FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, the CHMP was of the opinion that although the efficacy of doxycycline 40mg daily has not been demonstrated in patients with ocular rosacea, the literature data combined with the results from the two placebo-controlled studies submitted indicated no specific safety concerns in this subgroup.
Danish: Desuden mente CHMP, at selvom der ikke er påvist en virkning af 40 mg doxycyclin dagligt hos patienter med okulær rosacea, tyder data fra litteraturen sammen med resultaterne af de to indsendte, placebokontrollerede undersøgelser på, at der ikke findes specielle sikkerhedsspørgsmål for denne undergruppe.
English: Low levels of tetracyclines are secreted into the milk of lactating women.
Danish: Lave niveauer af tetracykliner udskilles i mælken hos ammende mødre.
English: Always take ORACEA exactly as your doctor has told you.
Danish: Tag altid ORACEA nøjagtigt efter lægens anvisning.
English: Do not take ORACEA if you are allergic (hypersensitive) to any medicinal product in the tetracycline family, including doxycycline or minocycline, or to any of the other ingredients of ORACEA (see section 6.)
Danish: Tag ikke ORACEA hvis De er overfølsom (allergisk) over for medicin af tetracyklin-typen, herunder doxycyclin eller minocyclin eller et af de øvrige indholdsstoffer i ORACEA (se pkt.
English: The capsule should be taken in the morning with adequate amounts of water in order to reduce the risk of oesophageal irritation and ulceration (see section 4.4).
Danish: Kapslen bør tages om morgenen med rigelige mængder vand med henblik på at reducere risikoen for irritation og ulceration i spiserøret (se pkt.
English: Both studies showed significant superiority of Oracea compared with placebo.
Danish: Begge undersøgelser viste, at Oracea var signifikant overlegen i forhold til placebo.
English: All patients receiving doxycycline, including ORACEA, should be advised to avoid excessive sunlight or artificial ultraviolet light whilst receiving doxycycline and to discontinue therapy if phototoxicity (eg skin eruption etc) occurs.
Danish: Alle patienter, der modtager doxycyclin, herunder ORACEA, bør rådgives til at undgå for meget sollys eller kunstigt ultraviolet lys, mens de modtager doxycyclin, og de skal rådes til at afbryde behandlingen, hvis der optræder fototoksicitet (f.eks. hududslæt).
English: Doxycycline is excreted in the urine and faeces as unchanged active substance.
Danish: Doxycyclin udskilles i urin og fæces som uændret aktivt stof.
English: If administered in combination with these agents, coagulation parameters including INR should be monitored and, if necessary, the doses of the anticoagulant medicinal products reduced.
Danish: Ved administration i kombination med sådanne stoffer bør koagulationsparametrene, herunder INR, monitoreres, og doserne af de antikoagulerende lægemidler bør om nødvendigt reduceres.
English: However, studies were conducted to evaluate the efficacy and safety of Oracea in conjunction to active treatment such as metronidazole, showing that Oracea, given as an adjunct to metronidazole, is far superior to metronidazole alone and that no difference in efficacy was found between low and high doses of doxycycline.
Danish: Der blev dog udført undersøgelser for at vurdere Oraceas virkning og sikkerhed sammen med aktive behandlinger så som metronidazol, og de viste, at behandlinger hvor Oracea blev givet som supplement til metronidazol, er meget mere effektive end metronidazol alene, og der blev ikke fundet nogen forskel mellem virkningen af høje og lave doxycyclindoser.
English: The extensive clinical experience of longterm treatment with doxycycline at higher dosages (100-200 mg daily) and the fact that all Phase 3 studies indicate that Oracea is well tolerated and demonstrates a safety profile comparable to placebo was considered reassuring.
Danish: De omfattende kliniske erfaringer med langvarig behandling med doxycyclin i højere doser (100-200 mg dagligt) og den kendsgerning, at alle fase 3 undersøgelserne tyder på, at Oracea tåles godt og viser en sikkerhedsprofil, der er sammenlignelig med placebo, blev betragtet som betryggende.
English: The binding of doxycycline to plasma proteins, epidermal tissue and faeces must be taken into account as only the free fraction (10%) of doxycycline is antibacterially active following the oral administration of 40 mg doxycycline.
Danish: Bindingen af doxycyclin til plasmaproteiner, epidermalt væv og fæces skal tages i betragtning, da kun den frie fraktion (10%) af doxycyclin er antibakterielt aktivt efter oral indtagelse af 40 mg doxycyclin.
English: As for other tetracyclines, doxycycline forms a stable calcium complex in any boneforming tissue.
Danish: Som andre tetracykliner danner doxycyclin et stabilt calciumkompleks i knogledannende væv.
English: When doxycycline is administered shortly before, during or after courses of isotretinoin, there is the possibility of potentiation between the medicinal products to cause reversible pressure increase in the intracranial cavity (pseudotumour cerebri).
Danish: Når doxycyclin administreres kort forinden, under eller efter en kur med isotretinoin, er der risiko for, at lægemidlerne indbyrdes kan forstærke hinanden og dermed skabe reversibelt forhøjet tryk i den intrakranielle kavitet (pseudotumor cerebri - falsk hjernesvulst).
English: Although not observed during clinical studies with low dose doxycycline (40 mg/day), the risk for development of resistance in the normal microflora cannot be excluded in patients treated with ORACEA.
Danish: Selv om det ikke er observeret i kliniske forsøg med lave doser doxycyclin (40 mg/dag), kan risikoen for at udvikle modstandsdygtighed i den normale mikroflora ikke udelukkes hos patienter, der behandles med ORACEA.
English: However, at the present time, insufficient data exist for reassurance that the interactions described with higher doses of doxycycline will not occur with ORACEA.
Danish: Imidlertid er der på nuværende tidspunkt utilstrækkelig dokumentation for, at de interaktioner, der beskrives i forbindelse med højere doser doxycyclin, ikke vil optræde i forbindelse med ORACEA.
English: With regard to target site exposure of bacteria to doxycycline, the Applicant referred to several publications stating that the resulting concentrations of antibacterially-active drug will be very low, leading to a very low risk of resistance pressure.
Danish: Med hensyn til målstedet for bakteriernes udsættelse for doxycyclin, henviste ansøgeren til flere publikationer, der angiver at de resulterende koncentrationer af det antibakterielt aktive lægemiddel vil være meget lav, og at risikoen for udvikling af resistens derfor er lav.
English: In assessing the benefit/risk of Oracea, the current situation of limited treatment options for rosacea was taken into consideration, as well as the fact that Oracea is expected to provide an alternative to the international guidelines recommending off-label use of doxycycline (or other tetracycline derivates) for the treatment of rosacea, with the associated decrease in risk for adverse events.
Danish: I vurderingen af benefit/risk-forholdet Oracea blev den nuværende situation med begrænsede behandlingsmuligheder for rosacea taget i betragtning samt den kendsgerning, at Oracea forventes at være et alternativ til off-label-brugen af doxycyclin (eller andre teracyclinderivater), der anbefales af internationale retningslinjer til behandling af rosacea, med den forbundne nedsatte risiko for bivirkninger.
English: United Kingdom
Danish: Forenede Kongerige /Storbritannien
English: In cases of significant overdose, doxycycline therapy should be stopped immediately and symptomatic measures undertaken as required.
Danish: I tilfælde af signifikant overdosering bør behandlingen med doxycyclin afbrydes omgående, og der bør startes symptomatisk behandling efter behov.
English: The usual dose of ORACEA is less than half the usual doses of doxycycline used for antimicrobial therapy.
Danish: Den normale dosis ORACEA er mindre end halvdelen af de sædvanlige doser doxycyclin, der anvendes til antimikrobiel behandling.
English: Rifampicin, barbiturates, carbamazepine, diphenylhydantoin, primidone, phenytoin and chronic alcohol abuse may accelerate the decomposition of doxycycline due to enzyme induction in the liver thereby decreasing its half-life.
Danish: Rifampicin, barbiturater, carbamazepin, diphenylhydantoin, primidon, phenytoin og kronisk alkoholmisbrug kan øge hastigheden af nedbrydningen af doxycyclin på grund af enzyminduktion i leveren, hvorved dets halveringstid bliver nedsat.
English: Isotretinoin is prescribed to patients with a severe case of acne.
Danish: Isotretinoin ordineres til patienter med alvorlige tilfælde af akne.
English: Long term use of doxycycline may result in significant absorption by the suckling infant and is therefore not recommended because of a theoretical risk of dental discolouration and decreased bone growth of the suckling child.
Danish: Langtidsbrug af doxycyclin kan resultere i signifikant absorption hos det ammende spædbarn og frarådes derfor på grund af den teoretiske risiko for misfarvning af tænderne samt nedsat knoglevækst hos det ammende barn.
English: The Applicant should further agree to 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 desuden samtykke i at færdiggøre undersøgelsen og indsende en rapport inden for et rimeligt tidsrum (for eksempel 2 år) fra godkendelsesdatoen.
English: Hypersensitivity to the active substance, to other tetracyclines or to any of the excipients.
Danish: Overfølsomhed over for det aktive stof, over for andre tetracykliner eller over for et eller flere af hjælpestofferne.
English: This may include the discontinuation of doxycycline and the institution of specific antibiotic therapy.
Danish: Dette kan omfatte afbrydelse af behandlingen med doxycyclin og start af en specifik antibiotikabehandling.
English: Very rare: Glossitis, dysphagia, enterocolitis.
Danish: Meget sjælden: Glossitis, dysfagi, enterocolitis.
English: Treatment with higher doses of tetracyclines is associated with emergence of resistant intestinal bacteria, such as enterococci and enterobacteria.
Danish: Behandling med højere doser tetracykliner er associeret med udvikling af resistente tarmbakterier, såsom Enterococci og Enterobacteriaceae.
English: The administration of tetracyclines during the second and the third trimesters results in permanent discolouration of the deciduous teeth in the offspring.
Danish: Administration af tetracykliner under andet og tredje trimester resulterede i permanent misfarvning af barnets mælketænder.
English: The most commonly reported adverse reactions in patients treated with ORACEA, ie those which occurred with ≥ 3% frequency on ORACEA and with a frequency at least 1% higher than on placebo, were nasopharyngitis, diarrhoea and hypertension.
Danish: De hyppigst indberettede bivirkninger hos patienter behandlet med ORACEA, dvs. de bivirkninger der forekom med en hyppighed på ≥ 3 % i ORACEA-gruppen og med en hyppighed, der var mindst 1 % højere end i placebo-gruppen, var nasofaryngitis, diare og hypertension.
English: In contrast to higher, antimicrobial doses of doxycycline that may lead to the development of resistance and opportunistic overgrowth, long-term clinical trial experience with doxycycline 40 mg/day confirms the good tolerability of doxycycline at this dose level during prolonged treatment.
Danish: I modsætning til højere, antimikrobielle doser af doxycyclin, der kan medføre udvikling af resistens og opportunistisk overvækst, bekræfter langvarige erfaringer med doxycyclin 40 mg/dag, at denne dosis tolereres godt ved langvarig behandling.
English: Adverse reactions typical of the tetracycline class of medicinal products are less likely to occur during medication with ORACEA, due to the reduced dosage and the relatively low plasma levels involved.
Danish: De hyppigheder, der er typiske for lægemidler i gruppen af tetracykliner, vil optræde med mindre sandsynlighed under medicinering med ORACEA på grund af den reducerede dosering og de relativt lave plasmaniveauer.
English: Always take ORACEA with an adequate amount of water to wash down the capsule, since this reduces the risk of irritation or ulcer in the throat or gullet.
Danish: Tag altid ORACEA sammen med rigelige mængder vand for at skylle kapslen ned, da dette nedsætter risikoen for irritation eller sårdannelse i halsen eller spiserøret.
English: Tetracyclines and methoxyflurane used in combination have been reported to result in fatal renal toxicity.
Danish: Det er rapporteret, at tetracykliner og methoxyfluran anvendt i kombination har resulteret i fatal nyretoksicitet.
English: * Tell your doctor immediately or go to casualty if you suffer side effects such as swollen face, lips, tongue and throat, difficulty in breathing, hives or itchy skin and eyes, or rapid heart beat (palpitations) and feeling faint.
Danish: * Kontakt omgående Deres læge, eller henvend Dem på skadestuen, hvis De får bivirkninger såsom hævelse i ansigt, læber, tunge og hals, åndedrætsbesvær, nældefeber eller kløende hud eller øjne, eller hurtige hjerteslag (palpitationer), eller hvis De føler, at De skal besvime.
English: In the event of the development of diarrhoea during treatment with ORACEA, the possibility of pseudomembranous colitis should be considered and appropriate therapy instituted.
Danish: I tilfælde af udvikling af diare under behandling med ORACEA skal risikoen for pseudomembran colitis tages i betragtning, og der bør iværksættes passende behandling.
English: Thyroid function is normal.
Danish: Skjoldbruskkirtelfunktionen er normal.
English: There is a possibility that ORACEA reduces the effectiveness of oral contraceptives, resulting in pregnancy.
Danish: Der er en mulighed for, at ORACEA nedsætter effekten af p-piller, hvilket kan resultere i graviditet.
English: Concurrent use of cyclosporin has been reported to decrease the half-life of doxycycline.
Danish: Samtidig brug af cyclosporin er blevet rapporteret at nedsætte halveringstiden af doxycyclin.
English: The applicant concluded that higher mg/kg doses led to higher plasma concentrations, but did not lead to increased clinical efficacy and that anti-inflammatory-dose doxycycline (40-mg formulation) conferred peak anti-inflammatory efficacy in the treatment of rosacea.
Danish: Ansøgeren konkluderede, at højere mg/kg doser førte til højere plasmakoncentrationer, men ikke til en øget klinisk virkning, samt at en antiinflammatorisk dosis af doxycyclin (formulering med 40 mg) gav en maksimal antiinflammatorisk effekt ved behandling af rosacea.
English: Doxycycline blood levels in patients treated with ORACEA are lower than in those treated with conventional antimicrobial formulations of doxycycline.
Danish: Niveauet af doxycyclin i blodet hos patienter, der behandles med ORACEA, er lavere end hos patienter, der behandles med konventionelle antimikrobielle formuleringer af doxycyclin.
English: In rats, doses of 50 mg/kg/day doxycycline caused a decrease in the straight-line velocity of sperm but did not affect male or female fertility or sperm morphology.
Danish: Hos rotter forårsagede doser på 50 mg/kg/dag doxycyclin et fald i sædcellernes hastighed i lige linje men påvirkede ikke mandlig eller kvindelig fertilitet eller sædcellernes morfologi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/PVC/AClAR BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS ALUMINIUM/PVC/ACLAR-BLISTER
English: Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney.
Danish: Bivirkninger, der blev observeret i dyreforsøg med gentagne doser, omfattede hyperpigmentering af skjoldbruskkirtlen samt tubulær degeneration i nyrerne.
English: ORACEA contains doxycycline in a formulation designed to yield plasma levels below the antimicrobial threshold.
Danish: ORACEA indeholder doxycyclin i en formulering, der er beregnet til at producere plasmaniveauer under den antimikrobielle grænse.
English: Gastrointestinal adverse reactions overall occurred in a higher proportion of patients on ORACEA (13.4%) than on placebo (8.6%).
Danish: Mave-tarmbivirkninger generelt forekom hos en større andel af de patienter, der fik ORACEA (13,4 %) end hos placebopatienterne (8,6 %).
English: Do not use ORACEA after the expiry date which is stated on the outer pack and blister after Batch No.
Danish: Brug ikke ORACEA efter den udløbsdato, der står på pakningen.
English: This reaction was shown to be reversible when the medicinal product was discontinued.
Danish: Dette fænomen viste sig at være reversibelt ved ophør af behandlingen.
English: • Nausea, vomiting, anorexia
Danish: • Kvalme, opkastning, anoreksi
English: ORACEA should be swallowed whilst in an upright sitting or standing posture.
Danish: ORACEA bør synkes, mens patienten sidder i oprejst stilling eller står op.
English: Inform your physician - if you have liver disease if you have a history of predisposition to candidiasis overgrowth or are currently experiencing an oral or vaginal yeast or fungal infection - if you suffer from the muscle disease called myasthenia gravis - if you suffer from colitis - if you suffer from oesophageal irritation or ulceration - if you have the type of rosacea which affects the eyes - if you expose your skin to strong sunlight or artificial sunlight, because more severe sunburn may occur in some people taking doxycycline.
Danish: Fortæl det til Deres læge - hvis De har en leversygdom - hvis De tidligere har været prædisponeret for candidiasis overvækst, eller hvis De i øjeblikket har en gær- eller svampeinfektion i munden eller i vagina - hvis De lider af en muskelsygdom, der kaldes myasteni (myasthenia gravis) - hvis De lider af colitis (betændelse i tyktarmen) - hvis De har irritation eller sår i spiserøret - hvis De har den type rosacea, der påvirker øjnene - hvis De udsætter Deres hud for stærk solskin eller kunstigt sollys, da nogle mennesker, der tager medicin med det aktive stof, doxycyclin, kan få svære solforbrændinger.
English: Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
Danish: De studier, der indtil videre er gennemført, indikerer, at dette ikke forekommer i forbindelse med brugen af doxycyclin hos patienter med nedsat nyrefunktion.
English: Capsule contents
Danish: Kapslens indhold
English: Doxycycline has no or negligible influence on the ability to drive and use machines.
Danish: Doxycyclin påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: To avoid oesophageal irritation and ulceration, adequate fluids (water) should be taken with this medicinal product (see section 4.2).
Danish: For at undgå irritation og ulceration i spiserøret bør patienten drikke tilstrækkelig væske (vand) sammen med dette lægemiddel (se pkt.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apoteket.
English: Regarding the risk of resistance induction, the Applicant provided data from several studies demonstrating that the 100 mg doxycycline dose leads to marked emergence of resistant strains in the oral and intestinal micro flora.
Danish: Med hensyn til risikoen for at skabe resistens, leverede ansøgeren data fra flere undersøgelser, der viste at en dosis på 100 mg doxycyclin fører til en markant fremkomst af resistente stammer i mikrofloraen i mund og tarme.
English: Do not take antacids, multi-vitamins or other products that contain calcium (such as milk and dairy products and calcium-containing fruit juices), aluminium, magnesium (including quinapril tablets, which are taken for high blood pressure), iron or bismuth, or cholestyramine, activated charcoal or sucralfate until 2 to 3 hours after taking ORACEA.
Danish: De må ikke tage anticider, multi-vitaminer eller andre produkter, der indeholder kalk (såsom mælk og mælkeprodukter samt frugtsaft, der indeholder kalk), aluminium, magnesium (herunder quinapril-tabletter, som tages mod for højt blodtryk), jern eller bismuth eller kolestyramin, aktivt kul eller sukralfat før 2 til 3 timer efter indtagelse af ORACEA.
English: If administered in combination with these medicinal products, blood glucose levels should be monitored and, if necessary, the doses of the sulphonylureas should be reduced.
Danish: Hvis doxycyclin administreres i kombination med sådanne lægemidler, bør blodsukkerniveauerne monitoreres, og sulfonylurea-doserne bør om nødvendigt reduceres.
English: Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C Yellow No. 10 aluminium lake Opacode Black S-1-8115
Danish: Indigokarmin aluminium lake Allura rød AC aluminium lake Brilliant Blue FCF aluminium lake D & C gul nr. 10 aluminium lake Opacode sort S-1-8115
English: In case of overdose there is, however, a risk of parenchymatous hepatic and renal damage and of pancreatitis.
Danish: Der er dog i tilfælde af overdosering risiko for parenkymatøs lever- og nyreskade samt pancreatitis.
English: PHARMACEUTICAL FORM Modified-release hard capsule Beige capsule, No. 2 size, bear the marking “CGPI 40”.
Danish: LÆGEMIDDELFORM Hård kapsel med modificeret udløsning Beige kapsel, størrelse nr. 2, påtrykt “CGPI 40”.
English: The CHMP acknowledges that available studies and pharmacokinetic data indicate that Oracea (40 mg doxycycline daily) is less likely to induce resistance in the normal micro biota than 100 mg doxycycline daily, and thus does not consider this issue to be a major objection that should preclude an approval of the product.
Danish: CHMP erkender, at tilgængelige undersøgelser og farmakokinetiske data indicerer, at det er mindre sandsynligt, at Oracea (40 mg doxycyclin om dagen) inducerer resistens i den normale, residentielle mikroflora end 100 mg doxycyclin om dagen, og betragter derfor ikke dette spørgsmål som værende en større forhindring for godkendelsen af produktet.
English: Six studies addressed the emergence issue in low dose doxycycline (40 mg daily), focusing on the effects on the intestinal microflora, on subgingival microflora and saliva and on the skin flora.
Danish: Seks undersøgelser omhandlede problemet med fremkomsten ved lave doser af doxycyclin (40 mg om dagen) og fokuserede på påvirkningen af mikroflora i tarmene, den subgingivale mikroflora, spyttet og hudfloraen.
English: The plasma concentration of doxycycline following administration of ORACEA is well below the level required to inhibit mircoorganisms commonly associated with bacterial diseases.
Danish: Plasmakoncentrationen af doxycyclin efter administration af ORACEA ligger ret langt under det niveau, der kræves til at hæmme de mikroorganismer, der normalt associeres med bakteriesygdomme.
English: Medicinal products which increase gastric pH may reduce the absorption of doxycycline, and should be taken at least 2 hours after doxycycline.
Danish: Lægemidler, der øger pH-værdien i maven, kan reducere absorptionen af doxycyclin og bør først tages mindst to timer efter indtagelse af doxycyclin.
English: [See Annex I - To be completed nationally]
Danish: [Se Bilag I - skal udfyldes nationalt]
English: Thus, the present application for Oracea (doxycycline 40 mg tablets) is not for a New Chemical Entity but aims to develop a formulation designed for once a day oral administration that could provide steady state doxycycline plasma concentrations at the anti-inflammatory level but not at the antimicrobial level.
Danish: Denne ansøgning for Oracea (doxycyclintabletter á 40 mg) er derfor ikke for et nyt kemisk stof, men er rettet mod at udvikle en formulering, der er beregnet til én daglig indtagelse per os, der kan give en steady-state plasmakoncentration af doxycyclin på et niveau, der har en antiinflammatorisk, men ikke en antimikrobiel virkning.
English: The following side effects may occur commonly (affects 1 to 10 users in 100) during treatment with ORACEA:
Danish: Følgende bivirkninger kan optræde almindeligt (påvirker 1 til 10 ud af 100 brugere) under behandlingen med ORACEA: