FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST
Danish: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANKRIG
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements
Danish: Ubrugte lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.
English: Thiomersal Aluminium hydroxide Sodium chloride
Danish: Thiomersal Aluminiumhydroxid Natriumchlorid
English: Sodium hydroxide3
Danish: Natriumhydroxid3
English: First injection:
Danish: Injektion:
English: One 2 ml dose intramuscularly in the neck in the area behind the ear, according to the following schedule:
Danish: 2 ml administreres intramuskulært, i nakken bag øret som følger: Basisvaccination
English: Aluminium (as hydroxide) .................................................................................... 1.4 mg
Danish: Aluminium (som hydroxid) ...................................................................................................... 1,4 mg
English: Adhesins: F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminium adjuvant
Danish: Adhesiner F4, (F4ab, F4ac, F4ad), F5, F6,F41 Aluminium adjuvans.
English: Broached vial: 3 hours.
Danish: Anbrudt hætteglas: 3 timer.
English: Neocolipor suspension for injection
Danish: Neocolipor injektionsvæske, suspension
English: In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
Danish: Hos søer og gylte inducerer vaccinen specifik serokonvertering hos vaccinerede dyr.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE {ART/TYPE}
English: E. coli adhesin F4 (F4ab, F4ac, F4ad), at least....................................................... 2.1 SA U* E. coli adhesin F5, at least ...................................................................................... 1.7 SA.U* E. coli adhesin F6, at least ...................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................... 1.7 SA.U*
Danish: E.coli adhesin F4, (F4ab, F4ac, F4ad), min .............................................................................. 2,1 SA.U* E.coli adhesin F5, min ............................................................................................................... 1,7 SA.U* E.coli adhesin F6, min ............................................................................................................... 1,4 SA.U* E.coli adhesin F41, min ............................................................................................................. 1,7 SA.U*
English: Sodium chloride4
Danish: Natriumchlorid4
English: Name and address of the manufacturer of the biological active substance
Danish: Fremstiller af det biologisk aktive stof
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Intramuscular injection
Danish: Intramuskulær injektion.
English: The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant.
Danish: Vaccinen indeholder de inaktiverede stammer af E. Coli med adhesinerne F4ab, F4ac, F4ad, F5, F6 og F41, der forårsager neonatal enterotoxicose hos pattegrise, i aluminiumhydroxid adjuvans.
English: PACKAGE LEAFLET Neocolipor
Danish: INDLÆGSSEDDEL Neocolipor
English: *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
Danish: til at opnå en agglutinerende antistof-titer på 1 log10 i marsvin.
English: 4.2 Indications for use specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: D. STATEMENT OF THE MRLs WHICH ARE, ACCEPTED IN ACCORDANCE WITH COUNCIL REGULATION (EEC) No 2377/90
Danish: i henhold til Rådets forordning (EØF) nr. 2377/90, med senere ændringer, og i overensstemmelse med artikel 34.4b, i Rådets forordning (EØF) nr. 726/2004 af 31. marts 2004.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
Danish: Reduktion af neonatal enterotoxicosis hos pattegrise, forårsaget af E. Coli stammer, med adhesinerne F4ab, F4ac, F4ad, F5, F6 og F41, i løbet af de første levedage.
English: Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
Danish: Inaktiveret vaccine i adjuvans til reduktion af neonatal enterotoxicosis hos pattegrise, forårsaget af E. Coli stammer, med adhesinerne F4ab, F4ac, F4ad, F5, F6 og F41.
English: One 2 ml dose according to the following schedule: Primary vaccination:
Danish: En 2-ml dosis som følger: Basisvaccination 1.
English: MANUFACTURER FOR THE BATCH RELEASE MERIAL
Danish: Ansvarlig for batchfrigivelse: MERIAL
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: C. BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE SALG, UDLEVERING OG BRUG
English: Veterinary medicinal product subject to prescription.
Danish: Produktet må kun udleveres efter veterinærrecept.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Danish: ANGIVELSE AF DET AKTIVE STOFFER OG ANDRE INDHOLDSSTOFFER
English: In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to a physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp.
English: Shake the vial vigorously before use.
Danish: Omryst grundigt før brug.
English: 2 ml = 1 dose 5d
Danish: 2 ml = 1 dosis 5d 10 ml hætteglas.
English: 2 ml = 1 dose 25 d
Danish: 2 ml = 1 dosis 25d 50 ml hætteglas.
English: 2 ml = 1 dose 10 d
Danish: 2 ml = 1 dosis 10d 20 ml hætteglas.
English: Adjuvant: Aluminium (as hydroxide) ........................................................................................................... 1.4 mg
Danish: Adjuvans: Aluminium (som hydroxid) ...................................................................................................... 1,4 mg
English: EU/2/98/008/001 10 ml vial.
Danish: EU/2/98/008/001 10 ml hætteglas.
English: EU/2/98/008/004 100 ml vial.
Danish: EU/2/98/008/004 100 ml hætteglas.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: EU/2/98/008/003 50 ml vial.
Danish: EU/2/98/008/003 50 ml hætteglas.
English: 100 ml vial
Danish: 50 doser 100 ml hætteglas
English: EU/2/98/008/002 20 ml vial.
Danish: EU/2/98/008/002 20 ml hætteglas.
English: Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper).
Danish: Æske à 5 doser i 10 ml hætteglas (glastype I hætteglas med butyl gummiprop) Æske à 10 doser i 20 ml hætteglas (glastype I hætteglas med butyl gummiprop) Æske à 25 doser i 50 ml hætteglas (glastype I hætteglas med buty gummilprop) Æske à 50 doser i 100 ml hætteglas (glastype I hætteglas med butyl gummiprop)
English: Box of 50-dose 100 ml vial (glass type I vial with butyl rubber stopper).
Danish: Æske à 5 doser i 10 ml hætteglas (glastype I hætteglas med buty gummilprop) Æske à 10 doser i 20 ml hætteglas (glastype I hætteglas med butyl gummiprop) Æske à 25 doser i 50 ml hætteglas (glastype I hætteglas med butyl gummiprop) Æske à 50 doser i 100 ml hætteglas (glastype I hætteglas med butyl gummiprop) Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: F4 (F4ab, F4ac, F4ad), at least .................................................................................................... 2.1 SA.U*
Danish: F4, (F4ab, F4ac, F4ad), min ...................................................................................................... 2,1 SA.U* F5, min ...................................................................................................................................... 1,7 SA.U* F6, min ...................................................................................................................................... 1,4 SA.U* F41, min .................................................................................................................................... 1,7 SA.U*
English: F5, at least ................................................................................................................................... 1.7 SA.U*
Danish: Thiomersal ................................................................................................................................ 0,2 mg Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: All food producing species For use as excipient
Danish: Aluminiumhydroxid1 Alle arter bestemt til levnedsmiddelproduktion
English: Complete response (CR) was evaluated at the end of Block 1.
Danish: Komplet respons (CR) blev evalueret ved slutningen af blok 1.
English: These results, though not mature, constituted the protocol defined final analysis.
Danish: Disse resultater udgjorde, til trods for at de ikke var endelige, den protokoldefinerede sidste analyse.
English: Bilirubin level
Danish: Bilirubin niveau
English: Injection into a vein is rapid, taking 3 to 5 seconds.
Danish: Injektion i en vene er hurtig, tager 3-5 sekunder.
English: The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
Danish: Mekanismen ved denne hændelse er ukendt, selvom en komponent kan skyldes autonom neuropati.
English: This medicine must not be used in children and adolescents because it is not known how it will affect them.
Danish: Denne medicin bør ikke bruges til børn og unge, da det ikke vides, hvordan lægemidlet vil påvirke dem.
English: The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Danish: Den endelige analyse af OS foretaget efter en median follow-up på 8,6 år viste ingen signifikant forskel i OS mellem de to behandlingsarme.
English: Your doctor may give you another medicine to control diarrhoea
Danish: Lægen kan give dig medicin til at kontrollere diarréen med
English: Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Danish: 18 % af patienterne opnåede eller havde et forbedret respons [MR (11 %) eller PR (7 %)] ved kombinationsbehandling.
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BDx group.
Danish: Den gennemsnitlige behandlingsvarighed var 13 uger for VDDx-gruppen og 11 uger for BDx-gruppen.
English: • Diarrhoea: if this happens, it is important that you drink more water than usual.
Danish: Hvis du har diarré, er det vigtigt, at du drikker mere vand, end du plejer.
English: n: ITT patients Progression free survival (IRC)
Danish: n: ITT patients Progressionsfri overlevelse (IRC)
English: From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Danish: Fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning straks anvendes efter tilberedning.
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III
Danish: Tabel 14: Resumé af sygdomsresultater fra fase III- (APEX) og fase II-studier Fase III
English: A hazard ratio less than 1 indicates an advantage for VMP
Danish: En Hazard ratio på mindre end 1 indikerer en fordel for VMP
English: Pregnancy and breast-feeding You must not use this medicine if you are pregnant, unless clearly necessary.
Danish: Graviditet og amning Du må ikke bruge denne medicin, hvis du er gravid, medmindre det er absolut nødvendigt.
English: In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant
Danish: I den refraktære population i fase II-studiet blev responsen fastlagt af en uafhængig evalueringskomité, og responskriterierne fra The European Bone Marrow Transplant Group blev brugt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis den rekonstituerede opløsning ikke anvendes straks, er opbevaringstider og -betingelser før anvendelse brugerens ansvar.
English: Consider reduction of the melphalan dose by 25% in the next cycle.
Danish: Overvej en 25 % reduktion af melphalandosis i den næste cyklus
English: In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Danish: I 6-måneders studiet med rotter, observeredes degenerativ effekt i både testikler og ovarier.
English: It is, therefore, likely that bortezomib could have a potential effect on either male or female fertility.
Danish: Det er derfor sandsynligt, at bortezomib kan have en potentiel effekt på enten mandlig eller kvindelig fertilitet.
English: An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Danish: Et effektivt re-induktion flerstofs-kemoterapi-regime blev administreret i 3 blokke.
English: If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated.
Danish: Hvis der er mistanke om PML, skal patienterne henvises til en PML-specialist, og der bør indledes passende diagnostiske undersøgelser for PML.
English: May be fatal if given by other routes
Danish: Kan være dødelig, hvis gives via andre administrationsveje.
English: • If several bortezomib doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Danish: • Hvis flere doser bortezomib i en cyklus bliver seponeret (≥ 3 doser under to gange ugentlig administration eller ≥ 2 doser under ugentlig administration)
English: The reported efficacy data are considered inconclusive (see section 4.2).
Danish: De rapporterede effektdata anses som værende ikkeentydig (se pkt.
English: No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Danish: Der var ingen information vedrørende mulige sequelae eller hyppighed af resolution af perifer neuropati tilgængeligt i dette studie.
English: 1-year Overall Survival (%)
Danish: Samlet overlevelse efter 1 år (%)
English: For these dose cohorts, the combined 1-year survival rate was 88.1%.
Danish: For disse dosiskohorter var den kombinerede overlevelse efter 1 år 88,1 %.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Danish: En protokoldefineret interimanalyse (baseret på 249 TTP-hændelser) affødte tidlig afslutning af studiet grundet effekt.
English: Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Danish: Sekundære effektmål omfattede progressionsfri overlevelse og samlet overlevelse.
English: by continuous infusion over 24 hours is not recommended.
Danish: ved kontinuerlig infusion over en periode på 24 timer.
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Danish: * Baseret på dosisændringer i fase II- og III-myelomatosestudier og erfaring efter markedsføring.
English: Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Danish: De fleste tilfælde af PML blev diagnosticeret inden for 12 måneder efter første dosis af bortezomib.
English: Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses.
Danish: Bortezomib elimineres hurtigere efter første dosis sammenlignet med efterfølgende doser.
English: By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Danish: Ved multivarians-analyse var responsraten uafhængig af myelomtype, performance status, kromosom 13 deletion-status og antallet eller typen af tidligere behandling.
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Danish: Grad 4 (livstruende konsekvenser; kræver akut intervention) og/eller autonom svær neuropati
English: In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (table 15).
Danish: Desuden viste de sekundære effektmål, som var relateret til respons og tid til hændelse, overensstemmende resultater for subkutan og intravenøs administration (tabel 15).
English: Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Danish: Din læge vil bestemme dosis af bortezomib ud fra din højde og vægt (areal af legemsoverflade).
English: BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Danish: BSA-normaliseret clearance af bortezomib hos pædiatriske patienter var den samme som den, der observeres hos voksne.
English: This medicinal product does not require any special temperature storage condition.
Danish: Dette lægemiddel har ingen særlige opbevaringsbetingelser.
English: There were 140 patients with ALL or LL enrolled and evaluated for safety; median age was 10 years (range 1 to 26).
Danish: 140 patienter med ALL eller LL blev inkluderet for at evaluere sikkerhed; den mediane alder var 10 år (rangerende fra 1 til 26).
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Danish: b Op til 6 cyklusser kan gives til patienter, der som minimum udviser partielt respons efter 4 cyklusser
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered B+M+P treatment.
Danish: På tidspunktet for en præspecificeret interimanalyse var det primære effektmål, tid til progression, opnået, og patienterne i M+P-armen blev tilbudt B+M+P-behandling.
English: e Median duration of follow up is 11.8 months
Danish: Median varighed af opfølgning er 11,8 måneder
English: The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Danish: Det primære effektmål var bedste bekræftede respons på genbehandling vurderet ud fra EBMTkriterierne.
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Danish: Den endelige opdatering af overlevelsesdata fandt sted med en median varighed af opfølgning på 60,1 måneder.
English: • low numbers of red or white blood cells
Danish: • Lavt antal røde eller hvide blodlegemer
English: B=bortezomib; M=melphalan, P=prednisone
Danish: B=bortezomib; M=melphalan, P=prednison
English: RR (Post-transplant)
Danish: RR (Posttransplantation)
English: In the BTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Danish: I BTDx-gruppen var 12 % af patienterne cytogenetisk klassificeret som højrisiko versus 16 % af patienterne i TDx-gruppen.
English: One hundred and twenty seven matched pairs of patients were identified.
Danish: Der blev identificeret 127 matchede patientpar.
English: Once weekly bortezomib (cycles 5-9)
Danish: En gang om ugen bortezomib (cyklus 5-9)
English: Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Danish: Væskeretention kan være en forudgående faktor for tegn og symptomer på hjertesvigt.
English: The resulting solution is then either injected into a vein or under the skin.
Danish: Opløsningen bliver derefter indsprøjtet i en vene eller under huden.
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Danish: Det primære effektmål var progressionsfri overlevelse baseret på en bedømmelse fra en uafhængig evalueringskomité (IRC).
English: After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Danish: Efter korrektion for BSA-effekten havde andre demografiske data, som f.eks. alder, legemsvægt og køn, ikke klinisk signifikant effekt på bortezomibclearance.
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 via det nationale rapporteringssystem anført i Appendiks V*.
English: In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Danish: I tilfælde af nye eller forværrede lungesymptomer (f.eks. hoste, dyspnø) er det nødvendigt med en hurtig diagnosticering, og at patienterne behandles i overensstemmelse hermed.
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Danish: Uanset β2-mikroglobulintal ved baseline var alle effektparametre (tiden indtil progression og samlet overlevelse samt responsrate) signifikant forbedret i bortezomib-armen.
English: (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Danish: (CrCl=20-39 ml/min/1,73 m2, n=9) og Alvorlig (CrCl < 20 ml/min/1,73 m2, n=3).
English: Reduction in serum M-protein population g n=667
Danish: Reduktion i serum M-protein Population g n=667
English: Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm.
Danish: Både hos de patienter, som var refraktære over for den seneste forudgående behandling, og de, der ikke var refraktære, var den samlede overlevelse signifikant længere, og responsraten var signifikant højere i bortezomib-armen.
English: • moderate to severe liver problems
Danish: • Moderate til svære problemer med leveren
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
Danish: Protokollen tillod, at patienterne fik dexametason, hvis de havde haft en mindre end optimal respons til bortezomib alene.
English: Intent to Treat Population b n=74
Danish: Intention to treat population b n=74
English: It is recommended that patients receive 2 cycles of bortezomib following a confirmation of a complete response.
Danish: Det anbefales, at patienterne får to cyklusser med bortezomib efter bekræftelse af komplet respons.
English: When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Danish: Når bortezomib gives sammen med thalidomid og dexamethason, er varigheden af en behandlingscyklus 28 dage (4 uger).
English: NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
Danish: NF-κB er en transskriptionsfaktor, hvis aktivering kræves til mange aspekter af tumorgenese, inklusive cellevækst og -overlevelse, angiogenese, celle-celle-interaktioner og metastase.