FrancophonIA/ELRC3.0 huggingface dataset:
English: The main issue for consideration was the failure to demonstrate that Teicoplanin Hospira is a generic of Targocid.
Danish: Det vigtigste spørgsmål, der skulle behandles, var den manglende påvisning af, at Teicoplanin Hospira er en generisk form af Targocid.
English: Therefore, the Applicant considers Teicoplanin Hospira to be a generic of Targocid.
Danish: Derfor mener ansøgeren, at Teicoplanin Hospira er en generisk form af Targocid.
English: While EUCAST approved subcomponent MICs are not available for any antibacterial, this should not constitute an argument against their use.
Danish: Selv om EUCAST-godkendte MIC'er for underkomponenter ikke er tilgængelige for noget antibakterielt middel, bør dette ikke være et argument imod brugen af dem. CHMP var enigt i ansøgerens svar og betragtede dette spørgsmål som løst.
English: In conclusion, the CHMP considers that the difference in concentration of the glycopeptide subcomponents precludes Teicoplanin Hospira being a considered a generic of Targocid, despite the composition being in line with the JP monograph and the draft Ph.Eur monograph.
Danish: CHMP er således af den opfattelse, at forskellene i koncentrationen af glykopeptidunderkomponenter udelukker, at Teicoplanin Hospira kan betragtes som en generisk form af Targocid, selv om sammensætningen er i overensstemmelse med den japanske farmakopés monografi og udkastet til monografi i Den Europæiske Farmakopé.
English: The Applicant discussed the compliance of Teicoplanin Hospira to the monographs, stating that the tighter controls over the individual components proposed signify that the active pharmaceutical ingredient used in Teicoplanin Hospira meets the requirements of both monographs and that the individual components are controlled to a far greater extent.
Danish: Ifølge ansøgeren tyder dette på, at de terapeutiske resultater i det væsentlige er ens. Ansøgeren redegjorde for Teicoplanin Hospiras overensstemmelse med monografierne og oplyste, at den skærpede kontrol med de enkelte komponenter, der er foreslået, betyder, at det aktive farmaceutiske stof, der anvendes i Teicoplanin Hospira, opfylder kravene i begge monografier, og at de enkelte komponenter kontrolleres i meget større udstrækning.
English: Ground 3: Furthermore the submitted additional non-clinical and serum bactericidal data are not considered sufficient to adequately demonstrate that Teicoplanin Hospira is a generic of the innovator Targocid
Danish: Begrundelse 3: De fremsendte yderligere ikke-kliniske data og data for den serumbaktericide aktivitet betragtes desuden ikke som tilstrækkelige til at påvise, at Teicoplanin Hospira er en generisk form af originallægemidlet Targocid.
English: The CHMP noted the data comparing the PK, PDD and safety of Teicoplanin Hospira and the originator.
Danish: CHMP noterede sig de data, der sammenligner Teicoplanin Hospiras og originallægemidlets farmakokinetik, farmakodynamik og sikkerhed.
English: The CHMP noted that the proposed specifications result in a considerably greater control of the individual subcomponents than if they had simply been in line with the monographs; however this does not establish that Teicoplanin Hospira is a generic of Targocid.
Danish: CHMP bemærkede, at de foreslåede specifikationer resulterer i en betydeligt større kontrol med de enkelte underkomponenter, end hvis de blot havde været i overensstemmelse med monografierne.
English: The Applicant stated that the antimicrobial potency of the drug is a sum of the component parts and that In vitro antibacterial potency is established by MIC testing.
Danish: Ansøgeren anførte, at lægemidlets antimikrobielle styrke er summen af bestanddelene, og at den antibakterielle styrke in vitro bestemmes ved MIC-test. Teicoplanin Hospira har en anden underkomponentsammensætning end originallægemidlet.
English: The CHMP endorsed the answer of the Applicant, from a pharmacodynamic point of view, free AUC is the most important PK parameter.
Danish: Set ud fra et farmakodynamisk synspunkt er det frie AUC det vigtigste farmakokinetiske parameter.
English: The Applicant submitted a request for a re-examination of the CHMP opinion, responding to the grounds supporting the decision that Teicoplanin Hospira cannot be considered to be a generic of the innovator Targocid and addressed one by one the three grounds for refusal of the granting of the Marketing Authorisations.
Danish: Ansøgeren fremsendte en anmodning om revurdering af CHMP's udtalelse og svarede på begrundelserne for beslutningen om, at Teicoplanin Hospira ikke kan betragtes som en generisk form af originallægemidlet Targocid.
English: Regarding safety, the data from study TEC062 showed no differences between Teicoplanin Hospira and Targocid, however, the premature termination of the study does not allow solid conclusions to be drawn, although there were no suggestions of any differential safety profile between the two products.
Danish: Hvad sikkerheden angår, viste dataene fra TEC062-undersøgelsen ingen forskelle på Teicoplanin Hospira og Targocid.
English: In addition, the evaluation of free drug AUC also failed to demonstrate equivalence.
Danish: Desuden kunne der heller ikke påvises ækvivalens med vurderingen af AUC (arealet under kurven) for det frie lægemiddel.
English: Teicoplanin Hospira has a different sub-component mix to the originator; however the Applicant considers that it is not reasonable to use total teicoplanin MICs to assess the impact of differing proportions of subcomponents.
Danish: Ansøgeren er dog af den opfattelse, at det ikke er rimeligt at bruge MIC'er for det totale teicoplanin til at vurdere virkningen af de forskellige andele af underkomponenter.
English: The Applicant is therefore requested to further justify that Teicoplanin Hospira is a generic of Targocid in writing and/or at an Oral Explanation in light of the CHMP opinion.“ The Applicant decided to address the List of Outstanding Issues during an oral explanation.
Danish: I lyset af CHMP's udtalelse bedes ansøgeren således begrunde yderligere, at Teicoplanin Hospira er en generisk form af Targocid, skriftligt og/eller ved hjælp af en mundtlig redegørelse”.
English: The Applicant did not further discuss the outcomes of the partially completed bioequivalence studies evaluating AUC and Cmax, as the CHMP considered that due to the nature of this drug, the whole drug (total) AUC is not appropriate to demonstrate bioequivalence.
Danish: CHMP var nemlig af den opfattelse, at som følge af dette lægemiddels natur er (totalt) AUC for det samlede lægemiddel ikke velegnet til at påvise bioækvivalens.
English: However, these results are not considered to demonstrate that Teicoplanin Hospira is a generic of Targocid, with regards to overall similarity.
Danish: Hvad den samlede lighed angår, betragtes disse resultater dog ikke som et bevis for, at Teicoplanin Hospira er en generisk form af Targocid.
English: The CHMP agreed with the Applicant response and considered the issue to be resolved.
Danish: CHMP godkendte ansøgerens svar.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protopic on 28 February 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Protopic den 28. februar 2002.
English: This means that it works on the immune system (the body's natural defences).
Danish: Det vil sige, at det virker på immunsystemet (kroppens naturlige forsvar).
English: The full EPAR for Protopic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Protopic findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: If there is no improvement after two weeks, the doctor should consider other treatment options.
Danish: Hvis der ikke er indtrådt nogen forbedring efter to uger, bør lægen overveje andre behandlingsmuligheder.
English: This is a summary of the European public assessment report (EPAR) for Protopic.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Protopic.
English: Generally, improvement is seen within one week of starting treatment.
Danish: Generelt kan der iagttages en forbedring inden for en uge efter behandlingsstart.
English: Protopic treatment should begin as soon as symptoms appear.
Danish: Behandlingen med Protopic bør indledes, så snart symptomerne opstår.
English: The doctor should review the need to continue maintenance treatment after a year.
Danish: Lægen skal taget behovet for at fortsætte vedligeholdelsesbehandlingen op til fornyet overvejelse efter et år.
English: Other information about Protopic
Danish: Andre oplysninger om Protopic
English: Tacrolimus has been used since the mid-1990s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Danish: Tacrolimus er siden midten af 1990'erne blevet anvendt til at forebygge afstødning hos transplantationspatienter (når immunsystemet angriber det transplanterede organ).
English: In children, this should include suspension of treatment to allow the doctor to assess whether continued treatment for the disease is necessary.
Danish: Hos børn skal dette omfatte suspendering af behandlingen, så lægen kan vurdere, hvorvidt det er nødvendigt at fortsætte behandlingen.
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 Protopic.
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 Protopic.
English: Protopic is an ointment that contains the active substance tacrolimus (0.1% and 0.03%).
Danish: Protopic er en salve, som indeholder det aktive stof tacrolimus (0,1 % eller 0,03 %).
English: In the longer study, Protopic could be used repeatedly without losing its effectiveness.
Danish: I den længere varende undersøgelse kunne Protopic anvendes gentagne gange uden at miste sin virkning.
English: Another study looked at the repeated use of Protopic for up to four years in about 800 patients.
Danish: I en anden undersøgelse så man nærmere på gentagen brug af Protopic i op til fire år hos ca. 800 patienter.
English: For more information about treatment with Protopic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Protopic, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Protopic, tacrolimus, is an immunomodulator.
Danish: Det aktive stof i Protopic, tacrolimus, er en immunmodulator.
English: Protopic can also be used to prevent flare-ups of the disease or prolong the time that patients are free from flare-ups.
Danish: Protopic kan også anvendes til at forebygge opblussen af sygdommen eller til at forlænge den periode, hvor patienterne er fri for opblussen.
English: All of the patients had atopic dermatitis that had responded to a maximum of six weeks of previous treatment with Protopic.
Danish: Alle patienterne havde atopisk dermatitis, som havde reageret på højst seks ugers tidligere behandling med Protopic.
English: The most common side effects with Protopic (seen in more than 1 patient in 10) are a burning sensation and itching at the application site.
Danish: De hyppigste bivirkninger ved Protopic (som optræder hos flere end 1 ud af 10 patienter) er en brændende fornemmelse og kløe på påføringsstedet.
English: Protopic should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Danish: Protopic bør kun ordineres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis.
English: In maintenance treatment, Protopic was more effective than placebo at reducing the number of flare-ups.
Danish: Til vedligeholdelsesbehandling var Protopic mere effektivt end placebo til at reducere antallet af opblussener.
English: Protopic is used in patients aged two years and above who do not respond well to or do not tolerate conventional treatments such as locally applied corticosteroids.
Danish: Protopic anvendes til patienter fra 2-årsalderen og derover, som ikke reagerer særlig godt på eller ikke tåler traditionelle behandlinger såsom lokalt påførte corticosteroider.
English: Children should use Protopic 0.03% twice a day for up to three weeks before reducing the frequency to once a day.
Danish: Til børn bør der anvendes Protopic 0,03 % to gange dagligt i op til tre uger, inden hyppigheden nedsættes til en gang dagligt.
English: The main measure of effectiveness was the improvement in the eczema seen at the end of the studies, after three or 12 weeks, using a scoring system that looks at all of the symptoms of atopic dermatitis.
Danish: Virkningen blev hovedsagelig målt på forbedringen af eksemen ved undersøgelsernes afslutning efter tre eller 12 uger ved hjælp af et score-system, hvor alle symptomer på atopisk dermatitis tages i betragtning.
English: While Protopic 0.03% can be used in all patients over two years of age, Protopic 0.1% is only used in adults and adolescents over 16 years of age.
Danish: Protopic 0,03 % kan anvendes til alle patienter over to år, mens Protopic 0,1 % kun kan anvendes til voksne og unge over 16 år.
English: The main measure of effectiveness was the number of flare-ups the patients had over a year.
Danish: Virkningen blev hovedsagelig målt på det antal af opblussener, patienterne havde i løbet af et år.
English: Each affected area is treated twice a day with Protopic until the skin is clear.
Danish: Hvert af de berørte områder behandles to gange dagligt med Protopic, indtil huden er helet.
English: When used for flare-ups, Protopic can be used for short-term and intermittent long-term treatment, but it should not be used continuously on a long-term basis.
Danish: Når Protopic anvendes til opblussen, kan det anvendes til kortvarig og intermitterende langvarig behandling, men det må ikke anvendes kontinuerligt til langvarig behandling.
English: In maintenance treatment, it is used in patients who usually have four or more flareups per year and who have had a response to an initial course of Protopic used twice a day for up to six weeks.
Danish: Det anvendes til vedligeholdelsesbehandling af patienter, som normalt har fire eller flere opblussener om året, og som har reageret på et initialt behandlingsforløb med Protopic anvendt to gange dagligt i op til seks uger.
English: The studies compared twice-weekly Protopic with placebo, although both groups of patients could use Protopic whenever they had a flare-up of the disease.
Danish: I undersøgelserne sammenlignedes Protopic to gange ugentligt med placebo, selv om begge patientgrupper kunne anvende Protopic, når de havde en opblussen af sygdommen.
English: Tacrolimus reduces the activity of the immune system, helping to relieve the skin inflammation and the itching.
Danish: Tacrolimus nedsætter immunsystemets aktivitet, hvilket medvirker til at lindre betændelsen og kløen i huden.
English: In both studies, the patients with moderate to severe disease who were using Protopic had an average of one flare-up over a year, compared with three in those using placebo.
Danish: I begge undersøgelser havde patienterne med moderat til svær sygdom, som fik Protopic, gennemsnitlig en opblussen i løbet af et år sammenlignet med tre hos dem, der fik placebo.
English: Protopic was compared either with placebo (a dummy treatment) or with hydrocortisone (a corticosteroid often used for eczema).
Danish: Protopic blev sammenlignet med placebo (en uvirksom behandling) eller med hydrocortison (et corticosteroid, som ofte anvendes mod eksem).
English: ‘Atopic' means that the dermatitis is linked to an allergy.
Danish: ‘Atopisk' vil sige, at denne dermatitis er allergisk betinget.
English: Adults should start treatment with Protopic 0.1% twice a day but should switch to less frequent application or use of the lower strength (0.03%) as the condition improves.
Danish: Voksne behandles indledningsvis med Protopic 0,1 % to gange dagligt, men denne dosis skal nedsættes til mindre hyppige påføringer eller lavere styrker (0,03 %), efterhånden som tilstanden forbedres.
English: For the full list of all the side effects reported with Protopic, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Protopic fremgår af indlægssedlen.
English: Maintenance treatment with Protopic has been studied in two main studies involving 224 patients aged 16 years or over, and 250 aged from two to 15 years.
Danish: Vedligeholdelsesbehandling med Protopic blev undersøgt i to hovedundersøgelser med inddragelse af 224 patienter på 16 år eller derover og 250 i alderen to til 15 år.
English: In the treatment of flare-ups of atopic dermatitis, Protopic was more effective than hydrocortisone at producing improvements in symptoms, although it also produced more burning than hydrocortisone.
Danish: Til behandling af opblussen af atopisk dermatitis var Protopic mere effektivt end hydrocortison til symptomlindring, selv om det også gav flere brændende fornemmelser end hydrocortison.
English: What is the risk associated with Protopic?
Danish: Hvilken risiko er der forbundet med Protopic?
English: If there are signs of a flare-up, treatment should revert to twice a day as above.
Danish: Hvis der er tegn på en opblussen, skal man vende tilbage til at give behandlingen to gange dagligt.
English: The CHMP decided that Protopic's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Protopic opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
English: Protopic should not be used in people who may be hypersensitive (allergic) to tacrolimus, any of the other ingredients or macrolides.
Danish: Protopic bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne.
English: When used as maintenance treatment, Protopic should be applied twice a week to areas of the skin commonly affected by the disease.
Danish: Når Protopic anvendes som vedligeholdelsesbehandling, skal det påføres to gange om ugen på de hudområder, der er mest berørt af sygdommen.
English: The use of Protopic in the treatment of flare-ups has been studied in six main studies involving 1,202 patients over the age of 16 years, and 1,535 aged from two to 16 years.
Danish: Protopic til behandling af opblussen blev undersøgt i seks hovedundersøgelser med deltagelse af 1 202 patienter over 16 år og 1 535 i alderen to til 16 år.
English: Why has Protopic been approved?
Danish: Hvorfor blev Protopic godkendt?
English: The ointment should be applied as a thin layer to the skin.
Danish: Salven påføres i et tyndt lag på huden.
English: Protopic is used to treat ‘flare-ups' (recurrence or worsening) of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin).
Danish: Protopic anvendes til behandling af opblussen (tilbagevenden eller forværring) af moderat til svær atopisk dermatitis (eksem, et kløende rødt udslæt på huden).
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness and dryness).
Danish: Atopisk dermatitis er en overreaktion af hudens immunsystem, der fremkalder en betændelsestilstand (kløe, rødt udslæt og tør hud).
English: What is Protopic?
Danish: Hvad er Protopic?
English: The way in which Protopic works in atopic dermatitis is not fully understood.
Danish: Det vides ikke med nøjagtighed, hvordan Protopic virker mod atopisk dermatitis.
English: What benefit has Protopic shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Protopic?
English: How has Protopic been studied?
Danish: Hvordan blev Protopic undersøgt?
English: What is Protopic used for?
Danish: Hvad anvendes Protopic til?
English: How is Protopic used?
Danish: Hvordan anvendes Protopic?
English: How does Protopic work?
Danish: Hvordan virker Protopic?
English: You may see an air bubble, and that is okay.
Danish: Du kan måske se en luftboble, og det er okay.
English: You may hear a 1st click.
Danish: Du hører muligvis et 1. klik.
English: • Several seconds later you may hear a 2nd click.
Danish: • Adskillige sekunder senere hører du muligvis et 2. klik.
English: Open.
Danish: Åbn.
English: Continue to hold
Danish: Fortsæt med at holde
English: Sometimes, fast injections can be painful.
Danish: Undertiden kan hurtige injektioner være smertefulde.
English:  Remember to wash your hands!
Danish:  Husk at vaske hænderne!
English: Not known (frequency cannot be estimated from available data):
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra tilgængelge data):
English: Wait 15-30 minutes
Danish: Vent 15-30 minutter
English: Fewer than half of at-risk subjects had an event
Danish: Færre end halvdelen af risikopatienterne havde en hændelse.
English: ASASa 40 ASAS 20 ASAS 5/6 ASAS partial remission BASDAIb 50
Danish: ASASa 40 ASAS 20 ASAS 5/6 ASAS delvis remission BASDAIb 50
English: The needle is hidden below the green base.
Danish: Kanylen er skjult under den grønne basis.
English: • Make sure you know the proper amount (volume) needed for dosing.
Danish: • Vær sikker på at du kender den korrekte mængde (volumen).
English: ATC code: L04AB04
Danish: ATC-kode: L04AB04
English: Be careful that it does not fall over.
Danish: Pas på at det ikke vælter.
English: Maintenance Dose Starting at Week 4
Danish: Vedligeholdelsesdosi s Startende ved uge 4
English: • Wash your hands thoroughly
Danish: • Vask hænderne grundigt
English: If you don't know the amount, STOP HERE and contact your doctor for further instruction.
Danish: Hvis du ikke kender mængden, STOP HER og kontakt lægen for yderligere instruktioner
English: The needle might be dirty or damaged.
Danish: Kanylen kan være snavset eller beskadiget.
English: The highest frequency seen among the various indications has been included.
Danish: Den højeste frekvens, der er set i forbindelse med de forskellige indikationer, er anført.
English: Percent Change in Total Fingernail NAPSI (%)
Danish: Procent ændring i Total Fingernail NAPSI (%)
English: This may mean there is an infection and therefore you should contact your doctor.
Danish: Dette kan være tegn på en infektion, og du skal derfor kontakte lægen.
English: ASDAS Inactive Disease hs-CRPd,f,g
Danish: ASDAS inaktiv sygdom hs-CRPd,f,g
English: • Use a different injection site every time:
Danish: • Brug forskellige injektionssteder hver gang:
English: Fatty areas, like your stomach, are generally the best injection sites.
Danish: Fedtholdige områder, som din mave, er almindeligvis de bedste injektionssteder.
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table 13).
Danish: Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (Tabel 13).
English: ASASa Partial Remission
Danish: ASASa Delvis Remission
English: Results from the overall UC-II study population are shown in Table 28.
Danish: Resultater fra den samlede UC-II studiespopulation er vist i tabel 28.
English: The Patient Reminder Cards should contain the following key elements:
Danish: Patientkortet skal indeholde følgende hovedelementer:
English: ASDASc Inactive Disease
Danish: ASDASc inaktiv sygdom
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4 % of the eyes at week 78.
Danish: BCVA blev enten forbedret eller vedligeholdt (< 5 forringelse i forhold til bogstaver) i 88,4 % af øjnene i uge 78.
English: There is no button on your pre-filled pen.
Danish: Der er ingen knap på din fyldte pen.
English: Contains 2 cartons and each carton contains:
Danish: Indeholder 2 kartoner og hvert karton indeholder: