FrancophonIA/ELRC3.0 huggingface dataset:
English: It also makes a miscarriage more likely.
Danish: Det øger også risikoen for abort.
English: Rare effects (may affect up to 1 in every 1000 people)
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer):
English: As a minimum requirement, female patients of childbearing potential must use at least one highly effective method of contraception (i.e. a user-independent form), or two complementary user-dependent forms of contraception.
Danish: Som et minimumskrav skal fertile kvindelige patienter anvende mindst én meget effektiv præventionsmetode (dvs. en brugeruafhængig form) eller to komplementære brugerafhængige former for prævention.
English: Women should undergo pregnancy test periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Danish: Kvinder bør få foretaget regelmæssige graviditetstests med 1-3 måneders mellemrum i en periode på 3 år efter behandlingsophør.
English: for acitretin this last bullet point should be:
Danish: for acitretin skal sidste punkt være:
English: • Negative pregnancy test results have been obtained before, during and 1 month after the end of treatment.
Danish: - Der skal foreligge negative graviditetstestresultater før, under og 1 måned efter behandlingens afslutning.
English: You must not take <TRADENAME> if you could get pregnant during treatment.
Danish: Du må ikke tage <HANDELSNAVN> hvis du kan blive gravid under behandlingen.
English: o [for acitretin this last bullet point should be]
Danish: o [for acitretin skal sidste punkt være]
English: The following boxed warning should be included in the PL for the oral retinoids acitretin, alitretinoin and isotretinoin, under the invented name:
Danish: Følgende advarselsboks skal indgå i indlægssedlen for de orale retinoider acitretin, alitretinoin og isotretinoin under særnavnet:
English: [TRADENAME] is strictly contraindicated in: - Pregnant women - Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met Pregnancy Prevention Programme This medicinal product is TERATOGENIC [INN] is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Programme are met:
Danish: [HANDELSNAVN] er strengt kontraindiceret hos: - Gravide kvinder - Fertile kvinder, medmindre alle betingelser i svangerskabsforebyggelsesprogrammet opfyldes.
English: • She understands the need and accepts to undergo regular pregnancy testing before, ideally monthly during treatment and 1 month after stopping treatment.
Danish: - Hun forstår behovet og accepterer at gennemgå regelmæssige graviditetstests før, helst månedligt under behandlingen og 1 måned efter ophør af behandlingen.
English: You must not take <TRADENAME> if you are breastfeeding.
Danish: Du må ikke tage <HANDELSNAVN>, hvis du ammer.
English: The warning regarding teratogenic effects and information on the pregnancy prevention programme should be aligned with the following text; furthermore a boxed warning as presented below should be added:
Danish: Advarslen om teratogene virkninger og oplysninger om svangerskabsforebyggelsesprogrammet skal afstemmes med følgende tekst.
English: • She understands the need and accepts to undergo regular pregnancy testing before, ideally monthly during treatment and periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Danish: - Hun forstår behovet og accepterer at gennemgå regelmæssige graviditetstests før, helst månedligt under behandlingen og med jævne mellemrum med 1-3 månedlige intervaller i en periode på 3 år efter ophør af behandlingen.
English: At least one month after the patient has started using contraception, and shortly (preferably a few days) prior to the first prescription, the patient should undergo a medically supervised pregnancy test.
Danish: Patienten bør få foretaget en medicinsk overvåget graviditetstest mindst en måned efter, at patienten er begyndt at bruge prævention og kort tid (helst få dage) før den første recept.
English: The following adverse reaction(s) should be included:
Danish: Følgende bivirkninger bør inkluderes:
English: End of treatment
Danish: Før behandling påbegyndes
English: DO NOT use <TRADENAME> if you are pregnant or thinking of becoming pregnant.
Danish: Brug IKKE <HANDELSNAVN>, hvis du er gravid eller overvejer at blive gravid.
English: You must not take <TRADENAME> if you are pregnant or if you think you might be pregnant.
Danish: Du må ikke tage <HANDELSNAVN>, hvis du er gravid, eller tror du kan være gravid.
English: Full patient information about the teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme should be given by the physician to all patients, both male and female.
Danish: Alle patienter - både mænd og kvinder - skal modtage fuldstændige oplysninger af lægen om den teratogene risiko og de strenge foranstaltninger til forebyggelse af graviditet som beskrevet i svangerskabsforebyggelsesprogrammet.
English: Also, if you become pregnant within one month [3 years for acitretin] after you stop taking <TRADENAME>, you should contact your doctor.
Danish: Du skal også kontakte lægen, hvis du bliver gravid inden for en måned [3 år for acitretin], efter du holder op med at tage <HANDELSNAVN>.
English: <TRADENAME> is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.
Danish: 4.3) under graviditet eller hos kvinder, der planlægger graviditet.
English: Do not take <TRADENAME> • If you are pregnant or breast-feeding.
Danish: Brug ikke <HANDELSNAVN>: hvis du er gravid eller ammer.
English: Talk to your doctor before taking <TRADENAME>: - If you have ever had any kind of mental health problems.
Danish: Tal med din læge, før du tager <HANDELSNAVN>:
English: Talk to your doctor before taking <TRADENAME>: - If you have ever had any mental health problems including depression, aggressive tendencies or mood changes.
Danish: hvis du nogensinde har haft psykiske problemer, herunder depression, aggressive tendenser eller humørsvingninger.
English: You must not get pregnant for one month after stopping this treatment because some medicine may still be left in your body.
Danish: Du må ikke blive gravid i en måned efter at have stoppet denne behandling, fordi noget af lægemidlet måske stadigvæk er i din krop.
English: You must not get pregnant for 3 years after stopping this treatment because some medicine may still be left in your body.
Danish: Du må ikke blive gravid i 3 år efter at have stoppet denne behandling, fordi noget af lægemidlet måske stadigvæk er i din krop.
English: You must have talked about contraception (birth control) with your doctor.
Danish: - Du skal have talt med lægen om prævention.
English: • Negative pregnancy test results have been obtained before, during and periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Danish: o [for acitretin skal sidste punkt være] - Der skal forligge negative graviditetstestresultater før, under og periodisk med 1-3 månedlige intervaller i en periode på 3 år efter ophør af behandlingen.
English: You must not get pregnant during treatment or for 3 years afterwards because some medicine may still be left in your body.
Danish: - Du må ikke blive gravid under behandling eller i 3 år efter, fordi noget af lægemidlet måske stadigvæk er i din krop.
English: You must not get pregnant during treatment or for a month afterwards because some medicine may still be left in your body.
Danish: - Du må ikke blive gravid under behandlingen eller i en måned efter behandling, fordi noget af lægemidlet måske stadigvæk er i din krop.
English: For all oral retinoids containing acitretin, tretinoin and bexarotene, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Danish: Alle orale retinoider, der indeholder acitretin, tretinoin og bexaroten, skal have ændret ordlyden i den eksisterende produktinformation (indsætning, ændring eller sletning af tekst) for at afspejle den aftalte ordlyd som angivet nedenfor.
English: Pregnancy
Danish: Produktresumé
English: For all topical retinoids containing adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Danish: Alle topikale retinoider, der indeholder adapalen, alitretinoin, isotretinoin, tretinoin og tazaroten, skal have ændret ordlyden i den eksisterende produktinformation (indsætning, ændring og sletning af tekst) for at afspejle den aftalte ordlyd som angivet nedenfor.
English: For all oral retinoids products containing alitretinoin and isotretinoin, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Danish: Alle orale retinoidprodukter, der indeholder alitretinoin og isotretinoin, skal have ændret ordlyden i den eksisterende produktinformation (indsætning, ændring og sletning af tekst) for at afspejle den aftalte ordlyd som angivet nedenfor.
English: For all oral retinoids containing acitretin, alitretinoin and isotretinoin, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below
Danish: Alle orale retinoider, der indeholder acitretin, alitretinoin og isotretinoin, skal have ændret ordlyden i den eksisterende produktinformation (indsætning, ændring eller sletning af tekst) for at afspejle den aftalte ordlyd som angivet nedenfor.
English: Prior to starting therapy
Danish: Dette lægemiddel er TERATOGENT.
English: The following sentence should be included at the end of the package leaflet (last sentence):
Danish: Følgende bivirkninger skal inddrages under systemorganklassen ”psykiske forstyrrelser”:
English: Levemir can be given at any time of day, provided that it is the same time each day.
Danish: Levemir kan gives på ethvert tidspunkt af dagen, når blot det er det samme tidspunkt hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levemir on 1 June 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levemir den 1. juni 2004.
English: The full EPAR for Levemir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levemir findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European public assessment report (EPAR) for Levemir.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levemir.
English: A risk management plan has been developed to ensure that Levemir is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Levemir anvendes så sikkert som muligt.
English: The change means that it is absorbed more slowly by the body, and takes longer to reach its target in the body.
Danish: Denne forskel bevirker, at det optages langsommere i kroppen og er længere om at nå sit mål i kroppen.
English: • alone as basal insulin
Danish: • alene som basal insulin
English: Levemir is used to treat diabetes in adults, adolescents and children from the age of one year.
Danish: Levemir anvendes til behandling af diabetes hos voksne, unge og børn fra et år.
English: Levemir has not been studied in children below one year of age.
Danish: Levemir er ikke undersøgt hos børn under 1 år.
English: What measures are being taken to ensure the safe and effective use of Levemir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Levemir?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levemir.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Levemir.
English: For more information about treatment with Levemir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levemir, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Additionally the weight benefit from liraglutide was sustained when adding Levemir.
Danish: Endvidere blev vægtfordelen ved liraglutid bibeholdt, når der blev tilføjet Levemir.
English: Other information about Levemir:
Danish: Andre oplysninger om Levemir
English: In four of the six studies in type 2 diabetes, patients also received one or two antidiabetes medicines taken by mouth.
Danish: I fire af de seks undersøgelser af type 2-diabetes fik patienterne desuden et eller to lægemidler mod diabetes, som blev indtaget gennem munden.
English: What is the risk associated with Levemir?
Danish: Hvilken risiko er der forbundet med Levemir?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levemir, 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 Levemir , herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Levemir is given as an injection under the skin in the abdominal (tummy) wall, the thigh, the upper arm, the shoulder or the buttock.
Danish: Levemir gives som injektion under huden i bugvæggen (maven), låret, overarmen, skulderen eller i ballerne.
English: The CHMP decided that Levemir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Levemir opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Insulin detemir is very slightly different from human insulin.
Danish: Insulin detemir adskiller sig en smule fra humant insulin.
English: Levemir has been studied in 1,575 adult patients with type 1 diabetes (when the pancreas cannot produce insulin) and over 2,500 adult patients with type 2 diabetes (when the body is unable to use insulin effectively).
Danish: Levemir blev undersøgt hos 1 575 voksne med type 1-diabetes (når bugspytkirtlen ikke kan danne insulin) og hos 2.500 voksne med type 2-diabetes (hvor kroppen ikke kan udnytte insulinet effektivt).
English: • in combination with a type of diabetes medicines called GLP-1 receptor agonists that are given by injection.
Danish: • i kombination med en type diabeteslægemidler, der kaldes GLP-1- receptoragonister, og som gives ved injektion.
English: The effects of Levemir have also been studied in combination with metformin and liraglutide (a GLP-1 receptor agonist).
Danish: Virkningerne a Levemir blev også undersøgt i kombination med metformin og liraglutid (en GLP-1receptoragonist).
English: For the full list of all side effects and restrictions with Levemir, see the package leaflet.
Danish: Den fuldstændige liste over alle bivirkninger og begrænsninger ved Levemir fremgår af indlægssedlen.
English: The studies compared Levemir with human insulin NPH (an intermediate-acting insulin) or insulin glargine (a long-acting insulin) given once or twice a day.
Danish: I undersøgelserne blev Levemir sammenlignet med humant insulin NPH (et middellangtvirkende insulin) eller insulin glargin (et langtidsvirkende insulin), som blev givet én eller to gange dagligt.
English: Patients using Levemir in combination with liraglutide and metformin achieved a decrease of 0.5% in Hb1Ac compared with no decrease in patients using liraglutide and metformin alone.
Danish: Patienter, der fik Levemir i kombination med liraglutid og metformin, opnåede et fald på 0,5 % i HbA1c sammenlignet med intet fald hos patienter, der fik liraglutid og metformin alene.
English: Levemir doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Danish: Det kan være nødvendigt at justere dosis af Levemir, når det gives sammen med visse andre lægemidler, der kan indvirke på blodglukosemængderne.
English: All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I alle undersøgelserne måltes mængden i blodet af et stof kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodglukosen er reguleret.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinet fungerer på samme måde som naturligt dannet insulin og hjælper glukosen til at trænge ind i cellerne fra blodet.
English: The most common side effect with Levemir (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Levemir (der optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (for lave blodglukosemængder).
English: This means that Levemir has a long duration of action.
Danish: Det betyder, at Levemir er langtidsvirkende.
English: When a GLP-1 receptor agonist is added to Levemir, the Levemir dose should be reduced, and subsequently adjusted according to the individual patient's blood glucose levels.
Danish: Når en GLP-1-receptoragonist gives i tillæg til Levemir, bør dosen af Levemir reduceres og efterfølgende tilpasses til den enkelte patients blodsukkerniveauer.
English: The studies showed that Levemir controls blood glucose levels in a similar manner to insulin NPH, with less risk of low blood glucose levels during the night and no associated weight gain.
Danish: Undersøgelserne viste, at Levemir regulerer blodsukkermængden på samme måde som insulin NPH, men med mindre risiko for lave blodglukosemængder i løbet af natten og uden den hermed forbundne vægtforøgelse.
English: It is available in cartridges and in pre-filled pens.
Danish: Det leveres i cylinderampuller og i fyldte penne.
English: In one study, 323 patients with type 2 diabetes whose blood glucose levels were not well controlled with metformin and liraglutide either received Levemir in addition to their treatment or continued on metformin and liraglutide alone.
Danish: 323 patienter med type 2-diabetes, hvis blodsukkermængder ikke var tilstrækkeligt reguleret med metformin og liraglutid, fik i en undersøgelse enten Levemir i tillæg til deres behandling eller fortsatte med metformin og liraglutid alene.
English: The dose of Levemir should be adjusted according to the individual patient's blood glucose (sugar) levels, which should be regularly tested to find the lowest effective dose.
Danish: Dosen af Levemir bør tilpasses den enkelte patients blodsukkerniveauer, som skal kontrolleres regelmæssigt for at bestemme den effektive minimumsdosis.
English: • in combination with injections of a short- or rapid-acting insulin at mealtimes
Danish: • i kombination med injektioner af et korttids- eller hurtigtvirkende insulin til måltider
English: Levemir is a solution for injection that contains the active substance insulin detemir.
Danish: Levemir er en injektionsvæske, opløsning, der indeholder det aktive stof insulin detemir.
English: • in combination with diabetes medicines taken by mouth
Danish: • i kombination med en type diabeteslægemidler, der indtages oralt
English: Why has Levemir been approved?
Danish: Hvorfor blev Levemir godkendt?
English: Levemir is a long-acting insulin.
Danish: Levemir er et langtidsvirkende insulin.
English: In combination with diabetes medicines taken by mouth, Levemir also controlled blood glucose levels in a similar manner to insulin glargine.
Danish: I kombination med orale diabeteslægemidler regulerede Levemir også blodsukkermængden på samme måde som insulin glargin.
English: What is Levemir?
Danish: Hvad er Levemir?
English: Levemir is a replacement insulin that is very similar to the insulin made by the body.
Danish: Levemir er en insulinerstatning, der er næsten identisk med det insulin, der dannes i kroppen.
English: What is Levemir used for?
Danish: Hvad anvendes Levemir til?
English: What benefit has Levemir shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Levemir?
English: How is Levemir used?
Danish: Hvordan anvendes Levemir?
English: How does Levemir work?
Danish: Hvordan virker Levemir?
English: Levemir has also been studied in two main studies involving 695 children and adolescents with diabetes aged 2-17 years in combination with insulin aspart and comparing it to insulin NPH.
Danish: Der blev også set nærmere på virkningen af Levemir i to hovedundersøgelser af 695 børn og unge fra 2-17 år.
English: How has Levemir been studied?
Danish: Hvordan blev Levemir undersøgt?
English: 10 x 1 tablets (unit dose)
Danish: 10 x 1 tabletter (unit dose)
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Route of Administration
Danish: EU Number
English: Pack size
Danish: Særnavn
English: Content Package size Withdrawal period
Danish: Emballage Indhold Pakningsstørrelse Tilbageholdelsestid
English: Packaging
Danish: Indgivelsesvej
English: Inactivated feline rhinotracheitis virus (605 strain): R.P.
Danish: Inaktiveret felint rhinotracheitisvirus, stamme 605: R.P.
English: --1 Inactivated feline panleukopenia virus (CU4 strain): R.P.
Danish: --1 Inaktiveret felint panleukopenivirus, stamme CU4: R.P.
English: 39-2.10 Inactivated feline Chlamydophila felis (Cello strain): R.P.
Danish: 1,39 - 2,10 Inaktiveret felint Chlamydophila felis,stamme Cello: R.P.
English: 8.5-12.25 Inactivated feline calicivirus (255 strain): R.P.
Danish: 8,50 - 12,25 Inaktiveret felint calicivirus, stamme 255:
English: 1.69-3.50 Inactivated feline leukaemia virus (61E strain): R.P.
Danish: 1,69 - 3,50 Inaktiveret felint leukæmivirus, stamme 61E:
English: Please use the following formula:
Danish: Brug venligst nedenstående formel:
English: Date of last renewal: 26 August 2016
Danish: Dato for seneste fornyelse: 26. august 2016
English: Higher overdoses have not been tested.
Danish: Højere overdoser er ikke testet.
English: Embryotoxic effects cannot be excluded.
Danish: Embryotoksisk effekt kan ikke udelukkes.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml indeholder:
English: No further stirring during administration is necessary.
Danish: Yderligere omrøring under administration er ikke nødvendig.
English: ATCvet code: QP52AC13.
Danish: ATCvet-kode: QP52AC13.
English: (L5 and adult stages)
Danish: (L5 og voksne stadier)
English: This procedure may need to be performed on all treatment days.
Danish: Denne procedure kan være nødvendig at gennemføre på alle behandlingsdage.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 December 2011
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 9. december 2011
English: After oral administration, fenbendazole is only partially absorbed.
Danish: Efter oral administration absorberes fenbendazol kun delvist.
English: Once opened, use by…
Danish: Efter åbning anvendes inden ...
English: The active substance in Panacur AquaSol is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Panacur AquaSol er en godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Remove contaminated clothes after spillage.
Danish: Fjern forurenet tøj efter eksponering.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/135/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/135/002