natgillin/translations-raw huggingface dataset:
It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration.
Priporočamo, da rekonstituirano zdravilo Visudyne pred uporabo pregledate s prostim očesom, da se prepričate, da v njem ni delcev in da ni spremenjene barve.
Adults, including the elderly (≥65 years old) Visudyne photodynamic therapy (PDT) is a two-step process:
Odrasli, vključno s starejšimi (starimi ≥ 65 let) Fotodinamična terapija (PDT) z zdravilom Visudyne je dvostopenjski postopek: Prva stopnja je 10-minutna intravenska infuzija zdravila Visudyne v odmerku 6 mg/m telesne površine, razredčenega v 30 ml infuzijske raztopine (glejte poglavje 6.6).
• Eye disorders: bleeding of the retina or into the vitreous humour (the clear gel-like substance that fills the eyeball behind the lens), swelling or fluid retention in the retina and displacement of the retina in the treated eye.
• Težave z očmi: slaba prekrvljenost mrežnice ali žilnice (žilne plasti v očesu) v zdravljenem očesu.
Infusion-related reaction, which may radiate to other areas, including but not limited to, the pelvis, shoulders or rib cage.
• Splošne težave: spremembe srčnega utripa, z infuzijo povezana reakcija, ki se lahko širi v druge predele, med drugim v medenico, rame ali prsni koš.
Infusion-related chest pain
PODATKI NA ZUNANJI OVOJNINI
4 years
6.3 Rok uporabnosti
Hypercholesteraemia.
Žilne bolezni občasni hipertenzija
Visudyne therapy should be considered carefully in patients with moderate hepatic dysfunction or biliary obstruction.
Pri bolnikih z zmerno motenim delovanjem jeter ali z obstrukcijo žolčnih izvodil je treba skrbno pretehtati primernost zdravljenja z zdravilom Visudyne.
(See sections 4.4, 4.6 and 4.8)
(glejte poglavja 4.4, 4.6 in 4.8).
No additional monitoring is required.
Dodaten nadzor ni potreben.
Your doctor will take special care:
Vaš zdravnik bo posebno pozoren:
(Frequency unknown)
(pogostnost ni znana)
Formulation specific warnings to be added here, if applicable
Posebna opozorila, povezana s formulacijo, se dodajo tukaj, če so na voljo.
Continue blood pressure monitoring until desired effect is achieved.
Nadaljujte z nadzorom krvnega tlaka, dokler ni dosežen želeni učinek.
If you have these conditions, your doctor may need to monitor additional tests or change the dose.
Če imate katero od omenjenih stanj, bo vaš zdravnik morda spremljal dodatne teste ali spremenil odmerek.
It can also be used to control high blood pressure after an operation.
Uporablja se lahko tudi za uravnavanje visokega krvnega tlaka po operaciji.
In this case, only the lowest posology should be used.
V teh primerih so lahko uporabljeni le najmanjši odmerki.
Patients with pre-existing elevated intracranial pressure
Bolniki z obstoječim zvišanim intrakranialnim tlakom
The medicine will be injected slowly into a vein.
Zdravilo bo počasi injicirano v veno.
4.5 Interaction with other medicinal products and other forms of interaction Enhancement of negative inotropic effect
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Poudarjen negativni inotropni učinek
In particular, tell your doctor if you are taking any of the following medicines:
Zdravniku morate še zlasti povedati, če uporabljate katero koli od teh zdravil:
In case of an overdose it is recommended to use routine measures including monitoring of cardiac and respiratory function.
V primeru prevelikega odmerjanja so priporočeni rutinski ukrepi, vključno s spremljanjem srčne in respiratorne funkcije.
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).
Kategorije pogostnosti neželenih učinkov so določene v skladu z naslednjim dogovorom: Zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
This will depend on much and how fast they want to reduce your blood pressure by.
Odmerek bo odvisen od tega, za koliko in kako hitro bodo želeli znižati vaš krvni tlak.
Intracranial pressure should be monitored, to allow calculation of the cerebral perfusion pressure.
Intrakranialni tlak je treba spremljati, da je omogočen izračun cerebralnega perfuzijskega tlaka.
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.
Režim odmerjanja za doseganje želenega krvnega tlaka se lahko razlikuje glede na ciljni krvni tlak, odziv bolnika in starost ali stanje bolnika.
You hospital will store this medicine appropriately
Bolnišnica bo primerno shranila zdravilo.
*cases have been also reported when used as tocolytic during pregnancy (see section 4.6)
*poročali so tudi o primerih, ko je bilo zdravilo med nosečnostjo uporabljeno kot tokolitik (glejte poglavje 4.6)
Patients with portal hypertension
Bolniki s portalno hipertenzijo
Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
V kliničnih študijah z nikardipinom ni bilo zajeto zadostno število oseb, starih 65 let in več, da bi se pokazalo, ali se odzivajo drugače kot mlajše osebe.
Healthcare professionals are asked to report any suspected adverse reactions via [national reporting system]
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na [nacionalni center za poročanje].
However, toxicity to reproduction has not been reported.
O vplivu na sposobnost razmnoževanja niso poročali.
This is reflected in relatively large and rapid changes in blood pressure, with minimal inotropic changes in cardiac function (baroreflex effect).
To se odraža v relativno velikih in hitrih spremembah krvnega tlaka z minimalnimi inotropnimi spremembami srčne funkcije (učinek barorefleksa).
Other common side effects (these may affect up to 1 in 10 people) are:
Drugi pogosti neželeni učinki (pojavijo se največ pri 1 od 10 bolnikov) so:
This includes medicines obtained without a prescription and herbal medicines.
To velja tudi za zdravila, ki ste jih dobili brez recepta, vključno z zdravili rastlinskega izvora.
Potential additive antihypertensive effect
Potencialni aditivni antihipertenzivni učinek
A hypertensive episode which often accompanies a stroke is not an indication for emergency antihypertensive therapy.
Hipertenzijska epizoda, ki pogosto spremlja kap, ni indikacija za nujno antihipertenzivno zdravljenje.
DATE OF REVISION OF THE TEXT To be completed nationally
DATUM ZADNJE REVIZIJE BESEDILA Izpolni država članica
Competitive neuromuscular blockers
Kompetitivni živčno-mišični zaviralci
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.
Krvni tlak in srčni utrip morata biti med infuzijo nadzorovana najmanj vsakih 5 minut, in sicer dokler vitalni znaki niso stabilni, vendar še vsaj 12 ur po zaključenem dajanju nikardipina.
In some patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) have been observed.
Pri nekaterih bolnikih z zmerno okvaro ledvic je bil opažen občutno nižji sistemski očistek in povečanje površine pod krivuljo (AUC).
This leaflet was approved in {month YYYY}.
Navodilo je bilo odobreno {MM/LLLL}.
QUALITATIVE AND QUANTITATIVE COMPOSITION To be completed nationally
KAKOVOSTNA IN KOLIČINSKA SESTAVA
The majority of undesirable effects are the consequence of the vasodilator effects of nicardipine.
Večina neželenih učinkov je posledica vazodilatornega učinka nikardipina.
Its action is produced mainly on arterial smooth muscle.
Deluje predvsem na gladke mišice arterij.
The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump.
Hitrost dajanja zdravila mora biti natančno nadzorovana z uporabo elektronske infuzijske črpalke ali volumetrične črpalke.
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.
O neželenih učinkih, naštetih spodaj, so poročali v kliničnih študijah in/ali v obdobju trženja in temeljijo na podatkih kliničnih preskušanj, ter so klasificirani v skladu z MedDRA klasifikacijo po organskih sistemih.
Within 8 days after myocardial infarction
V osmih dneh po miokardnem infarktu.
• Severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contraindicated
• hude preeklampsije, če drugi intravenski antihipertenzivi niso priporočljivi ali so kontraindicirani.
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.
Vzdrževalni odmerek: Ko je dosežen ciljni krvni tlak, je treba odmerek postopoma zmanjšati, običajno na 2-4 mg/h, da se ohrani učinkovitost zdravila.
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.
Nikardipina se ne sme uporabljati pri mnogoplodnih nosečnostih ali pri nosečnicah z oslabelim srčno-žilnim stanjem, razen če ni nobene druge sprejemljive alternative.
Rates can be increased by increments of 0.5 or 1 mg every 15 minutes.
Hitrost je mogoče zvečati za 0,5 ali 1 mg vsakih 15 minut.
At very low concentrations it inhibits the influx of calcium into the cell.
Pri zelo nizkih koncentracijah zavira vstop kalcija v celice .
Compensatory hypertension, i.e. in case of an arteriovenous shunt or aortic coarctation
Kompenzatorna hipertenzija, tj. v primeru arteriovenskega spoja ali koarktacije aorte.
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.
Zaradi tveganja hude hipotenzije pri materi in potencialno smrtno nevarne hipoksije ploda mora biti znižanje krvnega tlaka postopno in vedno skrbno nadzorovano.
If either occurs with nicardipine, consider decreasing the dose by half or stopping the infusion.
Če se zaradi nikardipina pojavi eno ali drugo, razmislite o zmanjšanju odmerka za polovico ali zaustavitvi infuzije.
It has been reported in animal experiments that the drug is excreted into breast milk.
Pri raziskavah na živalih so ugotovili, da se zdravilo izloča v materino mleko.
Precautions for use
NAVODILO ZA UPORABO
The combination of a calcium channel inhibitor and dantrolene is therefore potentially dangerous.
Kombinacija zaviralca kalcijevih kanalčkov in dantrolena je zato potencialno nevarna.
Pharmacotherapeutic class: selective calcium inhibitors with vascular effects, ATC code: C08CA04
Farmakoterapevtska skupina: selektivni zaviralci kalcijevih kanalčkov z delovanjem na žile, oznaka ATC: C08CA04
There were no significant differences in the principal pharmacokinetic parameters between severe renal dysfunction and normal renal function (see section 4.4)
Pri glavnih farmakokinetičnih parametrih ni bilo občutnih razlik med hudo okvaro delovanja ledvic in normalnim delovanjem ledvic (glejte poglavje 4.4)
Nicardipine is metabolized by cytochrome P450 3A4.
Nikardipin se presnavlja preko citokroma P450 3A4.
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.
Če boste imeli operacijo, bo vaš anesteziolog moral vedeti, katera druga zdravila jemljete, saj nekatera lahko vplivajo na delovanje zdravila Nikardipin raztopina za injiciranje.
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.
Po sočasni uporabi radioaktivnega intravenskega odmerka nikardipina skupaj s 30 mg peroralnim odmerkom vsakih 8 ur, so v 96 urah 49 % radioaktivnosti izmerili v urinu in 43 % v blatu.
Infusion site reactions can occur, particularly with prolonged duration of administration and in peripheral veins.
Do reakcije na mestu infundiranja lahko pride zlasti v primerih daljše uporabe in v perifernih venah.
• Malignant arterial hypertension/Hypertensive encephalopathy
• maligne arterijske hipertenzije/hipertenzivne encefalopatije,
Blood levels should be monitored and dosage of immunosuppressant and/or nicardipine should be reduced, if required.
Treba je spremljati krvne parametre in po potrebi zmanjšati odmerek imunosupresiva in/ali nikardipina.
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
Bolusna ali intravenska aplikacija, ki ni nadzorovana z uporabo elektronske infuzijske črpalke ali volumetrične črpalke, ni priporočljiva in lahko poveča tveganje za nastanek resne hipotenzije, zlasti pri starejših, otrocih in bolnikih z ledvično ali jetrno okvaro, ter nosečnicah.
Renal vascular resistance is decreased.
Ledvični žilni upor se zmanjša.
In animal studies, administration of verapamil and intravenous dantrolene has caused fatal ventricular fibrillation.
V študijah na živalih je dajanje verapamila in intravenskega dantrolena povzročila smrtno ventrikularno fibrilacijo.
Nicardipine should only be administered by specialists in well controlled environments, such as hospitals and intensive care units, with continuous monitoring of blood pressure.
Nikardipin lahko daje le zdravnik specialist v dobro nadzorovanih okoljih, kot so bolnišnice in oddelki za intenzivno nego, s stalnim nadzorom krvnega tlaka.
Headache is the most common side effect, and may affect more than 1 in 10 people.
Najpogostejši neželeni učinek je glavobol, ki se pojavi pri več kot 1 od 10 bolnikov.
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.
Med zdravljenjem vam bodo merili krvni tlak in prilagajali odmerek, da se vaš krvni tlak zagotovo zniža na normalno raven.
Nicardipine solution for injection is used to treat very severe high blood pressure.
Nikardipin raztopina za injiciranje se uporablja za zdravljenje zelo visokega krvnega tlaka.
Intravenous nicardipine [or invented name] is indicated for the treatment of acute life-threatening hypertension, particularly in the event of:
Nikardipin [ali izmišljeno ime] je v intravenski obliki indiciran za zdravljenje akutne življenjsko nevarne hipertenzije, zlasti v primeru:
There is insufficient information on the effects of nicardipine in newborns/infants.
O učinkih nikardipina na novorojenčke/dojenčke ni na voljo dovolj podatkov.
The safety and efficacy in low birth weight infants, newborns, nursing infants, infants, and children has not been established.
Varnost in učinkovitost zdravila pri dojenčkih z majhno porodno maso, novorojenčkih, dojenčkih, ki jih matere dojijo, drugih dojenčkih in otrocih še nista bili dokazani.
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.
Uporaba antihipertenzivov ni priporočena pri bolnikih, ki so doživeli ishemično kap, razen če akutna hipertenzija onemogoča primerno zdravljenje (npr. trombolizo) ali če obstaja poškodba drugega končnega organa, ki je kratkoročno življenjsko nevarna.
Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia.
Hitro farmakološko znižanje krvnega tlaka lahko povzroči sistemsko hipotenzijo in refleksno tahikardijo.
Severe aortic stenosis
Huda aortna stenoza.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: [to be completed nationally]
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom: [izpolni se individualno]
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)
Varnost in učinkovitost intravenske oblike nikardipina pri dojenčkih in otrocih še nista bili preskušeni v nadzorovanih kliničnih študijah, zato je pri tej populaciji potrebna posebna pozornost (glejte poglavje
Nicardipine should not be used during breastfeeding.
Nikardipina se med dojenjem ne sme uporabljati.
Known hypersensitivity to nicardipine or to any of the excipients listed in section 6.1
Preobčutljivost na nikardipin ali katero koli pomožno snov, navedeno v poglavju 6.1.
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.
Uporaba nikardipina pri hudi preeklampsiji v času tretjega trimesečja nosečnosti lahko morda povzroči neželeni tokolitični učinek, ki bi morda lahko vplival na spontano sprožitev poroda.
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).
Farmakokinetiko intravenskega dajanja nikardipina so preučevali pri osebah s hudo okvaro delovanja ledvic, ki so potrebovali dializo (očistek kreatinina < 10 ml/min), z blago/zmerno okvaro delovanja ledvic (očistek kreatinina 10-50 ml/min) in z normalnim delovanjem ledvic (očistek kreatinina > 50 ml/min).
Major hypotension can be treated by intravenous infusion of any plasma volume expander and supine position with the legs elevated.
Hudo hipotenzijo se lahko zdravi z intravensko infuzijo katerega koli zvečevalca volumna plazme in s položajem leže na hrbtu z dvignjenimi nogami.
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.
Študije z enim odmerkom ali tridnevnim dajanjem treh odmerkov na dan so, po peroralnemi ali intravenskem dajanju, pri ljudeh v urinu pokazale manj kot 0,03 % nespremenjenega nikardipina.
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.
V stanju dinamičnega ravnovesja sta bila Cmax in AUC občutno višja in očistek občutno nižji pri osebah z blago/zmerno okvaro delovanja ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
Maintenance dose: The maintenance dosage of 1 to 4 mcg/kg/min is recommended.
Vzdrževalni odmerek: priporočen je vzdrževalni odmerek 1-4 mikrograme/kg/min.
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.
Namesto infuzije je mogoče uporabiti 20 mg peroralne kapsule nikardipina v odmerku 60 mg/dan v treh dnevnih odmerkih ali 50 mg tablete s podaljšanim sproščanjem v odmerku 100 mg/dan v dveh dnevnih odmerkih.
Elderly patients may be more sensitive to nicardipine effects because of impaired renal and/or hepatic function.
Starejši bolniki so lahko občutljivejši na učinke nikardipina zaradi okvarjene ledvične in/ali jetrne funkcije.
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.
Najbolj zastopan presnovek v humanem urinu je glukuronid hidroksilne oblike, ki nastane z oksidativno cepitvijo N-metilbenzilnega dela in oksidacijo piridinskega obroča.
Initial dose: Treatment should start with the continuous administration of nicardipine at a rate of 3-5 mg/h for 15 minutes.
Začetni odmerek: Zdravljenje je treba začeti z neprekinjenim 15-minutnim dajanjem nikardipina s hitrostjo 3-5 mg/h.
Nicardipine should be administered by continuous intravenous infusion only.
Nikardipin se lahko daje le z neprekinjeno intravensko infuzijo.
Not known - phlebitis
Neznano - flebitis
Do not drink grapefruit juice or eat grapefruit whilst taking this medication as it may increase the blood levels of nicardipine
Če jemljete to zdravilo, ne pijte soka grenivke in ne jejte grenivk, saj to lahko zviša koncentracijo nikardipina v krvi.
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.
Profil izločanja zdravila po intravenskem odmerku je sestavljen iz treh faz z ustreznim razpolovnim časom: alfa 6,4 minute, beta 1,5 ure, gama 7,9 ur.
Combination with beta-blockers
Kombinacija z zaviralci adrenergičnih receptorjev beta
Therefore, it is recommended to use the same dose regimens as for elderly patients in patients with renal impairment.
Zato so pri bolnikih z okvaro ledvic priporočeni enaki odmerni režimi kot pri starejših bolnikih.
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.
Pri uporabi nikardipina na omejenem številu nosečnosti v prvih dveh trimesečjih, se do danes v klinični praksi niso pokazale kakršne koli malformacije ali posebej toksični učinki na plod.
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.
Uporaba centralnega venskega katetra ali razredčevanje raztopine lahko zmanjša tveganje za reakcijo na mestu infundiranja.
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.
V primeru, da je bil v času nosečnosti nikardipin uporabljen kot tokolitik, so opazili akutni pljučni edem (glejte poglavje 4.8), zlasti v primerih mnogoplodne nosečnosti (dvojčka ali več), ob intravenski poti uporabe in/ali s sočasno uporabo agonistov adrenergičnih receptorjev beta-2.
The antihypertensive effect will depend on the administered dose.
Antihipertenzivni učinek je odvisen od danega odmerka.
Nicardipine solution for injection will be given to you by a doctor, who will ensure that the correct dose is given for your condition.
Zdravilo Nikardipin raztopina za injiciranje vam bo injiciral zdravnik, ki bo zagotovil, da prejmete pravilen odmerek za vaše stanje.
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.
Pri ljudeh se vazodilatorno delovanje pojavi tako pri aplikaciji akutnega odmerka kot pri kronični aplikaciji v velikih in malih arterijah, kar zviša krvni pretok in izboljša arterijsko komplianco.
If any of the above apply to you, or you are not sure, tell your doctor before receiving Nicardipine solution for injection
Če menite, da se kaj od zgoraj navedenega nanaša na vas ali niste prepričani, se pred uporabo zdravila Nikardipin raztopina za injiciranje pogovorite s svojim zdravnikom.