FrancophonIA/ELRC3.0 huggingface dataset:
English: The need for concomitant use of appropriate additional therapy for additional relief of non-nasal symptoms, particularly ocular symptoms, is also highlighted.
Danish: Endvidere understreges nødvendigheden af sideløbende supplerende behandling til yderligere afhjælpning af ikke-nasale, navnlig okulære, symptomer.
English: Mention is made of the immunosuppressive effects of corticosteroids and the risk of exposure of patients to certain infections (e.g., chickenpox, measles), and of the importance of obtaining medical advice if such exposure occurs.
Danish: Der omtales kortikosteroiders immunosuppressive virkninger og risikoen ved eksponering af patienterne for visse infektioner (f.eks. skoldkopper og mæslinger) samt vigtigheden af lægelig vejledning i tilfælde af sådan eksponering.
English: Thus there is support for efficacy in the age group 3-5 years, and no difference in efficacy is to be expected in a 3 year old as compared to a 6 year old from a pharmacological perspective.
Danish: Der er således dokumentation for virkningen i aldersgruppen 3-5 år, og farmakologisk set ingen forskel i virkning mellem en 3-årig og en 6-årig.
English: The active ingredient of Nasonex, mometasone furoate monohydrate is a synthetic, 17-heterocyclic corticosteroid with anti-inflammatory activity.
Danish: Det aktive indholdsstof i Nasonex, mometasonfuroat monohydrat, er et syntetisk 17-heterocyklisk kortikosteroid med antiinflammatorisk aktivitet.
English: Two studies investigating sinusitis and also the results and analysis of an additional study (A2-3852) conducted to assess the clinical relevance of the observed effect size of the treatment showed that the clinical relevance of the data generated in these studies with respect to the indication proposed had not been established.
Danish: To undersøgelser af sinuitis og resultater og analyse af en supplerende undersøgelse (A2-3852) til vurdering af den kliniske relevans af den iagttagne behandlingseffekt viste, at dataene fra disse undersøgelser ikke kunne påvises at være klinisk relevante for den ansøgte indikation.
English: The results obtained for the user testing in variation UK/H/0196/001/II/032 submitted as a commitment to a renewal in the (MRP) and approved in January 2009, were considered acceptable by the CHMP.
Danish: CHMP godkendte resultaterne af brugertesten i ændringsansøgning UK/H/0196/001/II/032, der blev indsendt i forbindelse med en fornyelse under den gensidige anerkendelsesprocedure og godkendt i januar 2009.
English: Mometasone furoate is not recommended for use in case of nasal septum perforation (the reported instances of nasal septum perforation information is mentioned in section 4.8).
Danish: Mometasonfuroat frarådes anvendt ved perforation af septum nasi (de indberettede tilfælde af septumperforation er omtalt i punkt 4.8).
English: The section on ‘Fertility' was amended to include only the relevant conclusions from non-clinical toxicity studies in accordance with current Guideline on the summary of product characteristics.
Danish: Afsnittet »Fertilitet« blev ændret, så det kun indeholder de relevante konklusioner fra prækliniske toksicitetsundersøgelser i overensstemmelse med den gældende vejledning for produktresuméer.
English: In addition, this section gives warning concerning the presence of benzalkonium chloride excipient, which may cause nasal irritation.
Danish: Desuden indeholder dette afsnit en advarsel om hjælpestoffet benzalkoniumchlorid, som kan medføre nasal irritation.
English: The initial dose for rhinitis and nasal polyps is 100 µg once daily in each nostril (total daily dose of 200 µg).
Danish: Initialdosis ved rhinitis og nasale polypper er 100 µg én gang dagligt i hvert næsebor (total dagsdosis 200 µg).
English: The information proposed by the MAH in this section of the SmPC was listed under the headings absorption, distribution, biotransformation and elimination, and was considered to be acceptable by the CHMP, with the recommended amendments.
Danish: Markedsføringstilladelsesindehaverens oplysninger i dette punkt af produktresuméet blev angivet under overskrifterne absorption, fordeling, biotransformation og elimination og kunne godtages af CHMP med de anbefalede ændringer.
English: The mean scores for physician evaluations of total nasal symptoms showed greater reductions for mometasone furoate at all visits (ranging from 36 to 62%) compared to placebo (22% to 48%).
Danish: Gennemsnitsscore ved den lægelige vurdering af alle nasale symptomer viste ved alle konsultationer større reduktion med mometasonfuroat (område 36 %-62 %) end med placebo (22 %-48 %).
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Nasonex and associated names (see Annex I).
Danish: anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Nasonex og relaterede navne (se bilag I).
English: The submitted studies are not considered to support the prophylaxis of seasonal allergic rhinitis, since the data submitted for this indication are not conclusive with regard to the appropriate time point for start of treatment, considering that early start of treatment was not compared to starting at the time of symptom onset.
Danish: De forelagte undersøgelser findes ikke at støtte indikationen forebyggelse af sæsonbetinget allergisk rhinitis, da dataene for denne indikation ikke er konklusive med hensyn til det mest hensigtsmæssige tidspunkt for påbegyndelse af behandlingen, idet der ikke blev sammenlignet mellem påbegyndelse af behandlingen tidligt og ved indtræden af symptomer.
English: However inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
Danish: Inhalation eller oral administration af en overdosis af kortikosteroider kan imidlertid medføre suppression af den hypothalamiskhypofysære-adrenale akse.
English: - children and adolescents under 18 years of age have not been established in nasal polyposis.
Danish: - børn og unge under 18 år, idet nasal polypose ikke er en indikation hos denne aldersgruppe.
English: Based on the 9 studies in the original perennial rhinitis program, the perennial rhinitis indication was approved for MRP countries in 1997, and by the other concerned Member States between 1997 and 1998.
Danish: På grundlag af de ni undersøgelser i det oprindelige program for tilbagevendende rhinitis blev denne indikation i 1997 godkendt i landene omfattet af den gensidige anerkendelsesprocedure, og fra 1997 til 1998 i de øvrige berørte medlemsstater.
English: The onset of action of mometasone furoate in patients with allergic symptoms is rapid, and hence the observed effect after prophylactic treatment (as defined in the studies) could be related to a treatment effect as covered by the general rhinitis indication.
Danish: Virkningen af mometasonfuroat hos patienter med allergiske symptomer er hurtigt indsættende, hvorfor den iagttagne virkning efter forebyggende behandling (som defineret i undersøgelserne) kunne tilskrives en behandlingseffekt, der dækkes af den generelle rhinitisindikation.
English: These studies support the proposed indication for the symptomatic treatment of rhinitis (seasonal allergic and perennial) in adults.
Danish: Disse undersøgelser underbygger den foreslåede indikation symptomatisk behandling af rhinitis (sæsonbetinget allergisk og tilbagevendende) hos voksne.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Nasonex Nasal Spray and associated names in all subsets of the paediatric population in seasonal and perennial allergic rhinitis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af undersøgelser med Nasonex næsespray og relaterede navne hos alle undergrupper af den pædiatriske population ved sæsonbetinget og tilbagevendende allergisk rhinitis (se punkt 4.2 vedrørende pædiatrisk anvendelse).
English: Nasonex Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate
Danish: Nasonex næsespray, 50 µg, er en manuel pumpespray med afmålt dosis i en vandig opløsning med et indhold af mometasonfuroat monohydrat svarende til 0,05 vægtprocent mometasonfuroat; det vandige medium indeholder glycerin, mikrokrystallinsk cellulose og natriumcarboxymethylcellulose, natriumcitrat, citronsyre, benzalkoniumchlorid og polysorbat 80.
English: Six studies were conducted to demonstrate the efficacy of mometasone furoate in 2544 patients with seasonal allergic rhinitis randomised to treatment with mometasone furoate, placebo or active control.
Danish: Der er udført seks undersøgelser til påvisning af virkningen af mometasonfuroat hos 2 544 patienter med sæsonbetinget allergisk rhinitis, der blev randomiseret til behandling med mometasonfuroat, placebo eller aktivt kontrolpræparat.
English: A section on the systemic effects of corticosteroids including as well as reports of increased intraocular pressure following the use of intranasal corticosteroids has also been mentioned.
Danish: Der er desuden et afsnit om kortikosteroiders systemiske virkninger og om indberetninger om øget intraokulært tryk efter brug af intranasale kortikosteroider.
English: The indication for the treatment of nasal polyposis was accepted by the CHMP.
Danish: Indikationen behandling af nasal polypose blev godkendt af CHMP.
English: Therefore the use of mometasone furoate in perennial rhinitis in children over 3 years of age was considered to be acceptable by the CHMP as proposed by the MAH.
Danish: Anvendelsen af mometasonfuroat ved tilbagevendende rhinitis hos børn over tre år kunne derfor godkendes af CHMP som foreslået af indehaveren af markedsføringstilladelsen.
English: On the basis of 19 Phase II and III studies completed using mometasone furoate in adolescents and adults, a total dose 200 µg once daily was chosen as the standard clinical adolescent/adult dosage, allowing dose titration up to a maximum daily total dose of 400 mg.
Danish: På grundlag af 19 fase II- og III-undersøgelser med anvendelse af mometasonfuroat hos unge og voksne valgtes som klinisk standarddosis til denne patientgruppe en totaldosis på 200 µg én gang dagligt med mulighed for optitrering til en total dagsdosis på 400 µg.
English: Section 4.8 was restructured as suggested by the CHMP to increase readability and to comply with the QRD template and SmPC guideline.
Danish: Punkt 4.8 blev omstruktureret som foreslået af CHMP for at gøre det mere letlæseligt og rette det i ind efter QRD-skabelonen og vejledningen om produktresuméer.
English: Known hypersensitivity to the active substance, mometasone furoate, or to any of the excipients has been proposed as per the current Guideline on the Summary of Product Characteristics.
Danish: Kendt overfølsomhed for det aktive stof, mometasonfuroat, eller for et eller flere af hjælpestofferne, er foreslået i henhold til den gældende vejledning for produktresuméer.
English: Mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity.
Danish: Mometasonfuroat har ingen androgen, antiandrogen, østrogen eller antiøstrogen aktivitet.
English: Of the 6 studies, 4 were pooled, and the patient diary results showed a reduction from baseline of 33% compared to 15% in placebo-treated patients in the first 2 weeks of treatment with mometasone furoate.
Danish: Af de 6 undersøgelser blev de 4 poolet, og efter de første to ugers behandling med mometasonfuroat viste patientdagbøgerne en reduktion fra baseline på 33 %, sammenholdt med 15 % hos placebobehandlede patienter.
English: • The committee reviewed the data submitted by the MAH from the existing clinical and nonclinical studies and post-marketing experience with Nasonex and associated names as reported by the MAH justifying the proposed harmonisation of the product information.
Danish: • Udvalget gennemgik de data, der er forelagt af indehaveren af markedsføringstilladelsen fra eksisterende kliniske og prækliniske undersøgelser og erfaringer med Nasonex og relaterede navne efter markedsføring som begrundelse for den foreslåede harmonisering af produktinformationen:
English: • The committee considered the identified divergences for the Nasonex and associated names with respect to the sections therapeutic indications, posology and method of administration, as well as the remaining sections of the SmPC.
Danish: • Udvalget behandlede de konstaterede divergenser for Nasonex og relaterede navne hvad angår terapeutiske indikationer, dosering og administrationsvej samt de øvrige punkter af produktresuméet.
English: Mometasone furoate is contraindicated in the presence of untreated localised infection such as herpes simplex, involving the nasal mucosa, and also in patients who have experienced recent nasal surgery or trauma until healing has occurred because of the inhibitory effect of corticosteroids on wound healing.
Danish: Mometasonfuroat er kontraindiceret ved ubehandlede lokaliserede infektioner såsom herpes simplex, der inddrager af den nasale slimhinde, samt efter nylige operative indgreb og traumer på næsen indtil heling har fundet sted på grund af den hæmmende virkning af kortikosteroider på sårhelingen.
English: This section of the proposed SmPC contains information on the mechanism of action of mometasone furoate, and its pharmacodynamic effects in patients with seasonal allergic rhinitis.
Danish: Dette punkt i forslaget til produktresumé indeholder oplysninger om mometasonfuroats virkningsmekanisme og dets farmakodynamiske virkninger hos patienter med sæsonbetinget allergisk rhinitis.
English: The glucocorticoid-related effects of mometasone furoate observed in animal studies are described in this section.
Danish: I dette afsnit beskrives de glukokortikoidrelaterede virkninger af mometasonfuroat, der er iagttaget i dyreundersøgelser.
English: - children under 3 years of age in seasonal allergic rhinitis and perennial allergic rhinitis
Danish: - børn under tre år ved sæsonbetinget allergisk rhinitis og tilbagevendende allergisk rhinitis
English: Instead, text was introduced in Section 4.2 of the SmPC to clarify that treatment may need to be initiated a few days before the expected onset of the allergy season in patients with a history of moderate to severe symptoms of seasonal allergic rhinitis.
Danish: I stedet blev der indsat en tekst i punkt 4.2 i produktresuméet til præcisering af, at det kan være nødvendigt at påbegynde behandlingen nogle dage før den forventede start på allergisæsonen, når der i anamnesen er moderate til svære symptomer på sæsonbetinget allergisk rhinitis.
English: Grounds for the variation to the terms of the marketing authorisation(s) Whereas
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelse(r)n(e) Ud fra følgende betragtninger:
English: • The committee agreed with the harmonised summary of product characteristic, labelling and package leaflet proposed and discussed by the marketing authorisation holder.
Danish: • Udvalget godtog den harmonisering af produktresuméet, etiketteringen og indlægssedlen, som markedsføringstilladelsesindehaveren har foreslået og redegjort for.
English: As the amount of benzalkonium chloride - 0.02 mg per actuation is above the threshold of 10 micrograms /delivered dose, a statement that Nasonex contains benzalkonium chloride, which may cause nasal irritation is included in the PL, in accordance with the Guideline on Excipients in the label and PL (2003).
Danish: Da mængden af benzalkoniumchlorid - 0,02 mg per aktivering - er over tærsklen 10 µg/afgiven dosis, er der i indlægssedlen indsat en erklæring om, at Nasonex indeholder benzalkoniumchlorid, som kan medføre irritation af næsen.
English: Treatment of acute sinusitis
Danish: Behandling af akut sinuitis
English: Treatment of symptoms of rhinitis
Danish: Symptomatisk behandling af rhinitis
English: In case of inadequate response a dose increase to 100 µg twice daily in each nostril (total daily dose of 400 µg) has been proposed as in most Member States.
Danish: Ved inadækvat respons er der i de fleste medlemsstater foreslået dosisforhøjelse til 100 µg to gange dagligt i hvert næsebor (total dagsdosis 400 µg).
English: In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, it is recommended that mometasone furoate may need to be initiated some days before the expected start of the pollen season.
Danish: Ved anamnese med moderate til svære symptomer på sæsonbetinget allergisk rhinitis anbefales det om nødvendigt at påbegynde behandlingen med mometasonfuroat nogle dage før den forventede start på pollensæsonen.
English: Therefore the indication for the treatment acute sinusitis was not accepted by the CHMP.
Danish: Indikationen behandling af akut sinuitis blev derfor ikke godkendt af CHMP.
English: Seasonal allergic rhinitis
Danish: Sæsonbetinget allergisk rhinitis
English: The MAH has chosen not to include the indication for the prevention of nasal polyp relapse after functional endoscopic sinus surgery (FESS) in the proposed harmonized SmPC, which is approved only in Sweden.
Danish: Indehaveren af markedsføringstilladelsen har i det foreslåede harmoniserede produktresumé valgt at udelade indikationen forebyggelse af tilbagefald af nasal polypose efter funktionel endoskopisk sinuskirurgi, som kun er godkendt i Sverige.
English: Perennial rhinitis
Danish: Tilbagevendende rhinitis
English: The statement that there are no known effects on the ability to drive and use machines was considered to be acceptable by the CHMP.
Danish: CHMP godkendte erklæringen om, at der ikke er kendt påvirkning af evnen til at føre motorkøretøj eller betjene maskiner.
English: Therefore the indication for the prophylaxis of seasonal allergic rhinitis was not accepted by the CHMP.
Danish: CHMP godkendte derfor ikke indikationen forebyggelse af sæsonbetinget allergisk rhinitis.
English: It is also recommended that the effect on growth in the paediatric population is regularly monitored with prolonged treatment with nasal corticosteroids.
Danish: Ved langvarig behandling med nasale kortikosteroider hos den pædiatriske population anbefales derudover rutinemæssig overvågning af påvirkningen af væksten.
English: Information on the paediatric program and the study results (efficacy and safety) has been provided by the MAH.
Danish: Indehaveren af markedsføringstilladelse har forelagt oplysninger om det pædiatriske program og undersøgelsesresultaterne vedrørende virkning og sikkerhed.
English: Two 4-month randomized, placebo-controlled, double-blind, parallel-group multicentre, efficacy and safety treatment trials and a no-treatment, observational, follow-up study have been discussed in support of the indication for the treatment of nasal polyposis, where two doses of mometasone furoate compared with placebo (200 µg QD and BID) were investigated in a total of 664 subjects, of which 441 were treated with mometasone furoate.
Danish: Til støtte for indikationen nasal polypose er der virkningen og sikkerheden blevet undersøgt i to randomiserede, placebokontrollerede, dobbeltblindede multicenterundersøgelser med parallelle grupper af 4-måneders varighed og i en opfølgende observationsundersøgelse uden behandling.
English: The wording proposed by the MAH under the subheadings ‘Pregnancy' and ‘Lactation' was considered to be acceptable by the CHMP.
Danish: CHMP kunne godkende markedsføringstilladelsesindehaverens forslag til ordlyd under overskrifterne »graviditet« og »amning«.
English: Two randomised multicentre clinical studies from the MRP dossier have been referred to, where mometasone furoate was administered to patients with a history of seasonal allergic rhinitis.
Danish: Mometasonfuroat blev her administreret til patienter med tidligere sæsonbetinget allergisk rhinitis.
English: The MAH has proposed the current MRP PI that is supported by the available efficacy and safety data, as the basis for the harmonized PI.
Danish: Indehaveren af markedsføringstilladelserne har foreslået, at den gældende produktinformation fra den gensidige anerkendelsesprocedure anvendes som grundlag for den harmoniserede produktinformation.
English: In both studies patients' disease had not responded satisfactorily to other treatment.
Danish: I begge studier havde patienternes sygdom ikke reageret tilstrækkeligt på anden behandling.
English: Xeljanz received a marketing authorisation valid throughout the EU on 22 March 2017.
Danish: Xeljanz fik en markedsføringstilladelse med gyldighed i hele EU den 22. marts 2017.
English: Further information on Xeljanz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Xeljanz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most important side effect seen with the medicine is infection and there are specific recommendations to help healthcare professionals reduce this risk.
Danish: Den væsentligste bivirkning ved dette lægemiddel er infektion, og der er specifikke anbefalinger, som kan hjælpe sundhedspersoner med at reducere denne risiko.
English: As for all medicines, data on the use of Xeljanz are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Xeljanz løbende overvåget.
English: Other information about Xeljanz
Danish: Andre oplysninger om Xeljanz
English: Treatment may be stopped in patients who develop infection, which is a known side effect of the medicine, or in those with abnormal blood tests.
Danish: Behandlingen kan standses hos patienter, som udvikler infektion, der er en kendt bivirkning ved dette lægemiddel, eller hos patienter med unormale blodværdier.
English: The European Medicines Agency therefore concluded that Xeljanz's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Xeljanz opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Xeljanz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xeljanz?
English: Xeljanz contains the active substance tofacitinib.
Danish: Xeljanz indeholder det aktive stof tofacitinib.
English: For more information about using Xeljanz, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Xeljanz, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Xeljanz is available as tablet (5 and 10 mg) to be taken by mouth.
Danish: Xeljanz fås som tabletter (5 mg og 10 mg), der tages gennem munden.
English: The company that markets Xeljanz will provide educational materials to healthcare professionals and patients to increase awareness of the risks with the medicine, particularly the risk of serious infections, and how to manage them.
Danish: Den virksomhed, der markedsfører Xeljanz, skal udlevere informationsmateriale til sundhedspersoner og patienter for at øge bevidstheden om de risici, der er ved lægemidlet, navnlig risikoen for alvorlige infektioner, og om, hvordan man håndterer dem.
English: Most patients in these studies had tried other treatments before and most took Xeljanz with methotrexate.
Danish: De fleste af patienterne i disse studier havde prøvet andre behandlinger før, og de fleste fik Xeljanz i tillæg til metotrexat.
English: In general, the risks with Xeljanz were similar to those of other medicines of its class.
Danish: Overordnet set er risiciene ved Xeljanz de samme som ved andre lægemidler i samme klasse.
English: The second study compared Xeljanz with placebo in 395 patients.
Danish: Det andet studie sammenlignede Xeljanz med placebo hos 395 patienter.