FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects have been reported with horsetail herb medicines.
Danish: Der er indberettet bivirkninger ved brug af lægemidler, der indeholder padderok.
English: Extracts are prepared using a technique to extract compounds from plant material by putting the plant material in a solvent (such as ethanol or water) to dissolve compounds and form a liquid extract.
Danish: Ekstrakterne fremstilles ved at udtrække stoffer fra plantematerialet i ethanol eller vand.
English: The HMPC concluded that, on the basis of its long-standing use, these horsetail herb preparations can be used in minor problems affecting the urinary tract (structures that carry urine) to increase the
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at padderok i disse tilberedninger kan anvendes til at øge urinproduktionen og opnå en bedre gennemskylning af urinvejene ved lettere urinvejsproblemer.
English: For dry extracts the solvent is then evaporated.
Danish: Ved fremstilling af tørekstrakt fordampes opløsningsmidlet herefter for at opnå det tørre ekstrakt.
English: The ratio was approved in the 1990s.
Danish: Forholdet blev godkendt i 1990'erne.
English: 2.1 Critical Evaluation
Danish: 2.1 Kritisk vurdering
English: Treatment should not be extended beyond 14 days without review.
Danish: Behandlingen må ikke forlænges mere end 14 dage uden gennemgang.
English: The biggest problem is huge regional even local differences across Europe and within countries.
Danish: Det største problem er de store regionale og endda lokale forskelle inden for Europa og inden for de enkelte lande.
English: “Symptoms and signs of overdose
Danish: “Symptomer og tegn på overdosis
English: Most statements were either already covered by the proposed harmonised text, or lacked supportive evidence.
Danish: De fleste tekster var enten allerede dækket af den foreslåede harmoniserede tekst eller manglede understøttende dokumentation.
English: For Section 6.6, there are “No special requirements” for disposal of surplus materials.
Danish: Hvad angår punkt 6.6, er der “Ingen særlige forholdsregler” ved bortskaffelse af overskydende materiale.
English: Oral formulations of Augmentin have been available worldwide since 1981 and intravenous formulation since 1984.
Danish: Orale formuleringer af Augmentin har været tilgængelige siden 1981 og intravenøs formulering siden 1984.
English: See also section 4.4 regarding prolonged therapy.”
Danish: Se også punkt 4.4 vedrørende forlænget behandling.”
English: Sections 1, 2 and 3 are to be completed nationally.
Danish: Punkt 1, 2 og 3 skal udfyldes nationalt.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.”
Danish: Der skal tages højde for de officielle retningslinjer for korrekt anvendelse af antibakterielle midler".
English: Prior to harmonisation, at start of procedure, the indications for the various ratios were grouped as follows:
Danish: Før harmonisering ved procedurestarten var indikationerne for de forskellige forhold grupperet på følgende måde:
English: Similarly, Sections 6.1, 6.2, 6.3, 6.4 and 6.5 will also be completed nationally.
Danish: Samtidig skal punkt 6.1, 6.2, 6.3, 6.4 og 6.5 også udfyldes nationalt.
English: Thus the 16:1 ratio should be effective in all indications where efficacy of the other formulations has been shown.
Danish: Forholdet 16:1 skulle derfor være effektivt ved alle indikationer, hvor der er påvist virkning ved de andre formuleringer.
English: These indications are approved in all EU countries and Augmentin is accepted as an effective treatment in several national guidelines.
Danish: Disse indikationer er godkendt i alle EU-lande, og Augmentin er accepteret som en effektiv behandling i flere nationale retningslinjer.
English: “Not all the possible presentations of Augmentin suitable for use in all EU countries.
Danish: “Ikke alle de mulige pakningsstørrelser med Augmentin er passende til brug i alle EU-lande.
English: “The duration of therapy should be determined by the response of the patient.
Danish: ”Behandlingsvarigheden afhænger af patientens respons.
English: Dosing recommendations in this population can therefore not be made.
Danish: Der kan derfor ikke angives nogen doseringsanbefalinger for denne population.
English: These features make it an appropriate antibiotic for intra-abdominal infections.
Danish: Disse egenskaber gør det til et passende antibiotikum for intraabdominale infektioner.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AUGMENTIN AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF AUGMENTIN OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Intra-abdominal sepsis
Danish: Intraabdominal sepsis
English: This is a particularly important section for antibacterials.
Danish: Dette er et særlig vigtigt punkt, når det gælder antibakterielle midler.
English: The EUCAST Breakpoints should be used exactly as written by EUCAST and the lists of pathogens for all formulations were also restricted to the pathogens important for the harmonised indications.
Danish: EUCAST Breakpoints skal anvendes nøjagtigt, som det er beskrevet af EUCAST, og listerne over patogener for alle formuleringer blev også begrænset til de patogener, der er vigtige for de harmoniserede indikationer.
English: Section 4.5 - Interaction with other medicinal products, and other forms of interaction
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion
English: Some infections (e.g. osteomyelitis) require longer periods of treatment.
Danish: Nogle infektioner (f.eks. osteomyelitis) kræver længere behandlingsperioder.
English: This suggests that the lower doses of amoxicillin as used in some currently-approved regimens are appropriate.
Danish: Dette tyder på, at den lavere dosis amoxicillin, som anvendes i nogle nuværende godkendte regimer, er passende.
English: The PK of the clavulanic acid components are the same as the conventional Augmentin formulations.
Danish: PK for komponenterne med clavulansyre er de samme som for de konventionelle Augmentin-formuleringer.
English: Surgical prophylaxis with Augmentin IV should aim to protect the patient for the period of risk of infection.
Danish: Kirurgisk profylakse med Augmentin IV bør sigte mod at beskytte patienten i infektionens risikoperiode.
English: The benefit/risk assessment for the series of formulations approved in different Member States was conducted with reference to the existing resistance patterns in those Member States where the product is marketed.
Danish: Risk/benefit-vurderingen for den række formuleringer, der er godkendt i de forskellige medlemslande, blev udført med henvisning til eksisterende resistensmønstre i de medlemslande, hvor produktet markedsføres.
English: The recommendations for dosing patients with reduced renal and hepatic function have also been simplified and harmonised.
Danish: Anbefalingerne for dosering til patienter med nedsat nyre- og leverfunktion er også blevet forenklet og harmoniseret.
English: In adults, AOM is rare but the bacteria involved are the same as in children and the therapeutic choices do not differ.
Danish: Hos voksne er AOM sjælden, men de bakterier, der er involveret, er de samme som hos børn, og de terapeutiske valg adskiller sig ikke.
English: This ratio is not recommended for use in children less than six years of age.
Danish: Brugen af dette forhold anbefales ikke til børn, der er under 6 år.
English: A regular check of patency should be maintained (see section 4.4).
Danish: En regelmæssig undersøgelse af åbningen skal foretages (se punkt 4.4).
English: The paediatric recommendations have been harmonised according to weight ranges rather than age, with the sole exception of a lower age limit for very young patients.
Danish: Anbefalingerne til pædiatriske patienter er harmoniseret i overensstemmelse med vægtområder i stedet for alder med den ene undtagelse, der angår en nedre aldersgrænse for meget unge patienter.
English: The ADME properties of amoxicillin and clavulanic acid, alone and in combination, were also summarised.
Danish: ADMEegenskaberne for amoxicillin og clavulansyre, alene og i kombination, blev også opsummeret.
English: epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)
Danish: epiglottitis og sinusitis, når disse samtidig giver sig udslag i alvorlige systemiske tegn og symptomer)
English: Therefore any future applications for marketing authorisation for Augmentin presentations should be supported by a discussion of the appropriateness of those specific presentations for the selected Concerned Member States.
Danish: Enhver fremtidig ansøgning om markedsføringstilladelse for Augmentinpakningsstørrelser skal derfor understøttes af en redegørelse for egnetheden af disse specifikke pakninger til de valgte berørte medlemsstater.
English: In order to provide harmonised dosing recommendations for all countries, a standard dosage and higher dosage are proposed for each formulation, for both adults and children.
Danish: For at kunne angive harmoniserede doseringsanbefalinger til alle lande, angives der en foreslået standarddosering og en højere dosering for hver formulering til både voksne og børn.
English: This standard daily dose should not be exceeded, and is in fact a maximum daily dose contributing to the safe use of Augmentin.
Danish: Denne daglige standarddosering bør ikke overskrides og er reelt en maksimal daglig dosering, der er med til at gøre brugen af Augmentin sikker.
English: The benefit/risk assessment conducted by the CHMP has not addressed the use of these products in other markets, where different resistance patterns may apply.
Danish: Risk/benefit-vurderingen udført af CHMP omfattede ikke brugen af disse produkter på andre markeder, hvor der kan være andre resistensmønstre.
English: The CHMP agreed that the available evidence for this indication is not sufficient unless supported by clinical data and deleted this indication for all formulations.
Danish: CHMP vedtog, at den tilgængelige dokumentation for denne indikation ikke er tilstrækkelig, medmindre den understøttes af kliniske data og slettede denne indikation for alle formuleringer.
English: A higher regimen may be appropriate in some indications, and in regions with higher prevalence of resistant organisms, even if the infection is not categorised as ‘severe'.
Danish: Et højere regimen kan være relevant ved nogle indikationer og i områder med en større forekomst af resistente organismer, også selvom infektionen ikke er kategoriseret som "alvorlig".
English: All discussions specific to a particular Augmentin ratio are reflected below.
Danish: Alle de overvejelser, der er specifikke for et bestemt Augmentin-forhold, er angivet nedenfor.
English: This section contains detailed information of the conditions and special patient groups where Augmentin should be used with caution.
Danish: Dette punkt indeholder detaljerede oplysninger om tilstandene og specielle patientgrupper, hvor Augmentin skal bruges med forsigtighed.
English: Data on a few hundreds of patients and a summary of the clinical data in support of the treatment of osteomyelitis were provided.
Danish: Der blev opgivet data om nogle få hundrede patienter og en opsummering af de kliniske data til understøttelse af behandlingen af osteomyelitis.
English: The choice of presentations used in any one EU MS needs to be tailored to the prevalence of certain types of bacterial resistance, which is very variable between EU countries and will inevitably change over time.
Danish: Valget af pakningsstørrelser, der anvendes i en EU-medlemsstat, skal være skræddersyet til forekomsten af bestemte typer resistente bakterier, hvilket varierer meget mellem EU-landene og uundgåeligt vil ændres med tiden.
English: Regarding CAP, the 14:1 ratio is considered to appropriately cover PRSP.
Danish: Med hensyn til CAP anses forholdet på 14:1 for at være tilstrækkeligt dækkende for PRSP.
English: Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Danish: Gastrointestinale symptomer kan behandles symptomatisk med opmærksomhed på vand/elektrolytbalancen.
English: Hence, the daily dose of clavulanic acid will depend upon the frequency of administration and not the formulation.
Danish: Den daglige dosis af clavulansyre vil derfor afhænge af frekvensen af indgivelsen og ikke formuleringen.
English: Various comparative and non-comparative studies have been conducted in SSTIs including adults and children.
Danish: Forskellige sammenlignende og ikke-sammenlignende undersøgelser er udarbejdet for SSTI'er, der omfatter voksne og børn.
English: The 2:1 ratio has become a well-established dosing regimen in many countries, and has been the subject of numerous clinical studies, many of them by independent research groups and individuals.
Danish: Forholdet 2:1 er blevet et veletableret doseringsregimen i mange lande og har været underlagt en lang række kliniske undersøgelser, mange udført af uafhængige forskningsgrupper og personer.
English: The CHMP acknowledged the arguments and agreed that Augmentin is suitable for this indication.
Danish: CHMP anerkendte argumenterne og var enig i, at Augmentin er passende for denne indikation.
English: The discussion also focused on treatment duration and the CHMP agreed to amend Section 4.2 of the SPC.
Danish: Diskussionen fokuserede også på behandlingens varighed, og CHMP vedtog at ændre punkt 4.2 i produktresumeet.
English: This set of indications differs from that for the lower ratio formulations.
Danish: Dette sæt indikationer adskiller sig fra sættet for formuleringer med lavere forhold.
English: This is because the daily dose of amoxicillin delivered by this presentation (750 mg) is insufficient to treat these bacteria.
Danish: Dette skyldes, at den daglige dosis, der indgives af amoxicillin med denne pakningsstørrelse (750 mg), er utilstrækkelig til behandling af disse bakterier.
English: The CHMP requested the withdrawal of the septicaemia indication in general, since the focus of septicaemia has to be treated sufficiently and therefore this indication is not acceptable.
Danish: CHMP anmodede om tilbagekaldelse af septikæmi-indikationen generelt, da fokus på septikæmi skal behandles tilstrækkeligt, og denne indikation derfor ikke kan accepteres.
English: The data forms the basis of the corresponding sections in the proposed harmonised SPCs.
Danish: Dataene udgør grundlaget for de tilsvarende punkter i de foreslåede harmoniserede produktresuméer.
English: However, as the clinical trial data is mainly restricted to data in patients with CAP in the presence of co-morbidities, the CHMP restricted the indication to CAP.
Danish: Da de kliniske undersøgelsesdata dog er begrænset til data fra patienter med CAP ved tilstedeværelse af komorbiditeter, har CHMP begrænset indikationen til CAP.
English: • The 8:1 ratio formulations, for general use in the renally-normal population, approved in France only, and associated with their own set of indications.
Danish: • Formuleringer med forholdet 8:1, til almindelig brug hos personer med normal nyrefunktion, er kun godkendt i Frankrig og forbundet med deres egne sæt indikationer.
English: Pathogens with higher MIC tend to be more prevalent in patients with more serious infections, and a BID IV regimen could potentially lead to poorer outcomes.
Danish: Patogener med højere MIC har en tendens til at være mere fremherskende hos patienter med alvorligere infektioner, og et BID IV-regimen kunne muligvis resultere i dårligere resultater.
English: For animal bites, the administration of oral or parenteral antibiotics depends on the depth and severity of the wound and on the time since the bite occurred.
Danish: Ved dyrebid afhænger indgivelsen af oral eller parenteral antibiotika af dybden og alvorligheden af såret og af den tid, der er gået, siden biddet fandt sted.
English: Augmentin SR (Sustained-Release) was therefore developed to meet this new medical need.
Danish: Augmentin SR (depotformulering) blev derfor udviklet til at imødekomme dette nye medicinske behov.
English: “Treatment with Augmentin may be initiated by the use of an intravenous preparation and completed with an appropriate oral formulation as considered appropriate for the individual patient.”
Danish: “Behandlingen med Augmentin kan startes intravenøst og færdiggøres med en relevant oral formulering, der anses for at være passende for den enkelte patient.”
English: This increase in amoxicillin dose clearly makes this ratio more suitable than the 2:1 ratio and this ratio might be appropriate for some indications in at least some areas.
Danish: Denne øgede amoxicillin-dosis gør tydeligt dette forhold bedre egnet end forholdet 2:1, og dette forhold kunne være egnet til visse indikationer, i det mindste i nogle områder.
English: A full PIQ review was also conducted and the PL was revised accordingly.
Danish: Der blev også udført et komplet PIQ-review, og indlægssedlen er revideret i overensstemmelse med dette.
English: Section 4.7 - Effects on ability to drive and use machines
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: • Female genital infections.
Danish: • Infektioner i kvindelige kønsorganer.
English: There is no consensus on the appropriate treatment duration, as other factors such as the extent of infection, type of pathogen, clinical response, and presence of underlying risk factors are important considerations but the current SPCs only stipulate that patients on extended therapy beyond 14 days should be closely monitored.
Danish: Der er ingen konsensus om den passende varighed af behandlingen, da andre faktorer, som f.eks. omfanget af infektionen, typen af patogen, klinisk reaktion og tilstedeværelsen af underliggende risikofaktorer, er vigtige i overvejelserne, men de nuværende produktresuméer viser kun, at patienter i udvidet behandling over 14 dage skal overvåges nøje.
English: Empirical antibacterial therapy must provide broad-spectrum coverage of both aerobic and anaerobic pathogens.
Danish: Empirisk antibakteriel terapi skal give en bredspektret dækning af både aerobe og anaerobe patogener.
English: In addition, only a very small concentration of clavulanic acid (0.12mg/l) is needed to restore susceptibility of these isolates to amoxicillin.
Danish: Derudover skal der kun en lille koncentration af clavulansyre (0,12 mg/l) til for at gendanne disse isolaters følsomhed over for amoxicillin.
English: • Intra-abdominal infections
Danish: • Intraabdominal infektioner
English: Many guidelines for indications such as CAP and ABRS therefore recommended higher doses of amoxicillin to ensure that the eradication of infections caused by resistant pathogens continues and the potential for spread is reduced.
Danish: Mange retningslinjer for indikationer som f.eks. CAP og ABRS har derfor anbefalet højere doser af amoxicillin for at sikre, at eradikeringen af infektioner, der er forårsaget at resistente patogener, fortsætter, og at muligheden for spredning reduceres.
English: In addition, the number of intermediate penicillin susceptibility strains should also be considered, creating a need for high concentrations of amoxicillin.
Danish: Samtidig skal der også tages højde for antallet af intermediære penicillinfølsomme stammer, hvilket skaber et behov for høje koncentrationer af amoxicillin.
English: Resistance to amoxicillin in S. pneumoniae is currently low in a number of Member States, with the majority of MICs ≤ 1 μg/mL.
Danish: Resistensen over for amoxicillin i S. pneumoniae er på nuværende tidspunkt lav i en række medlemsstater, med hovedparten for MICs ≤ 1 μg/ml.
English: Data are lacking to support a specific mention of an acceptable maximal daily dose of clavulanic acid.
Danish: Der mangler data til støtte for særskilt at angive en acceptabel maksimal daglig dosis clavulansyre.
English: Safety data indicates that prolonged administration does not increase the incidence and severity of side effects compared to shorter therapeutic courses.
Danish: Sikkerhedsdata indikerer, at forlænget indgivelse ikke øger incidensen og sværhedsgraden af bivirkninger sammenlignet med kortere behandling.
English: A BID regimen would therefore probably not attain the required PK/PD target required to eradicate pathogens with higher MICs.
Danish: Et BID-regimen ville derfor sandsynligvis ikke opnå det ønskede PK/PD-mål om at eradikere patogener med højere MIC'er.
English: Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.
Danish: Tydelige kliniske tegn på infektion ved en operation kræver et normalt intravenøst forløb eller en post-operativ oral behandling.
English: Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
Danish: Profylakse af infektioner forbundet med større kirurgiske indgreb hos voksne, f.eks. infektioner, der omfatter:
English: Although many pathogens important for urinary tract infections exhibit resistance rates of > 10% towards Augmentin, it is considered a suitable alternative, as all antimicrobial agents with this indication share the problem and the choice of the agent depends on the patient and epidemiological situation.
Danish: Selvom mange patogener, der er vigtige for urinvejsinfektioner, udviser resistensrater på > 10 % mod Augmentin, anses det for at være et passende alternativ, da alle antimikrobielle midler med denne indikation deler problemet, og valget af middel afhænger af patienten og den epidemiologiske situation.
English: A recommended therapy is amoxicillin/clavulanic acid, especially if no bacteriological markers are available.
Danish: En anbefalet terapi er amoxicillin/clavulansyre, især hvis ingen bakteriologiske markører er tilgængelige.
English: The CHMP concluded that this general indication is not acceptable as neither amoxicillin/clavulanic acid nor amoxicillin are currently indicated for the treatment of diseases caused by N. gonorrhoeae.
Danish: CHMP konkluderede, at denne generelle indikation ikke kan accepteres, da hverken amoxicillin/clavulansyre eller amoxicillin for øjeblikket angives som behandling for sygdomme forårsaget af N. gonorrhoeae.
English: The CHMP agreed a text clearly stating that concomitant use of probenecid and Augmentin is not recommended.
Danish: CHMP vedtog en tekst, der klart angiver, at samtidig brug af probenecid og Augmentin ikke anbefales.
English: For the indications already discussed for the 2:1 ratio, the only difference is an increased amoxicillin dose of 0.5 g TID (adults).
Danish: For de allerede omtalte indikationer for forholdet 2:1 er den eneste forskel en øget amoxicillin-dosis på 0,5 g TID (voksne).
English: Augmentin ES suspension is recommended for dosing at 90/6.4 mg/kg/day in two divided doses at 12-hourly intervals for 10 days.
Danish: Augmentin ES-suspension anbefales ved dosering med 90/6,4 mg/kg/dag i to opdelte doser med intervaller på 12 timer i 10 dage.
English: This has been shown in in-vitro studies, in-vivo in numerous animal models, and has been confirmed by clinical trial data.
Danish: Dette er påvist i in vitro-undersøgelser, in vivo i flere dyremodeller, og det er bekræftet i data fra kliniske undersøgelser.
English: Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Danish: Der kan opstå kramper hos patienter med nedsat nyrefunktion eller hos patienter, der modtager høje doser.
English: The indication in community acquired pneumonia (CAP) is supported but the indications for ABS and AECB required further discussion.
Danish: Indikationen ved samfundserhvervet pneumoni (CAP) understøttes, men indikationerne for ABS og AECB kræver en nærmere redegørelse.
English: In order to pre-empt this situation the CHMP stated that:
Danish: For at komme denne situation i forkøbet fastlagde CHMP, at:
English: To date the 4:1 ratio has been approved widely in Europe and the approval in 1984 of the TID dosage was supported by clinical studies in paediatric and adult patients.
Danish: Til dato har forholdet 4:1 været tilgængeligt i det meste af Europa, og godkendelse af TID-dosen i 1984 blev underbygget af kliniske undersøgelser af pædiatriske og voksne patienter.