FrancophonIA/ELRC3.0 huggingface dataset:
English: Carefully removed scales and crusts and gently roughen all lesion surfaces.
Danish: Fjern omhyggeligt skæl og skorper og skrab forsigtigt alle læsionsoverflader, så de bliver ru.
English: Hypopigmentation
Danish: Smalspektret
English: What Ameluz is and what it is used for What you need to know before you use Ameluz How to use Ameluz
Danish: Det skal du vide, før du begynder at bruge Ameluz Sådan skal du bruge Ameluz Bivirkninger
English: d) Illumination using daylight for AK treatment: If conditions are suitable (see section a. Considerations before treatment), patients shall go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight.
Danish: a. Overvejelser før behandling), skal patienterne gå udenfor inden for 30 minutter efter påsmøring af gelen, og blive udenfor i 2 uafbrudte timer i fuld dagslys.
English: MAL Full patient clearance n (%)
Danish: MAL Patienter med fuldstændig heling n (%)
English: MAL Full lesion clearance n (%)
Danish: MAL Læsioner med fuldstændig heling n (%)
English: Moderate/ severe Atrophy None Mild
Danish: PPS - noninferioritet FAS - superioritet
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Narrow spectrum Ameluz
Danish: Hypopigme ntering
English: Frequency
Danish: Bredsprektret
English: Skin and subcutaneous disorders Uncommon
Danish: Ikke almindelig Rygsmerter
English: *Based on patient weight of 50 kg
Danish: *Baseret på en patientvægt på 50 kg
English: • if you are elderly and your dose needs to be increased.
Danish: • hvis du er ældre, og din dosis skal forhøjes.
English: Cumulative urinary excretion is <1 % of dose.
Danish: Kumulativ urinudskillelse er <1 % af dosis.
English: This medicinal product is indicated for long term treatment.
Danish: Dette lægemiddel er indiceret til langtidsbehandling.
English: It is important that you take Twynsta every day until your doctor tells you otherwise.
Danish: Det er vigtigt, at du tager Twynsta hver dag, indtil din læge siger noget andet.
English: Absolute bioavailability has been estimated to be between 64 and 80 %.
Danish: Den absolutte biotilgængelighed er mellem 64 % og 80 %.
English: Rare cystitis sepsis including fatal outcome
Danish: Sjældne cystitis sepsis inklusiv fatal udfald
English: • if you suffer from heart failure after a heart attack.
Danish: • hvis du lider af hjerteinsufficiens efter et hjerteanfald.
English: (It is also better to avoid Twynsta in early pregnancy - see Pregnancy section.)
Danish: (Det foretrækkes også at undgå Twynsta tidligt i graviditeten - se punktet Graviditet.)
English: Twynsta is used to treat high blood pressure
Danish: Twynsta bruges til at behandle højt blodtryk
English: Therefore, patients with heart failure should be treated with caution.
Danish: Derfor skal patienter med hjerteinsufficiens behandles med forsigtighed.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%.
Danish: Den andel af moderens dosis, der overføres til spædbarnet, er estimeret til at ligge i et interkvartilområde på 3-7 % med et maksimum på 15 %.
English: Carcinogenesis, mutagenesis
Danish: Karcinogenese, mutagenese
English: In vitro studies have shown that approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients.
Danish: In vitro-undersøgelser har vist, at ca. 97,5 % af det cirkulerende amlodipin er bundet til plasmaproteiner hos hypertensive patienter.
English: ketoconazole).
Danish: ketoconazol).
English: If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.
Danish: Hvis din læge har fortalt dig, at du har intolerance over for nogle sukkerarter, eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med din læge, før du tager eller får dette lægemiddel.
English: The antihypertensive effect of Twynsta was similar irrespective of age and gender, and was similar in patients with and without diabetes.
Danish: Den antihypertensive virkning af Twynsta var den samme uanset alder og køn, og den var ens hos patienter med og uden diabetes.
English: Clinical monitoring and dose adjustment may thus be required.
Danish: Der kan derfor være behov for klinisk monitorering og dosisjustering.
English: In two corresponding open-label long-term follow up studies performed over a further 6 months the effect of Twynsta was maintained over the trial period.
Danish: I to identiske åbne, langtids, follow-up studier gennemført over yderligere 6 måneder, blev virkningen af Twynsta fastholdt i hele studieperioden.
English: Your doctor will normally advise you to stop taking Twynsta before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Twynsta.
Danish: Lægen vil normalt råde dig til at stoppe med at tage Twynsta, før du bliver gravid, eller så snart du ved, du er gravid, og vil råde dig til at tage en anden medicin end Twynsta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 7. oktober 2010 Dato for seneste fornyelse: 20. august 2015
English: You may notice this as dizziness when standing up.
Danish: Det kan opleves som svimmelhed, når du rejser dig op.
English: Twynsta is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Twynsta frarådes tidligt i graviditeten og må ikke tages efter graviditetens tredje måned, da det kan forårsage alvorlig skade på din baby, hvis det anvendes efter graviditetens tredje måned.
English: The clinical translation of these PK variations may be more pronounced in the elderly.
Danish: Den kliniske tolkning af disse farmakokinetiske variationer kan være mere udpræget hos ældre.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaprotein (>99,5 %), hovedsagelig albumin og alfa-1-syreglykoprotein.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Danish: Den gennemsnitlige absolutte biotilgængelighed for telmisartan er ca. 50 %.
English: System Organ Class
Danish: Systemorgan-klasse
English: Amlodipine is a weak CYP3A inhibitor.
Danish: Amlodipin er en svag CYP3A-hæmmer.
English: If you have the impression that the effect of Twynsta is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Twynsta er for kraftig eller for svag, bør du tale med din læge eller dit apotek herom.
English: The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine.
Danish: Sikkerheden og tolerabiliteten ved brug af Twynsta er blevet evalueret i fem kontrollerede kliniske studier med over 3.500 patienter, hvoraf over 2.500 modtog telmisartan i kombination med amlodipin.
English: Gastric lavage may be worthwhile in some cases.
Danish: Ventrikelskylning kan være nyttig i nogle tilfælde.
English: Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Danish: Kliniske data er utilstrækkelige, hvad angår den mulige virkning af amlodipin på fertiliteten.
English: Grapefruit juice and grapefruit should not be consumed when you take Twynsta.
Danish: Du må ikke indtage grapefrugtjuice og grapefrugt, mens du tager Twynsta.
English: Rare hypoglycaemia (in diabetic patients)
Danish: Sjældne hypoglykæmi (hos diabetespatienter)
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 90 x 1 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 30 x 1 tabletter 56 tabletter 90 x 1 tabletter 98 tabletter
English: This medicinal product has moderate influence on the ability to drive and use machines.
Danish: Dette lægemiddel påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: • if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Danish: • hvis du har en forsnævring af hjerteklappen i aorta (aortastenose) eller kardiogent shock (en tilstand, hvor hjertet ikke er i stand til at forsyne kroppen med nok blod).
English: In some patients treated by calcium channel blockers, reversible biochemical changes in the head of spermatozoa have been reported.
Danish: Hos nogle patienter, der blev behandlet med calciumkanalblokkere, er der blevet rapporteret reversible biokemiske ændringer i hovedet af spermatozoer.
English: Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.
Danish: Amlodipin bør derfor påbegyndes i den lave ende af doseringsintervallet, og der bør udvises forsigtighed, både med den indledende behandling, og når dosis forhøjes.
English: The overall incidence of adverse reactions with Twynsta in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Danish: Den samlede incidens af bivirkninger ved Twynsta i det kliniske studieprogram var lav, idet kun 12,7 % af de behandlede patienter oplevede bivirkninger.
English: “Warnings and precautions”).
Danish: ”Advarsler og forsigtighedsregler”.
English: You must tell your doctor if you think you might be pregnant or are planning to have a baby.
Danish: Fortæl det til lægen, hvis du tror, du er gravid eller planlægger at blive gravid.
English: Plasma aldosterone levels are decreased by telmisartan.
Danish: Plasma-aldosteronniveauerne sænkes af telmisartan.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Danish: Når telmisartan tages sammen med mad, varierer reduktion i arealet under plasmakoncentrationskurven (AUC0-∞) fra ca. 6 % (40 mg-dosis) til ca. 19 % (160 mg-dosis).
English: It is recommended to take Twynsta with some liquid.
Danish: Det anbefales at tage Twynsta med væske.
English: • Rifampicin, erythromycin, clarithromycin (antibiotics).
Danish: • Rifampicin, erythromycin, clarithromycin (antibiotika).
English: Not known toxic epidermal necrolysis
Danish: Ikke kendt toksisk epidermal nekrolyse
English: You can take Twynsta with or without food.
Danish: Du kan tage Twynsta med eller uden mad.
English: Talk to your doctor before taking Twynsta if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager Twynsta, hvis du har eller tidligere har haft en af de følgende tilstande eller lidelser:
English: Suggested measures include induction of emesis and / or gastric lavage.
Danish: De anbefalede forholdsregler omfatter provokeret emesis og/eller ventrikelskylning.
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Danish: Hos raske frivillige har anvendelsen af aktivt kul i op til 2 timer efter administration af amlodipin 10 mg vist sig at reducere absorptionshastigheden af amlodipin.
English: Eye disorders Common visual disturbance (including diplopia)
Danish: Øjne: Almindelige synsforstyrrelser (herunder diplopi)
English: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Danish: Halveringstiden for amlodipin er forlænget, og AUC-værdierne er højere for patienter med nedsat leverfunktion; doseringsanbefalinger er ikke fastlagt.
English: In this same population amlodipine was associated with increased reports of pulmonary oedema.
Danish: I den samme population blev amlodipin associeret med et øget antal indberetninger af lungeødem.
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium,
Danish: • Medicin, der kan øge kaliumniveauet i blodet, såsom salterstatninger indeholdende kalium,
English: Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Danish: Calciumkanalblokkere, herunder amlodipin, skal anvendes med forsigtighed hos patienter med kongestiv hjerteinsufficiens, da de kan øge risikoen for fremtidige kardiovaskulære hændelser og mortalitet.
English: Pregelatinised starch (prepared from maize starch) Sodium hydroxide
Danish: Prægelatineret stivelse (fremstillet af majsstivelse) Natriumhydroxid
English: • ACE-inhibitors or aliskiren (see also information under the headings “Do not take Twynsta” and
Danish: • ACE-hæmmere eller aliskiren - se også information under overskrifterne ”Tag ikke Twynsta” og
English: Not known (frequency cannot be estimated from the available data): Severe allergic reactions with blistering eruptions of the skin and mucous membranes (toxic epidermal necrolysis).
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): Alvorlige overfølsomhedsreaktioner med udvikling af blærer på hud og slimhinder (toksisk epidermal nekrolyse).
English: Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.
Danish: Ved samtidig brug af kendte CYP3A4-induktorer kan plasmakoncentrationen af amlodipin variere.
English: Experimental data indicate that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.
Danish: Dyrestudier antyder, at amlodipin binder til både dihydropyridin- og ikke-dihydropyridin-bindingssteder.
English: • if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for telmisartan eller amlodipin eller et af de øvrige indholdsstoffer i Twynsta (angivet i punkt 6).
English: In this respect data concerning diastolic blood pressure are inconsistent.
Danish: Data for diastolisk blodtryk er her inkonsistente.
English: • Dantrolene (infusion for severe body temperature abnormalities).
Danish: • Dantrolen (infusion for svære anomalier af kropstemperaturen).
English: Both of these substances help to control your high blood pressure:
Danish: Begge disse stoffer hjælper med at kontrollere blodtrykket.
English: • Angiotensin II receptor antagonists.
Danish: • Angiotensin II-receptorantagonister
English: The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established.
Danish: Telmisartan/amlodipins sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure.
Danish: Tilsyneladende er der en tendens mod dosisafhængighed i forholdt til tid til tilbagevenden til baseline for det systoliske blodtryk.
English: Very rare pancreatitis, gastritis
Danish: Meget sjældne pankreatitis, gastritis
English: Talk to your doctor before taking Twynsta:
Danish: Kontakt lægen, før du tager Twynsta:
English: Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no exacerbation of toxicity was expected for the combination.
Danish: Da de prækliniske toksicitetsprofiler for telmisartan og amlodipin ikke er overlappende, forventedes ingen forværring i toksiciteten ved kombinationsbehandling.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensin-aldosterone system, the benefit risk ratio should be evaluated.
Danish: Før initiering af samtidig brug af lægemidler, der påvirker renin-angiotensin-aldosteronsystemet, skal risk-benefit-forholdet vurderes.
English: Twynsta is not recommended for use in patients with hereditary fructose intolerance (HFI).
Danish: Twynsta bør ikke anvendes til patienter med hereditær fructoseintolerans (HFI).
English: There are limited data from the use of telmisartan/amlodipine in pregnant women.
Danish: Der er begrænset data fra brug af telmisartan/amlodipin hos gravide kvinder.
English: potassium-sparing diuretics (certain ‘water tablets').
Danish: kaliumbesparende diuretika (visse vanddrivende tabletter).
English: No drug interaction studies have been conducted with cyclosporine and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable trough concentration increases (average 0% - 40%) of cyclosporine were observed.
Danish: Der er ikke udført interaktionsstudier med cyclosporin og amlodipin hos raske frivillige eller andre grupper, med undtagelse af nyretransplanterede patienter, hvor stigninger (gennemsnitlig 0 % - 40 %) i den variable trough koncentration af cyclosporin blev observeret.
English: Rare back pain, pain in extremity (leg pain)
Danish: Sjældne rygsmærter, smerter i ekstremiteterne (smerter i benene)
English: Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia.
Danish: Overdosering med amlodipin kan resultere i udtalt perifer vasodilatation og risiko for refleks-takykardi.
English: Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan/amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant.
Danish: Da der ikke er nogen viden vedrørende brugen af telmisartan under amning, frarådes brug af telmisartan/amlodipin, og alternative behandlinger med bedre dokumenterede sikkerhedsprofiler under amning foretrækkes, særligt under amning af en nyfødt eller et for tidligt født spædbarn.
English: Mechanistic Target of Rapamycin (mTOR) Inhibitors mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates.
Danish: Mechanistic Target of Rapamycin (mTOR)-hæmmere mTOR-hæmmere, såsom sirolimus, temsirolimus og everolimus, er CYP3A-substrater.
English: Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.
Danish: Mutagenicitetsstudier viste ingen lægemiddelrelaterede virkninger, hverken på gen- eller kromosomniveau.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Danish: Reproduktionsstudier hos rotter og mus har vist forsinket fødsel, forlænget fødselsvarighed og nedsat overlevelse af unger ved doser, som er ca. 50 gange større end den maksimalt anbefalede dosering til mennesker, baseret på mg/kg.
English: Twynsta once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range.
Danish: Twynsta én gang dagligt giver en effektiv og konsistent nedsættelse af blodtrykket i hele dosisintervallet på 24 timer.
English: The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products.
Danish: Den blodtrykssænkende virkning ved telmisartan/amlodipin kan øges ved samtidig brug med andre antihypertensiva.
English: Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).
Danish: Blodtrykket bør derfor monitoreres, og dosisjustering overvejes, både under og efter samtidig brug af andre lægemidler især kraftige CYP3A4-inducerende stoffer (f.eks. rifampicin, Hypericum perforatum).
English: Rare depression, anxiety, insomnia confusion
Danish: Sjældne depression, angst, søvnløshed konfusion
English: If any of the above applies to you, tell your doctor or pharmacist before taking Twynsta.
Danish: Hvis et eller flere af disse punkter gælder for dig, så tal med din læge eller apoteket, før du tager Twynsta.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Twynsta in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Twynsta i alle undergrupper af den pædiatriske population med hypertension (se pkt.
English: Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine.
Danish: 10 % uomdannet amlodipin og 60 % af amlodipin-metabolitterne udskilles i urinen.
English: Twynsta can be taken with or without food.
Danish: Twynsta kan tages sammen med mad eller uden mad.
English: No data from controlled clinical studies with the fixed dose combination or with the individual components are available.
Danish: Der er ingen data fra kontrollerede kliniske studier for fastdosiskombinationen eller for de enkelte aktive stoffer.
English: Remove your Twynsta tablet from the blister only directly prior to intake.
Danish: Tryk først Twynsta tabletten ud af blisterkortet, umiddelbart før du skal tage den.
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Danish: Rotter og mus, der blev behandlet med amlodipin i kosten i 2 år ved koncentrationer, der blev beregnet til at give daglige doseringsniveauer på 0,5, 1,25 og 2,5 mg/kg/dag, viste ingen evidens for karcinogenicitet.
English: : the event may be a chance finding or related to a mechanism currently not known : most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Danish: : hændelsen kan være en tilfældighed eller relateret til en endnu ukendt mekanisme : de fleste tilfælde af unormal leverfunktion/leversygdom rapporteret for telmisartan efter markedsføringen forekom hos japanske patienter.
English: PHARMACEUTICAL FORM AND CONTENTS 90 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 90 tabletter
English: : cases of interstitial lung disease (predominantly interstitial pneumonia and eosinophilic pneumonia) have been reported from post-marketing experience with telmisartan
Danish: : tilfælde af interstitiel lungesygdom (predominant interstitiel lungebetændelse og eosinofil lungebetændelse) er blevet rapporteret efter markedsføringen for telmisartan
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Twynsta.
Danish: Sepsis er kun set efter telmisartan alene, men kan ikke udelukkes for Twynsta.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m2 basis) was close to the maximum tolerated dose for mice but not for rats.
Danish: Den højeste dosis (for mus svarende til, og for rotter 2* gange den maksimalt anbefalede kliniske dosis på 10 mg udtrykt i mg/m2) var tæt på den maksimalt tolererede dosis for mus,