FrancophonIA/ELRC3.0 huggingface dataset:
English: Competitive neuromuscular blockers
Croatian: Kompetitivni neuromuskularni blokatori
English: In this case, only the lowest posology should be used.
Croatian: U tom slučaju potrebno je primjenjivati samo najnižu dozu.
English: Within 8 days after myocardial infarction
Croatian: Unutar 8 dana nakon infarkta miokarda
English: In particular, tell your doctor if you are taking any of the following medicines:
Croatian: Posebice je važno da obavijestite liječnika ako uzimate bilo koji od sljedećih lijekova:
English: It is advised to change the infusion site in case of any suspicion of infusion site irritation.
Croatian: Savjetuje se mijenjati mjesto infuzije u slučaju bilo kakve sumnje na iritaciju mjesta infuzije.
English: DATE OF REVISION OF THE TEXT To be completed nationally
Croatian: DATUM REVIZIJE TEKSTA Ispunjava država članica
English: The medicine will be injected slowly into a vein.
Croatian: Lijek se polako ubrizgava u venu.
English: Nicardipine
Croatian: nikardipin
English: If you have these conditions, your doctor may need to monitor additional tests or change the dose.
Croatian: Ako imate te probleme, Vaš liječnik će Vas možda morati pratiti, propisati dodatne pretrage ili promijeniti dozu.
English: *cases have been also reported when used as tocolytic during pregnancy (see section 4.6)
Croatian: *slučajevi su također prijavljeni kad se lijek primjenjivao kao tokolitik tijekom trudnoće (vidjeti dio 4.6)
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).
Croatian: često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Intracranial pressure should be monitored, to allow calculation of the cerebral perfusion pressure.
Croatian: Treba nadzirati intrakranijalni tlak kako bi se omogućio izračun tlaka cerebralne perfuzije.
English: Patients with pre-existing elevated intracranial pressure
Croatian: Bolesnici s postojećim povišenim intrakranijalnim tlakom
English: Do not drink grapefruit juice or eat grapefruit whilst taking this medication as it may increase the blood levels of nicardipine
Croatian: Nemojte piti sok od grejpfruta ili jesti grejpfrut dok uzimate ovaj lijek jer može povećati razine nikardipina u krvi.
English: In case of an overdose it is recommended to use routine measures including monitoring of cardiac and respiratory function.
Croatian: U slučaju predoziranja preporučuje se primjena rutinskih mjera uključujući i nadzor srčane i respiratorne funkcije.
English: Healthcare professionals are asked to report any suspected adverse reactions via [national reporting system]
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem [nacionalnog sustava prijave nuspojava].
English: Its action is produced mainly on arterial smooth muscle.
Croatian: Njegovo djelovanje nastaje uglavnom na glatkim mišićima arterija.
English: Formulation specific warnings to be added here, if applicable
Croatian: Ako je primjenjivo, ovdje dodati upozorenja specifična za formulaciju
English: This is reflected in relatively large and rapid changes in blood pressure, with minimal inotropic changes in cardiac function (baroreflex effect).
Croatian: To se odražava u relativno velikim i brzim promjenama krvnog tlaka uz minimalne inotropne promjene u funkciji srca (barorefleksni učinak).
English: It can also be used to control high blood pressure after an operation.
Croatian: Također se može primjenjivati za kontrolu visokog krvnog tlaka nakon kirurškog zahvata.
English: Patients with portal hypertension
Croatian: Bolesnici s portalnom hipertenzijom
English: Rates can be increased by increments of 0.5 or 1 mg every 15 minutes.
Croatian: Brzine se mogu povećati za po 0,5 ili 1 mg svakih 15 minuta.
English: Your doctor will take special care:
Croatian: Vaš će liječnik također posebice voditi računa:
English: (Frequency unknown)
Croatian: (Učestalost nije poznata)
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.
Croatian: Klinička ispitivanja nikardipina nisu uključivala dostatan broj ispitanika u dobi od 65 godina i više kako bi se odredilo jesu li na liječenje reagirali drugačije od mlađih ispitanika.
English: This will depend on much and how fast they want to reduce your blood pressure by.
Croatian: To će ovisiti o tome koliko brzo liječnik želi smanjiti Vaš krvni tlak.
English: • Malignant arterial hypertension/Hypertensive encephalopathy
Croatian: • maligne arterijske hipertenzije / hipertenzivne encefalopatije
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.
Croatian: U kliničkoj praksi primjena nikardipina tijekom prva dva trimestra u ograničenom broju trudnoća do sada nije otkrila nikakve malformacijske ili posebno fetotoksične učinke.
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.
Croatian: Krvni tlak i brzina otkucaja srca moraju se nadzirati najmanje svakih 5 minuta tijekom infuzije, a zatim dok vitalni znakovi ne budu stabilni, ali najmanje 12 sati nakon dovršetka primjene nikardipina.
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.
Croatian: Doza održavanja: kad je dosegnut ciljni tlak, dozu treba postupno smanjivati obično na između 2 i 4 mg/sat kako bi se održala terapijska djelotvornost.
English: There is insufficient information on the effects of nicardipine in newborns/infants.
Croatian: Nema dovoljno podataka o učincima nikardipina na novorođenčad/dojenčad.
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.
Croatian: Režim doziranja za postizanje željenog krvnog tlaka može varirati ovisno o ciljnom krvnom tlaku, odgovoru pacijenta te dobi ili stanju bolesnika.
English: Potential additive antihypertensive effect
Croatian: Potencijalni aditivni antihipertenzivni učinak
English: There were no significant differences in the principal pharmacokinetic parameters between severe renal dysfunction and normal renal function (see section 4.4)
Croatian: Nije bilo značajnih razlika u glavnim farmakokinetičkim parametrima između teške disfunkcije bubrega i normalne funkcije bubrega (vidjeti dio 4.4).
English: The antihypertensive effect will depend on the administered dose.
Croatian: Antihipertenzivni učinak ovisit će o primijenjenoj dozi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump.
Croatian: Brzina primjene mora se precizno kontrolirati uporabom elektroničnog perfuzora za štrcaljku ili volumetrijske pumpe.
English: Severe aortic stenosis
Croatian: Teška stenoza aorte
English: A hypertensive episode which often accompanies a stroke is not an indication for emergency antihypertensive therapy.
Croatian: Hipertenzivna epizoda koja često prati moždani udar nije indikacija za hitnu antihipertenzivnu terapiju.
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
Croatian: • disekcije aorte kada terapija beta-blokatorima kratkog djelovanja nije odgovarajuća ili u kombinaciji s beta-blokatorom kada sama beta-blokada nije djelotvorna
English: QUALITATIVE AND QUANTITATIVE COMPOSITION To be completed nationally
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
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.
Croatian: Ispitivanja koja su uključivala ili pojedinačnu dozu ili primjenu 3 puta dnevno tijekom 3 dana pokazala su da se manje od 0,03% nepromijenjenog nikardipina izlučuje u mokraći u ljudi nakon peroralne ili intravenske primjene.
English: [Product name]
Croatian: [Naziv lijeka]
English: Compensatory hypertension, i.e. in case of an arteriovenous shunt or aortic coarctation
Croatian: Kompenzatorna hipertenzija, tj. u slučaju arterio-venskog šanta ili koarktacije aorte
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)
Croatian: Sigurnost i djelotvornost intravenskog nikardipina nije ispitana u kontroliranim kliničkim ispitivanjima u dojenčadi ili djece, pa stoga treba biti posebno oprezan kod primjene lijeka u ovoj populaciju (vidjeti dio 4.2).
English: Pharmacotherapeutic class: selective calcium inhibitors with vascular effects, ATC code: C08CA04
Croatian: Farmakoterapijska skupina: selektivni inhibitori kalcija s učincima na krvne žile, ATK oznaka: C08CA04
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)
Croatian: Osim ako se ne primjenjuje putem središnjeg venskog katetera, razrijedite lijek na koncentraciju od 0,1-0,2 mg/ml prije primjene (vidjeti dio 6.2 za pojedinosti o kompatibilnim otopinama).
English: You hospital will store this medicine appropriately
Croatian: Vaša bolnica će čuvati lijek na odgovarajući način.
English: It has been reported in animal experiments that the drug is excreted into breast milk.
Croatian: Na ispitivanjima na životinjama zabilježeno je da se lijek izlučuje u mlijeko.
English: Known hypersensitivity to nicardipine or to any of the excipients listed in section 6.1
Croatian: Poznata preosjetljivost na nikardipin ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: Dantrolene
Croatian: Dantrolen
English: The combination of a calcium channel inhibitor and dantrolene is therefore potentially dangerous.
Croatian: Stoga se kombinacija inhibitora kalcijevih kanala i dantrolena smatra potencijalno opasnom.
English: If any of the above apply to you, or you are not sure, tell your doctor before receiving Nicardipine solution for injection
Croatian: Ako se bilo što od prethodno navedenog odnosi na Vas ili niste sigurni, obavijestite svog liječnika prije nego primite Nikardipin otopinu za injekciju.
English: Major hypotension can be treated by intravenous infusion of any plasma volume expander and supine position with the legs elevated.
Croatian: Značajna hipotenzija može se liječiti intravenskom infuzijom bilo kojeg ekspandera volumena plazme i ležećim položajem s povišenim nogama.
English: Magnesium
Croatian: Magnezij
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.
Croatian: Povremeno bolesnici razvijaju povećanu učestalost, trajanje ili težinu angine nakon početka ili porasta doze nikardipina ili tijekom trajanja liječenja.
English: Nicardipine is metabolized by cytochrome P450 3A4.
Croatian: Nikardipin se metabolizira putem citokroma P450 3A4.
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.
Croatian: Nuspojave navedene u nastavku uočene su tijekom kliničkih ispitivanja i/ili tijekom primjene nakon stavljanja lijeka u promet i temelje se na podacima iz kliničkih ispitivanja i prema MedDRA klasifikaciji organskih sustava.
English: Blood levels should be monitored and dosage of immunosuppressant and/or nicardipine should be reduced, if required.
Croatian: Potrebno je nadzirati razine lijeka u krvi, a dozu imunosupresiva i/ili nikardipina treba smanjiti ako je to potrebno.
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.
Croatian: Nikardipin smiju primjenjivati samo liječnici specijalisti u dobro kontroliranim okruženjima poput bolnica i jedinica intenzivne skrbi uz neprekidan nadzor krvnog tlaka.
English: Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia.
Croatian: Brza farmakološka smanjenja krvnog tlaka mogu uzrokovati sistemsku hipotenziju i refleksnu tahikardiju.
English: Ischaemic cardiovascular disease.
Croatian: Ishemijska kardiovaskularna bolest.
English: Your doctor will decide on the amount of Nicardipine solution for injection you will be given.
Croatian: Vaš liječnik će odrediti količinu Nikardipin otopine za injekciju koju ćete dobiti.
English: At very low concentrations it inhibits the influx of calcium into the cell.
Croatian: Pri vrlo niskim koncentracijama inhibira utok kalcija u stanice.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: [to be completed nationally]
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: The infusion rate should not exceed 15 mg/h.
Croatian: Brzina infuzije ne smije premašiti 15 mg/sat.
English: Unstable angina
Croatian: Nestabilna angina
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.
Croatian: Preporučuje se davanje kontinuirane infuzije nikardipina s početnom dozom od 1 do 5 mg/sat ovisno o krvnom tlaku i kliničkoj situaciji.
English: If either occurs with nicardipine, consider decreasing the dose by half or stopping the infusion.
Croatian: Ako se bilo što od toga dogodi uz primjenu nikardipina, uzmite u obzir smanjivanje doze za pola ili prekid infuzije.
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.
Croatian: Nikardipin se ne smije primjenjivati kod višeplodnih trudnoća ili u trudnica s ugroženim kardiovaskularnim stanjem osim ako nema druge prihvatljive alternative.
English: The safety and efficacy in low birth weight infants, newborns, nursing infants, infants, and children has not been established.
Croatian: Sigurnost i djelotvornost u dojenčadi male tjelesne težine, novorođenčadi, dojenčadi koja se hrani majčinim mlijekom, dojenčadi i djece nisu ustanovljene.
English: In animal studies, administration of verapamil and intravenous dantrolene has caused fatal ventricular fibrillation.
Croatian: U ispitivanjima na životinjama primjena verapamila i intravenskog dantrolena uzrokovala je smrtonosnu ventrikularnu fibrilaciju.
English: Not known - hepatic enzyme increased
Croatian: Nepoznato - povišeni jetreni enzimi
English: This leaflet was approved in {month YYYY}.
Croatian: Ova uputa je zadnji put revidirana u {mjesec GGGG}.
English: [Product specific formulation warnings to be completed nationally ]
Croatian: [Upozorenja specifična za formulaciju lijeka ispunjava država članica ]
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.
Croatian: Akutni plućni edem uočen je kad se nikardipin primjenjivao kao tokolitik tijekom trudnoće (vidjeti dio 4.8), posebice u slučajevima višeplodnih trudnoća (blizanci ili više fetusa), uz intravenski put primjene i/ili istodobnu primjenu beta-2 agonista.
English: Administered by systemic route, nicardipine is a potent vasodilator which diminishes total peripheral resistance and lowers blood pressure.
Croatian: Kad se primjenjuje sistemskim putem, nikardipin je potentni vazodilatator koji smanjuje ukupni periferni otpor i snižava krvni tlak.
English: 4.5 Interaction with other medicinal products and other forms of interaction Enhancement of negative inotropic effect
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Nicardipine should be administered by continuous intravenous infusion only.
Croatian: Nikardipin treba primjenjivati samo kontinuiranom intravenskom infuzijom.
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
Croatian: Bolus primjena ili intravenska primjenu koja se ne kontrolira primjenom elektroničkog perfuzora za štrcaljku ili volumetrijske pumpe ne preporučuje se jer može povećati rizik od ozbiljne hipotenzije, posebice u starijih osoba, u djece, u bolesnika s oštećenjem bubrega ili jetre te kod trudnoće.
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.
Croatian: Nakon istodobne primjene radioaktivne intravenske doze nikardipina uz peroralnu dozu od 30 mg koja se daje svakih 8 sati, 49% radioaktivnosti izlučeno je u mokraći, a 43% u stolici unutar 96 sati.
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.
Croatian: Dok primate lijek, mjerit će Vam se krvni tlak, a doza lijeka će se prilagoditi kako bi se osiguralo da Vam se krvni tlak smanji na normalnu razinu.
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)
Croatian: Nikardipin može povećati negativni inotropni učinak beta-blokatora i uzrokovati zatajenje srca u bolesnika s latentnim ili nekontroliranim zatajenjem srca (vidjeti dio 4.4).
English: Nicardipine solution for injection is used to treat very severe high blood pressure.
Croatian: Nikardipin otopina za injekciju primjenjuje se za liječenje vrlo visokog krvnog tlaka.
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.
Croatian: Nikardipin otopinu za injekciju dat će Vam liječnik koji će se pobrinuti da dobijete točnu dozu primjerenu za liječenje Vašeg stanja.
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.
Croatian: Moguće je također prijeći na peroralne kapsule nikardipina od 20 mg u dozi od 60 mg/dan podijeljeno u 3 dnevne doze, ili na tablete nikardipina od 50 mg s produljenim oslobađanjem u dozi od 100 mg/dan podijeljeno u 2 dnevne doze.
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).
Croatian: Farmakokinetika intravenski primijenjenog nikardipina proučavana je na ispitanicima s teškom disfunkcijom bubrega koja zahtijeva hemodijalizu (klirens kreatinina < 10 ml/min), s blagom/umjerenom disfunkcijom bubrega (klirens kreatinina 10-50 ml/min) i s normalnom funkcijom bubrega (klirens kreatinina > 50 ml/min).
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.
Croatian: Zbog rizika od teške hipotenzije kod majke i potencijalno smrtonosne fetalne hipoksije, pad krvnog tlaka treba biti postupan te ga uvijek treba pomno nadzirati.
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.
Croatian: U slučaju kirurškog zahvata Vaš anesteziolog mora znati koje druge lijekove uzimate jer neki od tih lijekova mogu utjecati na način djelovanja
English: In some patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) have been observed.
Croatian: U nekih bolesnika s umjerenim oštećenjem bubrega uočeni su znatno niži sistemski klirens i više vrijednosti površine ispod krivulje (AUC).
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.
Croatian: Najobilniji metabolit u ljudskoj mokraći je glukuronid u hidroksilnom obliku koji nastaje oksidativnim cijepanjem dijela Nmetilbenzila i oksidacijom piridinskog prstena.
English: Initial dose: Treatment should start with the continuous administration of nicardipine at a rate of 3-5 mg/h for 15 minutes.
Croatian: Početna doza: liječenje treba započeti kontinuiranom primjenom nikardipina brzinom od 3-5 mg/sat tijekom 15 minuta.
English: Intravenous nicardipine [or invented name] is indicated for the treatment of acute life-threatening hypertension, particularly in the event of:
Croatian: Intravenski nikardipin [ili zaštićeni naziv] je indiciran za liječenje akutne, po život opasne hipertenzije, posebice u slučaju:
English: In addition to general supportive measures, intravenous calcium preparations and vasopressors are clinically indicated for patients exhibiting the effects of calcium entry blockade.
Croatian: Pored općih suportivnih mjera, klinički su indicirani i intravenski pripravci kalcija i vazopresori za bolesnike koji pokazuju učinke blokade utoka kalcija.
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.
Croatian: Primjena nikardipina za tešku preeklampsiju tijekom trećeg trimestra trudnoće mogla bi uzrokovati neželjeni tokolitički učinak koji bi mogao interferirati sa spontanom indukcijom trudova.
English: In such case, the posology of the beta blocker should be individualized to the clinical situation.
Croatian: U takvom slučaju doziranje beta-blokatora treba prilagoditi kliničkoj situaciji pojedinačnog bolesnika.
English: [To be completed nationally if applicable]
Croatian: [Ispunjava država članica ako je primjenjivo]
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.
Croatian: Primjena središnjeg venskog katetera ili većeg razrjeđenja otopine mogla bi smanjiti rizik od pojave reakcije na mjestu infuzije.
English: After 30 minutes, depending on the effect observed, this rate can be increased or decreased by increments of 0.5 mg/h.
Croatian: Nakon 30 minuta, ovisno o uočenom učinku ova se brzina može povećati ili smanjiti za po 0,5 mg/sat.