FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Zoely, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zoely, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Danish: Hovedeffektmålet var det antal kvinder mellem 18 og 35 år, som blev gravide under eller kort tid efter behandlingen, udtrykt i graviditetshyppighed ved hjælp af "Pearl Index".
English: The most frequent side effects with Zoely (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Danish: De hyppigste bivirkninger ved Zoely (som optræder hos flere end 1 ud af 10 patienter) er acne og ændringer i menstruationsperioderne (f.eks. fravær eller uregelmæssighed).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoely, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zoely, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Zoely works by changing the body's hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Danish: Zoely virker ved at ændre kroppens hormonbalance og forhindre ægløsning ved at ændre den cervikale sekretion og gøre endometrium (livmodervæggen) tyndere.
English: What is Zoely?
Danish: Hvad er Zoely?
English: It should not be used in women who have pancreatitis (inflammation of the pancreas), severe liver problems, liver tumours or a history of liver tumours, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Danish: Det må ikke anvendes til kvinder, som har bugspytkirtelbetændelse (pankreatitis), svære leverproblemer, tumorer (eller tidligere har haft tumorer), visse kræfttyper eller unormal blødning fra skeden, hvis årsag ikke er diagnosticeret.
English: Zoely comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Danish: Zoely leveres i blisterpakker med 28 tabletter (24 hvide tabletter efterfulgt af 4 gule tabletter), der tages i rækkefølge, og hvor der anvendes klistermærker til at markere ugedagene for hver tablet.
English: What is the risk associated with Zoely?
Danish: Hvilken risiko er der forbundet med Zoely?
English: Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle.
Danish: Estradiol er det samme som det hormon, der dannes naturligt af æggestokkene under en menstruationscyklus.
English: The CHMP decided that the benefits of Zoely are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Zoely opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Zoely.
English: The participants were given either Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Danish: Deltagerne fik enten Zoely eller en anden p-pille, der indeholder drospirenon og ethinylestradiol, i et år (13 menstruationscyklusser).
English: Zoely is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not contain any active substance.
Danish: Zoely er et lægemiddel, der fås som 24 hvide "aktive" tabletter, der indeholder de aktive stoffer nomegestrolacetat (2,5 mg) og estradiol (1,5 mg), og fire gule "inaktive" tabletter (placebo), som ikke indeholder noget aktivt stof.
English: Why has Zoely been approved?
Danish: Hvorfor blev Zoely godkendt?
English: Zoely is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Danish: Zoely er en kombineret p-pille, som indeholder to aktive stoffer, nomegestrolacetat (et progestogen) og estradiol (et østrogen).
English: For the full list of all side effects reported with Zoely, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zoely fremgår af indlægssedlen.
English: Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle.
Danish: Nomegestrolacetat er afledt af et hormon, der kaldes progesteron, og som også dannes af æggestokkene under en menstruationscyklus.
English: How has Zoely been studied?
Danish: Hvordan blev Zoely undersøgt?
English: What benefit has Zoely shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zoely?
English: What is Zoely used for?
Danish: Hvad anvendes Zoely til?
English: How is Zoely used?
Danish: Hvordan anvendes Zoely?
English: How does Zoely work?
Danish: Hvordan virker Zoely?
English: No guideline was given.
Danish: Der blev ikke angivet nogen retningslinjer.
English: Topical - on the back of the animal
Danish: Topisk - på ryggen af dyret
English: It may be considered appropriate that such additional measures are applied in the future in the light of any new information.
Danish: Det vil muligvis i fremtiden blive anset for hensigtsmæssigt at indføre sådanne supplerende foranstaltninger på baggrund af eventuelle nye oplysninger.
English: • The duration of the study should be three consecutive years in order to consider seasonal and annual variations.
Danish: • Undersøgelsens varighed skal være tre på hinanden følgende år for at tage hensyn til sæsonbetonede og årlige variationer.
English: NOEC: the concentration in the study at which no effects are observed.
Danish: NOEC: Den koncentration i undersøgelsen, hvor der ikke iagttages nogen virkninger.
English: 6100 (horse, oral)
Danish: 6100 (heste, oral)
English: Not determined
Danish: Ikke bestemt
English: Direct therapeutic benefits
Danish: Direkte terapeutiske fordele
English: The field study should fulfil the following criteria:
Danish: Feltundersøgelsen skal opfylde følgende kriterier:
English: • Evidence of a trend i.e. increasing/decreasing concentrations or plateau.
Danish: • Tegn på en tendens, dvs. stigende/aftagende koncentrationer eller et plateau.
English: The following conditions should be fulfilled by all marketing authorisation holders: Conditions
Danish: Følgende betingelser skal opfyldes af alle indehavere af markedsføringstilladelse: Betingelser
English: Nevertheless, the results of this study supported the conclusion on persistence from the first study.
Danish: Resultaterne af denne undersøgelse støttede dog den første undersøgelses konklusion om persistens.
English: Do not contaminate watercourses with the product.
Danish: Undgå forurening af vandløb med produktet.
English: P. promelas (early life stages)
Danish: P. promelas (tidlige udviklingsstadier)
English: Stable Scenarios
Danish: Stabile scenarier
English: If the study is conducted in one geographical region, the marketing authorisation holders should justify that this is truly the worst case.
Danish: Hvis undersøgelsen udføres i en enkelt geografisk region, skal indehaverne af markedsføringstilladelse begrunde, at dette faktisk er værste tilfælde.
English: Daphnia magna (reproduction)
Danish: Daphnia magna (reproduktion)
English: To mitigate this risk, all precautions for use and disposal must be adhered to.
Danish: For at afbøde denne risiko skal alle forholdsregler for anvendelse og bortskaffelse overholdes.
English: The aforementioned internal and external parasites are recognised as causing significant loss of production and negatively impacting on animal welfare.
Danish: Ovennævnte interne og eksterne parasitter er anerkendt som årsag til betydelige produktionstab og forringet dyrevelfærd.
English: Detailed information on the field study design (protocol), including proposals for timelines for the provision of interim reports, should be submitted to the CVMP.
Danish: Detaljeret information om feltundersøgelsens design (protokol), herunder forslag til tidsplan for forelæggelse af foreløbige rapporter, skal forelægges for CVMP.
English: Environmental profile of alternatives
Danish: Miljøprofil af alternativer
English: The duration of the uptake (exposure) and depuration phases were 28 and 49 days, respectively.
Danish: Varigheden afoptagelses- (eksponerings-) og udskillelsesfasen var henholdsvis 28 og 49 dage.
English: Add, to all products:
Danish: For alle produkter tilføjes:
English: • The study should be performed in one or more European geographical regions, representing worst case climatic and epidemiological conditions and adjacent to small water bodies.
Danish: • Undersøgelsen udføres i en eller flere europæiske geografiske regioner, der repræsenterer værste tilfælde klimatiske og epidemiologiske forhold og støder op til små vandområder.
English: The Committee was also asked to recommend whether the marketing authorisations for the aforementioned veterinary medicinal products should be maintained, varied, suspended or withdrawn.
Danish: Udvalget blev desuden anmodet om at fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne for ovenstående veterinærlægemidler bør opretholdes, ændres, suspenderes eller inddrages.
English: Mineralisation (evolution of 14CO2) accounted for up to 5% of the applied radioactivity.
Danish: Mineralisering (udvikling af 14CO2) svarede til op til 5 % af den tilførte radioaktivitet.
English: Both studies were performed with Chironomus riparius exposed via spiked sediment.
Danish: Begge undersøgelser er udført med Chironomus riparius, der blev eksponeret via forurenet sediment.
English: However, the data provided for Tier B and C assessment do not comply with current standards.
Danish: De forelagte data for niveau B- og C-vurdering opfylder derimod ikke nugældende normer.
English: However, it has to be noted that the use of QSAR values as a substitute for experimental data for pharmaceuticals is not supported as no validated models are available for pharmaceuticals.
Danish: Det skal dog bemærkes, at brugen af QSAR-værdier som erstatning for eksperimentelle data for lægemidler ikke er underbygget, da der ikke findes validerede modeller for lægemidler.
English: Environmental risks have been identified for this product and special precautions apply.
Danish: Der er identificeret miljørisici for dette produkt, og der gælder særlige forholdsregler.
English: In case of insufficient space on the label:
Danish: Ved pladsmangel på etiketten:
English: The conditions imposed on the marketing authorisations are described in Annex IV.
Danish: Betingelserne for markedsføringstilladelserne fremgår af bilag IV.
English: The final study report should be submitted to the CVMP for assessment.
Danish: Den endelige undersøgelsesrapport skal forelægges for CHMP til vurdering.
English: The EC50 and the NOEC were established as >86.9 µg/l and 86.9 µg/l.
Danish: EC50 og NOEC blev bestemt til >86,9 µg/l og 86,9 µg/l.
English: Additional benefits
Danish: Yderligere fordele
English: Concentration
Danish: Koncentration
English: 53 (cattle, pour-on)
Danish: 53 (kvæg, pour-on)
English: The CVMP considered that assessment of secondary poisoning can only be used as supportiveinformation but is not part of the PBT assessment.
Danish: CVMP fandt, at vurdering af sekundær forgiftning kun kan anvendes som støttende oplysninger, men ikke er en del af PBT-vurderingen.
English: However, toxicity to sediment-dwelling organisms is still very likely.
Danish: Imidlertid er toksicitet over for vandlevende organismer alligevel meget sandsynlig.
English: The abovementioned data should be provided to the CVMP for assessment not later than 5 years after the Commission Decision on this referral procedure.
Danish: Ovenstående data skal forelægges for CVMP til vurdering senest 5 år efter Kommissionens beslutning om denne indbringelsesprocedure.
English: A terrestrial plant study with 12 weed species was also provided which was considered not relevant for the current assessment.
Danish: Der blev desuden forelagt en undersøgelse af terrestriske planter med 12 ukrudtsarter; denne blev dog ikke anset for relevant for den aktuelle vurdering.
English: The subsequent evaluation of data generated further to the fulfilment of these conditions should be undertaken by the CVMP due to the complexity of the data thus generated and in the interest of maintaining the harmonised EU approach achieved by this referral procedure.
Danish: Den efterfølgende evaluering af data, der genereres i tilslutning til opfyldelsen af disse betingelser, bør foretages af CVMP på grund af kompleksiteten afde således genererede data og med henblik på at opretholde den harmoniserede EU-tilgang, der opnås gennem denne henvisningsprocedure.
English: PBT substances pose a hazard where the fate and behaviour in the environment and its toxicity in the long-term cannot be predicted.
Danish: PBT-stoffer udgør en fare, når deres skæbne og opførsel i miljøet og deres langsigtede toksicitet ikke kan forudsiges.
English: Labelling:
Danish: Etikettering:
English: As exposure of aquatic organism is unlikely to occur, the toxicity will be reduced significantly.
Danish: Da eksponering af akvatiske organismer er usandsynlig, vil toksiciteten være reduceret væsentligt.
English: The CVMP considered that such warning is not in line with good agricultural practice and therefore should be deleted from the product information.
Danish: CVMP fandt, at en sådan anvisning ikke er i overensstemmelse med god landbrugspraksis og derfor bør slettes fra produktinformationen.
English: Dung flies were shown to be the most sensitive species as demonstrated in laboratory tests and in field studies.
Danish: Gødningsfluer blev påvist at være den mest følsomme art som påvist i laboratorietests og i feltundersøgelser.
English: So far, no criteria for bioaccumulation assessment in sediment or soil organisms have been established and the classification is based on the standard bioaccumulation study in fish.
Danish: Der er hidtil ikke fastlagt kriterier for vurderingen af bioakkumulering i sediment- eller jordlevende organismer, og klassificeringen er baseret på standardundersøgelsen af bioakkumulering i fisk.
English: This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
Danish: Dette indebærer, at når moxidectin får mulighed for at tilføres til vandområder, kan det have alvorlig og varig indvirkning på det akvatiske liv.
English: Germany CC-Pharma GmbH In den Feldern 2
Danish: Tyskland CC-Pharma GmbH In den Feldern 2
English: Low High
Danish: Lav Høj
English: It can be concluded that there is a negligible risk for secondary poisoning from moxidectin.
Danish: Det kan konkluderes, at der er ubetydelig risiko for sekundær forgiftning med moxidectin.
English: The third acute study following the same procedures was conducted in bluegill (Lepomis macrochirus).
Danish: Den tredje akutte undersøgelse efter samme metode blev udført i blågællede molaer (Lepomis macrochirus).
English: Ireland Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
Danish: Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
English: Daphnia magna (acute)
Danish: Daphnia magna (akut)
English: A risk to the environment has been identified which can be partially mitigated by appropriate risk mitigation measures.
Danish: Der er identificeret en miljørisiko, som delvis kan afbødes gennem passende risikoreducerende foranstaltninger.
English: Material balance, calculated as the percent of applied radioactivity, was maintained within guideline specification (90-110% of applied radioactivity) for all four soils.
Danish: Stofbalancen, beregnet som procentdel af den tilførte radioaktivitet, blev holdt inden for specifikationen i retningslinjerne (90-110 % af den tilførte radioaktivitet) for alle fire jordarter.
English: EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.
Danish: EC50: Den koncentration, der medfører, at 50 % af individerne af den testede art påvirkes negativt, dvs. både dødelighed og subletale virkninger.
English: It was concluded that moxidectin degrades in soil with a dissipation half-life (DT50) of approximately 2 months and slowly mineralises.
Danish: Det blev konkluderet, at moxidectin nedbrydes i jord med en nedbrydningshalveringstid (DT50) på ca. 2 måneder og langsomt mineraliseres.
English: Altogether, the marketing authorisation holders concluded that the likelihood of moxidectin to bioaccumulate in fish is rather low.
Danish: Overordnet konkluderede indehaverne af markedsføringstilladelsen, at sandsynligheden for bioakkumulering af moxidectin i fisk er ret lav.
English: Non-extractable residues accounted for 4-10% of the radioactivity applied to the soil.
Danish: Ikke-ekstraherbare rester svarede til 4-10 % af den radioaktivitet, der var tilført jorden.
English: The bioconcentration factors were also determined as a function of lipid content of the fish following normalisation for a lipid content of 5%.
Danish: Biokoncentrationsfaktorerne blev desuden bestemt som funktion af fiskens lipidindhold normaliseret til et lipidindhold på 5 %.
English: Within 60 months of Commission Decision for this procedure
Danish: Senest 60 måneder efter Kommissionens beslutning vedrørende denne procedure
English: Germany Continental Farmaceutica s.p.r.
Danish: Tyskland Continental Farmaceutica s.p.r.
English: In conclusion, withdrawal of veterinary medicinal products containing moxidectin from the European market would limit the number of adequate therapeutic alternatives which is not considered desirable from a resistance perspective.
Danish: Som konklusion vil tilbagetrækning af veterinærlægemidler indeholdende moxidectin fra det europæiske marked begrænse antallet af egnede behandlingsalternativer, hvilket ikke anses for ønskeligt ud fra et resistensperspektiv.
English: 0.025 (cattle, pour-on)
Danish: 0,025 (kvæg, pour-on)
English: However, it has to be noted that other factors such as low moisture content also lead to reduced degradation.
Danish: Det skal dog bemærkes, at andre faktorer såsom lavt fugtindhold fører til reduceret nedbrydning.
English: For the assessment of persistence, two Good Laboratory Practice (GLP ) compliant laboratory studies were provided.
Danish: Til vurdering af persistens er der forelagt to Good Laboratory Practice (GLP-) laboratorieundersøgelser.
English: No appropriate risk mitigation measures can be established for dung fauna, hence, warning sentences should be included in the product information.
Danish: Der kan ikke fastsættes egnede risikobegrænsende foranstaltninger for gødningsfauna, hvorfor der skal indsættes advarselssætninger i produktinformationen.
English: A comprehensive risk assessment for moxidectin and dung fauna has been provided.
Danish: Der er forelagt en omfattende risikovurdering for moxidectin og gødningsfauna.
English: Within 12 months of Commission Decision for this procedure
Danish: Senest 12 måneder efter Kommissionens beslutning vedrørende denne procedure
English: Residues in dung were toxic to dung flies for more than 7 days or for more than 28 days after treatment, depending on study duration, species and formulation.
Danish: Restkoncentrationer i gødning var toksiske for gødningsfluer i over 7 dage eller længere end 28 dage efter behandling, alt efter undersøgelsens varighed, dyrearten og formuleringen.
English: As the mean recovery of moxidectin at the end of the study (63 days) was less than 50%, a value of 63 days is used as half-life value of moxidectin.
Danish: Da den gennemsnitlige genfinding af moxidectin ved undersøgelsens slutning (63 dage) var under 50 %, anvendes 63 dage som halveringstid for moxidectin.
English: Other precautions regarding impact on the environment
Danish: Andre forholdsregler vedrørende miljøvirkning
English: The second study was performed in accordance with the US FDA Environmental Assessment Technical Assistance Document no. 4.087 which is comparable to the current OECD methods.
Danish: Den anden undersøgelse er udført i overensstemmelse med US FDA Environmental Assessment Technical Assistance Document nr. 4.087, som er sammenligneligt med de nuværende OECD-metoder.
English: Germany was of the opinion that a potential serious risk to the environment may arise from the use of veterinary medicinal products containing moxidectin and consequently, action should be taken at EU level since veterinary medicinal products containing moxidectin are authorised in the majority of the EU/EEA Member States.
Danish: Tyskland var af den opfattelse, at der kunne opstå en potentiel alvorlig risiko for miljøet ved brug af veterinærlægemidler indeholdende moxidectin, og at der derfor burde gribes ind på EU-plan, da veterinærlægemidler indeholdende moxidectin er godkendt i de fleste EU-/EØS-medlemsstater.
English: That is, the marketing authorisation holders argued that mean land surface temperatures during spring/summer in predominant agricultural regions in Europe are likely to be higher leading to a faster degradation.
Danish: Indehaverne af markedsføringstilladelsen hævdede således, at de gennemsnitlige temperaturer på jordoverfladen om foråret/sommeren i de mest fremtrædende i landbrugsområder i Europa forventes at blive højere, hvilket vil føre til hurtigere nedbrydning.
English: 5.3 Environmental properties
Danish: 5.3 Miljøegenskaber
English: Horse and Pony
Danish: Heste og ponyer
English: However, when considering PBT status, the established criteria are based on evaluation of persistence at a soil temperature of 12 °C and this is accepted as mean European temperature.
Danish: Ved vurderingen af PBT-status er de etablerede kriterier imidlertid baseret på vurdering af persistensen ved en jordtemperatur på 12 °C, der er accepteret som den europæiske gennemsnitstemperatur.
English: The LC50 for mortality was established as 37.2 mg/kg; the corresponding NOEC was 20 mg/kg.
Danish: LC50 for dødelighed blev bestemt til 37,2 mg/kg; den tilsvarende NOEC-værdi var 20 mg/kg.
English: • Concentrations of moxidectin in the different target matrices.
Danish: • Koncentrationerne af moxidectin i de forskellige medier.
English: On the other hand, there is evidence from literature (Prichard et al., 2012)18 that the resistance against avermectins and moxidectin is not always genetically identical, which implies that avermectin resistant parasite strains can be successfully treated with moxidectin.
Danish: På den anden side er der i litteraturen (Prichard et al., 2012)18 evidens for, at resistensen mod avermectiner ikke altid er genetisk identisk med resistens mod moxidectin, hvilket antyder, at avermectinresistente stammer af parasitter kan behandles tilfredsstillende med moxidectin.
English: The respective risk quotient for moxidectin is 0.01 which is below the trigger value of 1.
Danish: Den pågældende risikokvotient for moxidectin er 0,01, altså under den udløsende værdi på 1.
English: In the second study no effects on D. magna survival and reproduction were seen at a concentration of 10 ng/l over the test period.
Danish: I den anden undersøgelse sås ingen effekt på overlevelse og reproduktion af D. magna ved en koncentration på 10 ng/l gennem forsøgsperioden.
English: Consequently, risk mitigation measures tempering a quantitative risk are considered suitable neither to eliminate the hazard nor to prevent emission into the environment.
Danish: Risikobegrænsende foranstaltninger, der nedsætter en kvantitativ risiko, anses derfor hverken for egnede til at eliminere faren eller forhindre udledning til miljøet.