FrancophonIA/ELRC3.0 huggingface dataset:
English: • The medicine Esmya, used to treat uterine fibroids, has been reviewed because cases of serious liver problems have occurred in women taking the medicine, including four cases that resulted in liver transplantation.
Danish: • Lægemidlet Esmya, der anvendes mod uterusfibromer, er blevet gennemgået som følge af en række tilfælde af alvorlige leverproblemer, der er set hos kvinder, som tager lægemidlet, herunder fire tilfælde, der endte med levertransplantation.
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are benign (non-cancerous) tumours of the womb, in women who have not reached the menopause.
Danish: Esmya blev godkendt i EU i 2012 til behandling af moderate til svære symptomer på uterusfibromer (godartede svulster i livmoderen) hos kvinder, der ikke har nået overgangsalderen.
English: Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb).
Danish: Esmya anvendes til at behandle moderate til svære symptomer på uterusfibromer (godartede tumorer i livmoderen).
English: • Healthcare professionals prescribing Esmya in the EU will receive a letter with further details once a European Commission decision has been issued.
Danish: • Der er sendt et brev med nærmere oplysninger til de sundhedspersoner, der ordinerer Esmya i EU.
English: • Four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury have been reported in patients treated with Esmya (ulipristal acetate).
Danish: • Der er rapporteret om tilfælde af leverskade hos patienter, der blev behandlet med Esmya (ulipristalacetat), herunder fire tilfælde af alvorlig leverskade, som medførte levertransplantation.
English: ATCvet code: QI05AD02.
Danish: ATCvet kode: QI05AD02.
English: Date of first authorisation: 06/03/2003 Date of last renewal: 06/03/2013
Danish: Dato for første markedsføringstilladelse: 06/03/2003 Dato for seneste fornyelse af markedsføringstilladelse: 06/03/2013
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet ( 2 °C - 8 °C ).
English: The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
Danish: De aktive stoffer er principielt af biologisk oprindelse med henblik på at give aktiv immunitet i henhold til Forordning (EU) 470/2009.
English: A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
Danish: En let temperaturforøgelse (max. 1,5 oC) kan forekomme i 1 dag, undtagelsesvis i 2 dage.
English: The excipients, including adjuvants, 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Danish: adjuvans, der er nævnt i produktresuméets afsnit 6.1, er enten tilladte stoffer, for hvilke det er angivet i tabel 1 i bilaget til Kommissionens forordning (EU) No 37/2010, at der ikke kræves nogen MRL-værdier eller opfattes som at høre ind under Forordning (EU) No 470/2009, når de anvendes som angivet i dette lægemiddel.
English: Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Danish: Efter administration af en overdosis af vaccinen, er der ikke observeret andre bivirkninger end de under punkt 4.6. beskrevet.
English: A transient swelling which usually regresses within 4 days may appear at the injection site.
Danish: Forbigående hævelse , der sædvanligvis forsvinder i løbet af 4 dage, kan forekomme på injektionsstedet.
English: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Danish: Aktiv immunisering af heste, der er 4 måneder eller ældre, mod influenza for at nedsætte kliniske symptomer og virusudskillelse efter infektion.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 10 doser : 10 hætteglas à 1 dosis
English: In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
Danish: Undtagelsesvis kan der iagttages apati og nedsat ædelyst dagen efter vaccination.
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Danish: Undtagelsesvis kan der ses hypersensitivitetsreaktion, der kan kræve korrekt symptomatisk behandling.
English: The vaccine stimulates active immunity against equine influenza.
Danish: Vaccinen stimulerer aktiv immunitet mod influenza.
English: Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.
Danish: Varighed af immunitet opnået efter vaccinationsprogrammet: 5 måneder efter basisvaccination og 1 år efter tredje vaccination.
English: Manufacturer responsible for the batch release: MERIAL
Danish: Fremstiller af batchfrigivelse: MERIAL,
English: In very rare occasions, abscessation may be observed.
Danish: I meget sjældne tilfælde kan der ses abscesdannelse.
English: Carbomer ........................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Danish: Carbomer……………………………………………………………………… ............................... .4 mg Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: 2nd scheme - vaccination against equine influenza and tetanus:
Danish: 2. program - vaccination mod influenza og tetanus:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1st scheme - vaccination against equine influenza:
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ 1. program - vaccination mod hesteinfluenza:
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som , men ikke blandet med Merials dræbte vaccine mod rabies; dog på et andet administrationssted
English: Pain, local hyperthermia and muscle stiffness can occur in rare cases.
Danish: I sjældne tilfælde kan der forekomme smerte, lokal hyperthermi og muskelstivhed.
English: - Revaccination: 5 months after primary vaccination course followed by annual booster injections.
Danish: - Revaccination: 5 måneder efter basisvaccination og derefter årlig revaccination.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Danish: I tilfælde af forøget infektionsrisiko eller utilstrækkelig colostrumoptagelse, kan der gives yderligere en injektion ved 4 måneders alderen efterfulgt af det fulde vaccinationsprogram (basisvaccination 5-6 måneder gamle og 4-6 uger senere fulgt af revaccination).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: In very rare occasions, abcessation may be observed.
Danish: I meget sjældne tilfælde kan der ses bylddannelse.
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Danish: Administrer en dosis (1 ml) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: - Basisvaccination med ProteqFlu-Te: første injektion fra 5-6 måneders alderen, anden injektion 4-6 uger senere.
English: Administer one dose (1 ml of ProteqFlu), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later.
Danish: Administrer en dosis (1 ml ProteqFlu) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: - Basisvaccination: første injektion fra 5-6 måneders alderen, anden injektion 4-6 uger senere.
English: In rare occasions swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
Danish: Hævelse på op til 15-20 cm i diameter (der kan vare i op til 2-3 uger) observeres sjældent.
English: 1st scheme - vaccination against equine influenza:
Danish: 1. program - vaccination mod hesteinfluenza:
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Danish: Vaccinestammerne vCP2242 og vCP3011 er rekombinant canarypox virus der afgiver hæmagglutinin HA genet fra hhv. influenza virusstammerne A/eq/Ohio/03 (amerikansk stamme, Florida undergruppe clade 1) og A/eq/Richmond/1/07 (Amerikansk stamme, Florida undergruppe clade 2) hos hest.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: BETINGELSER, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: ProteqFlu suspension for injection for horses
Danish: ProteqFlu Suspension til injektion til hest.
English: Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Danish: Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt: Efter administration af en overdosis af vaccinen, er der ikke observeret andre bivirkninger end de der er beskrevet under ”Bivirkninger”.
English: Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............. ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .. ≥ 5.3 log10 FAID50*
Danish: Influenza A/eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242) ..............≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinant canarypox virus (vCP3011) ...................................................................................................................................≥ 5,3 log10 FAID50* * vCP indhold kontrolleret ved global FAID50 (fluorescent assay" infektiøs dosis 50 %) og qPCR rate mellem vCP.
English: PACKAGE LEAFLET FOR: ProteqFlu suspension for injection for horses
Danish: INDLÆGSSEDDEL ProteqFlu Injektionsvæske, suspension, til heste.
English: Bioavailability is 65 to 70 %.
Danish: Biotilgængeligheden er 65 til 70 %.
English: This needs point further discussion.
Danish: Dette punkt kræver nærmere redegørelse.
English: ATC code: C09A A04
Danish: ATC-kode: C09A A04
English: Limited data are available for overdosage in humans.
Danish: Der er begrænsede data til rådighed om overdosering hos mennesker.
English: Overall conclusion on benefit/risk
Danish: Samlet konklusion vedrørende benefit/risk-forhold
English: When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.
Danish: Såfremt der er planlagt eller konstateret graviditet, skal der skiftes til en alternativ behandling så hurtigt som muligt.
English: This may occur at any time during therapy.
Danish: Dette kan forekomme på ethvert tidspunkt under behandlingen.
English: The mechanism of this syndrome is not understood.
Danish: Mekanismen bag dette syndrom er ikke afklaret.
English: The following LoQ was adopted by the CHMP in April 2005:
Danish: Følgende liste med spørgsmål (LoQ) blev vedtaget af CHMP i april 2005:
English: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.
Danish: Meget almindelig (>1/10); almindelig (>1/100, <1/10); ualmindelig (>1/1000, <1/100); sjælden (>1/10000, <1/1000); meget sjælden (<1/10000), inklusive isolerede tilfælde.
English: No carcinogenicity has been observed in long term studies in rats and mice.
Danish: Der er ikke observeret nogen carcinogenicitet i langtidsstudier af rotter og mus.
English: An official referral for arbitration was notified by the Netherlands to the CHMP on 17.03.2005.
Danish: Nederlandene indbragte officielt en sag med henblik på voldgift for CHMP den 17.3.2005.
English: The decrease in blood pressure occurs rapidly.
Danish: Nedsættelsen af blodtrykket sker hurtigt.
English: The treatment should be discontinued one day prior to the surgery.
Danish: Behandlingen skal seponeres én dag før operationen.
English: This effect is anticipated and is usually not a reason to discontinue treatment.
Danish: Denne virkning er forudset og er normalt ikke grund til at seponere behandlingen.
English: If required, diuretic therapy may be resumed.
Danish: Hvis det er påkrævet, kan den diuretiske behandling genoptages.
English: PHARMACEUTICAL FORM Tablets.
Danish: LÆGEMIDDELFORM Tabletter.
English: Efficacy and safety of use in children has not been established.
Danish: Anvendelse til børn Effekt og sikkerhed for anvendelse til børn er ikke fastlagt.
English: Results in this population are less convincing and further differentiation of risk may be needed before this patient group can be included in the wording of the indication.
Danish: Resultaterne i denne patientgruppe er mindre overbevisende, og yderligere risikodifferentiering kan være nødvendig, før denne patientgruppe kan indgå i ordlyden af indikationen.
English: The results showed that treatment with perindopril once daily resulted in a significant absolute reduction in the primary endpoint.
Danish: Resultaterne viste, at behandling med perindopril én gang dagligt resulterede i en væsentlig absolut risikoreduktion for det primære endepunkt.
English: Studies in patients with heart failure have demonstrated:
Danish: Studier af patienter med hjerteinsufficiens har påvist:
English: Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy.
Danish: Nogle af disse patienter har udviklet alvorlige infektioner, som i nogle få tilfælde ikke har responderet på intensiv antibiotikabehandling.
English: Caution is therefore recommended since these patients may be volume and/or salt depleted.
Danish: Det anbefales derfor at udvise forsigtighed, da disse patienter kan blive volumen- og/eller saltdepleterede.
English: Perindopril is contraindicated during the second and third trimesters of pregnancy.
Danish: Perindopril er kontraindiceret under andet og tredje trimester af graviditeten.
English: increased cardiac output and improved cardiac index.
Danish: øget kardialt output og forbedret kardialt indeks.
English: About 20 % of the total quantity of perindopril absorbed is converted into perindoprilat, the active metabolite.
Danish: Ca. 20 % af den totale mængde absorberet perindopril omdannes til perindoprilat, den aktive metabolit.
English: Very rare: erythema multiforme
Danish: Meget sjældne: erythema multiforme
English: If perindopril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Danish: Hvis der anvendes perindopril til sådanne patienter, anbefales periodisk kontrol af antallet af hvide blodceller, og patienterne skal instrueres om at rapportere ethvert tegn på infektion.
English: • A warning has been introduced in Section 4.4:
Danish: • Der er indsat en advarsel i afsnit 4.4:
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMÉET FREMLAGT AF EMEA
English: recommended dose
Danish: anbefalet dosis
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Danish: Ved føring af motorkøretøj eller betjening af maskiner bør man tage højde for, at der kan forekomme lejlighedsvis svimmelhed eller træthed.
English: After repeated administration, no accumulation of perindopril is observed.
Danish: Efter gentagne doser er der ikke observeret nogen akkumulering af perindopril.
English: The applicant subsequently sent on 23.02.2005 a Position Paper to all MS stating that the indication proposed by the RMS was not acceptable, and that a broader indication reflecting the study population should be approved, namely:
Danish: Efterfølgende indsendte ansøgeren den 23.2.2005 til alle medlemsstater en erklæring om, at den af referencemedlemsstaten foreslåede indikation ikke var acceptabel, og at der burde godkendes en bredere indikation, som afspejlede hele populationen i undersøgelsen, nemlig:
English: Therefore, use in children is not recommended.
Danish: Derfor frarådes anvendelse til børn.
English: This wording would be in line with the general CHMP policy regarding products using composite endpoints for evaluation of efficacy.
Danish: Denne ordlyd vil være på linje med CHMP's generelle politik for produkter, hvis virkning evalueres ved hjælp af sammensatte endepunkter.
English: It is recommended that <COVERSYL and associated names> is taken once daily in the morning before a meal.
Danish: Det anbefales, at <COVERSYL og øvrige navne> tages én gang dagligt om morgenen før et måltid.
English: Patients with a history of revascularisation would be included in these groups of patients.
Danish: Patienter med tidligere revaskularisering ville være omfattet af disse patientgrupper.
English: • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for Coversyl and associated names (see Annex I),
Danish: • CHMP har behandlet indbringelsen i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003 vedrørende Coversyl og tilknyttede navne (jf. bilag I).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COVERSYL AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF COVERSYL OG TILKNYTTEDE NAVNE (se bilag I)
English: Renal blood flow increases as a rule, while the glomerular filtration rate (GFR) is usually unchanged.
Danish: Som regel øges den renale blodgennemstrømning, mens den glomerulære filtrationsrate (GFR) sædvanligvis er uændret.
English: Haemodialysed patients * ClCR < 15
Danish: Hæmodialysepatienter * ClKR < 15
English: The CHMP believes that the lack of a statistically significant difference for two of the three components of the composite endpoint in the EUROPA study is not a reason to restrict the indication to a single component, given that a positive and fully consistent trend for these two components is observed.
Danish: CHMP finder ikke, at den manglende signifikante forskel for to af de tre komponenter af det sammensatte endepunkt i EUROPA-undersøgelsen giver grund til at begrænse indikationen til en enkelt komponent, eftersom der ses en positiv og fuldstændig konsistent tendens for disse to komponenter.
English: • Hereditary or idiopathic angioedema;
Danish: • Hereditært eller idiopatisk angioødem;
English: After oral administration, the absorption of perindopril is rapid and the peak concentration complete within 1 hour.
Danish: Efter oral indgift absorberes perindopril hurtigt, og den maksimale koncentration nås inden for 1 time.
English: These effects are usually reversible.
Danish: Dette er sædvanligvis reversibelt.
English: In responding patients, normalisation is achieved within a month and persists without the occurrence of tachyphylaxis.
Danish: Hos patienter, der reagerer på behandlingen, opnås normalisering inden for en måned og er vedvarende uden forekomst af tachyphylaxis.
English: This indication was endorsed by several CMS.
Danish: Denne indikation blev godkendt af flere af de berørte medlemsstater.
English: The antihypertensive activity is maximal between 4 and 6 hours after a single dose and is sustained for at least 24 hours: trough effects are about 87-100 % of peak effects.
Danish: Den antihypertensive aktivitet er maksimal mellem 4 og 6 timer efter en enkelt dosis og varer i mindst 24 timer: Den gennemsnitlige effekt er ca. 87-100 % af den maksimale effekt.
English: Very rare: pancreatitis
Danish: Meget sjældne: pancreatitis
English: The peak plasma concentration of perindoprilat is achieved within 3 to 4 hours.
Danish: Den maksimale plasmakoncentration af perindoprilat opnås i løbet af 3 til 4 timer.
English: In such cases, <COVERSYL and associated names> should promptly be discontinued and appropriate monitoring should be initiated and continued until complete resolution of symptoms has occurred.
Danish: I sådanne tilfælde skal <COVERSYL og øvrige navne> seponeres omgående, og passende observation skal initieres og fortsættes, indtil symptomerne er svundet fuldstændig.
English: The dose should be increased only if the previous lower dose is well tolerated.
Danish: Doseringen bør kun øges, hvis den forudgående lavere dosis tolereres godt.
English: • the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
Danish: • anså CHMP benefit/risk-forholdet for ovenstående udvidelse af indikationen for gunstigt.
English: Dissociation of perindoprilat bound to angiotensin converting enzyme leads to an “effective” elimination half-life of 25 hours, resulting in steady-state within 4 days.
Danish: Dissociering af perindoprilat bundet til det angiotensinkonverterende enzym bevirker en ”effektiv” halveringstid for eliminering på 25 timer, der resulterer i steady-state inden for 4 dage.
English: The recommended starting dose is 4 mg given once daily in the morning.
Danish: Den anbefalede startdosis er 4 mg, der indgives én gang dagligt om morgenen.
English: This benefit was statistically significant for non-fatal MI, one of the components of the combined endpoint.
Danish: Denne gavnlige virkning var statistisk signifikant for ikke-dødeligt MI, den ene komponent i det kombinerede endepunkt.
English: Protein binding is slight (binding of perindoprilat to angiotensin converting enzyme is less than 30 %), but is concentration-dependent.
Danish: Proteinbindingen er lille (perindoprilats binding til det angiotensinkonverterende enzym er mindre end 30 %), men er koncentrationsafhængig.
English: A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
Danish: En forbigående hypotensiv respons er ikke kontraindikation for fortsat dosis, der som regel kan gives uden problemer, når blodtrykket er øget efter volumenekspansion.
English: In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.
Danish: Hos patienter med normal nyrefunktion og ingen yderligere komplicerende faktorer forekommer neutropeni sjældent.
English: The other metabolites show no inhibition of ACE activity in vitro.
Danish: De andre metabolitter viser ingen hæmning af ACE-aktivitet in vitro.
English: The CHMP recommended the granting of the type II variation to extend the indication.
Danish: CHMP anbefalede godkendelse af type II-ændringen med den udvidede indikation.
English: It is not known whether perindopril is excreted into human breast milk.
Danish: Det vides ikke, om perindopril udskilles i modermælken.
English: Pregnancy: <COVERSYL and associated names> should not be used during the first trimester of pregnancy.
Danish: Graviditet <COVERSYL og øvrige navne> må ikke bruges under første trimester af graviditeten.
English: The volume of distribution is approximately 0.2 l/kg for unbound perindoprilat.
Danish: Distributionsmængden er ca. 0,2 l/kg for ubundet perindoprilat.