FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sinerem could not have been approved for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste over spørgsmål på tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Sinerem ikke kunne være blevet godkendt til diagnostisk brug ved karakterisering af lymfeknuder visualiseret ved MR-scanning (magnetisk resonansscanning) under evaluering af primær tumorspredning ved cancer i bækkenregionen.
English: Sinerem was to be used as a diagnostic agent in patients undergoing an MRI scan.
Danish: Sinerem skulle have været anvendt som diagnostisk middel hos patienter, som gennemgår en MRscanning.
English: There were inconsistencies between readers regarding any improvement Sinerem may have brought in detecting cancer spread in lymph nodes during an MRI scan, and Sinerem could not therefore be considered as useful in the management of patients with such conditions.
Danish: Fortolkerne var uenige med hensyn til den eventuelle forbedring, Sinerem havde givet ved påvisning af cancerspredning i lymfeknuder under en MR-scanning, og Sinerem kunne derfor ikke betragtes som nyttig ved behandling af patienter med disse lidelser.
English: The very small size of the particles allows them to be carried in the body, and to enter the lymphatic system.
Danish: Da partiklerne er så små, kan de transporteres rundt i kroppen og trænge ind i det lymfatiske system.
English: The company informed the CHMP that compassionate use programmes using Sinerem are ongoing and will be reconsidered accordingly.
Danish: Virksomheden informerede CHMP om, at der nu gennemføres programmer for anvendelse af Sinerem med særlig udleveringstilladelse, og at de ville blive taget op til fornyet overvejelse efter tilbagetrækningen af ansøgningen.
English: Sinerem was to be used in patients with pelvic cancers.
Danish: Sinerem skulle anvendes hos patienter med cancer i bækkenregionen.
English: Once in the lymphatic system, the nanoparticles are taken up by a certain type of immune system cell called ‘macrophages' within the lymph nodes.
Danish: Når nanopartiklerne er inde i det lymfatiske system, optages de af en bestemt type immunforsvarsceller, "makrofager" i lymfeknuderne.
English: 30 May 2013 EMA/318380/2013
Danish: Den 25. juli 2013 EMA/318380/2013
English: Diane 35 was first authorised in 1985.
Danish: Diane 35 blev første gang godkendt i 1985.
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Danish: Yderligere oplysninger om PRAC's anbefaling og baggrunden for denne gennemgang findes på agenturets websted.
English: However, to minimise this risk, further measures should be implemented in addition to the updated product information.
Danish: For at minimere risikoen bør der imidlertid træffes andre foranstaltninger foruden opdatering af produktinformationen.
English: • Healthcare professionals will be sent a letter with further details.
Danish: • Der er udsendt et brev til sundhedspersoner med nærmere enkeltheder.
English: • You should not stop taking these medicines before speaking to your doctor.
Danish: • Du skal ikke holde op med at tage disse lægemidler, før du har talt med lægen.
English: • You should always read the package leaflet and be aware that there is a low risk of blood clots with these medicines.
Danish: • Du skal altid læse indlægssedlen og være opmærksom på, at der er en lille risiko for blodpropper med disse lægemidler.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Anbefalingerne fra PRAC blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh), som vedtog et endeligt standpunkt.
English: Its main responsibility is to resolve disagreements between Member States involved in mutual recognition or decentralised procedures, to ensure that patients have the same level of protection, no matter where they are in the EU.
Danish: Dets hovedansvar er at afklare uoverensstemmelser mellem medlemsstaterne i forbindelse med gensidig anerkendelse eller decentrale procedure for at sikre, at patienterne får samme grad af beskyttelse, uanset hvor i EU de befinder sig.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Denne gennemgang blev først foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: The risk of thromboembolism occurring with these medicines is low and well known.
Danish: Risikoen for tromboemboli med disse lægemidler er lav og velkendt.
English: The French decision followed a national review of the medicine by ANSM.
Danish: Den franske beslutning fulgte efter en national gennemgang af lægemidlet foretaget af ANSM.
English: Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France.
Danish: Trods anbefalingen fra PRAC fastholdt ANSM suspenderingen af markedsføringstilladelsen for disse lægemidler i Frankrig.
English: The review of Diane 35 and its generics was initiated in February 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Danish: Gennemgangen af lægemidler indeholdende Diane 35 blev indledt i februar 2013 på anmodning af Frankrig i medfør af artikel 107i i direktiv 2001/83/EF, også kaldet EU-hasteproceduren.
English: These recommendations have been endorsed by the CMDh, a body representing EU Member States.
Danish: Disse anbefalinger blev vedtaget af CMDh, et organ, der repræsenterer EU's medlemsstater.
English: The CMDh is a medicines regulatory body representing the EU Member States.
Danish: CMDh er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater.
English: The efficacy in moderate and severe acne with or without seborrhoea and /or hirsutism is demonstrated in more than 30 clinical trials.
Danish: Virkningen ved moderat og svær acne med eller uden seborré og/eller hirsutisme er dokumenteret i mere end 30 kliniske undersøgelser.
English: • If you are using these medicines for other conditions you should make a non-urgent appointment with your doctor to review your treatment.
Danish: • Hvis du bruger disse lægemidler til andre formål, skal du få en ikke-akut tid hos lægen for at få gennemgået din behandling.
English: • In the treatment of alopecia androgenetica and acne without androgenic features, the data on efficacy is limited.
Danish: • Til behandling af alopecia androgenetica og acne uden androgene kendetegn findes der kun begrænsede oplysninger om virkning.
English: Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Danish: Lægemidler indeholdende cyproteronacetat 2 mg og ethinylestradiol 35 µg er godkendt via nationale procedurer og fås på recept i alle EU's medlemsstater undtagen Cypern.
English: You should immediately report any relevant symptoms to your doctor, such as pain and swelling in the legs, or breathlessness and a sharp pain in the chest.
Danish: Du skal straks melde om alle relevante symptomer til lægen, såsom smerter og hævelse i benene, kortåndethed og skærende smerter i brystet.
English: These medicines work by blocking the effects of a class of hormones called androgens.
Danish: Disse lægemidler virker ved at blokere virkningen af androgene hormoner.
English: This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.
Danish: Ved gennemgangen fandtes alvorlige tromboemboliske hændelser og omfattende ikke-godkendt anvendelse af disse lægemidler udelukkende til præventionsformål.
English: Cyproterone also supresses ovulation and therefore has a contraceptive effect.
Danish: Cyproteron undertrykker desuden ægløsningen og virker derfor svangerskabsforebyggende.
English: These recommendations are based on a review of all available data on the risk of thromboembolism as well as the benefits of Diane 35 and its generics:
Danish: Disse anbefalinger er baseret på en gennemgang af alle foreliggende data om risikoen for tromboemboli samt fordelene ved Diane 35 og de tilsvarende generiske produkter:
English: As the CMDh position was adopted by majority vote and not by consensus, the CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU.
Danish: Eftersom CMDh's standpunkt blev vedtaget ved en flertalsafgørelse og ikke enstemmigt, blev CMDh's standpunkt overgivet til Europa-Kommissionen, som den 25. juli 2013 traf en retligt bindende afgørelse for hele EU.
English: These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Danish: Disse foranstaltninger består i udlevering af informationsmateriale til ordinerende læger og patienter med fremhævelse af risiciene for tromboemboli, f.eks. i form af en tjekliste til den ordinerende læge med henblik på at sikre, at risici, tegn og symptomer drøftes med patienten.
English: The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months.
Danish: Gennemgangen af Diane 35 og de tilsvarende generiske produkter skete på foranledning af den franske lægemiddelstyrelse Agence nationale de sécurité du médicament et des produits de santé (ANSM), efter at denne havde besluttet at suspendere Diane 35 og de tilsvarende generiske produkter i Frankrig inden for tre måneder.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels).
Danish: Den 29. maj 2013 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh) ved en flertalsafgørelse (26:1) anbefalingen fra Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), som konkluderede, at fordelene ved Diane 35 (cyproteronacetat 2 mg/ethinylestradiol 35 µg) og tilsvarende generiske produkter opvejer risiciene, forudsat at der træffes en række foranstaltninger til minimering af risikoen for tromboemboli (blodpropper i karrene).
English: • For the treatment of acne, these medicines should only be used after topical therapy or systemic antibiotic treatment has failed.
Danish: • Til acnebehandling må disse lægemidler kun anvendes, når topikal behandling eller systemisk antibiotikabehandling har slået fejl.
English: • Doctors should review patients on Diane 35 and generics in line with these recommendations at their next scheduled appointment.
Danish: • Patienter, der er i behandling med Diane 35 og de tilsvarende generiske produkter, bør gennemgås af lægen i overensstemmelse med disse anbefalinger ved næste planlagte besøg.
English: • You should be aware that there are factors that can increase the risk of blood clots in blood vessels, such as increasing age, smoking, obesity and prolonged immobility.
Danish: • Du skal være opmærksom på, at risikoen for blodpropper i karrene kan øges af visse faktorer såsom tiltagende alder, rygning, overvægt og langvarig inaktivitet.
English: • The review also showed that the excess risk of VTE is highest during the first year of use of Diane 35 and its generics or when restarting or switching from an oral hormonal contraceptive to Diane 35 and its generics after a pill-free interval of at least one month.
Danish: • Gennemgangen viste desuden, at overrisikoen for venøs tromboemboli er højst i det første år, hvor kvinden anvender Diane 35 eller tilsvarende generiske produkter, samt ved genoptagelse af eller overgang til behandling med Diane 35 eller tilsvarende generiske produkter efter mindst 1 måneds pause uden piller.
English: • Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.
Danish: • Lægen bør forklare patienten om risikoen for tromboemboli og risikofaktorer såsom tiltagende alder, rygning, overvægt og langvarig immobilitet.
English: Because the CMDh took this position by majority it will now be sent to the European Commission, which will adopt a legally binding decision.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til Europa-Kommissionen, som godkendte det og vedtog en retligt bindende afgørelse den 25. juli 2013.
English: Data on the risk of arterial thromboembolism (ATE) with Diane and its generics are sparse and indicate that this risk is lower than for VTE.
Danish: For arteriel tromboemboli (ATE) er oplysningerne om risikoen med Diane og de tilsvarende generiske produkter sparsomme og tyder på, at denne risiko er lavere end for venøs tromboemboli.
English: The risk of blood clots in the veins with these medicines is 1.5 to 2 times higher than for combined oral contraceptives (COCs) containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Danish: Risikoen for blodpropper i venerne med disse lægemidler er 1,5-2 gange højere end med kombinerede orale præventionsmidler indeholdende levonorgestrel og kan svare til risikoen med præventionsmidler indeholdende gestoden, desogestrel eller drospirenon.
English: Observational studies have shown that the risk of venous thromboembolism (VTE) with these medicines is 1.5 to 2 times higher than for COCs containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Danish: Observationsundersøgelser har vist, at risikoen for venøs tromboemboli (VTE) med disse lægemidler er 1,5-2 gange højere end med kombinerede orale antikonceptionsmidler indeholdende levonorgestrel og kan svare til risikoen med antikonceptionsmidler indeholdende gestoden, desogestrel eller drospirenon.
English: • The review confirmed the rare and known risk of thromboembolism with Diane 35 and its generics.
Danish: • Gennemgangen bekræftede den kendte risiko for sjældne tilfælde af tromboemboli med Diane 35 og de tilsvarende generiske produkter.
English: These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age.
Danish: Disse lægemidler bør udelukkende anvendes til behandling af moderat til svær acne i forbindelse med androgenfølsomhed og/eller hirsutisme (for kraftig uønsket behåring hos kvinder) hos kvinder i den fødedygtige alder.
English: Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism.
Danish: Samtidig brug af Diane 35 eller de tilsvarende generiske produkter og anden hormonel prævention vil udsætte kvinderne for en højere dosis østrogen og øge risikoen for tromboemboli.
English: Diane 35 and its generics act also as hormonal contraceptives and stopping them means that you will have to use another form of contraception to prevent unwanted pregnancies.
Danish: Diane 35 og de tilsvarende generiske produkter virker desuden som hormonel prævention, og når du holder op med at tage dem, betyder det, at du skal bruge anden form for prævention for at undgå uønsket graviditet.
English: Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives.
Danish: Da Diane 35 og de tilsvarende generiske produkter virker som hormonelle præventionsmidler, bør kvinder ikke tage disse lægemidler sammen med andre hormonelle præventionsmidler.
English: • If you have any questions you should speak to your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: However, when used for acne, they should only be used if other treatments, such as those applied to the skin and antibiotics, have failed.
Danish: Desuden bør lægemidlerne kun anvendes til acnebehandling, når andre behandlingsmuligheder såsom topikal behandling eller antibiotikabehandling har slået fejl.
English: • In terms of effectiveness, the available data support the use of Diane 35 and its generics in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism, in women of reproductive age.
Danish: • De foreliggende data støtter virkningen af Diane 35 og de tilsvarende generiske produkter til behandling af moderat til svær acne i forbindelse med androgenfølsomhed og/eller hirsutisme hos kvinder i den fødedygtige alder.
English: • Diane 35 and its generics should only be used for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Danish: • Diane 35 og de tilsvarende generiske produkter må kun anvendes til behandling af moderat til svær acne relateret til androgenfølsomhed (med eller uden seborré) og/eller hirsutisme hos kvinder i den fødedygtige alder.
English: • Since Diane 35 and its generics act also as hormonal contraceptives, they should not be used in combination with other hormonal contraceptives.
Danish: • Diane 35 og de tilsvarende generiske produkter virker som hormonelle antikonceptionsmidler og bør derfor ikke anvendes i kombination med andre hormonelle antikonceptionsmidler.
English: Once the European Commission has adopted its decision, all EU Member States where Diane 35 and its generics are authorised must follow it and ensure that all agreed risk minimisation measures, including changes to the information to prescribers and patients, are implemented.
Danish: Europa-Kommissionens efterfølgende afgørelse om opretholdelse af markedsføringstilladelsen med de vedtagne risikominimeringsforanstaltninger, herunder ændringer af informationer til praktiserende læger og patienter, skal imidlertid gennemføres i alle EU's medlemsstater.
English: • Diane 35 and its generics should only be used to treat moderate to severe acne (related to sensitivity to hormones called androgens) and/or hirsutism in women of child-bearing age.
Danish: • Diane 35 og de tilsvarende generiske produkter må kun anvendes til behandling af moderat til svær acne (i forbindelse med følsomhed for androgene hormoner) og/eller hirsutisme (kraftig behåring) hos kvinder i den fødedygtige alder. Til acne må produkterne dog kun anvendes, når andre behandlingsmuligheder, såsom lokal behandling af huden og antibiotikabehandling, har slået fejl.
English: Lot {number}
Danish: Lot {nummer}
English: 10 x 1 dose 50 x 1 dose
Danish: 10 x 1 doser 50 x 1 doser
English: This resolves without any treatment.
Danish: Disse forsvinder uden nogen behandling.
English: Subcutaneous use (under the skin).
Danish: Subkutan anvendelse (under huden).
English: Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση , Ελλάδα
Danish: Αθηνών - Λαμίας, T.K.14452, Μεηαμόρθωζη, Ελλάδα
English: After the second injection, and subsequent administrations, this reaction is markedly reduced.
Danish: Efter den anden injektion, og efterfølgende injektioner, reduceres denne reaktion markant.
English: Store and transport refrigerated (2 C - 8 C).
Danish: Opbevares og transporteres nedkølet (2°C - 8°C).
English: Anaphylactic reactions have been reported in very rare cases.
Danish: Anafylaktiske reaktioner er observeret i meget sjældne tilfælde.
English: In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Danish: I tilfælde af anafylaktisk shock, bør en korrekt symptomatisk behandling gives.
English: A moderate and transient local reaction (<2 cm) is commonly observed after the first injection.
Danish: En moderat og forbigående lokal reaktion (< 2 cm) er almindeligt forekommende efter den første injektion.
English: ATCvet code: QI06AH07.
Danish: ATCvet-kode: QI06AH07
English: * Cell culture infectious dose 50%.
Danish: * Cellekultur infektiøs dosis 50 %
English: Date of first authorisation: 25/06/2009.
Danish: Dato for første tilladelse: 25/06/2009 Dato for seneste fornyelse af markedsføringstilladelsen: 06/06/2014
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år.
English: Re-vaccinations:
Danish: Revaccination:
English: De-worming at least 10 days prior to vaccination is recommended.
Danish: Ormebehandling anbefales mindst 10 dage før vaccination.
English: Special warnings for each target species: Vaccinate healthy animals only.
Danish: Særlige advarsler for hver dyreart: Kun raske dyr må vaccineres.
English: For active immunisation of cats from eight weeks of age against:
Danish: Aktiv immunisering af katte, der er 8 uger gamle eller ældre, mod:
English: Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Danish: Let smerte ved palpation, nysen eller konjunktivitis kan forekomme i sjældne tilfælde.
English: Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
Danish: 3 % aluminiumhydroxidgel udtrykt som mg Al
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre lægemidler til dyr.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Anvend ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. Lægemidlet anvendes straks efter opblanding.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).
English: It has been demonstrated that this spread did not cause adverse reactions on non-vaccinated cats.
Danish: Det er påvist, at denne spredning ikke forårsager bivirkninger hos ikke-vaccinerede katte.
English: The use is not recommended during lactation.
Danish: Anvendelse under laktation frarådes.
English: Only feline leukaemia virus (FeLV) negative cats should be vaccinated.
Danish: Kun felin leukæmivirus (FeLV)-negative katte bør vaccineres.
English: Purified extract of Quillaja saponaria
Danish: Renset ekstrakt af Quillaja saponaria
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Do not use in pregnant cats.
Danish: Må ikke anvendes til drægtige katte.
English: In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.
Danish: I tilfælde hvor der forventes tilstedeværelse af maternelle antistoffer, bør en tredje injektion gives fra killingerne er 15 uger gamle.