FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAHs of medicinal products with substances related to valproate shall conduct a retrospective observational study to investigate the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring.
Danish: Indehaverne af markedsføringstilladelse for lægemidler, der indeholder stoffer relateret til valproat, skal gennemføre et retrospektivt observationsstudie for at undersøge sammenhængen mellem paternel eksponering for valproat og risikoen for medfødte anomalier og udviklingsmæssige sygdomme i nervesystemet, herunder autisme hos afkommet.
English: The MAHs of medicinal products with substances related to valproate shall develop and submit educational materials according to agreed core elements.
Danish: Indehaverne af markedsføringstilladelse for lægemidler, der indeholder stoffer relateret til valproat, skal udarbejde og fremsende informationsmateriale i overensstemmelse med de vedtagne væsentlige elementer.
English: The MAHs of medicinal products with substances related to valproate shall conduct an observational study to evaluate and identify the best practices for switching of valproate in clinical practice.
Danish: Indehaverne af markedsføringstilladelse for stoffer, der er relateret til valproat, skal gennemføre et observationsstudie for at evaluere og identificere bedste praksis for skift af valproat-behandling i klinisk praksis.
English: MAHs are encouraged to extend the ongoing drug utilisation study (DUS).
Danish: Indehaverne af markedsføringstilladelse opfordres til at udvide det igangværende studie af lægemiddelanvendelsen.
English: The MAHs of medicinal products with substances related to valproate shall perform a survey among patients to assess knowledge of the patients with regards to PPP as well as receipt/use of educational materials.
Danish: Indehaverne af markedsføringstilladelse for stoffer relateret til valproat skal gennemføre en undersøgelse blandt patienterne for at vurdere deres viden om graviditetsforebyggelsesprogrammet samt modtagelse/brug af informationsmaterialerne.
English: The MAHs of medicinal products with substances related to valproate shall perform a drug utilisation study to assess the effectiveness of the new risk minimisation measures and to further characterise the prescribing patterns for valproate.
Danish: Indehaverne af markedsføringstilladelse for lægemidler indeholdende stoffer, der er relateret til valproat, skal gennemføre et studie af lægemiddelanvendelsen for at vurdere virkningen af de nye risikominimerende foranstaltninger og yderligere undersøge ordinationsmønsteret for valproat.
English: The MAHs of medicinal products with substances related to valproate shall perform a survey among HCP to assess knowledge of HCP and behaviour with regard to PPP as well as receipt/use of DHPC and educational materials.
Danish: Indehaverne af markedsføringstilladelse for stoffer relateret til valproat skal gennemføre en undersøgelse blandt sundhedspersoner for at vurdere deres viden og adfærd med hensyn til graviditetsforebyggelsesprogrammet samt modtagelse/brug af det direkte brev og informationsmaterialerne.
English: ATCvet code: QI09AL
Danish: ATCvet-kode: QI09AL
English: Date of first authorization: 06/11/2015.
Danish: Dato for første markedsføringstilladelse: 06/11/2015.
English: Each dose (2 ml) contains:
Danish: Hver dosis (2 ml) indeholder:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller anses ikke for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Shelf life of the veterinary medicinal product as package for sale: 18months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 18 måneder.
English: Incompatibilities: Do not mix with any other vaccine or immunological product.
Danish: Uforligeligheder: Må ikke blandes med andre vacciner eller immunologiske lægemidler.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Den aktive substans, som principielt er af biologisk oprindelse, og hvis formål er at producere aktiv immunitet, falder ikke inden for anvendelsesområdet af Kommissionens Forordning (EF) nr.
English: Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies).
Danish: Lokale vævsreaktioner i form af hævelse på injektionsstedet der kan være forbundet med lokal varme, rødme og smerte ved berøring er meget almindelige og kan vare op til to dage (baseret på laboratorieundersøgelser af sikkerheden).
English: This resolved spontaneously within 24 hours without treatment.
Danish: Dette forsvinder spontant inden for 24 timer uden behandling.
English: 125 doses
Danish: 125 doser
English: Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
Danish: Når beholderen rystes, forsvinder den sorte aflejring, og emulsionen bliver ensartet igen.
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.
Danish: Farmakoterapeutisk gruppe: immunologiske lægemidler til svin, inaktiverede virale og inaktiverede bakterielle vacciner til svin.
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af de(t) biologisk aktive stof(fer)
English: No information is available on the safety of this vaccine in breeding boars.
Danish: Der foreligger ingen oplysninger om sikkerheden af denne vaccine hos avlsorner.
English: 10 x 25 doses 10 x 50 doses 4 x 125 doses
Danish: 10 x 25 doser 10 x 50 doser 4 x 125 doser
English: The vaccine also contains inactivated Mycoplasma hyopneumoniae.
Danish: Vaccinen indeholder også inaktiveret Mycoplasma hyopneumoniae.
English: BELGIUM
Danish: Neuve BELGIEN
English: In a laboratory study, a post-mortem examination of the injection site, performed 4 weeks after the administration of a single dose of the vaccine, revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
Danish: I et laboratoriestudie viste en undersøgelse af injektionsstedet (under en obduktion) 4 uger efter administration af en enkeltdosis af vaccinen en let inflammatorisk reaktion, hvilket kunne ses ved manglende vævsnekrose og kun let fibrose.
English: Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
Danish: Inaktiveret Mycoplasma hyopneumoniae, stamme P-5722-3
English: In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2°C.
Danish: Hos enkelte svin kan det være almindeligt, at temperaturen stiger mere end 2 °C i forhold til temperaturen før behandlingen.
English: A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose.
Danish: Der blev observeret en forbigående stigning i kropstemperatur (i gennemsnit 0,8°C) 4 timer efter administration af en overdosis på 2 x tilladt dosis.
English: During Storage, a slight black deposit may appear and the emulsion may separate into two distinct phases.
Danish: Der kan forekomme en lille, sort aflejring under opbevaring, og emulsionen kan skilles i to adskilte lag.
English: High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Danish: Hætteglas af HDPE med 50 ml, 100 ml og 250 ml (med hhv. 25, 50 og 125 doser) med et lukke af chlorobutylelastomer og forseglet med en aluminiumshætte.
English: It is intended to stimulate active immunity against PCV2 and Mycoplasma hyopneumoniae in pigs.
Danish: Den er beregnet til at stimulere aktiv immunitet mod PCV2 og Mycoplasma hyopneumoniae hos svin.
English: Thiomersal Squalane Poloxamer 401 Polysorbate 80 Monobasic potassium phosphate anhydrous Sodium chloride Potassium chloride Disodium phosphate anhydrous Sodium phosphate dibasic heptahydrate Disodium tetraborate decahydrate EDTA tetrasodium Water for injections
Danish: Dinatriumphosphat, vandfri Dibasisk natriumphophat heptahydrat Dinatriumtetraborat decahydrat Tetranatrium EDTA Vand til injektionsvæsker
English: 25 doses 50 doses
Danish: 25 doser 50 doser
English: Duration of immunity: 23 weeks after vaccination.
Danish: Varighed af immunitet: 23 uger efter vaccination.
English: A slight black deposit may appear and the emulsion may separate into two distinct phases during storage.
Danish: Der kan forekomme en lille sort aflejring under opbevaring, og emulsionen kan skilles i to adskilte lag.
English: EXP {month/year} Once broached use immediately.
Danish: EXP (Måned/år) Anvendes straks efter anbrud.
English: Suvaxyn Circo+MH RTU emulsion for injection for pigs
Danish: Suvaxyn Circo+MH RTU injektionsvæske, emulsion til svin
English: In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: For active immunization of pigs from the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.
Danish: Aktiv immunisering af svin i alderen 3 uger og opefter mod Mycoplasma hyopneumoniae for at reducere lungelæsioner forårsaget af infektion med M. hyopneumoniae.
English: PACKAGE LEAFLET: Suvaxyn Circo+MH RTU emulsion for injection for pigs
Danish: INDLÆGSSEDDEL Suvaxyn Circo+MH RTU injektionsvæske, emulsion til svin
English: Onset of immunity: from 3 weeks after vaccination.
Danish: Indtræden af immunitet: 3 uger efter vaccination.
English: Cardboard box of 10 vials of 50 ml (25 doses) or 100 ml (50 doses).
Danish: Papæske med 10 hætteglas med 50 ml (25 doser) eller 100 ml (50 doser).
English: Cardboard box of 1 vial of 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses).
Danish: Papæske med 1 hætteglas med 50 ml (25 doser), 100 ml (50 doser) eller 250 ml (125 doser).
English: The vaccine contains an inactivated recombinant chimeric Porcine Circovirus type 1 containing the Porcine Circovirus type 2 ORF2 protein and inactivated Mycoplasma hyopneumoniae.
Danish: Vaccinen indeholder et inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint circovirus type 2 ORF2-protein og inaktiveret Mycoplasma hyopneumoniae.
English: Vaccinate only healthy animals.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Kun raske dyr må vaccineres.
English: Cardboard box of 4 vials of 250 ml (125 doses).
Danish: Papæske med 4 hætteglas med 250 ml (125 doser).
English: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein Inactivated Mycoplasma hyopneumoniae strain P-5722-3
Danish: Inaktiveret, rekombinant kimært PCV type 1 med PCV type 2 ORF2-protein 2,3-12,4 RP Inaktiveret Mycoplasma hyopneumoniae, stamme P-5722-3
English: 1348 Louvain-la-Neuve
Danish: 1348 Louvain-la
English: Following administration of an oral [
Danish: Efter administration af en oral [
English: This effect was observed after 24 weeks and maintained for 76 weeks.
Danish: Denne virkning blev observeret efter 24 uger og opretholdt i 76 uger.
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Hvad du skal gøre, hvis du har glemt at tage en tablet, afhænger af, hvor lang tid der er til din næste dosis.
English: Diet and exercise can help your body use its blood sugar better.
Danish: Diæt og motion kan hjælpe din krop med at forbruge blodsukkeret bedre.
English: The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Danish: • PRAC behandlede proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004 for så vidt angår de produkter, der er anført i bilag A
English: If you note an increase in such symptoms, you should also contact your doctor.
Danish: Hvis du mærker en stigning i den slags symptomer, skal du også kontakte lægen.
English: The reduction of cardiovascular death in these patients was consistent with the overall study population.
Danish: Reduktion i kardiovaskulær død hos disse patienter var konsistent med den overordnede studiepopulation.
English: The PRAC therefore considered that the risk may constitute a possible class effect;
Danish: • PRAC var derfor af den opfattelse, at risikoen kan skyldes en mulig klasseeffekt
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret på følgende måde: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Insulin dose (IU/day) at week 52
Danish: Insulindosis (IE/dag) ved uge 52
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel og under behandlingen:
English: • increased levels of “ketone bodies” in your urine or blood
Danish: • forhøjet niveau af ketonstoffer i urinen eller blodet
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%, respectively.
Danish: Variabiliteten mellem patienter og restvariabiliteten for oral clearance af empagliflozin var henholdsvis 39,1 % og 35,8 %.
English: • a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: • din ånde lugter sødligt, en sød eller metallisk smag i munden eller en unormal lugt fra din urin eller sved.
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Danish: C]-empagliflozinopløsning til raske frivillige var fordelingen til røde blodceller ca. 37 % og plasmaproteinbindingen var 86 %.
English: Blood glucose levels, which are too high because of your type 2 diabetes, are thereby reduced.
Danish: Blodsukkertallet, som er for højt på grund af din type 2-diabetes, sænkes herved.
English: By blocking this protein, the medicine causes glucose (blood sugar), sodium (salt) and water to be removed via the urine.
Danish: Når medicinen blokerer dette protein, fjernes glucose (blodsukker), natrium (salt) og vand i højere grad via urinen.
English: Other side effects while taking Jardiance: Common
Danish: Andre bivirkninger ved at tage Jardiance:
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'):
Danish: Diabetisk ketoacidose, ses sjældent (kan forekomme hos op til 1 ud af 1.000 patienter) Følgende symptomer er tegn på diabetisk ketoacidose (se også afsnit 2, 'Advarsler og forsigtighedsregler'):
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection
Danish: Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infektioner Urinvejsinfektion
English: • blood tests may show changes related to kidney function (creatinine or urea)
Danish: • blodprøver kan vise ændringer relateret til nyrefunktionen (kreatinin eller urinstof)
English: An urge to pass urine or more frequent urination may be due to the way Jardiance works, but they can also be signs of urinary tract infection.
Danish: Stærk vandladningstrang eller hyppigere vandladning kan skyldes måden Jardiance virker på, men kan også være et tegn på urinvejsinfektion.
English: Hypoglycaemia (when used with sulphonylurea or insulin)
Danish: Hypoglykæmi (ved anvendelse sammen med sulfonylurinstof eller insulin)
English: Because no specific risk factors could be identified apart from general amputation risk factors potentially contributing to the events, the PRAC recommended that patients should be advised on routine preventative foot care and maintaining adequate hydration as a general advice to prevent amputation;
Danish: • Eftersom der ikke kunne identificeres nogen specifik risikofaktor, ud over generelle amputationsrisici, som muligvis kan bidrage til hændelserne, anbefalede PRAC som generelt råd til forebyggelse af amputation, at patienter bør rådgives om almindelig forebyggende fodpleje og fastholdelse af passende hydrering
English: The efficacy for preventing cardiovascular mortality has not been conclusively established in users of DPP-4 inhibitors or in Black patients because the representation of these groups in the EMPA-REG OUTCOME study was limited.
Danish: Virkning med hensyn til forebyggelse af kardiovaskulær mortalitet er ikke blevet fastslået konklusivt for patienter, der fik DPP-4-hæmmer, eller for sorte patienter, da disse grupper var begrænset repræsenteret i EMPA-REG OUTCOME-studiet.
English: Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Danish: Både forbedring af glykæmisk kontrol og reduktion af kardiovaskulær morbiditet og mortalitet er integrerede dele af behandlingen af type 2-diabetes.
English: The glucosuria observed with empagliflozin is accompanied by diuresis which may contribute to sustained and moderate reduction of blood pressure.
Danish: Den glukosuri, der er observeret med empagliflozin, er ledsaget af diurese, som kan bidrage til en vedvarende og moderat blodtryksreduktion.
English: The genital tract infections were mild or moderate in intensity.
Danish: Disse genitale infektioner var af let eller moderat intensitet.
English: Initial increases in creatinine and initial decreases in estimated glomerular filtration rates in patients treated with empagliflozin were generally transient during continuous treatment or reversible after drug discontinuation of treatment.
Danish: De initiale stigninger i kreatininindholdet og de initiale fald i den glomerulære filtrationshastighed hos patienter behandlet med empagliflozin var generelt forbigående under kontinuerlig behandling eller reversible efter seponering af behandlingen.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg (Figure 1) and confirmed by an improved overall survival (Table 10).
Danish: Reduktionen i kardiovaskulær død var omtrent den samme for empagliflozin 10 mg og 25 mg (figur 1) og blev bekræftet af en bedre samlet overlevelse (tabel 10).
English: • about what you can do to prevent dehydration
Danish: • så I kan drøfte, hvad du kan gøre for at forebygge væskemangel (dehydrering).
English: If you forget to take Jardiance
Danish: Hvis du har glemt at tage Jardiance
English: • straining or pain when emptying the bladder
Danish: • besvær med eller smerte ved tømning af blæren
English: The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.
Danish: Den glukosuri, natriurese og osmotiske diurese, der er observeret med empagliflozin, kan bidrage til forbedrede kardiovaskulære resultater.
English: • Jardiance can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
Danish: • Jardiance kan bruges som den eneste diabetesmedicin hos patienter, der ikke tåler metformin (en anden diabetesmedicin).
English: In 6 placebo-controlled trials of 18 to 24 weeks duration, 3,534 patients were included of which 1,183 were treated with placebo and 2,351 with empagliflozin.
Danish: I 6 placebokontrollerede studier af 18 til 24 ugers varighed inkluderedes 3.534 patienter, hvoraf 1.183 fik placebo og 2.351 empagliflozin.
English: Empagliflozin as add-on to basal insulin
Danish: Empagliflozin som supplement til basal insulin
English: Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes
Danish: Jardiance er indiceret til behandling af voksne med utilstrækkeligt kontrolleret type 2-diabetes mellitus som supplement til diæt og motion - som monoterapi, når metformin betragtes som uhensigtsmæssigt på grund af intolerans - som supplement til andre antidiabetika
English: Five studies had treatment durations of 24 weeks; extensions of those and other studies had patients exposed to empagliflozin for up to 102 weeks.
Danish: I forlængelser af disse og andre studier blev patienter eksponeret for empagliflozin i op til 102 uger.
English: Initiation of empagliflozin therapy in this population is not recommended (see section 4.2).
Danish: Initiering af behandling med empagliflozin hos denne population anbefales ikke (se pkt.
English: Table 10:Treatment effect for the primary composite endpoint, its components and mortality Placebo
Danish: Tabel 10: Behandlingens virkning, hvad angår det primære sammensatte endepunkt, endepunktets komponenter og mortalitet
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m
Danish: I den farmakokinetiske populationsanalyse blev AUC anslået til at være 13,5 % højere hos asiater med et BMI på 25 kg/m2 sammenlignet med ikke-asiater med et BMI på 25 kg/m
English: Macrogol (400) Iron oxide yellow (E172)
Danish: Macrogol (400) Jernoxid, gul (E172)
English: The PRAC was therefore of the view that the risk of lower limb amputation should be included in the product information for all products listed in Annex A, with a warning highlighting to healthcare professional and patients the importance of routine preventative foot care.
Danish: • PRAC var derfor af den opfattelse, at risikoen for amputation af nedre ekstremiteter bør tilføjes produktinformationen for alle de lægemidler, der er anført i bilag A, sammen med en advarsel, der gør sundhedspersoner og patienter opmærksomme på betydningen af almindelig forebyggende fodpleje.
English: Patients with high baseline HbA1c >10%
Danish: Patienter med høj baseline-HbA1c >10 %
English: eGFR ≥30 to <60 ml/min/1.73 m²
Danish: eGFR ≥30 til <60 ml/min/1,73 m²
English: • blood tests may show changes in blood fat (cholesterol) levels in your blood
Danish: • blodprøver kan vise ændringer i blodets indhold af fedt (kolesterol)
English: The PRAC considered that the available data on amputation in the CANVAS and CANVAS-R trials confirm that treatment with canagliflozin may contribute to an increased risk of amputation of the lower limb, mainly of the toe;
Danish: • PRAC fandt, at de tilgængelige data om amputation i CANVAS- og CANVAS-Rundersøgelserne bekræfter, at behandling med canagliflozin kan bidrage til en øget risiko for amputation af nedre ekstremiteter, primært tæer
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m
Danish: I denne analyse blev AUC anslået til at være henholdsvis 5,82 %, 10,4 % og 17,3 % lavere hos patienter med et BMI på 30, 35 og 45 kg/m2 sammenlignet med patienter med et BMI på 25 kg/m