue disorders Common Rash^; Pruritus
Danish: Mave-tarm-kanalen Almindelig Opkastning; diarré; nausea; abdominalsmerter^; Ikke almindelig
English: For example:
Danish: For eksempel:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Præparatoplysningerne kan efterfølgende opdateres af de relevante myndigheder i medlemsstaten, eventuelt i samarbejde med referencemedlemsstaten, i overensstemmelse med de procedurer, der er fastsat i kapitel 4 i afsnit III i direktiv 2001/83/EF.
English: Severe heart failure (NYHA Class IV)
Danish: Alvorlig hjerteinsufficiens (NYHA-klasse IV)
English: The dosage should be adjusted to the severity of the disorder and the complaints of the patient.
Danish: Doseringen skal justeres i forhold til sygdommens sværhedsgrad og patientens klager.
English: [Invented name] may affect or be affected by some other medicines.
Danish: [Særnavn] kan påvirke eller blive påvirket af visse andre lægemidler.
English: These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.
Danish: Disse ændringer til relevante afsnit i produktresuméet og indlægssedlen er resultatet af referralproceduren.
English: Some other medicines may also affect or be affected by the treatment of [Invented name].
Danish: Visse andre lægemidler kan også påvirke eller blive påvirket af behandlingen med [særnavn].
English: For all ibuprofen-containing products
Danish: For alle præparater, der indeholder ibuprofen
English: You should therefore always seek the advice of your doctor or pharmacist before you use [Invented name] with other medicines.
Danish: Derfor skal du altid spørge lægen eller apotekspersonalet til råds, før du tager [særnavn] sammen med andre lægemidler.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til relevante afsnit i produktresuméet og indlægssedlen
English: B. Package Leaflet Section 2 - What you need to know before you take [Invented name]
Danish: B. Indlægsseddel Afsnit 2 - Det skal du vide, før du begynder at tage [særnavn]
English: You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:
Danish: Tal med lægen eller apotekspersonalet om din behandling, før du tager [særnavn], hvis du:
English: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Danish: Bivirkningerne kan minimeres ved at anvende den laveste effektive dosis, der er nødvendig til at kontrollere symptomerne, i så kort tid som muligt (se pkt.
English: For all dexibuprofen-containing products
Danish: For alle præparater, der indeholder dexibuprofen
English: Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).
Danish: Der foreligger kun begrænsede data om risikoen for arteriel trombose ved dexibuprofen, men det er rimeligt at antage, at risikoen ved høje doser af dexibuprofen (1200 mg/dag) er sammenlignelig med den, der er forbundet med høje doser af ibuprofen (2400 mg/dag).
English: Do not exceed the recommended dose or duration of treatment.
Danish: Tag ikke mere medicin end anbefalet, og tag ikke medicinen i længere tid end anbefalet.
English: - have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”).
Danish: - har hjerteproblemer, herunder hjertesvigt eller angina (brystsmerter), eller hvis du har haft et hjerteanfald, har fået foretaget en bypass-operation, har haft sygdom i perifere arterier (dårligt blodomløb i benene eller fødderne på grund af snævre eller blokerede blodårer) eller har haft nogen form for slagtilfælde (herunder "mini-slagtilfælde" eller forbigående blodprop i hjernen).
English: Concomitant administration of dexibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
Danish: Samtidig administration af dexibuprofen og acetylsalicylsyre anbefales generelt ikke på grund af en potentielt øget bivirkningsfrekvens.
English: - medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Danish: - lægemidler, som nedsætter etforhøjet blodtryk (ACE-hæmmere som f.eks. captopril, betablokkere som f.eks. atenolol, angiotensin-II-receptorantagonister som f.eks. losartan)
English: Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
Danish: Samtidig administration af ibuprofen og acetylsalicylsyre anbefales generelt ikke på grund af en potentielt øget bivirkningsfrekvens.
English: Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.
Danish: Samlet set tyder epidemiologiske studier ikke på, at lave doser af ibuprofen (f.eks. ≤ 1200 mg/dag) er forbundet med en øget risiko for arterielle trombotiske hændelser.
English: - have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Danish: - har forhøjet blodtryk, sukkersyge eller forhøjet kolesterol, hvis der er nogen i din familie, der har eller har haft hjertesygdomme eller slagtilfælde, eller hvis du ryger.
English: Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred.
Danish: Nogle farmakodynamiske studier viser, at acetylsalicylsyres virkning på dannelsen af tromboxan eller trombocytaggregation blev nedsat ved administration af enkeltdoser af ibuprofen på 400 mg inden for 8 timer før eller 30 minutter efter en dosis acetylsalicylsyre (81 mg) med umiddelbar udløsning.
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Danish: Der foreligger ingen data for dexibuprofen, men det er rimeligt at antage, at der kan forekomme lignende interaktion mellem dexibuprofen (= S(+)-ibuprofen, som er den farmakologisk aktive enantiomer af ibuprofen) og lavdosis acetylsalicylsyre.
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Danish: Der foreligger ingen data for dexibuprofen, men det er rimeligt at antage, at der kan forekomme lignende interaktion mellem dexibuprofen (= S(+)ibuprofen,den farmakologisk aktive enantiomer af ibuprofen) og lavdosis acetylsalicylsyre.
English: - medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
Danish: - lægemidler, som hindrer blodet i at størkne (dvs. som fortynder blodet eller forebygger blodpropper, f.eks. acetylsalicylsyre, warfarin, ticlopidin)
English: Anti-inflammatory/pain-killer medicines like dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.
Danish: Anti-inflammatorisk (hæmmer betændelses lignende tilstande)/smertestillende medicin som f.eks. dexibuprofen kan være forbundet med en let øget risiko for hjerteanfald eller slagtilfælde, særligt nårdet bruges i høje doser.
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).
Danish: Det anses ikke for at være sandsynligt, at der er en klinisk relevant virkning ved lejlighedsvis brug af ibuprofen (se pkt.
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Danish: Patienter med ukontrolleret hypertension, kongestiv venstresidig hjerteinsufficiens (NYHA II-III), bekræftet iskæmisk hjertesygdom, perifer arteriesygdom og/eller cerebrovaskulær sygdom bør kun behandles med ibuprofen efter nøje overvejelse, og høje doser (2400 mg/dag) bør undgås.
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording]
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion [Afsnittet skal ændres, så det afspejler følgende formulering]
English: Section 5.1 - Pharmacodynamic properties [The section should be amended to reflect the following wording]
Danish: Afsnit 5.1 - Farmakodynamiske egenskaber [Afsnittet skal ændres, så det afspejler følgende formulering]
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Danish: En klinisk relevant virkning ved lejlighedsvis brug af ibuprofen anses ikke for at være sandsynlig (se pkt.
English: Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.
Danish: Anti-inflammatorisk (hæmmer betændelseslignende tilstande)/smertestillende medicin som f.eks. ibuprofen kan være forbundet med en let øget risiko for hjerteanfald eller slagtilfælde, særligt når det bruges i høje doser.
English: Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.
Danish: Eksperimentelle data tyder på, at ibuprofen muligvis kompetitivt hæmmer virkningen af lavdosis acetylsalicylsyre på trombocytaggregation ved samtidig administration.
English: Warnings and precautions [The section should be amended to reflect the following wording]
Danish: Advarsler og forsigtighedsregler [Afsnittet skal ændres, så det afspejler følgende formulering]
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.
Danish: Initieringaf langvarig behandling hos patienter med risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) skal også nøje overvejes, særligt hvis høje dexibuprofendoser (1200 mg/dag) er nødvendige.
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.
Danish: Patienter med ukontrolleret hypertension, kongestivvenstresidig hjerteinsufficiens (NYHA II-III), bekræftet iskæmisk hjertesygdom, perifer arteriesygdom og/eller cerebrovaskulær sygdom børkun behandles med dexibuprofen efter nøje overvejelse, og høje doser (1200 mg/dag) børundgås.
English: Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.
Danish: Der er usikkerheder vedrørende ekstrapolation af disse data til den kliniske situation, men muligheden for, at regelmæssig langvarig behandling med ibuprofen kan nedsætte den kardioprotektive virkning lavdosis acetylsalicylsyre, kan ikke udelukkes.
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Danish: Initiering af langvarig behandling hos patienter med risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) skal også nøje overvejes, særligt hvis høje ibuprofendoser (2400 mg/dag) er nødvendige.
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen [Afsnittet skal ændres, så det afspejler følgende formulering]
English: Other medicines and [Invented name] [The section should be amended to reflect the following wording]
Danish: Brug af anden medicin sammen med [særnavn] [Afsnittet skal ændres, så det afspejler følgende formulering]
English: Section 4.3 - Contraindications [The section should be amended to reflect the following wording]
Danish: Punkt 4.3 - Kontraindikationer [Afsnittet skal ændres, så det afspejler følgende formulering]
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Danish: Kliniske studier tyder på, at ibuprofen, særligt ved høje doser (2400 mg/dag), kan være forbundet med en let øget risiko for arterielle trombotiske hændelser (f. eks. myokardieinfarkt eller apopleksi).
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Danish: Kliniske studier tyder på, at ibuprofen, særligt ved høje doser (2400 mg/dag), kan være forbundet med en let øget risiko for arterielle trombotiske hændelser (f. eks. myokardieinfarkt eller apopleksi) (se pkt.
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording (if sub-sections exist this wording should be included in the relevant sub-section, e.g. concomitant use not recommended)]
Danish: [Afsnittet skal ændres, så det afspejler den følgende formulering (hvis der er underafsnit, skal denne formulering medtages i det relevante underafsnit, for eksempel om at samtidig brug ikke anbefales)]
English: Section 4.8 - Undesirable effects [The section should be amended to reflect the following wording]
Danish: Afsnit 4.8 - Bivirkninger [Afsnittet skal ændres, så det afspejler følgende formulering]
English: Further information on Buvidal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Buvidal.
Danish: Yderligere information om Buvidal findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Buvidal.
English: Patients cannot take the medicine home or inject it themselves.
Danish: Patienter må ikke tage lægemidlet hjemme eller selv foretage indsprøjtningen.
English: As for all medicines, data on the use of Buvidal are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Buvidal løbende overvåget.
English: Buvidal is used in adults and adolescents aged over 16 years who are also receiving medical, social and psychological support.
Danish: Buvidal anvendes til voksne og unge over 16 år, som også får lægehjælp samt social og psykologisk støtte.
English: Buvidal (buprenorphine)
Danish: Buvidal (buprenorphin)
English: Although information on the long-term safety of the new formulation was lacking, the Agency's view was that the benefit of Buvidal outweighs the identified risk and it can be authorised for use in the EU.
Danish: Selvom der mangler information om sikkerheden på længere sigt, var agenturet af den opfattelse, at fordelene ved Buvidal opvejer de identificerede risici, og anbefalede, at det kan godkendes til anvendelse i EU.
English: An overview of Buvidal and why it is authorised in the EU
Danish: En oversigt over Buvidal, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Buvidal?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Buvidal?
English: Other information about Buvidal
Danish: Andre oplysninger om Buvidal
English: During the 25 weeks of treatment, 35% of patients given Buvidal had a negative urine test, compared with 28% of patients taking the comparator tablets.
Danish: I løbet af 25 ugers behandling havde 35 % af de patienter, der fik Buvidal, en negativ urinprøve, sammenlignet med 28 % af de patienter, der fik sammenligningstabletterne.
English: For more information about using Buvidal, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Buvidal, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Buvidal is given in a different way.
Danish: Det vil sige, at det svarer til et "referencelægemiddel", der indeholder samme aktive stof, men indgives på en anden måde.
English: This means it can be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Danish: Det betyder, at det kan anvendes på en kontrolleret måde for at hjælpe med at forebygge abstinenssymptomer og reducere trangen til at misbruge andre opioider.
English: The reference medicine for Buvidal is Subutex.
Danish: Referencelægemidlet for Buvidal er Subutex.
English: A study involving 428 patients with opioid dependence showed that Buvidal was effective at reducing patients' intake of opioid drugs.
Danish: Et studie, der omfattede 428 patienter, der var afhængige af opioider, viste, at Buvidal var effektivt til at reducere patienters indtag af opioide lægemidler.
English: It can only be obtained with a prescription and can only be given by a healthcare professional.
Danish: Det udleveres kun efter recept og skal indgives af sundhedspersonale.
English: Side effects reported with Buvidal are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Buvidal vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Patients who have never taken buprenorphine before should be given a 4 mg buprenorphine tablet and be monitored for one hour before being given Buvidal, to make sure they tolerate the medicine.
Danish: Patienter, der aldrig har taget buprenorphin før, bør gives en 4 mg buprenorphin-tablet og overvåges i en time, inden de får Buvidal for at sikre, at de tolererer lægemidlet.
English: Buvidal is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Danish: Buvidal er et lægemiddel, som anvendes til at behandle afhængighed af opioider (narkotika) som f.eks. heroin eller morfin.
English: The main measure of effectiveness was based on the number of urine samples that tested negative for opioids.
Danish: Det vigtigste mål for behandlingens virkning var antallet af urinprøver, der blev testet negative for opioider.
English: Why is Buvidal authorised in the EU?
Danish: Hvorfor er Buvidal godkendt i EU?
English: What is Buvidal and what is it used for?
Danish: Hvad er Buvidal, og hvad anvendes det til?
English: The European Medicines Agency concluded that Buvidal was at least as effective as buprenorphine tablets at treating opioid dependence.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Buvidal var mindst lige så effektivt som buprenorphin-tabletter til at behandle opioidafhængighed.
English: Weekly or monthly injections with Buvidal would offer an additional option for managing the condition.
Danish: Ugentlige eller månedlige indsprøjtninger med Buvidal vil være en ekstra mulighed for at behandle lidelsen.
English: The dose of Buvidal can be adjusted and patients can be switched between weekly and monthly injections according to the patient's need and the judgement of the treating doctor.
Danish: Buvidal-dosen kan tilpasses, og patienterne kan skifte mellem ugentlige og månedlige indsprøjtninger afhængig af patientens behov og lægens vurdering.
English: For patients dependent on short-acting opioids (e.g. morphine or heroin), the first dose is given at least 6 hours after the patient last used an opioid.
Danish: Til patienter, der er afhængige af korttidsvirkende opioider (f.eks. morfin eller heroin), gives første dosis mindst 6 timer, efter at patienten sidst har indtaget et opioid.
English: What are the risks associated with Buvidal?
Danish: Hvilke risici er der forbundet med Buvidal?