FrancophonIA/ELRC3.0 huggingface dataset:
English: INDICATION(S) For treatment of clinical signs, including oedema and effusion, related to congestive heart failure.
Danish: INDIKATIONER Til behandling af kliniske tegn, herunder ødem og effusion, relateret til kongestivt hjertesvigt.
English: PHARMACEUTICAL FORM Tablets
Danish: LÆGEMIDDELFORM Tabletter
English: Blister pack
Danish: Blisterpakning
English: PACKAGE SIZE 30 tablets 100 tablets
Danish: PAKNINGSSTØRRELSE 30 tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske
English: 4.2 Indications for use, specifying the target species For treatment of clinical signs, including oedema and effusion, related to congestive heart failure.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til behandling af kliniske tegn, herunder ødem og effusion, relateret til kongestivt hjertesvigt.
English: Sodium laurilsulfate Crospovidone Microcrystalline cellulose Sodium stearyl fumarate Bacon flavour
Danish: Mikrokrystallinsk cellulose Natriumstearylfumarat Baconsmag
English: People with known hypersensitivity to torasemide or other sulphonamides should administer the veterinary medicinal product with caution.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Personer med kendt overfølsomhed over for torasemid eller over for andre sulfonamider bør administrere veterinærlægemidlet med forsigtighed.
English: Refer to section 4.5.
Danish: 4.6 i betragtning.
English: Special precautions for use in animals:
Danish: Særlige forsigtighedsregler vedrørende brugen:
English: Co-administration of loop diuretics and NSAIDs can result in a decreased natriuretic response.
Danish: Administration af slyngediuretika sammen med NSAID'er kan føre til et nedsat natriuretisk respons.
English: Co-administration of loop diuretics and non-steroidal anti-inflammatory drugs can result in a decreased natriuretic response.
Danish: Interaktion med andre lægemidler og andre former for interaktion Administration af slyngediuretika sammen med nonsteroide antiinflammatoriske lægemidler kan føre til et nedsat natriuretisk respons.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkning(er) i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr)
English: 3 mg of torasemide
Danish: 3 mg torasemid
English: UpCard 3 mg, 7.5 mg and 18 mg tablets: oblong white to off-white tablets with 3 break-lines on each side.
Danish: UpCard 3 mg, 7,5 mg og 18 mg tabletter: aflange hvide til off-white tabletter med 3 delekærve på hver side.
English: UpCard 0.75 mg tablets: oblong white to off-white tablets with 1 break-line on each side.
Danish: UpCard 0,75 mg tabletter: aflange hvide til off-white tabletter med 1 delekærv på hver side.
English: UpCard 3 mg tablets for dogs
Danish: UpCard 3 mg tabletter til hunde
English: 18 mg of torasemide
Danish: 18 mg torasemid
English: UpCard 18 mg tablets for dogs
Danish: UpCard 18 mg tabletter til hunde
English: UpCard 7.5 mg tablets for dogs
Danish: UpCard 7,5 mg tabletter til hunde
English: UpCard 0.75 mg tablets are oblong white to off-white tablets with 1 break-line on each side.
Danish: UpCard 0,75 mg tabletter er aflange hvide til off-white tabletter med en delekærv på hver side.
English: UpCard 0.75 mg tablets for dogs
Danish: UpCard 0,75 mg tabletter til hunde
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)
English: 0.75 mg of torasemide
Danish: 0,75 mg torasemid
English: PACKAGE LEAFLET FOR: UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs
Danish: INDLÆGSSEDDEL TIL: UpCard 0,75 mg tabletter til hunde UpCard 3 mg tabletter til hunde UpCard 7,5 mg tabletter til hunde UpCard 18 mg tabletter til hunde
English: UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs torasemide
Danish: UpCard 0,75 mg tabletter til hunde UpCard 3 mg tabletter til hunde UpCard 7,5 mg tabletter til hunde UpCard 18 mg tabletter til hunde torasemid
English: UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs
Danish: UpCard 0,75 mg tabletter til hunde UpCard 3 mg tabletter til hunde UpCard 7,5 mg tabletter til hunde UpCard 18 mg tabletter til hunde
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: 7.5 mg of torasemide
Danish: 7,5 mg torasemid
English: Dogs
Danish: BRUG
English: 18 mg of torasemide For the full list of excipients, see section 6.1.
Danish: 18 mg torasemid Alle hjælpestoffer er anført under pkt.
English: The indicated period of use is 3 years.
Danish: Det anførte anvendelsesperiode er 3 år.
English: In total, about 5 million Implanon implants have been sold worldwide up to July 2008.
Danish: På verdensplan er der i alt blevet solgt omkring 5 millioner Implanon-implantater indtil juli 2008.
English: Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Danish: Da der ikke var opnået enighed på dag 60, blev proceduren henvist til CHMP.
English: 81737 Munich Germany
Danish: 81737 Munich Tyskland
English: Thus, the possibility of an excess risk is not supported by these post-marketing data.
Danish: Muligheden for en for stor risiko understøttes således ikke af disse postmarkedsføringsdata.
English: The information already included in section 4.4 of the SPC is considered sufficient.
Danish: De oplysninger, der allerede er medtaget i punkt 4.4 i produktresumeet, anses for at være tilstrækkelige.
English: ANNEX IV CONDITIONS FOR THE RENEWAL OF THE MARKETING AUTHORISATION
Danish: BILAG IV BETINGELSER FOR FORNYELSEN AF MARKEDSFØRINGSTILLADELSEN
English: Co. Dublin Ireland
Danish: Co. Dublin Irland
English: The difference between the observed and the expected numbers of cases is substantial and is unlikely to be explained by underreporting alone.
Danish: Forskellen mellem det observerede og det forventede antal sager er væsentlig, og det er ikke sandsynligt, at den udelukkende kan forklares ved underindberetning.
English: This is well known and sometimes a reason for method discontinuation.
Danish: Dette er velkendt og fører somme tider til seponering af metoden.
English: One contraceptive method will not fulfil all requirements at all times and, therefore, a wide choice of methods appears to be necessary in order for each individual woman to find a method that suits the current needs.
Danish: En enkelt kontraceptiv metode kan ikke opfylde alle krav til enhver tid, og derfor ser det ud til at være nødvendigt med et bredt udvalg af metoder, for at hver enkelt kvinde kan finde en metode, der opfylder de aktuelle behov.
English: The renewal will be granted for 5 years with the following conditions:
Danish: Markedsføringstilladelsen fornyes for 5 år under følgende betingelser:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF IMPLANON
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF IMPLANON
English: This is because Mirena represents a continuous and long-term systemic progestogen exposure in young women.
Danish: Det skyldes, at Mirena repræsenterer en kontinuerlig systemisk eksponering for gestagener over lang tid hos unge kvinder.
English: GROUNDS FOR OPINION
Danish: BEGRUNDELSER FOR UDTALELSEN
English: - the obvious benefits are the long duration of use and the lack of compliance problems
Danish: - De klare fordele er den lange anvendelsesperiode og ingen problemer med compliance
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE MED NAVNE, LÆGEMIDDELFORM, LÆGEMIDLETS STYRKE, ADMINISTRATIONSVEJ OG MARKEDSFØRINGSINDEHAVERE I MEDLEMSLANDENE
English: The ENG dose released by Implanon is equivalent to 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the 3rd year.
Danish: Den dosis etonogestrel, der frigives af Implanon, svarer til 60-70 μg/dag kort efter indsættelsen, og denne dosis falder til ca. 40 μg/dag i starten af det andet år og til ca. 25-30 μg/dag ved slutningen af det tredje år.
English: Almost all women experience a decrease in the total amount of blood loss, even those with an increase in the number of bleeding days.
Danish: Næsten alle kvinder oplever en formindskelse af det samlede blodtab, selv de kvinder, der har et øget antal blødningsdage.
English: Thus, many women actually experience a benefit with the bleeding pattern although the lack of predictability may remain a problem for some.
Danish: Mange kvinder har således en fordel ved blødningsmønstret, selvom den manglede forudsigelighed kan være et problem for nogle.
English: All experience shows that careful information and counselling before method start as well as support counselling and bleeding diary during use are important for long-term acceptability and compliance.
Danish: Alle erfaringer viser, at grundig orientering og rådgivning før opstart af metoden samt støtterådgivning og blødningsdagbog er vigtigt for acceptabilitet og compliance over lang tid.
English: The first European renewal of Implanon was successfully completed in 2003.
Danish: Den første fornyelse af markedsføringstilladelsen for Implanon i EU blev gennemført tilfredsstillende i 2003.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder skal med referencemedlemsstaten som koordinator sikre, at følgende betingelser bliver opfyldt af indehaveren af markedsføringstilladelsen:
English: The final results of the Mirena study were deemed to be of relevance and should contribute to the evaluation of the safety for Implanon.
Danish: De endelige resultater af Mirena-undersøgelsen blev anset som relevante og skal bidrage til evalueringen af sikkerheden ved Implanon.
English: It is crucial - and should be self evident - that anyone, who performs insertions/removals must be well trained and familiar with those procedures, as incorrect insertions will lead to removal problems.
Danish: Det er afgørende og bør være indlysende, at enhver, der foretager indsættelse/fjernelse, skal være grundigt oplært i og fortrolig med disse procedurer, da forkerte indsættelser vil medføre problemer ved fjernelse.
English: Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, France
Danish: Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, Frankrig
English: Although Mirena releases levonorgestrel in a very low dose, the data would seem to be relevant also for implants.
Danish: Selvom Mirena frigiver en meget lille dosis levonorgestrel, synes dataene også at være relevante for implantater.
English: 5340 BH, Oss The Netherlands
Danish: 5340 BH, Oss Holland
English: - bleeding pattern disturbances should not be considered as a serious health issue,
Danish: - Forstyrrelser i blødningsmønsteret skal ikke betragtes som et alvorligt helbredsproblem
English: A second European renewal was initiated in September 2007, in which a majority of EU member states agreed that the benefit/risk profile continues to be positive and supported the recommendation of the RMS to grant another 5-year renewal.
Danish: I september 2007 blev der indledt endnu en fornyelse af markedsføringstilladelsen, hvor de fleste EU-medlemsstater var enige om, at risk/benefit-forholdet stadig var positivt, og støttede referencemedlemsstatens anbefaling om at forny markedsføringstilladelsen for 5 år mere.
English: The additional data on this issue that will come from the active monitoring programme in the USA is welcome, in particular the data on efficacy in obese women.
Danish: De yderligere data om dette spørgsmål, som vil komme fra det aktive monitoreringsprogram i USA, er velkomne, især data om virkningen hos stærkt overvægtige kvinder.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Danish: CHMP vurderede sagen og de tilgængelige data, inklusive spørgsmålene stillet af de berørte medlemsstater, der havde rejst indsigelser.
English: A RMP proposal for Implanon NXT will be part of this variation.
Danish: Et forslag til en risikostyringsplan for Implanon NXT skal være en del af denne ændring.
English: The study includes correction for the age of the study population, enabling comparisons to the Implanon user population and therefore, the final results of this study will be of relevance also for Implanon.
Danish: Undersøgelsen omfatter korrektion for undersøgelsespopulationens alder, hvilket gør det muligt at sammenligne med Implanons brugerpopulation, og de endelige resultater af denne undersøgelse vil således også være relevante for Implanon.
English: Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spain
Danish: Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spanien
English: The implant is a single rod of 4 cm length and 2 mm in diameter and contains 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) co-polymer.
Danish: Implantatet er en enkelt stav, der er 4 cm lang og 2 mm i diameter, og som indeholder 68 mg etonogestrel (ENG), der er dispergeret i en matrix af ethylenvinylacetat-copolymer.
English: Similarly, the removal of Implanon due to irregular bleeding should not be regarded as a serious consequence since the “surgical intervention” to remove Implanon must be considered minimal, requiring a 0,5-1cm superficial skin incision, after which the implant can be easily extracted.
Danish: Ligeledes skal fjernelse af Implanon på grund af uregelmæssig blødning ikke betragtes som en alvorlig konsekvens, da det “kirurgiske indgreb” til fjernelse af Implanon kan anses for at være minimalt, idet det kun kræver en overfladisk incision i huden på 0,5-1 cm, hvorefter implantatet let kan udtages.
English: • The MAH will develop further information and counselling materials for the Health Care Professionals and the women about the bleeding patterns that may be experienced during use of Implanon, which can be presented to the woman when she is considering use of Implanon for contraception.
Danish: • Indehaveren af markedsføringstilladelsen skal udarbejde yderligere oplysnings- og rådgivningsmaterialer til sundhedspersonale og kvinder om blødningsmønstre, der kan forekomme ved anvendelse af Implanon, og disse kan forelægges kvinden, når hun overvejer at anvende Implanon som kontraception.
English: Implanon was approved in the EU during a MR procedure with the Netherlands (NL) as reference member state (RMS) and has been marketed since 1998 with the indication “contraception”.
Danish: Implanon blev godkendt i EU gennem proceduren for gensidig anerkendelse med Nederlandene som referencemedlemsstat og har været markedsført siden 1998 med indikationen “svangerskabsforebyggelse”.
English: The CHMP considers that bleeding pattern disturbance should not be considered as a serious health issue, as it disappears immediately upon discontinuation and is not associated with any known health risk to the woman.
Danish: CHMP vurderer, at forstyrrelserne i blødningsmønster ikke skal anses for at være et alvorligt helbredsproblem, da de forsvinder umiddelbart efter seponering og ikke er forbundet med nogen kendt sundhedsrisiko for kvinder.
English: The CHMP, having considered the data submitted in the application is of the opinion that further risk minimisation activities are necessary for the safe and effective use of the medicinal product.
Danish: Efter at have gennemgået de i ansøgningen indsendte data er CHMP af den opfattelse, at det er nødvendigt med yderligere risikominimeringsaktiviteter med henblik på en sikker og effektiv anvendelse af lægemidlet.
English: The CHMP agreed on the following proposal for conditions of the renewal of the Marketing Authorisation previously presented by the RMS:
Danish: CHMP vedtog følgende forslag til betingelser for fornyelse af den markedsføringstilladelse, der tidligere blev fremlagt af referencemedlemsstaten:
English: The CHMP is of the opinion that a new epidemiological study of breast cancer in Implanon users is not justified at the present time.
Danish: CHMP er af den opfattelse, at en ny epidemiologisk undersøgelse af brystkræft hos brugere af Implanon ikke er berettiget på nuværende tidspunkt.
English: However, although the bleeding pattern often is unpredictable, many women report reduction in episode frequency and total number of bleeding days compared to their normal menstrual pattern.
Danish: Selvom blødningsmønstret ofte er uforudsigeligt, beretter mange kvinder dog om færre blødninger og et lavere samlet antal blødningsdage sammenlignet med deres normale menstruationsmønster.
English: • The body weight at the time of removal will be asked for in case of early removal (including pregnancy) in the AMP.
Danish: • Der spørges om kropsvægten på fjernelsestidspunktet ved tidlig fjernelse (inklusive graviditet) i det aktive monitoreringsprogram.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gældende produktresumé, etikettering og indlægsseddel er den endelige version udarbejdet efter proceduren for Koordineringsgruppen.
English: Of some relevance is the interim analysis data from the ongoing case-control study of the progestogen releasing contraceptive IUD (Mirena) (ICPE meeting report, 2008).
Danish: Data fra interimanalysen fra den igangværende case-kontrol-undersøgelse af gestagenfrigivende intrauterine kontraceptiva (Mirena) er af nogen relevans (rapport fra ICPE-møde, 2008).
English: • The MAH will continue with the 6-monthly reports of all unintended pregnancy and insertion/removal related problems (IRRE) during the next 5 year renewal period.
Danish: • Indehaveren af markedsføringstilladelsen skal fortsætte med halvårlige indberetninger af alle utilsigtede graviditeter og problemer forbundet med indsættelse/fjernelse i løbet af den næste 5-årige fornyelsesperiode.
English: The CHMP was of the view that written informed consent in the EU is associated with products where there are established serious risks and that the introduction of a request for informed consent for Implanon, one of several widely used methods of contraception, is unjustified and would strongly signal a risk that is certainly not present.
Danish: CHMP var af den opfattelse, at skriftligt informeret samtykke i EU er forbundet med produkter, hvor der er påvist alvorlige risici, samt at indførelsen af et krav om informeret samtykke for Implanon, der er én af mange bredt anvendte kontraceptive metoder, er ubegrundet og ville være et stærkt signal om en risiko, som bestemt ikke er til stede.
English: The contraceptive action of Implanon is primarily achieved by inhibition of ovulation.
Danish: Den kontraceptive virkning af Implanon opnås primært ved ovulationshæmning.
English: In addition, the following issues should be included in the RMP proposal:
Danish: Derudover skal følgende punkter medtages i forslaget til risikostyringsplanen:
English: However, a number of concerns were raised by the objecting CMS which did not consider the second renewal acceptable.
Danish: De berørte medlemsstater, der rejste indsigelser, havde imidlertid en række betænkeligheder og fandt ikke den anden fornyelse acceptabel.
English: The proposal by the MAH to further update bleeding data information in section 4.8 with new US data and to improve the information material on bleeding pattern was endorsed.
Danish: Der var tilslutning til forslaget fra indehaveren af markedsføringstilladelsen om yderligere opdatering af oplysninger om blødningsdata i punkt 4.8 med de nye data fra USA samt om at forbedre informationsmaterialet om blødningsmønstre.
English: Implanon 68 mg implant 68mg Implant
Danish: Implanon 68 mg implant 68 mg Implantat
English: Furthermore, the reports on Implanon removals in breast cancer patients from the US AMP program are likely to yield valuable information from case series that are expected to be relatively complete.
Danish: Dertil kommer, at indberetninger om fjernelse af Implanon hos brystkræftpatienter fra det aktive monitoreringsprogram i USA sandsynligvis giver værdifulde oplysninger fra case-serier, der forventes at være stort set fuldførte.
English: - no signals of an increased risk of breast cancer have been identified,
Danish: - Der er ikke konstateret tegn på en forøget risiko for brystkræft
English: The CHMP considered that bleeding irregularities are expected with all progestogen-only methods, in particular those that inhibit ovulation.
Danish: CHMP vurderer, at blødningsuregelmæssigheder forventes med alle metoder med kun gestagen, især de typer, som hæmmer ovulation.
English: It is acknowledged that the available studies have limitations, e.g. the lack of data on the associations with POPs, limited power to examine risk relationships in subgroups, and further no meaningful data to examine the effects of implants.
Danish: Det er anerkendt, at de tilgængelige undersøgelser har begrænsninger, f.eks. manglende data om forbindelsen med gestagen-minipiller, begrænset evne til at undersøge risikosammenhængen i undergrupper og desuden ingen betydningsfulde data til undersøgelse af virkningen af implantater.
English: The RMP will be submitted to the RMS within 3 months and will include the activities mentioned in the conditions of the renewal of the Marketing Authorisation.
Danish: Risikostyringsplanen skal indsendes til referencemedlemsstaten inden 3 måneder og skal omfatte de aktiviteter, der er nævnt i betingelserne for fornyelse af markedsføringstilladelsen.
English: In summary, the CHMP agreed that there is at this time no firm evidence of an association between Implanon exposure and an increased risk of breast cancer in young women.
Danish: Alt i alt er CHMP enig i, at der på nuværende tidspunkt ikke er nogen klar evidens for en forbindelse mellem eksponering for Implanon og en forøget risiko for brystkræft hos unge kvinder.
English: Implanon is a non-biodegradable, long-acting, progestagen-only contraceptive implant inserted subdermally.
Danish: Implanon er et ikke-biologisk nedbrydeligt, langtidsvirkende kontraceptivt implantat, der kun indeholder gestagen, og som indsættes subdermalt.
English: The CHMP acknowledged the issue of underreporting but did not consider that any signals indicating an increased risk of breast cancer have been identified.
Danish: CHMP erkendte, at der var et problem med underindberetning, men fandt ikke, at der var identificeret nogle tegn, som tydede på en forøget risiko for brystkræft.
English: Furthermore, the degree of underreporting is assumed to be lower for Implanon compared to spontaneous ADR reporting in general, therefore the CHMP does not consider that spontaneous reports on breast cancer in users of Implanon give rise to a new signal of an adverse effect.
Danish: Graden af underindberetning antages endvidere at være lavere for Implanon end for spontan indberetning af bivirkninger generelt, og CHMP vurderer derfor ikke, at spontane indberetninger om brystkræft hos brugere af Implanon giver anledning til nye tegn på en bivirkning.
English: • The MAH will submit a type II variation in 2009 to introduce the new Implanon (Implanon NXT).
Danish: • Indehaveren af markedsføringstilladelsen skal indsende en type II-ændring i 2009 for at indføre den nye Implanon (Implanon NXT).