FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose at end of titration (μg/hr)
Croatian: Doza na kraju titracije (μg/h)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2005
Croatian: Datum prvog odobrenja: 21. veljače 2005.
English: Only five had malignant pain.
Croatian: U samo pet bolesnika bol je bila maligna.
English: This is because almost all of the filtered active substance is rapidly endocytosed and ultimately transported back to the systemic circulation.
Croatian: To je zbog toga što gotovo sva filtrirana djelatna tvar prolazi brzu endocitozu i konačno se prenosi natrag u sistemsku cirkulaciju.
English: - You may have an increased level of an enzyme called creatine kinase in your blood and although this does not usually cause any symptoms or problems, your doctor is likely to monitor its level.
Croatian: - Možda imate povećanu razinu enzima koji se naziva kreatin kinaza u krvi i iako to obično ne uzrokuje simptome ili tegobe, liječnik će vjerojatno pratiti razinu tog enzima.
English: 44b 17489 Greifswald Germany
Croatian: 44b 17489 Greifswald Njemačka
English: What you need to know before you are given Prialt
Croatian: Što morate znati prije nego počnete primati Prialt
English: Prialt may also cause or worsen depression in people that are already susceptible.
Croatian: Prialt može također prouzročiti ili pogoršati depresiju u osoba koje su već otprije osjetljive.
English: Efficacy results from study 96-002
Croatian: Rezultati djelotvornosti u ispitivanju 96-002
English: Ziconotide does not interact with opiate receptors.
Croatian: Zikonotid ne ulazi u interakciju s opioidnim receptorima.
English: These studies suggest that these alternative methods of administration of ziconotide may be possible however, due to the limited numbers of patients, these results are inconclusive and there is currently insufficient evidence available to make definitive recommendations for such alternative dosing regimens.
Croatian: Ta ispitivanja pokazuju da te druge metode primjena zikonotida jesu moguće, međutim, zbog ograničenog broja bolesnika ti rezultati nisu uvjerljivi i zasad nema dovoljno dokaza za konačnu preporuku o primjeni takvih alternativnih režima doziranja.
English: Infections and infestations sepsis, meningitis
Croatian: Infekcije i infestacije sepsa, meningitis
English: During a convulsion, the person's muscles contract and relax repeatedly and the person may lose consciousness.
Croatian: Za vrijeme konvulzije, mišići osobe se ponavljano stežu i opuštaju pa je mogući gubitak svijesti.
English: These effects were defined by exaggerated pharmacological actions of ziconotide and not by neurotoxic lesions or target organ toxicity.
Croatian: Ti su učinci bili definirani pretjeranim farmakološkim djelovanjem zikonotida, a ne neurotoksičnim lezijama ili toksičnošću ciljnog organa.
English: However, maximal effects may be delayed for approximately 24 hours in some patients.
Croatian: Međutim, u nekih bolesnika maksimalni učinci mogu biti odgođeni približno 24 sata.
English: The minimal interval between dose increases is 24 hours; the recommended interval, for safety reasons, is 48 hours or more.
Croatian: Najkraći interval između povećanja doze je 24 sata; iz sigurnosnih razloga, preporučeni interval je 48 sati ili više.
English: • Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people).
Croatian: • Pomisli na samoubojstvo ili pokušaj samoubojstva (mogu se javiti u do 1 na 100 osoba).
English: Ziconotide did not induce bacterial gene mutation and was not genotoxic.
Croatian: Zikonotid nije inducirao genske mutacije bakterija i nije bio genotoksičan.
English: However, the potential for severe allergic reactions cannot be excluded and spontaneous reports of anaphylactic reactions have been received.
Croatian: Ipak, ne može se isključiti mogućnost teških alergijskih reakcija, a zaprimljene su i spontane prijave anafilaktičkih reakcija.
English: Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics, ATC code: N02BG08
Croatian: Farmakoterapijska skupina: analgetici, drugi analgetici i antipiretici, ATK oznaka: N02BG08
English: Children and adolescents Prialt is not recommended for use in children and adolescents.
Croatian: Prialt se ne preporučuje za primjenu u djece i adolescenata.
English: Many responsive patients obtain near-maximal analgesia within a few hours of delivery of an appropriate dose.
Croatian: Mnogi bolesnici u kojih je postignut odgovor ostvare gotovo maksimalnu analgeziju u roku od nekoliko sati nakon primjene odgovarajuće doze.
English: 17493 Greifswald-Insel Riems Germany
Croatian: 17493 Greifswald-Insel Riems Njemačka
English: 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)
Croatian: Manje često (≥ 1/1000 i < 1/100) Rijetko (≥ 1/10 000 i < 1/1000) Vrlo rijetko (< 1/10 000)
English: The primary endpoint was the percent change in VASPI score.
Croatian: Primarni ishod bio je postotak promjene u rezultatu VASPI.
English: - If you notice any adverse change in your thinking, mood or memory, please tell your doctor.
Croatian: - Ako Vam se pojavi neželjena promjena u Vašem razmišljanju, raspoloženju ili pamćenju, molimo obavijestite liječnika.
English: Your doctor will adjust the dose of Prialt according to the severity of your pain by adding no more than 2.4 micrograms/day.
Croatian: Liječnik će Vam prilagoditi dozu Prialta prema jačini bola koji osjećate, dodajući ne više od 2,4 mikrograma/dan.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ziconotide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je odlučiti treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja zikonotidom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: What Prialt is and what it is used for What you need to know before you are given Prialt How to use Prialt
Croatian: Što je Prialt i za što se koristi Što morate znati prije nego počnete primati Prialt Kako primjenjivati Prialt Moguće nuspojave
English: The efficacy of IT ziconotide in study 301 was lower than in the previous two, short-term studies.
Croatian: Djelotvornost intratekalnog zikonotida bila je u ispitivanju 301 manja nego u prethodna dva kratka ispitivanja.
English: Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted (see section 5.1).
Croatian: Iako je zikonotid ispitivan u dugotrajnim, otvorenim kliničkim ispitivanjima djelotvornosti i sigurnosti, kontrolirana ispitivanja trajanja duljeg od 3 tjedna nisu provedena (vidjeti dio 5.1).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se lijek ne primijeni odmah, vrijeme čuvanja lijeka u primjeni i uvjeti prije primjene odgovornost su korisnika, i to vrijeme obično ne bi smjelo biti dulje od 24 sata pri temperaturi od 2°C do 8°C, osim kad je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: If this happens, consult your doctor or hospital immediately.
Croatian: Ako se to dogodi, odmah se posavjetujte s liječnikom ili otiđite u bolnicu.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se liječniku za savjet prije nego što primite ovaj lijek.
English: Elevations in creatine phosphokinase were usually asymptomatic.
Croatian: Povišenje kreatin fosfokinaze obično je bilo asimptomatsko.
English: Ziconotide must be administered as a continuous infusion via an intrathecal catheter, using an external or internally implanted mechanical infusion pump capable of delivering an accurate infusion volume.
Croatian: Zikonotid se mora primijeniti kao neprekinuta infuzija kroz intratekalni kateter, uporabom vanjske ili unutarnje implantirane mehaničke infuzijske pumpe koja može isporučiti točan volumen infuzije.
English: In turn, this inhibits their release of neurotransmitters (including Substance P) and therefore, the spinal signalling of pain.
Croatian: Nadalje, to inhibira njihovo otpuštanje neurotransmitera (uključujući tvar P) te na taj način kralježničnu signalizaciju bola.
English: Therefore, catheter tip placement should be carefully considered to allow adequate access to spinal nociceptive segments whilst minimising medicinal product concentrations at cerebral levels.
Croatian: Stoga je potrebno pažljivo izabrati mjesto uvođenja katetera kako bi se omogućio odgovarajući pristup nociceptivnim spinalnim segmentima uz istodobno minimalno koncentriranje lijeka na cerebralnim razinama.
English: There is no evidence of the development of pharmacological tolerance to ziconotide in patients.
Croatian: Nema dokaza o razvoju farmakološke tolerancije na zikonotid u bolesnika.
English: Given the occurrence of analgesia and adverse reactions at similar doses, the recommended interval between dose increases is 48 hours or more.
Croatian: S obzirom na pojavu analgezije i nuspojava pri sličnim dozama, preporučeni interval između povećanja doze iznosi 48 sati ili više.
English: The cognitive effects of ziconotide are typically reversible within 1 - 4 weeks after discontinuation of the medicinal product, but may persist in some cases.
Croatian: Učinci zikonotida na kognitivne sposobnosti obično se povlače unutar 1 do 4 tjedna nakon prekida primjene lijeka, ali se u nekim slučajevima mogu zadržati.
English: The patient and health-care providers must be familiar with the handling of the external or internal infusion system and be aware of the need to guard against infection.
Croatian: Bolesnik i zdravstveni djelatnici moraju biti upoznati s rukovanjem vanjskim i unutarnjim infuzijskim sustavima i moraju biti svjesni potrebe nadzora da se ne pojavi infekcija.
English: • Coma (may affect up to 1 in 100 people) - a state of unconsciousness with difficulty responding or waking up.
Croatian: • Koma (može se javiti u do 1 na 100 osoba) - stanje bez svijesti uz otežano reagiranje ili buđenje.
English: Postural hypotension was observed in almost all subjects who received high intravenous doses of ziconotide.
Croatian: Posturalna hipotenzija opažena je u gotovo svih ispitanika koji su primili visoke intravenske doze zikonotida.
English: Because of this, after the first use of Prialt, the reservoir should be emptied and refilled after 14 days.
Croatian: Zbog toga, nakon prve primjene lijeka Prialt spremnik treba isprazniti i ponovno napuniti nakon 14 dana.
English: These studies were of short duration, 5 and 6 days respectively, and used a more rapid dose escalation and higher doses than recommended in Section 4.2.
Croatian: Ta su ispitivanja trajala kratko, 5 odnosno 6 dana, i u njima su primijenjene doze povećavane brže i bile su više od onih preporučenih u dijelu 4.2.
English: However, ziconotide did not induce cell transformation in the in vitro Syrian hamster embryo (SHE) assay and did not increase cell proliferation (pre-neoplastic lesion formation) or apoptosis after subchronic intrathecal exposure in dogs.
Croatian: Međutim, zikonotid nije inducirao transformaciju stanica u testu in vitro provedenom na embriju sirijskog hrčka (SHE) i nije pospješio proliferaciju stanica (stvaranje preneoplastičnih lezija) ili apoptozu nakon subkronične intratekalne izloženosti u pasa.
English: The frequency and severity of adverse reactions were also lower.
Croatian: Učestalost i težina nuspojava također su bile manje.
English: Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤ 9.6 μg/day.
Croatian: Otprilike 75% bolesnika u kojih je odgovor na liječenje zadovoljavajući, treba dozu ≤ 9,6 μg/dan.
English: If discontinuing opiates when initiating ziconotide therapy, opiate withdrawal should be gradual.
Croatian: Ako se obustavlja primjena opioida kada se uvodi terapija zikonotidom, opioide treba ukidati postupno.
English: Cardiac disorders atrial fibrillation
Croatian: Srčani poremećaji fibrilacija atrija
English: Cognitive impairment typically appears after several weeks of treatment.
Croatian: Kognitivna oštećenja u pravilu se javljaju nakon nekoliko tjedana liječenja.
English: The event may be self limited, but ziconotide should be discontinued until the event resolves.
Croatian: Događaj može proći sam od sebe, ali primjenu zikonotida treba prekinuti dok se događaj ne povuče.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Učinci u nekliničkim ispitivanjima opaženi su samo prilikom izloženosti koje su se smatrale dovoljno višim od maksimalne ljudske izloženosti što pokazuje malo značenje za kliničku primjenu.
English: How to use Prialt
Croatian: Kako primjenjivati Prialt
English: Observations included transient and reversible neurological effects consisting of tremors, uncoordinated movements and hyper- and hypoactivity.
Croatian: Opažanja su uključivala prolazne i reverzibilne neurološke učinke kao što su tremor, nekoordinirani pokreti, hiperaktivnost i hipoaktivnost.
English: All patients in the 301 study had failed IT therapy with combinations of analgesics and their physicians considered that 97% of the patients were refractory to currently available treatments.
Croatian: U ispitivanju 301 intratekalna terapija s kombinacijama analgetika bila je neuspješna u svih bolesnika i njihovi liječnici smatrali su da je 97% bolesnika refraktorno na postojeća dostupna liječenja.
English: Efficacy results from study 95-001
Croatian: Rezultati djelotvornosti u ispitivanju 95-001
English: Combination studies with IT Morphine
Croatian: Ispitivanja kombinacije s intratekalnim morfinom
English: Elevations of creatine phosphokinase
Croatian: Povišenje kreatin fosfokinaze
English: The long-term consequences to neuronal function of continuous N-type calcium-channel block have not been demonstrated in experimental animals.
Croatian: Dugoročne posljedice kontinuiranog bloka kalcijevih kanala N-tipa na funkciju neurona nisu dokazane u pokusnih životinja.
English: Administration of medicinal products by the intrathecal route carries the risk of potential serious infections, such as meningitis, which may be life threatening.
Croatian: Primjena lijekova intratekalnim putem uključuje rizik od potencijalno ozbiljnih infekcija kao što je meningitis, koji može biti životno opasan.
English: Ziconotide has moderate influence on the ability to drive and use machines.
Croatian: Zikonotid umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.
Croatian: Zikonotid je indiciran za liječenje teške, kronične boli u odraslih kojima je potrebna intratekalna analgezija.
English: What Prialt contains - The active substance is ziconotide.
Croatian: Što Prialt sadrži - Djelatna tvar je zikonotid.
English: No accumulation of ziconotide in plasma following long-term IT administration (up to 9 months) has been observed.
Croatian: Nije opažena akumulacija zikonotida u plazmi nakon dugotrajne intratekalne primjene (do 9 mjeseci).
English: The plasma pharmacokinetics following intravenous doses (0.3 - 10 μg/kg/24 hr) were also studied.
Croatian: Ispitivana je također farmakokinetika plazme nakon primjene intravenskih doza (0,3 - 10 μg/kg/24 h).
English: In clinical trials, 88% of patients experienced adverse reactions.
Croatian: U kliničkim ispitivanjima nuspojave na primjenu lijeka imalo je 88% bolesnika.
English: • Convulsions (may affect up to 1 in 100 people) - convulsions (fits) are when a person's body shakes rapidly and uncontrollably.
Croatian: • Konvulzije (mogu se javiti u do 1 na 100 osoba) - konvulzije (napadaji) su kada se tijelo osobe brzo i nekontrolirano trese.
English: The safety of ziconotide administered as a continuous intrathecal infusion has been evaluated in more than 1,400 patients participating in acute and chronic pain clinical trials.
Croatian: Sigurnost primjene zikonotida kao neprekinute intratekalne infuzije procijenjena je u više od 1400 bolesnika koji su sudjelovali u kliničkim ispitivanjima akutne i kronične boli.
English: It is unknown whether ziconotide/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se zikonotid/metaboliti u majčino mlijeko u ljudi.
English: Ziconotide is a peptide consisting of 25 naturally-occurring amino acids of the L-configuration, and does not appear to be appreciably metabolised in the CSF.
Croatian: Zikonotid je peptid koji se sastoji od 25 prirodnih aminokiselina L-konfiguracije, i čini se da se ne metabolizira mjerljivo u cerebrospinalnoj tekućini.
English: Only a small number of patients have received systemic chemotherapy and IT ziconotide.
Croatian: Samo je mali broj bolesnika primao sistemsku kemoterapiju i intratekalni zikonotid.
English: Ziconotide was not teratogenic in rats and rabbits at exposures < 100 times human plasma levels.
Croatian: Zikonotid nije bio teratogen u štakora i kunića pri izloženosti < 100 puta većoj od plazmatskih koncentracija u čovjeka.
English: The optimal intrathecal placement of the catheter tip has not been established.
Croatian: Optimalno mjesto za intratekalno uvođenje katetera nije ustanovljeno.
English: Though statistically significant relationships and reasonable correlation between cerebrospinal fluid (CSF) exposure (AUC, Cmax) and clinical response measures have been observed following 1 hour IT administration, no well-defined dose-concentration-response relationships have yet been identified.
Croatian: Iako su opaženi statistički značajni odnosi i umjerena korelacija između izloženosti cerebrospinalne tekućine (AUC, Cmax) i izmjerenog kliničkog odgovora 1 sat nakon intratekalne primjene, još nisu ustanovljeni jasno definirani odnosi između doze, koncentracije i odgovora.
English: Prialt is supplied in packs containing a single vial of 20 ml.
Croatian: Prialt se isporučuje u pakiranjima koja sadrže jednu bočicu od 20 ml.
English: The use of lower doses through continuous administration was demonstrated to achieve efficacy with fewer adverse reactions.
Croatian: Pokazalo se da se kontinuiranom primjenom nižih doza postiže djelotvornost uz manje nuspojava.
English: The recommended starting dose is no more than 2.4 micrograms per day.
Croatian: Preporučena početna doza ne prelazi 2,4 mikrograma na dan.
English: • Rhabdomyolysis (may affect up to 1 in 100 people) - is breakdown of muscle fibres that can lead to kidney damage.
Croatian: • Rabdomioliza (može se javiti u do 1 na 100 osoba) - propadanje mišićnih vlakana koje može uzrokovati oštećenje bubrega.
English: Prialt has been shown to be chemically and physically compatible with the implantable Synchromed pump and the external CADD-Micro pump at the concentration levels indicated above.
Croatian: Prialt se pokazao kemijski i fizikalno kompatibilan s ugradivom pumpom Synchromed i vanjskom pumpom CADD-Micro u prethodno navedenim razinama koncentracija.
English: Ziconotide may cause confusion, somnolence and other neurological adverse reactions, therefore patients must be advised not to drive or operate machines if affected.
Croatian: Zikonotid može prouzročiti smetenost, somnolenciju i druge neurološke nuspojave; stoga bolesnike treba upozoriti da ne upravljaju vozilima i strojevima ako opaze takvo djelovanje.
English: Type I glass vials with butyl rubber stoppers coated with fluorinated polymer.
Croatian: I s čepovima od butilne gume prevučenim fluoriranim polimerom.
English: Possible long-term local toxic effects on the spinal cord have not been excluded and preclinical data in this respect are limited (see section 5.3).
Croatian: Mogući lokalni toksični učinci na kralježničnu moždinu pri dugotrajnoj primjeni nisu isključeni, a pretklinički podaci u tom su smislu ograničeni (vidjeti dio 5.3).
English: However, in clinical trials it has been observed that patients who tolerate doses of 21.6 μg/day following slow titration over a 3 to 4-week period, generally tolerate higher doses up to 48.0 μg/day.
Croatian: Međutim, u kliničkim je ispitivanjima primijećeno da bolesnici koji podnose doze od 21,6 μg/dan, nakon polagane titracije tijekom 3 do 4 tjedna, obično podnose više doze do 48,0 μg/dan.
English: The infusion dose rate ranged from 0.03 - 912 μg/day, with a median final dose rate of 7.2 μg/day.
Croatian: Doza infuzije iznosila je od 0,03 - 912 μg/dan, s medijanom konačne doze od 7,2 μg/dan.
English: opiate infusion dose should be gradually tapered over a few weeks and replaced with a pharmacologically equivalent dose of oral opiates.
Croatian: Bolesnicima kojima se obustavljaju intratekalni opioidi, dozu intratekalne infuzije opioida treba postupno smanjivati tijekom nekoliko tjedana i zamijeniti ih farmakološki ekvivalentnom dozom peroralnih opioida.
English: The introduction of air into the pump reservoir or cartridge should be minimized, as oxygen can degrade ziconotide.
Croatian: Uvođenje zraka u spremnik ili uložak pumpe treba smanjiti na najmanju moguću mjeru jer kisik može razgraditi zikonotid.
English: If needed, the dose may be decreased or injection stopped if the side effects are too great.
Croatian: Ako je potrebno, dozu se može smanjiti ili zaustaviti ubrizgavanje u slučaju da su nuspojave prevelike.
English: - If you develop any tenderness in the area around the tube without signs of infection, you should seek advice from your doctor as soon as possible as tenderness may be an early sign of infection.
Croatian: - Ako Vam se pojavi osjetljivost u predjelu oko cjevčice bez znakova infekcije, trebate se obratiti liječniku za savjet čim prije jer osjetljivost može biti rani znak infekcije.
English: No formal studies assessing the impact of renal or hepatic dysfunction have been conducted; however, given that peptidases are present in various body organs, it is not anticipated that renal or hepatic dysfunction will significantly impact systemic exposure of ziconotide.
Croatian: Nisu provedena službena ispitivanja procjene utjecaja bubrežne ili jetrene disfunkcije; međutim, s obzirom da su peptidaze prisutne u različitim tjelesnim organima, ne očekuje se da će bubrežna ili jetrena disfunkcija značajno utjecati na sistemsku izloženost zikonotidu.
English: The maximum dose is 21.6 micrograms/day.
Croatian: Najveća doza je 21,6 mikrograma/dan.
English: How to store Prialt
Croatian: Kako čuvati Prialt
English: The median dose at response is approximately 6.0 μg/day and approximately 75% of responsive patients require ≤ 9.6 μg/day.
Croatian: Medijan doze za postizanje odgovora iznosi približno 6,0 μg/dan, a otprilike 75% bolesnika s odgovorom treba dozu od ≤ 9,6 μg/dan.
English: Prialt is supplied in packs containing a single vial of either 1 ml, 2 ml or 5 ml.
Croatian: Prialt se isporučuje u pakiranjima koja sadrže jednu bočicu od 1 ml, 2 ml ili 5 ml.
English: Prialt is used for the treatment of severe, long-term pain in adults who need a painkiller by intrathecal injection (injection into the space that surrounds the spinal cord and the brain).
Croatian: Prialt se primjenjuje za liječenje teške, dugotrajne boli u odraslih kojima je potreban lijek protiv bolova u obliku intratekalne injekcije (injekcija u prostor koji okružuje kralježničnu moždinu i mozak).
English: Meningitis due to the entrance of organisms along the catheter track or inadvertent contamination of the infusion system is a known complication of intrathecal medicinal product administration, especially with external systems.
Croatian: Meningitis prouzročen ulaskom organizama duž katetera ili nehotičnom kontaminacijom infuzijskog sustava poznata je komplikacija u primjeni intratekalnih lijekova, osobito putem vanjskih sustava.