FrancophonIA/ELRC3.0 huggingface dataset:
English: For Orlistat 60 mg capsules:
Danish: For Orlistat, kapsler, 60 mg:
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.”
Danish: Symptomerne kan omfatte gulfarvning af hud og øjne, kløe, mørkfarvet urin, mavesmerter og ømhed hen over leveren (mærkes som smerter foran i højre side under brystkassen), sommetider med appetitløshed.
English: [Product name] is not recommended for people taking acarbose.”
Danish: [særnavn]anbefales ikke til personer, som tager acarbose.”
English: Section 4.8 “Hepatitis that may be serious”
Danish: “Hepatitis, som kan blive alvorlig”
English: For Orlistat 120 mg capsules: “[Product name] is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).”
Danish: For Orlistat, kapsler, 120 mg: ”[særnavn] anbefales ikke til patienter, som tager acarbose (et lægemiddel, som anvendes til at behandle type 2 sukkersyge).”
English: • “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Danish: • Oxalatnefropati (ophobning af calciumoxalat, hvilket kan give nyresten).
English: “Other medicines and [Product name]”
Danish: ”Brug af anden medicin sammen med [særnavn]”
English: • “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Danish: • “acarbose (et lægemiddel, som anvendes til behandling af type 2-sukkersyge).
English: • “Hepatitis (inflammation of the liver).
Danish: • Leverbetændelse (hepatitis).
English: ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
Danish: ÆNDRINGER, DER SKAL INDFØRES I DE PÅGÆLDENDE AFSNIT AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Danish: Følgende ordlyd skal, hvis den er relevant, indgå i indlægssedlen for de markedsføringstilladelser, der skal ændres:
English: SECTION 4 - POSSIBLE SIDE EFFECTS
Danish: BIVIRKNINGER
English: SECTION 2 - BEFORE YOU TAKE [PRODUCT NAME]
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE [SÆRNAVN]
English: See Chapter 2, take extra care with [Product name]”
Danish: Se afsnit 2, vær ekstra forsigtig med at tage [særnavn].
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
Danish: PRODUKTRESUMÉ
English: The European Commission issued a decision on 27 February 2017.
Danish: Europa-Kommissionen traf en afgørelse den 27. februar 2017.
English: What is gentamicin?
Danish: Hvad er gentamicin?
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/117)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 February 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs (meat and offal).
Danish: CVMP blev anmodet om at gennemgå alle tilgængelige data for restkoncentrationer og anbefale tilbageholdelsestider for kvæg (kød og mælk) og grise (kød og indmad).
English: Belgium noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pig meat and offal from 28 days to 150 days.
Danish: Belgien konstaterede, at der i EU gælder forskellige godkendte tilbageholdelsestider for kvæg og grise for veterinærlægemidler, der indeholder gentamicin og dispenseres som injektionsvæske, opløsning, f.eks. kød og indmad fra kvæg: fra 28 dage til 210 dage, mælk fra kvæg: 2 til 7 dage, idet det for nogle af produkterne angives "må ikke anvendes hos køer, hvis mælk er bestemt til konsum", samt kød og indmad fra grise: 28 dage til 150 dage.
English: Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs EMA/144816/2017
Danish: Spørgsmål og svar om veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, til kvæg og grise EMA/144816/2017
English: On 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs, due to concerns related to the withdrawal periods set for the aforementioned products.
Danish: Den 8. januar 2016 indledte Belgien derfor en procedure i medfør af artikel 35 i direktiv 2001/82/EF for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, til kvæg og grise som følge af betænkeligheder ved tilbageholdelsestiderne for de førnævnte produkter.
English: Why were veterinary medicinal products containing gentamicin presented as solutions for injection reviewed?
Danish: Hvorfor blev veterinærlægemidler, der indeholder gentamicin dispenseret som injektionsvæske, undersøgt?
English: Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Danish: Indehaverne af markedsføringstilladelse fremsendte egne data og videnskabelige referencer vedrørende virkning og restkoncentrationer.
English: On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection.
Danish: Den 10. november 2016 afsluttede Det Europæiske Lægemiddelagentur (agenturet) en gennemgang af forbrugersikkerheden ved tilbageholdelsestiden for kvæg (kød og mælk) og grise (kød og indmad), der behandles med veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning.
English: Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and agreed that the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) should be amended to provide assurance for consumer safety and also agreed that the subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remain unknown.
Danish: Efter evaluering af de aktuelt tilgængelige oplysninger konkluderede CVMP, at det overordnede benefit/risk-forhold for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, er positivt, og vedtog, at tilbageholdelsestiderne for kvæg (kød og mælk) og grise (kød og indmad) bør ændres af hensyn til forbrugersikkerheden; udvalget vedtog ligeledes, at subkutan administration ikke længere bør anbefales til kvæg og grise, eftersom restkinetikken fra injektionsstedet fortsat ikke er kendt.
English: The CVMP recommended that the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection should be varied in order to amend the product information accordingly.
Danish: CVMP anbefalede, at markedsføringstilladelserne for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, ændres, og at produktinformationen ændres tilsvarende.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and recommended amendments to withdrawal periods for cattle and pigs to provide assurance for consumer safety.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at det overordnede benefit/risk-forhold for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, er positivt, og anbefalede ændring af tilbageholdelsestiden for kvæg og grise af hensyn til forbrugersikkerheden.
English: Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs
Danish: Spørgsmål og svar om veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, til kvæg og grise
English: (ratio 1:1)
Danish: (Forhold 1:1)
English: Rarely:
Danish: Sjældent:
English: Reduced efficacy
Danish: Reduceret effektivitet
English: SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RIGEVIDON (see Annex I)
Danish: FAGLIGE KONKLUSIONER SAMLET RESUME AF DEN FAGLIGE VURDERING AF RIGEVIDON (se bilag I)
English: There is no antidote, and further treatment should be symptomatic.
Danish: Der findes ingen antidot, og yderligere behandling bør være symptomatisk.
English: This risk increases with age and with the extent of smoking and is particularly marked in women over 35 years of age.
Danish: Risikoen øges med alderen og omfanget af rygningen og er særlig markant hos kvinder over 35 år.
English: ATC code: G 03 AA 07
Danish: ATC-kode: G 03 AA 07
English: Tablets should never be delayed for longer than 7 days.
Danish: Tabletterne bør aldrig seponeres i mere end 7 dage.
English: No serious, harmful effects after overdose have been reported.
Danish: Der er ikke indberettet nogen alvorlige, skadelige effekter i tilfælde af overdosering.
English: How to delay or shift a period:
Danish: Sådan forsinkes eller ændres en menstruation:
English: One tablet is taken daily for 21 consecutive days.
Danish: Der tages en tablet daglig i 21 på hinanden følgende dage.
English: Number of breast cancers
Danish: Antal brystcancertilfælde
English: Cancers found up to the age of:
Danish: Cancer fundet op til en alder af:
English: After abortion in 1st trimester
Danish: Efter abort i 1. trimester
English: Changes usually remain within the normal laboratory reference range.
Danish: Ændringerne forbliver i reglen inden for de normale laboratoriereferenceområder.
English: For long-term users of these medicinal products, use of other contraceptives should be advised.
Danish: For langtidsbrugere af disse lægemidler bør anvendelse af andre præventionsmidler tilrådes.
English: Some of the original levonorgestrel is also circulating as 17β-sulphate.
Danish: Noget af det oprindelige levonorgestrel cirkulerer også som 17β-sulfat.
English: Diarrhoea may reduce the efficacy by preventing full absorption.
Danish: Diarré kan reducere effektiviteten ved at hindre komplet absorption.
English: Thus, the following advice may be given in daily practice: Week 1:
Danish: Derfor kan følgende råd gives i daglig praksis:
English: It is important to emphasise that the tablet-free interval should not be extended.
Danish: Det er vigtigt at understrege, at den tabletfri periode ikke bør forlænges.
English: The extension can be carried on for as long as desired until the end of the second blister pack.
Danish: Forlængelsen kan vare så længe, det ønskes, indtil slutningen af den anden blisterpakning.
English: The area under curve and Cmax may over time be expected to increase slightly.
Danish: Området under kurven og Cmax kan forventes at stige lidt med tiden.
English: Ethinylestradiol Absorption:
Danish: Etinylestradiol Absorption:
English: Assessment and examination prior to starting combined oral contraceptives
Danish: Vurdering og undersøgelse forud for start på kombinerede orale præventionsmidler
English: Other methods of contraception should be considered for those women over 35 years old who smoke.
Danish: Andre præventionsmidler bør overvejes for de kvinder over 35 år, som ryger.
English: - Smoking (women over 35 should be warned not to smoke if they wish to use combined oral contraceptives).
Danish: Rygning (kvinder over 35 bør advares mod at ryge, hvis de ønsker at anvende oral kombinationsprævention).
English: The woman may also be advised to stop taking tablets from the current blister pack.
Danish: Kvinden kan også tilrådes at ophøre med at tage tabletter fra den aktuelle blisterpakning.
English: The more forgotten tablets, and the closer to the usual tablet-free interval this takes place, the greater the risk of pregnancy.
Danish: Jo flere tabletter, der er glemt over, og jo tættere på den normale tabletfri periode, dette sker, desto større er risikoen for graviditet.
English: The tablets should be started on day 1 in the woman's normal cycle (i.e. on the first day the woman has a menstrual bleed).
Danish: Tabletterne bør påbegyndes dag 1 i kvindens normale cyklus (dvs. den første dag, hvor kvinden har menstruation).
English: Hence, the evaluation of any irregular bleeding should be considered after a period of adaptation of approximately 3 cycles.
Danish: Derfor bør evaluering af eventuelle uregelmæssige blødninger tages i betragtning efter en tilvænningsperiode på cirka 3 cyklusser.
English: All women who use oral contraceptives should be strongly advised not to smoke.
Danish: Alle kvinder, der anvender orale præventionsmidler bør kraftigt opfordres til ikke at ryge.
English: In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors the woman should be advised to contact her physician.
Danish: I tilfælde af forværring, udvidelse eller første forekomst af nogen af disse lidelser eller risikofaktorer skal kvinden tilrådes at kontakte sin læge.
English: If intercourse has taken place during the previous 7 days, the possibility of pregnancy must be considered.
Danish: Hvis der har fundet samleje sted i de foregående 7 dage, bør muligheden for graviditet tages i betragtning.
English: Reduced cycle control
Danish: Reduceret cykluskontrol
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: - Obesity (body mass index above 30 kg/m²).
Danish: Obesitas (body mass index (bmi) over 30 kg/m²).
English: If the tablets have been taken according to the instructions described in section 4.2, it is unlikely that the woman is pregnant.
Danish: Hvis pillerne er blevet taget i overensstemmelse med vejledningen, som er beskrevet i afsnit 4.2, er det usandsynligt, at kvinden er gravid.
English: Based on the finding that:
Danish: På baggrund af konstateringen af:
English: Advice in the case of vomiting/diarrhoea
Danish: Råd i tilfælde af opkastning/diarré
English: Week 3:
Danish: Uge 3:
English: Oral contraception.
Danish: Oral prævention.
English: which can be re-absorbed, thereby creating an enterohepatic circulation.
Danish: som kan reabsorberes, og dermed danne en enterohepatisk cirkulation.
English: The tablets must be taken in the order given on the blister pack, every day at approximately the same time point.
Danish: Tabletterne skal tages i den rækkefølge, der er angivet på blisterpakningen, hver dag på cirka samme tidspunkt.
English: − Pregnancy or suspected pregnancy (see section 4.6)
Danish: Graviditet eller mistanke om graviditet (se afsnit 4.6).
English: Therefore the CHMP has recommended that there are no objections for the granting of the Marketing
Danish: CHMP har derfor anbefalet, at der ikke er indsigelser til hinder for udstedelse af en markedsføringstilladelse for Rigevidon.
English: If there is risk of STI/HIV the correct and consistent use of condoms is recommended, either alone or with another contraceptive method.
Danish: Hvis der er risiko for SOS/HIV, anbefales korrekt og vedvarende anvendelse af kondomer, enten alene eller sammen med en anden præventionsmetode.
English: Note: This SPC is the one that was Annexed to the Commission Decision on this Article 29 referral for levonogestrel and ethinylestradiol containing medicinal products.
Danish: Bemærk: Dette er det SPC, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 29 arbitreringssag vedrørende lægemidler indeholdende levonorgestrel og etinylestradiol.
English: Breakthrough bleeding and unintended pregnancies have been reported.
Danish: Gennembrudsblødning og utilsigtede graviditeter er rapporteret.
English: The woman may start the tablet intake immediately.
Danish: Kvinden kan starte tabletindtagelsen umiddelbart.
English: The bioavailability is approximately 100% and levonorgestrel is not subject to first-pass metabolism.
Danish: Biotilgængeligheden er cirka 100%, og levonorgestrel er ikke underkastet first-pass-metabolisme.
English: Instructions for use and handling No special requirements.
Danish: Eventuelle instruktioner vedrørende anvendelse og håndtering Ingen særlige forholdsregler.
English: Before the start or resumption of treatment with oral contraceptives a complete personal and family medical history must be obtained and a physical examination performed, in accordance with the contraindications (see section 4.3) and warnings (see “Warnings” in this section).
Danish: Før start på eller genoptagelse af behandling med orale præventionsmidler skal der indhentes en komplet personlig og familiemæssig anamnese og foretages en helbredsundersøgelse i overensstemmelse med kontraindikationer (se afsnit 4.3) og advarsler (se “Advarsler” i dette afsnit).
English: Chloasma may occasionally occur, in particular in women with a medical history of chloasma gravidarum.
Danish: Chloasma kan sommetider forekomme, specielt hos kvinder med chloasma gravidarum i anamnesen.
English: Following presystemic conjugation and first-pass metabolism, the absolute bioavailability is 60%.
Danish: Efter præsystemisk konjugation og first-pass-metabolisme er den absolutte biotilgængelighed 60%.
English: How is Rigevidon taken ?
Danish: Hvordan tages Rigevidon ?
English: Pack sizes: 1×21 and 3×21 coated tablets
Danish: Pakningsstørrelser: 1×21 og 3×21 overtrukne tabletter
English: Ethinylestradiol is to 98.8% bound to plasma proteins, almost entirely to albumin.
Danish: Etinyleradiol er 98,8% bundet til plasmaproteiner, næsten helt til albumin.e
English: The intra-individual and interindividual variability in pharmacokinetics of COCs is significant.
Danish: Den intraindividuelle og interindividuelle variation i farmakokinetikken af COC-produkter er betydelig.
English: If the delay exceeds 12 hours, the contraceptive protection may be reduced.
Danish: Hvis forsinkelsen overstiger 12 timer, kan den præventive beskyttelse være reduceret.
English: Handling of missed tablets may be managed by the following two basic rules:
Danish: Håndtering af glemte tabletter kan ske efter en af følgende to grundregler:
English: This increased risk gradually declined over 10 years following cessation of oral contraception.
Danish: Den forhøjede risiko mindskedes gradvist i løbet af 10 år efter ophør med brug af oral prævention.
English: If vomiting occurs within 3-4 hours after tablet taking, absorption may not be complete.
Danish: Dersom der forekommer opkastning inden for 3-4 timer efter indtagelse af en tablet, vil absorptionen muligvis ikke være komplet.
English: The reduced contraceptive protection may, however, be prevented by adjusting the tablet intake.
Danish: Den reducerede præventionsbeskyttelse kan dog forebygges ved at justere tabletindtagelsen.
English: No preceding hormonal contraceptive use in the past month.
Danish: Intet hormonelt præventionsmiddel anvendt i den foregående måned.
English: If the woman does not want to change her usual tablet intake, she should take the required extra tablet(s) from another blister pack.
Danish: Dersom kvinden ikke ønsker at ændre sin normale tabletindtagelse, skal hun tage de(n) nødvendige ekstra tablet(ter) fra en anden blisterpakning.
English: Other: cholelithiasis.
Danish: Andet: cholelitiasis.
English: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Danish: Ordineringsinformationen for samtidigt indgivne lægemidler bør kontrolleres for at identificere potentielle interaktioner.
English: In such cases, it is recommended that treatment with oral contraceptives be discontinued (in the case of elective surgery at least 4 weeks prior to the operation) and should not be resumed until 2 weeks after complete remobilisation.
Danish: sådanne tilfælde anbefales det at seponere behandlingen med oral prævention (i tilfælde af elektiv kirurgi mindst 4 uger før operationen) og ikke genoptage behandlingen før to uger efter komplet rehabilitering.
English: Ethinylestradiol is rapidly and completely absorbed, and peak plasma levels are reached after 1.5 hours.
Danish: Etinylestradiol absorberes hurtigt og komplet, og højeste plasmaniveauer nås efter 1,5 time.
English: These studies do not present evidence for a causal relationship.
Danish: Disse undersøgelser beviser intet vedrørende kausale sammenhænge.
English: Metabolic clearance is subject to marked inter-individual variation which may partly explain the wide variation in the concentrations of levonorgestrel observed among patients.
Danish: Metabolsk clearance er underkastet markant inter-individuel variation, som delvist kan forklare den brede variation i koncentrationen af levonorgestrel, der observeres blandt patienterne.
English: If these extra precautions overrun the end of the pack, the next pack should be started without a break.
Danish: Hvis disse ekstra foranstaltninger overlapper afslutningen af den pakningen, skal den næste pakning påbegyndes uden pause.
English: Levonorgestrel is to a large extent bound to albumin and SHBG (Sex Hormon Binding Globulin) in plasma.
Danish: Levonorgestrel er i vidt omfang bundet til albumin og SHBG (Sex Hormon Binding Globulinkønshormonbindende globulin) i plasma.
English: − postterapeutic amenorrhoea.
Danish: postterapeutisk amenorré.
English: In this case the advice concerning missed tablets, described above should be followed.
Danish: I så fald bør rådet vedrørende oversprungne tabletter som beskrevet ovenfor følges.
English: Women should be advised that oral contraceptives do not protect against HIV (AIDS) or other sexually transmitted infections (STI).
Danish: Kvinden bør vejledes om, at p-piller ikke beskytter mod HIV-infektioner (AIDS) eller andre seksuelt overførte sygdomme (SOS).
English: There is no consensus, whether the occurrence of these cases is related to use of oral contraceptives.
Danish: Der er ingen konsensus med hensyn til, om forekomsten af disse hændelser har forbindelse til anvendelsen af oral prævention.
English: Regular intake of Rigevidon is resumed after the usual 7 days tablet-free interval.
Danish: Regelmæssig indtagelse af Rigevidon genoptages efter de sædvanlige 7 dages tabletfri periode.
English: Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracyclines, although the mechanism of action is unclear.
Danish: Præventionssvigt er også rapporteret ved antibiotika, så som ampicillin og tetracycliner, selv om virkningsmekanismen ikke er klar.
English: Seven days of uninterrupted tablet taking is required to maintain adequate suppression of the hypothalamus-pituitary-ovarian-axis.
Danish: Det kræver 7 dages uafbrudt tabletindtagelse at bevare tilstrækkelig undertrykkelse af hypothalamus-hypofyse-ovarie-aksen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 10.
Danish: Markedsføringstilladelsens nummer Dato for første tilladelse/fornyelse af tilladelsen Dato for revision af teksten