FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 ml (10 doses) 50 ml (25 doses)
Danish: 20 ml (10 doser) 50 ml (25 doser)
English: Porcilis ColiClos suspension for injection for pigs
Danish: Porciilis ColiClos, injektionsvæske, suspension, til svin
English: Sodium chloride Potassium chloride Disodium hydrogen phosphate Potassium dihydrogenphosphate Simethicone
Danish: Natriumchlorid Kaliumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat Simeticon
English: 100 ml (50 doses) 200 ml (100 doses) 250 ml (125 doses)
Danish: 100 ml (50 doser) 200 ml (100 doser) 250 ml (125 doser)
English: 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 200 ml (100 doses) 250 ml (125 doses)
Danish: 20 ml (10 doser) 50 ml (25 doser) 100 ml (50 doser) 200 ml (100 doser) 250 ml (125 doser)
English: To stimulate active immunity in order to provide passive immunity to the progeny against enterotoxicosis caused by E. coli expressing fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and against (necrotic) enteritis caused by C. perfringens type C. Vaccination results in an antibody response with neutralizing activity against LT toxin.
Danish: Til stimulering af aktiv immunitet for opnåelse af passiv immunitet hos afkom mod enterotoksikose forårsaget af E. coli, der udtrykker fimbrieadhæsinerne F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) og mod nekrotiserende enteritis (tarmbrand) forårsaget af C. perfringens type C. Vaccination resulterer i et antistofsvar med neutraliserende virkning over for LT-toksin.
English: For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those E. coli strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by C. perfringens type C.
Danish: Til passiv immunisering af smågrise ved aktiv immunisering af søer og gylte for reduktion af dødelighed og kliniske symptomer i de første levedage forårsaget af de E. coli stammer, der udtrykker adhæsinerne F4ab (K88ab), F4ac (K88ac), F5 (K99) eller F6 (987P), eller forårsaget af C. perfringens type C.
English: Immunological properties of the product: To stimulate active immunity in order to provide passive immunity to the progeny against enterotoxicosis caused by E. coli expressing fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and against (necrotic) enteritis caused by C. perfringens type C.
Danish: Immunologiske egenskaber: Til stimulering af aktiv immunitet for opnåelse af passiv immunitet hos afkom mod enterotoksikose forårsaget af E. coli, der udtrykker fimbrie adhæsinerne F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) og mod nekrotiserende enteritis (tarmbrand) forårsaget af C. perfringens type C.
English: Name and address of the manufacturers of the biological active substances
Danish: Navn og adresse på fremstillerne af de biologisk aktive stoffer Intervet International B.V.
English: IM
Danish: A.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Intervet International B.V.
English: - F6 fimbrial adhesin
Danish: -F6 fimbrieadhæsin
English: - F5 fimbrial adhesin
Danish: -F5 fimbrieadhæsin
English: - F4ac fimbrial adhesin
Danish: -F4ac fimbrieadhæsin
English: Cardboard box with a vial of 20, 50, 100, 200 or 250 ml
Danish: Karton med et hætteglas af 20, 50, 100, 200 eller 250 ml
English: Cardboard box with a PET vial of 20, 50, 100, 200 or 250 ml.
Danish: Kartonæsker med PET-hætteglas a 20, 50, 100, 200 eller 250 ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket til hætteglas a 20, 50 ml
English: Cardboard box with type I glass vial of 20 ml, 50 ml, 100 ml or 250 ml.
Danish: Kartonæske med hætteglas (type I) a 20, 50, 100 eller 250 ml.
English: adhe.
Danish: B.
English: Cardboard box with a glass vial of 20, 50, 100 or 250 ml.
Danish: Karton med hætteglas a 20, 50, 100 og 250 ml.
English: Treatment should not be restarted until the woman is completely mobilised.
Danish: Behandlingen bør ikke genoptages, før kvinden er fuldstændig mobiliseret.
English: • drinking too much alcohol
Danish: • at drikke for meget alkohol
English: This applies to the following medicines:
Danish: Det gælder følgende lægemidler:
English: Regularly check your breasts.
Danish: Undersøg dine bryster regelmæssigt.
English: • if you become pregnant
Danish: • hvis du bliver gravid
English: Date of first authorisation: 16 December 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 16. december 2014 Dato for seneste fornyelse:
English: Therapy should then be continued as before.
Danish: Behandlingen bør derefter fortsætte som før.
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: kan ikke estimeres ud fra forhåndenværende data
English: The recommended dose is one tablet once daily.
Danish: Den anbefalede dosis er én tablet én gang dagligt.
English: There is no specific antidote.
Danish: Der er ingen specifik antidot.
English: • any of the conditions mentioned under ‘Do not take DUAVIVE'
Danish: • en af de tilstande, der er nævnt under "Tag ikke Duavive"
English: You are advised to:
Danish: Du opfordres til:
English: Povidone (E1201)
Danish: Povidon (E1201)
English: If you notice any of the following:
Danish: Hvis du bemærker én eller flere af følgende:
English: County Kildare Ireland
Danish: County Kildare Irland
English: Annual monitoring of serum triglyceride levels should therefore be considered.
Danish: Årlig monitorering af serumtriglyceridniveauet bør derfor overvejes.
English: • getting older
Danish: • at blive ældre
English: This medicine is not for use in children and adolescents below 18 years old.
Danish: Dette lægemiddel må ikke anvendes til børn og unge under 18 år.
English: The additional risk becomes clear within a few years.
Danish: Den øgede risiko viser sig inden for nogle få år.
English: Free or biological active hormone concentrations are unchanged.
Danish: Frie eller biologisk aktive hormonkoncentrationer er uændrede.
English: No overall differences in safety or efficacy were observed between women aged >65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out.
Danish: Der blev ikke observeret nogen generelle forskelle i sikkerhed eller effekt mellem kvinder > 65 år og yngre kvinder, men større følsomhed hos nogle ældre personer kan ikke udelukkes.
English: The use of DUAVIVE carries risks, which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Danish: Brug af Duavive indebærer risici, som bør overvejes, når det skal besluttes, om du skal starte med at tage det, eller om du skal fortsætte med at tage det.
English: • if you have cancer.
Danish: • hvis du har kræft
English: Your doctor may decide to perform a physical examination.
Danish: Din læge kan beslutte at udføre en helbredsundersøgelse.
English: The occurrence of such a reaction is more likely in the first year of treatment.
Danish: Det er mere sandsynligt, at en sådan hændelse forekommer i det første år af behandlingen.
English: If you are having an operation
Danish: Hvis du skal opereres
English: Other things that can increase the risk of stroke include:
Danish: Andre forhold, der kan øge risikoen for slagtilfælde, omfatter:
English: This might lead to irregular bleeding.
Danish: Dette kan medføre uregelmæssig blødning.
English: • if you are seriously overweight (BMI >30 kg/m
Danish: • hvis du er svært overvægtig (BMI større end 30 kg/m2)
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and treatment should only be continued as long as the benefit outweighs the risk.
Danish: I alle tilfælde bør der foretages en nøje vurdering af fordele og risici mindst en gang om året, og behandlingen bør kun fortsættes, så længe fordele opvejer risici.
English: * Taken from baseline incidence rates in developed countries Overall risk ratio.
Danish: * Fra incidens-rater ved baseline i udviklede lande Samlet risk ratio.
English: Do not take this medicine if you are pregnant, or if you think you might be pregnant.
Danish: Tag ikke dette lægemiddel, hvis du er gravid, eller hvis du tror, at du kan være gravid.
English: The extra risk depends on how long you take HRT.
Danish: Denne øgede risiko afhænger af, hvor længe du tager HRT.
English: Swallow the tablet whole with a glass of water.
Danish: Synk tabletten hel sammen med et glas vand.
English: Ask your doctor when you can start taking this medicine again.
Danish: Spørg lægen om, hvornår du kan starte med at tage dette lægemiddel igen.
English: There is no evidence that HRT will prevent a heart attack.
Danish: Der er ingen dokumentation, der tyder på, at HRT vil forebygge et hjerteanfald.
English: Steady-state concentrations are achieved by the second week of once-daily administration.
Danish: Steady-state-koncentrationer opnås i den anden uge med administration én gang dagligt.
English: The data from the largest randomised trial are summarised below:
Danish: Data fra det største randomiserede studie er opsummeret nedenfor:
English: Free T4 and free T3 concentrations are unaltered.
Danish: Koncentrationen af frit T4 og frit T3 er uændret.
English: Medical examination/follow-up
Danish: Lægeundersøgelse/opfølgning
English: No foetal developmental anomalies were observed.
Danish: Der blev ikke observeret anomalier i fosterudviklingen.
English: Speak to your doctor for advice.
Danish: Bed din læge om råd.
English: These may be signs of a liver disease
Danish: Det kan være tegn på en leversygdom
English: Before you start taking this medicine, your doctor will ask you about your own and your family's medical history.
Danish: Før du begynder at tage dette lægemiddel, vil din læge spørge dig om din og din families sygdomshistorie.
English: Speak to your doctor if you think this dose is too strong or not strong enough.
Danish: Tal med lægen, hvis du mener, at denne dosis er for høj eller ikke er tilstrækkelig høj.
English: DUAVIVE is used for:
Danish: Duavive anvendes til:
English: • any lumps you can see or feel
Danish: • knuder, du kan se eller mærke
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i originalpakningen for at beskytte mod fugt.
English: Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Danish: Din læge vil ordinere den laveste dosis til behandling af dit symptom i kortest mulig tid.
English: • if you have systemic lupus erythematosus (SLE).
Danish: • hvis du har systemisk lupus erythematosus (SLE)
English: DUAVIVE and your heart or circulation
Danish: Duavive og dit hjerte eller kredsløb
English: • if you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
Danish: • hvis du har et problem med blodpropper, der kræver langtidsbehandling med et lægemiddel, som bruges til at forebygge blodpropper
English: • if you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, if you need to have surgery)
Danish: • hvis du er ude af stand til at gå i længere tid på grund af en større operation, alvorlig skade eller sygdom (se også punkt 3, hvis du skal opereres)
English: • Discolouration of the skin on the face or other parts of the body
Danish: • Misfarvning af huden i ansigtet eller andre dele af kroppen
English: Conditions which need supervision
Danish: Tilstand som kræver overvågning
English: You will only be prescribed this medicine if your symptoms seriously hinder your daily life and your doctor determines that other types of HRT are not appropriate for you.
Danish: Du får kun ordineret dette lægemiddel, hvis dine symptomer er til stærk gene i din dagligdag, og hvis din læge fastslår, at andre typer af HRT ikke er hensigtsmæssige for dig.
English: If you are going to have surgery, tell the surgeon you are taking DUAVIVE.
Danish: Hvis du skal opereres, skal du fortælle kirurgen, at du tager Duavive.
English: Serious venous thromboembolic events may occur rarely (less than 1 case per 1,000 patients).
Danish: Alvorlige venøse tromboemboliske hændelser forekommer sjældent (færre end 1 tilfælde pr. 1.000 patienter).
English: Intolerance to contact lenses
Danish: Intolerans over for kontaktlinser
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Danish: Men den vender tilbage til normal inden for nogle få år (højst 5), efter behandlingen er ophørt.
English: Age range (years)
Danish: Aldersgruppe (år)
English: As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery.
Danish: Som hos alle postoperative patienter skal profylaktiske forholdsregler overvejes for at forebygge VTE efter operationen.
English: EU/1/14/960/001 28 tablets
Danish: EU/1/14/960/001 28 tabletter
English: This may include an examination of your breasts and/or an internal examination, if necessary, or if you have any special concerns.
Danish: Det kan omfatte en undersøgelse af dine bryster og/eller en gynækologisk undersøgelse, hvis det er nødvendigt, eller hvis du har nogle særlige bekymringer.
English: • Difficulty wearing contact lenses
Danish: • Problem med at bære kontaktlinser
English: Circulating oestrogens exist in a dynamic equilibrium of metabolic interconversions.
Danish: Cirkulerende østrogener eksisterer i en dynamisk balance af metaboliske interkonversioner.
English: The risk ratio is not constant but will increase with increasing duration on use.
Danish: Risk ratio er ikke konstant, men vil stige med stigende behandlingsvarighed
English: During these check-ups, discuss with your doctor the benefits and risks of continuing with DUAVIVE.
Danish: Ved disse undersøgelser bør du tale med lægen om de fordele og risici, der er ved at fortsætte med Duavive.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Danish: Under behandlingen anbefales regelmæssige undersøgelser, hvis hyppighed og karakter tilpasses den enkelte kvinde.
English: • Painful red bumps on the skin
Danish: • Smertefulde røde knopper på huden
English: Tell your doctor if you have any medical problems or illnesses.
Danish: Fortæl det til lægen, hvis du har helbredsproblemer eller sygdomme.
English: The most commonly reported adverse reaction is abdominal pain, occurring in more than 10% of patients in clinical trials.
Danish: De hyppigst rapporterede bivirkninger er abdominal-smerter, som forekommer hos mere end 10 % af patienterne i de kliniske studier.
English: The relative risk does not change with age or time since menopause.
Danish: Den relative risiko ændrer sig ikke med alderen eller længden af tidsperioden efter menopausen.
English: Mean ± SD Steady-State Pharmacokinetic Parameters (n=24) Cmax (ng/mL)
Danish: Mean ± SD steady-state farmakokinetiske parametre (n=24) Cmax (ng/ml)
English: Change in cervical ectropion and secretion
Danish: Ændring i cervikal ektropion og sekretion
English: Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland.
Danish: Pfizer Ireland Pharmaceuticals, Little Connell Newbridge, County Kildare, Irland.
English: However, if it is almost time to take your next tablet, skip the tablet you missed and only take your next scheduled tablet.
Danish: Men hvis det næsten er tid til at tage din næste tablet, skal du springe den glemte tablet over og kun tage den næste planlagte tablet.
English: Some medicines may interfere with the effect of DUAVIVE.
Danish: Visse lægemidler kan påvirke virkningen af Duavive.
English: Talk to your doctor before taking this medicine if you have ever had any of the following problems, as these may return or become worse during treatment with DUAVIVE.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis du nogensinde har haft et eller flere af følgende problemer, da de kan komme tilbage eller blive værre under behandlingen med Duavive.
English: Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Danish: Resultaterne fra det største randomiserede placebo-kontrollerede studie (WHI-studiet) og det største epidemiologiske studie (MWS) er anført nedenfor.
English: Stop taking DUAVIVE and see a doctor immediately
Danish: Stop med at tage Duavive og kontakt straks lægen
English: AUCss (nghr/mL)
Danish: AUCss (ngt/ml)
English: Do not store above 25ºC.
Danish: Må ikke opbevares ved temperaturer over 25 ºC.
English: You may need to stop taking DUAVIVE about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see Blood clots in a vein).
Danish: Du skal muligvis stoppe med at tage Duavive ca. 4-6 uger før operationen for at nedsætte risikoen for en blodprop (se afsnit 2, Blodpropper i en vene).
English: Once you have started this medicine you should see your doctor for regular check-ups (at least once a year).
Danish: Når du er startet med at bruge dette lægemiddel, bør du blive undersøgt regelmæssigt af din læge (mindst en gang om året).
English: Oestrogens circulate in the blood largely bound to SHBG and albumin.
Danish: Østrogener cirkulerer i blodet, især bundet til SHBG og albumin.
English: Reasons for immediate withdrawal of therapy
Danish: Årsager til øjeblikkeligt ophør med behandlingen
English: Oestrogen therapy use does not improve cognitive function.
Danish: Brug af østrogenbehandling forbedrer ikke den kognitive funktion.
English: Breast cancer risk associated with the use of oestrogens alone is represented by several studies.
Danish: Risikoen for brystcancer, der er associeret med brugen af østrogener alene, er repræsenteret i flere studier.
English: See your doctor as soon as possible if you notice any changes, such as:
Danish: Du skal gå til lægen hurtigst muligt, hvis du bemærker nogen ændringer, f. eks.:
English: • An effect on the way in which your blood sugar (glucose) levels are controlled including increased glucose levels in the blood
Danish: • Virkning på den måde, dit blodsukker (glukose) kontrolleres, herunder øget glucoseniveau i blodet
English: This increase is most likely attributable to age-related changes in hepatic function.
Danish: Denne stigning kan sandsynligvis tilskrives aldersrelaterede ændringer i leverfunktionen.
English: These findings are considered rat-specific and presumably not relevant in humans.
Danish: Disse fund vurderes at være specifikke for rotter og er formodentlig ikke relevante for mennesker.
English: The number of extra cases of stroke due to use of HRT will increase with age.
Danish: Antallet af yderligere slagtilfælde på grund af HRT-brug vil stige med alderen.
English: • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
Danish: • en øget risiko for at få en østrogenfølsom form for kræft (f. eks. hvis en mor, søster eller bedstemor har haft brystkræft)
English: This medicinal product contains sorbitol which may affect the bioavailability of other concomitantly administered medicinal products.
Danish: Dette lægemiddel indeholder sorbitol, som kan påvirke biotilgængeligheden af andre samtidigt administrerede lægemidler.
English: If more than one tablet has been forgotten, only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets.
Danish: Hvis mere end én tablet glemmes, skal kun den seneste tablet tages, og patienten må ikke tage dobbeltdosis som erstatning for glemte tabletter.
English: These tumours are known to occur in aged nonhuman primates and were considered spontaneous in the aged monkeys and irrelevant to humans.
Danish: Disse tumorer er kendte for at forekomme hos ældre ikke-humane primater og blev betragtet som spontane hos ældre aber og uden relevans for mennesker.
English: Exacerbation of porphyria; hypocalcaemia (in patients with disease that can predispose to severe hypocalcaemia)
Danish: Forværring af porfyri, hypocalcæmi (hos patienter med sygdom, der kan prædisponere for svær hypocalcæmi )
English: Negligible (1%) amounts of BZA are eliminated in urine.
Danish: Ubetydelige ( 1 %) mængder bazedoxifen elimineres i urinen.
English: The absolute bioavailability of BZA is approximately 6%.
Danish: Den absolutte biotilgængelighed for bazedoxifen er ca. 6 %.
English: Investigations, including appropriate imaging tools, e.g., mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Danish: Undersøgelser, herunder relevante billeddiagnosticeringsværktøjer, f. eks. mammografi, bør udføres i overensstemmelse med gældende screeningsprincipper, tilpasset den enkelte patients kliniske behov.
English: If a tablet is forgotten, it should be taken as soon as the patient remembers.
Danish: Hvis en tablet glemmes, skal den tages, så snart patienten husker det.
English: These substitute for the loss of oestrogen production in menopausal women, and alleviate menopausal symptoms.
Danish: Disse substituerer for tabet af østrogenproduktion hos menopausale kvinder og lindrer menopausale symptomer.
English: 17β-estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite.
Danish: 17βestradiol omdannes reversibelt til estron, og begge kan omdannes til estriol, som er den vigtigste urinmetabolit.
English: The experience treating women older than 65 years is limited.
Danish: Der er begrænset erfaring med behandling af kvinder over 65 år.
English: If so, you should see your doctor more often for check-ups:
Danish: Hvis det er tilfældet, bør du gå til lægen oftere for at blive undersøgt:
English: Talk to your doctor if you have any concerns.
Danish: Tal med lægen, hvis du er bekymret.
English: The risk of having a stroke is about 1.5 times higher in HRT users than in non-users.
Danish: Risikoen for at få et slagtilfælde er ca. 1,5 gange så høj for HRT-brugere som for ikke-brugere.
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Danish: T3-resinoptagelsen er nedsat, hvilket afspejles i forhøjet TBG.
English: You may also have ulcers in the mouth, eyes or genitals and have a fever
Danish: Du kan også få sår i mund, øjne eller på kønsdelene og få feber.
English: Since you are more likely to get a blood clot in your veins as you get older and if any of the following applies to you, inform your doctor promptly:
Danish: Eftersom sandsynligheden for, at du får en blodprop i venerne, bliver større med alderen, og hvis noget af det følgende gælder for dig, skal du straks fortælle det til lægen:
English: If this happens, you should avoid driving or operating machines until your doctor tells you that it is safe to do so.
Danish: Hvis dette sker, bør du undgå at føre motorkøretøj og betjene maskiner, indtil din læge fortæller dig, at det er sikkert at gøre det.
English: Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Danish: Østrogener fordeles bredt i kroppen og findes generelt i højere koncentrationer i kønshormonernes målorganer.
English: DUAVIVE and cancer
Danish: Duavive og kræft
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger det nationale rapporteringssystem anført i Appendiks V.
English: If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first.
Danish: Hvis du beslutter at stoppe med at tage dette lægemiddel, før den ordinerede behandling er færdig, bør du tale med lægen først.
English: Dementia; depression; mood altered; changes in libido
Danish: Demens, depression, humørændring, ændringer i libido
English: If you have any unexpected vaginal bleeding, you must contact your doctor as soon as possible.
Danish: Hvis du har uventet blødning fra skeden, skal du kontakte lægen hurtigst muligt.
English: Risk ratio & 95% CI
Danish: Risikoratio & 95 % CI