FrancophonIA/ELRC3.0 huggingface dataset:
English: If it is flashing red, contact your healthcare provider immediately.
Danish: Kontakt straks Deres læge eller sundhedspersonalet, hvis den blinker rødt.
English:  The on-body injector leaked, contact your healthcare provider immediately as you may need a replacement dose.
Danish:  Kontakt straks Deres læge eller sundhedspersonalet, hvis on-body-injektoren er utæt, da det kan betyde, at De skal have en erstatningsdosis.
English: If there is blood, press a clean cotton ball or gauze pad on the application site.
Danish: Tryk en ren tot vat eller en gazetampon ned på påsætningsstedet, hvis der er blod.
English: • a pre-filled syringe of Neulasta; and
Danish: • en fyldt injektionssprøjte med Neulasta, og • afspritningsservietter eller lignende.
English: After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Danish: Injektionssprøjtens kanylebeskyttelse vil dække kanylen, når stemplet slippes.
English: Do not shake the pre-filled syringe.
Danish: Ryst ikke den fyldte injektionssprøjte.
English: Belly
Danish: Mave
English: - Whilst wearing the Neulasta on body injector it is important that you keep the Alert Card provided by your doctor, pharmacist or nurse with you.
Danish: - Det er vigtigt, at De har det patientkort på Dem, som De har fået udleveret af lægen, apotekspersonalet eller sundhedspersonalet, når De bærer on-body-injektoren med Neulasta.
English: Neulasta 6 mg solution for injection
Danish: Neulasta 6 mg injektionsvæske, opløsning
English:  Status light is red, contact your healthcare provider immediately as you may need a replacement dose.
Danish:  Kontakt straks Deres læge eller sundhedspersonalet, hvis statuslampen er rød, da det kan betyde, at De skal have en erstatningsdosis.
English: • Keep used syringes out of the sight and reach of children.
Danish: • Opbevar de brugte sprøjter utilgængeligt for børn.
English: Method of administration
Danish: ANVENDELSESMÅDE
English: Anaphylaxis
Danish: Anafylaksi
English: Get emergency medical help right away.
Danish: Denne tilstand kræver øjeblikkelig behandling.
English: UNBLISTERED SYRINGE LABEL
Danish: INJEKTIONSSPRØJTEETIKET (UDEN BLISTERPAKNING)
English: Keep the syringe and sharps disposal container out of sight and reach of children.
Danish: Opbevar injektionssprøjter og kanylebøtte utilgængeligt for børn.
English: Neulasta 6 mg solution for injection pegfilgrastim
Danish: Neulasta 6 mg injektionsvæske, opløsning pegfilgrastim
English: Cutaneous vasculitis
Danish: Seglcelleanæmi
English: Neulasta 6 mg solution for injection in pre-filled syringe
Danish: Neulasta 6 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: Used plunger
Danish: Brugt kanyle
English: If the on-body injector has been knocked or pulled, the cannula may become dislodged.
Danish: Kanylen kan løsrive sig, hvis der bankes på on-body-injektoren eller trækkes i den.
English: If the adhesive becomes noticeably wet (saturated) with fluid, or you see dripping, contact your healthcare provider immediately as you may need a replacement dose.
Danish: Kontakt straks Deres læge eller sundhedspersonalet, da De kan have brug for en erstatningsdosis, hvis klæbemidlet bliver tydeligt vådt (gennemblødt), eller hvis De kan se det drypper.
English: London, 20 August 2009 Doc.
Danish: London, den 20. August 2009 Dok.
English: Questions and answers on the withdrawal of the marketing authorisation application for Bosatria mepolizumab
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Bosatria mepolizumab
English: What is Bosatria?
Danish: Hvad er Bosatria?
English: The main measure of effectiveness was the number of patients who could have their daily prednisone dose reduced to 10 mg or lower for a period of eight weeks.
Danish: Det primære effektmål var antallet af patienter, som kunne få deres daglige dosis prednison reduceret til 10 mg eller derunder i en periode på otte uger.
English: The effects of Bosatria were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Bosatria blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: It contains the active substance mepolizumab.
Danish: Det indeholder det aktive stof mepolizumab.
English: The application was at day 180 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 180, da virksomheden trak sin ansøgning tilbage.
English: During the study the patients received either Bosatria or placebo while the amount of prednisone they received was gradually reduced.
Danish: I løbet af undersøgelsen fik patienterne enten Bosatria eller placebo, mens den mængde prednison, de fik, gradvist blev reduceret.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at træffe afgørelse om denne udtalelse.
English: The CHMP was also concerned that the method used by the company to quantify the different forms of the active substance in the medicine was not appropriate.
Danish: En anden af CHMP's betænkeligheder var, at den metode, som virksomheden anvender til at bestemme mængden af de forskellige former for det aktive stof i lægemidlet, ikke var velegnet.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Bosatria is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Bosatria kan ses her.
English: This is a disease in which eosinophils (a type of white blood cell) start growing out of control, they accumulate in the tissues of many organs, and can cause damage to organs such as the heart, liver and lungs.
Danish: Det er en sygdom, hvor eosinofiler (en type hvide blodlegemer) begynder at formere sig uhæmmet og samler sig i vævet på mange organer, og det kan medføre skader på organer som hjertet, leveren og lungerne.
English: What was Bosatria expected to be used for?
Danish: Hvad forventedes Bosatria anvendt til?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), der er opbygget, så det genkender og binder sig til en bestemt struktur (kaldet et antigen), som findes i organismen.
English: In one main study involving 85 adults with hypereosinophilic syndrome, Bosatria was compared with placebo (a dummy treatment).
Danish: I en hovedundersøgelse, der omfattede 85 voksne med hypereosinofilt syndrom, blev Bosatria sammenlignet med placebo (en virkningsløs behandling).
English: The CHMP was of the opinion that the main study did not provide sufficient evidence to show that Bosatria was effective in reducing the need for corticosteroid treatment.
Danish: CHMP var af den opfattelse, at hovedundersøgelsen ikke gav tilstrækkelig dokumentation for, at Bosatria var effektivt til at begrænse behovet for kortikosteroidbehandling.
English: The company informed the CHMP that Bosatria will continue to be made available for patients in the open-label extension study and compassionate use programmes.
Danish: Virksomheden har informeret CHMP om, at Bosatria fortsat vil være tilgængeligt for patienter i den åbne forlængelsesundersøgelse og i programmer med særlig udleveringstilladelse.
English: All patients lacked the FIP1L1-PDGRF fusion gene and were receiving treatment with prednisone (a corticosteroid) that was helping to stabilise their symptoms.
Danish: Alle patienter manglede FIP1L1PDGRF-fusionsgenet og modtog behandling med prednison (et kortikosteroid), der var med til at stabilisere deres symptomer.
English: How is Bosatria expected to work?
Danish: Hvordan forventes Bosatria at virke?
English: Mepolizumab has been designed to attach to a chemical messenger called interleukin 5 (IL-5), which is involved in the growth of eosinophils.
Danish: Mepolizumab er udviklet til at binde sig til et kemisk signalstof kaldet interleukin 5 (IL-5), som har betydning for væksten af eosinofiler.
English: The active substance in Bosatria, mepolizumab, is a monoclonal antibody.
Danish: Det aktive stof i Bosatria er mepolizumab, som er et monoklonalt antistof.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Bosatria?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Bosatria eller i programmer for anvendelse af Bosatria med særlig udleveringstilladelse?
English: Bosatria was expected to be used to treat adults with hypereosinophilic syndrome.
Danish: Bosatria forventedes anvendt til behandling af voksne med hypereosinofilt syndrom.
English: Bosatria is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Bosatria er et pulver, der anvendes til at fremstille en infusionsvæske, opløsning (drop i en vene).
English: By attaching to IL-5, mepolizumab was expected to reduce the accumulation of eosinophils in the blood, thereby relieving the symptoms of patients with hypereosinophilic syndrome.
Danish: Det forventedes, at mepolizumab ved at binde sig til IL-5 kunne reducere ophobningen af eosinofiler i blodet og dermed lindre symptomerne hos patienter med hypereosinofilt syndrom.
English: On 28 July 2009, Glaxo Group Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Bosatria, for the treatment of adults with hypereosinophilic syndrome to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Danish: Den 28. juli 2009 meddelte Glaxo Group Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Bosatria til behandling af voksne med hypereosinofilt syndrom med det formål at begrænse eller overflødiggøre behovet for kortikosteroidbehandling og at mindske eosinofiltallet i blodet.
English: Bosatria was expected to be used in patients who lack a gene called the ‘FIP1L1-PDGRF fusion gene' to reduce or eliminate the need for the patients to be treated with corticosteroids (steroids used to treat the disease) and to reduce the level of eosinophils in the blood.
Danish: Bosatria forventedes anvendt til patienter, som mangler et gen, der kaldes "FIP1L1-PDGRFfusionsgenet", med det formål at begrænse eller overflødiggøre behandlingen af patienter med kortikosteroider (steroider, der anvendes til at behandle denne sygdom) og at mindske eosinofilniveauet i blodet.
English: Bosatria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2004 for the treatment of hypereosinophilic syndrome.
Danish: Den 29. juli 2004 blev Bosatria udpeget som lægemiddel til sjældne sygdomme til behandling af hypereosinofilt syndrom.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Bosatria could not have been approved for the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Bosatria ikke kunne have været godkendt til behandling af voksne, som har hypereosinofilt syndrom og mangler FIP1L1-PDGRF-fusionsgenet, med det formål at begrænse eller overflødiggøre behovet for kortikosteroidbehandling og at mindske eosinofiltallet.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Bosatria did not outweigh its risks in the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Bosatria ikke opvejede risiciene til behandling af voksne, som har hypereosinofilt syndrom og mangler FIP1L1-PDGRF-fusionsgenet, med det formål at begrænse eller overflødiggøre behovet for kortikosteroidbehandling og at mindske eosinofiltallet.
English: It's important to follow these instructions carefully.
Danish: Det er vigtigt at følge disse vejledninger nøje.
English: A healthy lifestyle will also help you to get the most benefit from your treatment.
Danish: En sund livsstil vil desuden hjælpe dig til at få mest ud af behandlingen.
English: Efficacy was evaluated in 2,928 patients.
Danish: Effekten blev evalueret hos 2.928 patienter.
English: • feeling tired and exhausted
Danish: • følelse af at være træt og udmattet
English: This is to check that you are being given the right amount of medicine.
Danish: Dette er for at undersøge, om du får den rigtige mængde medicin.
English: You can help stop this happening by doing the following:
Danish: Du kan mindske risikoen for at dette forekommer ved at gøre følgende:
English: SMPR (per patient year)
Danish: SMPR (pr. patientår)
English: Choose the date that best fits your routine.
Danish: Vælg en dato, som bedst passer til dine rutiner.
English: - If your kidneys are not functioning normally.
Danish: • hvis dine nyrer ikke fungerer normalt
English: - Choose one day of the month that will be easy to remember.
Danish: • Vælg en månedsdato, så det er let at huske.
English: You can drink water but no other drinks.
Danish: Du må drikke vand, men ingen andre drikkevarer.
English: Poor healing of these fractures has also been reported.
Danish: Dårlig heling af disse frakturer er også blevet rapporteret.
English: This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 2).
Danish: Dette blev vist ved både den primære analyse efter et år og i den bekræftende analyse efter to års endpoint (tabel 2).
English: Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Danish: Opmærksomheden bør også henledes på muligheden for eksisterende samtidig hypomagnæsi.
English: There are few data available on patients of African origin.
Danish: Der er kun få tilgængelige data vedrørende patienter af afrikansk oprindelse.
English: Taking this medicine
Danish: Når du tager denne medicin
English: See dosing instructions, above.
Danish: Se doseringsvejledning ovenfor.
English: The release of pharmaceuticals in the environment should be minimized.
Danish: Udledningen af lægemidler til miljøet bør minimeres.
English: Do not let the tablet dissolve in your mouth.
Danish: Lad ikke tabletten opløses i munden
English: No data are available.
Danish: Ingen data er tilgængelige.
English: Please consult your doctor.
Danish: Tal med din læge.
English: The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Danish: Analysen af SMPR var tidsjusteret og tog højde for, at en eller flere hændelser opstået i en enkelt 12 ugers periode, kunne være potentielt relateret.
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke denne medicin, hvis noget af ovenstående passer på dig.
English: Patients should not take two tablets within the same week.
Danish: Patienterne må ikke tage to tabletter indenfor samme uge.
English: Not known (frequency cannot be estimated from the available data): • asthma attack
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) • astmaanfald
English: 747 70 Opava-Komarov Czech Republic
Danish: 747 70 Opava-Komarov Tjekkiet
English: Urinary CTx **
Danish: Urin CTx **
English: Multiple events were therefore, counted only once in any given 12 week period for the purposes of the analysis.
Danish: Multiple hændelser blev derfor kun talt én gang i en 12 ugers periode til analyseformålet.
English: • It also helps to prevent other bone problems that may need surgery or radiotherapy.
Danish: • Det hjælper med at forebygge andre knogleproblemer, som kan kræve operation eller strålebehandling.
English: There was no indication of a waning of the effect over time.
Danish: Der var ingen tegn på aftagende effekt over tid.
English: Mean relative changes from baseline % [95 % CI]
Danish: Gennemsnitlige relative ændringer fra baseline % [95 % CI]
English: You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Ibandronic Acid Teva tablet.
Danish: Du kan vælge enten den samme dato (som f.eks. den 1. i hver måned) eller den samme dag (som f.eks. den første søndag i hver måned) til indtagelsen af din Ibandronsyre Teva-tablet.
English: Taking your monthly tablet
Danish: Indtagelse af din månedlige tablet
English: When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Danish: Ved indtagelse 30 minutter før et måltid er reduktionen i biotilgængelighed ca. 30 %.
English: • serious, potentially life-threatening allergic reaction
Danish: • alvorlig, eventuelt livstruende, allergisk reaktion
English: The tablet should preferably be taken on the same date each month.
Danish: Tabletten skal helst tages på samme dato hver måned.
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Danish: Det primære endepunkt i undersøgelsen var skeletal morbidity period rate (SMPR).
English: Especially:
Danish: Især:
English: Instead, consult your calendar and find out when your next scheduled dose is.
Danish: Kig i stedet i din kalender og find ud af, hvornår din næste planlagte dosis skal indtages.
English: All Skeletal Related Events (SREs)
Danish: Alle knoglerelaterede hændelser (SREs)
English: The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.
Danish: Jo tidligere en kvinde når menopausen, jo større er risikoen for knoglebrud ved osteoporose.
English: It is important that you take Ibandronic Acid Teva at the right time and in the right way.
Danish: Det er vigtigt, at du tager Ibandronsyre Teva på det rigtige tidspunkt og på den rigtige måde.
English: Mutagenicity/Carcinogenicity:
Danish: Mutagenicitet/carcinogenicitet:
English: It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Danish: Det er vigtigt at forsøge at forhindre knoglenekrose i kæben i at udvikle sig, da det er en smertefuld tilstand, som kan være vanskelig at behandle.
English: Water with a high concentration of calcium should not be used.
Danish: Vand med en høj calciumkoncentration må ikke anvendes.
English: Date of latest renewal: 25 June 2015
Danish: Dato for første markedsføringstilladelse: 17. september 2010 Dato for seneste fornyelse: 25. juni 2015
English: If you wear dentures you should make sure these fit properly.
Danish: Hvis du har tandproteser bør du sørge for, at disse sidder ordentligt fast.
English: If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Danish: Hvis du tager én tablet hver anden dag eller én gang om ugen, spørg da din læge eller apoteket til råds.
English: 2 years
Danish: 2 år.
English: No statistically significant difference was attained after 1 year of treatment (p=0.056).
Danish: Ingen statistisk signifikant forskel blev opnået efter 1 års behandling (p=0,056).
English: Talk to your doctor first if you want to drive, use machine or tools.
Danish: Tal med din læge først, hvis du vil køre bil eller arbejde med maskiner.
English: *See further information below †Identified in post-marketing experience.
Danish: * Se yderligere information nedenfor † Identificeret ved erfaringer efter markedsføring.
English: Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or increased mechanical strength even at doses in the toxic range.
Danish: Både daglig og intermitterende langtidsadministration (med forlængede dosisfri intervaller) til rotter, hunde og aber var forbundet med dannelse af ny knogle med normal kvalitet og bevaret eller øget mekanisk styrke, selv ved toksiske doser.
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Danish: For at reducere risikoen for at udvikle knoglenekrose i kæben, er der nogle forholdsregler du bør tage.
English: The vertebral fracture risk reduction was very consistent with that seen in the overall population.
Danish: Den vertebrale risiko reduktion var meget lig den, der blev set for den samlede population.
English: The results from these trials are summarised below.
Danish: Resultaterne fra denne undersøgelse er beskrevet i det følgende.
English: The serum calcium level may fall to hypocalcaemic values.
Danish: Serum-calcium kan falde til hypokalcæmiske værdier.
English: Other disturbances of bone and mineral metabolism should also be effectively treated.
Danish: Andre forstyrrelser i knogle- og mineralmetabolismen skal ligeledes behandles effektivt.
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Danish: Disse transverse eller korte oblikke frakturer kan forekomme hvor som helst på femur, fra lige under trochanter minor til lige over det suprakondylære svaj.
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Danish: I en multivariat analyse kunne alder ikke påvises som en uafhængig faktor for nogen af de undersøgte farmakokinetiske parametre.
English: These could be signs of bone damage in the ear.
Danish: Det kan være tegn på skader på knoglerne i øret.
English: Wed. Thu.
Danish: Man. Tir.
English: Manufacturer:
Danish: Fremstiller:
English: Never take two Ibandronic Acid Teva tablets within the same week.
Danish: Tag aldrig to Ibandronsyre Teva tabletter inden for den samme uge.
English: Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i.e. months 3, 6, 12 and 24.
Danish: Der blev set klinisk betydende reduktioner i serum-CTX-koncentrationerne på alle målte tidspunkter, dvs. efter 3, 6, 12 og 24 måneder.
English: Drink a full glass of milk before you go. Do not make yourself sick.
Danish: Drik et helt glas mælk inden du kører.
English: The optimal duration of bisphosphonate treatment for osteoporosis has not been established.
Danish: Den optimale varighed af bisphosphonatbehandling af osteoporose er ikke fastlagt.
English: Interactions with other medicinal products
Danish: Interaktioner med andre lægemidler
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger er anført efter MedDRA systemorganklasse og frekvenser.
English: Cellulose microcrystalline Povidone K-30
Danish: Cellulose, mikrokrystallinsk Povidon K-30
English: All patients received 500 mg calcium and 400 IU vitamin D daily.
Danish: Alle patienter fik dagligt 500 mg calcium og 400 IE D-vitamin.
English: Do not lie down.
Danish: Fremkald ikke opkastning, og læg dig ikke ned.
English: Quality of Life *
Danish: Livskvalitet *
English: A relative risk reduction of 61 % was observed after 2 years (p=0.0006).
Danish: En relativ risikoreduktion på 61 % blev observeret efter 2 år (p=0,0006).
English: Month 3
Danish: Måned 3