natgillin/translations-raw huggingface dataset:
• Udvalget behandlede de konstaterede divergenser for Zinacef og relaterede navne hvad angår terapeutiske indikationer, dosering, administrationsvej samt i de øvrige afsnit af produktresuméet.
• 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,
CHMP bemærkede desuden at der ikke forelå sammenlignende, placebokontrollerede eller dobbeltblindede undersøgelse ved den begrænsede indikation svære øre-næse-hals-infektioner.
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.
CHMP gennemgik den forelagte dobbeltblindede, komparative, randomiserede undersøgelse og anså dens design for tilfredsstillende.
The CHMP noted the submitted double blind, comparative, randomized study and considered it to be adequately designed.
Som konklusion anså CHMP indikationen “komplicerede urinvejsinfektioner, herunder pyelonefritis” for acceptabel.
In conclusion, the CHMP considered the indication “complicated urinary tract infections, including pyelonephritis” to be acceptable.
CHMP fandt, at dataene vedrørende knoglepenetration ikke kunnet opveje de manglende støttende kliniske data.
The CHMP considered that the data on bone penetration did not outweigh the lack of supportive clinical data.
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.
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.
• 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.
• 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,
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.
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.
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)”.
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.
CHMP anbefalede derfor, at denne indikation udgår.
The CHMP therefore recommended the removal of this indication.
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.
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.
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.
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.
Som konklusion anså CHMP dataene for utilstrækkelige som støtte for indikationerne septikæmi og meningitis, og anbefalede derfor, at disse indikationer udgår.
In conclusion, the CHMP judged the data insufficient to support the septicaemia and meningitis indications and therefore recommended their removal.
Som konklusion vedtog CHMP en harmoniseret ordlyd til afsnit
In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
På grundlag af de forelagte data kunne CHMP godtage indikationerne “bløddelsinfektioner: cellulitis, erysipelas og sårinfektioner”.
Based on the provided data, the CHMP considered the indication “soft-tissue infections: cellulitis, erysipelas and wound infections” to be acceptable.
Som konklusion anså CHMP indikationen for acceptabel.
In conclusion, the CHMP considered the indication to be acceptable.
CHMP konkluderede, at behandling af meningitis ikke støttes af de kliniske data eller data fra European Committee on Antimicrobial Susceptibility Testing (EUCAST).
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.
CHMP fandt, at de foreliggende data ikke støtter denne indikation, og anbefalede derfor, at den udgår.
The CHMP considered that the available data did not support this indication and therefore recommended its removal.
CHMP gennemgik dataene for nyfødte, herunder dosisområde og dosisinterval.
The CHMP reviewed the data in neonates, including the data on dosing range and dosing interval.
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.
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.
Infektioner i hud og underliggende væv
Skin and soft-tissue infections
• 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).
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).
CHMP anså denne indikation for at være utilstrækkeligt dokumenteret og anbefalede derfor, at den udgår.
The CHMP considered this indication to be inadequately supported and therefore recommended its removal.
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.
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.
• Ikke-nosokomiel pneumoni.
• Community acquired pneumonia.
Ikke-nosokomiel pneumoni
Community acquired pneumonia
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.
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.
• Forebyggelse af infektion ved gastrointestinale (herunder esofageale), ortopædiske, kardiovaskulære og gynækologiske kirurgiske indgreb (herunder kejsersnit).
• Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic,
Infektioner i knogler og led
Bone and joint infections
Dato for første markedsføringstilladelse: 16. oktober 2009 Dato for seneste fornyelse: 30. juni 2014
Date of first authorisation: 16 October 2009 Date of latest renewal: 30 June 2014
Exforge HCT anbefales derfor ikke til denne population.
Therefore, Exforge HCT is not recommended in this population.
Børn og unge Brug af Exforge HCT til børn og unge under 18 år frarådes.
Children and adolescents The use of Exforge HCT in children and adolescents under 18 years of age is not recommended.
Du bør aldrig tage Exforge HCT igen.
You should never take Exforge HCT again.
Doseringen af Exforge HCT skal baseres på doserne af de individuelle komponenter i kombinationen ved tidspunktet for omskiftningen.
The dose of Exforge HCT should be based on the doses of the individual components of the combination at the time of switching.
Se også information under ovrskriften ”Tag ikke Exforge HCT”.
See also information under the heading “Do not take Exforge HCT”.
Exforge HCT er blevet undersøgt i et dobbeltblindet, aktivt-kontrolleret studie hos hypertensive patienter.
Exforge HCT was studied in a double-blind, active controlled study in hypertensive patients.
Inden skift til Exforge HCT skal patienter være kontrolleret på stabile doser af monokomponenterne taget på samme tid.
Before switching to Exforge HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Det er imidlertid vigtigt at tage i betragtning, at Exforge HCT kan øge den hypotensive virkning af andre antihypertensive stoffer.
However, it is important to take into account that Exforge HCT may increase the hypotensive effect of other antihypertensive agents.
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.
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.
Den sædvanlige dosis af Exforge HCT er én tablet daglig.
The usual dose of Exforge HCT is one tablet per day.
Brug ikke pakninger med Exforge HCT, som er beskadiget eller viser tegn på at have været forsøgt åbnet.
Do not use any Exforge HCT pack that is damaged or shows signs of tampering.
Tag ikke Exforge HCT sammen med grapefrugt eller grapefrugtjuice.
Do not take Exforge HCT with grapefruit or grapefruit juice.
Det er ikke relevant at anvende Exforge HCT hos den pædiatriske population (patienter under 18 år) til indikationen essentiel hypertension.
There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller en uge efter indtagelse af Exforge HCT.
These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Exforge HCT.
Beskyt huden mod sollys og UVstråler, mens du tager Exforge HCT.
Protect your skin from sun exposure and UV rays while taking Exforge HCT.
Den fulde blodtrykssænkende effekt blev opnået 2 uger efter, at patienterne fik den maksimale dosis af Exforge HCT.
The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Exforge HCT.
Hvis Exforge HCT anvendes under amning, bør dosis holdes så lav som muligt.
If Exforge HCT is used during breast-feeding, doses should be kept as low as possible.
Den anbefalede dosis af Exforge HCT er én tablet dagligt, som helst skal tages om morgenen.
The recommended dose of Exforge HCT is one tablet per day, to be taken preferably in the morning.
Der er ingen erfaringer med brug af Exforge HCT til gravide kvinder.
There is no experience on the use of Exforge HCT in pregnant women.
Exforge HCT kan tages sammen med eller uden mad.
Exforge HCT can be taken with or without food.
- Du kan tage Exforge HCT sammen med eller uden mad.
You can take Exforge HCT with or without food.
Exforge HCT skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
Exforge HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Hvis du holder op med at tage Exforge HCT, kan det resultere i, at din sygdom bliver værre.
Stopping your treatment with Exforge HCT may cause your disease to get worse.
På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Exforge HCT til patienter, som kort tid forinden har modtaget nyretransplantation.
To date there is no experience of the safe use of Exforge HCT in patients who have had a recent kidney transplantation.
Exforge HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
Exforge HCT should be discontinued if hypercalcaemia develops during treatment.
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).
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).
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.
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.
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.
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.
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.
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).
Derudover kan samtidig brug af Exforge HCT og NSAID føre til en forværring af nyrefunktionen og en stigning i serumkalium.
Furthermore, concomitant use of Exforge HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Baseret på eksisterende data med komponenterne anbefales brug af Exforge HCT ikke under første trimester og er kontraindiceret i graviditetens andet og tredje trimester.
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).
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.
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.
Da thiazider nedsætter den renale clearance, kan risikoen for lithium-toksicitet muligvis være yderligere øget med Exforge HCT.
Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Exforge HCT.
Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Exforge HCT, anbefales det at seponere behandlingen.
If photosensitivity reaction occurs during treatment with Exforge HCT, it is recommended to stop the treatment.
Absorptionshastigheden og absorptionsfraktionen af amlodipin, valsartan og hydrochlorthiazid fra Exforge HCT er de samme, som når de administreres som individuelle doseringer.
The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Exforge HCT are the same as when administered as individual dosage forms.
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.
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.
Hvis du får disse symptomer, skal du stoppe med at tage Exforge HCT og kontakte din læge med det samme.
If you get these symptoms, stop taking Exforge HCT and contact your doctor straight away.
De mest almindelige årsager til, at behandlingen blev afbrudt, var i dette kontrollerede kliniske studie med Exforge HCT svimmelhed og hypotension (0,7 %).
In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Exforge HCT were dizziness and hypotension (0.7%).
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).
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).
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.
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.
• ACE-hæmmere eller aliskiren (se også information under overskrifterne ”Tag ikke Exforge
• ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge HCT” and “Warnings and precautions”).
De indberettede bivirkninger med Exforge HCT eller en af dens tre aktive stoffer (amlodipin, valsartan og hydrochlorthiazid) er anført nedenfor og kan forekomme ved brug af Exforge HCT.
The side effects reported with Exforge HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of Exforge HCT.
Hvis noget af ovenstående gælder for dig, må du ikke tage Exforge HCT, og du skal tale med din læge.
If any of the above applies to you, do not take Exforge HCT and talk to your doctor.
På grund af indholdet af hydrochlorthiazid er Exforge HCT kontraindiceret ved symptomatisk hyperurikæmi.
Due to the hydrochlorothiazide component, Exforge HCT is contraindicated in symptomatic hyperuricaemia.
I prækliniske studier foretaget i adskillige dyrearter med amlodipin, valsartan, hydrochlorthiazid, valsartan/hydrochlorthiazid, amlodipin/valsartan og amlodipin/valsartan/hydrochlorthiazid (Exforge HCT), var der ikke bevis for systemisk toksicitet eller toksicitet i målorganet, der skadelig kunne påvirke udviklingen af Exforge HCT til kliniske studier med mennesker.
In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Exforge HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Exforge HCT for clinical use in humans.
• rifampicin (bruges fx til behandling af tuberkulose), erythromycin, clarithromycin (antibiotika);
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
Exforge HCT er kontraindiceret til patienter med hyperkalcæmi og bør kun anvendes efter korrektion af præeksisterende hyperkalcæmi.
Exforge HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Efter oral administration af Exforge HCT hos voskne raske personer, opnås peak plasma koncentrationer af amlodipin, valsartan og hydrochlorthiazid efter henholdsvis 6-8 timer, 3 timer, og 2 timer.
Following oral administration of Exforge HCT in normal healthy adults, peak plasma concentrations of amlodipine, valsartan and hydrochlorothiazide are reached in 6-8 hours, 3 hours, and 2 hours, respectively.
Ældre patienter, især dem, der tager den højeste dosis af Exforge HCT (10 mg/320 mg/25 mg) skal regelmæssigt have deres blodtryk kontrolleret.
Elderly patients, particularly those taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Frekvens Exforge HCT
Frequency Exforge HCT
Exforge HCT's sikkerhedsprofil, som er præsenteret herunder, er baseret på kliniske afprøvninger udført med Exforge HCT og de kendte sikkerhedsprofiler af de individuelle komponenter amlodipin, valsartan og hydrochlorthiazid.
The safety profile of Exforge HCT presented below is based on clinical studies performed with Exforge HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Patienter, som fører motorkøretøj eller betjener maskiner under behandling med Exforge HCT, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
Patients taking Exforge HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Exforge HCT bruges til at behandle forhøjet blodtryk hos voksne patienter, hvis blodtryk allerede er kontrolleret med amlodipin, valsartan og hydrochlorthiazid, og som kan drage fordel af at tage én tablet, som indeholder alle tre stoffer.
Exforge HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.
Exforge HCT enkelte komponenter
Exforge HCT individual component
Der er ingen erfaring med overdosering af Exforge HCT.
There is no experience of overdose with Exforge HCT.
Hos patienter, der tager Exforge HCT, og som får bivirkninger som svimmelhed, hovedpine, træthed eller kvalme, kan reaktionsevnen blive påvirket.
If patients taking Exforge HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Exforge HCT tabletter indeholder tre stoffer, som kaldes amlodipin, valsartan og hydrochlorthiazid.
Exforge HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide.