FrancophonIA/ELRC3.0 huggingface dataset:
English: ORACEA should be used with caution in patients with a history of predisposition to candidiasis overgrowth.
Danish: ORACEA bør anvendes med forsigtighed hos patienter med en anamnese med prædisponering for candidiasis-overvækst.
English: ORACEA and certain other medications may not work properly when taken together.
Danish: ORACEA og visse andre lægemidler vil muligvis ikke virke korrekt, når de tages samtidig.
English: To date no significant acute toxicity has been described in the case of a single oral intake of a multiple of therapeutic doses of doxycycline.
Danish: Der er til dato ikke beskrevet tilfælde af signifikant akut toksicitet i tilfælde af en enkelt oral indtagelse af flere terapeutiske doser doxycyclin.
English: - The CHMP considers that Oracea is well tolerated and is satisfied with the safety profile when in conjunction with the commitment to carry out a post-marketing study as set out in Annex IV and the revision of the Summary of Product Characteristics as set out in Annex III,
Danish: - CHMP finder, at Oracea tåles godt, og er tilfreds med sikkerhedsprofilen sammen med en forpligtelse til at udføre en postmarketingsundersøgelse, som fremgår af bilag IV og en ændring af produktresuméet, som fremgår af bilag III,
English: This reaction is more common during long-term use of the medicinal product but has been observed following repeated short-term courses.
Danish: Denne reaktion optræder hyppigst ved langtidsbehandling med stoffet men er set efter gentagne korttidsbehandlinger.
English: Nasopharyngitis Sinusitis Fungal infection
Danish: Nasofaryngitis Sinusitis Svampeinfektion
English: If you are taking certain treatments for diabetes, your doctor may need to check whether the dose of the diabetes treatment has to be changed.
Danish: Hvis De tager visse behandlingen for diabetes, vil Deres læge muligvis være nødt til at undersøge, hvorvidt Deres dosis af diabetes-behandlingen skal ændres.
English: BATCH NUMBER Batch No..
Danish: BATCHNUMMER Batchnr.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Swallow whole, do not crush or chew.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Synkes hele, må ikke knuses eller tygges.
English: Tetracyclines used concurrently with oral contraceptives have in a few cases resulted in either breakthrough bleeding or pregnancy.
Danish: Tetracykliner anvendt samtidig med orale præventionsmidler har i nogle få tilfælde resulteret i enten gennembrudsblødning eller graviditet.
English: The scope, design and endpoints of the study should be in line with similar trials published in the literature and the study protocol should be validated by and submitted to the National Competent Authority of the Reference Member State within three months of approval.
Danish: Formålet, designet og slutpunktet for undersøgelsen skal være i overensstemmelse med lignende undersøgelser, hvis resultater er publiceret, og undersøgelsesprotokollen skal godkendes af og indsendes til referencemedlemsstatens nationale kompetente myndighed inden for tre måneder efter godkendelsen.
English: Swallow the capsule whole and do not chew it.
Danish: Synk kapslen hel; kapslen må ikke tygges.
English: The following adverse reactions have been observed in patients receiving tetracyclines:
Danish: Følgende bivirkninger er observeret hos patienter, der får tetracykliner:
English: In the pivotal placebo-controlled studies with ORACEA in rosacea, 269 patients were treated with ORACEA 40 mg once daily and 268 patients were treated with placebo for 16 weeks.
Danish: I de pivotale, placebokontrollerede studier med ORACEA hos patienter med rosacea blev 269 patienter behandlet med ORACEA 40 mg én gang daglig, og 268 patienter blev behandlet med placebo i 16 uger.
English: The scope, design and end-points should be in line with similar trials published in the literature.
Danish: Formålet, designet og slutpunkterne skal være i overensstemmelse med lignende undersøgelser, hvis resultater er publiceret.
English: Like all medicines, ORACEA can cause side effects, although not everybody gets them.
Danish: ORACEA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: As a consequence, doxycycline is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Danish: Som konsekvens heraf er doxycyclin kontraindiceret i andet og tredje trimester af graviditet (se pkt.
English: This probably leading to a higher risk for adverse reactions, such as development of resistance in the commensal microflora.
Danish: Dette medfører formentlig en højere risiko for bivirkninger så som udvikling af resistens i den kommensale mikroflora.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Tetracyclines.
Danish: Farmakoterapeutisk klassifikation: Antibakterielt lægemiddel til systemisk brug, tetracykliner.
English: Therefore clinicians should bear in mind that in many cases overdose is likely to produce blood concentrations of doxycycline within the therapeutic range for antimicrobial treatment, for which there is a large quantity of data supporting the safety of the medicinal product.
Danish: Lægen bør derfor huske på, at overdosering i mange tilfælde med sandsynlighed vil give koncentrationer af doxycyclin i blodet, der ligger inden for det terapeutiske område for antimikrobiel behandling, for hvilken der findes en stor mængde data, der understøtter sikkerheden af lægemidlet.
English: Sugar spheres (Maize starch, Sucrose)
Danish: Sukkersfærer (majsstivelse, sukrose)
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med fruktoseintolerans, glukose-galaktose-malabsorption eller sukrase-isomaltase-mangel bør ikke tage dette lægemiddel.
English: In humans, the use of tetracyclines during tooth development may cause permanent discolouration of the teeth (yellow-grey-brown).
Danish: Hos mennesker kan brugen af tetracykliner under tandudviklingen forårsage permanent misfarvning af tænderne (gul-grå-brun).
English: Treatment:
Danish: Behandling:
English: The daily dose is 40 mg (1 capsule).
Danish: Den daglige dosis er 40 mg (1 kapsel).
English: SE - ORACEA 40 mg modified release hard capsules UK - ORACEA 40 mg modified release hard capsules DE - ORACEA 40 mg modified release hard capsules IE - ORACEA 40 mg modified release hard capsules AT - ORACEA 40 mg modified release hard capsules FI - ORACEA 40 mg modified release hard capsules LU - ORACEA 40 mg modified release hard capsules NL - ORACEA 40 mg modified release hard capsules IT - ORACEA 40 mg modified release hard capsules
Danish: SE - ORACEA 40 mg hårde kapsler med modificeret udløsning UK - ORACEA 40 mg hårde kapsler med modificeret udløsning DE - ORACEA 40 mg hårde kapsler med modificeret udløsning IE - ORACEA 40 mg hårde kapsler med modificeret udløsning AT - ORACEA 40 mg hårde kapsler med modificeret udløsning FI - ORACEA 40 mg hårde kapsler med modificeret udløsning LU - ORACEA 40 mg hårde kapsler med modificeret udløsning NL - ORACEA 40 mg hårde kapsler med modificeret udløsning IT - ORACEA 40 mg hårde kapsler med modificeret udløsning
English: Consequently, the CHMP considered the clinical efficacy of Oracea to be sufficiently demonstrated in the two placebo-controlled phase 3 studies and the issue to be resolved.
Danish: Som følge heraf anså CHMP Oraceas kliniske virkning for at være tilstrækkeligt påvist i de to placebokontrollerede fase 3 undersøgelser og problemet for at være løst.
English: Following oral administration of ORACEA, mean peak plasma concentrations were 510 ng/mL after a single dose and 600 ng/mL at steady state (Day 7).
Danish: Efter oral administration af ORACEA var middel peak-plasmakoncentrationer 510 ng/ml efter en enkelt dosis og 600 ng/ml ved steady-state (dag 7).
English: Following the administration of the 40 mg modified release formulation of doxycycline, the maximum excreted concentrations of doxycycline will be between 0.03 - 0.16 mg/L for all excretion mechanisms.
Danish: Efter indtagelse af 40 mg af den ændrede formulering af doxycyclin, vil de maksimale, udskilte koncentrationer af doxycyclin være mellem 0,03 og 0,16 mg/l for alle udskillelsesmekanismer.
English: You should continue to take ORACEA until your doctor tells you to stop.
Danish: Hvis De holder op med at tage ORACEA De bør fortsætte med at tage ORACEA, indtil Deres læge fortæller Dem, at De skal standse.
English: Oesophagitis and oesophageal ulceration have been reported most often in patients administered the hyclate salt in capsule form.
Danish: Oesophagitis og ulceration i spiserøret er indberettet hyppigst hos patienter, der har fået administreret hyclat-saltet i kapselform.
English: Interactions affecting doxycycline:
Danish: Interaktioner der påvirker doxycyclin:
English: Doxycycline has been shown to inhibit neutrophil activity and several pro-inflammatory reactions including those associated with phospholipase A2, endogenous nitric oxide and interleukin-6.
Danish: Doxycyclin har vist sig at hæmme neutrofilers aktivitet og flere proinflammatoriske reaktioner, herunder de der associeres med fosfolipase A2, endogen nitritoxid og interleukin-6.
English: Other treatments for ulcers or heartburn may also reduce the effectiveness of ORACEA and should not be taken until at least 2 hours after ORACEA.
Danish: Andre behandlinger for mavesår eller halsbrand kan ligeledes nedsætte virkningen af ORACEA, og de bør ikke tages før mindst to timer efter indtagelse af ORACEA.
English: The CHMP proposed the amendment of section 4.4 of the SPC, in order to minimise the risk for withholding treatment from patients with ocular rosacea.
Danish: CHMP foreslog en ændring af afsnit 4.4 i produktresuméet for at mindske risikoen for tilbageholdelse af behandling hos patienter med okulær rosacea.
English: Hypersensitivity reactions including anaphylaxis There have also been reports of: Anaphylactoid purpura
Danish: Overfølsomhedsreaktioner, herunder anafylakse Der har også været rapporter om: Anafylaktoid purpura
English: ORACEA has been evaluated in two pivotal randomised, double-blind, placebo-controlled, 16-week studies in 537 patients with rosacea (10 to 40 papules and pustules, and two or fewer nodules).
Danish: ORACEA er blevet evalueret i to pivotale, randomiserede, dobbeltblinde, placebokontrollerede, 16ugers studier med 537 patienter med rosacea (10 til 40 papula og pustula og to eller færre nodula).
English: Treatment of rosacea is mainly aimed at reducing the papulopustular lesions while the erythema and telangiectasia components are difficult to alleviate.
Danish: Behandlingen af rosacea er hovedsageligt rettet mod at mindske de papulopustuløse læsioner, mens erytemet og telangiesktasien er vanskelige at lindre.
English: Infections and infestations: Very rare: Anogenital candidiasis
Danish: Infektioner og parasitære sygdomme: Meget sjælden: Anogenital candidiasis
English: Second and third trimesters of pregnancy (see section 4.6).
Danish: Andet og tredje trimester i graviditeten (se pkt.
English: Methacrylic acid-ethyl acrylate copolymer (1:1)
Danish: Methacrylsyre-ethylacrylat copolymer (1:1)
English: These effects were seen at exposure levels of 1.5 to 2 times those seen in humans administered ORACEA at the proposed dose.
Danish: Disse bivirkninger blev set ved eksponeringer, der var 1,5 til 2 gange højere end dem, der blev set hos mennesker, der fik administreret ORACEA ved den foreslåede dosis.
English: In the event of a severe acute hypersensitivity reaction (eg anaphylaxis), treatment with ORACEA must be stopped at once and the usual emergency measures taken (eg administration of antihistamines, corticosteroids, sympathomimetics and, if necessary, artificial respiration).
Danish: I tilfælde af en svær akut overfølsomhedsreaktion (f.eks. anafylakse) skal behandlingen med ORACEA afbrydes omgående, og de sædvanlige forholdsregler tages (f.eks. administration af antihistaminer, kortikosteroider, sympatomimetika og om nødvendigt kunstigt åndedræt).
English: Finally, the CHMP also acknowledged the difficulty in breaking down the different subgroups of rosacea since symptoms often overlap between the different subtypes and recognised that Oracea is aimed towards the treatment of papules and pustules rather than treatment of rosacea as a whole or treatment of a specific subtype.
Danish: Endelig anerkendte CHMP også vanskelighederne med at nedbryde de forskellige undergrupper af rosacea, der ofte overlapper mellem forskellige undertyper, og erkendte at Oracea i højere grad er rettet mod behandling af papler og pustler end mod behandling af rosacea som en helhed eller behandling af en bestemt undertype.
English: The Applicant was also requested to revise the SPC for Oracea, in sections 4.4 and 5.1 due to the lack of experience in patients with ocular rosacea, as seen in the adopted revised Product Information.
Danish: Ansøgeren blev også bedt om, at revidere afsnit 4.4 og 5.1 i produktresuméet for Oracea på grund af manglende erfaring med patienter med okulær rosacea, således som det ses i de tilpassede og reviderede produktoplysninger.
English: Dialysis does not alter serum doxycycline half-life and thus would not be of benefit in treating cases of overdose.
Danish: Dialyse ændrer ikke doxycyclins halveringstid i serum og vil derfor ikke være gavnlig til behandling af en overdosering.
English: Excipient: Each hard capsule contains 102 - 150 mg of sucrose.
Danish: Hjælpestof: Hver hård kapsel indeholder 102 - 150 mg sukrose.
English: The recommendations below regarding the potential interactions between doxycycline and other medicinal products are based upon experience with the larger doses generally used in antimicrobial formulations of doxycycline rather than with ORACEA.
Danish: Nedenstående anbefalinger vedrørende potentielle interaktioner mellem doxycyclin og andre lægemidler er snarere baseret på erfaring med de større doser, der normalt anvendes i antimikrobielle formuleringer med doxycyclin, end på erfaring med ORACEA.
English: Doxycycline showed no mutagenic activity and no convincing evidence of clastogenic activity.
Danish: Doxycyclin viste ingen mutagen aktivitet og ingen overbevisende evidens af klastogen aktivitet.
English: In vivo microbiological studies using similar exposure to the active substance for 6 to 18 months could not demonstrate any effect on the dominating bacterial flora sampled from the oral cavity, skin, intestinal tract and vagina.
Danish: In vivo mikrobiologiske studier, der anvendte lignende eksponering for det aktive stof i 6 til 18 måneder, kunne ikke påvise nogen virkning på den dominerende bakterieflora, der blev indsamlet fra mundhulen, huden, tarmkanalen og vagina.
English: • Inflammation of the nose and throat
Danish: • Betændelse i næse og hals
English: In common with the use of antimicrobial medicinal products in general, there is a risk of the development of pseudomembranous colitis with doxycycline treatment.
Danish: Ligesom med anvendelse af antimikrobielle lægemidler generelt er der risiko for at udvikle pseudomembran colitis i forbindelse med doxycyclin-behandling.
English: Adverse reactions reported for tetracycline antibiotics as a class are listed following the table.
Danish: Bivirkninger indberettet for tetracyklin-antibiotika som klasse er opstillet efter tabellen.
English: How to store ORACEA Further information
Danish: Sådan opbevarer De ORACEA Yderligere oplysninger
English: The only treatments currently widely authorized in the EU are topical therapies containing metronidazole or azelaic acid, which require twice daily administration and may give rise to local adverse events such as skin irritation or worsening of rosacea.
Danish: De eneste behandlinger, der på nuværende tidspunkt er godkendt i store dele af EU, er kutane midler, der indeholder metronidazol eller azelainsyre, som kræver, at de bruges to gange dagligt, og som kan medføre lokale bivirkninger så som irritation af huden eller en forværring af rosacea.
English: The Applicant addressed the concern that no comparator study was provided by arguing that a controlled clinical trial using an active comparator such as systemic doxycycline was not required, as the development program was in line with a number of ICH guidelines CPMP/ICH/291/95 and CPMP/ICH/135/95 which do not require an active comparator and with the E10 Guidance for the choice of control group in clinical trials (CPMP/ICH/364/96), which supports the use of a placebo control group as the most appropriate design where ethically and practically feasible.
Danish: Ansøgeren imødegik betænkelighederne ved at anføre, at der ikke fandtes en sammenlignende undersøgelse, ved at argumentere for at en kontrolleret klinisk undersøgelse, der brugte et aktivt middel til sammenligning, ikke var påkrævet, da programmet for udviklingen var i overensstemmelse med en række ICH-retningslinjer CPMP/ICH/291/95 og CPMP/ICH/135/95, der ikke kræver sammenligning med et aktivt middel, og med E10-retningslinjerne for valg af kontrolgruppe i kliniske undersøgelser (CPMP/ICH/364/96), der støtter brug af placebo i kontrolgrupper som værende mest passende, når det er etisk og praktisk muligt.
English: The CHMP agreed with the ICH guidelines, stating that an active comparator is not required if it is considered ethically and practically feasible to use placebo in the control group.
Danish: CHMP var enige med ICH-retningslinjerne i, at sammenligning med et aktivet stof ikke var nødvendig, da det vurderes at være både etisk og praktisk muligt at anvende placebo til kontrolgruppen.
English: However, as there are no data to support safety in hepatic impairment at this lower dose, ORACEA should be administered with caution to patients with hepatic impairment or to those receiving potentially hepatotoxic medicinal products.
Danish: Da der imidlertid ikke findes data, der støtter sikkerheden hos patienter med nedsat leverfunktion ved denne lave dosis, bør ORACEA administreres med forsigtighed til patienter med nedsat leverfunktion samt til patienter, der modtager potentielt levertoksiske lægemidler.
English: The capsules are beige in colour and bear the marking “CGPI 40”.
Danish: Kapslerne er beige og påtrykt “CGPI 40”.
English: However, it can not be excluded that long-term use of Oracea can lead to emergence of resistant intestinal bacteria such as Enterobacteriaceae and enterococci, as well as to enrichment of resistance genes.
Danish: Det kan dog ikke udelukkes, at langtidsbrug af ORACEA kan føre til udvikling af resistente tarmbakterier såsom Enterobacteriaceae og Enterococci samt til opformering af resistensgener.
English: If superinfection is suspected, appropriate measures should be taken, including consideration of discontinuing ORACEA.
Danish: Hvis der er mistanke om en superinfektion, bør der tages passende forholdsregler, og det bør overvejes at afbryde behandlingen med ORACEA.
English: What ORACEA is and what it is used for Before you take ORACEA How to take ORACEA Possible side effects
Danish: ORACEAS virkning og hvad De skal bruge det til Det skal De vide, før De begynder at tage ORACEA Sådan skal De tage ORACEA Bivirkninger
English: In both studies, the mean reduction in the total inflammatory lesion count was significantly greater in the ORACEA group than in the placebo group:
Danish: I begge studier var middelreduktionen i det totale antal inflammatoriske læsioner signifikant højere i ORACEA-gruppen end i placebo-gruppen:
English: If these manifestations appear during the course of the treatment Oracea should be discontinued and the patient should be referred to an ophthalmologist.
Danish: Hvis disse manifestationer optræder under behandlingsforløbet, bør Oraceabehandlingen afbrydes, og patienten henvises til en oftalmolog.
English: The Applicant should complete this study and file a report within a reasonable period of time (e.g. 2 years) from the date of approval.
Danish: Ansøgeren skal færdiggøre undersøgelsen og indsende en rapport inden for et rimeligt tidsrum (for eksempel 2 år) fra godkendelsesdatoen.
English: Based on these findings it is scientifically reasonable to conclude that the effect of low dose doxycycline on the normal residential flora including E coli, Enterococci, Staphylococci and Streptococci to be almost non-existent and concluded that the risk of inducing resistance development is negligible.
Danish: På grundlag af disse fund er det fagligt forsvarligt at konkludere, at effekten af en lav dosis af doxycyclin på den normale flora her i blandt E coli, enterokokker, stafylokokker og streptokokker er næsten ikke-eksisterende, og at risikoen for at inducere udvikling af resistens er ubetydelig.
English: If you take an overdose of ORACEA, there is a risk of damage to the liver, kidneys or pancreas.
Danish: Hvis De tager en overdosis af ORACEA, er der risiko for beskadigelse af lever, nyrer eller bugspytkirtel.
English: At this dose systemic exposure experienced by rats is likely to have been approximately 4 times that seen in humans taking the recommended dose of ORACEA.
Danish: Ved denne dosis er den systemiske eksponering hos rotterne sandsynligvis cirka 4 gange så stor, som den der ses hos mennesker, der tager den anbefalede dosis ORACEA.
English: The terminal elimination half-life of doxycycline after administration of ORACEA was approximately 21 h after a single dose and approximately 23 h at steady state.
Danish: Doxycyclins terminale elimineringshalveringstid efter administration af ORACEA var cirka 21 timer efter en enkelt dosis og cirka 23 timer ved steady-state.
English: if you have a condition causing absence of acid in the stomach (achlorhydria) or if you have had surgery on the upper part of the gut (called the duodenum).
Danish: hvis De har en lidelse, der medfører mangel på syre i maven (aklorhydri), eller hvis De er blevet opereret i den øvre del af tarmene (kaldet duodenum).
English: Intestinal absorption of unabsorbed doxycycline should be minimised by administering magnesium or calcium salt-containing antacids to produce non-absorbable chelate complexes with doxycycline.
Danish: Intestinal absorption af ikke absorberet doxycyclin bør minimeres ved administration af antacider, der indeholder magnesium- eller kalciumsalte med henblik på at producere ikke-absorberbare chelatkomplekser af doxycyclin.
English: Although not observed in clinical trials with ORACEA, the use of tetracyclines at higher doses may increase the incidence of vaginal candidiasis.
Danish: Selv om det ikke er observeret i kliniske forsøg med ORACEA, kan brugen af tetracykliner ved højere doser øge hyppigheden af vaginal candidiasis.
English: LIST OF EXCIPIENTS Contains also sucrose See leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også sukrose Se indlægssedlen for yderligere oplysninger.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGER AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: The antianabolic action of tetracyclines may cause an increase in BUN.
Danish: Tetracykliners antianaboliske virkning kan medføre en øgning i BUN.
English: However, increased knowledge of the ecological effects of long-term administration of low-dose doxycycline is highly desirable, and the Applicant is requested to commit to submitting a study protocol for a well designed post-marketing clinical study investigating emergence of resistance in relevant bacterial groups in the intestinal and upper respiratory tract for validation and to carry out a study accordingly within 3 months of approval.
Danish: En øget viden om de økologiske virkninger af langvarig indtagelse af doxycyclin i lave doser, er dog ønskelig, og ansøgeren anmodes om at forpligte sig til at indsende en studieprotokol for et veltilrettelagt postmarketingsstudie, der undersøger fremkomsten af resistens i relevante bakteriegrupper i tarmsystemet og de øvre luftveje til vurdering og efterfølgende at udføre undersøgelsen inden for 3 måneder efter godkendelsen.