FrancophonIA/ELRC3.0 huggingface dataset:
English: The company also provided results of a mathematical (modelling and simulation) exercise to predict the levels of the active substances and the medicine's effectiveness in clearing the virus from the blood in different circumstances.
Danish: Virksomheden fremlagde også resultaterne af en matematisk beregning (modellering og simulering) til forudsigelse af niveauerne af de aktive stoffer og lægemidlets virkning, hvad angår fjernelse af virusset fra blodet under forskellige omstændigheder.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal is based on strategic business reasons for this specific product.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes strategiske forretningsmæssige årsager relateret til dette specifikke lægemiddel.
English: The active substances in Cokiera are effective against hepatitis C virus genotypes 1a and 1b.
Danish: De aktive stoffer i Cokiera virker mod hepatitis C-virus genotype 1a og 1b.
English: How is Cokiera expected to work?
Danish: Hvordan forventes Cokiera at virke?
English: On 3 August 2016, AbbVie Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cokiera, for the treatment of chronic hepatitis C.
Danish: Den 3. august 2016 meddelte AbbVie Ltd. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Cokiera til behandling af kronisk hepatitis C.
English: Cokiera is an antiviral medicine containing the active substances dasabuvir, ombitasvir, paritaprevir and ritonavir.
Danish: Cokiera er et antiviralt lægemiddel, der indeholder de aktive stoffer dasabuvir, ombitasvir, paritaprevir og ritonavir.
English: EMA/541043/2016
Danish: 16. september 2016 EMA/541043/2016
English: The CHMP considered that the data provided did not properly show how the size of meals affect absorption of the active substances from Cokiera and therefore how well Cokiera works.
Danish: CHMP vurderede, at de fremlagte data ikke i tilstrækkelig grad viste, hvordan størrelsen af måltider påvirker optagelsen i kroppen af de aktive stoffer i Cokiera, og dermed hvor godt Cokiera virker.
English: Because all the active substances in Cokiera were already included in authorised medicines, the company presented the results of studies to see whether the active substances from Cokiera were ‘bioequivalent' to the authorised medicines.
Danish: Da alle de aktive stoffer i Cokiera allerede er indeholdt i godkendte lægemidler, fremlagde virksomheden resultaterne fra undersøgelser til bekræftelse af, at de aktive stoffer i Cokiera er "bioækvivalente" med de godkendte lægemidler.
English: All four active substances in Cokiera are already available in authorised medicines for treating chronic hepatitis C. It was expected that combining the substances in a single tablet would make it simpler for patients to take their medicine.
Danish: Alle fire aktive stoffer i Cokiera er allerede tilgængelige i godkendte lægemidler til behandling af kronisk hepatitis C. Det var forventet, at kombinationen af stofferne i en enkelt tablet ville gøre det lettere for patienterne at tage deres medicin.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cokiera could not have been approved for the treatment of chronic hepatitis C in adults.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Cokiera ikke kunne være blevet godkendt til behandling af kronisk hepatitis C hos voksne.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Cokiera.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om Cokiera.
English: Cokiera was expected to be used for treating adults with chronic (long-term) hepatitis C. Hepatitis C is an infection of the liver caused by the hepatitis C virus.
Danish: Cokiera forventedes anvendt til behandling af voksne med kronisk (langvarig) hepatitis C, der er en leverinfektion, som forårsages af hepatitis C-virus.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Cokiera eller i programmer for anvendelse af Cokiera med særlig udleveringstilladelse?
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this specific product.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Cokiera med særlig udleveringstilladelse.
English: Ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Danish: Ombitasvir virker ved at blokere virkningen af hepatitis C-virussets protein "NS5A", mens paritaprevir blokerer virkningen af et andet protein, "NS3/4A".
English: Dasabuvir blocks the action of an enzyme in the hepatitis C virus, called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Danish: De aktive stoffer i Cokiera virker på forskellig måde: Dasabuvir virker ved at blokere virkningen af et enzym i hepatitis C-virusset kaldet "NS5B RNA-afhængig polymerase", der er et enzym, som virusset behøver for at kunne formere sig.
English: Ritonavir, the fourth active substance, slows down the removal of paritaprevir from the body by blocking an enzyme called CYP3A that breaks down paritaprevir.
Danish: hastighed, hvormed paritaprevir fjernes fra kroppen, idet det blokerer det såkaldte CYP3A-enzym, som nedbryder paritaprevir.
English: 16 September 2016 EMA/541043/2016 EMEA/H/C/0004235
Danish: EMEA/H/C/0004235
English: Generally, these reactions were mild or moderate.
Danish: Disse bivirkninger var generelt milde eller moderate.
English: Treatment should be initiated as appropriate.
Danish: Passende behandling bør påbegyndes.
English: How often this happens is not known from the data that is available.
Danish: Hvor ofte dette forekommer vides ikke fra de data, der foreligger.
English: This section is divided into the following subsections:
Danish: Dette afsnit er inddelt i følgende underafsnit:
English: Cmax was not significantly changed.
Danish: Cmax blev ikke ændret signifikant.
English: The injection volume for these patients should be calculated as follows:
Danish: Injektionsvolumen for disse patienter beregnes som følger:
English: Wash your hands thoroughly with soap and warm water.
Danish: Vask hænderne grundigt med sæbe og varmt vand.
English: 4 years
Danish: 4 år.
English: Has it been 48 hours or longer since your last bowel movement?
Danish: Er der gået 48 timer eller længere siden du sidst havde afføring?
English: Your doctor will determine your dose.
Danish: Din læge vil fastsætte din dosis.
English: Gender No meaningful gender differences have been observed.
Danish: Køn Der er ikke observeret nogen væsentlige kønsforskelle.
English: The following side effects are very common and may affect more than 1 in 10 people.
Danish: De følgende bivirkninger er meget almindelige og kan påvirke flere end ét ud af 10 mennesker.
English: There is no need to worry about this as it will not affect the accuracy of the dose or pose any risk to your health.
Danish: Der er ingen grund til bekymring, da det ikke vil påvirke nøjagtigheden af dosis eller udgøre en helbredsrisiko.
English: Hold the syringe in one hand like a pencil.
Danish: Hold sprøjten i den ene hånd som en blyant.
English: At any time, the patient's assigned dose could be reduced based on tolerability.
Danish: Patienternes tildelte dosis kunne til hver en tid reduceres baseret på tolerabilitet.
English: When you hear a click sound that means the entire contents were injected.
Danish: Når du hører en kliklyd, betyder det, at alt indholdet er injiceret.
English: Studies have been conducted in juvenile rats and dogs.
Danish: Der er udført forsøg med unge rotter og hunde.
English: This medicine is for use in adults (aged 18 and over).
Danish: Dette lægemiddel er beregnet til voksne (18 år og derover).
English: There was no evidence of teratogenicity in rats or rabbits.
Danish: Der blev ikke påvist nogen teratogenicitet i rotter eller kaniner.
English: Doses may also be given with longer intervals, as per clinical need.
Danish: Doserne kan også gives med længere interval, alt efter klinisk behov.
English: Do not give this medicine to children and adolescents under the age of 18 because the potential risks and benefits are not known.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, da de potentielle risici og fordele ikke er kendte.
English: Opioids are prescribed by your doctor.
Danish: Opioider ordineres af din læge.
English: Avoid repeated injections at the exact same spot previously used.
Danish: Undgå gentagne injektioner på præcis det samme sted som tidligere.
English: The terminal disposition half-life (t1/2) is approximately 8 hours.
Danish: Den terminale halveringstid (t1/2) er ca. 8 timer.
English: Other common side effects that may affect up to 1 in 10 people are:
Danish: Andre almindelige bivirkninger, der kan påvirke op til ét ud af 100 mennesker, er:
English: PATIENT CHECKLIST
Danish: PATIENTENS TJEKLISTE
English: If it is not, do not use the solution.
Danish: Hvis det ikke er tilfældet, må opløsningen ikke bruges.
English: The usual administration schedule is one single dose every other day.
Danish: Det normale behandlingsprogram er en enkelt dosis hver anden dag.
English: Your doctor will decide if you can use Relistor if you are pregnant.
Danish: Din læge vil afgøre, om du kan bruge Relistor, hvis du er gravid.
English: In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician.
Danish: I tilfælde af en overdosis skal tegn eller symptomer på ortostatisk hypotension monitoreres og rapporteres til en læge.
English: Throughout both study periods, patients maintained their usual laxative regimen.
Danish: I løbet af begge forsøgsperioder opretholdt patienterne deres sædvanlige laksativ-regimen.
English: • If you are receiving supportive care for your advanced illness, this medicine will only be used for a limited period of time, which will usually be less than 4 months.
Danish: • Hvis du får understøttende behandling for din fremskredne sygdom, vil dette lægemiddel kun blive anvendt i en begrænset tidsperiode, hvilket sædvanligvis vil være mindre end 4 måneder.
English: Dizziness is a common side effect of this medicine.
Danish: Svimmelhed er en almindelig bivirkning ved dette lægemiddel.
English: If you stop using Relistor You should talk to a doctor or pharmacist if you want to stop using this medicine.
Danish: Hvis du holder op med at bruge Relistor Du skal tale med en læge eller apoteket, hvis du ønsker at stoppe med at anvende dette lægemiddel.
English: If you push the plunger completely, you will hear a ‘click' sound.
Danish: Hvis du skubber stemplet helt ned, vil du høre et ”klik”.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: This will mean that the safety mechanism has been activated, and the needle will disappear into the syringe.
Danish: Det betyder, at sikkerhedsmekanismen er blevet aktiveret, og nålen forsvinder ind i sprøjten.
English: Your doctor will tell you whether you should stop or continue taking your usual laxatives when you start using this medicine.
Danish: Din læge vil fortælle dig, om du skal stoppe eller fortsætte med at tage dine sædvanlige afføringsmidler, når du begynder at bruge dette lægemiddel.
English: Are you mobile enough to reach the toilet, or do you have a caregiver looking after you who can help?
Danish: Er du mobil nok til at kunne gå på toilettet selv, eller er der plejepersonale, der kan hjælpe dig?
English: Dose (mL) = patient weight (kg) x 0.0075
Danish: Dosis (ml) = patientens vægt (kg) x 0,0075
English: Due to the safety design of the syringe, a small air bubble may be resistant to removal.
Danish: På grund af sprøjtens sikkerhedsudformning kan en lille luftboble være svær at fjerne.
English: The steady-state volume of distribution (Vss) is approximately 1.1 L/kg.
Danish: Fordelingsvolumen ved steady state (Vss) er ca. 1,1 l/kg.
English: However, this resulted in a small reduction in total clearance (from 107 L/h to 95 L/h).
Danish: Det medførte imidlertid en mindre reduktion i den samlede clearance (fra 107 l/t til 95 l/t).
English: Therefore, Relistor should only be administered with caution in these patients.
Danish: Relistor bør derfor kun indgives til disse patienter med forsigtighed.
English: This should be taken into account when prescribing methylnaltrexone bromide for such patients.
Danish: Der bør tages højde for dette ved ordination af methylnaltrexonbromid til sådanne patienter.
English: There may be a little bleeding at the injection site.
Danish: Der kan forekomme en mindre blødning på injektionsstedet.
English: The majority of patients had a primary diagnosis of back pain.
Danish: Hovedparten af patienterne havde en primærdiagnose med rygsmerter.
English: This section contains important questions that you will need to answer before you take Relistor, and during treatment with Relistor.
Danish: Dette afsnit indeholder vigtige spørgsmål, som du skal besvare, før du tager Relistor, og mens du er i behandling med Relistor.
English: Are you receiving opioid therapy (for example morphine or codeine) for your illness?
Danish: Er du i behandling med opioider (for eksempel morfin eller kodein) for din sygdom?
English: Always have the outer carton of the medicine with you, even if it is empty.
Danish: Medbring altid medicinens emballage, også selvom den er tom.
English: • Do not use a Relistor pre-filled syringe more than one time, even if there is medicine in the syringe.
Danish: • Brug ikke Relistor i fyldt injektionssprøjte mere end en gang, selv om der er mere medicin i sprøjten.
English: Subcutaneous use (SC)
Danish: Subkutan anvendelse (s.c.)
English: Approximately half of the dose is excreted in the urine and somewhat less in faeces.
Danish: Omkring halvdelen af dosis udskilles i urinen og noget mindre i fæces.
English: Make sure you stop pushing the plunger when you feel resistance.
Danish: Vær opmærksom på at holde op med at skubbe stemplet nedad, når du føler en modstand.
English: Relistor can be injected without regard to food.
Danish: Relistor kan injiceres uden hensyn til fødeindtagelse.
English: There was no evidence of a differential effect of gender on safety or efficacy.
Danish: Der var intet bevis for en kønsrelateret forskel i sikkerhed eller virkning.
English: Therefore, no dose adjustment is recommended based on age.
Danish: Dosisjustering på grund af alder anbefales derfor ikke.
English: • If you are allergic to methylnaltrexone bromide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for methylnaltrexonbromid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Always make sure you have the correct dose in the syringe.
Danish: Sørg altid for at have den korrekte dosis i sprøjten.
English: You may receive either a pack containing an inner carton with everything needed for the injection, or a single vial only.
Danish: Du får enten udleveret en pakning med en indre karton, der indeholder alt, hvad der skal bruges til injektionen, eller kun et enkelt hætteglas.
English: Push the full length of the needle into the skin at a slight angle (45 degrees) with a quick, short motion.
Danish: Pres kanylens fulde længde ind i huden i en lille vinkel på 45 grader med en hurtig, kort bevægelse.
English: You may use a sharps container (such as a yellow biohazard container).
Danish: Du kan bruge en kanyleboks (som f.eks. en gul beholder til biologisk risikomateriale).
English: Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia.
Danish: Patienter, der har forstyrrelser i blod-hjerne-barrieren, kan have en øget risiko for opioidabstinenser og/eller nedsat analgesi.
English: The 8 mg pre-filled syringe will only be used to treat these patients if the dose needs to be decreased because of another medical problem.
Danish: Den 8 mg fyldte injektionssprøjte vil kun blive brugt til at behandle disse patienter, hvis der er brug for at dosis nedsættes på grund af et andet medicinsk problem.
English: A total of 136, 21, and 82 patients received at least one open-label dose in studies 301, 301EXT, and 302EXT, respectively.
Danish: I alt 136, 21 og 82 patienter fik mindst én ublindet dosis i henholdsvis forsøg 301, 301EXT og 302EXT.
English: Wincentego Pola 21 58-500 Jelenia Góra, Poland
Danish: Wincentego Pola 21 58-500 Jelenia Góra, Polen
English: • Nausea (feeling sick)
Danish: • Kvalme (føler dig syg)
English: Methylnaltrexone bromide is minimally bound to human plasma proteins (11.0 % to 15.3 %) as determined by equilibrium dialysis.
Danish: Methylnaltrexonbromid er minimalt bundet til humane plasmaproteiner (11,0 % til 15,3 %) som bestemt ved ligevægtsdialyse.
English: Once you have drawn the medicine into the syringe, it must be used within 24 hours because Relistor is affected by light and may not work properly if it is left in the syringe for longer than 24 hours.
Danish: Når du har trukket lægemidlet op i sprøjten, skal det anvendes inden for 24 timer, da Relistor påvirkes af lyset og måske ikke fungerer korrekt, hvis det efterlades i sprøjten i længere end 24 timer.
English: Your doctor may allow you to take other medicines, including those used for constipation.
Danish: Din læge kan give dig lov til at tage anden medicin, herunder medicin mod forstoppelse.
English: You may see some fluid or bubbles inside the vial when the syringe is properly filled.
Danish: Du kan se noget væske eller nogle bobler i hætteglasset, når sprøjten fyldes korrekt.
English: Pharmacotherapeutic group: Laxatives, Peripheral opioid receptor antagonists, ATC code: A06AH01
Danish: Perifere opioid-receptor-antagonister, ATC-kode: A06AH01
English: Data from 133 (62 methylnaltrexone bromide, 71 placebo) patients were analysed.
Danish: Data fra 133 (62 methylnaltrexonbromid, 71 placebo) patienter blev analyseret.
English: Methylnaltrexone bromide should not be used during pregnancy unless clearly necessary.
Danish: Methylnaltrexonbromid bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: The rate of laxation response was maintained throughout the extension studies for those patients who continued treatment.
Danish: Responsraten for afføring blev fastholdt gennem forlængelsesforsøget for de patienter, der fortsatte behandlingen.
English: If you experience any of these side effects, which are either severe or will not go away, you should talk to your doctor:
Danish: Hvis du oplever nogen af disse bivirkninger, der enten er kraftige eller ikke vil forsvinde, bør du tale med din læge:
English: Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Danish: Omdannelse til methyl-6naltrexol-isomerer og methylnaltrexonsulfat synes at være den primære metaboliseringsvej.
English: Effect on cardiac repolarisation
Danish: Effekt på hjertets repolarisering
English: The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.
Danish: Mekanismen af denne virkning er ukendt, men den humane, hjerte-kaliumionkanal synes ikke at være involveret.
English: Select a flat, clean, well-lit working surface where you can lay out the contents of your Relistor carton.
Danish: Vælg et plant, rent, godt belyst underlag, hvor du kan placere indholdet af pakningen med Relistor.
English: Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement.
Danish: Data fra kliniske forsøg viser, at behandling med methylnaltrexonbromid kan medføre hurtig afføring (inden for 30 til 60 minutter i gennemsnit).
English: The following packs are available:
Danish: Følgende pakninger kan fås:
English: This injection should not be mixed in the same syringe with any other medicine.
Danish: Denne injektion må ikke blandes med anden medicin i samme sprøjte.
English: Make sure you have set aside a proper amount of time to complete the injection.
Danish: Sørg for at have afsat nok tid til at udføre injektionen.
English: Relistor was administered every 3.2 days (median dosing interval, with a range of 1-39 days).
Danish: Relistor blev givet med 3,2 dages mellemrum (det mediane doseringsinterval i perioden 1 - 39 dage).
English: Severity and worsening of symptoms Patients should be advised to promptly report severe, persistent, and/or worsening symptoms.
Danish: Sværhedsgrad og forværring af symptomer Patienterne skal instrueres om straks at indberette kraftige, vedvarende og/eller tiltagende symptomer.
English: It treats constipation that is caused by medicines for moderate to severe pain called opioids (for example morphine or codeine).
Danish: Det behandler forstoppelse, som skyldes medicin mod moderate til stærke smerter, benævnt opioider (f.eks. morfin eller codein).
English: There may be local laws about how you should throw away used needles and syringes.
Danish: Der kan være lokale regler om bortskaffelse af brugte kanyler og sprøjter.
English: Clean the injection site with an alcohol swab and let it dry.
Danish: Rens injektionsstedet med en spritserviet og lad det tørre.
English: Make sure that the dose prescribed by your doctor matches the dose on the pre-filled syringe label.
Danish: Vær sikker på, at den dosis, din læge har udskrevet, svarer til dosen på etiketten på den fyldte injektionssprøjte.
English: • It is important to be near a toilet with assistance available if necessary, since bowel movement may happen within 30 minutes after injection of the medicine.
Danish: • Det er vigtigt at være i nærheden af et toilet, hvor du kan få hjælp, hvis du har brug for det, da afføring kan ske inden for 30 minutter efter injektion af medicinen.
English: The effect on race could not be analysed because the study population was predominantly Caucasian (90 %).
Danish: Det kunne ikke analyseres, om der var en racemæssig forskel, fordi studiepopulationen hovedsageligt var kaukasisk (90 %).
English: The use of methylnaltrexone bromide for treating opioid-induced constipation beyond 48 weeks has not been evaluated in clinical trials.
Danish: Anvendelse af methylnaltrexonbromid til behandling af opioidinduceret obstipation udover 48 uger er ikke blevet evalueret i kliniske forsøg.
English: Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg.
Danish: Patienter, hvis vægt ligger uden for områderne, doseres med 0,15 mg/kg.
English: Date of first authorisation: 02 July 2008 Date of latest renewal: 27 May 2013
Danish: Dato for første markedsføringstilladelse: 02/07/2008 Dato for seneste fornyelse: 27/05/2013