FrancophonIA/ELRC3.0 huggingface dataset:
English: Amoxil is approved for marketing in Europe in 17 different formulations: two strengths of capsules (250 mg and 500 mg), two strengths of dispersible tablets (750 mg and 1 g), four strength of powder for oral suspension (125 mg/1.25 ml, 125 mg/5 ml, 250 mg/5 ml, 500 mg/5 ml), four strength of powder for oral suspension in sachets (250, 500, 1g and 3g) and four strength of 125 mg/1.25 ml powder for solution for injection or infusion via intravenous or intramuscular route (IV/IM) or both (250 mg (intravenous or intramuscular, IV/IM), 500 mg (IV/IM), 1g (IV/IM and IM) and 2g (IV)).
Danish: Amoxil har markedsføringstilladelse i Europa i 17 forskellige formuleringer: To styrker kapsler (250 mg og 500 mg), to styrker orodispersible tabletter (750 mg og 1 g), 4 styrker pulver til oral suspension (125 mg/1,25 ml, 125 mg/5 ml, 250 mg/5 ml, 500 mg/5 ml), fire styrker afdelt pulver til oral suspension (250 mg, 500 mg, 1 g og 3 g) og fire styrker 125 mg/1,25 ml pulver til injektionsvæske eller infusionsvæske til intravenøs eller intramuskulær (IV/IM) indgift eller begge dele (250 mg (intravenøs eller intramuskulær, IV/IM), 500 mg (IV/IM), 1 g (IV/IM og IM) samt 2 g (IV)).
English: Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen, dog blev de fleste punkter overladt til national udarbejdelse.
English: The list of organisms susceptible to amoxicillin was updated.
Danish: Listen over amoxicillin-følsomme organismer blev ajourført.
English: Peptidoglycan is an integral structural component of the bacterial cell wall and serves to maintain the shape and integrity of the cell.
Danish: Peptidoglycan er en integreret strukturel komponent i bakteriers cellevæg og tjener til opretholdelse af cellens form og integritet.
English: However higher cure rates were observed with longer treatment duration (7-10 days) and when the causative organisms were susceptible to amoxicillin.
Danish: Helbredelsesraten var dog højere ved længere behandling (7-10 dage), og når de sygdomsfremkaldende organismer var følsomme for amoxicillin.
English: These tables are preceded by general recommendations on factors to consider when selecting the dose and duration of treatment, with a cross reference to 4.4, and followed by a reference to treatment guidelines to be considered when selecting the posology.
Danish: Disse tabeller forudgås af generelle anbefalinger om faktorer, der skal tages i betragtning ved valg af dosis og behandlingsvarighed, med krydshenvisning til 4.4, og efterfølges af en henvisning til behandlingsretningslinjer for valg af dosering.
English: A harmonised wording of the warning around the potential interference with diagnostic tests already present in 5 member states was also proposed to be implemented across all MS, which was accepted.
Danish: Der blev desuden foreslået en harmoniseret ordlyd til den advarsel om potentiel interferens med diagnosetest, der i forvejen blev anvendt i fem medlemsstater, således at den blev gældende i alle medlemsstater, hvilket blev godkendt.
English: However amoxicillin alone or in combination with metronidazole was found effective in the treatment of severe dental infections in several studies conducted between 1990 and 2005.
Danish: Amoxicillin, enten alene eller i kombination af metronidazol, blev derimod fundet effektivt til behandling af svære dentale infektioner i flere undersøgelser udført mellem 1990 og 2005.
English: The efficacy rates for amoxicillin were around 80%, which is comparable to the different active controls used in the studies presented.
Danish: Virkningsraterne for amoxicillin var omkring 80 %, som er sammenligneligt med de forskellige aktive kontrolbehandlinger i de forelagte undersøgelser.
English: The few studies presented include different conditions, which further decreases the evidence in support for each condition.
Danish: De få forelagte undersøgelser omfatter forskellige sygdomme, hvilket yderligere begrænser evidensen til støtte for hver sygdom.
English: The risk of precipitation in bladder catheter for the parenteral formulation was also included.
Danish: Risikoen for udfældning i et blærekateter for den parenterale formulering blev ligeledes medtaget.
English: Generally, cure rates were lower than in other indications with a high incidence of relapse and recurrence.
Danish: Helbredelsesraterne var som helhed lavere end ved de andre indikationer, og tilbagefald var hyppige.
English: On the basis of its pharmacokinetics, the total daily recommended amount is usually given in three divided doses.
Danish: På baggrund af farmakokinetikken anbefales den totale dagsdosis sædvanligvis fordelt på tre doser.
English: Gastrointestinal infections
Danish: Gastrointestinale infektioner
English: Furthermore amoxicillin is recommended as a treatment option in several recent clinical guidelines.
Danish: Amoxicillin anbefales desuden som behandlingsvalg i flere nyere kliniske retningslinjer.
English: The CHMP as a consequence, concluded that the benefit-risk balance of Amoxil and associated names remains favourable, subject to the agreed changes to the product information.
Danish: konkluderede CHMP, at benefit/risk-forholdet for Amoxil og relaterede navne fortsat er positivt under forudsætning af de vedtagne ændringer af produktinformationen.
English: The manufacture and control of both the active substance and the finished product comply with CHMP and International Conference on Harmonisation (ICH) guidelines.
Danish: Fremstilling og kontrol af både lægemiddelstoffet og det færdige præparat er i overensstemmelse med retningslinjerne fra CHMP og fra den internationale konference om harmonisering (ICH).
English: Furthermore, recent guidelines do not support the use of amoxicillin for genital infections such as pelvic inflammatory disease or vaginosis, other antibiotics are recommended.
Danish: Desuden støtter de nyere retningslinjer ikke anvendelse af amoxicillin til genitale infektioner såsom inflammatorisk bækkensygdom eller vaginose, hvortil der anbefales andre antibiotika.
English: The use of varying dose regimens ranging from 40 mg/kg/day to 90 mg/kg/day showed efficacy rates of around 90% in majority of the trials.
Danish: Med forskellige dosisregimer fra 40 mg/kg/dag til 90 mg/kg/dag opnåedes virkningsrater omkring 90 % i de fleste af undersøgelserne.
English: Furthermore amoxicillin is recommended in several guidelines (e.g. American College of Gastroenterology, National Institute for Health and Care Excellence) in combination with a proton pump inhibitor and clarithromycin.
Danish: Amoxicillin anbefales yderligere i flere retningslinjer (f.eks. fra American College of Gastroenterology og National Institute for Health and Care Excellence) i kombination med en protonpumpehæmmer og clarithromycin.
English: The growing resistance to amoxicillin of H. influenzae and M. catarrhalis (through β-lactamase production) and S. pneumoniae and H. influenzae (through changes in protein binding site) increased the risk of treatment failure, therefore amoxicillin should not be used as empirical treatment in these infections.
Danish: Den voksende resistens over for amoxicillin af H. influenzae og M. catarrhalis (gennem produktion af βlactamase) og S. pneumoniae og H. influenzae (gennem ændringer i proteinbindingssted) øger risikoen for behandlingssvigt, hvorfor amoxicillin ikke bør anvendes som empirisk behandling ved disse infektioner.
English: The harmonised dossier was provided for the active substance (amoxicillin sodium and amoxicillin trihydrate) and for the different formulations of the finished product containing this substance.
Danish: Det forelagte harmoniserede dossier omfattede det aktive stof (amoxicillinnatrium og amoxicillintrihydrat) og de forskellige formuleringer af det færdige produkt med dette aktive stof.
English: The content of this section was the same across MSs, however the wording used varied slightly.
Danish: Indholdet af dette punkt var det samme i alle medlemsstater, dog med lidt afvigende ordlyd.
English: Many clinical trials have demonstrated that amoxicillin is as efficacious and well tolerated when the total daily dose is divided in two doses as when divided in three doses.
Danish: Mange kliniske undersøgelser har vist, at amoxicillin er lige så effektivt og veltolereret når dagsdosis fordeles på to doser som på tre doser.
English: The CHMP therefore was of the view that this indication was no longer relevant for amoxicillin and should be removed from the product information across all member states.
Danish: CHMP var derfor af den opfattelse, at denne indikation ikke længere var relevant for amoxicillin og burde slettes af produktinformationen i alle medlemsstater.
English: Therefore the CHMP was of the view that the prophylaxis indication continues to be appropriate for all formulations.
Danish: CHMP var derfor af den opfattelse, at profylakseindikationen fortsat er hensigtsmæssig for alle formuleringer.
English: The harmonisation of the Quality documentation (Module 3) has been also included in this procedure at the request of the marketing authorisation holder (MAH).
Danish: Harmoniseringen af dokumentationen vedrørende kvalitet (modul 3) er ligeledes omfattet af denne procedure på anmodning af indehaveren af markedsføringstilladelsen.
English: It is hereafter summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Danish: Nedenfor er sammenfattet hovedpunkterne i harmoniseringen af de forskellige afsnit af produktresuméet.
English: In addition, in some studies amoxicillin was only used as follow-on therapy after intravenous use of other antibiotics.
Danish: I nogle af undersøgelserne blev amoxicillin desuden kun anvendt som opfølgende behandling efter at andre antibiotika var anvendt intravenøst.
English: In addition, for the parenteral and intramuscular formulations further dosing recommendation are given for neonates above 4kg up to 3 months and premature neonates weighing less than 4kg.
Danish: Fra de parenterale og intramuskulære formuleringer er der desuden dosisanbefalinger for nyfødte over 4 kg op til 3 måneder og for præmature nyfødte på under 4 kg.
English: The CHMP reviewed the totality of the data and consulted its Infectious Diseases Working Party on the proposed harmonised PI.
Danish: CHMP gennemgik samtlige data og rådførte sig med arbejdsgruppen vedrørende infektionssygdomme om den foreslåede harmoniserede produktinformation.
English: Early in the procedure, the MAH proposed to remove some indications in which amoxicillin is no longer considered suitable and therefore are not discussed in the report.
Danish: Tidligt under proceduren foreslog indehaveren af markedsføringstilladelsen at fjerne visse indikationer, som amoxicillin ikke længere anses for egnet til, og som derfor ikke er omhandlet i rapporten.
English: The interaction with test results was moved to section 4.4 in line with the SmPC Guideline.
Danish: Interaktion med undersøgelser blev flyttet til punkt 4.4 i overensstemmelse med retningslinjerne for produktresuméer.
English: The risk of Jarisch-Herxheimer reaction when amoxicillin is used in treatment of Lyme disease was also included in the harmonised PI.
Danish: Risikoen for Jarisch-Herxheimer-reaktion, når amoxicillin anvendes til behandling af Lymesygdom, er ligeledes medtaget i den harmoniserede produktinformation.
English: In addition a cross reference to section 4.2, 4.4 and 5.1 is included at the beginning of the section, in particular to highlight that “amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin”.
Danish: Desuden tilføjes en krydshenvisning til punkt 4.2, 4.4 og 5.1 i begyndelsen af afsnittet, navnlig for at fremhæve, at "til visse infektionstyper er amoxicillin ikke egnet som behandling, medmindre den patogene organisme i forvejen er identificeret og vides at være følsom, eller der er meget stor sandsynlighed for, at den pågældende patogen er egnet til behandling med amoxicillin”.
English: Amoxicillin in triple therapy achieved eradication rates around 80-85% in the various studies presented.
Danish: Amoxicillin i tripelkombinationsbehandling bevirkede en eradikationsrate på 80-85 % i de forskellige forelagte undersøgelser.
English: Treatment and prophylaxis of endocarditis- all formulations
Danish: Behandling og profylakse af endokarditis - alle formuleringer
English: The CHMP concluded that the risks associated with them were considered sufficiently addressed by wording in other sections of the PI and were removed from this section.
Danish: CHMP konkluderede, at de tilknyttede risici måtte anses for at være tilstrækkeligt imødegået af ordlyden i andre afsnit af produktinformationen, hvorfor de blev slettet fra dette afsnit.
English: The proposed wording from the MAH was accepted with minor clarifications and available information on effect on fertility was requested to be included.
Danish: Den foreslåede ordlyd fra indehaveren af markedsføringstilladelsen blev godkendt med mindre præciseringer, og der blev anmodet om tilføjelse af de foreliggende oplysninger om virkning på fertilitet.
English: Therefore while amoxicillin should not be used as empirical treatment in this indication, the CHMP concluded that the indication should be maintained with a cross-reference to section 4.4.
Danish: Skønt amoxicillin ikke bør anvendes som empirisk behandling med denne indikation, konkluderede CHMP derfor, at indikationen bør opretholdes med krydshenvisning til punkt 4.4.
English: The CHMP accepted the MAH proposal for a harmonised wording including information on possible gastrointestinal symptoms, crystalluria, with the addition of the potential the risk of seizures.
Danish: CHMP godtog markedsføringstilladelsesindehaverens forslag til en harmoniseret ordlyd, herunder oplysninger om mulige gastrointestinale symptomer og krystalluri med tilføjelse af den potentielle risiko for krampeanfald.
English: However several retrospective studies point to indicate a good efficacy in the treatment of prosthetic joints infections.
Danish: Flere retrospektive undersøgelser peger dog på god virkning ved behandling af infektioner i ledproteser.
English: The MAH proposed to harmonise the paediatric dosing recommendations using the most commonly approved mg/kg dose (40 - 90 mg/kg/day in divided doses).
Danish: Indehaveren af markedsføringstilladelsen foreslog at harmonisere den pædiatriske dosisanbefaling ved at anvende den hyppigst godkendte dosering i mg/kg (4090 mg/kg/dag fordelt på flere doser).
English: • The committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including clinical trials, open studies, , literature studies and reviews as well as evidence-based and consensus guidelines.
Danish: • udvalget gennemgik de af markedsføringstilladelsesindehaveren forelagte data til underbygning af den foreslåede harmonisering af produktinformationen, herunder kliniske undersøgelser, åbne undersøgelser, litteraturundersøgelser og oversigtsartikler samt evidens- og konsensusbaserede retningslinjer.
English: Several warnings were in place in all (or all but one) member states with slightly different wordings (Hypersensitivity reactions, renal impairment, crystalluria, skin reactions (including in patients with infectious mononucleosis, anticoagulant), overgrowth of non-susceptible microorganisms, prolonged therapy) and the harmonised proposal of the MAH was considered acceptable.
Danish: Der var flere forskellige advarsler i kraft i alle medlemsstater (eller i alle undtagen en) med lidt forskellig ordlyd (hypersensitivitetsreaktioner, nyrefunktionsnedsættelse, krystalluri, hudreaktioner (bl.a. hos patienter med infektiøs mononukleose eller i antikoagulansbehandling), overvækst af ikke-følsomme mikroorganismer, langvarig behandling), og markedsføringstilladelsesindehaverens harmoniseringsforslag kunne godtages.
English: Several statement regarding important information about excipients present in some member states (sodium, aspartame, sodium benzoate, lactose and sorbitol) were harmonised as well.
Danish: Ligeledes harmoniseredes en række vigtige oplysninger om hjælpestoffer, som blev anvendt i nogle medlemsstater (natrium, aspartam, natriumbenzoat, lactose og sorbitol).
English: Inhibition of peptidoglycan synthesis leads to weakening of the structure, usually followed by cell lysis and bacterial death.
Danish: Hæmning af peptidoglycansyntesen medfører svækkelse af strukturen og efterfølges sædvanligvis af bakteriens lyse og død.
English: The MAH presented two small clinical trials and five retrospective case studies as well as reviews and guidelines.
Danish: Indehaveren af markedsføringstilladelsen fremlagde to små kliniske undersøgelser og fem retrospektive case-undersøgelser samt oversigtsartikler og retningslinjer.
English: For all indications, to encourage the responsible use of antibacterial agents and to direct prescribers to take note of any existing national or local guidance and opinions on how antibacterial agents should be used the following sentence will be included in this section: “Consideration should be given to official guidance on the appropriate use of antibacterial agents”.
Danish: For alle indikationer indsættes følgende sætning i dette afsnit for at tilskynde til forsvarlig brug af antibakterielle midler og gøre den ordinerende læge opmærksom på eventuelle foreliggende nationale eller lokale retningslinjer og udtalelser om korrekt brug af antibakterielle midler: "Officielle retningslinjer for forsvarlig brug af antibiotika bør følges".
English: Only the contraindications around hypersensitivity to the active substance (or any of the penicillins and beta-lactam agents) and the excipients are harmonised.
Danish: Kun kontraindikationerne vedrørende overfølsomhed for det aktive stof (eller ethvert penicillin eller ßlactamantibiotikum) og hjælpestofferne er harmoniseret.
English: Amoxicillin exerts its effect through inhibition of penicillin-binding transpeptidase proteins, disrupting peptidoglycan cross-linking in the cell-wall synthesis of both Gram-negative and Gram-positive organisms.
Danish: Amoxicillins virkning skyldes hæmning af penicillinbindende transpeptidaseproteiner, som afbryder peptidoglycan-tværbindingen ved syntesen af cellevæggen hos både gramnegative og grampositive organismer.
English: Other sections of the SmPC have been updated in line with their respective Quality harmonised documentation provided in Module 3 and in line with the current QRD template.
Danish: Andre punkter i produktresuméet er blevet ajourført i overensstemmelse med den pågældende harmoniserede dokumentation om kvalitet i modul 3 og i overensstemmelse med den gældende QRDskabelon.
English: The use of amoxicillin in treating respiratory infections is further reflected in many national and European guidelines which recommend amoxicillin empiric treatment of community acquired pneumonia in adults and children.
Danish: Anvendelsen af amoxicillin til behandling af luftvejsinfektioner afspejler sig yderligere i mange nationale og europæiske retningslinjer, der anbefaler amoxicillin til empirisk behandling af samfundserhvervet pneumoni hos voksne og børn.
English: The CHMP accepted the MAH proposal when it was adequately specified by infection site as detailed below for oral and parenteral formulations.
Danish: CHMP godtog markedsføringstilladelsesindehaverens forslag i det omfang det var tilstrækkeligt specificeret efter infektionssted som angivet nedenfor for orale og parenterale formuleringer.
English: The CHMP considered that this indication was supported by appropriate data.
Danish: CHMP fandt, at denne indikation var underbygget med tilstrækkelige data.
English: Considering that meningitis is a relatively rare infection, and that several guidelines recommend the use of amoxicillin in meningitis, the CHMP considered that taken altogether the data provided supports the use of amoxicillin in this indication.
Danish: I betragtning af, at meningitis er en forholdsvis sjælden infektion, og at anvendelse af amoxicillin ved meningitis anbefales i flere retningslinjer, fandt CHMP, at de forelagte data som helhed støtter anvendelsen af amoxicillin til denne indikation.
English: Separated dosing recommendations are provided for the oral, parenteral and intramuscular formulations for adults and children above 40kg, for children below 40kg, for patients with renal impairment including those under haemodialysis.
Danish: Der er særskilte dosisanbefalinger for de orale, parenterale og intramuskulære formuleringer til voksne og børn over 40 kg, til børn under 40 kg og til patienter med nedsat nyrefunktion, herunder dialysepatienter.
English: Amoxicillin treatment is furthermore mentioned in several European national and Pan European consensus and evidence based guidelines national and for Lyme disease including disseminated Lyme disease and Lyme arthritis.
Danish: Behandling med amoxicillin nævnes yderligere i flere europæiske nationale og paneuropæiske konsensus- og evidensbaserede retningslinjer og for Lymesygdom, herunder dissemineret Lyme-sygdom og Lyme-artritis.
English: Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) - Parenteral formulation
Danish: Svære øre-næse-hals-infektioner (såsom mastoiditis, peritonsillære infektioner, epiglottitis og sinuitis, som er ledsaget af svære systemiske tegn og symptomer) - parenteral formulering
English: Several national guidelines and international societies including the World Health Organization recommend amoxicillin either as first or second line treatment for streptococcal pharyngitis.
Danish: Flere nationale retningslinjer og internationale sammenslutninger, herunder WHO, anbefaler amoxicillin som enten første- eller andetvalgsbehandling ved streptokokfaryngitis.
English: Amoxicillin could be an option in these indications, however as most cases would be due to staphylococci or streptococci, agents with broader spectrum of activity would be required.
Danish: Amoxicillin er et muligt valg til disse indikationer, men da de fleste tilfælde er forårsaget af stafylokokker eller streptokokker, behøves mere bredspektrede midler.
English: In addition several guidelines recommend the use of amoxicillin as first choice in these infections.
Danish: Flere retningslinjer anbefaler desuden amoxicillin som førstevalgsbehandling ved disse infektioner.
English: There are very few randomised trials that have evaluated the efficacy of antibiotic prophylaxis in infectious endocarditis.
Danish: Der findes kun meget få randomiserede undersøgelser, der har vurderet virkningen af antibiotisk profylakse ved infektiøs endokarditis.
English: The indication “genitourinary tract infections” is approved in all countries where Amoxil has a marketing authorisation, however only 7 used this general indication.
Danish: Indikationen "urogenitale infektioner" er godkendt i alle lande, hvor Amoxil har markedsføringstilladelse, men kun i syv af dem blev denne generelle indikation anvendt.
English: Information in this section consistently reflects across MSs that amoxicillin does not affect the ability to drive or use machines.
Danish: I alle medlemsstater angives det i dette punkt konsekvent, at amoxicillin ikke påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Bacterial meningitis - Parenteral formulation
Danish: Bakteriel meningitis - parenteral formulering
English: While all the clinical trials conducted in this indication are not recent, a number of recent clinical guidelines recommend the use of amoxicillin in urinary tract infections indications.
Danish: Ikke alle de kliniske undersøgelser ved denne indikation er af nyere dato, men en række nyere kliniske retningslinjer anbefaler amoxicillin til indikationen urinvejsinfektioner.