FrancophonIA/ELRC3.0 huggingface dataset:
English: The package leaflet (PL) was amended in accordance with the changes made to the SmPC.
Danish: Indlægssedlen blev ændret i overensstemmelse med de foreslåede ændringer af produktresuméet.
English: The MAH provided pharmacodynamic and pharmacokinetic data in animal models (a study in rats and another one in rabbits), children (five studies) and adults (two studies) which demonstrated a good penetration of amoxicillin in the cerebrospinal fluid (CSF).
Danish: Indehaveren af markedsføringstilladelsen fremlagde farmakodynamiske og farmakokinetiske data i dyremodeller (én undersøgelse i rotter og én i kaniner), hos børn (fem undersøgelser) og voksne (to undersøgelser).
English: In line with the CHMP guidelines, indications should describe the specific types of clinical infections for which the risk-benefit relationship is considered to be favourable, therefore indications such as upper or lower respiratory tract infections are no longer acceptable and the MAH has further specified those.
Danish: I henhold til CHMP's retningslinjer skal indikationerne beskrive de specifikke typer kliniske infektioner, for hvilke benefit/risk-forholdet anses for positivt.
English: The MAH presented a number of clinical studies conducted in adults and children between 1986 and 1999 comparing amoxicillin to placebo or other antibiotics as well as recommendations from guideline groups and meta-analysis that support the use of amoxicillin in adults and children with sinusitis.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en række kliniske undersøgelser, der er udført hos voksne og børn mellem 1986 og 1999, hvor amoxicillin blev sammenlignet med placebo eller andre antibiotika, foruden anbefalinger fra retningslinjer og en metaanalyse til støtte for anvendelse af amoxicillin hos voksne og børn med sinuitis.
English: Treatment with amoxicillin generally produced high clinical and bacteriological response rates (around 90%), with efficacy similar to the antibiotic comparators.
Danish: Behandling med amoxicillin resulterede sædvanligvis i høje kliniske og bakteriologiske responsrater (omkring 90 %) og en virkning svarende til de antibiotika, det blev sammenlignet med. CHMP anså fortsat amoxicillin for effektivt til behandling af akut bakteriel sinuitis.
English: The MAH provided data suggesting that the penetration of amoxicillin into bone is adequate, even when the tissue is infected and pharmacokinetic/pharmacodynamic data supporting the use of amoxicillin in these conditions however the clinical evidence is very limited.
Danish: Indehaveren af markedsføringstilladelsen forelagde dels data, der tyder på, at penetrationen af amoxicillin i knoglerne er tilstrækkelig selv i inficeret væv, dels farmakokinetiske/farmakodynamiske data til støtte for anvendelsen af amoxicillin ved disse sygdomme.
English: The MAH presented clinical studies in paediatrics conducted between 1986 and 2005 including comparative trials with macrolides and cephalosporins as well as recommendations from various treatment guideline groups based in the US and in the EU that support the use of amoxicillin in “acute otitis media”.
Danish: Indehaveren af markedsføringstilladelsen fremlagde kliniske pædiatriske undersøgelser udført mellem 1986 og 2005, herunder sammenlignende undersøgelser med makrolider og cefalosporiner, samt anbefalinger fra forskellige retningslinjegrupper i USA og EU, der støtter anvendelsen af amoxicillin ved "akut otitis media".
English: Acute exacerbations of chronic bronchitis (AECB) - all formulations
Danish: Akutte eksacerbationer af kronisk bronkitis - alle formuleringer
English: Typhoid and paratyphoid fever - oral formulations
Danish: Tyfus og paratyfus - orale formuleringer
English: Although the MAH has submitted a limited number of studies, those demonstrate the efficacy of amoxicillin when the susceptibility of the bacterium is known.
Danish: Indehaveren af markedsføringstilladelsen har kun forelagt et begrænset antal undersøgelser, men disse godtgør virkningen af amoxicillin, når bakteriens følsomhed kendes.
English: the CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Amoxil and associated names (see Annex I).
Danish: • udvalget godtog den harmonisering af produktresuméet, etiketteringen, indlægssedlen og kvalitetsdokumentationen i modul 3, der er foreslået af indehaverne af markedsføringstilladelse anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægssedler fremgår af bilag III for Amoxil og relaterede navne (se bilag I)
English: The MAH submitted results of six randomised controlled trials comparing amoxicillin alone or in combination with probenecid 500 mg TID to other antibiotics and placebo, as well as an observational cohort study conducted in children and adults between 1989 and 2008 with amoxicillin, all in treatment of type I Lyme disease (erythema migrans).
Danish: Indehaveren af markedsføringstilladelsen forelagde resultaterne af seks randomiserede, kontrollerede undersøgelser, hvor amoxicillin alene eller i kombination med probenecid 500 mg tre gange dagligt blev sammenlignet med andre antibiotika og placebo, samt en observationskohorteundersøgelse med amoxicillin hos børn og voksne udført mellem 1989 og 2008.
English: The MAH has submitted small clinical trials conducted as part of the initial clinical development of oral and parenteral amoxicillin, numerous clinical studies conducted since then, mostly by independent research groups and individuals and studies published in the literature in peer-reviewed journals in support of the proposed harmonised PI.
Danish: Til støtte for den foreslåede harmoniserede produktinformation har indehaveren af markedsføringstilladelsen forelagt små kliniske undersøgelser, der blev udført som led i den oprindelige kliniske udvikling af oralt og parenteralt amoxicillin, en lang række senere kliniske undersøgelser, hovedsagelig udført af uafhængige forskningsgrupper og personer, samt undersøgelser publiceret i tidsskrifter med peer-review.
English: The MAH also considered the SmPC Guideline and implemented the current QRD template.
Danish: Indehaveren af markedsføringstilladelsen har desuden taget hensyn til retningslinjerne for produktresuméer og implementeret den gældende QRD-skabelon.
English: Other contraindications, in patients with infectious mononucleosis, in combination with methotrexate and in patients with acute lymphocytic leukaemia were in place in a few member states.
Danish: Enkelte medlemsstater anvendte andre kontraindikationer: infektiøs mononukleose, kombination med methotrexat og akut lymfatisk leukæmi.
English: Prosthetic joints infections (PJIs) - all formulations
Danish: Infektioner i ledproteser - alle formuleringer
English: The MAH presented clinical studies in children and adults, including pregnant women, conducted between 1973 and 1993 with oral and parenteral amoxicillin as well as recommendations from various treatment guideline groups that support the use of amoxicillin in these indications.
Danish: Til støtte for anvendelsen af amoxicillin ved disse indikationer forelagde indehaveren af markedsføringstilladelsen kliniske undersøgelser udført mellem 1973 og 1993 med oralt og parenteralt amoxicillin hos børn og voksne, herunder gravide kvinder, og anbefalinger fra forskellige behandlingsretningslinjegrupper.
English: Skin and soft tissues infections (SSTI)
Danish: Infektioner i hud og underliggende væv
English: The MAH presented seven clinical studies conducted between 1989 and 2001 as well as recommendations from various treatment guideline groups that support the use of amoxicillin in AECB.
Danish: Indehaveren af markedsføringstilladelsen forelagde syv kliniske undersøgelser udført mellem 1989 og 2001 samt anbefalinger fra behandlingsretningslinjegrupper til støtte for anvendelsen af amoxicillin ved akutte eksacerbationer af kronisk bronkitis.
English: Recently updated international guidelines support the use of amoxicillin in prophylaxis of infectious endocarditis for patients at higher risk.
Danish: Brug af amoxicillin til profylakse af infektiøs endokarditis hos højrisikopatienter støttes af internationale retningslinjer, der nylig er ført ajour.
English: including as a first choice, for treatment and prophylaxis of endocarditis.
Danish: Flere nationale retningslinjer støtter brugen af amoxicillin, også som førstevalg, til behandling og profylakse af endokarditis.
English: A user test and bridging reports or justification for not providing either were provided for the package leaflet of the different formulations and were considered acceptable by CMHP.
Danish: Til indlægssedlerne for de forskellige formuleringer blev der forelagt brugertest og brobygningsrapporter eller begrundelse for ikke at fremlægge dem.
English: Genitourinary tract infections
Danish: Urogenitale infektioner
English: Community acquired pneumonia (CAP) - all formulations
Danish: Samfundserhvervet pneumoni - alle formuleringer
English: The CHMP requested that the warning of the potential occurrence of seizures in patients treated with high doses or with renal insufficiency or seizures history, treated epilepsy and meningeal damage present in one MS, be maintained as related adverse experiences such as myoclonic activity and seizures have been reported with beta-lactam antibiotics.
Danish: nyreinsufficiens, krampeanfald i anamnesen, behandling for epilepsi eller meningeal skade, da ßlactamantibiotika har givet anledning til tilknyttede indberetninger såsom myoklonisk aktivitet og krampeanfald.
English: In line with the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) the MAH was requested to provide the dose regimen and the duration of treatment courses tabulated by indication.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at angive dosisregime og behandlingsvarighed tabuleret for hver indikation - i overensstemmelse med retningslinjerne for vurdering af lægemidler indiceret til behandling af bakterielle infektioner (CPMP/EWP/558/95 rev. 2).
English: The MAH presented clinical studies conducted in adults and children between 1993 and 2008 as well as recommendations from various treatment guideline groups that support the use of amoxicillin in tonsillitis and pharyngitis particularly that due to group A beta-haemolytic streptococcal infections (GABHS).
Danish: Indehaveren af markedsføringstilladelsen forelagde kliniske undersøgelser udført hos voksne og børn mellem 1993 og 2008 samt anbefalinger fra retningslinjegrupper, der støtter anvendelsen af amoxicillin ved tonsillitis og faryngitis, navnlig forårsaget af betahæmolytiske streptokokker gruppe A. Ved forskellige dosisregimer var virkningsraten omkring 90 % i størstedelen af undersøgelserne, og virkningen svarede til sammenligningspræparaterne.
English: The MAH presented clinical studies in adults and paediatrics conducted between 1992 and 2008, as well as recommendations from various treatment guideline groups that support the use of amoxicillin in CAP.
Danish: Indehaveren af markedsføringstilladelsen forelagde kliniske undersøgelser udført mellem 1992 og 2008 samt anbefalinger fra behandlingsretningslinjegrupper til støtte for anvendelsen af amoxicillin ved samfundserhvervet pneumoni.
English: Although there is a paucity of clinical studies in adult AOM patients, taking into account the similarity in bacteriological aetiology and pathogenesis of adult sinusitis and AOM, it was considered that the clinical data demonstrating that amoxicillin is an effective treatment in ABS can be extrapolated to support efficacy of amoxicillin in the treatment of adult AOM.
Danish: Det skønnedes imidlertid, at de kliniske data til dokumentation af amoxicillins effektivitet ved akut bakteriel sinuitis kan ekstrapoleres til støtte for virkningen ved akut otitis media hos voksne på baggrund af ligheden i bakteriologisk ætiologi og patogenese mellem sinuitis og akut otitis media hos voksne.
English: Considering that amoxicillin has been in use for many years and is indicated for use in a broad range of infections, in line with the Addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013), the CHMP was of the view that, based on the available data, the proposed indication was adequately justified..
Danish: I betragtning af, at amoxicillin har været i brug i mange år og er indiceret til en bred række infektioner, fandt CHMP den ansøgte indikation tilfredsstillende begrundet med de foreliggende data.
English: In line with the SmPC guideline the adverse events that may however occur and could influence the ability to drive or use machines are listed in the section; this was accepted by the CHMP.
Danish: Under dette punkt er dog anført kendte bivirkninger med indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: In line with the SmPC guideline and QRD template, the MAH has listed the ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, sorted by MedDRA System Organ Class.
Danish: Markedsføringstilladelsesindehaveren har opført bivirkningerne fordelt på MedDRA-systemorganklasse i henhold til retningslinjerne for produktresuméer og QRD-skabelonen.
English: The indication “lower respiratory tract infections” is approved in all countries where Amoxil has a marketing authorisation, however such general indication is no longer acceptable and the CHMP accepted the MAH proposal to replace it by specific terms, as detailed below.
Danish: En sådan generel indikation kan imidlertid ikke længere godkendes, og CHMP godtog markedsføringstilladelsesindehaverens forslag om at erstatte den med specifikke indikationer som beskrevet nedenfor.
English: Nearly a quarter of the patients were over 80 years of age.
Danish: Næsten en fjerdedel af patienterne var over 80 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Osseor on 21 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Osseor den 21. september 2004.
English: Other information about Osseor
Danish: Andre oplysninger om Osseor
English: The full EPAR for Osseor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Osseor findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Osseor should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Danish: Osseor bør tages mindst to timer efter et måltid, mælk, mælkeprodukter eller kalciumtilskud, helst ved sengetid.
English: A risk management plan has been developed to ensure that Osseor is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Osseor anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Osseor.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Osseor.
English: This showed that the risk of broken bones is reduced.
Danish: Dette viste, at risikoen for knoglebrud er mindsket.
English: Patients should also receive calcium or vitamin D supplements if they are not getting enough from their diet.
Danish: Patienterne bør desuden tage tilskud af kalcium eller vitamin D, hvis de ikke får tilstrækkeligt heraf gennem kosten.
English: These materials will also remind doctors of the approved used of the medicine.
Danish: Materiale gør ligeledes lægerne opmærksom på lægemidlets godkendte anvendelse.
English: Treatment should only be started by a doctor with experience of treating osteoporosis.
Danish: Behandlingen bør indledes af en læge med erfaring i behandling af osteoporose.
English: Osseor has been studied in almost 7,000 elderly women in two large studies.
Danish: Osseor blev anvendt i to store undersøgelser hos næsten 7 000 ældre kvinder.
English: The study looked at changes in the bone density after one year of treatment.
Danish: Undersøgelsen så på ændringer i knogletætheden efter et års behandling.
English: Osseor is taken as one sachet once a day.
Danish: Der tages et brev Osseor en gang dagligt.
English: What measures are being taken to ensure the safe and effective use of Osseor?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Osseor?
English: The company will also carry out a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Danish: Virksomheden gennemfører også en undersøgelse med henblik på evaluering af de foranstaltninger, der er truffet for at minimere risikoen for hjerte- og kredsløbsproblemer.
English: Osseor is intended for long-term use.
Danish: Osseor er beregnet til langtidsbehandling.
English: For more information about treatment with Osseor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Osseor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The contents of the sachet are added and mixed into a glass of water to form a suspension, which is drunk just after being prepared.
Danish: Brevets indhold røres og blandes i et glas vand til en suspension, som drikkes straks efter tilberedningen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Osseor.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Osseor.
English: The CHMP decided that Osseor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Osseor opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Osseor in preventing bone breaks.
Danish: Som helhed var resultaterne af den anden undersøgelse i sig selv utilstrækkelige til at påvise en gavnlig virkning af Osseor til forebyggelse af knoglebrud.
English: Osseor is a medicine that contains the active substance strontium ranelate.
Danish: Osseor er et lægemiddel, der indeholder det aktive stof strontiumranelat.
English: What is the risk associated with Osseor?
Danish: Hvilken risiko er der forbundet med Osseor?
English: It must not be used in people who are temporarily or permanently immobilised, such as people on bed rest or recovering from surgery.
Danish: Det må ikke anvendes til personer, som er midlertidigt eller vedvarende immobiliseret såsom sengeliggende personer eller personer, som er ved at komme sig efter et kirurgisk indgreb.
English: The most common side effects with Osseor (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Danish: De hyppigste bivirkninger ved Osseor (som kan optræde hos mere end 1 ud af 10 patienter) er overfølsomhedsreaktioner på huden (udslæt, kløe, urticaria (kløende udslæt) og hævelse under huden (angioødem)) og muskel-, knogle- og ledsmerter.
English: • peripheral arterial disease (obstruction of the blood flow in the arteries, usually in the legs);
Danish: • perifer arteriesygdom (obstruktion af blodgennemstrømningen i arterierne, sædvanligvis i benene)
English: In order to reduce the risk of heart attack, Osseor must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Danish: For at reducere risikoen for hjertetilfælde må Osseor heller ikke anvendes til patienter med højt blodtryk, som ikke er tilstrækkelig kontrolleret, eller til patienter, som har eller har haft et af følgende problemer:
English: Osseor must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Danish: Osseor må ikke anvendes til patienter, som har eller har haft en venøs tromboemboli (problemer som følge af dannelse af blodpropper i venerne såsom i ben eller lunger).
English: It is available as 2 g sachets containing granules that are made up into an oral (by mouth) suspension.
Danish: Det fås som 2 mg breve indeholdende granulat, der blandes til en oral suspension (indtages gennem munden).
English: The first study included 1,649 women with osteoporosis who had already had a broken bone in the spine and the second included over 5,000 women whose osteoporosis was affecting the hip.
Danish: Den første undersøgelse omfattede 1 649 kvinder med osteoporose, som allerede havde brud på rygsøjlen, og den anden omfattede godt 5 000 kvinder, hos hvem osteoporosen havde angrebet hoften.
English: In addition, education materials are sent to patients and healthcare professionals prescribing Osseor reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Danish: Der udsendes desuden oplysningsmateriale til patienter og sundhedspersoner, som forventes at ordinere Osseor, for at gøre opmærksom på risikoen for hjerte- og kredsløbsproblemer med lægemidlet og behovet for regelmæssig kontrol.
English: When looking at results of the two studies taken together, fewer women in the Osseor group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Osseor compared with 389 out of 3,256 for placebo).
Danish: Når man ser på resultaterne af de to undersøgelser under et, udviklede færre kvinder i Osseor-gruppen brud et andet sted end på rygsøjlen (inklusive hoften) end i placebogruppen (331 ud af 3 295 for Osseor, sammenlignet med 389 ud af 3 256 for placebo).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Osseor, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Osseor, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: • ischaemic heart disease (such as angina or a heart attack);
Danish: • iskæmisk hjertesygdom (såsom angina ellert hjertetilfælde)
English: Why has Osseor been approved?
Danish: Hvorfor blev Osseor godkendt?
English: However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Osseor.
Danish: Hvis man alene ser på kvinder på 74 år eller derover med specielt svage lårbensknogler, tyder resultaterne dog på, at Osseor mindsker risikoen for hoftebrud.
English: In the first study, Osseor reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Osseor developed a new break in the spine, compared with 33% of the 723 who took placebo.
Danish: I den første undersøgelse mindskede Osseor risikoen for nye brud på rygsøjlen med 41 % i løbet af tre år: 21 % af de 719 kvinder, der tog Osseor, fik nye brud på rygsøjlen, sammenholdt med 33 % af de 723, der fik placebo.