FrancophonIA/ELRC3.0 huggingface dataset:
English: Pulmonary oedemaa
Danish: Lungeødema
English: • headache
Danish: - hovedpine
English: Please tell your doctor immediately during treatment with Accofil, if you:
Danish: Fortæl det til lægen, før du påbegynder behandlingen, hvis du har: - Seglcelleanæmi, da Accofil kan medføre seglcellekrise.
English: Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Danish: Hvis leukocyttallet stiger til > 70 x 109/l, skal administrationen af filgrastim seponeres eller dosis nedsættes.
English: In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Danish: Pædiatriske patienter med svær kronisk neutropeni og/eller cancer
English: If you use more Accofil than you should
Danish: Hvis du har brugt for meget Accofil
English: General disorders and administrat ion site conditions
Danish: Almene symptomer og reaktioner på administrationss tedet
English: ATCvet code: QI06AH10.
Danish: ATCvet-kode: QI06AH.
English: EU/2/04/048/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/048/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Danish: EU/2/04/048/001 Lyofilisat (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/2/04/048/002 Lyofilisat (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the feline leukaemia component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Danish: Revaccination: - den første revaccination skal foretages for alle komponenterne et år efter basisvaccinationen, - efterfølgende revaccinationer skal foretages: hvert år for felin leukæmi komponenten og med intervaller på op til tre år for rhinotracheitis, calicivirus og panleukopeni komponenterne.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGERVEDRØRENDE UDLEVERING OG BRUG
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Danish: Type I glasflaske indeholdende 1 dosis af lyofilisat og type I glasflaske indeholdende 1 ml solvens, begge lukket med en butyl elastomer prop og forseglet med en aluminiumskapsel.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Danish: Aktiv immunisering af katte, der er 8 uger eller ældre: - mod felin viral rhinotracheitis for at reducere kliniske tegn, - mod calicivirus infektion for at reducere kliniske tegn, - mod felin panleukopeni til forebyggelse af dødsfald og kliniske tegn, - mod leukæmi til forebyggelse af persistent viræmi og kliniske tegn på sygdommen.
English: Purevax RCP FeLV solvent
Danish: Purevax RCP FeLV solvens
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the feline leukaemia component.
Danish: Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis, calicivirus og panleukopeni komponenterne og 1 år for felin leukæmi komponenten.
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Danish: Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus, felin calicivirus, felin panleukopeni virus og felin leukæmivirus.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Danish: Ved mistanke om tilstedeværelse af høje værdier af maternelle antistoffer over for rhinotracheitis, calicivirus eller panleukopeni komponenterne (fx hos 9-12 uger gamle killinger født af hunkatte, der var vaccineret før drægtighed, og/eller ved kendskab til eller mistanke om, at moderdyret har været udsat for de pågældende patogener), bør basisvaccination udsættes, til killingerne er 12 uger gamle.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) ......................................... >104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ....................................... >2,0 ELISA U. Svækket felin panleukopeni virus (PLI IV) ..................................................................... >103,5 CCID501
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Danish: Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus og panleukopeni samt 2 uger efter basisvaccination for felin leukæmi.
English: FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 10 7.2 CCID501 1 cell culture infective dose 50%.
Danish: FeLV rekombinant canarypox virus (vCP97) .................................................................. >107,2 CCID501 1 cellekultur infektiøs dosis 50%.
English: Gentamicin, at most .......................................................................................................................... 23 µg
Danish: Gentamycin max................................................................................................................................ 23 µg
English: Gentamicin, at most .......................................................................................................................... 23 µg Solvent:
Danish: Gentamycin max................................................................................................................................. 23 µg Solvens:
English: Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Danish: Purevax RCP FeLV Lyofilisat og solvens til injektionsvæske, suspension.
English: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Danish: Purevax RCP FeLV, lyofilisat og solvens til injektionsvæske, suspension.
English: 21 January 2011
Danish: 21 januar 2011
English: The European Commission issued a decision on 21 January 2011.
Danish: Europa-Kommissionen traf en afgørelse den 21 januar 2011.
English: Vascace Plus is authorised in the EU via national procedures.
Danish: Vascace Plus er godkendt i EU efter nationale procedurer.
English: What is Vascace Plus?
Danish: Hvad er Vascace Plus?
English: It is used to treat hypertension (high blood pressure).
Danish: Det anvendes til at behandle hypertension (for højt blodtryk).
English: The recommended dosage of Vascace Plus is one tablet administered once daily.
Danish: Den anbefalede dosis af Vascace Plus er én tablet, som tages en gang dagligt.
English: It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II.
Danish: Det blokerer virkningen af ACE-enzymet, som er ansvarligt for dannelsen af et hormon i kroppen, der kaldes angiotensin II.
English: Why was Vascace Plus reviewed?
Danish: Hvorfor blev Vascace Plus vurderet igen?
English: On 20 November 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace Plus in the EU.
Danish: Den 20. november 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Vascace Plus i EU.
English: The CHMP recommended that Vascace Plus should be used for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone.
Danish: CHMP anbefalede, at Vascace Plus bliver anvendt til behandling af hypertension hos patienter, hvis blodtryk ikke kontrolleres tilstrækkeligt med cilazapril alene.
English: Other sections of the prescribing information such as those on special warnings, interactions with other medicines, and pregnancy and lactation and side effects were also harmonised.
Danish: Andre punkter i ordinationsoplysningerne blev også harmoniseret, såsom særlige advarsler, interaktion med andre lægemidler og graviditet og amning.
English: It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.
Danish: Det virker ved at øge urinproduktionen, reducere mængden af væske i blodet og sænke blodtrykket.
English: It must not be used in patients with a history of angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor, in patients with hereditary or idiopathic angioedema or in patients with kidney impairment or anuria (a condition in which a patient cannot make or pass urine).
Danish: Det må ikke anvendes hos patienter, der tidligere har haft angioødem (hævelser under huden) i forbindelse med tidligere behandling med en ACE-hæmmer, hos patienter med hereditært eller idiopatisk angioødem eller hos patienter med nedsat nyrefunktion eller anuri (en tilstand, hvor patienten ikke kan lade vandet).
English: Vascace Plus is also available in the EU under other trade names: Co-Inhibace, Dynorm Plus, Inhibace Plus and Inibace Plus.
Danish: Vascace Plus markedsføres ligeledes i EU under andre særnavne: Co-Inhibace, Dynorm Plus, Inhibace Plus og Inibace Plus.
English: Vascace Plus is a medicine that contains the active substances cilazapril and hydrochlorothiazide.
Danish: Vascace Plus er et lægemiddel, der indeholder de aktive stoffer cilazapril og hydrochlorthiazid.
English: By blocking the production of this hormone, cilazapril allows the blood vessels to widen, thereby reducing blood pressure.
Danish: Ved at blokere dannelsen af dette hormon gør cilazapril det muligt for blodkarrene at udvide sig, hvorved blodtrykket falder.
English: The European Medicines Agency has completed a review of Vascace Plus.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af Vascace Plus.
English: Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg) EMA/652293/2010
Danish: Spørgsmål og svar vedrørende Vascace Plus og relaterede navne (cilazapril/hydrochlorthiazid tabletter, 5/12,5 mg) EMA/652293/2010
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace Plus in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Vascace Plus i Den Europæiske Union (EU).
English: Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg)
Danish: Spørgsmål og svar vedrørende Vascace Plus og relaterede navne (cilazapril/hydrochlorthiazid tabletter, 5/12,5 mg)
English: Vascace Plus should not be used in patients who are hypersensitive (allergic) to cilazapril or other ACE inhibitors, hydrochlorothiazide or other thiazides diuretics, or to any other ingredients of the medicine.
Danish: Vascace Plus må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for cilazapril eller andre ACE-hæmmere, hydrochlorthiazid eller andre thiazid-diuretika eller et af de øvrige indholdsstoffer i lægemidlet.
English: Cilazapril is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Danish: Cilazapril er en ACE-hæmmer (angiotensinkonverterende enzymhæmmer).
English: Vascace Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Vascace Plus skulle harmoniseres.
English: How often will you be given HALAVEN?
Danish: Hvor ofte vil du få HALAVEN?
English: Median months
Danish: Median måneder
English: Your doctor will determine how many cycles of treatment you should receive.
Danish: Din læge vil bestemme, hvor mange behandlingscyklusser du skal have.
English: This patient group has not been studied.
Danish: Denne patientgruppe er ikke blevet undersøgt.
English: Any Grade 3 or 4 in the previous cycle
Danish: Enhver grad 3 eller 4 i forudgående cyklus
English: Pregnant staff should not handle HALAVEN.
Danish: Gravide medarbejdere bør ikke håndtere HALAVEN.
English: Rare or not known
Danish: Sjælden eller ikke kendt
English: PROBABILITY OF SURVIVAL
Danish: SANDSYNLIGHED FOR OVERLEVELSE
English: The frequency of this condition is not known but it can be life-threatening.
Danish: Hyppigheden af denne sygdom er ikke kendt, men den kan være livstruende.
English: From spontaneous reporting c
Danish: Fra spontane rapporter c
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke straks anvendes er opbevaringstiderne og forholdene under anvendelse brugerens ansvar.
English: No Grade 4 events Rare
Danish: Ingen grad 4-hændelser Sjælden
English: The dose of eribulin should not be re-escalated after it has been reduced.
Danish: Dosis af eribulin må ikke optrappes igen, efter den er blevet reduceret.
English: No dose adjustments are recommended for the elderly population.
Danish: Der anbefales ingen dosisjustering for den ældre population.
English: In the event of an overdose, the patient should be closely monitored.
Danish: I tilfælde af en overdosering skal patienten nøje overvåges.
English: There was no significant difference in progression-free survival or overall response rate between the treatment arms in the overall population.
Danish: Der var ingen signifikant forskel i progressionsfri overlevelse eller samlet responsrate mellem behandlingsarmene for den samlede population.
English: The doctor may also then decide to reduce the dose you are given.
Danish: Lægen kan på det tidspunkt også beslutte sig for at reducere din dosis.
English: HALAVEN is for intravenous use.
Danish: HALAVEN er til intravenøs anvendelse.
English: In the event of extravasation, treatment should be symptomatic.
Danish: I tilfælde af ekstravasation skal behandlingen være symptomatisk.
English: No in vivo data are available.
Danish: Ingen in vivo data er tilgængelige.
English: Dose reduction recommendations for retreatment are shown in the following table.
Danish: Anbefalinger for dosisreduktion ved genbehandling vises i den følgende tabel.
English: Creatinine clearance was estimated with the Cockcroft-Gault formula.
Danish: Kreatininclearance blev estimeret ved hjælp af Cockcroft-Gault-formlen.
English: There are no data from the use of eribulin in pregnant women.
Danish: Der er ingen data fra anvendelse af eribulin til gravide kvinder.
English: This result was confirmed with an updated overall survival analysis carried out at 77% of events.
Danish: Dette resultat blev bekræftet i en opdateret overlevelsesanalyse, som blev udført efter 77 % af hændelserne var indtrådt.
English: The transport protein involved in this process is unknown.
Danish: Transportproteinet, som er involveret i denne proces, er ukendt.
English: The use of gloves, goggles, and protective clothing is recommended.
Danish: Der anbefales brug af handsker, beskyttelsesbriller og beskyttelsestøj.
English: The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height.
Danish: Den dosis, du får, er baseret på din krops overfladeareal (udtrykt i kvadratmeter, eller m2), som beregnes ud fra din vægt og højde.
English: Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal.
Danish: Afhængigt af resultaterne af dine blodprøver kan lægen udsætte indgivelsen af lægemidlet, indtil blodprøverne igen er normale.
English: If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Danish: Hvis noget af dette påvirker dig, skal du fortælle det til lægen, som kan vælge at stoppe behandlingen eller nedsætte dosis.
English: If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water.
Danish: Hvis huden kommer i kontakt med opløsningen, skal den straks vaskes grundigt med sæbe og vand.
English: Antiemetic prophylaxis including corticosteroids should be considered.
Danish: Forebyggende antiemetika, herunder kortikosteroider, skal overvejes.
English: If you experience any of the following serious symptoms, stop taking HALAVEN and seek medical attention straightaway:
Danish: Hvis du oplever nogle af følgende alvorlige bivirkninger, skal du holde op med at tage HALAVEN og straks søge lægehjælp:
English: In the pivotal trials, the corresponding publications and in some other regions e.g. the United States and Switzerland, the recommended dose is based on the salt form (eribulin mesilate).
Danish: I de pivotale studier og de tilsvarende publikationer samt i visse andre regioner, f.eks. USA og Schweiz, er den anbefalede dosis baseret på saltet (eribulinmesilat).
English: In the EU the recommended dose refers to the base of the active substance (eribulin).
Danish: I EU henviser den anbefalede dosis til basen af det aktive stof (eribulin).
English: It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment.
Danish: Det kan også forårsage permanente frugtbarhedsproblemer i fremtiden hos mænd, der tager behandlingen, og de bør diskutere dette med deres læge, før de starter behandlingen.
English: Number of Events
Danish: Antal hændelser
English: Patients must have progressed within 6 months of their last chemotherapeutic regimen.
Danish: Patienterne skal have oplevet progression inden for 6 måneder efter deres sidste kemoterapiregime.
English: Includes Grade 5 events.
Danish: Inkluderer grad 5-hændelser b
English: Time (months) NUMBER OF PATIENTS AT RISK:
Danish: Tid (måneder) ANTAL PATIENTER MED RISIKO:
English: HALAVEN 71 Dacarbazine
Danish: HALAVEN 71 Dacarbazin
English: Hypokalaemia, hypocalcaemia or hypomagnesaemia should be corrected prior to initiating HALAVEN and these electrolytes should be monitored periodically during therapy.
Danish: Hypokaliæmi, hypocalcæmi eller hypomagnesiæmi bør korrigeres, før HALAVEN påbegyndes, og disse elektrolytter skal overvåges periodisk i løbet af behandlingen.
English: New onset or worsening of pre-existing peripheral neuropathy has also been reported.
Danish: Nyopstået eller forværring af eksisterende perifer neuropati er også blevet rapporteret.
English: Each carton contains either 1 or 6 vials.
Danish: Hver karton indeholder enten 1 eller 6 hætteglas.
English: Patients should be closely monitored for signs of peripheral motor and sensory neuropathy.
Danish: Patienterne skal overvåges nøje for tegn på perifer motorisk og sensorisk neuropati.
English: Monitoring of complete blood counts should be performed on all patients prior to each dose of eribulin.
Danish: Det fuldstændige blodbillede skal følges for alle patienter før hver dosis eribulin.
English: These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
Danish: Disse kunne være tegn på en ikke almindelig allergisk reaktion (kan forekomme hos op til 1 ud af 100 personer).
English: Management of overdose should include supportive medical interventions to treat the presenting clinical manifestations.
Danish: Behandling af en overdosering skal omfatte understøttende medicinsk indgriben for at behandle de kliniske manifestationer, patienten fremviser.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX41
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, ATC-kode: L01XX41
English: These may be signs of a condition called sepsis - a severe and serious reaction to an infection.
Danish: Dette kan være tegn på en tilstand, der kaldes sepsis (blodforgiftning)en svær og alvorlig reaktion på en infektion.
English: Eribulin is weakly bound to plasma proteins.
Danish: Eribulin bindes kun svagt til plasmaproteiner.
English: To ensure that the whole dose of HALAVEN is given it is recommended that a saline solution is flushed into the vein after HALAVEN is given.
Danish: For at sikre, at hele dosen af HALAVEN er givet, anbefales det, at der skylles med en saltvandsopløsning i venen, efter HALAVEN er indgivet.
English: Insomnia Depression
Danish: Søvnløshed Depression
English: Eribulin is mainly (up to 70%) eliminated through biliary excretion.
Danish: Eribulin elimineres hovedsageligt (op til 70 %) gennem biliær udskillelse.
English: It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Danish: Det er en strukturelt simplificeret, syntetisk analog til halichondrin B, et naturligt produkt isoleret fra den marine svamp Halichondria okadai.
English: - A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.
Danish: - En alvorlig forstyrrelse af blodstørkningen, der fører til udbredt dannelse af blodpropper og indre blødninger.
English: Severe hepatic impairment (Child-Pugh C) has not been studied but it is expected that a more marked dose reduction is needed if eribulin is used in these patients.
Danish: Svært nedsat leverfunktion (Child-Pugh C) er ikke blevet undersøgt, men det forventes, at en mere markant dosisreduktion er nødvendig, hvis eribulin anvendes til disse patienter.
English: Sepsis is uncommon (may affect up to 1 in 100 people) and can be lifethreatening and may result in death.
Danish: Sepsis er ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) og kan være livstruende og medføre døden.
English: Frequency categories 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) and very rare (< 1/10,000).
Danish: Kategorierne over hyppigheder er defineret som: 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) og meget sjælden
English: Note: Concomitant anti-HER2 therapy was not included in Study 305 and Study 301.
Danish: Bemærk: Samtidig behandling med anti-HER2 blev ikke inkluderet i studie 305 og studie 301.
English: No carcinogenicity studies have been conducted with eribulin.
Danish: Der er ikke udført karcinogenicitetsstudier med eribulin.
English: There is no relevant use of HALAVEN in children and adolescents for the indication of breast cancer.
Danish: Det er ikke relevant at anvende HALAVEN til børn og unge til indikationen brystcancer.
English: TIME (months) NUMBER OF PATIENTS AT RISK HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabine 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
Danish: HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabin 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
English: Both adverse reactions resolved with supportive care.
Danish: Begge bivirkninger gik væk med understøttende behandling.