FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that the bacterial species most frequently involved in skin and soft tissue infections (i.e. staphylococci and streptococci) are sensitive to cefuroxime.
Danish: CHMP konstaterede, at de oftest involverede bakteriearter ved infektioner i hud og underliggende væv (dvs. stafylokokker og streptokokker) er følsomme for cefuroxim.
English: The CHMP considered that treatment with cefuroxime axetil might not curtail further transmission of the infection.
Danish: CHMP tog i betragtning, at behandlingen med cefuroximaxetil ikke nødvendigvis begrænser videre overførsel af infektionen.
English: Zinnat contains cefuroxime axetil which is an oral pro-drug of cefuroxime, a second generation cephalosporin antibacterial agent.
Danish: Zinnat indeholder cefuroximaxetil, som er et oralt prodrug til cefuroxim, der er et andengenerations cefalosporin.
English: Based on the submitted study data, the CHMP considered the indication for the treatment of early Lyme disease to be acceptable.
Danish: På grundlag af de forelagte undersøgelser godkendte CHMP indikationen behandling af Lymes sygdom i tidligt stadium.
English: The CHMP reviewed the dosage recommendations for each individual indication and agreed that infections suspected or proven to be due to less susceptible bacterial species (such as penicillin intermediate S. pneumonia, M. catarrhalis and H. influenzae) should be treated with 500 mg administered every 12 hours.
Danish: CHMP gennemgik dosisanbefalingerne for hver enkelt indikation og fastslog, at infektioner, der formodes eller er fastslået at være forårsaget af mindre følsomme arter (såsom intermediære penicillinresistente S. pneumoniae, M. catarrhalis og H. influenzae) bør behandles med 500 mg hver 12. time.
English: Regarding patients with hepatic impairment, the CHMP noted that there is no available data.
Danish: For patienter med nedsat leverfunktion konstaterede CHMP, at der ikke foreligger nogen dokumentation.
English: For the paediatric population, the CHMP agreed that the dosage should be 15 mg/kg twice daily, to a maximum of 250 mg twice daily.
Danish: Til den pædiatriske population fastslog CHMP, at doseringen bør være 15 mg/kg to gange dagligt, maksimaldosis 250 mg to gange dagligt.
English: In children, the CHMP similarly recommended a dosage of 15 mg/kg BID (250 mg twice daily up to 500 mg daily) for the cystitis indication.
Danish: Hos børn anbefalede CHMP tilsvarende en dosering på 15 mg/kg to gange dagligt (250 mg to gange dagligt op til 500 mg dagligt) til cystitisindikationen.
English: Based on the submitted data, including studies by Hoberman, 2011, Tähtinen, 2011, Pessey, 1999, Gooch, 1996, McLinn, 1994, McLinn, 1990, Schwarz, 1991, Brodie, 1990 and Pichichero, 1990, the CHMP considered the proposed indication to be acceptable.
Danish: CHMP godkendte den foreslåede indikation på grundlag af de forelagte data, herunder undersøgelser foretaget af Hoberman, 2011, Tähtinen, 2011, Pessey, 1999, Gooch, 1996, McLinn, 1994, McLinn, 1990, Schwarz, 1991, Brodie, 1990 og Pichichero, 1990.
English: • The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and other clinical documentation, justifying the proposed harmonisation of the product information;
Danish: • Udvalget gennemgik de data, der er forelagt af indehaveren af markedsføringstilladelsen fra kliniske undersøgelser, den publicerede litteratur og den kliniske dokumentation som grundlag for den foreslåede harmonisering af produktinformationen.
English: • The committee considered the identified divergences for Zinnat and associated names regarding the therapeutic indications and the posology and method of administration sections, as well as in the remaining sections of the SmPC,
Danish: • Udvalget behandlede de konstaterede divergenser for Zinnat og relaterede navne hvad angår terapeutiske indikationer, dosering, administrationsvej og de øvrige afsnit af produktresuméet.
English: Skin and soft tissue infections
Danish: Infektioner i hud og underliggende væv
English: The CHMP reviewed all available data and also noted that less susceptible pathogens cannot be managed by using higher doses of cefuroxime axetil than the maximum daily dose of 500 mg, due to the toxic degradation products of cefuroxime axetil and a lack of safety data.
Danish: CHMP gennemgik alle de foreliggende data og bemærkede, at infektioner med mindre følsomme patogene organismer ikke kan behandles ved at anvende højere doser af cefuroximaxetil end den maksimale daglige dosis på 500 mg på grund af toksiske nedbrydningsprodukter af cefuroximaxetil og manglende sikkerhedsdata.
English: The CHMP noted the large degree of divergences in the nationally approved posologies and recommendations and therefore reviewed the available data to support a harmonised Section 4.2.
Danish: CHMP konstaterede, at der er store divergenser i de nationalt godkendte doseringer og anbefalinger, og gennemgik derfor den foreliggende dokumentation for et harmoniseret afsnit 4.2.
English: Zinnat was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the abovementioned product.
Danish: Zinnat blev sat på listen over produkter, som skal have opdateret produktresuméet, fordi medlemsstaterne har truffet divergerende afgørelser vedrørende godkendelse af produktet.
English: The CHMP inserted a statement advising that the cefuroxime axetil suspension formulation is not bioequivalent to the tablet formulation and are not substitutable on a milligram-per-milligram basis, due to differences in bioavailability and the time-concentration curve.
Danish: CHMP indsatte en erklæring om, at cefuroximaxetil som suspension ikke er bioækvivalent med tabletformuleringen, og at de to formuleringer ikke kan erstatte hinanden på milligram-formilligram basis som følge af forskelle i biotilgængeligheden og i forløbet af tidskoncentrationskurven.
English: The CHMP considered that the available clinical and PK/PD data confirm that a twice daily regimen of cefuroxime axetil is an effective dosage and that the use of cefuroxime axetil given three times daily is unsupported by the clinical and safety data.
Danish: CHMP fandt, at de foreliggende kliniske og farmakokinetiske/farmakodynamiske data bekræfter, at et dosisregime for cefuroximaxetil på to gange dagligt er effektivt, mens anvendelse af cefuroximaxetil tre gange dagligt ikke støttes af de kliniske data eller sikkerhedsdata.
English: The CHMP noted the large degree of divergences in the nationally approved indications and therefore reviewed the available data supporting each indvidual indication.
Danish: CHMP konstaterede, at der er store divergenser mellem de nationalt godkendte indikationer, og gennemgik derfor den foreliggende dokumentation for hver enkelt indikation.
English: For the cystitis indication, the CHMP recommended an adult dosing regimen of 250 mg BID, to ensure adequate urinary concentrations of cefuroxime and thus the eradication of the key uropathogens implicated.
Danish: Til cystitisindikationen anbefalede CHMP et dosisregime for voksne på 250 mg to gange dagligt for at sikre tilstrækkelig koncentration af cefuroxim i urinvejene og dermed eradikation af de vigtigste involverede urinvejspatogener.
English: Based on the available data, the CHMP concluded that cefuroxime axetil is not suitable in the treatment of uncomplicated gonorrhoea (urethritis and cervicitis) and therefore recommends the removal of the proposed indication.
Danish: På grundlag af de foreliggende data konkluderede CHMP, at cefuroximaxetil ikke er velegnet til behandling af ukompliceret gonorré (urethritis og cervicitis), og anbefalede derfor, at den foreslåede indikation udgår.
English: “Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1).
Danish: Som konklusion vedtog CHMP følgende harmoniserede indikationer og ordlyd til afsnit 4.1: “Zinnat er indiceret til behandling af nedenstående infektioner hos voksne og børn over tre måneder) (se afsnit 4.4 og 5.1).
English: However, having reviewed the submitted data, including studies by Kristo, 2005, Falagas, 2008, Zervos, 2003 as well as a Cochrane systematic review conducted by Ahovuo-Saloranta, 2008, a meta-anlysis by Young, 2008 and a systematic review by Ip, 2005, the CHMP considered the proposed indication to be acceptable.
Danish: CHMP kunne dog godkende den foreslåede indikation efter at have gennemgået de forelagte data, herunder undersøgelser udført af Kristo, 2005, Falagas, 2008, Zervos, 2003, en systematisk Cochrane-gennemgang udført af Ahovuo-Saloranta, 2008, en metaanalyse udført af Young, 2008 og en systematisk gennemgang foretaget af Ip, 2005.
English: Having reviewed the submitted data, including studies by Aujard, 1995, Gooch, 1993 and Scholz, 2004, as well as studies by the German Society for Paediatric Infectious Diseases and an open, parallel group MAH-sponsored study conducted in general practice centres in the UK, France and Germany in 1989, the CHMP considered that the data supported the proposed indication.
Danish: Efter gennemgang af de forelagte data fandt CHMP den foreslåede indikation veldokumenteret gennem undersøgelserne udført af Aujard, 1995, Gooch, 1993 og Scholz, 2004, undersøgelser udført af Deutsche Gesellschaft für Pädiatrische Infektiologie samt en åben parallelgruppeundersøgelse, der blev sponsoreret af indehaveren af markedsføringstilladelsen og udført på almenmedicinske centre i Storbritannien, Frankrig og Tyskland i 1989.
English: Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Zinnat and associated names is favourable.
Danish: Grundlaget for indbringelsen var harmonisering af produktresuméet, etiketteringen og indlægssedlen På grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, vurderingsrapporterne fra rapportøren og co-rapportøren samt de faglige drøftelser i udvalget fandt CHMP benefit/risk-forholdet for Zinnat og relaterede navne positivt.
English: The CHMP therefore concluded that cefuroxime axetil is not an appropriate agent for the empirical treatment of community acquired pneumonia and recommends the removal of this indication.
Danish: CHMP konkluderede derfor, at cefuroximaxetil ikke er velegnet til empirisk behandling af ikke-nosokomiel pneumoni, og anbefalede, at denne indikation udgår.
English: Having reviewed the submitted clinical documentation, which consisted of four adequately designed relatively large (>300 patients) double-blinded, comparative studies, the CHMP considered the proposed indication to be acceptable.
Danish: CHMP godkendte den foreslåede indikation efter gennemgang af den forelagte kliniske dokumentation, der består af fire relativt store (>300 patienter), dobbeltblindede sammenlignende undersøgelser med velegnet design.
English: Uncomplicated skin and soft tissue infections.
Danish: • Ukomplicerede infektioner i hud og underliggende væv:
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holders,
Danish: • Udvalget godkendte den harmonisering af produktresuméet, etiketteringen og indlægssedlen,
English: The CHMP also adopted a harmonised wording for the remaining sections of the Zinnat SmPC and brought the labelling and the package leaflet in line with the adopted harmonised SmPC.
Danish: Mindre divergenser i andre afsnit af produktresuméet, etiketteringen og indlægssedlen CHMP vedtog desuden en harmoniseret ordlyd til de øvrige afsnit af produktresuméet for Zinnat og rettede etiketteringen og indlægssedlen ind efter det vedtagne harmoniserede produktresumé.
English: Regarding patients with renal impairment, the CHMP reviewed the data and concluded that the proposed dosing guidelines in patients with renal impairment were acceptable.
Danish: For patienter med nedsat nyrefunktion godkendte CHMP de foreslåede doseringsretningslinjer efter gennemgang af dokumentationen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sprimeo on 22 August 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sprimeo den 22. august 2007.
English: Other information about Sprimeo
Danish: Andre oplysninger om Sprimeo
English: The full EPAR for Sprimeo can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Sprimeo 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 Sprimeo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sprimeo.
English: It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Sprimeo.
Danish: Den skal tages sammen med et let måltid, helst på samme tid hver dag, men der må ikke indtages grapefrugtjuice sammen med Sprimeo.
English: It is available as tablets (150 mg and 300 mg).
Danish: Det fås som tabletter (150 mg og 300 mg).
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 Sprimeo.
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 Sprimeo.
English: The dose of Sprimeo may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Danish: Dosis af Sprimeo kan øges til 300 mg én gang dagligt hos patienter, hvis blodtryk ikke er tilstrækkeligt reguleret.
English: The CHMP therefore decided that the benefits of Sprimeo are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget afgjorde derfor, at fordelene ved Sprimeo overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The recommended dose of Sprimeo is 150 mg once a day.
Danish: Den anbefalede dosis af Sprimeo er 150 mg én gang dagligt.
English: EPAR summary for the public aliskiren
Danish: EPAR - sammendrag for offentligheden aliskiren
English: In five of the studies, the effects of Sprimeo taken alone were compared with those of placebo (a dummy treatment).
Danish: I fem af undersøgelserne blev virkningerne af Sprimeo anvendt alene sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: For more information about treatment with Sprimeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sprimeo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Sprimeo is a medicine that contains the active substance aliskiren.
Danish: Sprimeo er et lægemiddel, der indeholder det aktive stof aliskiren.
English: Sprimeo is used to treat essential hypertension (high blood pressure) in adults.
Danish: Sprimeo anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: Sprimeo has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Danish: Sprimeo er blevet anvendt i 14 hovedundersøgelser, hvori der deltog 10 000 patienter med essentiel hypertension.
English: The CHMP noted that Sprimeo is effective in reducing blood pressure when used alone or in combination.
Danish: CHMP konstaterede, at Sprimeo er effektivt til at nedsætte blodtrykket, hvad enten det anvendes alene eller i kombination.
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, or in women who are more than three months pregnant.
Danish: Det må ikke anvendes hos patienter, som har haft angioødem (hævelse under huden) med aliskiren, arveligt angioødem eller angioødem af ukendt årsag eller hos kvinder, som er mere end tre måneder henne i graviditeten.
English: What is the risk associated with Sprimeo?
Danish: Hvilken risiko er der forbundet med Sprimeo?
English: For the full list of all side effects reported with Sprimeo, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Sprimeo fremgår af indlægssedlen.
English: Sprimeo also reduced blood pressure in patients with diabetes and patients who were overweight.
Danish: Sprimeo nedsatte også blodtrykket hos patienter med sukkersyge og hos overvægtige patienter.
English: The active substance in Sprimeo, aliskiren, is a renin inhibitor.
Danish: Det aktive stof i Sprimeo, aliskiren, er en reninhæmmer.
English: Why has Sprimeo been approved?
Danish: Hvorfor blev Sprimeo godkendt?
English: Sprimeo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Danish: Når Sprimeo blev anvendt alene, var det mere effektivt end placebo og lige så effektivt som sammenligningslægemidlerne til at nedsætte blodtrykket.
English: When the results of the five studies comparing Sprimeo taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Sprimeo, from an average of 99.4 mmHg at the start of the study.
Danish: I de fem undersøgelser, hvor Sprimeo blev anvendt alene og sammenlignet med placebo, fik patienter under 65 år i gennemsnit mindsket det diastoliske blodtryk med 9,0 mmHg efter otte ugers behandling med Sprimeo, 150 mg.
English: Combination studies looked at Sprimeo used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Danish: I kombinationsundersøgelserne blev Sprimeo anvendt sammen med en ACE-hæmmer (ramipril),en ARB (valsartan), en betablokker (atenolol), en kalciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
English: What benefit has Sprimeo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Sprimeo?
English: Sprimeo must not be used by people who are hypersensitive (allergic) to aliskiren or any of the other ingredients.
Danish: Sprimeo må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aliskiren eller andre af indholdsstofferne.
English: The most common side effects with Sprimeo (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Danish: Den almindeligste bivirkning ved Sprimeo (som optræder hos mellem 1 og 10 patienter ud af 100) er svimmelhed, diarré, artralgi (ledsmerter) og hyperkalæmi (for højt kaliumindhold i blodet).
English: What is Sprimeo?
Danish: Hvad er Sprimeo?
English: However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Sprimeo should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Danish: Efter gennemgang af undersøgelsen ALTITUDE anbefalede CHMP imidlertid i februar 2012, at Sprimeo ikke bør anvendes sammen med en ACEhæmmer eller en ARB hos patienter med sukkersyge eller moderat til svær nyrefunktionsnedsættelse.
English: Sprimeo may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Danish: Sprimeo kan anvendes alene eller kombineret med anden medicin mod for højt blodtryk bortset fra “angiotensinkonvertasehæmmere” (“ACE-hæmmere”) eller “angiotensinreceptorantagonister” (ARB) hos patienter med sukkersyge eller moderat til svært nedsat nyrefunktion.
English: Sprimeo in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: Sprimeo kombineret med en ACE-hæmmer eller en ARB må ikke anvendes til patienter med sukkersyge eller moderat til svær nyrefunktionsnedsættelse.
English: How has Sprimeo been studied?
Danish: Hvordan blev Sprimeo undersøgt?
English: What is Sprimeo used for?
Danish: Hvad anvendes Sprimeo til?
English: Sprimeo must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Danish: Sprimeo må heller ikke anvendes sammen med ciclosporin, itraconazol eller andre såkaldte “potente P
English: The studies with Sprimeo in combination with other medicines showed additional decreases in blood pressure compared with the decreases produced by these medicines alone.
Danish: Undersøgelserne viste, at når Sprimeo blev anvendt sammen med andre lægemidler, mindskedes blodtrykket mere, end når disse lægemidler anvendes alene.
English: Sprimeo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Danish: Sprimeo blev dels taget alene, dels i kombination med andre lægemidler og blev sammenlignet med andre lægemidler mod for højt blodtryk.
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Sprimeo.
Danish: Hos patienter over 65 år og hos dem, der fik Sprimeo i større doser, blev blodtrykket sænket yderligere.
English: How is Sprimeo used?
Danish: Hvordan anvendes Sprimeo?
English: How does Sprimeo work?
Danish: Hvordan virker Sprimeo?
English: They are available in Austria, Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Danish: De er tilgængelige i Østrig, Belgien, Bulgarien, Tjekkiet, Tyskland, Grækenland, Ungarn, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Portugal, Rumænien, Slovakiet og Slovenien.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 09 September 2019.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EUmedlemsstater den 9. september 2019.
English: The review of bacterial lysate medicines was initiated on 28 June 2018 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af bakterielysatholdige lægemidler blev iværksat den 28. juni 2018 på Italiens foranledning, jf. artikel 31 i direktiv 2001/83/EF.
English: Bacterial lysate medicines have been authorised via national procedures.
Danish: Bakterielysatholdige lægemidler er godkendt via nationale procedurer.
English: • If you have any questions or concerns about your medicine, discuss them with your doctor or pharmacist.
Danish: • Hvis du har spørgsmål eller betænkeligheder i forbindelse med dit lægemiddel, kan du drøfte dem med din læge eller apotekspersonalet.
English: The CHMP therefore recommended that use of the medicines for prevention can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026.
Danish: CHMP anbefalede derfor, at brugen af lægemidlerne til forebyggelse kan fortsætte, men at virksomhederne skal fremlægge yderligere data om sikkerhed og virkning fra nye kliniske studier inden 2026.