FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant investigated the solubility of drug substance across the physiological pH range and confirmed the very low solubility of glimepiride.
Danish: Ansøgeren undersøgte lægemiddelstoffets opløselighed gennem det fysiologiske pH-område og bekræftede glimepirids meget lave opløselighed.
English: However, concerns were raised regarding the evidence of bioequivalence, considering the study conducted with the 1 mg tablet to be insufficient to provide evidence of bioequivalence for the higher strengths, as bioequivalence studies for substances with low solubility should be conducted at the highest strength according to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), unless the active substance is highly soluble or if there are safety/tolerability reasons.
Danish: Der blev imidlertid fremsat betænkeligheder vedrørende dokumentationen af bioækvivalens, hvor undersøgelsen med 1-mg-tablet blev betragtet som utilstrækkelig til at dokumentere bioækvivalens for højere styrker, da bioækvivalensundersøgelser for stoffer med lav opløselighed bør udføres med højeste styrke i henhold til CHMP's retningslinjer for undersøgelse af bioækvivalens (CPMP/EWP/QWP/1401/98 Rev. 1/Korr), medmindre det aktive stof er letopløseligt, eller hvis der er sikkerhedsmæssige/tolerabilitetsmæssige årsager.
English: The CHMP was therefore of the view that absorption is not dependent or limited by in vivo drug dissolution and that the low solubility of glimepiride does not prevent granting a biowaiver for the 2, 3 and 4 mg strengths.
Danish: CHMP var derfor af den opfattelse, at absorption ikke er afhængig eller begrænset af in vivostofopløsning, og at glimepirids lave opløselighed ikke forhindrer tildeling af en ”biowaiver" ved styrkerne 2, 3 og 4 mg.
English: The CHMP assessed the open label, randomized, comparative bioavailability study of glimepiride 1 mg tablets under fasting conditions and the Applicant justifications for the design of the study.
Danish: CHMP vurderede den åbne, randomiserede, sammenlignende biotilgængelighedsundersøgelse af glimepirid 1-mg-tabletter under fastebetingelser og ansøgerens begrundelser for undersøgelsens udformning.
English: The CHMP considered that the dissolution studies confirmed that the low dissolution of glimepiride is related to the drug substance rather than to the formulation and that all strengths of the proposed product have similar qualitative and quantitative compositions, leading to similar in vivo absorption.
Danish: CHMP fandt, at opløsningsundersøgelserne bekræftede, at den lave opløsning af glimepirid var relateret til lægemiddelstoffet og ikke til formuleringen, og at alle styrker af det foreslåede lægemiddel havde samme kvalitative og kvantitative sammensætninger, hvilket medfører tilsvarende in vivo-optagelse.
English: The CHMP also reviewed the biopharmaceutical data and agreed that the proposed and the reference products have similar dissolution profiles, when comparing the 1 mg and the 4 mg strengths separately.
Danish: CHMP gennemgik også de biofarmaceutiske data og besluttede, at det foreslåede lægemiddel og referencelægemidlerne havde samme opløsningsprofil, når 1-mg-styrken og 4-mg-styrken sammenlignes separat.
English: The CHMP assessed the Applicant justifications and agreed that glimepiride is associated with a risk of hypoglycaemic reactions, in particular in healthy subjects, including at the lowest 1 mg dose.
Danish: CHMP vurderede ansøgerens begrundelser og besluttede, at glimepirid var forbundet med en risiko for hyperglykæmiske reaktioner, især hos sunde testpersoner, selv ved den laveste 1-mg-dosis.
English: • the CHMP considered the conducted bioequivalence study to be adequate to demonstrate bioequivalence between the proposed and the reference products,
Danish: • CHMP mente, at den udførte bioækvivalensundersøgelse var tilstrækkelig til at påvise bioækvivalens mellem det foreslåede lægemiddel og referencelægemidlerne
English: The CHMP therefore considered that the conducted fasting bioequivalence study using the 1 mg strength was acceptable and adequate to demonstrate bioequivalence between test and reference formulations, while ensuring the safety of the study subjects.
Danish: CHMP mente derfor, at den bioækvivalensundersøgelse hos fastende, der blev udført med 1-mg-styrken, var acceptabel og tilstrækkelig til at påvise bioækvivalens mellem test- og referenceformuleringer under hensyntagen til testpersonernes sikkerhed.
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Glimepirida Parke-Davis and associated names (see Annex I).
Danish: • CHMP vurderede, at den ønskede ”biowaiver" for styrkerne 2, 3 og 4 mg var acceptabel har CHMP anbefalet bevilling af markedsføringstilladelse, for hvilken produktresuméet, etiketteringen og indlægssedlen forbliver i henhold til den endelige udgave, der blev udarbejdet i forbindelse med koordineringsgruppens procedure, og som nævnt i bilag III for Glimepirida Parke-Davis og relaterede navne (se bilag I).
English: Having reviewed the available literature, the Applicant concluded that fasting studies involving glimepiride appeared to be associated with a considerable risk of hypoglycaemia, even with the 1 mg dose.
Danish: Efter at have gennemgået den tilgængelige litteratur konkluderede ansøgeren, at fasteundersøgelser, der involverer glimepirid, syntes at være forbundet med en betragtelig risiko for hyperglykæmi, selv med en dosis på 1 mg. Ansøgeren udforskede efterfølgende antageligheden af at gennemføre en undersøgelse med brug af 1-mg-tabletten med henblik på at afstå fra undersøgelser med højere styrker.
English: The CHMP considered that a further bioequivalence study using the 4 mg dose is not anticipated to provide significantly better discriminatory power between the different formulations, given the biopharmaceutical features of this glimepiride formulation and that such a study would therefore be unnecessary and ethically unacceptable, given the risk of hypoglycaemia.
Danish: CHMP var også af den opfattelse, at de fremlagte biofarmaceutiske og farmakokinetiske data bekræftede den tilstrækkelige følsomhed af den bioanalytiske metode og yderligere støttede antageligheden af den ønskede ”biowaiver” for styrkerne 2, 3 og 4 mg. CHMP mente, at en yderligere bioækvivalensundersøgelse med en dosis på 4 mg ikke kunne forventes at give væsentlig større, diskriminerende styrke mellem de forskellige formuleringer på grund af de biofarmaceutiske egenskaber ved denne glimepiridformulering, og at en sådan undersøgelse derfor ville være unødvendig og etisk uacceptabel på grund af risikoen for hyperglykæmi.
English: Packaging Content (concentration)
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (koncentration)
English: ATCvet code: QI09AB03.
Danish: ATCvet-kode: QI09AB03
English: Duration of immunity: six months.
Danish: Varighed af immunitet: seks måneder.
English: Date of first authorisation: 4/07/2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 4/07/2014 Dato for seneste fornyelse af markedsføringstilladelse:
English: To stimulate active immunisation against swine erysipelas.
Danish: Til stimulering af aktiv immunisering mod svine-erysipelas.
English: Onset of immunity: three weeks after completion of the basic vaccination scheme.
Danish: Indtræden af immunitet: Tre uger efter gennemførelse af basisvaccinationsplanen.
English: IMMUNOLOGICAL PROPERTIES
Danish: EGENSKABER IMMUNOLOGISKE EGENSKABER
English: Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer, adjuvanserne eller et eller flere af hjælpestofferne.
English: Special precautions for use in animals None.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Ingen.
English: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran
Danish: Aluminiumhydroxid ............................................................................................. 5,29 mg (aluminium) DEAE-dextran
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF (FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: Suspension for injection.
Danish: Hvidlig suspension til injektion.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles (20 ml, 50 ml) and vials (20 ml, 50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER FLASK (20 ml, 50 ml), HÆTTEGLAS (20 ml, 50 ml)
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) bottles (100 ml and 250 ml) and vials (100 ml)
Danish: KARTONÆSKE, (20 ml, 50 ml, 100ml, og 250ml) FLASK (100 ml, 250 ml) OG HÆTTEGLAS (100 ml)
English: In 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 vises til lægen.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer)
English: Special precautions for use in animals:
Danish: Særlige forsigtighedsregler vedrørende brug til dyr
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første åbning af den indre emballage: nvendes straks
English: PACKAGE LEAFLET: ERYSENG suspension for injection for pigs
Danish: INDLÆGSSEDDEL: ERYSENG injektionsvæske, suspension til grise
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated bacterial vaccines, erysipelothrix.
Danish: Inaktiverede bakterielle vacciner, erysipelothrix.
English: Intramuscular use.
Danish: Intramuskulær anvendelse
English: Store and transport refrigerated Do not freeze.
Danish: Opbevares og transporteres nedkølet.
English: ERYSENG suspension for injection for pigs
Danish: ERYSENG Injektionsvæske, suspension til grise
English: Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ..................... ELISA > 3.34 log2 IE50%* * IE50% - Inhibition ELISA 50%.
Danish: Inaktiveret Erysipelothrix rhusiopathiae, stamme R32E11 ............ ELISA > 3,34 log2 IE50 % * * IE50 % hæmning ELISA - 50 %
English: • allergic reactions as described above
Danish: • allergiske reaktioner som beskrevet ovenfor
English: • hair loss: in most cases normal hair growth should return.
Danish: • hårtab: i de fleste tilfælde vil normal hårvækst vende tilbage.
English: 1 to day 4.
Danish: 1 til dag 4.
English: More severe reactions may occur.
Danish: Der kan også opstå mere alvorlige reaktioner.
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Danish: TTP = tid indtil progression; “ne” angiver, at værdien ikke kunne estimeres eller endnu ikke var klarlagt.
English: Results on these end-points were supportive of the primary end-points results.
Danish: Resultaterne fra disse endepunkter understøttede de resultaterne fra de primære endepunkter.
English: Tumour size ≤2 cm >2 cm
Danish: Tumorstørrelse ≤ 2 cm > 2 cm
English: • low blood pressure.
Danish: • lavt blodtryk.
English: Elimination A study of
Danish: Elimination Der er gennemført et studie med
English: OS (Primary end-point):
Danish: OS (primært endepunkt):
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Danish: Din læge vil drøfte disse bivirkninger med dig og forklare mulige risici og fordele ved behandlingen.
English: The infusion will last approximately one hour during which you will be in the hospital.
Danish: Infusionen vil vare cirka 1 time, mens du er på hospitalet.
English: Unopened vial 24 months.
Danish: Uåbnede hætteglas 24 måneder.
English: Frequency not known (cannot be estimated from available data):
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: In some cases concomitant factors may have contributed to the development of these effects.
Danish: Andre samtidige risikofaktorer kan muligvis i nogle tilfælde have medvirket til udviklingen af disse virkninger.
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Danish: Ingen statistiske forskelle blev observeret mellem behandlingsgrupperne for så vidt angår Global Quality of Life.
English: Full analysis set (intent-to-treat)
Danish: Full analysis-sæt (intent-to-treat)
English: • if you have a severe liver disease.
Danish: • hvis du har en alvorlig leversygdom
English: Median time to progression (weeks):
Danish: Mediantid indtil progression (uger):
English: • raised liver enzymes (hence the need for regular blood tests).
Danish: • forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver).
English: A final analysis was performed with an actual median follow up of 96 months.
Danish: Der blev udført en endelig analyse med en faktisk medianopfølgning på 96 måneder.
English: A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Danish: I alt 70 Gy blev anbefalet til accelererede regimener og 74 Gy til hyperfraktionerede systemer.
English: Two interim analyses and one final analysis were performed.
Danish: Der blev udført to interimanalyser og en endelig analyse.
English: Neuro-motor events are mainly characterised by weakness.
Danish: Neuromotoriske hændelser er hovedsageligt kendetegnet ved svækkelse.
English: NL-1316 BN Almere The Netherlands
Danish: NL-1316 BN Almere Holland
English: Taxespira contains alcohol.
Danish: Taxespira indeholder alkohol.
English: The peripheral oedema usually starts at the lower extremities and may become generalised with a weight gain of 3 kg or more.
Danish: Det perifere ødem starter sædvanligvis i underekstremiteterne og kan blive generaliseret med en vægtstigning på 3 kg eller mere.
English: Not all pack sizes are marketed.
Danish: Ikke alle pakningsstørrelser er markedsført.
English: This is because Taxespira or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Danish: Det skyldes, at Taxespira eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
English: Age category 1 <50 years ≥50 years
Danish: Alderskategori 1 < 50 år ≥ 50 år
English: Age category 2 <35 years ≥35 years
Danish: Alderskategori 2 < 35 år ≥ 35 år
English: The dose will depend on your weight and your general condition.
Danish: Den sædvanlige dosis vil afhænge af din vægt og din almene tilstand.
English: If the patient continues to experience these reactions at 60 mg/m 2, the treatment should be discontinued.
Danish: Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m2, bør behandlingen stoppes.
English: Cases of permanent alopecia (frequency not known) have been reported.
Danish: Tilfælde af permanent alopeci (frekvens ikke kendt) er rapporteret.
English: • change in the colour of your nails, which may detach
Danish: • ændring af farven på neglene, som kan løsne sig
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Danish: Alle materialer, der er anvendt til fortynding og administration, skal bortskaffes i overensstemmelse med standardprocedurerne.
English: The first interim analysis was planned 3 years after the date when half of study enrollment was done.
Danish: Den første interimanalyse var planlagt til 3 år efter datoen, hvor halvdelen af tilmeldingerne til studiet var nået.
English: Name and address of the manufacturers responsible for batch release Hospira UK Limited
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Hospira UK Limited
English: DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Danish: DFSdata var ikke statistisk signifikante, men blev alligevel forbundet med en positiv tendens til fordel for TAC.
English: All except one patient in each arm were diagnosed with CHF more than 30 days after the treatment period.
Danish: Alle patienter undtagen en enkelt i hver behandlingsarm blev diagnosticeret med CHF mere end 30 dage efter behandlingsperioden.
English: During treatment, you may be given other medicines to maintain the number of your blood cells.
Danish: Under behandlingen kan du få anden medicin til at opretholde antallet af blodceller.
English: The estimated hazard ratio was using Cox proportional hazard model with treatment group as the factor.
Danish: Den estimerede hazard ratio blev udregnet ved hjælp af Cox proportional hazard-model med behandlingsgruppe som faktor.
English: If crystals appear, the solution must no longer be used and shall be discarded.
Danish: Hvis der forekommer krystaller, må opløsningen ikke længere anvendes, men skal kasseres.
English: • injection site reactions at the site of a previous reaction.
Danish: • reaktioner på injektionsstedet på stedet for en tidligere reaktion.
English: Fluid retention has not been accompanied by acute episodes of oliguria or hypotension.
Danish: Væskeretention har ikke været ledsaget af akutte episoder af oliguri eller hypotension.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • på anmodning fra det Europæiske Lægemiddelagentur • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The hospital staff will monitor your condition closely during treatment.
Danish: Din tilstand vil blive nøje overvåget af hospitalspersonalet under behandlingen.
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Danish: Din læge vil beregne dit legemsoverfladeareal i kvadratmeter (m²) og fastlægge den dosis, du skal have.
English: Before each treatment with Taxespira, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Taxespira.
Danish: Før hver behandling med Taxespira vil du få taget blodprøver for at kontrollere, om du har nok blodceller og den nødvendige leverfunktion til at få Taxespira.
English: Quality of life parameters
Danish: Parametre for Quality of Life
English: Median survival (months)
Danish: Medianoverlevelse (måneder)
English: You should usually receive your infusion once every 3 weeks.
Danish: Du vil normalt få en infusion én gang hver 3. uge.
English: Such information will allow her/him to decide whether a dose reduction is needed.
Danish: Denne information vil give lægen mulighed for at vurdere, om det er nødvendigt at nedsætte din dosis.
English: Recommendations for the safe handling
Danish: Anbefalinger til sikker håndtering
English: A total of 1006 patients with KPS ≥60 were randomized to the following treatment groups:
Danish: I alt 1.006 patienter med KPS ≥60 blev randomiseret til følgende behandlingsgrupper:
English: The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Danish: Mængden af alkohol i dette lægemiddel kan have virkninger på centralnervesystemet (den del af nervesystemet, der omfatter hjernen og rygmarven).
English: • if the number of your white blood cells is too low.
Danish: • hvis du har for lavt antal hvide blodlegemer
English: Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Danish: Reversible kutane reaktioner blev observeret, og de var almindeligvis milde til moderate.
English: Ask your doctor for advice before being given any medicine.
Danish: Spørg altid lægen til råds, før du tager nogen form for medicin.
English: The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Danish: Den overordnede responsrate var 6,8 % hos de evaluerbare patienter, og medianvarigheden af respons var 26,1 uger.
English: In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
Danish: I tilfælde af en overdosis skal patienten indlægges på specialafdeling, og de vitale funktioner skal følges nøje.
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); very rare (<1/10,000); not known (cannot be estimated from available data).
Danish: Hyppigheden defineres således: 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated.
Danish: Hvis pulmonale symptomer udvikles eller forværres, skal patienterne overvåges nøje, undersøges omgående og sættes i passende behandling.
English: The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: Taxespira's sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Taxespira.
Danish: Din læge kan ændre dosis og indgivelseshyppighed afhængigt af dine blodprøver, din almene tilstand og din reaktion på Taxespira.
English: ER/PR-negative or Grade 3 or tumour size >5 cm
Danish: ER/PR-negativ eller grad 3 eller tumorstørrelse > 5 cm
English: Pain intensity score improved during treatment in both groups indicating adequate pain management.
Danish: Smerteintensitets-scoren blev forbedret under behandling i begge grupper, hvilket indikerer en god smertekontrol.
English: Second episode: stop 5-FU only, at all subsequent cycles.
Danish: Anden episode: Stop kun 5-FU i alle efterfølgende cyklusser.
English: Contraception in males and females An effective method of contraception should be used during treatment.
Danish: Kontraception til mænd og kvinder Der skal anvendes effektiv kontraception under behandlingen.
English: Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk.
Danish: Docetaxel er et lipofilt stof, men det vides ikke, om det udskilles i human mælk.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Danish: Primær G-CSF-profylakse blev gjort obligatorisk i TAC-armen, efter 230 patienter var blevet randomiseret.
English: Taxespira will be administered to you by a healthcare professional.
Danish: Taxespira vil blive indgivet til dig af sundhedspersonalet.
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Danish: Dette regimen blev administreret hver 3. uge i 4 cyklusser i tilfælde, hvor der som et minimum blev observeret en mindre respons (> 25 % reduktion i den todimensionelt målte tumorstørrelse) efter 2 cyklusser.
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Danish: Behandlingscyklussens længde var 3 uger for TCF-armen og 4 uger for CF-armen.