FrancophonIA/ELRC3.0 huggingface dataset:
English: For a dose of 6 mg/m body surface (see section 4.2) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5%) solution for infusion to a final volume of 30 ml.
Danish: 4.2) og fortynd den med glucose 50 mg/ml (5%) infusionsvæske, opløsning, til et endeligt volumen på 30 ml.
English: After 12 months, these patients showed a difference of 28% between treatment groups (67% for Visudyne patients compared to 39% for placebo patients, p<0.001); the benefit was maintained at 24 months (59% versus 31%, p<0.001).
Danish: Efter 12 måneder sås hos disse patienter en difference på 28% mellem behandlingsgrupperne (67% i gruppen af patienter behandlet med Visudyne mod 39%
English: Anaesthesia
Danish: Anæstesi
English: Extravasation of the solution for infusion
Danish: Ekstravasation af infusionsvæsken, opløsningen
English: Infusion-related reaction, which may radiate to other areas, including but not limited to, the pelvis, shoulders or rib cage.
Danish: • Almene symptomer: ændringer i hjerterytmen (pulsen), infusionsrelaterede reaktioner, som kan stråle til andre steder, bl.a. men ikke begrænset til bækkenet, skuldrene eller brystkassen.
English: Visudyne therapy should be considered carefully in patients with moderate hepatic impairment or biliary obstruction since no experience has been gained in these patients.
Danish: Der er ingen erfaring vedrørende behandling med Visudyne hos patienter med moderat nedsat leverfunktion eller obstruktion af galdevejene.
English: Rare (may affect up to 1 in 1,000 people) • Eye disorders: lack of blood circulation to the retina or choroids (the vascular layer of the eye)
Danish: • Øjensygdomme: Manglende blodcirkulation til nethinden eller årehinden (øjets vaskulære lag)
English: If any of these apply to you, tell your doctor.
Danish: Fortæl det til din læge, hvis noget af det ovenstående passer på dig.
English: If you are under 18 years of age
Danish: Hvis du er under 18 år
English: No additional monitoring is required.
Danish: Der er ikke behov for yderligere monitorering.
English: (Frequency unknown)
Danish: (Ukendt hyppighed)
English: (See sections 4.4, 4.6 and 4.8)
Danish: 4.4, 4.6 og 4.8).
English: However, toxicity to reproduction has not been reported.
Danish: Der er imidlertid ikke rapporteret om reproduktionstoksicitet.
English: Formulation specific warnings to be added here, if applicable
Danish: Formuleringsspecifikke advarsler tilføjes her, hvis relevant
English: It can also be used to control high blood pressure after an operation.
Danish: Det kan også anvendes til at kontrollere for højt blodtryk efter en operation.
English: In this case, only the lowest posology should be used.
Danish: I disse tilfælde bør kun den laveste dosis anvendes.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION To be completed nationally
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Udfyldes nationalt
English: Your doctor will take special care:
Danish: Din læge vil være ekstra forsigtig:
English: The antihypertensive effect will depend on the administered dose.
Danish: Den antihypertensive virkning afhænger af den administrerede dosis.
English: Frequency categories are defined according to the following convention: 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) and not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne er defineret i henhold til følgende konvention: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: 4.5 Interaction with other medicinal products and other forms of interaction Enhancement of negative inotropic effect
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Forøgelse af negativ inotrop virkning
English: Within 8 days after myocardial infarction
Danish: Inden for 8 dage efter myokardieinfarkt
English: Competitive neuromuscular blockers
Danish: Kompetitive neuromuskulære blokkere
English: Patients with portal hypertension
Danish: Patienter med portal hypertension
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger
English: Other common side effects (these may affect up to 1 in 10 people) are:
Danish: Andre almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede):
English: In case of an overdose it is recommended to use routine measures including monitoring of cardiac and respiratory function.
Danish: I tilfælde af overdosering anbefales det at anvende rutinemæssige tiltag, inklusive monitorering af hjertefunktion og respiration.
English: Renal vascular resistance is decreased.
Danish: Den renale vaskulære modstand er nedsat.
English: The dosage regimen to achieve the desired blood pressure can vary depending on the targeted blood pressure, the response of the patient, and the age or status of the patient.
Danish: Doseringsregimet til opnåelse af det ønskede blodtryk kan variere afhængigt af målblodtrykket, patientens respons og patientens alder eller status.
English: If you have suffered a recent stroke
Danish: Hvis du for nylig har haft et slagtilfælde
English: The medicine will be injected slowly into a vein.
Danish: Dette lægemiddel vil blive indsprøjtet langsomt i en blodåre.
English: Its action is produced mainly on arterial smooth muscle.
Danish: Dets virkning foregår primært på arterielle glatte muskler.
English: Potential additive antihypertensive effect
Danish: Potentiel additiv antihypertensiv virkning
English: Blood pressure and heart rate must be monitored at least every 5 minutes during the infusion, and then until vital signs are stable, but at least for 12 hours after the end of the administration of nicardipine.
Danish: Blodtryk og hjertefrekvens skal monitoreres mindst hver 5. minut under infusionen og herefter, indtil de vitale tegn er stabile, dog i mindst 12 timer efter afsluttet nicardipinadministrationen.
English: In particular, tell your doctor if you are taking any of the following medicines:
Danish: Det er særligt vigtigt, at du fortæller det til lægen, hvis du tager et eller flere af følgende lægemidler:
English: This is reflected in relatively large and rapid changes in blood pressure, with minimal inotropic changes in cardiac function (baroreflex effect).
Danish: Dette genspejles i relativt store og hurtige ændringer i blodtrykket med minimale inotrope ændringer i hjertefunktionen (barorefleksvirkning).
English: There is insufficient information on the effects of nicardipine in newborns/infants.
Danish: Der er utilstrækkelig information om nicardipins virkninger hos nyfødte/spædbørn.
English: If your high blood pressure is because of narrowing of a heart valve or other defects in the heart If you have had a heart attack in the last eight days
Danish: Hvis dit høje blodtryk skyldes forsnævring ved hjerteklappen eller andre hjertefejl Hvis du har haft et hjerteanfald inden for de sidste otte dage
English: At very low concentrations it inhibits the influx of calcium into the cell.
Danish: I meget lave koncentrationer hæmmer det tilløbet af calcium i cellen.
English: Studies involving either a single dose, or administration 3 times daily for 3 days, have shown that less than 0.03% of unchanged nicardipine is recovered in the urine in humans after oral or intravenous administration.
Danish: I studier med enten en enkeltdosis eller administration 3 gange dagligt i 3 dage har vist, at mindre end 0,03 % uomdannet nicardipin genfindes i urinen hos mennesker efter oral eller intravenøs administration.
English: [Product specific formulation warnings to be completed nationally ]
Danish: [Advarsler vedrørende produktspecifikke formuleringer udfyldes nationalt]
English: It is advised to change the infusion site in case of any suspicion of infusion site irritation.
Danish: Det anbefales at ændre infusionsstedet ved enhver formodning om irritation på infusionsstedet.
English: Unstable angina
Danish: Ustabil angina
English: Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Danish: Kliniske studier med nicardipin inkluderede ikke et tilstrækkeligt antal forsøgsdeltagere på 65 år og derover til at klarlægge, om de responderer anderledes en yngre personer.
English: Nicardipine is not dialyzable.
Danish: Nicardipin er ikke dialyserbart.
English: Nicardipine
Danish: Nicardipin
English: Blood levels should be monitored and dosage of immunosuppressant and/or nicardipine should be reduced, if required.
Danish: Blodniveauerne bør monitoreres og dosis af immunsuppressiva og/eller nicardipin om nødvendigt reduceres.
English: Do not drink grapefruit juice or eat grapefruit whilst taking this medication as it may increase the blood levels of nicardipine
Danish: Drik ikke grapefrugtjuice og spis ikke grapefrugter, mens du tager dette lægemiddel, da det kan øge indholdet af nicardipin i blodet.
English: Pharmacotherapeutic class: selective calcium inhibitors with vascular effects, ATC code: C08CA04
Danish: Farmakoterapeutisk klassifikation: selektive calciumhæmmere med vaskulære virkninger, ATC-kode: C08CA04
English: Infusion site reactions can occur, particularly with prolonged duration of administration and in peripheral veins.
Danish: Der kan indtræde reaktioner på infusionsstedet, særligt ved langvarig administration og i perifere vener.
English: *cases have been also reported when used as tocolytic during pregnancy (see section 4.6)
Danish: * der er også indberettet tilfælde ved brug som tokolytikum under graviditet (se pkt.
English: In some patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) have been observed.
Danish: Hos visse patienter med moderat nyreinsufficiens er der set en signifikant lavere systemisk clearance og et større areal under kurven (AUC).
English: It has been reported in animal experiments that the drug is excreted into breast milk.
Danish: I dyreforsøg er det indberettet, at lægemidlet udskilles i mælk.
English: Headache is the most common side effect, and may affect more than 1 in 10 people.
Danish: Den hyppigste bivirkning er hovedpine, der kan forekomme hos flere end 1 ud af 10 behandlede.
English: If you are allergic to nicardipine or any of the other ingredients of this medicine (listed in section 6)
Danish: Hvis du er allergisk over for nicardipin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump.
Danish: Infusionshastigheden skal kontrolleres præcist ved brug af en elektronisk sprøjtepumpe eller en volumetrisk pumpe.
English: Healthcare professionals are asked to report any suspected adverse reactions via [national reporting system]
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via [det nationale rapporteringssystem] 4.9 Overdosering
English: Your blood pressure will be taken whilst you are receiving treatment and the dose adjusted to make sure you have a fall in your blood pressure to normal levels.
Danish: Du vil få målt dit blodtryk, mens du får behandlingen, og dosis vil blive tilpasset for at sikre, at dit blodtryk falder til et normalt niveau.
English: • Malignant arterial hypertension/Hypertensive encephalopathy
Danish: • Malign arterial hypertension/hypertensiv encefalopati
English: Maintenance dose: When the target pressure is reached, the dose should be reduced progressively, usually to between 2 and 4 mg/h, to maintain the therapeutic efficacy.
Danish: Vedligeholdelsesdosis: Når målblodtrykket er nået, bør dosis reduceres gradvist, som regel til mellem 2 og 4 mg/t, for at opretholde den terapeutiske virkning.
English: Common - orthostatic hypotension
Danish: Almindelig - ortostatisk hypotension
English: This medicine will be given to you in hospital.
Danish: Du vil få dette lægemiddel på et hospital.
English: Due to the risk of severe maternal hypotension and potentially fatal foetal hypoxia, the decrease in blood pressure should be progressive and always closely monitored.
Danish: På grund af risikoen for svær maternel hypotension og potentielt dødelig føtal hypoksi bør blodtryksfaldet være progressivt og altid tæt monitoreret.
English: Nicardipine should only be administered by specialists in well controlled environments, such as hospitals and intensive care units, with continuous monitoring of blood pressure.
Danish: Nicardipin bør kun administreres af specialister i velkontrollerede omgivelser, såsom hospitaler og intensivafdelinger, under kontinuerlig monitorering af blodtrykket.
English: After coadministration of a radioactive intravenous dose of nicardipine with an oral 30 mg dose given every 8 hours, 49% of the radioactivity was recovered in the urine and 43% in the feces within 96 hours.
Danish: Efter samtidig administration af en radioaktiv intravenøs dosis af nicardipin og en oral dosis på 30 mg indgivet hver 8. time blev 49 % af radioaktiviteten genfundet i urinen og 43 % i fæces i løbet af 96 timer.
English: Initial dose: Treatment should start with the continuous administration of nicardipine at a rate of 3-5 mg/h for 15 minutes.
Danish: Startdosis: Behandlingen bør starte med kontinuerlig administration af nicardipin ved en hastighed på 3-5 mg/t i 15 minutter.
English: Intravenous nicardipine [or invented name] is indicated for the treatment of acute life-threatening hypertension, particularly in the event of:
Danish: Intravenøs nicardipin [eller produktnavn] er indiceret til behandling af akut, livstruende hypertension, særligt i tilfælde af:
English: Therefore, it is recommended to use the same dose regimens as for elderly patients in patients with renal impairment.
Danish: Det anbefales derfor at anvende samme doseringsregime til patienter med nyreinsufficiens som til ældre patienter.
English: A hypertensive episode which often accompanies a stroke is not an indication for emergency antihypertensive therapy.
Danish: Et slagtilfælde er ofte ledsaget af en hypertensiv episode, men dette er ikke en indikation for akut antihypertensiv behandling.
English: Nicardipine and its metabolites are excreted in human milk at very low concentrations.
Danish: Nicardipin og dets metabolitter udskilles i human mælk i meget lave koncentrationer.
English: The combination of a calcium channel inhibitor and dantrolene is therefore potentially dangerous.
Danish: Kombination af en calciumblokker og dantrolen er derfor potentielt farlig.
English: Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia.
Danish: Hurtig farmakologisk reduktion i blodtrykket kan fremkalde systemisk hypotension og reflekstakykardi.
English: A switch can also be made to oral nicardipine 20mg capsules at dosage of 60 mg/day in 3 daily doses, or to nicardipine 50 mg extended-release tablets, at dosage of 100mg/day, in 2 daily doses.
Danish: Der kan også foretages et skift til oral nicardipin 20 mg kapsler i en dosering på 60 mg/dag fordelt på 3 daglige doser eller til nicardipin 50 mg depotkapsler i en dosering på 100 mg/dag fordelt på 2 daglige doser.
English: • Aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective
Danish: • Aortadissektion, når behandling med korttidsvirkende betablokkere ikke er velegnet, eller i kombination med en betablokker, når beta-blokade alene ikke er effektiv.
English: Nicardipine should be administered by continuous intravenous infusion only.
Danish: Nicardipin bør kun administreres som kontinuerlig intravenøs infusion.
English: Occasionally, patients have developed an increased frequency, duration, or severity of angina upon starting or increasing nicardipine dosage, or during the course of treatment.
Danish: Lejlighedsvist har patienter udviklet øget hyppighed, varighed eller sværhedsgrad af angina-anfald i forbindelse med opstart eller dosisøgning af nicardipin eller under behandlingen.
English: This will depend on much and how fast they want to reduce your blood pressure by.
Danish: Dosis afhænger af, hvor meget og hvor hurtigt lægen ønsker at sænke dit blodtryk.
English: In animal studies, administration of verapamil and intravenous dantrolene has caused fatal ventricular fibrillation.
Danish: I dyrestudier har administration af verapamil og intravenøs dantrolen forårsaget dødelig ventrikelflimren.
English: Rates can be increased by increments of 0.5 or 1 mg every 15 minutes.
Danish: Hastigheden kan øges i trin af 0,5 eller 1 mg hvert 15. minut.
English: The safety and efficacy in low birth weight infants, newborns, nursing infants, infants, and children has not been established.
Danish: Sikkerhed og virkning hos spædbørn med lav fødselsvægt, nyfødte, ammede spædbørn, spædbørn og børn er ikke klarlagt.
English: Nicardipine is contra-indicated in unstable angina and immediately following myocardial infarction (see section
Danish: Nicardipin er kontraindiceret ved ustabil angina og umiddelbart efter myokardieinfarkt (se pkt.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Det gælder også medicin, som du har købt uden recept, herunder naturlægemidler.
English: The use of antihypertensive drugs is not recommended in ischemic stroke patients unless acute hypertension precludes the administration of an adequate treatment (e.g. thrombolysis) or there is other end-organ damage which is lifethreatening in the short term.
Danish: Antihypertensiva anbefales ikke til patienter med iskæmisk attak, medmindre akut hypertension udelukker administration af en hensigtsmæssig behandling (f.eks. trombolyse), eller der er anden beskadigelse af målorganer, som er livstruende på kort sigt.
English: Dantrolene
Danish: Dantrolen
English: Bolus administration or intravenous administration not controlled by the use of an electronic syringe driver or a volumetric pump is not recommended and can increase the risk of serious hypotension, particularly in the elderly, in children, in patients with renal or hepatic impairment and in pregnancy
Danish: Bolusadministration eller intravenøs administration, der ikke er kontrolleret af en elektronisk sprøjtepumpe eller volumetrisk pumpe, frarådes, da det kan øge risikoen for alvorlig hypotension, særligt hos ældre, børn, patienter med nyre- eller leverinsufficiens og hos gravide kvinder.
English: In clinical practice, the use of nicardipine during the first two trimesters in a limited number of pregnancies has not revealed any malformative or particular foetotoxic effect to date.
Danish: Til dato har klinisk brug af nicardipin i de første to trimestre hos et begrænset antal gravide kvinder ikke medført nogen misdannelser eller særlige føtotoksiske virkninger.
English: Nicardipine should not be used in multiple pregnancies or in pregnant women with compromised cardio-vascular condition, except if there is no other acceptable alternative.
Danish: Nicardipin bør kun anvendes ved flerfoldsgraviditeter eller hos gravide kvinder med kompromitteret kardiovaskulær sygdom, hvis der ikke findes et acceptabelt alternativ.
English: Administered by systemic route, nicardipine is a potent vasodilator which diminishes total peripheral resistance and lowers blood pressure.
Danish: Ved systemisk administration er nicardipin en potent vasodilatator, der reducerer den totale perifere modstand og sænker blodtrykket.
English: Major hypotension can be treated by intravenous infusion of any plasma volume expander and supine position with the legs elevated.
Danish: Udtalt hypotension kan behandles med intravenøs infusion af et hvilket som helst plasmavolumenekspanderende stof og placering i rygleje med benene i hævet position.
English: Nicardipine solution for injection will be given to you by a doctor, who will ensure that the correct dose is given for your condition.
Danish: Du vil få Nicardipin injektionsvæske af en læge, som vil sørge for, at du får den korrekte dosis til din sygdom.
English: Nicardipine solution for injection is used to treat very severe high blood pressure.
Danish: Nicardipin injektionsvæske anvendes til behandling af alvorligt forhøjet blodtryk.
English: The active substance is nicardipine.
Danish: Aktivt stof: nicardipin.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Advarsler
English: If you are having an operation, your anaesthetist will need to know which other medicines you are taking, as some of these can affect the way Nicardipine solution for injection works.
Danish: Hvis du skal opereres, har din bedøvelseslæge brug fra at vide, hvilke andre lægemidler, du tager, da visse lægemidler kan påvirke virkningen af Nicardipin injektionsvæske.
English: If either occurs with nicardipine, consider decreasing the dose by half or stopping the infusion.
Danish: Hvis en af disse virkninger indtræder med nicardipin, bør det overvejes at halvere dosis eller at stoppe infusionen.
English: The most abundant metabolite in human urine is the glucuronide of the hydroxy form, which is formed by the oxidative cleaving of the N-methylbenzyl moiety and the oxidation of the pyridine ring.
Danish: Hovedmetabolitten i human urin er glukuronidet af hydroxyformen, der dannes ved oksidativ spaltning af N-methylbenzyl-delen og oksidering af pyridinringen.
English: In animal experiments where this drug was administered at a high dose during the terminal stage of pregnancy, an increase in fetal deaths, delivery disturbances, decrease in the body weight of offsprings, and suppression of post-natal body weight gain were reported.
Danish: I dyreforsøg, hvor dette lægemiddel blev administreret i en høj dosis sidst i graviditeten, blev der rapporteret om en stigning i fosterdød, fødselsforstyrrelser, nedsat legemsvægt hos afkommet og undertrykkelse af postnatal vækstøgning.
English: Digoxin levels should be monitored when concomitant therapy with nicardipine is initiated.
Danish: Digoxinniveauerne bør monitoreres, når behandling med nicardipin indledes.
English: The safety and efficacy of nicardipine IV has not been tested in controlled clinical trials in infants or children, thus special care is required in this population (refer to section 4.2)
Danish: Sikkerheden og virkningen af intravenøs nicardipin er ikke blevet evalueret i kontrollerede kliniske forsøg med spædbørn og børn, og der skal derfor udvises særlig forsigtighed i denne population (se pkt.
English: If you have these conditions, your doctor may need to monitor additional tests or change the dose.
Danish: Hvis noget af ovenstående gælder for dig, vil lægen eventuelt udføre yderligere tests eller ændre dosis.
English: Nicardipine has a greater selectivity for L-type calcium channels in vascular smooth muscle than cardiac myocytes.
Danish: Nicardipin har større selektivitet for calciumkanaler af L-typen i vaskulære glatte muskler end i kardiale myocytter.
English: The use of a central venous line or of a greater dilution of the solution could reduce the risk of occurrence of infusion site reaction.
Danish: Brug af et centralt venekateter eller større fortynding af infusionsvæsken kan eventuelt reducere risikoen for reaktioner på infusionsstedet.
English: 6.6 Special precautions for disposal and other handling To be completed nationally
Danish: 6.6 Regler for bortskaffelse og anden håndtering Udfyldes nationalt
English: Nicardipine should only be used for life-threatening hypertension in paediatric intensive care settings or postoperative contexts.
Danish: Nicardipin bør kun anvendes mod livstruende hypertension på pædiatriske intensivafdelinger eller i postoperativ kontekst.