FrancophonIA/ELRC3.0 huggingface dataset:
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 var store divergenser mellem de nationalt godkendte doseringer og anbefalinger, og gennemgik derfor de foreliggende data til støtte for et harmoniseret afsnit 4.2.
English: The CHMP also noted that although the most common coexisting pathogen in patients with gonorrhoea is Chlamydia trachomatis, no data on combination therapy (cefuroxime with other antibiotic) for treatment of patients co-infected by N. gonorrhoeae and C. trachomatis, or by N. gonorrhoeae and anaerobic bacteria, was submitted.
Danish: CHMP konstaterede desuden, at skønt Chlamydia trachomatis er den hyppigste samtidigt forekommende patogene art ved gonorré, er der ikke forelagt data om kombinationsbehandling (cefuroxim kombineret med et andet antibiotikum) ved koinfektion med N. gonorrhoeae og C. trachomatis eller med N. gonorrhoeae og anaerobe bakterier.
English: The CHMP considered the submitted data, consisting of eleven small, non-comparative studies and two open labelled, comparative studies.
Danish: CHMP gennemgik de forelagte data bestående af 11 små, ikke-sammenlignende undersøgelse og to åbne sammenlignende undersøgelser.
English: The CHMP defined neonates as infants younger than 3 weeks, including newborns and agreed that cefuroxime has been used in neonates for many years without any serious safety concerns.
Danish: CHMP definerede nyfødte som spædbørn fra fødslen indtil 3 uger, og konstaterede, at det aktive stof er blevet anvendt hos nyfødte i mange år uden alvorlige sikkerhedsmæssige problemer.
English: Zinacef contains cefuroxime sodium, a second generation cephalosporin antibacterial agent.
Danish: Zinacef indeholder cefuroximnatrium, der er et andengenerations cefalosporin.
English: Regarding patients with renal impairment, the CHMP reviewed the data and considered the proposed dosing guidelines to be acceptable.
Danish: For patienter med nedsat nyrefunktion gennemgik CHMP dataene og godtog de foreslåede doseringsretningslinjer.
English: The CHMP considered the proposed indication wording to be too general and noted that most upper respiratory tract infections respond well to oral therapy or are spontaneously cured.
Danish: CHMP fandt den foreslåede ordlyd af indikationen for generel og bemærkede, at de fleste øvre luftvejsinfektioner responderer godt på oral behandling eller helbredes spontant.
English: Having reviewed the available data, consisting of small non-comparative studies, the CHMP considered it to be very limited and of questionable methodology.
Danish: Efter gennemgang af de foreliggende data, der består af små, ikke-sammenlignende undersøgelser, fandt CHMP, at dokumentationen er meget begrænset og de anvendte metoder tvivlsomme.
English: The CHMP agreed that the commonly used intravenous and intramuscular dosing regimens (e.g., 750 mg to 1500 mg given every 8 hours) are expected to provide efficacy for organisms with minimum inhibitory concentrations (MICs) up to, and including, 8 μg/mL.
Danish: CHMP anså de almindeligt anvendte intravenøse og intramuskulære dosisregimer (f.eks. 750-1 500 mg hver ottende time) for at være virksomme mod organismer med mindste hæmmende koncentration (MIC) til og med 8 μg/ml.
English: • The committee considered the identified divergences for Zinacef 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 Zinacef og relaterede navne hvad angår terapeutiske indikationer, dosering, administrationsvej samt i de øvrige afsnit af produktresuméet.
English: The CHMP also noted that no comparative, placebo-controlled or double-blinded studies were available in the restricted indication severe ear, nose and throat-infections.
Danish: CHMP bemærkede desuden at der ikke forelå sammenlignende, placebokontrollerede eller dobbeltblindede undersøgelse ved den begrænsede indikation svære øre-næse-hals-infektioner.
English: The CHMP noted the submitted double blind, comparative, randomized study and considered it to be adequately designed.
Danish: CHMP gennemgik den forelagte dobbeltblindede, komparative, randomiserede undersøgelse og anså dens design for tilfredsstillende.
English: In conclusion, the CHMP considered the indication “complicated urinary tract infections, including pyelonephritis” to be acceptable.
Danish: Som konklusion anså CHMP indikationen “komplicerede urinvejsinfektioner, herunder pyelonefritis” for acceptabel.
English: The CHMP considered that the data on bone penetration did not outweigh the lack of supportive clinical data.
Danish: CHMP fandt, at dataene vedrørende knoglepenetration ikke kunnet opveje de manglende støttende kliniske data.
English: The CHMP noted the large degree of divergences in the nationally approved indications and therefore reviewed the available data supporting each indvidual indication and the patient age groups.
Danish: CHMP konstaterede, at der var store divergenser mellem de nationalt godkendte indikationer, og gennemgik derfor de foreliggende data til støtte for hver enkelt indikation og patientaldersgruppe.
English: • The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and clinical documentation, justifying the proposed harmonised 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 harmoniserede produktinformation.
English: The CHMP reviewed the two open studies submitted but stated that cefuroxime is not active against many of the bacterial species isolated in obstetric and gynaecological infections, either due to inherent resistance or due to acquired resistance.
Danish: CHMP gennemgik de to forelagte åbne undersøgelser, men anførte, at cefuroxim ikke er aktivt mod en stor del af de bakteriearter, der isoleres fra obstetriske og gynækologiske infektioner, hvilket enten skyldes naturlig eller erhvervet resistens.
English: Having reviewed all submitted data to support the various prophylaxis indications proposed for cefuroxime, the CHMP considered the indication “Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular and gynaecological surgery (including caesarean section)” to be acceptable.
Danish: Efter gennemgang af alle de forelagte data til støtte for de forskellige foreslåede indikationer med profylaktisk anvendelse af cefuroxim godkendte udvalget “forebyggelse af infektion ved gastrointestinale (herunder esofageale), og ortopædiske, kardiovaskulære og gynækologiske kirurgiske indgreb (herunder kejsersnit)”.
English: The CHMP therefore recommended the removal of this indication.
Danish: CHMP anbefalede derfor, at denne indikation udgår.
English: The CHMP noted that although only one double-blind study was submitted, several other comparatorcontrolled and randomised studies were also submitted, several of which were performed recently and showed adequate efficacy of cefuroxime.
Danish: CHMP konstaterede, at der kun var forelagt en enkelt dobbeltblindet undersøgelse, men at der også forelå adskillige andre randomiserede undersøgelser med aktivt sammenligningspræparat, hvoraf flere var af nyere data og viste tilfredsstillende virkning af cefuroxim.
English: The CHMP reviewed the submitted data and agreed that staphylococci and streptococci, the bacterial species most frequently involved in skin and soft tissue infections, are sensitive to cefuroxime.
Danish: CHMP gennemgik de forelagte data og tilsluttede sig, at stafylokokker og streptokokker, som er de oftest involverede bakteriearter ved infektioner i hud og underliggende væv, er følsomme for cefuroxim.
English: In conclusion, the CHMP judged the data insufficient to support the septicaemia and meningitis indications and therefore recommended their removal.
Danish: Som konklusion anså CHMP dataene for utilstrækkelige som støtte for indikationerne septikæmi og meningitis, og anbefalede derfor, at disse indikationer udgår.
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Danish: Som konklusion vedtog CHMP en harmoniseret ordlyd til afsnit
English: Based on the provided data, the CHMP considered the indication “soft-tissue infections: cellulitis, erysipelas and wound infections” to be acceptable.
Danish: På grundlag af de forelagte data kunne CHMP godtage indikationerne “bløddelsinfektioner: cellulitis, erysipelas og sårinfektioner”.
English: In conclusion, the CHMP considered the indication to be acceptable.
Danish: Som konklusion anså CHMP indikationen for acceptabel.
English: The CHMP concluded that the clinical data and the data from the European Committee on Antimicrobial Susceptibility Testing (EUCAST) did not support the treatment of meningitis.
Danish: CHMP konkluderede, at behandling af meningitis ikke støttes af de kliniske data eller data fra European Committee on Antimicrobial Susceptibility Testing (EUCAST).
English: The CHMP considered that the available data did not support this indication and therefore recommended its removal.
Danish: CHMP fandt, at de foreliggende data ikke støtter denne indikation, og anbefalede derfor, at den udgår.
English: The CHMP reviewed the data in neonates, including the data on dosing range and dosing interval.
Danish: CHMP gennemgik dataene for nyfødte, herunder dosisområde og dosisinterval.
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 Zinacef 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 Zinacef og relaterede navne positivt.
English: Skin and soft-tissue infections
Danish: Infektioner i hud og underliggende væv
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Zinacef and associated names (see Annex I).
Danish: • Udvalget godtog den harmonisering af produktresuméet, etiketteringen og indlægssedlen, der er foreslået af indehaveren af markedsføringstilladelsen anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilkeproduktresumé, etikettering og indlægsseddel fremgår af bilag III for Zinacef og relaterede navne (se bilag I).
English: The CHMP considered this indication to be inadequately supported and therefore recommended its removal.
Danish: CHMP anså denne indikation for at være utilstrækkeligt dokumenteret og anbefalede derfor, at den udgår.
English: The CHMP also adopted a harmonised wording for the remaining sections of the Zinacef 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 Zinacef og rettede etiketteringen og indlægssedlen ind efter det vedtagne harmoniserede produktresumé.
English: • Community acquired pneumonia.
Danish: • Ikke-nosokomiel pneumoni.
English: Community acquired pneumonia
Danish: Ikke-nosokomiel pneumoni
English: The CHMP considered that for parenteral cefuroxime, the less susceptible bacteria include mainly Enterobacteriaceae (i.e. E. coli, P. mirabilis and Klebsiella spp).The CHMP therefore followed the EUCAST breakpoints for Enterobactariaceae at 8ug/mL to recommend a dosing regimen of 1500 mg every 8 hours for the treatment of infections caused by the above bacteria.
Danish: CHMP fulgte derfor EUCAST-tærskelværdierne for Enterobacteriaceae på 8 ug/ml og anbefalede et dosisregime på 500 mg hver ottende time til behandling af infektioner forårsaget af de nævnte bakterier.
English: • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic,
Danish: • Forebyggelse af infektion ved gastrointestinale (herunder esofageale), ortopædiske, kardiovaskulære og gynækologiske kirurgiske indgreb (herunder kejsersnit).
English: Bone and joint infections
Danish: Infektioner i knogler og led
English: Date of first authorisation: 16 October 2009 Date of latest renewal: 30 June 2014
Danish: Dato for første markedsføringstilladelse: 16. oktober 2009 Dato for seneste fornyelse: 30. juni 2014
English: Therefore, Exforge HCT is not recommended in this population.
Danish: Exforge HCT anbefales derfor ikke til denne population.
English: Children and adolescents The use of Exforge HCT in children and adolescents under 18 years of age is not recommended.
Danish: Børn og unge Brug af Exforge HCT til børn og unge under 18 år frarådes.
English: You should never take Exforge HCT again.
Danish: Du bør aldrig tage Exforge HCT igen.
English: The dose of Exforge HCT should be based on the doses of the individual components of the combination at the time of switching.
Danish: Doseringen af Exforge HCT skal baseres på doserne af de individuelle komponenter i kombinationen ved tidspunktet for omskiftningen.
English: See also information under the heading “Do not take Exforge HCT”.
Danish: Se også information under ovrskriften ”Tag ikke Exforge HCT”.
English: Exforge HCT was studied in a double-blind, active controlled study in hypertensive patients.
Danish: Exforge HCT er blevet undersøgt i et dobbeltblindet, aktivt-kontrolleret studie hos hypertensive patienter.
English: Before switching to Exforge HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Danish: Inden skift til Exforge HCT skal patienter være kontrolleret på stabile doser af monokomponenterne taget på samme tid.
English: However, it is important to take into account that Exforge HCT may increase the hypotensive effect of other antihypertensive agents.
Danish: Det er imidlertid vigtigt at tage i betragtning, at Exforge HCT kan øge den hypotensive virkning af andre antihypertensive stoffer.
English: Exforge HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Exforge HCT frarådes i den tidlige periode af graviditeten og må ikke tages, når du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje graviditetsmåned.
English: The usual dose of Exforge HCT is one tablet per day.
Danish: Den sædvanlige dosis af Exforge HCT er én tablet daglig.
English: Do not use any Exforge HCT pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger med Exforge HCT, som er beskadiget eller viser tegn på at have været forsøgt åbnet.
English: Do not take Exforge HCT with grapefruit or grapefruit juice.
Danish: Tag ikke Exforge HCT sammen med grapefrugt eller grapefrugtjuice.
English: There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Danish: Det er ikke relevant at anvende Exforge HCT hos den pædiatriske population (patienter under 18 år) til indikationen essentiel hypertension.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Exforge HCT.
Danish: Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller en uge efter indtagelse af Exforge HCT.
English: Protect your skin from sun exposure and UV rays while taking Exforge HCT.
Danish: Beskyt huden mod sollys og UVstråler, mens du tager Exforge HCT.
English: The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Exforge HCT.
Danish: Den fulde blodtrykssænkende effekt blev opnået 2 uger efter, at patienterne fik den maksimale dosis af Exforge HCT.
English: If Exforge HCT is used during breast-feeding, doses should be kept as low as possible.
Danish: Hvis Exforge HCT anvendes under amning, bør dosis holdes så lav som muligt.
English: The recommended dose of Exforge HCT is one tablet per day, to be taken preferably in the morning.
Danish: Den anbefalede dosis af Exforge HCT er én tablet dagligt, som helst skal tages om morgenen.
English: There is no experience on the use of Exforge HCT in pregnant women.
Danish: Der er ingen erfaringer med brug af Exforge HCT til gravide kvinder.
English: Exforge HCT can be taken with or without food.
Danish: Exforge HCT kan tages sammen med eller uden mad.
English: You can take Exforge HCT with or without food.
Danish: - Du kan tage Exforge HCT sammen med eller uden mad.
English: Exforge HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Exforge HCT skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
English: Stopping your treatment with Exforge HCT may cause your disease to get worse.
Danish: Hvis du holder op med at tage Exforge HCT, kan det resultere i, at din sygdom bliver værre.
English: To date there is no experience of the safe use of Exforge HCT in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Exforge HCT til patienter, som kort tid forinden har modtaget nyretransplantation.
English: Exforge HCT should be discontinued if hypercalcaemia develops during treatment.
Danish: Exforge HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Exforge HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Danish: Et statistisk signifikant større antal af patienterne opnåede blodtrykskontrol (<140/90 mmHg) med Exforge HCT (71 %) sammenlignet med hver af de tre tokombinationsbehandlinger (45-54 %) (p<0,0001).
English: Clinically significant hypotension due to Exforge HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering af Exforge HCT kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Your doctor will normally advise you to stop taking Exforge HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge HCT.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Exforge HCT, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Exforge HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Exforge HCT i alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
English: Furthermore, concomitant use of Exforge HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Danish: Derudover kan samtidig brug af Exforge HCT og NSAID føre til en forværring af nyrefunktionen og en stigning i serumkalium.
English: Based on the existing data with the components, the use of Exforge HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Danish: Baseret på eksisterende data med komponenterne anbefales brug af Exforge HCT ikke under første trimester og er kontraindiceret i graviditetens andet og tredje trimester.
English: Exforge HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Danish: Exforge HCT skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serumkreatinin kan stige hos disse patienter.
English: Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Exforge HCT.
Danish: Da thiazider nedsætter den renale clearance, kan risikoen for lithium-toksicitet muligvis være yderligere øget med Exforge HCT.
English: If photosensitivity reaction occurs during treatment with Exforge HCT, it is recommended to stop the treatment.
Danish: Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Exforge HCT, anbefales det at seponere behandlingen.
English: The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Exforge HCT are the same as when administered as individual dosage forms.
Danish: Absorptionshastigheden og absorptionsfraktionen af amlodipin, valsartan og hydrochlorthiazid fra Exforge HCT er de samme, som når de administreres som individuelle doseringer.
English: Exforge HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Danish: Exforge HCT er tilgængelig i pakninger, der indeholder 14, 28, 30, 56, 90, 98 eller 280 filmovertrukne tabletter, i multipakninger med 280 tabletter (bestående af 4 kartoner, der hver indeholder 70 tabletter eller 20 kartoner, der hver indeholder 14 tabletter), og i hospitalspakninger med 56, 98 eller 280 tabletter i perforerede enkeltdosis-blistere.
English: If you get these symptoms, stop taking Exforge HCT and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Exforge HCT og kontakte din læge med det samme.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Exforge HCT were dizziness and hypotension (0.7%).
Danish: De mest almindelige årsager til, at behandlingen blev afbrudt, var i dette kontrollerede kliniske studie med Exforge HCT svimmelhed og hypotension (0,7 %).
English: Talk to your doctor or pharmacist before taking Exforge HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Exforge HCT - hvis du har et lavt niveau af kalium eller magnesium i blodet (med eller uden symptomer som fx muskelsvaghed, muskelkramper, unormal hjerterytme).
English: Exforge HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Danish: Exforge HCT kan tages af patienter på 65 år og derover med samme dosis som for voksne patienter og på samme måde, som de allerede tager de tre stoffer, som kaldes amlodipin, valsartan og hydrochlorthiazid.
English: • ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge HCT” and “Warnings and precautions”).
Danish: • ACE-hæmmere eller aliskiren (se også information under overskrifterne ”Tag ikke Exforge