FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the patient is below 18 years of age: The CRESTOR 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
Danish: • hvis patienten er under 18 år: Crestor 40 mg egner sig ikke til brug hos børn og unge under 18 år
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CRESTOR AND ASSOCIATED NAMES
Danish: ÆNDRINGER, DER SKAL INDFØRES I DE RELEVANTE AFSNIT AF INDLÆGSSEDLEN FOR CRESTOR OG TILKNYTTEDE NAVNE
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CRESTOR AND ASSOCIATED NAMES
Danish: ÆNDRINGER, DER SKAL INKLUDERES I DE RELEVANTE PUNKTER AF PRODUKTRESUMEET FOR CRESTOR OG RELATEREDE NAVNE
English: Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.
Danish: Børn og teenagere skal sættes på en standard kolesterolsænkende diæt før opstart af rosuvastatinbehandling.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rosuvastatin in all subsets of the paediatric population in the treatment of homozygous familial hypercholesterolaemia, primary combined (mixed) dyslipidaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med rosuvastatin i alle undergrupper af den pædiatriske population ved behandling af homozygot familiær hyperkolesterolæmi, primær kombineret (blandet) dyslipidæmi og ved forebyggelse af kardiovaskulære hændelser (se pkt.
English: The evaluation of linear growth (height), weight, BMI (body mass index), and secondary characteristics of sexual maturation by Tanner staging in paediatric patients 6 to 17 years of age taking rosuvastatin is limited to a two-year period.
Danish: Vurdering af lineær vækst (højde), vægt, BMI (Body Mass Index) og sekundære indikationer på seksuel modning ifølge Tanner Stage hos pædiatriske patienter i alderen 6 til 17 år, som tager rosuvastatin, er begrænset til en 2-årig periode.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure and valid at the time of the Commission Decision.
Danish: Dette produktresumé og denne indlægssedel er resultatet af referralproceduren.
English: You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels.
Danish: Du er blevet rådet til at tage statiner, da kostomlægning og mere motion ikke altid er nok til at sænke kolesteroltallet.
English: Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Danish: Homozygot familiær hyperkolesterolæmi, som supplement til diæt og anden lipidsænkende behandling (f.eks. LDL-aferese), eller hvis sådanne behandlinger ikke er velegnede.
English: Patients aged 6 to 9 years (n=64) could titrate to a maximum dose of 10 mg once daily and patients aged 10 to 17 years (n=134) to a maximum dose of 20 mg once daily.
Danish: Patienter i alderen 6 til 9 år (n = 64) kunne titreres til en maksimal dosis på 10 mg én gang dagligt, og patienter i alderen 10 til 17 år (n = 134) til en maksimal dosis på 20 mg én gang dagligt.
English: In a double-blind, randomized, multi-centre, placebo-controlled, 12-week study (n=176, 97 male and 79 female) followed by a 40-week (n=173, 96 male and 77 female), open-label, rosuvastatin dosetitration phase, patients 10-17 years of age (Tanner stage II-V, females at least 1 year postmenarche) with heterozygous familial hypercholesterolaemia received rosuvastatin 5, 10 or 20 mg or placebo daily for 12 weeks and then all received rosuvastatin daily for 40 weeks.
Danish: I et dobbelblindt, randomiseret, placebo-kontrolleret 12-ugers multicenterstudie (n=176, 97 drenge og 79 piger), efterfulgt af en 40-ugers (n=173, 96 drenge og 77 piger) open-label dosistitreringsfase for rosuvastatin, fik patienter i alderen 10-17 år (Tanner Stage II-V, kvinder mindst ét år efter menarche) med heterozygot familiær hyperkolesterolæmi rosuvastatin 5, 10 eller 20 mg eller placebo dagligt i 12 uger, hvorefter alle fik rosuvastatin dagligt i 40 uger.
English: At the end of the 40-week, open-label, titration to goal, dosing up to a maximum of 20 mg once daily, 70 of 173 patients (40.5%) had achieved the LDL-C goal of less than 2.8 mmol/l.
Danish: Efter den 40-ugers open-label-titrering til måldosis ved doser på op til maksimalt 20 mg én gang dagligt havde 70 ud af 173 patienter (40,5 %) opnået LDL-C-målet på under 2,8 mmol/l.
English: Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Danish: Voksne, unge og børn på 6 år og derover med primær hyperkolesterolæmi (type IIa inklusive heterozygot familiær hyperkolesterolæmi) eller kombineret dyslipidæmi (type IIb), som supplement til diæt, når responset på diæt og andre ikke-farmakologiske foranstaltninger (f.eks. motion og vægtreduktion) er utilstrækkeligt.
English: After 24 months of treatment with rosuvastatin, the LS mean percent reduction from the baseline value in LDL-C was -43% (Baseline: 236 mg/dL, Month 24: 133 mg/dL).
Danish: Efter 24 måneders behandling med rosuvastatin var den gennemsnitlige, procentvise reduktion i LDL-C i forhold til baseline -43 % (beregnet ved mindste kvadraters metode) (baseline: 236 mg/dl, måned 24: 133 mg/dl).
English: For each age group, the LS mean percent reductions from baseline values in LDL-C were -43% (Baseline: 234 mg/dL, Month 24: 124 mg/dL), -45% (Baseline: 234 mg/dL, 124 mg/dL ), and -35% (Baseline: 241 mg/dL, Month 24: 153 mg/dL) in the 6 to <10, 10 to <14, and 14 to <18 age groups, respectively.
Danish: I de enkelte aldersgrupper var den gennemsnitlige, procentvise reduktioner i LDL-C i forhold til baseline henholdsvis -43 % (beregnet ved mindste kvadraters metode) (baseline: 234 mg/dl, måned 24: 124 mg/dl), -45 % (baseline: 234 mg/dl, 124 mg/dl) og -35 % (baseline: 241 mg/dl, måned 24: 153 mg/dl) i aldersgrupperne 6 til <10, 10 til <14 og 14 til <18.
English: What you need to know before you take CRESTOR
Danish: Sådan skal du tage Crestor
English: In a clinical trial of children and adolescents receiving rosuvastatin for 52 weeks, CK elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently compared to observations in clinical trials in adults (see Section 4.8).
Danish: I et klinisk forsøg, hvor børn og unge fik rosuvastatin i 52 uger, blev der hyppigere observeret stigninger i kreatinkinase til mere end 10 gange øvre grænseværdi og muskelsymptomer efter motion eller øget fysisk aktivitet end i kliniske forsøg med voksne (se pkt.
English: Children and adolescents 6 to 17 years of age (Tanner Stage <II-V) In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
Danish: Børn og unge i alderen 6 til 17 år (Tanner Stage <II-V) Hos børn og unge med heterozygot familiær hyperkolesterolæmi er den normale startdosis 5 mg dagligt.
English: No effect on growth, weight, BMI or sexual maturation was detected after 24 months of treatment (see Section 4.4).
Danish: Der blev ikke observeret nogen indvirkning på vækst, vægt, BMI eller seksuel modning efter 24 måneders behandling (se pkt.
English: After two years of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 5.1).
Danish: Efter 2 års studiebehandling blev der ikke registreret nogen påvirkning af vækst, vægt, BMI eller seksuel modning (se pkt.
English: After 52 weeks of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 4.4).
Danish: Efter 52 ugers forsøgsbehandling blev der ikke registreret nogen påvirkning af vækst, vægt, BMI eller seksuel modning (se pkt.
English: • In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily.
Danish: • Hos børn i alderen 6 til 9 år med heterozygot familiær hyperkolesterolæmi er det normale dosisinterval 5-10 mg oralt én gang dagligt.
English: • In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily.
Danish: • Hos børn i alderen 10 til 17 år med heterozygot familiær hyperkolesterolæmi er det normale dosisinterval 5-20 mg oralt én gang dagligt.
English: How to take CRESTOR [Existing information on the paediatric population should be replaced with the following:]
Danish: Det skal du vide, før du begynder at tage Crestor [Eksisterende information om den pædiatriske population skal erstattes af følgende:] Børn og unge
English: Rosuvastatin was also studied in a 2-year open-label, titration-to-goal study in 198 children with heterozygous familial hypercholesterolaemia aged 6 to 17 years (88 male and 110 female, Tanner stage <II-V).
Danish: Rosuvastatin blev også undersøgt hos 198 børn i alderen 6 til 17 år (88 drenge og 110 piger, Tanner stage ≤ II-V) med heterozygot familiær hyperkolesterolæmi i et 2-årigt studie med åben behandling og titrering til måldosis.
English: Amendments to the Summary of Product Characteristics and Package Leaflet
Danish: Ændringer til produktresuméet og indlægssedlen fremlagt af Det Europæiske Lægemiddelagentur
English: 5.2 Pharmacokinetic properties [Existing information on the paediatric population should be replaced with the following:] Paediatric population: Two pharmacokinetic studies with rosuvastatin (given as tablets) in paediatric patients with heterozygous familial hypercholesterolaemia 10-17 or 6-17 years of age (total of 214
Danish: Pædiatrisk population: To farmakokinetiske studier med rosuvastatin (givet som tabletter) hos pædiatriske patienter i alderen 10-17 år og 6-17 år med heterozygot familiær hyperkolesterolæmi (i alt 214 patienter) viste, at eksponeringen hos pædiatriske patienter tilsyneladende er sammenlignelig med eller lavere end eksponeringen hos voksne patienter.
English: • You have a high cholesterol level.
Danish: • du har for meget kolesterol i blodet, og derfor kan risikere at få en blodprop eller et slagtilfælde.
English: The recommended dose is 200 mg once a day for 6 days.
Danish: Den anbefalede dosis er 200 mg én gang dagligt i 6 dage.
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere oplysninger findes i resuméet af risikostyringsplanen .
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sivextro on 23 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sivextro den 23. marts 2003.
English: It works by preventing certain bacteria from making proteins, thereby stopping their growth.
Danish: Det virker ved at forhindre visse bakterier i at danne proteiner, så deres vækst standser.
English: The full EPAR and risk management plan summary for Sivextro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Sivextro 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 Sivextro.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sivextro.
English: 85.5% of patients treated with Sivextro in the first study and 88.0% in the second study were cured, compared with 86.0% and 87.7% respectively of patients treated with linezolid.
Danish: 85,5% af de patienter, der blev behandlet med Sivextro i den første undersøgelse, og 88,0 % i den anden undersøgelse, blev helbredt, sammenholdt med henholdsvis 86,0 % og 87,7 % af dem, der blev behandlet med linezolid.
English: It contains the active substance tedizolid.
Danish: Det indeholder det aktive stof tedizolid.
English: Patients who are started on the infusion may be switched to the tablets when appropriate.
Danish: Patienter, der er sat i behandling med infusion, kan skifte til tabletterne, når det er hensigtsmæssigt.
English: Although the infections in the studies were not severe, the CHMP considered that the results also apply to severe infections.
Danish: Skønt infektionerne i undersøgelserne ikke var svære, fandt CHMP, at resultaterne også gælder for svære infektioner.
English: A risk management plan has been developed to ensure that Sivextro is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Sivextro anvendes så sikkert som muligt.
English: Other information about Sivextro
Danish: Andre oplysninger om Sivextro
English: In both studies patients received 6 days of treatment with Sivextro which was compared with a 10-day treatment of linezolid.
Danish: I begge undersøgelser fik patienterne 6 dages behandling med Sivextro, som blev sammenlignet med 10 dages behandling med linezolid.
English: What is Sivextro and what is it used for?
Danish: Hvad er Sivextro, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sivextro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Sivextro opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Sivextro's safety profile is comparable to that of linezolid and was considered acceptable.
Danish: Sikkerhedsprofilen af Sivextro fandtes at være sammenlignelig med linezolid og blev anset for acceptabel.
English: Before using Sivextro, doctors should consider official guidance on the appropriate use of antibiotics.
Danish: Ved ordination af Sivextro bør lægen tage hensyn til officielle retningslinjer for forsvarlig brug af antibiotika.
English: What measures are being taken to ensure the safe and effective use of Sivextro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sivextro?
English: In both studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
Danish: I begge undersøgelser blev behandlingens virkning hovedsagelig bedømt på den andel af patienterne, hos hvem infektionen var helbredt efter behandlingen.
English: Sivextro was at least as effective as linezolid at curing the infection.
Danish: Sivextro var mindst lige så effektivt som linezolid til at helbrede infektionen.
English: Why is Sivextro approved?
Danish: Hvorfor blev Sivextro godkendt?
English: It is not intended to provide practical advice on how to use Sivextro.
Danish: Det er ikke en praktisk vejledning i, hvordan Sivextro bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sivextro, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Sivextro, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The most common side effects with Sivextro (which may affect between 2 and 7 people in 100) are nausea (feeling sick), headache, diarrhoea and vomiting.
Danish: De hyppigste bivirkninger ved Sivextro (kan forekomme hos mellem 2 og 7 ud af 100 personer), er kvalme, hovedpine, diarré og opkastning.
English: What are the risks associated with Sivextro?
Danish: Hvilke risici er der forbundet med Sivextro?
English: The active substance in Sivextro, tedizolid, is a type of antibiotic called an oxazolidinone.
Danish: Det aktive stof i Sivextro, tedizolid, er et antibiotikum af typen oxazolidinoner.
English: In light of the need for new antibiotics targeting multi-resistant bacteria, especially those available as an oral (given by mouth) formulation, the CHMP concluded that Sivextro could be a valuable alternative treatment option for bacterial infections of the skin and of skin structures.
Danish: Da der er behov for nye antibiotika, der virker på multiresistente bakterier, navnlig dem, der fås i en formulering til indgift gennem munden (oralt), konkluderede CHMP, at Sivextro kunne være et værdifuldt behandlingsalternativ ved bakterielle infektioner i hud og underliggende væv.
English: Sivextro was compared with linezolid (another oxazolidinone) in two main studies involving a total of 1,333 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Danish: Sivextro blev sammenlignet med linezolid (et andet oxazolidinon) i to hovedundersøgelser, hvori der deltog i alt 1 333 patienter med akutte bakterielle infektioner i hud og underliggende væv såsom cellulitis, hudabscesser og sårinfektioner.
English: For more information about treatment with Sivextro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sivextro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Sivextro can only be obtained with a prescription.
Danish: Lægemidlet Sivextro udleveres kun efter recept.
English: Sivextro is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Danish: Sivextro er et antibiotikum, der anvendes hos voksne til behandling af kortvarige (akutte) bakterielle infektioner i hud og underliggende væv såsom betændelse i de dybe lag af huden (cellulitis), bylder (hudabscesser) og sårinfektioner.
English: Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg).
Danish: Sivextro fås som et pulver, der anvendes til at fremstille en injektionsvæske, som gives med drop i en vene (infusion), og som tabletter (200 mg).
English: A list of bacteria against which Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de bakterier, som Sivextro virker mod, findes i produktresuméet, der også er en del af denne EPAR.
English: For practical information about using Sivextro, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Sivextro, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Sivextro has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Danish: som sædvanlige antibiotika ikke virker mod (såsom meticillinresistente Staphylococcus aureus (MRSA)).
English: For the full list of all side effects and restrictions with Sivextro, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Sivextro fremgår af indlægssedlen.
English: How is Sivextro used?
Danish: Hvordan anvendes Sivextro?
English: What benefits of Sivextro have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Sivextro?
English: How does Sivextro work?
Danish: Hvordan virker Sivextro?
English: The submission of a revised protocol should take place within 10 days after the Commission Decision.
Danish: Der skal indsendes en revideret protokol senest 10 dage efter Kommissionens afgørelse.
English: Condition considered essential for the safe and effective use of the medicinal product including pharmacovigilance
Danish: Betingelse, der anses for at være af afgørende betydning for en sikker og virkningsfuld brug af lægemidlet, herunder lægemiddelovervågning
English: a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed.
Danish: Der skal udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet som angivet i udtalelsen.
English: The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Danish: De nationale kompetente myndigheder skal med referencemedlemsstaten som koordinator sikre, at følgende betingelser bliver opfyldt af indehaveren af markedsføringstilladelse:
English: Treatment is divided into 2 phases: induction and consolidation.
Danish: Behandlingen er opdelt i to faser: induktion og konsolidering.
English: The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.
Danish: Infusionen bør vare én til to timer, men kan vare længere, hvis patienten får visse bivirkninger.
English: Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Danish: Yderligere information vedrørende Arsenic trioxide Accord findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
English: • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Danish: • patienter med akut promyelocyt leukæmi, der ikke har reageret på tidligere behandling med et retinoid eller lægemidler mod kræft, eller når deres sygdom er vendt tilbage efter en sådan behandling.
English: The recommended dose of Arsenic trioxide Accord depends on the patient's weight.
Danish: Den anbefalede dosis af Arsenic trioxide Accord afhænger af patientens vægt.
English: It is given as an infusion (drip) into a vein.
Danish: Det gives som infusionsvæske (drop) i en vene.
English: Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Danish: Arsenic trioxide Accord anvendes til behandling af voksne (over 18 år) med akut promyelocyt leukæmi (APL), en sjælden form for leukæmi (kræft i de hvide blodlegemer), som skyldes en genetisk "translokation" (når to kromosomer bytter gener).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Arsenic trioxide Accord kan sammenlignes med Trisenox.
English: Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Arsenic trioxide Accord er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Arsenic trioxide Accord optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Danish: Arsenic trioxide Accord fås kun på recept, og brugen af det bør overvåges af en læge med erfaring i behandling af patienter med akut leukæmi.