FrancophonIA/ELRC3.0 huggingface dataset:
English: Harmonisation of the existing SmPCs relating to the clinical sections, for Kytril film-coated tablets and solutions for injection, are discussed below:
Danish: Harmonisering af de eksisterende produktresuméer vedrørende de kliniske afsnit for Kytril filmovertrukne tabletter og injektionsvæske, opløsning beskrives nedenfor: Punkt 4.1 - Terapeutiske indikationer
English: Based on the available data, the indication for Kytril solution for injection in the treatment and prevention of delayed CINV was not agreed by the CHMP.
Danish: På grundlag af de foreliggende data var CHMP ikke enig i indikationen for Kytril injektionsvæske, opløsning til behandling og forebyggelse af forsinket CINV.
English: The MAH also proposed Kytril solution for injection in children aged 2 years and above for the prevention and treatment of acute CINV, which was accepted by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen foreslog også Kytril injektionsvæske, opløsning hos børn i alderen 2 år og derover til forebyggelse af akut CINV, hvilket blev accepteret af CHMP.
English: There is insufficient clinical evidence to recommend administration of Kytril solution for injection to children in the prevention and treatment of RINV and PONV.
Danish: Der er ikke tilstrækkelig klinisk evidens til at anbefale administration af Kytril injektionsvæske, opløsning til børn til forebyggelse og behandling af RINV og PONV.
English: However as agreed by the CHMP, the administration of Kytril solution for injection is recommended in children aged 2 years and above, only for the prevention and treatment of acute CINV.
Danish: Det blev dog godkendt af CHMP, at Kytril injektionsvæske, opløsning udelukkende anbefales til børn på 2 år og derover til forebyggelse og behandling af akut CINV.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Kytril and associated names (see Annex I).
Danish: • produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse,
English: The SmPC wording regarding QT prolongation has been agreed through the Article 46 procedure as follows “As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with Kytril (See sections 4.4 and 4.5).” The CHMP endorsed the MAH's proposal to place QT-prolongations as a description of selected adverse events, because the ECG modifications including the QT-prolongation seen were minor and generally not of clinical significance.
Danish: Produktresuméets ordlyd vedrørende QT-forlængelse er blevet godkendt via artikel 46-proceduren på følgende måde: "For så vidt angår andre 5-HT3-antagonister, er der rapporteret om EKGændringer med Kytril, herunder QT-forlængelse (se punkt 4.4 og 4.5)".
English: Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.'
Danish: Kytril filmovertrukne tabletter er indiceret til voksne til forebyggelse af forsinket kvalme og opkastning, der er forbundet med kemoterapi og strålebehandling."
English: Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.'
Danish: Kytril injektionsvæske, opløsning er indiceret til forebyggelse af forsinket kvalme og opkastning, der er forbundet med kemoterapi og strålebehandling."
English: The SmPC does not recommend administration of Kytril solution for injection for paediatric use in RINV and PONV.
Danish: I produktresuméet anbefales ikke administration af Kytril injektionsvæske, opløsning til pædiatrisk brug ved RINV og PONV.
English: Section 4.2 - Posology and method of administration The harmonised proposed text proposed by the MAH was accepted by the CHMP for both the tablets and solution for injection.
Danish: Den harmoniserede ordlyd, som var foreslået af indehaveren af markedsføringstilladelsen, blev godkendt af CHMP for både tabletter og injektionsvæske, opløsning.
English: Based solely on the hypersensitivity reaction, the CHMP agreed that rash should also be listed.
Danish: CHMP godkendte, at udslæt også skulle fremgå af listen, udelukkende på baggrund af overfølsomhedsreaktionen.
English: Section 4.1 - Therapeutic Indications
Danish: Punkt 4.2 - Dosering og indgivelsesmåde
English: --1 Rabies virus, strain SPBN GASGAS, live - 106.8 to 108.1 FFU* per 1.7 ml dose * Focus forming units
Danish: --1 Rabiesvirus, stamme SPBN GASGAS, levende - 106.8 til 108.1 FFU* pr. 1,7 ml dosis * Focus Forming Units - Fokusdannende enheder
English: • The Committee considered the (Co-)Rapporteur's assessment report;
Danish: • Udvalget tog hensyn til (co-)rapportørens vurderingsrapport
English: In addition, the applicant refers to relevant clinical guidelines.
Danish: Ansøgeren henviser desuden til relevante kliniske retningslinjer.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC where Germany raised objections as a potential serious risk to public health;
Danish: • Udvalget behandlede indbringelsessagen i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF, idet Tyskland havde gjort indvendinger vedrørende en potentiel alvorlig risiko for den offentlige sundhed
English: This specific dose is also supported by bibliographical evidence submitted by the applicant.
Danish: Denne specifikke dosis understøttes også af bibliografisk evidens, som ansøgeren har fremlagt.
English: According to Article 10b of Directive 2001/83/EC, new clinical or non-clinical trials relating to the combination (although not the individual active substances) should be submitted.
Danish: I henhold til artikel 10b i direktiv 2001/83/EF bør der forelægges nye kliniske eller ikke-kliniske studier af kombinationen (dog ikke af de enkelte aktive stoffer).
English: • The Committee was of the view that the submitted bibliographical data demonstrate sufficiently the safety and efficacy of the proposed fixed dose combination product.
Danish: • Udvalget var af den opfattelse, at de fremlagte bibliografiske data i tilstrækkelig grad påviser sikkerheden og virkningen af den pågældende fastdosiskombination.
English: This referral procedure concerns the products in UK, AT and DE.
Danish: Denne indbringelsesprocedure vedrører lægemidlerne i Det Forenede Kongerige, Østrig og Tyskland.
English: Data from studies of higher doses of diclofenac or other NSAIDs can be extrapolated to support the efficacy and safety of the specific combination.
Danish: Data fra studier af højere doser af diclofenac eller andre NSAID'er kan ekstrapoleres til at understøtte virkningen og sikkerheden af den specifikke kombination.
English: DE is in agreement with the CHMP conclusion.
Danish: Tyskland er enig i CHMP's konklusion.
English: A decentralised procedure (DCP) with the UK as reference Member State (RMS) and AT, EE, LT, LV and MT as CMSs, concluded positively on 7 November 2016 (UK/H/6135/001/DC).
Danish: En decentraliseret procedure med Det Forenede Kongerige som referencemedlemsstat og Østrig, Estland, Litauen, Letland og Malta som berørte medlemsstater sluttede med et positivt resultat den 7. november 2016 (UK/H/6135/001/DC).
English: The applicant has submitted a review of the literature relating to the use of diclofenac and omeprazole in combination.
Danish: Ansøgeren har fremlagt en gennemgang af litteraturen vedrørende brug af kombinationen af diclofenac og omeprazol.
English: It is noted that the bioequivalence has been demonstrated between the free combination of the recognised reference formulations of the individual mono-components and the proposed fixed combination product and there are no outstanding concerns regarding quality and non-clinical issues.
Danish: Det bemærkes, at bioækvivalensen mellem den frie kombination af de godkendte referenceformuleringer af de enkelte bestanddele og den ansøgte fastdosiskombination er påvist, og der er ingen udestående betænkeligheder vedrørende kvalitet og ikke-kliniske problemstillinger.
English: The 75 mg daily dose of diclofenac is approved for other diclofenac products in the EU for the symptomatic treatment of rheumatic disease.
Danish: Dosen på 75 mg diclofenac dagligt er godkendt for andre diclofenac-produkter i EU til symptomatisk behandling af reumatiske sygdomme.
English: Notice to Applicants Volume 2A Chapter 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf daily.
Danish: Meddelelse til ansøgere, bind 2A, kapitel 1. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf
English: The applicant Temmler Pharma GmbH submitted in Germany (DE) an application for a Marketing Authorisation (MA) for Diotop 75 mg / 20 mg modified-release hard capsules, under Article 10b of Directive 2001/83/EC.
Danish: Ansøgeren, Temmler Pharma GmbH, indsendte i Tyskland en ansøgning om markedsføringstilladelse for Diotop 75 mg/20 mg hårde kapsler med modificeret udløsning i henhold til artikel 10b i direktiv 2001/83/EF.
English: However, the CHMP took into consideration the Guideline on clinical development of fixed combination medicinal products2 and concluded by consensus that the development of Diotop 75 mg/20 mg is in line with it, since the Guideline does not preclude extrapolation from higher doses and different substances if scientifically justified.
Danish: CHMP tog imidlertid hensyn til retningslinjerne for klinisk udvikling af fastdosis-lægemidler2 og konkluderede enstemmigt, at udviklingen af Diotop 75 mg/20 mg er i overensstemmelse med disse retningslinjer, idet retningslinjerne ikke udelukker ekstrapolering fra højere doser og forskellige stoffer, hvis det er videnskabeligt begrundet.
English: Moreover the mechanisms for both NSAID-associated GI toxicity and the gastro-protective efficacy of omeprazole are not expected to differ across the different non-selective NSAIDs studied, which are all associated with a risk of upper GI complications.
Danish: Desuden forventes mekanismerne for både NSAID-associeret mave-tarm-toksicitet og omeprazols beskyttende virkning på mave-tarm-slimhinden ikke at være forskellige mellem de undersøgte ikkeselektive NSAID'er, som alle er forbundet med en risiko for komplikationer i den øvre del af mavetarm-kanalen.
English: Bioequivalence has been demonstrated between Diotop 75 mg / 20 mg and the free combination of the recognised reference formulations of the individual mono-components.
Danish: Bioækvivalens er påvist mellem Diotop 75 mg/20 mg og den frie kombination af de godkendte referenceformuleringer af de enkelte bestanddele.
English: DE considered that extrapolation across different substances, doses and studies is not considered to be an acceptable approach and thus the safety and efficacy of Diotop 75 mg / 20 mg has not been sufficiently shown.
Danish: Tyskland fandt, at ekstrapolering på tværs af forskellige stoffer, doser og studier ikke kan anses for at være en acceptabel tilgang, og at sikkerheden ved og virkningen af Diotop 75 mg/20 mg ikke er tilstrækkeligt påvist.
English: • The Committee considered the totality of the data submitted by the applicant in support of Diotop 75 mg / 20 mg modified-release capsules, hard;
Danish: • Udvalget tog hensyn til alle de data, som ansøgeren havde fremlagt til støtte for Diotop 75 mg/20 mg, hårde kapsler med modificeret udløsning
English: CHMP also noted that there is a risk of GI complications with diclofenac 75 mg QD based on epidemiological data.
Danish: CHMP bemærkede også, at der er en risiko for mave-tarm-komplikationer med diclofenac 75 mg én gang dagligt baseret på epidemiologiske data.
English: The DCP application was withdrawn from EE, LT, MT and LV during the national phase.
Danish: Ansøgningen i henhold til den decentraliserede procedure blev trukket tilbage i Estland, Litauen, Malta og Letland under den nationale procedure.
English: The Committee, as a consequence, considers that the benefit-risk balance of Diotop 75 mg / 20 mg modified-release capsules, hard and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Danish: Udvalget finder derfor, at benefit/risk-forholdet for Diotop 75 mg/20 mg, hårde kapsler med modificeret udløsning, og relaterede navne er positivt, og anbefaler derfor udstedelse af markedsføringstilladelse for de lægemidler, der er anført i bilag I til CHMP's udtalelse.
English: In addition, there are literature data from several large RCTs supporting the safety and efficacy of omeprazole 20 mg daily for the treatment, maintenance and/or prevention of NSAID-associated gastroduodenal ulceration in patients with arthritis.
Danish: Der er derudover litteraturdata fra adskillige store randomiserede kliniske studier, som understøtter sikkerheden og virkningen af omeprazol 20 mg dagligt til behandling, vedligeholdelsesbehandling og/eller forebyggelse af sår i mavesækken og tolvfingertarmen hos patienter med artritis.
English: Based on the review of all available data, the CHMP considers that the benefit-risk balance of Diotop 75 mg / 20 mg modified-release capsules, hard and associated names is favourable and therefore recommends the granting of the marketing authorisation.
Danish: På basis af gennemgangen af alle de tilgængelige data vurderer CHMP, at benefit/risk-forholdet for Diotop 75 mg/20 mg, hårde kapsler med modificeret udløsning, og relaterede navne er positivt, og anbefaler derfor udstedelse af markedsføringstilladelse.
English: However, according to Notice to Applicants Volume 2A Chapter 1 Section 5.51 , a mixed-dossier can be accepted.
Danish: Imidlertid kan et kombineret dossier accepteres i henhold til Meddelelse til ansøgere, bind 2A, kapitel 1, pkt.
English: Therefore, the CHMP considered that in the context of the harmonised gastro protection indication for omeprazole products in the European Union, the totality of the data presented by the applicant and the well-known safety and efficacy profile of omeprazole and diclofenac, the therapeutic efficacy and the safety of Diotop 75 mg/20 mg is adequately justified.
Danish: På baggrund af den harmoniserede indikation i EU vedrørende omeprazol-produkters beskyttende virkning på mave-tarm-slimhinden, alle de af ansøgeren fremlagte data og den velkendte sikkerheds- og virkningsprofil for omeprazol og diclofenac vurderede CHMP derfor, at den terapeutiske virkning og sikkerhed af Diotop 75 mg/20 mg er tilstrækkeligt begrundet.
English: The proposed indication is: symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers who are adequately controlled with diclofenac and omeprazole.
Danish: Den ansøgte indikation er: symptomatisk behandling af reumatoid artritis, osteoartritis og ankyloserende spondylitis hos voksne patienter, der har risiko for at udvikle NSAID-associeret mavesår og/eller sår i tolvfingertarmen, og som er tilstrækkeligt regulerede med diclofenac og omeprazol.
English: The CHMP acknowledged that there is no literature data regarding the specific free combination of diclofenac 75 mg QD and omeprazole 20 mg QD.
Danish: CHMP anerkendte, at der ikke findes litteratur-data vedrørende den specifikke frie kombination af diclofenac 75 mg dagligt og omeprazol 20 mg dagligt.
English: Each modified release capsule contains 75 mg diclofenac sodium (25 mg as gastroresistant pellets and 50 mg as prolonged release pellets) and 20 mg of omeprazole (gastro-resistant pellets).
Danish: Hver kapsel med modificeret udløsning indeholder 75 mg diclofenacnatrium (25 mg som enteropellets og 50 mg som depotpellets) og 20 mg omeprazol (enteropellets).
English: Diotop 75 mg / 20 mg is a fixed dose combination product consisting of diclofenac sodium and omeprazole.
Danish: Diotop 75 mg/20 mg er en fastdosiskombination bestående af diclofenacnatrium og omeprazol.
English: Diotop 75 mg / 20 mg is intended for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers, who are adequately controlled with diclofenac and omeprazole.
Danish: Diotop 75 mg/20 mg er beregnet til symptomatisk behandling af reumatoid artritis, osteoartritis og ankyloserende spondylitis hos voksne patienter, der har risiko for at udvikle NSAID-associeret sår i mavesækken og/eller tolvfingertarmen, og som er tilstrækkeligt regulerede med diclofenac og omeprazol.
English: However, the position of DE was that this particular combination of diclofenac/omeprazole in the specific doses 75 mg / 20 mg administered once daily has never been tested in any published study and no new clinical data has been generated.
Danish: Referencemedlemsstaten Det Forenede Kongerige finder, at den fremlagte evidens er tilstrækkelig til at understøtte sikkerheds- og effektprofilen for Diotop 75 mg/20 mg. Tyskland var imidlertid af den opfattelse, at denne specifikke kombination af diclofenac/omeprazol i de specifikke doser 75 mg/20 mg, administreret én gang dagligt, aldrig er blevet undersøgt i et publiceret studie, og at der ikke er genereret nye kliniske data.
English: The relevant contribution of omeprazole to the desired therapeutic effect of the product has been demonstrated; the addition of a proton pump inhibitor in patients requiring long-term use of NSAIDs who are at risk of gastroduodenal ulceration has previously been recommended by the CHMP.
Danish: CHMP har tidligere anbefalet tilføjelsen af en protonpumpehæmmer hos patienter, der har behov for langvarig anvendelse af NSAID'er, og som har risiko for sårdannelse i mavesækken og tolvfingertarmen.
English: Moreover, following an Article 30 procedure of Directive 2001/83/EC for Losec and associated names (EMEA/H/A-30/1001), the harmonised indications for omeprazole products include the prevention of NSAID-associated gastric and duodenal ulcers in patients at risk with omeprazole dosed at 20 mg
Danish: 30/1001) omfatter de harmoniserede indikationer for omeprazol-produkter forebyggelse af NSAIDassocierede sår i mavesækken og tolvfingertarmen hos risikopatienter (omeprazol 20 mg dagligt).
English: Packaging Content (concentration)
Danish: Emballage Koncentration Pakningsstørr elser
English: Package size
Danish: Lægemiddelform
English: (In these studies efficacy was not investigated).
Danish: (I disse undersøgelser blev effekten ikke undersøgt.)
English: ATC vet code: QP53BE03.
Danish: ATCvet-kode: QP53BE03.
English: Date of first authorisation: 31/01/2018.
Danish: Dato for første markedsføringstilladelse: 31/01/2018.
English: A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Danish: En yderligere dyrlægeundersøgelse anbefales 30 dage efter behandlingen, da nogle dyr kan behøve en anden behandling.
English: All dogs recovered without treatment.
Danish: Alle hunde kom sig uden behandling.
English: Plasma protein binding was determined in vitro and calculated at ≥99.9%.
Danish: Plasmaproteinbindingen blev bestemt in vitro og beregnet til ≥ 99,9 %.
English: Interactions with other medicinal products and other forms of interactions: None known.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Ingen kendte.
English: Each tablet contains:
Danish: Hver tyggetablet indeholder:
English: The bioavailability of sarolaner following oral dosing was high at >85%.
Danish: Biotilgængeligheden af sarolaner efter oral indgift var høj (> 85 %).
English: Tablets can be administered with or without food.
Danish: Tabletter kan administreres med eller uden føde.
English: No treatment-related clinical signs were observed.
Danish: Der blev ikke observeret behandlingsrelaterede kliniske tegn.
English: A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues.
Danish: Det blev fundet i en fordelingsundersøgelse, at 14C-sarolaner-relaterede rester i vid udstrækning blev fordelt i vævet.
English: Half-life was comparable for the intravenous and oral routes at 12 and 11
Danish: Halveringstiden var sammenlignelig for intravenøs og oral indgift ved henholdsvis dag 12 og 11.
English: Ticks on the animal prior to administration are killed within 24 hours.
Danish: Flåter, der forefindes på dyret før administration, dræbes i løbet af 24 timer.
English: These signs typically resolve without treatment.
Danish: Disse symptomer forsvinder typisk uden behandling.
English: As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.
Danish: Da infektion med Demodex er en multi-faktoriel sygdom anbefales det også at behandle eventuelle underliggende sygdomme på passende måde.
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Danish: Veterinærlægemidlet kan indgå i en behandlingsstrategi til kontrol af loppeallergi-dermatitis (Flea Allergy Dermatitis - FAD).
English: Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg).
Danish: Det blev fundet, at sarolaner havde en lav clearance (0,12 ml/min/kg) og et moderat fordelingsvolumen (2,81 l/kg).
English: Puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should not be treated unless so advised by a veterinarian.
Danish: Hvalpe, der er under 8 uger gamle, og/eller hunde med en kropsvægt på mindre end 1,3 kg, bør ikke behandles, medmindre det anbefales af en dyrlæge.
English: Glucose, liquid (81.5% solids) Spray dried pork liver powder Hydrolysed vegetable protein Gelatin type A
Danish: Glucose, flydende (81,5 % faststof) Spraytørret svineleverpulver Frysetørret vegetabilsk protein Gelatine type A
English: Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects.
Danish: Laboratorieforsøg med rotter og kaniner har ikke frembragt tegn på teratogene effekter.
English: Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Danish: Behandlingen bør forsættes, indtil hudskrabning er negativ i mindst 2 på hinanden følgende prøver med 1 måneds mellemrum.
English: EU/2/17/220/001 (5 mg, 3 tablets) EU/2/17/220/002 (10 mg, 3 tablets) EU/2/17/220/003 (20 mg, 3 tablets) EU/2/17/220/004 (40 mg, 3 tablets) EU/2/17/220/005 (80 mg, 3 tablets) EU/2/17/220/006 (120 mg, 3 tablets)
Danish: EU/2/17/220/001 (5 mg, 3 tabletter) EU/2/17/220/002 (10 mg, 3 tabletter) EU/2/17/220/003 (20 mg, 3 tabletter) EU/2/17/220/004 (40 mg, 3 tabletter) EU/2/17/220/005 (80 mg, 3 tabletter) EU/2/17/220/006 (120 mg, 3 tabletter)
English: One carton contains one blister of 3 tablets.
Danish: En æske indeholder en blisterpakning med 3 tabletter.
English: Tablet strength (mg sarolaner)
Danish: Tablettens styrke (mg sarolaner)
English: To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required.
Danish: For at hindre børn i at få adgang til produktet må der kun fjernes én tyggetablet ad gangen fra blisterpakningen, og kun når det er nødvendigt.
English: Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose.
Danish: Sarolaner tåles godt af collier med deficient multidrug-resistance-protein 1 (MDR1 -/-) efterfulgt af en enkelt oral administration ved 5 gange den anbefalede dosis.