FrancophonIA/ELRC3.0 huggingface dataset:
English: A PECsurfacewater refined by FOCUS modelling and corrected as a sum of predicted surface water concentration of amoxicillin and clavulanic acid (combination) was calculated as 0.036 μg/l.
Danish: PECoverfladevand blev beregnet til 0,036 μg/l, en værdi, der blev gjort mere præcis ved FOCUSmodelberegning og korrigeret som summen af de forventede koncentrationer i overfladevand af amoxicillin og clavulansyre (kombination).
English: STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names contains amoxicillin and clavulanic acid (in the form of the potassium salt) at a ratio 4:1 as active ingredients.
Danish: STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, og relaterede navne, indeholder de aktive indholdsstoffer amoxicillin og clavulansyre (som kaliumsaltet) i forholdet 4:1.
English: STRENZEN 500/125 mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients.
Danish: STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, indeholder amoxicillin og clavulansyre som aktive indholdsstoffer.
English: In conclusion, the benefit-risk ratio is considered positive for STRENZEN 500/125 mg/g powder for use in drinking water for pigs.
Danish: Som konklusion anses benefit/risk-forholdet for positivt for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs
Danish: Videnskabelige konklusioner og begrundelse for udstedelse af markedsføringstilladelse for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin
English: Overall summary of the scientific evaluation of STRENZEN 500/125 mg/g powder for use in drinking water for pigs
Danish: Samlet resumé af den videnskabelige vurdering af STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin
English: Predicted environmental concentrations (PECs) of amoxicillin and clavulanic acid in soil were calculated in phase I. All PECsoil values for amoxicillin exceeded the trigger value 100 μg/kg.
Danish: I fase I beregnedes de forventede miljøkoncentrationer (PEC) af amoxicillin og clavulansyre i jord.
English: Grounds for the granting of marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs
Danish: Begrundelse for udstedelse af markedsføringsgodkendelse for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin
English: United Kingdom
Danish: Tjekkiet
English: 5 May 2009 EMEA/215198/2009
Danish: 5. maj 2009 EMEA/215198/2009
English: The final opinion was converted into a Decision by the European Commission on 5 May 2009.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 5. maj
English: The Decentralised Procedure IE/V/0200/001/DC started on 19 January 2007.
Danish: Den decentrale procedure IE/V/0200/001/DC blev indledt den 19. januar 2007.
English: UNISOL 10% ORAL SOLUTION
Danish: UNISOL 10 % ORAL OPLØSNING
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR
Danish: UDTALELSE EFTER EN INDBRINGELSE I HENHOLD TIL ARTIKEL 33, STK. 4, VEDRØRENDE
English: International Non-Proprietary Name (INN): Enrofloxacin
Danish: Internationalt fællesnavn (INN): Enrofloxacin
English: The Rapporteur and Co-Rapporteur appointed were: Dr Anja Holm (Denmark) and Dr Boris Kolar (Slovenia), respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. Anja Holm (Danmark) og dr. Boris Kolar (Slovenien).
English: Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Danish: Enrofloxacin er et syntetisk, bredspektret antimikrobielt stof, som tilhører fluoroquinolongruppen af antibiotika.
English: On the basis of the grounds for referral, the points considered by the CVMP were:
Danish: På basis af begrundelsen for indbringelsen af sagen blev følgende punkter taget i betragtning af CVMP:
English: The Committee limited its considerations to the data presented by the Applicant in the dossier for this product in line with the restrictions in legislation with respect to data on environmental risk.
Danish: Udvalget begrænsede sine betragtninger til de data, som ansøgeren havde fremlagt i dossieret for produktet, i overensstemmelse med begrænsningerne i lovgivningen med hensyn til data om miljørisici.
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredient.
Danish: Udvalget fremsatte ikke betragtninger eller drog konklusioner med hensyn til konklusionernes anvendelighed på andre godkendte produkter indeholdende det samme aktive stof.
English: Written explanations were provided by the Applicant on 17 November 2008.
Danish: Virksomheden fremsendte skriftlige redegørelser den 17. november 2008.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Ireland and the Concerned Member States were Belgium, Czech Republic, Germany and Poland.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Irland og de berørte medlemsstater Belgien, Den Tjekkiske Republik, Tyskland og Polen.
English: On 29 April 2008 Ireland, referred the matter to the EMEA under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that enrofloxacin may present a potential serious risk to the environment (risk to blue-green algae and to terrestrial plants).
Danish: Den 29. april 2008 henviste Irland i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF sagen til EMEA på grund af betænkeligheder rejst af Tyskland med hensyn til, at enrofloxacin kan udgøre en potentielt alvorlig miljørisiko (risiko for blågrønne alger og for terrestriske planter).
English: The applicant, Universal Farma S.L., submitted an application for a decentralised procedure for Unisol 10% Oral Solution, indicated for chickens and turkeys and for oral administration via the drinking water.
Danish: Ansøgeren, Universal Farma S.L., indgav en ansøgning via den decentrale procedure for Unisol 10 % Oral Opløsning, som er indiceret til høns og kalkuner og er til oral anvendelse via drikkevandet.
English: • Identification of a potential serious risks to blue-green algae and terrestrial plants arising from the use of Unisol 10% Oral solution.
Danish: • identifikation af potentielt alvorlige risici for blågrønne alger og for terrestriske planter som følge af anvendelsen af Unisol 10 % Oral Opløsning.
English: • Adequacy of the data available in respect to the environmental risk assessment for blue-green algae and terrestrial plants;
Danish: • om de fremlagte data var tilstrækkelige med hensyn til miljørisikovurderingen for blågrønne alger og for terrestriske planter
English: During its 13-15 January 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion that the use of the product as recommended does not constitute a risk for the environment and therefore the points of disagreement raised by Germany should not prevent the granting of a Marketing Authorisation.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige drøftelse i udvalget vedtog CVMP på sit møde den 13.-15. januar 2009 ved konsensus en udtalelse om, at den anbefalede anvendelse af produktet ikke udgjorde en miljørisiko, og at de punkter, hvorom der var uenighed, og som var blevet rejst af Tyskland, ikke burde være til hinder for udstedelse af en markedsføringstilladelse.
English: July 2020
Danish: Juli 2020
English: 1 Hardly understandable.
Danish: 1 Næppe forståelig.
English: MedDRA Preferred term
Danish: MedDRA Foretrukken term
English: 3 Apparently normal language.
Danish: 3 Tilsyneladende normalt sprog.
English: No information is available.
Danish: Der foreligger ingen information.
English: Date of first authorisation: 30 May 2017
Danish: Dato for første markedsføringstilladelse: 30 maj 2017
English: 1 Requires external assistance to walk, or can crawl only.
Danish: 1 Kræver ekstern hjælp til at gå, eller kan kun kravle.
English: Cmax, µg/ml AUC0-t, µg-hr/ml Vz, ml
Danish: Cmaks, µg/ml AUC0-t, µg-t/ml Vz, ml
English: 0 Can no longer walk or crawl.
Danish: 0 Kan ikke længere gå eller kravle.
English: 2 Independent gait, as defined by ability to walk without support for 10 steps.
Danish: 2 Uafhængig gang, defineret som evne til at gå 10 skridt uden støtte.
English: Annual reports to be submitted as part of the annual reassessment
Danish: Der skal indsendes årlige rapporter som led i den årlige revurdering.
English: 0 No intelligible words or vocalizations.
Danish: 0 Ingen forståelige ord eller vokaliseringer.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre hjemmesider om sjældne sygdomme og om, hvordan de behandles.
English: This medicine may cause other side effects:
Danish: Dette lægemiddel kan give andre bivirkninger:
English: This score signifies a decline from a previous level of ability (from the individual maximum reached by the child).
Danish: Denne score indebærer en forringelse fra et tidligere niveau af taleevnen (fra den maksimale score opnået af det individuelle barn).
English: MedDRA System organ class
Danish: MedDRA Systemorganklasse
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Hvis du har yderligere spørgsmål om brugen af dette lægemiddel, så spørg lægen.
English: All infusion components must be sterile.
Danish: Alle infusionskomponenter skal være sterile.
English: The medicine is slowly pumped through the implanted device.
Danish: Lægemidlet pumpes langsomt gennem den implanterede anordning.
English: See Figure 1.
Danish: Se figur 1.
English: Clinical and laboratory monitoring
Danish: Klinisk og laboratoriemæssig monitorering
English: Please consult your doctor.
Danish: Tal med lægen.
English: Effects of the potentially increased medicinal product exposure on the periphery are unknown.
Danish: Virkninger af den potentielt hævede lægemiddeludsættelse på periferien er ukendt.
English: However, these signs may also occur in the context of device-related infections.
Danish: Disse tegn kan imidlertid også opstå i forbindelse med udstyrsrelateret infektion.
English: Product issues
Danish: Produktproblemer
English: The doctor may decide on additional monitoring if it is needed.
Danish: Lægen kan beslutte at foretage yderligere kontrol, hvis det er nødvendigt.
English: Total dose administered every other week (mg)
Danish: Total dosis der administreres hver anden uge (mg)
English: It is important to initiate treatment in children as young as possible, although patients less than 3 years of age were not included in the pivotal study.
Danish: Det er vigtigt at indlede behandling hos børn så tidligt som muligt, selvom patienter under 3 år ikke var inkluderet i pivotalstudiet.
English: In people with CLN2 disease, these materials build-up in certain parts of the body, mainly the brain.
Danish: Hos mennesker med CLN2sygdom ophobes disse materialer i visse dele af kroppen, hovedsageligt i hjernen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: På grund af manglende forligelighedsstudier må dette lægemiddel ikke blandes med andre lægemidler.
English: In addition, these investigations included very small animal numbers, mostly tested single dose groups and lacked appropriate controls.
Danish: Derudover inkluderede disse undersøgelser et meget lavt antal dyr, hvoraf de fleste grupper blev testet med enkeltdosis og manglede tilsvarende kontrolgrupper.
English: • Extension Set with 0.2 micron filter: Impromediform GmbH
Danish: • Forlængersæt med 0,2 mikron filter: Impromediform GmbH
English: CL, ml/hr t1/2, hr
Danish: CL, ml/t t1/2, t
English: Consideration of dose adjustments may be necessary for patients who may not tolerate the infusion.
Danish: Det kan være nødvendigt at overveje at justere dosis for patienter, der ikke kan tolerere infusionen.
English: When compared to the expected rate of decline based on natural history, the study results are statistically significant (p < 0.0001) (see Table 4).
Danish: Ved sammenligning med den forventede forringelsesrate, baseret på naturlig historie, var studieresultaterne statistisk signifikante (p < 0,0001) (se Tabel 4).
English: An extension line may be added if needed.
Danish: En forlængerslange kan tilføjes efter behov.
English: Treatment should be based on the benefits and risks to the individual patient as assessed by the physician.
Danish: Behandling skal baseres på fordele og risici for den individuelle patient efter lægens skøn.
English: Figure 1: Infusion System Set Up
Danish: Figur 1: Opsætning af infusionssystemet
English: • Two single-use syringes compatible with the pump equipment.
Danish: • To engangssprøjter, der er forligelige med pumpeudstyret.
English: Vision and seizure scores when combined with CLN2 score (motor and language domains) remain stable.
Danish: Visions- og anfaldsscorer, når de kombineres med CLN2-score (motor- og sprogdomæner) forbliver stabile.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Pre-treatment of patients with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of infusion.
Danish: Der anbefales præmedicinering med antihistaminer med eller uden antipyretika til patienterne 30 til 60 minutter inden start på infusionen.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before treatment with this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får behandling med dette lægemiddel.
English: Product should only be withdrawn from the unopened vials immediately prior to use.
Danish: Produktet må kun udtages fra de uåbnede hætteglas umiddelbart inden anvendelse.
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: No decline noted yet.
Danish: Der kan endnu ikke bemærkes forringelse.
English: Rate of Decline (points/48 weeks)a Overall (n = 23)
Danish: Forringelsesrate (point/48 uger) I alt (n = 23)
English: Brineura contains sodium:
Danish: Brineura indeholder natrium:
English: Age groups
Danish: Aldersgrupper
English: No correlations were found between higher ADA titres and reductions in efficacy measurements.
Danish: Der blev ikke fundet nogen korrelation mellem højere ADA-titre og målinger af nedsat effektivitet.
English: The device helps the medicine to reach a specific part of the brain.
Danish: Anordningen sørger for, at lægemidlet når en bestemt del af hjernen.
English: Convulsions are a common manifestation of CLN2 disease and are expected to occur in this population.
Danish: Konvulsioner er et almindeligt tegn på CLN2-sygdom og forventes at forekomme hos denne population.
English: Language has become recognizably abnormal: some intelligible words, may form short sentences to convey concepts, requests, or needs.
Danish: Sproget er tydeligvis blevet unormalt: Nogle ord er forståelige, kan danne korte sætninger for at udtrykke tanker, spørgsmål eller behov.
English: Hypersensitivity reactions were reported in 14 out of 24 patients (58%) treated with Brineura.
Danish: Der blev indberettet overfølsomhedsreaktioner hos 14 ud af 24 patienter (58 %), der blev behandlet med Brineura.
English: Five patients experienced a single point decrease, and 3 patients experienced a 2 point decrease.
Danish: 5 patienter havde et fald på et enkelt point, og 3 patienter havde et fald på 2 point.
English: • Program the pump alarms to sound at the most sensitive settings for pressure, rate, and volume limits.
Danish: • Programmer pumpens alarmer til at udløses ved de mest følsomme indstillinger for tryk-, hastigheds- og volumengrænser.
English: The pharmacokinetic parameters in CSF were assessed in 17 patients and are summarized in Table 5 below.
Danish: De farmakokinetiske parametre i CSV blev vurderet hos 17 patienter og er opsummeret i tabel 5 nedenfor.
English: The posology selected for patients is based on age at time of treatment and should be adjusted accordingly (see Table 1).
Danish: Den valgte dosering for patienten er baseret på alder på behandlingstidspunkt og skal justeres i overensstemmelse hermed (se tabel 1).
English: *Cerliponase alfa is produced in mammalian Chinese Hamster Ovary cells.
Danish: *Cerliponase alfa produceres i mammale ovarieceller fra kinesisk hamster.
English: CSF (N=17) Mean (SD)
Danish: CSV (N = 17) Middeltal (SD)
English: The safety and efficacy of Brineura in children less than 3 years of age has not yet been established.
Danish: Sikkerheden og virkningen af Brineura hos børn under 3 år gamle, er endnu ikke fastslået.
English: These precautions are of particular importance in patients below 3 years of age.
Danish: Disse forholdsregler er især vigtige hos patienter under 3 år.
English: • Syringe: Braun and BD Luer-Lok
Danish: • Sprøjte: Braun og BD Luer-Lok
English: Language
Danish: Sprog
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILADLSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE VILKÅR
English: Patients with advanced CLN2 disease and newborns may have decreased integrity of the blood-brain barrier.
Danish: Patienter med fremskreden CLN2sygdom og nyfødte kan have aftagende integritet af blod-hjernebarrieren.
English: Both patients have received 8 infusions and the overall safety profile of Brineura in these younger patients appears consistent with the safety profile observed in older children.
Danish: Begge patienter har fået 8 infusioner, og den overordnede sikkerhedsprofil hos disse unge patienter lader til at stemme overens med den observerede sikkerhedsprofil hos ældre børn.
English: The dose may be reduced by 50% and/or the infusion rate decreased to a slower rate.
Danish: Dosis kan reduceres med 50 %, og/eller infusionshastigheden kan sættes ned.
English: A syringe volume of 10 to 20 ml is recommended.
Danish: Der anbefales en sprøjtevolumen på 10 til 20 ml.
English: Non-interventional post-authorisation safety study (PASS): Study 190-501.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): Studie 190-501.
English: So far safety results in younger patients appears consistent with the safety profile observed in older children.
Danish: Indtil nu tyder sikkerhedsresultater for yngre patienter på konsistens med den sikkerhedsprofil, der er observeret hos ældre børn.
English: There is limited data in patients older than 8 years of age.
Danish: Der er begrænsede data for patienter over 8 år gamle.
English: A total of 15 patients out of 23 (65%) had no overall decline in CLN2 score, irrespective of baseline score, and 2 of these 15 patients increased their score by one point during the treatment period.
Danish: I alt 15 patienter ud af 23 (65 %) havde ingen forringelse i CLN2-scoren, uanset baseline-scoren, og 2 ud af disse 15 patienter øgede deres score med 1 point i løbet af behandlingsperioden.
English: This disease model primarily served to investigate the pharmacodynamic and pharmacokinetic properties of cerliponase alfa, but also aimed to evaluate the toxicity of the substance.
Danish: Denne sygdomsmodel skulle primært bruges til at undersøge de farmakodynamiske og farmakokinetiske egenskaber ved cerliponase alfa, men forsøgte også at evaluere stoffets toksicitet.
English: Genotoxicity, carcinogenicity and reproductive toxicity investigations have not been performed.
Danish: Der er ikke udført undersøgelser af genotoksicitet, carcinogenicitet eller reproduktionstoksicitet.
English: Inadequate levels of TPP1 cause CLN2 disease, resulting in neurodegeneration, loss of neurological function and death during childhood.
Danish: Utilstrækkelige niveauer af TPP1 forårsager CLN2-sygdom, hvilket resulterer i neurodegeneration, tab af neurologisk funktion og død i barndommen.
English: Birth to < 6 months 6 months to < 1 year 1 year to < 2 years
Danish: Fra fødsel til < 6 måneder 6 måneder til < 1 år 1 år til < 2 år
English: A length of 150 to 206 cm (not to exceed 400 cm) and an inner diameter of 0.1 cm is recommended.
Danish: Der anbefales en længde på 150 til 206 cm (må ikke være længere end 400 cm) og en indvendig diameter på 0,1 cm.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Danish: Opbevaringstider ogbetingelser inden anvendelse er brugerens ansvar.
English: You should not receive Brineura treatment during pregnancy unless clearly necessary.
Danish: Du må ikke modtage behandling med Brineura under graviditet, medmindre det tydeligt er nødvendigt.
English: Treatment may be interrupted if the device needs to be replaced or until the infection clears.
Danish: Behandlingen kan blive afbrudt, hvis anordningen skal udskiftes, eller indtil infektionen går væk.
English: Upon completion of the infusion, the patient status should be clinically assessed and observation may be necessary for longer periods if clinically indicated, particularly in patients less than 3 years.
Danish: Når infusionen er slut, skal patientens status vurderes klinisk, og det kan være nødvendigt med længerevarende observation, hvis det er klinisk indiceret, især hos patienter under 3 år.
English: The medicine and solution will be given over about 2 to 4 hours and 30 minutes according to your or your child's dose.
Danish: Lægemidlet og skyllevæsken gives over et tidsrum på ca. 2 til 4 timer og 30 minutter ifølge din eller dit barns dosis.
English: Thus, the non-clinical development is inconclusive with respect to the clinical safety of cerliponase alfa.
Danish: Derfor er den ikke-kliniske udvikling inkonklusiv med hensyn til den kliniske sikkerhed af cerliponase alfa.
English: These studies used the aggregate of the motor and language domains of a disease-specific clinical rating scale (see Table 3) to assess disease progression.
Danish: Disse studier anvendte den samlede sum af de motoriske og sproglige domæner på en sygdomsspecifik, klinisk rating-skala (se tabel 3) til at vurdere sygdomsprogression.
English: After long periods of use, the access device may need to be replaced and will be determined by your doctor.
Danish: Efter lang tids anvendelse skal adgangsudstyret muligvis udskiftes; dette vil lægen afgøre.
English: Not known (frequency cannot be estimated based on available data) device is displaced and does not function correctly when preparing for infusion inflammation of the brain due to device-related infection
Danish: Ikke kendt (hyppighed kan ikke estimeres baseret på tilgængelige data) Anordningen forskubbes og fungerer ikke korrekt ved klargøring til infusion Inflammation i hjernen, som skyldes udstyrsrelateret infektion
English: There are no data on the use of Brineura in pregnant women.
Danish: Der er ingen data fra anvendelse af Brineura til gravide kvinder.