FrancophonIA/ELRC3.0 huggingface dataset:
English: The Mutual Recognition Procedure started on 21 October 2005.
Danish: Den gensidige anerkendelsesprocedure indledtes den 21. oktober 2005.
English: Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur.
Danish: Lekkerkerker (Nederlandene) til rapportør og dr. Hudson (Det Forenede Kongerige) til medrapportør.
English: The Denmark referred the reasons for disagreement to the EMEA on 31 March 2006.
Danish: Danmark fremsendte begrundelserne for uenighederne til EMEA den 31. marts 2006.
English: The final opinion was converted into a Decision by the European Commission on 11/10/2006.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
English: The arbitration procedure started on 27 April 2006.
Danish: Voldgiftsproceduren indledtes den 27. april 2006.
English: Supplementary information was provided by the Marketing Authorisation Holder on 23 May 2006.
Danish: Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 23. maj 2006.
English: Winthrop Pharmaceuticals UK Ltd submitted applications for mutual recognition of Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Danish: Winthrop Pharmaceuticals UK Ltd indgav ansøgninger om gensidig anerkendelse af Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne på grundlag af den markedsføringstilladelse, Danmark udstedte den 30. september 2002.
English: The scope of the referral was to agree whether Doxazosin “Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Danish: Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxazosin “Winthrop” 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer.
English: Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (Doxazosin) is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Danish: Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa-1-receptorblokerende stof, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
English: Oral explanations were given by the Marketing Authorisation Holder on 27 June 2006.
Danish: Indehaveren af markedsføringstilladelsen afgav mundtlige redegørelser den 27. juni 2006.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn ( INN): Doxazosin
English: The study should be based on an agreed protocol.
Danish: Studiet skal udføres på baggrund af en aftalt protokol.
English: - Allow the area to dry for 15 minutes.
Danish: - Lad området tørre i 15 minutter.
English: Frequencies have been defined according to the following convention:
Danish: Frekvenserne er defineret i henhold til følgende konvention:
English: Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017
Danish: Dato for første markedsføringstilladelse: 15. november 2012 Dato for seneste fornyelse: 13. juli 2017
English: In rabbits there were no major abnormalities.
Danish: Hos kaniner var der ingen større abnormiteter.
English: Instructions for use: - Open a new tube each time you use this medicine.
Danish: Vejledning til brug: - Åbn en ny tube hver gang du bruger denne medicin.
English: No overall differences in safety or efficacy were observed between younger and older patients.
Danish: Ingen generelle forskelle i sikkerhed eller effekt blev observeret mellem yngre og ældre patienter.
English: Patients were followed every 3 months for 12 months (see table 5).
Danish: Patienterne blev fulgt hver 3. måned i 12 måneder (se tabel 5).
English: Necrosis in the dermis was rarely observed.
Danish: Nekrose i dermis blev sjældent observeret.
English: The compliance rate was high, with 98% of the patients completing these studies.
Danish: Compliance var høj, idet 98% af patienterne fuldførte studierne.
English: - Do not swallow this medicine.
Danish: - Slug ikke denne medicin.
English: - Do not apply more gel than your doctor has advised.
Danish: - Påfør ikke mere gel end hvad lægen har tilrådet.
English: The final study report shall be submitted:
Danish: Den endelige studierapport skal indsendes:
English: - Do not get Picato in your eyes.
Danish: - Få ikke Picato i øjnene.
English: 8 weeks after randomisation
Danish: 8 uger efter randomisering
English: This side effect is uncommon.
Danish: Denne bivirkning er ikke almindelig.
English: Experience with treatment of a larger area
Danish: Erfaring med behandling af et større område
English: Results demonstrated no systemic absorption.
Danish: Resultatet viste ingen systemisk absorption.
English: Immunocompromised patients
Danish: Immunokompromitterede patienter
English: The level of efficacy varied between the individual anatomical locations.
Danish: Virkningsgraden varierede mellem de individuelle anatomiske lokaliteter.
English: Picato must not be ingested.
Danish: Picato må ikke indtages.
English: Management of overdose should consist of treatment of clinical symptoms.
Danish: Behandling af overdosis bør bestå af behandling af kliniske symptomer.
English: Clear colourless gel.
Danish: Klar farveløs gel.
English: After this period, the treatment area may be washed using mild soap and water.
Danish: Efter denne periode, kan behandlingsområdet vaskes med mild sæbe og vand.
English: You should avoid the use of Picato if you are pregnant.
Danish: Du bør undgå brugen af Picato hvis du er gravid.
English: For treatment of the neck:
Danish: For behandling af halsen:
English: - Avoid sunlight as much as possible (including sunlamps and tanning beds).
Danish: - Undgå sollys så meget som muligt (herunder sollamper og solarier).
English: gel 2 tubes
Danish: gel 2 tuber
English: Experience with more than one treatment course
Danish: Erfaring med mere end én behandling
English: Take care not to transfer gel from the treatment area into your eyes.
Danish: Pas på ikke at overføre gel fra behandlingsområdet til dine øjne.
English: At 12 months, the complete clearance rates in these groups were 31% and 19% respectively.
Danish: Ved 12 måneder var raten for fuldstændig heling i disse grupper henholdsvis 31% og 19%.
English: Wash the area with soap and water.
Danish: Vask området med vand og sæbe.
English: d p<0.001; compared to vehicle by logistic regression with treatment, study and anatomical location.
Danish: d p<0.001; sammenlignet med vehikel ved logistisk regression med behandling, studie og anatomisk placering.
English: Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age.
Danish: Aktinisk keratose forekommer ikke hos børn, og denne medicin må ikke anvendes til børn og teenagere under 18 år.
English: gel 3 tubes
Danish: gel 3 tuber
English: - Squeeze the gel from one tube onto a fingertip.
Danish: - Tryk gel fra én tube ud på en fingerspids.
English: The results of the randomised and blinded second treatment course are presented in table 6.
Danish: Resultatet af den randomiserede og blindede 2. behandling er præsenteret i tabel 6.
English: There are no data from the use of ingenol mebutate in pregnant women.
Danish: Der er ingen data fra anvendelse af ingenolmebutat til gravide kvinder.
English: The side effects may get worse for up to 1 week after you have stopped using this medicine.
Danish: Bivirkningerne kan blive værre i op til 1 uge efter du er stoppet med at bruge dette lægemiddel.
English: Seek medical attention right away if you experience an allergic reaction that may include swelling of the mouth, tongue or throat when using this medicine.
Danish: Opsøg straks lægehjælp, hvis du oplever allergisk reaktion, som kan medføre hævelse af mund, tunge eller hals, når du bruge dette lægemiddel.
English: If you have previously used Picato or other similar medicines tell your doctor before starting the treatment.
Danish: Hvis du tidligere har brugt Picato eller anden lignende medicin fortæl det til lægen, før du begynder behandlingen.
English: However, due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.
Danish: Men på grund af sygdommens art, bør overdreven udsættelse for sollys (herunder sollamper og solarier) undgås eller minimeres.
English: Do not apply Picato on open-wounds or damaged skin.
Danish: Påfør ikke Picato i åbne sår eller på skadet hud
English: Should the symptoms described above intensify beyond the first week after you have stopped using this medicine, or if there is discharge of pus, you might have an infection and should contact your doctor or pharmacist.
Danish: Bliver symptomerne beskrevet ovenfor mere udtalte efter den første uge efter du har stoppet brugen af dette lægemiddel, eller hvis der er udsivning af pus, kan du muligvis have en infektion og du skal kontakte din læge eller apoteket.
English: to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: sjælden (≥ 1/10.000 til <1/1000); meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This medicine does not have any effect on your ability to drive or to use machines.
Danish: Dette lægemiddel har ingen virkning på din evne til at føre eller anvende maskiner.
English: The trial included a large group of severely sun-damaged patients.
Danish: Studiet inkluderede en stor gruppe patienter med svære solskader.
English: Should any occur, talk to your doctor immediately.
Danish: Skulle dette forekomme, kontakt lægen med det samme.
English: If you use Picato for treatment of the neck
Danish: Hvis du bruger Picato til behandling på halsen
English: The gel from the tube should be squeezed onto a fingertip and spread evenly over the entire treatment area, allowing it to dry for 15 minutes.
Danish: Gelen fra tuben skal trykkes ud på en fingerspids og spredes jævnt over hele behandlingsområdet, lad det tørre i 15 minutter.
English: Paediatric population There is no relevant use of Picato in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevante indikationer for Picato i den pædiatriske population.
English: Hypersensitivity (including angioedema)
Danish: Overfølsomhed (herunder angioødem)
English: Long-term follow up
Danish: Langtidsopfølgning
English: - If you are allergic to ingenol mebutate or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for ingenolmebutat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i pkt.
English: If you have been prescribed two different strengths for treatment of two different areas you should make sure that you use the prescribed strength on the correct area.
Danish: Hvis du har fået ordineret to forskellige styrker til behandling af to forskellige områder, skal du sikre dig, at du anvender den ordinerede styrke til det korrekte område.
English: Remove the cap from the tube just before use.
Danish: Fjern hætten fra tuben umiddelbart før brug.
English: Name and address of the manufacturer responsible for batch release LEO Laboratories Ltd.
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse LEO Laboratories Ltd.
English: The first treatment course, given open label, resulted in a complete clearance rate of 62% (277/450).
Danish: Den første behandling, givet åbent, resulterede i en rate for fuldstændig heling på 62% (277/450).
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1000 til <1/100);
English: 149 patients in the Picato group and 140 in the vehicle group were followed for 12 months.
Danish: 149 af patienterne i Picatogruppen og 140 i vehikel-gruppen blev fulgt i 12 måneder.
English: A repeat treatment course of Picato can be given if an incomplete response is seen at a follow-up examination after 8 weeks or if lesions that are cleared at this examination recur in subsequent examinations.
Danish: Gentagen behandling med Picato kan gives, hvis en ufuldstændig respons viser sig ved en opfølgningsundersøgelse efter 8 uger, eller hvis ophelede læsioner fra denne undersøgelse forekommer igen ved senere undersøgelser.
English: After using this medicine the skin where you apply it is likely to get red, peel and have scabs.
Danish: Efter at have anvendt dette lægemiddel, kan huden, hvor du påfører det have tendens til at blive rødt, skalle og danne skorper.
English: If you forget to use Picato
Danish: Hvis du glemmer at bruge Picato
English: Contact with the eyes can cause chemical conjunctivitis and corneal burns.
Danish: Kontakt med øjnene kan forårsage kemisk konjunktivitis og hornhindeforbrændinger.
English: Statistically significant differences in patient reported outcomes were observed in favour of patients receiving Picato compared to those receiving vehicle gel.
Danish: Statistisk signifikante forskelle i patientrapporterede resultater blev observeret til fordel for patienter, der fik Picato i forhold til dem, der modtog vehikelgel.
English: - Be vigilant for any new scaly red patches, open sores, elevated or warty growths within the treatment area.
Danish: - Vær opmærksom på nye skællende røde plamager, åbne sår, forhøjet eller vortelignende vækst indenfor behandlingsområdet.
English: The PRAC is of the opinion that a thorough review is needed of the impact of all available data related to skin malignancies, including the results of study LP0041-63, on the benefit risk balance of Picato.
Danish: PRAC er af den opfattelse, at det er nødvendigt med en grundig gennemgang af virkningen af alle tilgængelige data om hudmaligniteter, herunder resultaterne fra LP0041-63 studiet, på benefit/risk-forholdet for Picato.
English: Othera aOther includes shoulder, back, leg.
Danish: Andeta aAndet inkluderer skulder, ryg, ben.
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, other chemotherapeutics, ATC code: D06BX02.
Danish: Farmakoterapeutisk klassifikation: Antibiotika og kemoterapeutika til udvortes brug, andre kemoterapeutika, ATC-kode: D06BX02
English: - Do not cover the treated area with air- or water-tight bandages after you have applied this medicine.
Danish: - Du må ikke dække det behandlede område med luft- eller vandtætte bandager efter at du har påført denne medicin.
English: Wash your hands again if you happen to touch the area where you applied the gel.
Danish: Vask dine hænder igen, hvis du tilfældigvis kommer til at røre det område, hvor du har anvendt gelen.
English: If an area on the face or scalp and another area on the trunk or extremities are simultaneously treated, then patients should be advised to ensure they use the appropriate strengths.
Danish: Hvis et område i ansigtet eller hårbunden behandles samtidigt med et andet område på kroppen eller ekstremiteterne bør patienterne informeres om at sikre sig, at de anvender de korrekte styrker.
English: Patients continued in the studies for an 8 week follow-up period during which they returned for clinical observations and safety monitoring.
Danish: Patienterne fortsatte i studierne, i en 8-ugers opfølgningsperiode, med kliniske observationer og sikkerhedsovervågning.
English: Fertility No fertility studies have been performed with ingenol mebutate.
Danish: Fertilitet Ingen fertilitetsstudier er udført med ingenolmebutat
English: Optimal therapeutic effect can be assessed approximately 8 weeks after treatment.
Danish: Optimal terapeutisk virkning kan vurderes cirka 8 uger efter behandlingen.
English: Actinic keratoses are rough areas of skin found in people who have been exposed to too much sunshine over the course of their lifetime.
Danish: Aktiniske keratoser er ru hudområder, der findes hos mennesker, der har været udsat for for meget sol i løbet af deres levetid.
English: Caps of HDPE.
Danish: Hætter af HDPE.
English: Table 6 Complete clearancea of the field 8 weeks after randomisation and Month 12 Field recalcitrantc
Danish: Tabel 6 Fuldstænding helinga af området 8 uger efter randomisering og ved måned 12 Behandlingsområde genstridigc
English: Picato should not be applied immediately after taking a shower or less than 2 hours before bedtime.
Danish: Picato bør ikke påføres umiddelbart efter at have taget et brusebad eller mindre end 2 timer før sengetid.
English: If treating the hands, only the fingertip which is used for applying the gel should be washed.
Danish: Hvis hænderne behandles, skal kun fingerspidsen, som anvendes til påføring af gelen, vaskes.
English: On each scheduled dosing day, the study gel was applied to the entire treatment area.
Danish: På hver planlagt dosisdag i undersøgelsen blev gelen påført på hele behandlingsområdet.
English: Picato should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips.
Danish: Picato skal ikke anvendes i nærheden af øjnene, på indersiden af næseborene, på indersiden af ørerne eller på læberne.
English: Efficacy, measured as complete and partial clearance rate, as well as median percent reduction, was assessed at day 57 (see table 2).
Danish: Virkning, målt som total og delvis heling, såvel som median procent reduktion blev vurderet på dag 57 (se tabel 2).
English: - Make sure that your skin has healed from any other treatments or surgery before using this medicine.
Danish: - Sørg for at din hud er helet efter andre behandlinger eller operation, før du bruger denne medicin.
English: Following the application of ingenol mebutate, most patients (>95%) experienced one or more local skin response(s).
Danish: Efter påføring af ingenolmebutat oplevede de fleste patienter (>95%) én eller flere lokale hudreaktion(er).
English: Wash your hands thoroughly after you have applied the gel.
Danish: Vask dine hænder grundigt efter du har anvendt gelen.
English: Overdosing of Picato could result in an increased incidence of local skin responses.
Danish: Overdosering med Picato kan resultere i en øget forekomst af lokale hudreaktioner.
English: A total of 198 patients with complete clearance at day 57 (184 treated with Picato and 14 treated with vehicle) were followed for additionally 12 months.
Danish: I alt 198 patienter med total heling på dag 57 (184 behandlet med Picato og 14 behandlet med vehikel) blev fulgt i yderligere 12 måneder.
English: Swelling of the application site is very common (has been reported in more than 1 in 10 people).
Danish: Hævelse på påføringsstedet er meget almindelig (er rapporteret hos flere end 1 ud af 10 personer).
English: Only those patients who achieved complete clearance in the treated area at the end of the phase 3 studies (day 57) were eligible for long term follow-up.
Danish: Kun de patienter, som opnåede fuldstændig heling i det behandlede område ved udgangen af fase-3 studierne (dag 57), var berettiget til langtidsopfølgning.
English: The systemic pharmacokinetic profile of ingenol mebutate and its metabolites has not been characterised in humans due to the absence of quantifiable whole blood levels following cutaneous administration.
Danish: Den systemiske farmakokinetiske profil af ingenolmebutat og dets metabolitter er ikke blevet karakteriseret i mennesker på grund af fraværet af målbare blodkoncentrationer efter kutan administration.
English: Risk of progression to squamous cell carcinoma
Danish: Risiko for progression til pladecellekræft
English: Three prospective, observational long term 1 year follow-up studies were conducted to evaluate sustained efficacy by recurrence of actinic keratosis lesions in the treatment field, and safety in patients who had received treatment with Picato.
Danish: Tre prospektive, observationelle langtids-1-års-opfølgningsstudier blev gennemført for at evaluere vedvarende effekt ved genkomst af aktiniske keratose læsioner i behandlings området, og sikkerhed hos patienter, der havde fået behandling med Picato.
English: Drink plenty of water if you accidentally swallow this medicine and seek medical assistance.
Danish: Drik masser af vand, hvis du ved et uheld kommer til at sluge denne medicin, og søg lægehjælp.
English: In vitro study results demonstrate that ingenol mebutate does not inhibit or induce human cytochrome P450 isoforms.
Danish: In vitro data viser, at ingenolmebutat ikke hæmmer eller inducerer human cytokrom P450 isoformer.
English: Study patients ranged from 34 to 89 years of age (mean 64 and 66 years, respectively, for the two strengths) and 94% had Fitzpatrick skin type I, II, or III.
Danish: Forsøgspersonerne varierede i alder fra 34 til 89 år (gennemsnit 64 og 66 år, henholdsvis for de to styrker) og 94% havde Fitzpatrick hudtype I, II eller III.
English: Table 1 Adverse reactions by MedDRA System Organ Classification Frequency
Danish: Tabel 1 Bivirkninger i henhold til MedRA Sytemorganklasser Frekvens
English: In vivo and in vitro models have shown a dual mechanism of action for the effects of ingenol mebutate: 1) induction of local lesion cell death and 2) promoting an inflammatory response characterised by local production of proinflammatory cytokines and chemokines and infiltration of immunocompetent cells.
Danish: In vivo- og in vitro modeller har vist en dobbelt virkningsmekanisme for virkningerne af ingenolmebutat: 1) induktion af lokal læsions-celledød og 2) fremme en inflammatorisk respons kendetegnet ved lokal produktion af proinflammatoriske cytokiner og chemokiner og infiltrering med immunkompetente celler.