FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 301 (n = 220) was of longer duration (21 days), involved more cautious up-titration and lower doses of IT ziconotide, and enrolled the most refractory population of patients studied in the three studies.
Croatian: Ispitivanje 301 (n = 220) trajalo je dulje (21 dan), uključivalo je oprezniju titraciju prema višim dozama te niže doze intratekalnog zikonotida i uključivalo je populaciju bolesnika u koje se najteže postizao odgovor (refraktorna) u sva tri ispitivanja.
English: Cognitive and neuropsychiatric adverse reactions
Croatian: Kognitivne i neuropsihijatrijske nuspojave
English: Prialt contains the active substance ziconotide which belongs to a group of medicines, called analgesics or ‘painkillers'.
Croatian: Prialt sadržava djelatnu tvar zikonotid koja pripada skupini lijekova zvanih analgetici ili sredstva protiv bolova.
English: Before giving you Prialt, your doctor might decide to slowly stop giving you opiates (other types of medicinal product which are used to treat pain) into your spinal cord and instead replace with alternative pain medicinal products.
Croatian: Prije nego što počne primjenjivati Prialt, liječnik može odlučiti da Vam polako ukida primjenu opioida (druga vrsta lijekova koji služe za liječenje bola) u kralježničnu moždinu te da ih zamijeni drugim lijekovima protiv bolova.
English: Upon reaching the systemic circulation, ziconotide appears to be more extensively distributed, based on a plasma distribution volume of approximately 30 l and is only about 53% bound (non-specifically) to human plasma proteins.
Croatian: Kada uđe u sistemsku cirkulaciju, zikonotid se izgleda intenzivnije raspodijeli, plazmatski volumen distribucije iznosi približno 30 l i u ljudi se samo oko 53% veže (nespecifično) na proteine plazme.
English: If after starting Prialt you experience a worsening of your depression or have any other symptoms affecting your mood, please inform your healthcare professional.
Croatian: U slučaju da nakon što se počeli primati Prialt osjetite pogoršanje depresije ili imate neke druge simptome koji utječu na Vaše raspoloženje, molimo Vas da o tome obavijestite zdravstvenog djelatnika.
English: Bolus administration studies suggest that bolus dosing may be useful in identifying patients who may benefit from long term use of ziconotide, however, may result in more adverse reactions than administration by continuous infusion.
Croatian: Ispitivanja primjene bolusa pokazuju da doze u obliku bolusa mogu biti od pomoći kako bi se otkrili bolesnici koji mogu imati koristi od dugoročne primjene zikonotida, ali takva primjena može za posljedicu imati više nuspojava nego primjena kontinuiranom infuzijom.
English: Chronic animal studies have not been performed to assess the carcinogenic potential of ziconotide.
Croatian: Nisu provedena ispitivanja kronične toksičnosti na životinjama kako bi se procijenio karcinogeni potencijal zikonotida.
English: Ziconotide may cause or worsen depression with the risk of suicide in susceptible patients.
Croatian: Zikonotid može uzrokovati ili pogoršati depresiju s rizikom od samoubojstva u podložnih bolesnika.
English: Fluid matrix
Croatian: Put primjene Tekući matriks
English: As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods (see section 4.4).
Croatian: Budući da je rizik od meningitisa kao posljedice produljene kateterizacije intratekalnog prostora veći uz vanjski kateterski infuzijski sustav, za dulja razdoblja primjene zikonotida preporučuju se unutarnji sustavi (vidjeti dio 4.4).
English: If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse reactions.
Croatian: Ako je potrebno, dozu se može smanjiti za bilo koju količinu (uključujući zaustavljanje infuzije) radi kontrole nuspojava.
English: From a microbiological point of view, if the product is diluted it should be transferred to the infusion pump immediately.
Croatian: S mikrobiološkog stajališta, ako je lijek razrijeđen, treba ga odmah prebaciti u infuzijsku pumpu.
English: Prialt is given as a very slow continuous injection into the space surrounding the spinal cord (intrathecal use).
Croatian: Prialt se primjenjuje kao vrlo sporo neprekinuto ubrizgavanje u prostor oko kralježnične moždine (intratekalna primjena).
English: • Meningitis (may affect up to 1 in 100 people) - is inflammation of the coverings of the brain and spinal cord usually caused by an infection.
Croatian: • Meningitis (može se javiti u do 1 na 100 osoba) - upala ovojnica koje obavijaju mozak i kralježničnu moždinu obično prouzročena infekcijom.
English: An increased incidence of somnolence has been observed when ziconotide is administered concomitantly with systemic baclofen, clonidine, bupivacaine or propofol thus for the time being their simultaneous use is discouraged.
Croatian: Povećana incidencija somnolencije opažena je kada se zikonotid primjenjivao zajedno sa sistemskim baklofenom, klonidinom, bupivakainom ili propofolom pa se stoga u ovom trenutku ne podržava njihova istodobna primjena.
English: Changes in neurological signalling have not been studied in experimental animals.
Croatian: Promjene u neurološkoj signalizaciji u pokusnih životinja nisu ispitivane.
English: Most patients under observation recovered within 24 hours of withdrawal of the medicinal product.
Croatian: Većina bolesnika koji su promatrani oporavila se unutar 24 sata nakon prekida primjene lijeka.
English: The addition of IT morphine to stable doses of IT ziconotide is better tolerated (pruritis has been reported) (see section 5.1).
Croatian: Dodavanje intratekalnog morfina stabilnim dozama intratekalnog zikonotida bolje se podnosi (prijavljen je pruritus) (vidjeti dio 5.1).
English: In one clinical study a male cancer patient received an accidental IT ziconotide overdose of 744 μg over a 24-hour period (31 μg/hour) and resumed treatment at the intended dose after experiencing a reduction in Visual Analog Scale of Pain Intensity (VASPI) from 82 to 2.5 mm.
Croatian: U jednom kliničkom ispitivanju, muškarac koji je bolovao od karcinoma primio je slučajno prekomjernu intratekalnu dozu zikonotida od 744 μg tijekom 24 sata (31 μg/sat) a zatim je nastavio liječenje svojom određenom dozom nakon što je na vizualno analognoj ljestvici za mjerenje intenziteta bola (Visual Analog Scale of Pain Intensity, VASPI) zabilježeno smanjenje od 82 na 2,5 mm.
English: The re-introduction of ziconotide is not recommended in these patients.
Croatian: U tih se bolesnika ne preporučuje ponovno uvođenje zikonotida.
English: Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into the space around the spinal cord, and in the use of internal and external infusion pumps.
Croatian: Vaše liječenje Prialtom provodit će liječnik s iskustvom u davanju lijekova u prostor oko kralježnične moždine te u primjeni unutarnjih i vanjskih infuzijskih pumpi.
English: Prialt is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Prialt se ne preporučuje tijekom trudnoće niti u žena koje mogu rađati a ne koriste kontracepciju.
English: Ziconotide is a synthetic analogue of a ω-conopeptide, MVIIA, found in the venom of the Conus magus marine snail.
Croatian: Zikonotid je sintetički analog ω-konopeptida, MVIIA nađenog u otrovu morskog puža Conus magus.
English: The ziconotide dose should be reduced or discontinued if signs or symptoms of cognitive impairment or neuropsychiatric adverse reactions develop, but other contributing causes should also be considered.
Croatian: Dozu zikonotida treba smanjiti ili obustaviti ako se razviju znakovi ili simptomi kognitivnog oštećenja ili neuropsihijatrijske nuspojave, ali je potrebno uzeti u obzir i druge uzroke koji mogu pridonijeti njihovoj pojavi.
English: - If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness, confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis.
Croatian: - Ako imate neki od sljedećih simptoma: visoka temperatura, glavobolja, ukočen vrat, umor, smetenost, osjećaj mučnine, povraćanje ili povremeni napadaji, to mogu biti znakovi meningitisa.
English: Based on very limited clinical investigations, both angiotensin converting enzyme inhibitors (e.g., benazepril, lisinopril and moexipril) and HIV protease inhibitors (e.g., ritonavir, saquinavir, indinavir), have no readily apparent effect on plasma ziconotide exposure.
Croatian: Na temelju ograničenih kliničkih istraživanja, i inhibitori angiontenzin konvertirajućeg enzima (npr. benazepril, lizinopril i moeksipril) i inhibitori proteaza HIV-a (npr. ritonavir, sakvinavir, indinavir), nemaju očigledan učinak na razinu zikonotida u plazmi.
English: The generated free amino acids are expected to be taken up by cellular carrier systems and either subjected to normal intermediary metabolism or used as substrates for constitutive biosynthetic processes.
Croatian: Očekuje se da će tako nastale slobodne aminokiseline preuzeti stanični prijenosni sustavi te da će postati ili dio normalnog intermedijarnog metabolizma ili supstrati konstitutivnih biosintetskih procesa.
English: Medicinal products that affect specific peptidases/proteases would not be expected to impact upon ziconotide plasma exposure.
Croatian: Ne očekuje se da bi lijekovi koji utječu na specifične peptidaze/proteaze utjecali na koncentraciju zikonotida u plazmi.
English: Progressive elevation of the creatine kinase is uncommon.
Croatian: Progresivno povišenje kreatin kinaze nije često.
English: Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; < 0.04 ng/ml).
Croatian: Plazmatske koncentracije nakon neprekinute (≥ 48 h) intratekalne infuzije (≤ 21,6 μg/dan) čini se da su relativno niske i u pravilu se ne mogu detektirati (tj. oko 80% uzoraka plazme uzetih od bolesnika s bolovima ne sadrže mjerljivu količinu lijeka; < 0,04 ng/ml).
English: Metabolism and nutrition disorders appetite decreased, anorexia
Croatian: Poremećaji metabolizma i prehrane smanjeni apetit, anoreksija
English: Clinical studies 201 and 202 indicate that the combination of IT ziconotide and IT morphine may effectively reduce pain and decrease systemic opioid use over a sustained period of time for patients whose pain was inadequately controlled with their maximum tolerated dose of IT ziconotide (median 8.7 μg/day, mean 25.7 μg/day - study 201) or with IT morphine (study 202) alone.
Croatian: Klinička ispitivanja 201 i 202 pokazuju da kombinacija intratekalnog zikonotida i intratekalnog morfina može učinkovito smanjiti bol te tijekom kontinuiranog razdoblja smanjiti sistemsku primjenu opioida u bolesnika u kojih bol nije bila odgovarajuće kontrolirana primjenom maksimalno podnošljive doze samo intratekalnog zikonotida (medijan 8,7 μg/dan, srednja vrijednost 25,7 μg/dan - ispitivanje 201) ili intratekalnog morfina (ispitivanje 202).
English: Low plasma exposure occurs during IT infusion due to the low recommended IT infusion rates and relatively rapid plasma clearance (see section 5.2).
Croatian: Niska izloženost plazme događa se tijekom intratekalne infuzije zbog malih preporučenih brzina intratekalne infuzije a relativno brzog klirensa plazme (vidjeti dio 5.2).
English: Hypersensitivity reactions, including anaphylaxis, have not been observed during clinical trials and the immunogenicity of ziconotide administered by the IT route appears to be low.
Croatian: Reakcije preosjetljivosti, uključujući anafilaksiju, nisu opažene tijekom kliničkih ispitivanja i čini se da je imunogeničnost zikonotida primijenjenog intratekalno mala.
English: Vomiting and anorexia, and peripheral oedema were also observed when IT ziconotide was added to IT morphine.
Croatian: Povraćanje i anoreksija te periferni edem također su opaženi kad se intratekalni zikonotid dodavao intratekalnom morfinu.
English: Efficacy results from study 301
Croatian: Rezultati djelotvornosti u ispitivanju 301
English: It is unlikely that the degradation products of ziconotide will have significant biological activity, as peptides consisting of the individual peptide loop structures have been found to have binding affinities for N-type voltage sensitive calcium channels that are several orders of magnitude lower than that of the parent (ziconotide) compound.
Croatian: Nije vjerojatno da će razgradni produkti zikonotida imati značajno biološko djelovanje, jer je nađeno da peptidi sastavljeni od pojedinačnih struktura peptidne petlje imaju nekoliko puta manji afinitet vezanja za kalcijeve kanale osjetljive na napon N-tipa nego osnovni spoj (zikonotid).
English: - If you observe any signs of infection around the tube, such as skin redness, swelling, pain or discharge, you must tell your doctor immediately and seek treatment for the infection.
Croatian: - Opazite li znakove infekcije oko cjevčice, kao što je crvenilo kože, oticanje, bol ili iscjedak, obratite se odmah liječniku i zatražite liječenje infekcije.
English: Chemical and physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the pump has not previously been exposed to the medicinal product.
Croatian: Kemijska i fizikalna stabilnost u primjeni u trajanju od 14 dana pri temperaturi od 37°C dokazana je u pumpi Synchromed kada pumpa prethodno nije bila izložena lijeku.
English: Most adverse reactions were mild to moderate in severity and resolved over time.
Croatian: Većina nuspojava bile su blagog do umjerenog intenziteta i s vremenom su nestale.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza "Rok valjanosti" / "EXP".
English: However, low plasma ziconotide concentrations, metabolism by ubiquitous peptidases and relatively low plasma protein binding (see section 5.2) make metabolic-based interactions or plasma protein displacement type interactions between ziconotide and other medicinal products unlikely.
Croatian: Međutim, zbog niskih koncentracija zikonotida u plazmi, metabolizma preko ubikvitarnih peptidaza i relativno niskog vezanja na proteine plazme (vidjeti dio 5.2), interakcije na temelju metabolizma ili interakcije u obliku izmještanja s proteina plazme nisu vjerojatne između zikonotida i drugih lijekova.
English: The concentration of Prialt in a naïve pump may be reduced due to adsorption onto the surfaces of the device, and/or dilution by the residual space of the device.
Croatian: Koncentracija Prialta u pumpi koja prije nije bila upotrijebljena može se smanjiti zbog adsorpcije na površinama uređaja i/ili razrjeđenja u preostalom prostoru uređaja.
English: Dosing of ziconotide should be initiated at 2.4 μg/day and titrated on an individual patient basis according to the patient's analgesic response and adverse reactions.
Croatian: Doziranje zikonotida treba započeti dozom od 2,4 μg/dan i zatim titracijom prilagoditi svakom pojedinom bolesniku prema njegovom analgetičkom odgovoru i nuspojavama.
English: If you are experiencing depression or have a history of depression please inform your healthcare professional before you are commenced on Prialt.
Croatian: Ako imate depresiju ili ste je imali u prošlosti, molimo Vas da o tome obavijestite zdravstvenog djelatnika prije nego što počnete primati Prialt.
English: IT and intravenous pharmacokinetics data are summarised below.
Croatian: Podaci intratekalne i intravenske farmakokinetike sažeto su prikazani u nastavku.
English: Prialt is supplied as a clear, colourless solution in single use vials.
Croatian: Prialt se isporučuje kao bistra, bezbojna otopina u bočicama za jednokratnu uporabu.
English: The aetiologies of pain in studies 95-001 (malignant pain) and 96-002 (non-malignant pain) were varied and included bone pain (n = 38) mostly due to bone metastases (n = 34), myelopathy (n = 38), half of whom had spinal cord injury with paralysis (n = 19), neuropathy (n = 79), radiculopathy (n = 24), spinal pain (n = 91) mostly due to failed back surgery (n = 82), and other aetiologies (n = 82).
Croatian: Etiologije bola u ispitivanju 95-001 (maligna bol) i 96-002 (nemaligna bol) bile su različite i uključivale su bol kostiju (n = 38) uglavnom zbog metastaza u kostima (n = 34), mijelopatiju (n = 38), od čega je pola bolesnika imalo ozljedu kralježnične moždine s paralizom (n = 19), neuropatiju (n = 79), radikulopatiju (n = 24), spinalnu bol (n = 91) većinom zbog neuspjelog kirurškog zahvata (n = 82) i bol druge etiologije (n = 82).
English: Following one-hour IT administration (1 - 10 μg), both cumulative exposure (AUC; range: 83.6608 ng/h/ml) and peak exposure (Cmax; range: 16.4 - 132 ng/ml) values were variable and dose-dependent, but appeared only approximately dose-proportional.
Croatian: Nakon intratekalne primjene (1 - 10 μg) u trajanju od jednog sata, kumulativna izloženost (AUC; raspon: 83,6 - 608 ng/h/ml) i najviša izloženost (Cmax; raspon: 16,4 - 132 ng/ml) imale su vrijednosti promjenjive i ovisne o dozi, ali činile su se samo približno proporcionalne dozi.
English: The duration of treatment has ranged from one-hour bolus infusion to continuous use for more than 6 years.
Croatian: Trajanje liječenja bilo je u rasponu od jednosatne infuzije u obliku bolusa do neprekinute primjene tijekom više od 6 godina.
English: The most common adverse reactions reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%), headache (12%), asthenia (13%), vomiting (11%), and somnolence (10%).
Croatian: Najčešće prijavljene nuspojave iz dugotrajnih kliničkih ispitivanja bile su omaglica (42%), mučnina (30%), nistagmus (23%), stanje smetenosti (25%), poremećen hod (16%), oštećenje pamćenja (13%), zamagljen vid (14%), glavobolja (12%), astenija (13%), povraćanje (11%) i somnolencija (10%).
English: Median ziconotide CSF volume of distribution (Vd: 99 ml) is between the spinal cord CSF volume (approximately 75 ml) and total CSF volume (approximately 130 ml).
Croatian: Medijan distribucije u volumenu cerebrospinalne tekućine za zikonotid (Vd: 99 ml) nalazi se između volumena cerebrospinalne tekućine u kralježničnoj moždini (približno 75 ml) i ukupnog volumena cerebrospinalne tekućine (približno 130 ml).
English: In subchronic continuous intrathecal infusion studies in rats and dogs, behavioural effects were seen at doses ≥ 8-fold the maximum recommended clinical intrathecal infusion dose of 21.6 μg/day (on a mg/kg basis).
Croatian: U ispitivanjima neprekinute intratekalne infuzije srednjeg trajanja u štakora i pasa, učinci na ponašanje opaženi su pri dozama ≥ 8 puta od najviše preporučene doze kliničke intratekalne infuzije od 21,6 μg/dan (na temelju mg/kg).
English: The maximum intended intrathecal dose of ziconotide in clinical trials was 912 μg/day following upward titration over 7 days.
Croatian: U kliničkim ispitivanjima maksimalna namjeravana intratekalna doza zikonotida bila je 912 μg/dan, nakon titracije prema višim vrijednostima u trajanju od 7 dana.
English: Elevations in creatine kinase
Croatian: Povišenje kreatin kinaze
English: Patients and physicians must be vigilant for typical symptoms and signs of meningitis.
Croatian: Bolesnici i liječnici moraju pozorno pratiti moguću pojavu simptoma i znakova meningitisa.
English: - In patients that suffer from severe long term pain, there is a higher likelihood of suicide and attempted suicide than in the general population.
Croatian: - U bolesnika koji trpe dugotrajnu bol postoji veća vjerojatnost za samoubojstvo i pokušaj samoubojstva nego u općoj populaciji.
English: In the event of progressive elevation, or clinically significant elevation in association with clinical features of myopathy or rhabdomyolysis, discontinuation of ziconotide should be considered.
Croatian: U slučaju progresivnog povišenja ili klinički značajnog povišenja povezanog s kliničkom slikom miopatije ili rabdomiolize, potrebno je razmotriti prekid primjene zikonotida.
English: Each vial contains 1, 2 or 5 ml solution for infusion.
Croatian: Jedna bočica sadrži 1, 2 ili 5 ml otopine za infuziju.
English: No adverse effects on female reproduction and post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
Croatian: U štakora nisu opaženi učinci na reprodukciju u ženki i postnatalni razvoj pri sistemskoj izloženosti do 2300 puta većoj od izloženosti pri najvećoj preporučenoj intratekalnoj dozi u ljudi.
English: It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide.
Croatian: Preporučuje se neuropsihijatrijska procjena bolesnika prije i poslije početka primjene intratekalnog zikonotida.
English: NCCs regulate neurotransmitter release in specific neuronal populations responsible for the spinal processing of pain.
Croatian: Blokatori kalcijevih kanala N-tipa reguliraju otpuštanje neurotransmitera u specifičnoj populaciji neurona odgovornih za spinalni prijenos boli.
English: Although only limited data are available, there is no obvious effect of race, height, weight, gender or age on CSF ziconotide exposure after IT administration.
Croatian: Iako su dostupni tek ograničeni podaci, pri intratekalnoj primjeni nije opažen utjecaj rase, visine, težine, spola ili dobi na koncentraciju zikonotida u cerebrospinalnoj tekućini.
English: The majority had spinal pain (n = 134), especially failed back surgery (n = 110); a lower proportion had neuropathy (n = 36).
Croatian: Većina ih je imala bol u kralježnici (n = 134), a osobito oni s neuspjelim kirurškim zahvatom kralježnice (n = 110); manji je broj imao neuropatiju (n=36).
English: Clinical efficacy and safety There were three placebo-controlled clinical trials of IT ziconotide.
Croatian: Klinička djelotvornost i sigurnost Provedena su tri placebom kontrolirana ispitivanja s intratekalnim zikonotidom.
English: Monitoring of creatine phosphokinase is recommended.
Croatian: Preporučuje se praćenje kreatin fosfokinaze.
English: In patients with severe chronic pain there is a higher incidence of suicide and suicide attempts than in the general population.
Croatian: U bolesnika s teškom kroničnom boli veća je incidencija samoubojstva i pokušaja samoubojstva nego u općoj populaciji.
English: Due to the wide distribution of these peptidases it is not expected that hepatic or renal impairment would affect the systemic clearance of ziconotide.
Croatian: Zbog velike raspodjele tih peptidaza ne očekuje se da će oštećenje jetre ili bubrega utjecati na sistemski klirens zikonotida.
English: In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to 70,000 μg/day or 3,200 times the maximum recommended daily intrathecal infusion dose.
Croatian: U ispitivanjima intravenske infuzije, zdravi muški dobrovoljci primili su zikonotid u dozama do 70 000 μg/dan ili 3200 puta većim od najviše preporučene dnevne doze intratekalne infuzije.
English: Intrathecal use.
Croatian: Intratekalna primjena.
English: The use of Prialt has been reported to cause confusion and drowsiness.
Croatian: Prijavljeno je da primjena lijeka Prialt uzrokuje smetenost i pospanost.
English: Two short-term studies, 95-001 (malignant pain) and 96-002 (non malignant pain), involving 366 patients, demonstrated the efficacy of IT ziconotide in severe chronic pain using the percent change in Visual Analog Scale of Pain Intensity (VASPI) as the primary efficacy measure.
Croatian: U dva kratkotrajna ispitivanja, 95-001 (maligna bol) i 96-002 (nemaligna bol) provedena na 366 bolesnika, dokazana je djelotvornost intratekalnog zikonotida u slučaju teške kronične boli na temelju postotka promjene na vizualno analognoj ljestvici za mjerenje intenziteta bola (Visual Analog Scale of Pain Intensity, VASPI) kao primarne mjere djelotvornosti.