FrancophonIA/ELRC3.0 huggingface dataset:
English: - If there is still a possibility that you can get pregnant, Raloxifene Teva could harm your unborn child. - If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
Danish: - hvis du bliver eller har været behandlet for blodpropper (blodprop i de dybe vener (dyb venetrombose), blodprop i lungerne (lungeemboli) eller blodprop i øjets nethinde (nethindevenetrombose).
English: Pharmaco-therapeutic group: Selective oestrogen receptor modulator.
Danish: Farmakoterapeutisk klassifikation: Selektiv østrogenreceptormodulator, ATC-kode: G03XC01
English: for the spine 37 % decreased and 63 % increased; and for the total hip 29 % decreased and 71 % increased.
Danish: I forsøgene til forebyggelse af osteoporose var den procentdel af forsøgspersoner, som oplevede en forøgelse eller en reduktion af BMD under behandling med raloxifen, henholdsvis 37 % og 63 % for rygsøjlen og henholdsvis 29 % og 71 % for hoften.
English: Must not be used in women with child bearing potential.
Danish: Må ikke anvendes af fertile kvinder.
English: Raloxifene must not be taken by women of child bearing potential.
Danish: Raloxifen må ikke anvendes af fertile kvinder.
English: Reproductive system and breast disorders Common: Mild breast symptoms a such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome Common: Peripheral oedema Investigations
Danish: Meget almindelig: Influenzalignende syndrom Almindelig: Perifert ødem
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Raloxifene Teva is used to treat and prevent osteoporosis in postmenopausal women.
Danish: Raloxifen Teva bruges til at behandle og forebygge knogleskørhed hos kvinder, der har passeret overgangsalderen.
English: • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Danish: • Gener fra mave-tarm-kanalen, såsom kvalme, opkastning, mavesmerter, fordøjelsesbesvær.
English: Tel.: +36 1 288 64 00
Danish: Teva Gyógyszergyár Zrt., Tel.: +36 1 288 64 00
English: Pregnancy
Danish: Amning
English: Skin and subcutaneous tissue disorders Common: Rash a
Danish: Hud og subkutane væv
English: Uncommon: Fatal strokes
Danish: Almindelig: Hududslæta
English: - This medicine has been prescribed for you only.
Danish: Denne indlægsseddel blev senest ændret
English: BATCH NUMBER Lot
Danish: Mave-tarm-kanalen
English: Posology
Danish: Undersøgelser
English: Breast-feeding
Danish: INFORMATION I BRAILLESKRIFT
English: Nervous system disorders Common: Headache, including migraine a
Danish: Almindelig: Hovedpine, herunder migrænea Ikke almindelig: Apopleksi med dødelig udgang
English: Musculoskeletal and connective tissue disorders Common: Leg cramps
Danish: Almindelig: Kramper i benene
English: MA (EU) number (Invented) name
Danish: MA (EU) procedurenr.
English: Pharmaceutical form
Danish: Styrke Lægemiddelform Indgivelsesvej
English: The recommended dose is one tablet once a day taken with food and at the same time each day.
Danish: Den anbefalede dosis er én tablet én gang dagligt sammen med et måltid og på samme tidspunkt hver dag.
English: Senshio received a marketing authorisation valid throughout the EU on 15 January 2015.
Danish: Senshio fik en markedsføringstilladelse med gyldighed i hele EU den 15. januar 2015.
English: Further information on Senshio can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/senshio .
Danish: Yderligere information om Senshio findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/senshio.
English: Senshio (ospemifene)
Danish: Senshio (ospemifen)
English: As for all medicines, data on the use of Senshio are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Senshio løbende overvåget.
English: Senshio is available as tablets (60 mg).
Danish: Senshio fås som tabletter (60 mg).
English: Other information about Senshio
Danish: Andre oplysninger om Senshio
English: Since Senshio is given by mouth the Agency considered that this medicine is a valuable alternative for women for whom local treatment is unsuitable.
Danish: Da Senshio gives gennem munden, var agenturet af den opfattelse, at dette lægemiddel er et nyttigt alternativ for kvinder, som den lokale behandling ikke egner sig til.
English: Women also received non-hormonal vaginal lubricant for use as needed.
Danish: Kvinderne fik også et ikke-hormonelt vaginalt fugtighedsmiddel til brug efter behov.
English: An overview of Senshio and why it is authorised in the EU
Danish: En oversigt over Senshio, og hvorfor det er godkendt i EU
English: This means that it acts in the same way as oestrogen in some tissues in the body such as the vagina and so helps to reduce symptoms of vulvovaginal atrophy.
Danish: Det betyder, at det virker på samme måde som østrogen i visse væv i kroppen, såsom vagina, og dermed bidrager til at reducere symptomerne på vulvovaginal atrofi.
English: What measures are being taken to ensure the safe and effective use of Senshio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Senshio?
English: Side effects reported with Senshio are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Senshio vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Senshio, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Senshio, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: As the levels of oestrogen hormones fall during the menopause, the vaginal lining may become thin and dry.
Danish: Da niveauet af østrogenhormoner falder i løbet af overgangsalderen, kan slimhinden i skeden blive tynd og tør.
English: The European Medicines Agency decided that Senshio's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Senshio opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The main measure of effectiveness was related to the change in symptoms such as pain associated with sexual activity and vaginal dryness, using a validated questionnaire.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i symptomer såsom smerter i forbindelse med seksuel aktivitet og vaginal tørhed ved hjælp af et valideret spørgeskema.
English: The studies also showed that Senshio was effective in restoring the vaginal environment including its acidity and thickness of the lining.
Danish: Studierne viste også, at Senshio var effektivt til at genoprette det vaginale miljø, herunder surhedsgraden og slimhindens tykkelse.
English: The Agency considered that the safety profile of Senshio, which was studied for up to 15 months, was in line with medicines working in a similar way (SERMs), but noted, however, that long-term use of SERMs might be associated with risks such as endometrial hyperplasia, stroke and venous thromboembolism and requested further studies to investigate these risks with Senshio.
Danish: Agenturet fandt, at sikkerhedsprofilen for Senshio, som blev undersøgt i op til 15 måneder, var på linje med lægemidler, der virkede på en lignende måde (SERM), men bemærkede dog, at langtidsanvendelse af SERM kunne være forbundet med risici såsom endometriehyperplasi, slagtilfælde og venøs tromboemboli, og anmodede om yderligere studier for at undersøge disse risici ved Senshio.
English: In addition, it must not be used in patients with unexplained vaginal bleeding or patients with endometrial hyperplasia (abnormal thickening of the lining of the womb).
Danish: Desuden må det ikke anvendes til patienter med uforklarlig vaginal blødning eller patienter med endometriehyperplasi (unormal fortykkelse af livmoderslimhinderne).
English: The company that markets Senshio is carrying out a study to further investigate long-term potential risks such as endometrial hyperplasia, stroke and venous thromboembolism.
Danish: Den virksomhed, der markedsfører Senshio, gennemfører et studie for yderligere at undersøge potentielle langtidsrisici, såsom endometriehyperplasi, slagtilfælde og venøs tromboemboli.
English: What is Senshio and what is it used for?
Danish: Hvad er Senshio, og hvad anvendes det til?
English: What are the risks associated with Senshio?
Danish: Hvilke risici er der forbundet med Senshio?
English: Why is Senshio approved?
Danish: Hvorfor er Senshio godkendt?
English: Some women must not use Senshio, including those who have or have had problems with blood clots in veins such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye).
Danish: Nogle kvinder må ikke anvende Senshio, herunder dem, der har eller har haft problemer med blodpropper i blodårerne, f.eks. dyb venetrombose (DVT), lungeemboli (en blodprop i lungerne) og trombose i nethindeblodåren (en blodprop bagerst i øjet).
English: Regarding pain during sexual activity, 58% of women using Senshio reported relief in the first study (compared with 42% receiving placebo) and 63% reported relief during the second study (compared with 48% receiving placebo).
Danish: Hvad angår smerter under seksuel aktivitet, berettede 58 % af de kvinder, der anvendte Senshio, om lindring i det første studie (sammenlignet med 42 % af dem, der fik placebo) og 63 % berettede om lindring i det andet studie (sammenlignet med 48 % af dem, der fik placebo).
English: Senshio has been compared with placebo (a dummy treatment) in two main studies involving over 1,700 postmenopausal women with vulvovaginal atrophy.
Danish: Senshio blev sammenlignet med placebo (en uvirksom behandling) i to hovedstudier, der omfattede over 1.700 kvinder med vulvovaginal atrofi, som var forbi overgangsalderen.
English: The most commonly reported side effects with Senshio (affecting up to 1 in 10 people) are vulvovaginal candidiasis and other mycotic (fungal) infections, hot flushes, headache, muscle spasms, vaginal bleeding, vaginal and genital discharge, and rash.
Danish: De hyppigst indberettede bivirkninger ved Senshio (som kan forekomme hos op til 1 ud af 10 personer) er vulvovaginal candidiasis (svamp i skeden) og andre svampeinfektioner, hedeture, hovedpine, muskelspasmer, vaginal blødning, vaginalt og genitalt udflåd samt udslæt.
English: Oestrogen hormones help to maintain the health of tissue in and around the vagina.
Danish: Østrogenhormoner bidrager til at holde vævet i og omkring skeden sundt.
English: It is used in women who cannot use oestrogen therapy applied in the vagina.
Danish: Det anvendes hos kvinder, som ikke kan få østrogenbehandling i vagina (skeden).
English: The Agency noted that the degree of improvement with Senshio was comparable to that with oestrogen treatments that are applied to the vagina.
Danish: Agenturet bemærkede, at forbedringen med Senshio var sammenlignelig med forbedringen med østrogenbehandling i skeden.
English: For the full list of side effects and restrictionsof Senshio, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Senshio fremgår af indlægssedlen.
English: Senshio is a medicine used to treat moderate to severe symptoms of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and painful sexual intercourse) in women who have been through the menopause.
Danish: Senshio er et lægemiddel, der anvendes til behandling af moderate til svære symptomer på vulvovaginal atrofi (tørhed, irritation og ømhed omkring det genitale område samt smerter ved samleje) hos kvinder, der er forbi overgangsalderen.
English: Senshio must also not be used in women who have breast cancer or another cancer that is sex-hormone dependent such as endometrial cancer (cancer of the womb).
Danish: Senshio må heller ikke anvendes til kvinder, der har brystkræft eller andre kønshormonrelaterede kræfttyper, såsom livmoderkræft.
English: In the second study, 62% of women using Senshio reported relief from vaginal dryness after 12 weeks (compared with 53% in the placebo group).
Danish: I det andet studie berettede 62 % af de kvinder, der anvendte Senshio, om lindring af tørheden i skeden efter 12 uger (sammenlignet med 53 % i placebogruppen).
English: In the first study, 66% of women using Senshio reported relief from vaginal dryness (mild or no symptoms) after 12 weeks' treatment compared with 49% in the placebo group.
Danish: I det første studie berettede 66 % af de kvinder, der anvendte Senshio, om lindring af tørheden i skeden (mild eller ingen symptomer) efter 12 ugers behandling sammenholdt med 49 % i placebogruppen.
English: Senshio improved symptoms of vulvovaginal atrophy in postmenopausal women.
Danish: Senshio forbedrede symptomerne på vulvovaginal atrofi hos kvinder, der var forbi overgangsalderen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Senshio have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Senshio.
English: How is Senshio used?
Danish: Hvordan anvendes Senshio?
English: This can cause irritation and soreness and make sexual intercourse painful.The active substance in Senshio, ospemifene, is a selective oestrogen receptor modulator (SERM).
Danish: Det aktive stof i Senshio, ospemifen, er en selektiv østrogenreceptormodulator (SERM).
English: What benefits of Senshio have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Senshio?
English: How does Senshio work?
Danish: Hvordan virker Senshio?
English: However, ospemifene does not work in the same way in other tissues such as the breast and womb, where such activity could cause hyperplasia (growth) of tissues which could lead to cancer.
Danish: Her kan det forårsage hyperplasi (vækst) af væv, der kan føre til kræft.
English: This summary was last updated in December 2017.
Danish: Dette sammendrag blev sidst ajourført i december 2017.
English: The full EPAR for Suvaxyn Circo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Suvaxyn Circo findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo on 7 February 2018.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suvaxyn Circo den 07/02/2018.
English: In the future, if the animals come into contact with the virus the immune system will be able to respond quickly to destroy the virus.
Danish: Hvis dyret efterfølgende kommer i kontakt med virusset, vil immunsystemet reagere hurtigt og dræbe virusset.
English: The purpose of these studies was to establish how long it took pigs to be fully protected and how long the protection against PCV2 lasted.
Danish: Undersøgelserne skulle fastlægge, hvor lang tid det tog for svin at opnå fuld beskyttelse, og hvor længe beskyttelsen mod PCV2 varede.
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Suvaxyn Circo.
English: The withdrawal period for meat from pigs treated with Suvaxyn Circo is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Suvaxyn Circo, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: Infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Danish: Infektioner kan frembringe kliniske tegn som f.eks. vægttab eller manglende vækst, forstørrede lymfeknuder, vejrtrækningsbesvær, bleg hud og gulsot.
English: The vaccine contains small amounts of a protein from PCV2 that have been killed (inactivated) so that they do not cause disease.
Danish: Vaccinen indeholder små mængder af et protein fra PCV2, som er dræbt (inaktiveret), så det ikke forårsager sygdom.
English: The most common side effects with Suvaxyn Circo (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature during the first 24 hours after vaccination and swelling (generally no wider than 2 cm) at the injection site which may last for up to 2 days.
Danish: De hyppigste bivirkninger ved Suvaxyn Circo (som kan forekomme hos flere end 1 ud af 10 dyr) er en kortvarig øget kropstemperatur i de første 24 timer efter vaccinering og hævelse (generelt ikke bredere end 2 cm) på injektionsstedet, som kan vare i op til 2 dage.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Suvaxyn Circo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Suvaxyn Circo also contains adjuvants (ingredients that strengthen the immune response) called squalane, poloxamer 401 and polysorbate 80.
Danish: Suvaxyn Circo indeholder også adjuvanser (ingredienser, som styrker immunreaktionen) kaldet squalen, poloxamer 401 og polysorbat 80.
English: The studies showed that the vaccine had its full effect against PCV2 by three weeks after vaccination.
Danish: Undersøgelserne viste, at vaccinen havde fuld virkning mod PCV2 tre uger efter vaccinationen.
English: This will help protect the pigs against porcine circovirus infections.
Danish: Derved bliver svinene beskyttet mod infektioner med porcint circovirus.
English: Suvaxyn Circo+MH RTU is already approved in the EU.
Danish: Suvaxyn Circo+MH RTU er allerede godkendt i EU.
English: Suvaxyn Circo is a vaccine.
Danish: Suvaxyn Circo er en vaccine.
English: Protection lasted 23 weeks after vaccination for PCV2.
Danish: Beskyttelsen varede i 23 uger efter vaccination mod PCV2.
English: Other information about Suvaxyn Circo
Danish: Andre oplysninger om Suvaxyn Circo
English: When Suvaxyn Circo is given to pigs the animals' immune system recognises the viral protein as ‘foreign' and makes antibodies against it.
Danish: Når Suvaxyn Circo gives til svin, genkender dyrenes immunsystem virusproteinet som "fremmed" og danner antistoffer mod det.
English: The studies on the effectiveness of Suvaxyn Circo were carried out with a similar vaccine, Suvaxyn Circo+MH RTU, which contains PCV2 and the bacteria Mycoplasma hyopneumoniae.
Danish: Undersøgelserne af Suvaxyn Circos virkning blev gennemført med en lignende vaccine, Suvaxyn Circo+MH RTU, som indeholder PCV2 og bakterien Mycoplasma hyopneumoniae.
English: Suvaxyn Circo porcine circovirus vaccine (inactivated)
Danish: Suvaxyn Circo porcint circovirus-vaccine (inaktiveret)
English: Suvaxyn Circo, which is available as a liquid for injection, is given to pigs from three weeks of age as a single injection into the muscle in the neck behind the ear.
Danish: Suvaxyn Circo fås som injektionsvæske og gives til svin fra treugersalderen som en enkelt injektion i nakkemuskulaturen bag øret.
English: What is Suvaxyn Circo and what is it used for?
Danish: Hvad er Suvaxyn Circo, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Suvaxyn Circo.
Danish: Det er ikke en praktisk vejledning i, hvordan Suvaxyn Circo bør anvendes.
English: Suvaxyn Circo contains an inactivated (killed) active substance derived from porcine circovirus type 2.
Danish: Suvaxyn Circo indeholder et inaktiveret (dræbt) aktivt stof afledt af porcint circovirus type 2.
English: The effectiveness of Suvaxyn Circo+MH RTU was first studied in several laboratory studies in pigs.
Danish: Virkningen af Suvaxyn Circo+MH RTU blev først undersøgt i adskillige laboratorieundersøgelser af svin.
English: Suvaxyn Circo is only available on prescription.
Danish: Suvaxyn Circo udleveres kun efter recept.
English: Suvaxyn Circo is a veterinary vaccine used to protect pigs over the age of 3 weeks against porcine circovirus type 2 (PCV2).
Danish: Suvaxyn Circo er en veterinærvaccine til beskyttelse af svin fra treugersalderen mod porcint circovirus type 2 (PCV2).
English: Why is Suvaxyn Circo approved?
Danish: Hvorfor blev Suvaxyn Circo godkendt?
English: What are the risks associated with Suvaxyn Circo?
Danish: Hvilke risici er der forbundet med Suvaxyn Circo?
English: For more information about treatment with Suvaxyn Circo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Suvaxyn Circo, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The field studies showed that Suvaxyn Circo reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
Danish: Feltundersøgelserne viste, at Suvaxyn Circo nedsatte PCV2-virusindholdet i blodet (viræmi) mere end hos svin, der fik en vaccination med et ikke-aktivt stof.
English: For the full list of restrictions and side effects with Suvaxyn Circo, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Suvaxyn Circo fremgår af indlægssedlen.
English: For practical information about using Suvaxyn Circo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Suvaxyn Circo, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is Suvaxyn Circo used?
Danish: Hvordan anvendes Suvaxyn Circo?
English: What benefits of Suvaxyn Circo have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Suvaxyn Circo?
English: How does Suvaxyn Circo work?
Danish: Hvordan virker Suvaxyn Circo?
English: 100 mg/ml
Danish: Pakningsstørrelse mg/ml
English: Name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK
Danish: Belgien, Bulgarien, Cypern, Danmark, Estland, Finland, Frankrig, Grækenland, Holland, Irland, Island, Letland, Litauen, Luxembourg, Malta, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige, Storbritannien, Tjekkiet, Tyskland, Ungarn, Østrig
English: Try to take the tablet at the same time each day.
Danish: Forsøg at tage tabletten på det samme tidspunkt hver dag.
English: Other sections were also harmonised.
Danish: Andre afsnit blev også harmoniseret.
English: It is important that you are aware of what these side effects may be.
Danish: Det er vigtigt, at du er opmærksom på, hvilke bivirkninger der kan forekomme.
English: Taking Atacand with food and drink (in particular alcohol)
Danish: Brug af Atacand sammen med mad og drikke (især alkohol)
English: The combination should be administered with caution, especially in the elderly.
Danish: Kombinationen bør administreres med forsigtighed, især hos ældre.
English: It is important to keep taking Atacand every day.
Danish: Det er vigtigt at tage Atacand hver dag.
English: It has no agonist activity.
Danish: Det er uden agonist-aktivitet.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen (Exp.) er den sidste dag i den nævnte måned.
English: The CHMP discussed the rational for this exclusion.
Danish: CHMP drøftede rationalet for denne udelukkelse.