FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult patients Intuniv has not been studied in adults with ADHD.
Danish: Voksne patienter Intuniv er ikke blevet undersøgt hos voksne med ADHD.
English: Guanfacine is an in vitro inhibitor of MATE1 and the clinical relevance of MATE1 inhibition cannot be excluded.
Danish: Guanfacin er en in vitro-hæmmer af MATE1, og den kliniske relevans af MATE1-hæmning kan ikke udelukkes.
English: Intuniv should not be used in children under the age of 6 years because efficacy and safety in this patient population has not been studied.
Danish: Intuniv bør ikke anvendes til børn under 6 år, da virkning og sikkerhed hos denne patientpopulation ikke er blevet undersøgt.
English: Dose Titration Schedule for Children Aged 6-12 years
Danish: Dosistitreringsskema for børn i alderen 6-12 år
English: • medicines that make you sleepy (sedatives)
Danish: • lægemidler, der gør dig søvnig (sedativa)
English: • your blood pressure and heart rate and other checks on your heart if appropriate
Danish: • dit blodtryk og din puls samt andre kontroller af dit hjerte, hvis det er relevant
English: Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Danish: Intuniv skal anvendes som en del af et omfattende behandlingsprogram for ADHD, der typisk omfatter psykoterapi, pædagogisk og social behandling.
English: Week 5 Week 6 Week 7
Danish: Uge 1 Uge 2 Uge 3 Uge 4 Uge 5 Uge 6 Uge 7
English: The dose may be adjusted in increments of not more than 1 mg per week.
Danish: Dosis kan justeres med trin på ikke over 1 mg om ugen.
English: • changes in liver blood test results (increased alanine aminotransferase)
Danish: • ændrede resultater af leverblodprøver (øget ALAT (alaninaminotransferase))
English: below).
Danish: 4 nedenfor).
English: The following table presents all adverse reactions based on clinical trials and spontaneous reporting.
Danish: Den følgende tabel opstiller alle bivirkninger på basis af kliniske studier og spontane rapporter.
English: Guanfacine was not genotoxic in a variety of test models, including the Ames test and an in vitro chromosomal aberration test.
Danish: Guanfacin var ikke genotoksisk i flere forskellige testmodeller, herunder Ames-test og en in vitro kromosomaberrationstest.
English: These reductions represent a percentage reduction of 56% vs. 33% for guanfacine vs. placebo, respectively.
Danish: Disse reduktioner udgør en procentvis reduktion på 56 % vs. 33 % for hhv. guanfacin vs. placebo.
English: Your doctor may increase your dose based on your body weight and how Intuniv is working for you but not by more than 1 mg per week.
Danish: Din læge kan øge din dosis baseret på din legemsvægt, og hvordan Intuniv virker på dig, men ikke med mere end 1 mg ugentligt.
English: The primary efficacy assessment was the ADHD-RS-IV total score.
Danish: Den primære virkningsvurdering var ADHD-RS-IV total score.
English: • Do not drink alcohol when taking this medicine as it may make you sleepy or drowsy.
Danish: • Du må ikke drikke alkohol, mens du tager lægemidlet, da det kan gøre dig søvnig eller døsig.
English: • Checklist prior to initiating treatment with Intuniv to identify patients at risk for serious undesirable effects
Danish: • Tjekliste før behandlingen med Intuniv påbegyndes for at identificere patienter med risiko for alvorlige bivirkninger
English: If two or more consecutive doses are missed, re-titration is recommended based on the patient's tolerability to guanfacine.
Danish: Hvis der springes to eller flere på hinanden følgende doser over, anbefales det at gentage titreringen baseret på patientens tolerabilitet over for guanfacin.
English: The effect of co-administration with psychostimulants was examined in an add-on study in partial responders to psychostimulants.
Danish: Virkningen af administration sammen med psykostimulantia blev undersøgt i et tillægsstudie af patienter med delvist respons på psykostimulantia.
English: • you have low or high blood pressure, heart problems or have a family history of heart problems
Danish: • du har et lavt eller højt blodtryk, hjerteproblemer, eller der er hjerteproblemer i familien
English: • medicines for epilepsy such as valproic acid
Danish: • lægemidler mod epilepsi, såsom valproinsyre
English: While you are taking this medicine your doctor will repeat these checks weekly during initial dosing, after dose adjustments, at least every 3 months for the first year and then at least twice a year.
Danish: Mens du tager dette lægemiddel, vil din læge gentage disse kontroller ugentligt i løbet af den indledende dosering, efter dosisjustering, mindst hver 3. måned i løbet af det første år, og dernæst mindst to gange årligt.
English: • weight increase/risk of obesity
Danish: • vægtøgning/risiko for fedme
English: Oral Methylphenidate
Danish: Oral methylphenidat
English: Effects on height, weight and Body Mass index (BMI) Children and adolescents treated with Intuniv may show an increase in their BMI.
Danish: Virkning på højde, vægt og BMI (Body Mass Index) Børn og unge i behandling med Intuniv kan vise en forhøjelse i deres BMI.
English: Intuniv should not be crushed, chewed or broken before swallowing because this increases the rate of guanfacine release.
Danish: Intuniv må ikke knuses, tygges eller knækkes, før den sluges, da dette øger hastigheden af guanfacinfrigørelsen.
English: • trouble sleeping (insomnia) or broken sleep (middle insomnia) or nightmares
Danish: • søvnproblemer (insomni) eller afbrudt søvn (søvnløshed midt om natten) eller mareridt
English: The safety and efficacy of guanfacine in adult and the elderly with ADHD has not been established and therefore should not be used in this group.
Danish: Guanfacins sikkerhed og virkning hos voksne og til ældre med ADHD er ikke klarlagt, og derfor bør lægemidlet ikke anvendes til denne gruppe.
English: The occurrence of somnolence/sedation and hypotension was most prominent in the first few weeks of treatment and diminished gradually thereafter.
Danish: Forekomsten af døsighed/sedation og hypotension var mest hyppig i løbet af de første få uger efter behandlingen og faldt gradvist derefter.
English: Guanfacine is a known antihypertensive agent.
Danish: Guanfacin er et kendt antihypertensivt stof.
English: Checks your doctor will do when you take Intuniv
Danish: Kontroller, din læge vil udføre, mens du tager Intuniv
English: Due to lack of proper toxicokinetic data, comparison to human clinical exposure was not possible.
Danish: Da der ikke foreligger egnede toksikokinetiske data, var en sammenligning med human klinisk eksponering ikke mulig.
English: Patients should be advised that somnolence and sedation can occur, particularly early in treatment or with dose increases.
Danish: Patienter skal informeres om, at døsighed og sedation kan forekomme, især tidligt i behandlingen eller ved dosisforhøjelser.
English: About ADHD
Danish: Om ADHD
English: • To stop the medicine, your doctor will slowly reduce your Intuniv dose to minimise any side effects.
Danish: • For at stoppe lægemidlet vil din læge vil langsomt nedtrappe din dosis af Intuniv for at mindske bivirkningerne.
English: By stimulating alpha 2A-adrenergic receptors, guanfacine reduces sympathetic nerve impulses from the vasomotor centre to the heart and blood vessels.
Danish: Ved at stimulere alfa2A-adrenerge receptorer reducerer guanfacin sympatiske nerveimpulser fra det vasomotoriske center til hjertet og blodkarrene.
English: These patients should receive further cardiac evaluation based on clinical judgement (see section 4.8).
Danish: Disse patienter bør gennemgå yderligere hjerteevaluering baseret på klinisk bedømmelse (se pkt.
English: • medicines that can affect the way Intuniv is eliminated by the liver (please see table below)
Danish: • lægemidler, der kan påvirke den måde, Intuniv udskilles af leveren på (se tabellen nedenfor)
English: These effects occur predominantly at the start of treatment and may occur less frequently as treatment continues.
Danish: Disse virkninger opstår primært ved behandlingsstart, og kan forekomme mindre hyppigt, når behandlingen fortsættes.
English: Do not stop taking this medicine without first talking to your doctor.
Danish: Du må ikke holde op med at tage dette lægemiddel uden først at kontakte lægen.
English: Nausea and vertigo.
Danish: Kvalme og svimmelhed (vertigo).
English: Dose adjustments (increase or decrease) to a maximum tolerated dose within the recommended optimal weight-adjusted dose range based upon clinical judgement of response and tolerability may occur at any weekly interval after the initial dose.
Danish: Dosisjusteringer (forhøjelser eller reduktioner) til en maksimalt tolereret dosis inden for det anbefalede optimale vægtjusterede dosisinterval baseret på klinisk bedømmelse af respons og tolerabilitet kan forekomme ved et hvilket som helst ugentligt interval efter initialdosis.
English: Intuniv contains the active substance guanfacine.
Danish: Intuniv indeholder det aktive stof guanfacin.
English: Guanfacine is moderately bound to plasma proteins (approximately 70%), independent of drug concentration.
Danish: Fordeling Guanfacin bindes moderat til plasmaproteiner (ca. 70 %), uafhængigt af lægemiddelkoncentrationer.
English: Food interactions
Danish: Fødevareinteraktion
English: For all patients, the recommended starting dose is 1 mg of guanfacine, taken orally once a day.
Danish: For alle patienter er den anbefalede startdosis 1 mg guanfacin, der tages oralt en gang dagligt.
English: • Chart for ongoing monitoring (vital signs, height, weight) of patients during treatment with Intuniv.
Danish: • Skema til løbende overvågning (vitale tegn, højde, vægt) for patienter i løbet af behandlingen med Intuniv.
English: • Do not take grapefruit juice with this medicine as it can have an effect on the way this medicine works.
Danish: • Tag ikke grapefrugtjuice sammen med lægemidlet, da det kan påvirke den måde, lægemidlet virker på.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Intuniv is launched all healthcare professionals who are expected to prescribe Intuniv are informed through an information letter on having access to / are provided with the following items:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, efter diskussion og aftale med de nationale kompetente myndigheder i hver medlemsstat, hvor Intuniv markedsføres, at alle læger og sundhedspersonale, som forventes at ordinere Intuniv, informeres via et informationsbrev om at have adgang til/blive forsynet med de følgende ting:
English: Guanfacine is a selective alpha2A-adrenergic receptor agonist in that it has 15-20 times higher affinity for this receptor subtype than for the alpha2B or alpha2C subtypes.
Danish: Guanfacin er en selektiv alfa2A-adrenerg receptoragonist, da den har 15-20 gange større affinitet for denne receptorundertype end for alfa2B-r eller alfa2C-undertyperne.
English: Immediate-release guanfacine tablets should not be substituted on a mg/mg basis, because of differing pharmacokinetic profiles.
Danish: Guanfacin-tabletter med øjeblikkelig udløsning bør ikke substitueres mg for mg, da de farmakokinetiske profiler er forskellige.
English: Intuniv should not be administered with high fat meals due to increased exposure, as it has been shown that high fat meals have a significant effect on the absorption of guanfacine.
Danish: Intuniv må ikke administreres sammen med måltider med et højt fedtindhold på grund af den øgede eksponering, da det er blevet vist, at måltider med højt fedtindhold har en signifikant virkning på absorptionen af guanfacin.
English: It is not known if Intuniv will affect your unborn baby.
Danish: Intuniv kan påvirke dit ufødte barn.
English: There are no or limited amount of data regarding effect on fertility from the use of guanfacine in humans.
Danish: Der er ingen eller utilstrækkelige data om virkningen på fertilitet fra anvendelse af guanfacin til mennesker.
English: • you are allergic to guanfacine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for guanfacin eller et af de øvrige indholdsstoffer i Intuniv (angivet i punkt 6).
English: • medicines that lower your blood pressure (antihypertensives)
Danish: • lægemidler, der sænker dit blodtryk (antihypertensiva)
English: The mechanism of this interaction is unknown, although both guanfacine and valproic acid are metabolised by glucuronidation, possibly resulting in competitive inhibition.
Danish: Mekanismen for denne interaktion er ukendt, selvom både guanfacin og valproinsyre metaboliseres ved glucuronidation, hvilket muligvis fører til kompetitiv hæmning.
English: Renal excretion is the major elimination pathway (80%) with parent drug accounting for 30% of the urinary radioactivity.
Danish: Nyreudskillelse er den primære eliminationsvej (80 %), hvor udgangsstoffet udgør 30 % af radioaktiviteten i urinen.
English: In particular, tell your doctor or pharmacist if you are taking any of the following types of medicines:
Danish: Du skal især fortælle det til lægen eller apotekspersonalet, hvis du tager nogle af de følgende typer lægemidler:
English: The ADHD Rating Scale is a measure of the core symptoms of ADHD.
Danish: ADHD klassifikationsskalaen er et mål for de grundlæggende symptomer på ADHD.
English: The mode of action of guanfacine in ADHD is not fully established.
Danish: Virkningsmekanismen for guanfacin for ADHD er ikke helt klarlagt.
English: • It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast).
Danish: • Det kan tages sammen med eller uden mad, men det må ikke tages sammen med fedtholdigt mad (f.eks. morgenmad med et højt fedtindhold).
English: • Checklist for ongoing monitoring and safety management of patients including titration phase during treatment with Intuniv
Danish: • Tjekliste for løbende overvågning og sikkerhedshåndtering af patienter, herunder titreringsfasen i løbet af behandlingen med Intuniv
English: In a drug interaction study, neither Intuniv nor Osmotic Release Oral System (OROS)methylphenidate HCl extended-release were found to affect the pharmacokinetics of the other medicinal products when taken in combination.
Danish: I et lægemiddelinteraktionsstudie blev det fundet, at hverken Intuniv eller Osmotic Release Oral System (OROS)-methylphenidat HCl påvirkede farmakokinetikken af andre lægemidler, når de blev taget i kombination.
English: Patients are advised against operating heavy equipment, driving or cycling until they know how they respond to treatment with Intuniv (see section 4.7).
Danish: Patienter rådes fra at betjene tungt udstyr, føre motorkøretøj eller cykle, indtil de ved, hvordan de responderer på behandlingen med Intuniv (se pkt.
English: Patients/caregivers should be instructed not to discontinue guanfacine without consulting their physician.
Danish: Nedtitrering og seponering Patienter/plejere skal instrueres i ikke at seponere guanfacin uden at kontakte lægen.
English: Dose reduction may be required in patients with severe renal impairment (GFR 29-15 ml/min) and an end stage renal disease (GFR<15 ml/min) or requiring dialysis.
Danish: Det kan være nødvendigt at reducere dosis hos patienter med svært nedsat nyrefunktion (GFR 29-15 ml/min) og en nyresygdom i slutstadiet (GFR<15 ml/min) eller dialysekrævende.
English: Haemodynamic instability has also been associated with a guanfacine overdose 3 times the recommended daily dose.
Danish: Hæmodynamisk ustabilitet er også blevet forbundet med en overdosering af guanfacin på 3 gange den anbefalede daglige dosis.
English: Depending on the patient's response and tolerability for Intuniv the recommended maintenance dose range is 0.05-0.12 mg/kg/day.
Danish: Afhængigt af patientens respons og tolerabilitet over for Intuniv er det anbefalede interval for vedligeholdelsesdosen fra 0,05-0,12 mg/kg/dag.
English: • Do not take this medicine with fatty foods (e.g., high fat breakfast), as it may affect the way this medicine works.
Danish: • Tag ikke lægemidlet sammen med mad med et højt fedtindhold (f.eks. morgenmad med et højt fedtindhold), da det kan påvirke den måde, lægemidlet virker på.
English: Special populations There have been no studies performed in children with ADHD under the age of 6 years with Intuniv.
Danish: Specielle populationer Der er ikke udført studier med Intuniv hos børn med ADHD under 6 år.
English: Preclinical research suggests guanfacine modulates signalling in the prefrontal cortex and basal ganglia through direct modification of synaptic noradrenalin transmission at the alpha 2- adrenergic receptors.
Danish: Præklinisk forskning tyder på, at guanfacin modulerer signaleringen i den præfrontale cortex og basale ganglier via direkte modifikation af synaptisk noradrenalintransmission ved alfa-2-adrenerge receptorer.
English: If you take more Intuniv than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget for meget Intuniv, bør du straks kontakte en læge eller tage på hospitalet.
English: All adverse reactions from post-marketing experience are italicised.
Danish: Alle bivirkninger fra erfaring efter markedsføring er skrevet med kursiv.
English: Concomitant administration of guanfacine with OCT1 substrates with a similar Tmax (e.g., metformin) may result in increases in Cmax of these medicinal products.
Danish: Samtidig administration af guanfacin og OCT1-substrater med en lignende Tmax (f.eks. metformin) kan medføre øget Cmax af disse lægemidler.
English: Guanfacine is cleared by the kidneys via filtration and active secretion and the liver.
Danish: Guanfacin udskilles af nyrerne via filtrering og aktiv secernering og via leveren.
English: Guanfacine showed embryo foetal developmental toxicity in mice and rats (NOAEL 0.5 mg/kg/day) and in rabbits (NOAEL 3.0 mg/kg/day) in the presence of maternal toxicity.
Danish: Guanfacin viste embryoføtal udviklingstoksicitet hos mus og rotter (NOAEL 0,5 mg/kg/dag) og hos kaniner (NOAEL 3,0 mg/kg/dag) ved tilstedeværelse af toksicitet hos moderdyret.
English: Prior to launch of Intuniv in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Intuniv markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
English: Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.
Danish: Intuniv er indiceret til behandling af attention deficit hyperactivity disorder (ADHD) hos børn og unge i alderen 6-17 år, hvor stimulantia ikke er egnede, ikke kan tolereres eller har vist sig at være ineffektive.
English: Breast-feeding It is unknown whether guanfacine and its metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om guanfacin og dets metabolitter udskilles i human mælk.
English: Dose Titration Schedule for Adolescents (Aged 13-17 Years)
Danish: Dosistitreringsskema for unge (i alderen 13-17 år)
English: Available pharmacodynamic and toxicological data in animals have shown excretion of guanfacine and its metabolites in milk (see section 5.3).
Danish: Tilgængelige farmakodynamiske og toksikologiske data fra dyr har vist udskillelse af guanfacin og dets metabolitter i mælk (se pkt.
English: Is a herbal preparation that is used to treat depression.
Danish: Er et naturlægemiddel, der bruges til at behandle depression.
English: There are no or limited amount of data from the use of guanfacine in pregnant women.
Danish: Graviditet Der er ingen eller utilstrækkelige data fra anvendelse af guanfacin til gravide kvinder.
English: • If you have missed two or more doses talk to your doctor as you may need to restart Intuniv with a lower dose.
Danish: • Hvis du har sprunget to eller flere doser over, skal du kontakte lægen, da det kan være, at du skal påbegynde Intuniv-behandlingen igen med en lavere dosis.
English: In case of concomitant use of strong and moderate CYP3A inhibitors, a 50% reduction of the guanfacine dose is recommended.
Danish: Ved samtidig anvendelse af kraftige og moderate CYP3A-hæmmere anbefales en 50 % reduktion af guanfacindosis.
English: If somnolence and sedation are judged to be clinically concerning or persistent, a dose decrease or discontinuation should be considered.
Danish: Hvis det bedømmes, at døsighed og sedation er klinisk bekymrende eller vedvarende, bør det overvejes at reducere eller seponere doseringen.
English: • tummy pain (abdominal pain).
Danish: • mavepine (abdominalsmerter).
English: Hypotension, bradycardia and syncope
Danish: Hypotension, bradykardi og synkope
English: Bradycardia occurred in 1.5%, hypotension in 3.2% and syncope occurred in 0.7% of all guanfacine-treated patients.
Danish: Bradykardi opstod hos 1,5 %, hypotension hos 3,2 % og synkope hos 0,7 % af alle guanfacinbehandlede patienter.
English: The majority of patients achieved an optimised dose between 0.05-0.12mg/kg/day.
Danish: Størstedelen af patienterne opnåede en optimeret dosis fra 0,05-0,12 mg/kg/dag.
English: The recommended dose is between 0.05 up to 0.12 mg per kg of bodyweight per day.
Danish: Den anbefalede dosis er fra 0,05 op til 0,12 mg pr. kg legemsvægt dagligt.
English: This results in a decrease in peripheral vascular resistance and blood pressure, and a reduction in heart rate.
Danish: Dette fører til en reduktion i perifer vaskulær modstand og blodtryk samt en nedsat puls.
English: Paediatric patients (children and adolescents 6-17 years old inclusive) who develop lethargy should be observed for the development of more serious toxicity including coma, bradycardia, and hypotension for up to 24 hours, due to the possibility of delayed onset of these symptoms.
Danish: Pædiatriske patienter (børn og unge i alderen 6 til og med 17 år), som udvikler letargi, bør observeres for udvikling af mere alvorlig toksicitet, herunder koma, bradykardi og hypotension i op til 24 timer, grundet muligheden for en forsinket start af disse symptomer.
English: Syncope may involve risks of falls or accidents, which could result in serious harm (see sections 4.8 and 4.7).
Danish: Synkope kan omfatte risikoen for fald eller uheld, hvilket kunne føre til alvorlig skade (se pkt.
English: When Intuniv is co-administered with valproic acid, patients should be monitored for potential additive central nervous system (CNS) effects and consideration should be given to the monitoring of serum valproic acid concentrations.
Danish: Når Intuniv administreres sammen med valproinsyre, skal patienterne overvåges for mulige additive virkninger på centralnervesystemet (CNS), og det bør overvejes at overvåge valproinsyrekoncentrationen i serum.
English: This medicine is used to treat ‘attention deficit hyperactivity disorder' (ADHD) in children and adolescents 6-17 years old for whom current stimulant medication is not appropriate and/or current medication does not adequately control ADHD symptoms.
Danish: Dette lægemiddel anvendes til at behandle 'attention deficit hyperactivity disorder' (ADHD) hos børn og unge i alderen 6-17 år, hvor aktuelt stimulerende medicin ikke er passende, og/eller hvor aktuel medicin ikke kontrollerer ADHD-symptomerne i tilstrækkelig grad.
English: Guanfacine-treated patients were in statistically significantly better conditions on the functional outcome as measured by the clinical global impression of severity (CGI-S) at endpoint compared to placebo-treated patients.
Danish: Guanfacinbehandlede patienter var i statistisk signifikant bedre form, hvad angår funktionelt udfald, målt ved klinisk globalt indtryk af sværhedsgrad (CGI-S) ved endepunktet, sammenlignet med placebobehandlede patienter.