FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with aripiprazole taken by mouth.
Danish: Det anvendes til vedligeholdelsesbehandling af skizofreni hos voksne, hos hvem sygdommen i forvejen er stabiliseret ved behandling med aripiprazol indtaget gennem munden.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Abilify Maintena opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The Committee considered that the monthly administration may help patients to adhere to their treatment.
Danish: Udvalget fandt, at doseringen en gang om måneden kan gøre det lettere for patienterne at følge behandlingen.
English: Abilify Maintena aripiprazole
Danish: Abilify Maintena aripiprazol
English: A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Abilify Maintena anvendes så risikofrit som muligt.
English: The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse.
Danish: Lægemidlet gives én gang om måneden ved langsom injektion i balderne eller deltamusklen (skulderen).
English: Since dopamine and 5hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.
Danish: Da dopamin og 5-hydroxytryptamin er inddraget ved skizofreni, medvirker aripiprazol til at normalisere hjerneaktiviteten, så de psykotiske symptomer mindskes og ikke kommer igen.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Danish: Aripiprazol menes hovedsagelig at virke ved delvis stimulation (som en såkaldt “partiel agonist”) af receptorerne for neurotransmitterne dopamin og 5hydroxytryptamin (også kaldet serotonin).
English: The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine.
Danish: Det aktive stof i Abilify Maintena, aripiprazol, er et antipsykotisk lægemiddel.
English: Other information about Abilify Maintena
Danish: Andre oplysninger om Abilify Maintena
English: The most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain.
Danish: De hyppigste bivirkninger med Abilify Maintena (som kan forekomme hos 5 eller flere ud af 100 behandlede) er vægtstigning, manglende evne til at sidde stille (akatisi), søvnbesvær (insomni) og smerte på injektionsstedet.
English: The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable.
Danish: CHMP bemærkede, at Abilify Maintena er lige så effektivt som aripiprazol indtaget gennem munden og har en tilsvarende sikkerhedsprofil bortset fra smerte på injektionsstedet, som blev anset for at kunne håndteres.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Abilify Maintena, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: What measures are being taken to ensure the safe and effective use of Abilify Maintena?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abilify Maintena?
English: Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection.
Danish: Abilify Maintena fås som et pulver (300 mg og 400 mg) og en opløsningsvæske (et solvens), der blandes og gives som depotinjektion.
English: For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Abilify Maintena, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Abilify Maintena is a medicine that contains the active substance aripiprazole.
Danish: Abilify Maintena er et lægemiddel, der indeholder det aktive stof aripiprazol.
English: Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning.
Danish: Abilify Maintena blev påvist at være lige så effektivt som aripiprazol indtaget gennem munden til at forebygge tilbagevenden af symptomerne på skizofreni.
English: Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: Skizofreni er en psykisk sygdom, der giver symptomer bl.a. i form tankeforstyrrelser og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
English: What is Abilify Maintena and what is it used for?
Danish: Hvad er Atosiban Maintena, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Abilify Maintena.
Danish: Det er ikke en praktisk vejledning i, hvordan Abilify Maintena bør anvendes.
English: What are the risks associated with Abilify Maintena?
Danish: Hvilke risici er der forbundet med Abilify Maintena?
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Danish: Det vil sige, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5-hydroxytryptamin, men ikke så kraftigt som neurotransmitterne.
English: Why is Abilify Maintena approved?
Danish: Hvorfor er Abilify Maintena blevet godkendt?
English: For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Abilify Maintena, kan du læse indlægssedlen eller kontakte din læge eller dit apotek
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af signalstoffer (neurotransmittere).
English: For the full list of all side effects reported with Abilify Maintena, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Abilify Maintena fremgår af indlægssedlen.
English: The dose may also need to be lowered in patients who are taking certain other medicines that slow the breakdown of aripiprazole in the body.
Danish: I tilfælde af bivirkninger kan dosis nedsættes til 300 mg. Dosisnedsættelse kan også være nødvendig for patienter, der tager visse andre lægemidler, som hæmmer nedbrydningen af aripiprazol i kroppen.
English: How is Abilify Maintena used?
Danish: Hvordan anvendes Abilify Maintena?
English: What benefits of Abilify Maintena have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Abilify Maintena?
English: How does Abilify Maintena work?
Danish: Hvordan virker Abilify Maintena?
English: Route of Administration
Danish: Pakningsstørrelse
English: This summary was last updated in 09/2014.
Danish: Dette sammendrag blev sidst ajourført i 09-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fortacin den 15. november 2013.
English: Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
Danish: Doseringen må ikke gentages oftere end hver fjerde time, og der må højst anvendes tre doser i løbet af 24 timer.
English: This is a summary of the European public assessment report (EPAR) for Fortacin.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fortacin.
English: Fortacin lidocaine / prilocaine
Danish: Fortacin lidocain/prilocain
English: The full EPAR for Fortacin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Fortacin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Fortacin
Danish: Andre oplysninger om Fortacin
English: What is Fortacin and what is it used for?
Danish: Hvad er Fortacin, og hvad anvendes det til?
English: Why is Fortacin approved?
Danish: Hvorfor er Fortacin blevet godkendt?
English: Fortacin must also not be used in patients whose partners are hypersensitive to these substances.
Danish: Fortacin må heller ikke anvendes hos patienter, hvis partnere er overfølsomme over for disse stoffer.
English: A risk management plan has been developed to ensure that Fortacin is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Fortacin anvendes så risikofrit som muligt.
English: There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Danish: Der var klare psykologiske fordele for patienterne og deres partnere, og bivirkningerne var lokale og kunne sædvanligvis håndteres.
English: What measures are being taken to ensure the safe and effective use of Fortacin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fortacin?
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Danish: I en forlængelse af de indledende undersøgelser blev nogle af patienterne fulgt i op til 9 måneder og havde stadig samme gavnlige virkning.
English: It is not intended to provide practical advice on how to use Fortacin.
Danish: Det er ikke en praktisk vejledning i, hvordan Fortacin bør anvendes.
English: What are the risks associated with Fortacin?
Danish: Hvilke risici er der forbundet med Fortacin?
English: The CHMP therefore decided that Fortacin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP afgjorde derfor, at fordelene ved Fortacin overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse med gyldighed i EU.
English: This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate.
Danish: Derved mindskes følsomheden for stimulation, og tiden indtil sædafgang forlænges.
English: Fortacin is a medicine containing the active substances lidocaine and prilocaine.
Danish: Fortacin er et lægemiddel, der indeholder de aktive stoffer lidocain og prilocain.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) fandt, at de aktive indholdsstoffer er en velkendt kombination af lokalbedøvende midler, og at anvendelsen af en lokal spray giver mindst mulig optagelse af aktivt indholdsstof og dermed mindst mulig risiko for bivirkninger, der omfatter hele kroppen.
English: In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.
Danish: I begge undersøgelser meldte de patienter, der fik lægemidlet, om væsentligt bedre kontrol, seksuel tilfredsstillelse og frustration end dem, der fik placebo.
English: It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Danish: Det anvendes til behandling af mænd med livslang (primær) for tidlig sædafgang, dvs. sædafgang, der begynder før penetration eller for tidligt under penetration).
English: The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Danish: De aktive stoffer i lægemidlet, lidocain og prilocain, er lokalbedøvende midler, der midlertidigt bedøver berøringsfladen gennem ikke varig blokering af signaloverførslen i nerverne.
English: The recommended dose is three sprays onto the head (glans) of the penis before intercourse.
Danish: Den anbefalede dosis er tre aktiveringer på penishovedet (glans) før samleje.
English: Fortacin can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Danish: Fortacin udleveres kun efter recept og leveres som kutanspray, opløsning, der afgiver 7,5 mg lidocain og 2,5 mg prilocain for hver aktivering.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fortacin, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Fortacin, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: For more information about treatment with Fortacin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fortacin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Danish: De hyppigste bivirkninger ved Fortacin (som kan forekomme hos op til 1 ud af 10 behandlede) er nedsat følsomhed (hypæstesi) og brænden omkring kønsorganerne hos både mænd og deres kvindelige partner, samt rejsningsproblemer (erektil dysfunktion) hos mænd.
English: Fortacin must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amide-type local anaesthetics).
Danish: Fortacin må ikke anvendes til patienter, der er overfølsomme (allergiske) over for de aktive indholdsstoffer i Fortacin eller andre lokalbedøvende midler med aktive indholdsstoffer, hvis struktur er beslægtet med indholdsstofferne i Fortacin (lokalanæstetika af amidtypen).
English: In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group.
Danish: I den anden undersøgelse var den gennemsnitlige tid til sædafgang 3,8 minutter hos de patienter, der anvendte lægemidlet, sammenholdt med 1,1 minut i placebogruppen.
English: What benefits of Fortacin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Fortacin?
English: How is Fortacin used?
Danish: Hvordan anvendes Fortacin?
English: For the full list of all side effects reported with Fortacin, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Fortacin fremgår af indlægssedlen.
English: For practical information about using Fortacin, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Fortacin, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients.
Danish: Virkningen blev hovedsagelig bedømt på den tid, der gik til sædafgang efter penetration, hvor godt sædafgangen kunne kontrolleres, og den seksuelle tilfredsstillelse eller frustration, der blev angivet af patienterne.
English: The effectiveness of Fortacin has been shown in two main studies involving a total of 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Danish: Virkningen af Fortacin er påvist i to hovedundersøgelser med deltagelse af i alt henholdsvis 256 og 300 heteroseksuelle voksne mænd med for tidlig sædafgang.
English: How does Fortacin work?
Danish: Hvordan virker Fortacin?
English: 21months
Danish: 21 måneder
English: Adults (18 years and over in age)
Danish: Voksne (18 år og derover)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 18. februar 2016
English: Absorption and elimination
Danish: Absorption og elimination
English: Do not use this medicine for more than 45 days after first opening the bottle.
Danish: Brug ikke dette lægemiddel mere end 45 dage efter første anbrud af flasken.
English: This leaflet was last revised in xxx <Other sources of information>
Danish: Denne indlægsseddel blev senest revideret i xxx <Andre informationskilder>
English: Do not take a double dose to make up for a forgotten capsule.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt kapsel.
English: No effect is expected from an oral iron product.
Danish: Der forventes ingen effekt fra et oralt jernprodukt.
English: No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account.
Danish: Ingen enkelt metode til vurdering er fuldstændig tilfredsstillende - kliniske kendetegn og laboratorieprøver må tages i betragtning.
English: - If you have received multiple blood transfusions.
Danish: - hvis du har fået mange blodtransfusioner.
English: Swallow the capsules whole.
Danish: Synk kapslerne hele.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP: The expiry date refers to the last day of that month.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Each bottle contains 56 capsules.
Danish: Hver flaske indeholder 56 kapsler.
English: Treatment duration will depend on the severity of iron deficiency but generally at least 12-weeks treatment is required.
Danish: Behandlingens varighed afhænger af, hvor svær jernmanglen er, men sædvanligvis behøves mindst 12 ugers behandling.
English: PHARMACEUTICAL FORM Capsules, hard.
Danish: LÆGEMIDDELFORM Kapsler, hårde.
English: IBD Studies
Danish: IBD-studier
English: No clinical studies are available to date.
Danish: Der er hidtil ikke udført kliniske undersøgelser.
English: Supportive and symptomatic measures reflecting best standard medical care should be implemented.
Danish: Der gives støttende og symptomatisk behandling, der afspejler bedste standardbehandling.
English: Do not give Feraccru to children or adolescents 17 years and under as it has not been studied in this age group.
Danish: Giv ikke Feraccru til børn eller unge på 17 år og derunder, da det ikke er undersøgt i denne aldersgruppe.
English: • Supplements or medicines that contain magnesium or calcium.
Danish: • kosttilskud eller lægemidler, der indeholder magnesium eller calcium
English: The results for the other key efficacy endpoints are shown in Table 2.
Danish: Resultaterne for de øvrige vigtigste endepunkter for virkning er gengivet i tabel 2.
English: However, the conducted reproductive toxicity studies are insufficient to discard any risk in humans.
Danish: De udførte reproduktionsundersøgelser er imidlertid utilstrækkelige til, at der kan ses bort fra enhver risiko hos mennesker.
English: The safety and efficacy of Feraccru in children (17 years and under) has not yet been established.
Danish: Sikkerheden og virkningen af Feraccru hos børn (17 år og derunder) er endnu ikke klarlagt.
English: Iron deficiency was also shown to be corrected by increase in ferritin levels in both studies.
Danish: Der blev endvidere påvist korrektion af jernmangel ved en stigning i ferritinniveauet i begge studier.
English: - If you have any illness causing iron overload or a disturbance in how your body uses iron.
Danish: - hvis du har en sygdom, der medfører overbelastning med jern eller forstyrrelse i, hvordan din krop bruger jern.
English: Shock can result from hypovolaemia or direct cardiotoxicity.
Danish: Der kan udvikles shock som følge af hypovolæmi eller direkte kardiotoksicitet.
English: NN: {number}>
Danish: NN: {nummer} >
English: Skip the missed dose and take the next dose as normal.
Danish: Spring den glemte dosis over, og tag næste dosis som du plejer.
English: A possible potential genotoxic potential for maltol could not be fully ruled out.
Danish: Et genotoksisk potentiale for maltol kunne ikke fuldstændig udelukkes.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale indberetningssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med skaffe mere information om sikkerheden af dette lægemiddel.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første periodiske, opdaterede sikkerhedsindberetning for dette lægemiddel inden for 6 måneder efter godkendelsen.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The vomit and stools may be grey or black.
Danish: Opkast og afføring kan være grå eller sort.
English: Table 2: Summary of Other Key Efficacy Endpoints (AEGIS 1/2)
Danish: Tabel 2: Sammenfatning af øvrige vigtige endepunkter for virkning (AEGIS 1/2)
English: Outer packaging: carton of 1 bottle
Danish: Ydre emballage: Karton med 1 flaske
English: The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests.
Danish: Behandlingen fortsættes så længe som nødvendigt for at genopfylde kroppens jerndepoter i henhold til blodprøver.