FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of intravenously administration of nicardipine was studied in subjects with severe renal dysfunction requiring hemodialysis (creatinine clearance < 10 ml/min), mild/moderate renal dysfunction (creatinine clearance 10 - 50 mi/min) and normal renal function (creatinine clearance >50 ml/min).
Danish: Farmakokinetikken af intravenøst administreret nicardipin er blevet undersøgt hos patienter med svært nedsat, hæmodialysekrævende nyrefunktion (kreatininclearance < 10 ml/min), let/moderat nedsat nyrefunktion (kreatininclearance 10-50 ml/min) og normal nyrefunktion (kreatininclearance > 50 ml/min).
English: If you have heart failure
Danish: Hvis du har hjertesvigt
English: If any of the above apply to you, or you are not sure, tell your doctor before receiving Nicardipine solution for injection
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du fortælle det til lægen, inden du får Nicardipin injektionsvæske.
English: None of the dose was recovered as unchanged nicardipine in the urine.The elimination profile of the drug following an intravenous dose consists of three phases, with corresponding half-life: alpha 6.4 min, beta 1.5 hours, gamma 7.9 hours.
Danish: Eliminationsprofilen af lægemidlet efter en intravenøs dosis består af tre faser med tilhørende halveringstider: alfa 6,4 min, beta 1,5 time, gamma 7,9 timer.
English: Heart rate is temporarily increased; as a result of a decrease in after-load, cardiac output is markedly and durably increased.
Danish: Hjertefrekvensen øges midlertidigt, og som følge af et fald i afterload er hjertets minutvolumen markant og vedvarende øget.
English: Not known - phlebitis
Danish: Ikke kendt - flebitis
English: Maintenance dose: The maintenance dosage of 1 to 4 mcg/kg/min is recommended.
Danish: Vedligeholdelsesdosis: Vedligeholdelsesdosis på 1 til 4 mikrogram/kg/min anbefales.
English: Since nicardipine is metabolized in the liver, it is recommended to use the same dose regimens as for elderly patients in patients with impaired liver function or reduced hepatic blood flow.
Danish: Da nicardipin metaboliseres i leveren, anbefales det at anvende samme doseringsregimer til patienter med nedsat leverfunktion eller nedsat hepatisk blodgennemstrømning som til ældre patienter.
English: This is because Nicardipine solution for injection can affect the way some other medicines work.
Danish: Det skyldes, at Nicardipin injektionsvæske kan påvirke virkningen af andre lægemidler.
English: The use of nicardipine for severe pre-eclampsia during the third trimester of pregnancy could potentially produce an undesirable tocolytic effect which could potentially interfere with the spontaneous induction of labour.
Danish: Brug af nicardipin ved svær præeklampsi i tredje graviditetstrimester kan potentielt medføre en uønsket tokolytisk virkning, som potentielt kan forstyrre den spontane induktion af fødsel.
English: This leaflet was approved in {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Nicardipine solution for injection contains nicardipine hydrochloride, which belongs to a group of medicines called calcium channel blockers.
Danish: Nicardipin injektionsvæske indeholder nicardipinhydrochlorid, der tilhører en gruppe lægemidler, der kaldes calciumblokkere.
English: Transition to an oral antihypertensive agent: discontinue nicardipine or titrate downward while appropriate oral therapy is established.
Danish: Skift til et oralt antihypertensivum: Nicardipin seponeres eller nedtitreres samtidig med, at passende oral behandling etableres.
English: Swollen legs or ankles
Danish: Hævede ben eller ankler
English: Nicardipine is metabolized by cytochrome P450 3A4.
Danish: Nicardipin metaboliseres via CYP3A4.
English: Common - lower limb oedema, palpitations Common - hypotension, tachycardia Not known -atrioventricular block, angina pectoris
Danish: Almindelig - ødem i underarme og -ben, palpitationer Almindelig - hypotension, takykardi Ikke kendt - atrioventrikulær blokade, angina pectoris
English: Annex III Summary of Product Characteristics and Package Leaflet
Danish: Bilag III Produktresume og indlægsseddel
English: At steady state, Cmax and AUC were significantly higher and clearance significantly lower in subjects with mild/moderate renal dysfunction compared with in subjects with normal renal function.
Danish: Ved steady state var Cmax og AUC signifikant højere og clearance signifikant lavere hos patienter med let/moderat nedsat nyrefunktion end hos patienter med normal nyrefunktion.
English: If you have chest pain
Danish: Hvis du har brystsmerter
English: Nicardipine in combination with intravenous corticosteroids and tetracosactide (except for hydrocortisone used as replacement therapy in Addison's disease) may cause a decrease in the antihypertensive effect Inhalational anaesthetics
Danish: Nicardipin i kombination med intravenøse kortikosteroider og tetracosactid (med undtagelse af hydrocortison anvendt som substitutionsbehandling ved Addisons sygdom) kan forårsage et fald i den antihypertensive virkning.
English: Concomitant administration of nicardipine and cyclosporine, tacrolimus or sirolimus results in elevated plasma cyclosporine/tacrolimus levels.
Danish: Samtidig administration af nicardipin og ciclosporin, tacrolimus eller sirolimus resulterer i øgede plasmaniveauer af ciclosporin/tacrolimus.
English: Ischaemic cardiovascular disease.
Danish: Iskæmisk kardiovaskulær sygdom
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Ikke relevant.
English: The infusion rate should not exceed 15 mg/h.
Danish: Infusionshastigheden bør ikke overstige 15 mg/t.
English: Limited clinical data suggests that the effects of inhaled anaesthetics (e.g. isoflurane, sevoflurane and enflurane) on nicardipine appear to be moderate.
Danish: Begrænsede kliniske data tyder på, at virkningerne af inhalationsanæstetika (f.eks. isofluran, sevofluran og enfluran) på nicardipin er moderate.
English: Heart problems leading to increased fluid in the lungs and shortness of breath Abdominal pain
Danish: Hjerteproblemer, der medfører øget væske i lungerne og åndenød Mavesmerter
English: It is recommended to provide a continuous infusion of nicardipine starting at the dose of 1 to 5 mg/h, depending on the blood pressure and clinical situation.
Danish: Det anbefales at give en kontinuerlig infusion af nicardipin, startende med en dosis på 1 til 5 mg/t afhængigt af blodtrykket og den kliniske situation.
English: Very common - headache
Danish: Meget almindelig - hovedpine Almindelig - svimmelhed
English: Compensatory hypertension, i.e. in case of an arteriovenous shunt or aortic coarctation
Danish: Kompensatorisk hypertension, fx i tilfælde af arterievenøs shunt eller coarctatio aortae.
English: Nicardipine may enhance the negative inotropic effect of beta-blockers and may cause heart failure in patient with latent or uncontrolled heart failure (see section 4.4)
Danish: Nicardipin kan øge den negative inotrope virkning af betablokkere og kan forårsage hjertesvigt hos patienter med latent eller ukontrolleret hjertesvigt (se pkt.
English: Nicardipine should be used with caution in patients with congestive heart failure or pulmonary oedema, particularly when these patients are receiving concomitant beta-blockers, as worsening of cardiac insufficiency may occur.
Danish: Nicardipin bør anvendes med forsigtighed hos patienter med kongestivt hjertesvigt eller lungeødem, særligt hvis disse patienter samtidig får betablokkere, da forværring af hjerteinsufficiens kan indtræde.
English: If you are taking beta-blockers
Danish: Hvis du tager betablokkere
English: In addition to general supportive measures, intravenous calcium preparations and vasopressors are clinically indicated for patients exhibiting the effects of calcium entry blockade.
Danish: Udover alment understøttende tiltag er der klinisk indikation for intravenøse calciumpræparater og vasopressorer hos patienter, hos hvem der ses calciumblokerende virkninger.
English: If your liver is not working properly, or you have had liver disease in the past If you have high pressure in the brain
Danish: Hvis du har hjertekramper (angina pectoris) Hvis din lever ikke fungerer korrekt, eller hvis du tidligere har haft en leversygdom Hvis du har forhøjet tryk i hjernen
English: Initial dose: In case of emergency, a starting dose of 0.5 to 5 mcg/kg/min is recommended
Danish: Startdosis: I akutte tilfælde anbefales en startdosis på 0,5 til 5 mikrogram/kg/min.
English: Common - flushing Not known - erythema
Danish: Almindelig - blussen Ikke kendt - erytem
English: Elderly patients may be more sensitive to nicardipine effects because of impaired renal and/or hepatic function.
Danish: Ældre patienter kan være mere følsomme over for virkningerne af nicardipin som følge af nedsat nyreog/eller leverfunktion.
English: In humans, the vasodilator action also occurs in both acute dose administration and chronic administration in the large and small arteries, increasing blood flow and improving arterial compliance.
Danish: Hos mennesker indtræder den vasodilaterende virkning i de store og små arterier både ved akut og kronisk administration, hvorved blodstrømningen øges, og den arterielle komplians forbedres.
English: Intravenous nicardipine at high doses has been reported to worsen portal vein hypertension and portal-systemic collateral blood flow index in cirrhotic patients.
Danish: Det er indberettet, at intravenøs nicardipin i høje doser forværrer portal hypertension og indekset for det portal-systemiske kollateralkredsløb hos cirrosepatienter.
English: Overdose with nicardipine hydrochloride can potentially result in marked hypotension, bradycardia, palpitations, flushing, drowsiness, collapse, peripheral oedema, confusion, slurred speech and hyperglycaemia.
Danish: Overdosering med nicardipinhydrochlorid kan potentielt resultere i udtalt hypotension, bradykardi, palpitationer, blussen, døsighed, kollaps, perifere ødemer, forvirring, sløret tale og hyperglykæmi.
English: The majority of undesirable effects are the consequence of the vasodilator effects of nicardipine.
Danish: Størstedelen af bivirkningerne opstår som følge af nicardipins vasodilaterende virkninger.
English: Nicardipine should be used with particular caution in these patients.
Danish: Nicardipin bør anvendes med særlig forsigtighed hos disse patienter.
English: It is recommended to provide a continuous infusion of nicardipine starting at 1 to 5 mg/h, depending on the blood pressure and clinical situation.
Danish: Kontinuerlig infusion af nicardipin, startende med 1 til 5 mg/t afhængigt af blodtrykket og den kliniske situation, anbefales.
English: Common - nausea, vomiting Not known - paralytic ileus
Danish: Almindelig - kvalme, opkastning Ikke kendt - paralytisk ileus
English: In such case, the posology of the beta blocker should be individualized to the clinical situation.
Danish: I sådanne tilfælde skal doseringen af betablokkeren tilpasses individuelt til den kliniske situation (se pkt.
English: There were no significant differences in the principal pharmacokinetic parameters between severe renal dysfunction and normal renal function (see section 4.4)
Danish: Der var ingen signifikante forskelle i de vigtigste farmakokinetiske parametre hos patienter med henholdsvis svært nedsat nyrefunktion og normal nyrefunktion (se pkt.
English: Reduction in blood platelets, which may increase the risk of bleeding or bruising Slow heart rhythm
Danish: Nedsat antal blodplader, hvilket kan øge risikoen for blødning og blå mærker Langsom hjerterytme (puls)
English: Intracranial pressure should be monitored, to allow calculation of the cerebral perfusion pressure.
Danish: Patienter med præeksisterende forhøjet intrakranielt tryk Det intrakranielle tryk bør monitoreres med henblik på beregning af det cerebrale perfusionstryk.
English: The co-administration of nicardipine with inhalational anaesthetics could induce a potential additive or synergistic hypotensive effect, as well as an inhibition by anaesthetics of the baroreflex heart rate increase associated with peripheral vasodilators.
Danish: Samtidig administration af nicardipin og inhalationsanæstetika kan forårsage en potentiel additiv eller synergistisk hypotensiv virkning samt en anæstetikaforårsaget hæmning af den barorefleksive hjertefrekvensstigning, der er forbundet med perifer vasodilatation.
English: Nicardipine has been shown to pass into the milk of lactating animals.
Danish: Det er påvist, at nicardipin udskilles i mælken hos diegivende dyr.
English: Co-administration of calcium channel blockers with itraconazole has shown an increased risk of adverse events, in particular oedema due to a decreased metabolism of the calcium channel blocker in the liver.
Danish: Samtidig administration af calciumblokkere og itraconazol er vist at øge risikoen for bivirkninger, især ødemer, som følge af nedsat metabolisering af calciumblokkeren i leveren.
English: The rate should not exceed 15 mg/h.
Danish: Hastigheden bør ikke overstige 15 mg/t.
English: Your doctor will decide on the amount of Nicardipine solution for injection you will be given.
Danish: Lægen vil fastlægge, hvor meget Nicardipin injektionsvæske, du skal have.
English: Potential risk groups are patients with a history of hepatic dysfunction or those with impaired hepatic function at the initiation of treatment with nicardipine.
Danish: Potentielle risikogruppper omfatter patienter med hepatisk dysfunktion i anamnesen og patienter med nedsat leverfunktion på tidspunktet for indledning af nicardipinbehandling.
English: Unless given by a central venous line, dilute to a concentration of 0.1 - 0.2 mg/ml before use (see section 6.2 for details of compatible solutions)
Danish: Medmindre indgivelse sker via et centralt venekateter, fortyndes til en koncentration på 0,1-0,2 mg/ml inden brug (se pkt.
English: This may cause dizziness, lightheadednesss or fainting Feeling sick or being sick
Danish: Dette kan forårsage svimmelhed, omtumlethed eller besvimelse.
English: Nicardipine is a second generation slow calcium channel inhibitor, and belongs to the phenyl-dihydropyridine group.
Danish: Nicardipin er en langsomt virkende andengenerationscalciumhæmmer, der tilhører phenyldihydropyridingruppen.
English: The most frequent events are headache, dizziness, peripheral oedema, palpitations and flushing
Danish: De hyppigste bivirkninger er hovedpine, svimmelhed, perifere ødemer, palpitationer og blussen.
English: prazosin and terazosin - Any other medicine for high blood pressure - Cimetidine (to treat indigestion or stomach ulcers) - Digoxin (used for heart conditions) - Amifostine (used to protect against the harmful effects of certain cancer treatments) - Medicines to treat depression, anxiety or other mental health problems - Strong painkilling medicines like morphine or codeine - Medicines used to treat inflammation such as steroids and tetracosactide - Magnesium injection (used to treat severe high blood pressure in pregnancy)
Danish: atenolol og metoprolol - Lægemidler mod kramper/epilepsi, såsom carbamazepin, phenobarbital, primidon og phenytoin - Baclofen (anvendes til behandling af muskelspasmer) - Lægemidler, der anvendes til at kontrollere kroppens immunsystem, såsom tacrolimus, sirolimus og ciclosporin - Itraconazol (anvendes til behandling af visse svampeinfektioner) - Rifampicin (anvendes til behandling af tuberkulose og visse andre infektioner) - Alfablokkere (anvendes til behandling af højt blodtryk eller prostataproblemer hos mænd), såsom doxazosin, prazosin og terazosin - Ethvert andet lægemiddel mod højt blodtryk - Cimetidin (anvendes til behandling af fordøjelsesbesvær og mavesår) - Digoxin (anvendes mod hjertesygdomme) - Amifostin (anvendes som beskyttelse mod skadelige virkninger af visse kræftlægemidler) - Lægemidler til behandling af depression, angst eller andre mentale problemer - Lægemidler mod stærke smerter, såsom morphin eller codein - Lægemidler til behandling af betændelseslignende tilstande (inflammation), såsom steroider og tetracosactid - Magnesium via indsprøjtning (anvendes til behandling af alvorligt forhøjet blodtryk under graviditeten)
English: Combination with beta-blockers
Danish: Kombination med betablokkere
English: Nicardipine solution for injection is a clear colourless solution.
Danish: Nicardipin injektionsvæske er en klar, farveløs opløsning.
English: In laboratory animals, overdosage also resulted in reversible hepatic function abnormalities, sporadic focal hepatic necrosis and progressive atrio-ventricular conduction block.
Danish: Hos laboratoriedyr har overdosering også resulteret i reversible leverfunktionsabnormiteter, sporadisk fokal levernekrose og progressiv blokering af den atrioventrikulære overledning.
English: [To be completed nationally if applicable]
Danish: [Udfyldes nationalt, hvor relevant]
English: Limited data suggest that nicardipine, as other calcium channel blockers, enhances neuromuscular block possibly by acting at the post-junctional region.
Danish: Begrænsede data tyder på, at nicardipin i lighed med andre calciumblokkere øger den neuromuskulære blokade, muligvis som følge af virkning på muskelfibersiden i den neuromuskulære overgang.
English: Dizziness
Danish: Hudrødme
English: You hospital will store this medicine appropriately
Danish: Dette lægemiddel vil blive opbevaret korrekt på hospitalet.
English: Co-administration of CYP 3A4 enzyme-inducing agents (e.g.carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone and rifampicin) may cause a decrease in the plasma concentrations of nicardipine.
Danish: Samtidig administration af CYP3A4-induktorer (f.eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon og rifampicin) kan forårsage et fald i plasmakoncentrationen af nicardipin.
English: Also, some other medicines can affect the way Nicardipine solution for injection works.
Danish: Andre lægemidler kan også påvirke virkningen af Nicardipin injektionsvæske.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [to be completed nationally]
Danish: Indehaver af markedsføringstilladelsen: [udfyldes individuelt]
English: Concomitant medications which could potentiate the antihypertensive effect of nicardipine include baclofen, alphablockers, tricyclic antidepressants, neuroleptics, opiods and amifostine Decrease of antihypertensive effect
Danish: Lægemidler, der kan forstærke den antihypertensive virkning af nicardipin ved samtidig administration, omfatter baclofen, alfablokkere, tricykliske antidepressiva, neuroleptika, opioider og amifostin.
English: Each pack contains [to be completed nationally].
Danish: Hver pakning indeholder [udfyldes individuelt].
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: [to be completed nationally]
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Caution should be exercised when using nicardipine in combination with a beta-blocker in patients with decreased cardiac function.
Danish: Der bør udvises forsigtighed ved brug af nicardipin i kombination med en betablokker hos patienter med nedsat hjertefunktion.
English: Patients with Stroke
Danish: Patienter med apopleksi
English: After 30 minutes, depending on the effect observed, this rate can be increased or decreased by increments of 0.5 mg/h.
Danish: Efter 30 minutter kan denne hastighed øges eller nedsættes i trin af 0,5 mg/t, afhængigt af den observerede virkning.
English: Nicardipine should be used with caution in patients with acute cerebral infarction.
Danish: Nicardipin bør anvendes med forsigtighed til patienter med akut hjerneinfarkt.
English: Co-administration of CYP3A4 enzyme-inhibiting agents (e.g. cimetidine, itraconazole and grapefruit juice) may cause an increase in the plasma concentrations of nicardipine.
Danish: Samtidig administration af CYP3A4-hæmmere (f.eks. cimetidin, itraconazol og grapefrugtjuice) kan forårsage en stigning i plasmakoncentrationen af nicardipin.
English: Doses higher than 4mg /h are generally not exceeded in the treatment of pre-eclampsia, however the rate should not exceed 15 mg/h.
Danish: Dosis overskrider normalt ikke 4 mg/t ved behandling af præeklampsi.
English: Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulphate is used concomitantly
Danish: På grund af den mulige risiko for lungeødem eller udtalte blodtryksfald bør der udvises forsigtighed ved samtidig administration af magnesiumsulfat.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE Udfyldes nationalt
English: What you need to know before you take Nicardipine solution for injection
Danish: Det skal du vide, før du begynder at tage Nicardipin injektionsvæske
English: After 30 minutes, depending on the effect observed, the rate should be increased or decreased by increments of 0.5 mg/h.
Danish: Efter 30 minutter bør hastigheden øges eller nedsættes i trin af 0,5 mg/t på baggrund af den observerede virkning.
English: Acute pulmonary oedema has been observed when nicardipine has been used as tocolytic during pregnancy (see section 4.8), especially in cases of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use of beta-2 agonists.
Danish: 4.8), specielt i tilfælde af flerfoldsgraviditet (tvillinger eller mere), ved intravenøs administration og/eller samtidig brug af beta-2-agonister.
English: Nicardipine should be used with caution in patients with suspected coronary ischemia.
Danish: Nicardipin bør anvendes med forsigtighed til patienter, hos hvem der er mistanke om koronar iskæmi.
English: Reversal of neuromuscular block by neostigmine appears not to be affected by nicardipine infusion.
Danish: Nicardipininfusion påvirker tilsyneladende ikke reverseringen af neuromuskulær blokade med neostigmin.
English: Nicardipine has been reported to increase the plasma levels of digoxin in pharmacokinetic studies.
Danish: I farmakokinetiske studier er det rapporteret, at nicardipin øger plasmaniveauet af digoxin.
English: Adverse reactions listed below have been observed during clinical studies and/or during marketed use and are based on clinical trial data and classified according to MedDRA System Organ Class.
Danish: Nedenstående bivirkninger er set i kliniske studier og/eller i forbindelse med brug efter markedsføring.
English: Do not take Nicardipine solution for injection
Danish: Tag ikke Nicardipin injektionsvæske
English: Vecuronium infusion dose requirements could be reduced by the concurrent use of nicardipine.
Danish: Den nødvendige dosis af vecuroniuminfusionsvæske kan være nedsat ved samtidig brug af nicardipin.
English: Not known - thrombocytopenia
Danish: Ikke kendt - trombocytopeni
English: The other ingredients are: [to be completed nationally]
Danish: Øvrige indholdsstoffer: [udfyldes individuelt]
English: 6.4 Special precautions for storage
Danish: 6.4 Særlige opbevaringsforhold Udfyldes nationalt
English: Nicardipine should not be used during breastfeeding.
Danish: Nicardipin bør ikke anvendes hos ammende kvinder.
English: Nicardipine should be used with particular caution in children with renal impairment.
Danish: Nicardipin bør anvendes med særlig forsigtighed hos børn med nyreinsufficiens.
English: Nicardipine is highly protein bound in human plasma over a wide concentration range.
Danish: Over et bredt koncentrationsområde bindes nicardipin i udtalt grad til proteiner i humant plasma.
English: Inflammation of the vein where the medicine has been given Changes in blood tests of how your liver is working
Danish: Ændringer i blodprøver til vurdering af din leverfunktion
English: What Nicardipine solution for injection contains
Danish: Nicardipin injektionsvæske indeholder