FrancophonIA/ELRC3.0 huggingface dataset:
English: The blister strips comprise of 2 layers, a clear thermoformable rigid film which is laminated with PCTFE to a PVC backing to which a push-through aluminium foil is adhered.
Danish: Blisterstrips består af 2 lag, en klar, stiv film, som kan formes termisk og er lamineret med PCTFE til en PVC-bagside, hvor en gennembrudsfolie af aluminium er påsat.
English: The tablets come in pack sizes of 7, 28 or 84 but not all pack sizes may be available.
Danish: Tabletterne fås i pakningsstørrelser med 7, 28 eller 84 tabletter, men ikke alle pakningsstørrelser kan nødvendigvis fås.
English: There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer.
Danish: Der var en signifikant reduktion i hyppigheden og omfanget af guanfacineksponering, når det blev administreret sammen med rifampin, en CYP3A4-inducer.
English: • Checklist for discontinuation of guanfacine including monitoring blood pressure and pulse of patients during downward titration.
Danish: • Tjekliste ved seponering af guanfacin; omfatter overvågning af patienternes blodtryk og puls i forbindelse med nedtitreringen.
English: Oppositional symptoms were evaluated as the change from baseline to endpoint in the Oppositional Subscale of the Conners' Parent Rating Scale - revised Long Form (CPRS-R:L) score.
Danish: Oppositionssymptomerne blev evalueret som ændringen fra baseline til endepunkt i oppositionsdelskalaen af Conners' Parent Rating Scale - revised Long Form (CPRS-R:L)-score.
English: Adolescents weighing 58.5 kg and above may be titrated to a 7 mg/day dose after the subject has completed a minimum of 1 week of therapy on a 6 mg/day dose and the physician has performed a thorough review of the subject's tolerability and efficacy.
Danish: Unge, der vejer 58,5 kg og derover, kan titreres til en dosis på 7 mg/dag, efter at personen har gennemført mindst 1 uges behandling med en dosis på 6 mg/dag, og efter at lægen har udført en grundig gennemgang af tolerabilitet og virkning for personen.
English: • lack of energy (lethargy)
Danish: • mangel på energi (letargi)
English: Shire Pharmaceuticals Ireland Limited (as MA Logo)
Danish: Shire Pharmaceuticals Ireland Limited (som logoet fra indehaveren af markedsføringstilladelsen)
English: Guanfacine also showed significant improvement in learning, school and family functioning as measured with the (WFIRS-P score).
Danish: Guanfacin viste signifikant forbedring i funktion ved indlæring, i skolen og familien, målt ved hjælp af (WFIRS-P-score).
English: A decision must be made whether to discontinue breast-feeding or to discontinue and/or abstain from Intuniv therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre og/eller behandling med Intuniv seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Effects on height, weight and body Mass index (BMI) Careful follow-up for weight suggests that children and adolescents who took Intuniv in the study (i.e., treatment for 7 days per week throughout the year) have demonstrated by an age- and sex-normalised mean change from baseline in BMI percentile, 4.3 over 1 year (average percentiles at baseline and 12 months were 68.3 and 73.1, respectively).
Danish: Virkning på højde, vægt og BMI (Body Mass Index) Omhyggelig opfølgning af vægten tyder på, at børn og unge, der tog Intuniv i studiet (dvs. behandling i 7 dage ugentligt i løbet af året), har udvist en gennemsnitlig alders- og kønsnormaliseret ændring fra baseline i BMI-procentil på 4,3 i løbet af 1 år (gennemsnitlige procentiler ved baseline og efter 12 måneder var hhv. 68,3 og 73,1).
English: Male fertility was affected at 8 mg/kg/day, the lowest dose tested, equivalent of 10.8 times the maximum recommended human dose of 0.12 mg/kg on a mg/m basis.
Danish: Fertiliteten hos hanner blev påvirket ved 8 mg/kg/dag, den mindste testede dosis, hvilket svarer til 10,8 gange den maksimalt anbefalede dosis til mennesker på 0,12 mg/kg baseret på mg/m2.
English: No carcinogenic effect of guanfacine was observed in studies of 78 weeks in mice at doses up to 10 mg/kg/day.
Danish: Der blev ikke observeret nogen karcinogen virkning af guanfacin i 78-ugers studier med mus ved doser op til 10 mg/kg/dag.
English: SHP503-401: In order to investigate the long term safety (especially effects on neurocognitive function) of Intuniv in Children and Adolescents Aged 6-17 Years with ADHD, the MAH should conduct and submit the results of a comparative safety study according to an agreed protocol.
Danish: SHP503-401: For at undersøge sikkerheden på langt sigt (især virkningerne på neurokognitiv funktion) af Intuniv hos børn og unge i alderen 6-17 år med ADHD skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af et sammenlignende sikkerhedsstudie i henhold til en aftalt protokol.
English: Guanfacine showed a significantly greater improvement in the ADHD-RS-IV total score compared with subjects receiving placebo.
Danish: Guanfacin viste en signifikant større forbedring i ADHD-RS-IV total score sammenlignet med personer, der fik placebo.
English: Somnolence/sedation, hypotension, bradycardia and syncope In the overall pool of guanfacine-treated patients, somnolence occurred in 40.6% and sedation in 10.2% of guanfacine-treated patients.
Danish: Døsighed/sedation, hypotension, bradykardi og synkope I den samlede pulje af guanfacinbehandlede patienter opstod døsighed hos 40,6 % og sedation hos 10,2 % af de guanfacinbehandlede patienter.
English: • Do not breast-feed while taking Intuniv unless told to do so by your doctor.
Danish: • Du må ikke amme, mens du tager Intuniv, medmindre lægen har bedt dig om det.
English: Intuniv can be administered with or without food but should not be administered with high fat meals, due to increased exposure (see section 5.2).
Danish: Intuniv kan administreres sammen med eller uden mad, men må ikke administreres sammen med måltider med højt fedtindhold på grund af en øget eksponering (se pkt.
English: The pharmacokinetics of guanfacine is similar in children (aged 6 to 12) and adolescents (aged 13 to 17) ADHD patients, and healthy adult volunteers.
Danish: Farmakokinetikken af guanfacin er tilsvarende for børn (i alderen 6-12 år) og unge (i alderen 13-17 år) hos ADHD-patienter og raske voksne frivillige.
English: Treatment must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.
Danish: Behandlingen skal påbegyndes under overvågning af en passende specialist i adfærdssygdomme hos børn og/eller unge.
English: Syncope/loss of consciousness
Danish: Synkope/bevidstløshed
English: 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustment.
Danish: Derefter skal overvågningen udføres hver 6. måned med hyppigere overvågning efter dosisjusteringer.
English: In this study, no effect on d-amphetamine exposure was observed following combination of Intuniv and lisdexamfetamine dimesylate.
Danish: I dette studie blev der ikke observeret nogen virkning af dexamfetamin-eksponering efter kombination af Intuniv og lisdexamfetamindimesylat.
English: The following effects may happen: low or high blood pressure, slow heart rate, slow breathing rate, feeling tired or exhausted.
Danish: Der kan evt. opstå de følgende virkninger: lavt eller højt blodtryk, langsom puls, langsom vejrtrækning, træthedsfølelse eller udmattelse.
English: Suboptimal response was defined as an ADHD-RS-IV total score of ≥24 and a CGI-S score ≥3 at screening and baseline.
Danish: Et suboptimalt respons var defineret som en ADHD-RS-IV total score på ≥24 og en CGI-S-score på ≥3 ved screening og baseline.
English: There is no evidence of any impact of ethnicity on the pharmacokinetics of Intuniv.
Danish: Der er ikke evidens for nogen påvirkning af etnicitet på Intunivs farmakokinetik.
English: The percentages of subjects who met response criteria (≥30% reduction from baseline in ADHD-RS-IV Total Score and a CGI-I value of 1 or 2) was 64.3% for guanfacine, 55.4% for atomoxetine and 42.3% for placebo.
Danish: Procentdelen af personer, som opfyldte responskriterierne (≥30 % reduktion fra baseline i ADHD-RS-IV total score og en CGI-I-værdi på 1 eller 2), var 64,3 % for guanfacin, 55,4 % for atomoxetin og 42,3 % for placebo.
English: • You may not notice an immediate effect upon starting treatment, some patients may notice an improvement after the first week but it could take longer.
Danish: Nogle patienter kan mærke en forbedring efter den første uge, men det kan tage længere.
English: Guanfacine is cleared both by the liver and the kidneys, and at least 50% of the clearance of guanfacine is hepatic.
Danish: Guanfacin udskilles både af lever og nyrer, og mindst 50 % af guanfacins clearance er via leveren.
English: • Information on the risks associated with Intuniv: Bradycardia, Syncope, Hypotension/decreased blood pressure, withdrawal blood pressure increase, sedative events and weight increase
Danish: • Information om risici forbundet med Intuniv: Bradykardi, synkope, hypotension/nedsat blodtryk, blodtryksstigning efter seponering, sederende hændelser og vægtøgning
English: Atazanavir, efavirenz, etravirine, fosamprenavir, indinavir, nevirapine, ritonavir, saquinavir
Danish: Atazanavir, efavirenz, etravirine, fosamprenavir, indinavir, nevirapin, ritonavir, saquinavir
English: You may feel dizzy and drowsy when taking this medicine, especially at the start of treatment and this may last for 2 to 3 weeks possibly longer.
Danish: Du kan føle dig svimmel og døsig, når du tager lægemidlet, især i begyndelsen af behandlingen, og det kan vare i 2 til 3 uger, muligvis længere.
English: Bacterial infections.
Danish: Bakterieinfektioner.
English: Pharmacotherapeutic group: Antihypertensives, antiadrenergic agents, centrally acting ATC code: C02AC02.
Danish: Farmakoterapeutisk klassifikation: Antihypertensiva, antiadrenerge stoffer, centralt virkende ATCkode: C02AC02.
English: • low blood pressure when standing up (orthostatic hypotension)
Danish: • lavt blodtryk, når man rejser sig op (ortostatisk hypotension)
English: Guanfacine is metabolised via CYP3A4/5-mediated oxidation, with subsequent phase II reactions of sulphation and glucuronidation.
Danish: Guanfacin metaboliseres via CYP3A4/5-medieret oxidation, med efterfølgende fase II-reaktioner som sulfation og glucuronidation.
English: In adults, the mean exposure of guanfacine increased (Cmax ~75% and AUC ~40%) when Intuniv was taken together with a high fat meal, compared to intake in the fasted state (see section 4.2).
Danish: Hos voksne var den gennemsnitlige eksponering af guanfacin forhøjet (Cmax ~ 75 % og AUC ~ 40 %), når Intuniv blev taget sammen med et måltid med højt fedtindhold sammenlignet med indtagelsen i fastende tilstand (se pkt.
English: In the event of a missed dose, Intuniv dosing can resume the next day.
Danish: Hvis en dosis springes over, kan doseringen med Intuniv genoptages dagen efter.
English: Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Your treatment will start under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.
Danish: Din behandling vil blive påbegyndt under overvågning af en passende specialist i adfærdssygdomme hos børn og/eller unge.
English: Treatment failure was defined as a ≥50% increase in ADHD-RS-IV total score and a ≥2 point increase in CGI-S score compared to the respective scores at the double-blind baseline visit.
Danish: Behandlingssvigt blev defineret som en ≥50 % stigning i ADHD-RS-IV total score og en ≥2 points forhøjelse i CGI-S-score sammenlignet med de tilhørende scores ved det dobbeltblindede baselinebesøg.
English: • If you stop taking this medicine your blood pressure and heart rate may increase (see section 4
Danish: • Hvis du holder op med at tage dette lægemiddel, kan dit blodtryk og din puls måske stige (se pkt.
English: Furthermore, based on in vitro studies, guanfacine may be an inhibitor of OCT1 at maximal portal vein concentrations.
Danish: I henhold til in vitro-studier tyder det desuden på, at guanfacin kan være en hæmmer af OCT1 ved maksimal portåre-koncentration.
English: Based on in vitro studies, guanfacine is a substrate of OCT1 and OCT2, but not BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1 or MATE2.
Danish: I henhold til in vitro-studier er guanfacin et substrat for OCT1 og OCT2, men ikke for BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1 og MATE2.
English: In a drug interaction study, administration of Intuniv in combination with lisdexamfetamine dimesylate induced a 19% increase in guanfacine maximum plasma concentrations, whereas exposure (AUC) was increased by 7%.
Danish: I et lægemiddelinteraktionsstudie inducerede administration af Intuniv i kombination med lisdexamfetamindimesylat en 19 % forhøjelse i den maksimale plasmakoncentration af guanfacin, hvorimod eksponering (arealet under kurven, AUC) var forhøjet med 7 %.
English: Do not stop taking Intuniv without talking to your doctor.
Danish: Du må ikke holde op med at tage Intuniv uden først at have talt med din læge.
English: At the end of their double-blind treatment, a significantly larger proportion of subjects in the guanfacine compared with placebo group were normal or borderline mentally ill as measured by the clinical global impression of severity (CGI-S) that includes assessment of functioning.
Danish: Ved slutningen af deres dobbeltblindede behandling var en signifikant større andel af personerne i gruppen med guanfacin normale eller med borderline psykisk sygdom sammenlignet med placebogruppen, målt ved CGI-S (clinical global impression of severity), der omfattede vurdering af funktion.
English: Suboxone
Danish: Suboxon
English: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone
Danish: Carbamazepin, oxcarbazepin, phenobarbital, phenytoin, primidon
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis noget af det ovenstående gælder for dig (eller du ikke er sikker), skal du kontakte din læge eller apotekspersonalet, før du tager dette lægemiddel.
English: The peak plasma concentrations (Cmax) and exposure (AUC) of guanfacine decreased by 54% and 70% respectively.
Danish: De maksimale plasmakoncentrationer (Cmax) og eksponeringen (AUC) for guanfacin faldt med hhv. 54 % og 70 %.
English: Do not take Intuniv if:
Danish: Tag ikke Intuniv:
English: Concomitant administration of guanfacine with MATE1 substrates may result in increases in the plasma concentrations of these medicinal products.
Danish: Samtidig administration af guanfacin og MATE1-substrater kan medføre øget plasmakoncentration af disse lægemidler.
English: Caution is also advised when treating patients with Intuniv who are being treated concomitantly with antihypertensives or other medicinal products that can reduce blood pressure or heart rate or increase the risk of syncope.
Danish: Der rådes også til forsigtighed ved behandling af patienter med Intuniv, hvis de samtidigt behandles med antihypertensiva eller andre lægemidler, der kan reducere blodtrykket eller pulsen eller øge risikoen for synkope.
English: Intuniv is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Intuniv bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Cardiovascular conditions (e.g. constriction of blood vessels in the lung).
Danish: Hjerte-kar-sygdomme (f.eks. sammentrækning af blodkar i lungerne).
English: Common: feeling drowsy (sedation), feeling dizzy (hypotension), slow heart beat (bradycardia).
Danish: Almindelig: søvnighed (sedation), svimmelhedsfølelse (hypotension), langsom puls (bradykardi).
English: Signs and symptoms of overdose may include hypotension, initial hypertension, bradycardia, lethargy, and respiratory depression.
Danish: Tegn og symptomer på overdosering kan omfatte hypotension, indledende hypertension, bradykardi, letargi og respirationsundertrykkelse.
English: General toxicity observed in animals (rat, dog) upon treatment with guanfacine included prolongation of uncorrected QT interval (heart), atrophic spleen and decreased white blood cells, affected liverincreased bilirubin and ALT levels included, irritated and inflamed intestines, increased creatinine and blood urea nitrogen levels (kidney), corneal clouding (eye) in rat and mouse only, alveolar macrophage infiltration & pneumonitis and reduced spermatogenesis.
Danish: Generel toksicitet observeret hos dyr (rotter, hunde) under behandling med guanfacin omfattede forlængelse af ukorrigeret QT-interval (hjerte), atrofisk milt og nedsat antal leukocytter, leverpåvirkning - herunder forhøjede bilirubin- og ALAT-niveauer, irriteret og betændt tarm, forhøjet kreatinin- og blod-urinstof-nitrogenniveauer (nyrer), uklarheder på hornhinden (øjet) kun hos rotter og mus, alveolær makrofaginfiltration og pneumonitis samt reduceret spermatogenese.
English: Guanfacine was superior to placebo in the long-term maintenance of treatment in children and adolescents with ADHD as measured by cumulative treatment failures (49.3% for Intuniv, and 64.9% for placebo, p=0.006).
Danish: Guanfacin var bedre end placebo ved den langvarige vedligeholdelse af behandlingen hos børn og unge med ADHD, målt ved kumulative behandlingssvigt (49,3 % for Intuniv og 64,9 % for placebo, p=0,006).
English: Before Intuniv is used with any other centrally active depressants (such as alcohol, sedatives, phenothiazines, barbiturates, or benzodiazepines) the potential for additive sedative effects should be considered.
Danish: Før Intuniv anvendes sammen med andre centralt virkende undertrykkende midler (såsom alkohol, sedativa, phenothiaziner, barbiturater eller benzodiazepiner), skal muligheden for additive sederende virkninger overvejes.
English: When stopping Intuniv, the dose must be tapered with decrements of no more than 1 mg every 3 to 7 days, and blood pressure and pulse should be monitored in order to minimise potential withdrawal effects, in particular increases in blood pressure and heart rate (see section 4.4).
Danish: Når Intuniv seponeres, skal dosen nedtrappes med højst 1 mg hver 3.-7. dag, og blodtryk og puls skal overvåges for at minimere eventuelle abstinenssymptomer, navnlig forhøjet blodtryk og forhøjet hjertefrekvens (se pkt.
English: Intuniv can cause syncope, hypotension and bradycardia.
Danish: Intuniv kan forårsage synkope, hypotension og bradykardi.
English: Intuniv should not be administered together with grapefruit juice (see section 4.5).
Danish: Intuniv må ikke administreres sammen med grapefrugtjuice (se pkt.
English: • feeling restless or irritable
Danish: • rastløshed eller irritabilitet
English: • unusual heart rhythm (sinus arrhythmia and first-degree arterioventricular block)
Danish: • unormal puls (sinusarytmi og 1. grads atrioventrikulært blok)
English: HIV infection.
Danish: Hiv-infektion.
English: If the inducing treatment is ended, retitration to reduce the guanfacine dose is recommended during the following weeks (see section 4.5).
Danish: Hvis induktionsbehandlingen er gennemført, anbefales en gentagen titrering for at reducere guanfacindosis i løbet af de følgende uger (se pkt.
English: Blood pressure and pulse should be monitored when reducing the dose or discontinuing Intuniv.
Danish: Blodtryk og puls skal overvåges ved dosisreduktion eller seponering af Intuniv.
English: The increases in blood pressure were observed in some individuals at the end of the follow up period which ranged between 3 and 26 weeks post final dose (see sections 4.2 and 5.1).
Danish: Der sås blodtryksstigninger hos nogle patienter ved udgangen af opfølgningsperioden, der varede fra 3 til 26 uger efter den sidste dosis (se pkt.
English: Intuniv can cause dizziness and somnolence.
Danish: Intuniv kan forårsage svimmelhed og døsighed.
English: The results showed that patients treated with add-on guanfacine improved more on the ADHD-RS-IV compared to those treated with add-on placebo (20.7 (12.6) points vs. 15.9 (11.8); difference: 4.9 95% CI 2.6 , 7.2).
Danish: Resultaterne viste, at patienter i behandling med guanfacin som tillæg viste en større forbedring i ADHD-RS-IV sammenlignet med patienter i behandling med placebo som tillæg (20,7 (12,6) points vs. 15,9 (11,8), forskel: 4,9 95 % CI 2,6; 7,2).
English: To minimise the risk of an increase in blood pressure upon discontinuation, the total daily dose of Intuniv should be tapered in decrements of no more than 1 mg every 3 to 7 days (see section 4.2).
Danish: For at minimere risikoen for forhøjet blodtryk ved seponering skal den samlede daglige Intuniv-dosis nedtrappes med højst 1 mg hver 3.-7. dag (se pkt.
English: The major circulating metabolite is 3-OH-guanfacine sulphate which lacks pharmacological activity.
Danish: Den primære cirkulerende metabolit er 3-OH-guanfacinsulfat, der ikke er farmakologisk aktivt.
English: Guanfacine is readily absorbed, with peak plasma concentrations reached approximately 5 hours after oral administration in paediatric patients (children and adolescents 6-17 years old inclusive).
Danish: Guanfacin absorberes let, og de maksimale plasmakoncentrationer nås ca. 5 timer efter oral administration til pædiatriske patienter (børn og unge i alderen 6 til og med 17 år).
English: In human hepatic microsomes, guanfacine did not inhibit the activities of the other major cytochrome P450 isoenzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 or CYP3A5); guanfacine is also not expected to be an inducer of CYP3A, CYP1A2 and CYP2B6.
Danish: Guanfacin hæmmede ikke aktiviteten af de andre primære cytokrom P450-isoenzymer (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 eller CYP3A5) i humane hepatiske mikrosomer; guanfacin forventes heller ikke at være en inducer af CYP3A, CYP1A2 og CYP2B6.
English: In a maintenance of efficacy study in children and adolescents, increases in mean systolic and diastolic blood pressure of approximately 3 mmHg and 1 mmHg, respectively, above original baseline were observed upon discontinuation of Intuniv.
Danish: I et vedligeholdelsesstudie af børn og unge sås stigninger i det gennemsnitlige systoliske og diastoliske blodtryk på hhv. ca. 3 mmHg og 1 mmHg i forhold til baseline efter seponering af Intuniv.
English: Uncommon: feeling faint or loss of conciousness (syncope).
Danish: Ikke almindelig: følelse af at besvime eller bevidstløshed (synkope).
English: Adjustments in the dose of valproic acid and Intuniv may be indicated when coadministered.
Danish: Justering af dosis af valproinsyre og Intuniv kan være indiceret ved samtidig administration.
English: CNS depressant medicinal products
Danish: CNS-undertrykkende lægemidler
English: Intuniv may cause somnolence and sedation predominantly at the start of treatment and could typically last for 2-3 weeks and longer in some cases.
Danish: Intuniv kan forårsage døsighed og sedation, hovedsageligt ved behandlingsstart, og det kan typisk vare i 2-3 uger og længere i nogle tilfælde.
English: This was a double-blind, randomised, placebo-controlled, dose-optimisation study, 9-weeks in duration conducted in the United States and Canada.
Danish: Dette var et dobbeltblindet, randomiseret, placebokontrolleret, dosisoptimeringsstudie af 9 ugers varighed, udført i USA og Canada.
English: During dose titration, weekly monitoring for signs and symptoms of somnolence and sedation, hypotension and bradycardia should be performed.
Danish: Under dosistitreringen bør der udføres en ugentlig overvågning for tegn og symptomer på døsighed og sedation, hypotension og bradykardi.