FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).
Danish: Hver filmovertrukken tablet indeholder 700 mg fosamprenavir som fosamprenavircalcium (svarende til ca. 600 mg amprenavir).
English: Atazanavir 300 mg once daily
Danish: Phenytoin 300 mg én gang daglig
English: Lovastatin: ↑ expected Simvastatin: ↑ expected (CYP3A4 inhibition by FPV/RTV)
Danish: Astemizol:  forventet Terfenadin:  forventet (FPV/RTV hæmmer CYP3A4)
English: Resistant to FPV/RTV
Danish: Følsomme over for FPV/RTV < 4 mutationer fra score
English: Signs to look out for include:
Danish: Hold øje med følgende:
English: FPV/RTV 700 mg/100 mg
Danish: FPV/RTV 700 mg/100 mg 2 gange daglig (n=105)
English: (Modest induction of CYP3A4 by FPV/RTV)
Danish: (FPV/RTV inducerer CYP3A4 beskedent)
English: 90 x 1 tablets (unit dose)
Danish: 90 x 1 tablet (enkeltdosisblister)
English: 32.27 g
Danish: Pulver: 32,27 g 1 flaske
English: Powder for oral suspension bottle (glass)
Danish: Pulver til oral suspension
English: Solution for injection Intravenous use vial (glass)
Danish: Intravenøs anvendelse Hætteglas (glas) 20 ml
English: 1 bottle
Danish: Flaske (glas)
English: l t o r
Danish: Pakningsstørrelse t r
English: Pharmaceutical Form Route of administration
Danish: Lægemiddelform Indgivelsesvej Emballage
English: This summary was last updated in 2-2013.
Danish: Dette sammendrag blev sidst ajourført i 2-2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adasuve on 20 February 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Adasuve den 20. februar 2013
English: This is a summary of the European public assessment report (EPAR) for Adasuve.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adasuve.
English: The full EPAR for Adasuve can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Adasuve findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Its action on receptors for other neurotransmitters may also play a role.
Danish: Dets virkning på receptorerne for andre neurotransmitter kan også spille en rolle.
English: Regarding its safety, most side effects are comparable to those of other antipsychotic medicines.
Danish: Hvad sikkerheden angår, er de fleste bivirkninger sammenlignelige med bivirkningerne af andre antipsykotiske lægemidler.
English: Agitation is a known complication of both mental illnesses.
Danish: Uro er en kendt komplikation ved begge sygdomme.
English: Other information about Adasuve
Danish: Andre oplysninger om Adasuve
English: Patients should be observed for signs of shortness of breath for one hour after each dose.
Danish: Patienterne bør observeres for tegn på kortåndethed en time efter hver dosis.
English: The effects of Adasuve were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Adasuve blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Adasuve was more effective than placebo at controlling agitation.
Danish: Adasuve var mere effektivt end placebo til at kontrollere uro.
English: Adasuve loxapine
Danish: Adasuve loxapin
English: The PEC score at the beginning of the study for these groups of patients was between 17 and 18.
Danish: Ved undersøgelsens begyndelse var PEC-score mellem 17 og 18 i disse patientgrupper.
English: Adasuve has been studied in two main studies.
Danish: Adasuve er blevet anvendt i to hovedundersøgelser.
English: The CHMP concluded that the benefits of Adasuve outweigh its risks and recommended that it be granted marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Adasuve overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The company that makes Adasuve must ensure that all healthcare professionals who are expected to use Adasuve receive an information pack containing key information on how to use the medicine as well as important safety information.
Danish: Den virksomhed, der fremstiller Adasuve, sørger for, at alle sundhedspersoner, der forventes at anvende Adasuve, modtager en informationspakke med de vigtigste oplysninger om, hvordan lægemidlet skal bruges, samt vigtig sikkerhedsinformation.
English: A fall in PEC score indicates an improvement in symptoms.
Danish: Et fald i PEC-score betyder en bedring af symptomerne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adasuve.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Adasuve.
English: For more information about treatment with Adasuve, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Adasuve, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Information on how to use the inhaler can be found in the package leaflet.
Danish: Oplysninger om brugen af inhalatoren findes i indlægssedlen.
English: One study involved 344 patients with schizophrenia and the second study involved 314 patients with bipolar disorder.
Danish: Den ene omfattede 344 patienter med skizofreni, den anden 314 patienter med bipolær sygdom.
English: Since these neurotransmitters are involved in agitation in schizophrenia and bipolar disorder, loxapine helps to normalise the activity of the brain, reducing agitation.
Danish: Da disse neurotransmittere er medvirkende ved uro ved skizofreni og ved bipolar sygdom, normaliserer loxapin hjerneaktiviteten og mindsker uroen.
English: The potential risk of bronchospasm is considered manageable and has been adequately addressed through risk minimisation measures.
Danish: Risikoen for bronkiekramper anses for at være håndterbar og er blevet imødegået tilfredsstillende med risikonedsættende foranstaltninger.
English: What measures are being taken to ensure the safe use of Adasuve?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Adasuve?
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 “neurotransmittere”, dvs. kemiske stoffer, som nervecellerne kommunikerer med indbyrdes.
English: Adasuve is a medicine that contains the active substance loxapine.
Danish: Adasuve er et lægemiddel, der indeholder det aktive stof loxapin.
English: It is available as an inhalation powder in a portable inhaler device for single use (4.5 mg and 9.1 mg).
Danish: Det leveres som et inhalationspulver i en bærbar inhalator til engangsbrug (4,5 mg og 9,1 mg).
English: Adasuve must not be used in people who are hypersensitive (allergic) to loxapine or any of the other ingredients.
Danish: Adasuve må ikke anvendes hos personer, der er overfølsomme (allergiske) over for loxapin eller andre af indholdsstofferne.
English: Loxapine works mainly by blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Danish: Loxapin menes hovedsagelig at virke på receptorerne for neurotransmitterne 5-hydroxytryptamin (serotonin) og dopamin.
English: The active substance in Adasuve, loxapine, is an antipsychotic medicine.
Danish: Det aktive stof i Adasuve, loxapin, er et antipsykotisk lægemiddel.
English: It must also not be used in patients with symptoms such as wheezing and shortness of breath or who have lung conditions such as asthma or chronic obstructive pulmonary disease.
Danish: Det må heller ikke anvendes hos patienter med symptomer som hvæsende vejrtrækning eller stakåndethed eller med lungesygdomme som astma eller kronisk obstruktiv lungesygdom (KOL).
English: Both studies compared 4.5 mg and 9.1 mg of Adasuve with placebo (a dummy treatment).
Danish: I begge undersøgelser blev 4,5 mg og 9,1 mg Adasuve sammenlignet med placebo (virkningsløs behandling).
English: Adasuve should only be used in a hospital under the supervision of a healthcare professional.
Danish: Adasuve må kun administreres i hospitalsomgivelser under opsyn af sundhedspersoner.
English: What is the risk associated with Adasuve?
Danish: Hvilken risiko er der forbundet med Adasuve?
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Danish: Skizofreni er en psykisk sygdom, der giver symptomer bl.a. i form af ankeforstyrrelser og taleforstyrrelser, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger.
English: Why has Adasuve been approved?
Danish: Hvorfor blev Adasuve godkendt?
English: A lower dose of 4.5 mg may be prescribed if the patient did not tolerate the initial dose of 9.1 mg or if a lower dose is considered more appropriate.
Danish: I stedet for en begyndelsesdosis på 9,1 mg kan der gives en lavere dosis på 4,5 mg, hvis den højere dosis ikke tåles af patienten, eller hvis lægen anser en lavere dosis for mere hensigtsmæssig.
English: Adasuve is used to rapidly control mild to moderate agitation in adults with schizophrenia or bipolar disorder.
Danish: Adasuve anvendes til hurtig kontrol af let til moderat uro hos voksne med skizofreni eller bipolær sygdom.
English: In the brain, it attaches to and blocks several different receptors on the surface of nerve cells.
Danish: I hjernen bindes det til forskellige typer receptorer på nervecellernes overflade og blokerer derved disse receptorer.
English: The CHMP concluded that Adasuve has been demonstrated to rapidly control (within minutes) mild to moderate agitation in patients with schizophrenia or bipolar disorder who are cooperative with using an inhaler.
Danish: CHMP konkluderede, at det er påvist, at Adasuve giver hurtig kontrol (i løbet af minutter) af let til moderat uro ved skizofreni eller bipolær sygdom, når patienten er samarbejdsvillig ved brug af inhalator.
English: This compared with a fall of 4.7 points in patients taking placebo.
Danish: Til sammenligning var der et fald på 4,7 point hos dem, der fik placebo.
English: For the full list of all side effects reported with Adasuve, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Adasuve fremgår af indlægssedlen.
English: The most common side effects with Adasuve are dysgeusia (taste disturbances), sedation or somnolence (sleepiness) and dizziness.
Danish: De almindeligste bivirkninger med Adasuve er smagsforstyrrelser, sløvhed eller søvnighed samt svimmelhed.
English: This compared with a fall of 5.8 points in patients taking placebo.
Danish: Til sammenligning var der et fald på 5,8 point hos dem, der fik placebo.
English: In the study in patients with schizophrenia, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.0 points and patients taking 9.1 mg had an average fall of 8.7 points.
Danish: I undersøgelsen med skizofreni var der et gennemsnitligt fald på 8,0 point i PEC-score hos patienter, der fik 4,5 mg Adasuve, og 8,7 point hos dem, der fik 9,1 mg Adasuve.
English: Bipolar disorder is a mental illness with alternating periods of high mood and depression.
Danish: Bipolær sygdom er en sygdom med skiftevis opstemthed og nedtrykthed.
English: An airway-opening medicine called a short-acting beta agonist should also be available for the treatment of patients who develop bronchospasm (excessive and prolonged contraction of the airway muscles).
Danish: På afdelingen skal der være rådighed over et luftvejsudvidende lægemiddel (en korttidsvirkende beta-agonist) til patienter, der får bronkospasme (bronkiekramper, kraftig og langvarig sammentrækning af muskulaturen i luftvejene).
English: How has Adasuve been studied?
Danish: Hvordan blev Adasuve undersøgt?
English: In the study in patients with bipolar disorder, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.2 points, and patients taking 9.1 mg had an average fall of 9.2 points.
Danish: I undersøgelsen med bipolær sygdom var der et gennemsnitligt fald på 8,2 point i PEC-score hos de patienter, der fik 4,5 mg Adasuve, og 9,2 point hos dem, der fik 9,1 mg Adasuve.
English: What is Adasuve?
Danish: Hvad er Adasuve?
English: What benefit has Adasuve shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Adasuve?
English: The main measure of effectiveness was the change in the patients' symptoms two hours after giving a dose of loxapine, assessed using a standard scale of agitation in patients with schizophrenia and bipolar disorder (positive and negative symptom scale, excited component: PEC score).
Danish: Symptomerne blev vurderet efter en standardskala for uro hos patienter med skizofreni og bipolær sygdom (PEC-score, “positive and negative symptom scale, excited component”).
English: In studies in agitated patients, bronchospasm was reported as an uncommon but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short acting beta-agonist.
Danish: Hos patienter med aktiv luftvejssygdom blev bronkiekramper derimod beskrevet som almindeligt forekommende og krævede ofte behandling med en korttidsvirkende beta-agonist.
English: The CHMP noted that the administration of Adasuve is non-invasive.
Danish: CHMP bemærkede, at Adasuve kan tages uden brug af injektion.
English: What is Adasuve used for?
Danish: Hvad anvendes Adasuve til?
English: If considered necessary the doctor may prescribe a second dose of 9.1 mg after two hours.
Danish: Behandlingen med Adasuve påbegyndes med inhalation af en enkelt dosis på 9,1 mg. Om nødvendigt vil lægen ordinere endnu en dosis på 9,1 mg efter 2 timer.
English: How is Adasuve used?
Danish: Hvordan anvendes Adasuve?
English: How does Adasuve work?
Danish: Hvordan virker Adasuve?
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product
Danish: Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet
English: • The risk of bladder cancer risk and relevant risk minimisation advice.
Danish: • Risikoen for blærekræft og relevant rådgivning i risikominimering.
English: Following oral administration of [
Danish: Efter oral administration af [
English: Date of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013
Danish: Dato for første markedsføringstilladelse: 19. november 2008 Dato for seneste fornyelse: 28. november 2013
English: However, this has not been established in the target population.
Danish: Dette er dog ikke fastslået i målpopulationen.
English: These changes are, however, not considered to be clinically relevant.
Danish: Disse ændringer betragtes dog ikke som klinisk relevante.
English: • if you are on dialysis.
Danish: • hvis du er i dialyse.
English: Then take your next dose at the usual time.
Danish: Tag derefter næste dosis til sædvanlig tid.
English: 112 tablets.
Danish: 112 tabletter.
English: Additional information on special populations Elderly (≥ 65 years)
Danish: specielle populationer Ældre patienter (≥ 65 år)
English: Statistical non-inferiority was not achieved.
Danish: Der blev ikke opnået statistisk noninferioritet.
English: Since this product has been marketed, the following side effects have also been reported:
Danish: Siden denne medicin er blevet markedsført er følgende bivirkninger blevet rapporteret:
English: You may have to take this treatment over a long period of time.
Danish: Det kan være nødvendigt med behandling i lang tid.
English: Medical attention may be needed.
Danish: Lægebehandling kan være nødvendig.
English: The pancreas makes both of these substances.
Danish: Bugspytkirtlen producerer begge disse stoffer.
English: Adjudicated cardiovascular events were balanced overall.
Danish: Bekræftede kardiovaskulære hændelser var overordnet set afbalanceret.
English: In the event of an overdose, supportive management is recommended.
Danish: I tilfælde af en overdosering anbefales understøttende behandling.
English: However, the magnitude of change is not clinically significant, so that Jalra can be given with or without food.
Danish: Men ændringens størrelse er ikke klinisk signifikant, så Jalra kan gives med eller uden mad.
English: Characteristics in specific groups of patients
Danish: Karakteristika hos specifikke grupper af patienter
English: The maximum daily dose is 100 mg.
Danish: Den maksimale daglige dosis er 100 mg.
English: The maximum change (increase or decrease) in the exposure to vildagliptin is ~30%, which is not considered to be clinically relevant.
Danish: Den maksimale ændring (stigning eller fald) i eksponeringen for vildagliptin er ~30 %, hvilket ikke betragtes som klinisk relevant.
English: (type A) and magnesium stearate.
Danish: (type A) og magnesiumstearat.
English: Contains lactose (see leaflet for further information).
Danish: Indeholder lactose (se indlægssedlen for yderligere information).
English: One side is debossed with “NVR”, and the other side with “FB”.
Danish: Den ene side er præget med ”NVR”, og den anden side er præget med ”FB”.
English: • Take Jalra every day for as long as your doctor tells you.
Danish: • Tag Jalra hver dag, så længe din læge siger, at du skal gøre det.
English: Should these occur, you should promptly consult your doctor.
Danish: Skulle disse forekomme skal du straks kontakte din læge.
English: Do not stop taking Jalra unless your doctor tells you to.
Danish: Hold ikke op med at tage Jalra, medmindre lægen siger det.
English: • Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: • Din læge holder øje med din sygdomstilstand for at kontrollere, at behandlingen virker, som den skal.
English: • Do not use this medicine after the expiry date which is stated on the blister and the carton after
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og pakningen efter
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported.
Danish: Der er rapporteret sjældne tilfælde af leverdysfunktion (inklusive hepatitis).
English: Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.
Danish: Selvom du nu begynder at tage medicin for din sukkersyge, er det vigtigt, at du følger den diæt og/eller den motionsplan, du har fået anbefalet.
English: If you forget to take a dose of this medicine, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis af medicinen, skal du tage den, så snart du husker det.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres 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), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Some symptoms need immediate medical attention: You should stop taking Jalra and see your doctor immediately if you experience the following side effects:
Danish: Nogle symptomer kræver øjeblikkelig lægelig opmærksomhed: Du bør stoppe med at tage Jalra og straks kontakte din læge, hvis du oplever nogle af følgende bivirkninger:
English: • if you have moderate or severe kidney disease (you will need to take a lower dose of Jalra).
Danish: • hvis du har en moderat eller alvorlig nyresygdom (det er nødvendigt, at du tager en lavere dosis af Jalra).
English: A no-effect level was not established.
Danish: Der blev ikke fastslået et nuleffektniveau.
English: It is used when diabetes cannot be controlled by diet and exercise alone.
Danish: Det bruges, når sukkersygen ikke kan kontrolleres med diæt og motion alene.
English: How to take Jalra • Swallow the tablets whole with some water.
Danish: Hvordan du skal tage Jalra • Synk tabletterne hele med lidt vand.
English: • if you suffer from heart failure.
Danish: • hvis du lider af hjertesvigt.
English: Embryo-foetal toxicity was evaluated in rats and rabbits.
Danish: Den embryoføtale toksicitet blev evalueret hos rotter og kaniner.
English: Administration of vildagliptin with food resulted in a decreased Cmax (19%).
Danish: Administration af vildagliptin sammen med mad resulterede i et fald i Cmax (19 %).
English: • if you have or have had a disease of the pancreas.
Danish: • hvis du har eller har haft en sygdom i bugspytkirtlen.
English: The active substance of Jalra, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Danish: Det aktive stof i Jalra, vildagliptin, tilhører en gruppe af lægemidler, der hedder ”orale antidiabetika”.
English: Your doctor will tell you exactly how many tablets of Jalra to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange Jalratabletter du skal tage.
English: Digoxin (Pgp substrate), warfarin (CYP2C9 substrate)
Danish: Digoxin (Pgp-substrat), warfarin (CYP2C9-substrat)
English: However, there were imbalances in baseline cardiovascular risk favouring placebo and the number of events was low, precluding firm conclusions.
Danish: Der var dog ubalance i den kardiovaskulær risiko ved baseline i placebos favør, og antallet af hændelser var lave, hvilket umuliggør en konkret konklusion.
English: Jalra is not a substitute for insulin in insulin-requiring patients.
Danish: Jalra kan ikke erstatte insulin hos insulinkrævende patienter.
English: EU/1/08/485/001 7 tablets EU/1/08/485/002 14 tablets EU/1/08/485/003 28 tablets EU/1/08/485/004 30 tablets EU/1/08/485/005 56 tablets EU/1/08/485/006 60 tablets EU/1/08/485/007 90 tablets EU/1/08/485/008 112 tablets EU/1/08/485/009 180 tablets EU/1/08/485/010 336 tablets
Danish: EU/1/08/485/001 7 tabletter EU/1/08/485/002 14 tabletter EU/1/08/485/003 28 tabletter EU/1/08/485/004 30 tabletter EU/1/08/485/005 56 tabletter EU/1/08/485/006 60 tabletter EU/1/08/485/007 90 tabletter EU/1/08/485/008 112 tabletter EU/1/08/485/009 180 tabletter EU/1/08/485/010 336 tabletter
English: There are no adequate data from the use of vildagliptin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af vildagliptin til gravide kvinder.
English: However, the major hydrolysis metabolite (LAY 151) can be removed by haemodialysis.
Danish: Hydrolysens hovedmetabolit (LAY 151) kan dog fjernes ved hæmodialyse.
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Danish: Du bør følge de anbefalinger for hud- og fodpleje, som du får af din læge eller sygeplejerske.
English: Information regarding overdose with vildagliptin is limited.
Danish: Information om overdosering med vildagliptin er begrænset.
English: Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Danish: Du får type 2 diabetes, hvis kroppen ikke producerer insulin nok, eller hvis det insulin, kroppen producerer, ikke fungerer så godt, som det skulle.
English: The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution.
Danish: Vildagliptins gennemsnitlige fordelingsvolumen ved steady state efter intravenøs administration (Vss) er 71 liter, hvilket indikerer ekstravaskulær distribution.