FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients who have long-term pain that requires painkillers to be injected directly into the spine is low, the disease is considered ‘rare', and Prialt was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Croatian: Budući da je broj bolesnika s kroničnom boli koja zahtjeva ubrizgavanje analgetika izravno u kralježnicu nizak, dotična se bolest smatra „rijetkom” te se Prialt označava kao lijek za liječenje rijetkih bolesti od 9. srpnja 2001.
English: The full EPAR for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) Prialt nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The starting dose of Prialt is 2.4 micrograms per day.
Croatian: Početna doza lijeka Prialt iznosi 2,4 mikrograma na dan.
English: For more information about treatment with Prialt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Prialt pročitajte u uputama o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Treatment with Prialt should only be carried out by a doctor who has experience in the intrathecal dosing of medicines.
Croatian: Liječenje lijekom Prialt smiju provoditi samo liječnici s iskustvom u intratekalnoj primjeni lijekova.
English: Prialt has been compared with placebo (a dummy treatment) in 589 patients with severe long-term pain in three main studies.
Croatian: Prialt je uspoređen s placebom (lažnim liječenjem) u 589 bolesnika sa snažnom kroničnom boli u tri glavna ispitivanja.
English: This is a summary of the European public assessment report (EPAR) for Prialt.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Prialt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prialt, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Prialt uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The active substance in Prialt, ziconotide, is a copy of a natural substance called omega-conopeptide, which is found in the venom of a type of sea snail.
Croatian: Djelatna tvar u lijeku Prialt, zikonotid, jest kopija prirodne tvari naziva omega-konopeptid koja se nalazi u otrovu jednog tipa morskih puževa.
English: What benefit has Prialt shown during the studies?
Croatian: Koje su koristi lijeka Prialt dokazane u ispitivanjima?
English: Prialt must not be used in patients at the same time as intrathecal chemotherapy (medicines to treat cancer that are injected into the spinal canal).
Croatian: Prialt se ne smije koristiti u bolesnika istovremeno s intratekalnom kemoterapijom (lijekovi za liječenje raka koji se ubrizgavaju u kralježnični kanal).
English: Prialt must be given as a very slow continuous infusion through an intrathecal catheter (a tube inserted into the spinal canal) using an infusion pump capable of delivering an accurate amount of the medicine.
Croatian: Prialt treba primjenjivati kao vrlo polaku kontinuiranu infuziju kroz intratekalni kateter (cjevčicu koja se uvodi u kralježnični kanal) pomoću infuzijske pumpe koja omogućuje isporuku točne količine lijeka.
English: In the third study, there was a trend for Prialt to be more effective than placebo, with the VASPI score changing from 81 mm before treatment to 68 mm in patients receiving Prialt and to 74 mm in patients receiving placebo.
Croatian: U trećem ispitivanju bio je prisutan trend da je Prialt bio djelotvorniji od placeba, pri čemu se VASPI rezultat mijenjao od 81 mm prije liječenja do 68 mm u bolesnika koji su primali Prialt te do 74 mm u bolesnika koji su primali placebo.
English: Ziconotide acts by blocking special pores called calcium channels on the surface of the nerve cells that transmit the pain signals.
Croatian: Zikonotid djeluje inhibirajući posebne pore naziva kalcijevi kanali na površini živčanih stanica koje prenose signale boli.
English: Prialt is used to treat 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 koristi za liječenje snažne kronične boli u odraslih osoba kojima je potrebna primjena analgetika intratekalnom injekcijom (injekcijom u prostor koji okružuje kralježničnu moždinu i mozak).
English: It decided that Prialt's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo je odlučilo da koristi od lijeka Prialt nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: By blocking the flow of calcium into the nerve cells, ziconotide interferes with the transmission of pain signals within the spine.
Croatian: Inhibirajući protok kalcija u živčane stanice, zikonotid interferira s prijenosom signala boli unutar kralježnice.
English: Prialt is a solution for infusion that contains the active substance ziconotide.
Croatian: Prialt je otopina za infuziju koja sadrži djelatnu tvar zikonotid.
English: What is Prialt used for?
Croatian: Za što se Prialt koristi?
English: Before treatment, patients with cancer or AIDS pain had an average VASPI score of 74 mm, and those with other types of pain had a score of 80 mm. After treatment, the scores in patients receiving Prialt decreased to 35 and 54 mm, respectively, while scores in patients receiving placebo were 61 and 72 mm.
Croatian: Prije liječenja, bolesnici s boli uzrokovanom rakom ili SIDA-om imali su prosječni VASPI rezultat 74 mm, a bolesnici s drugim tipovima boli imali su rezultat 80 mm.
English: How does Prialt work?
Croatian: Kako djeluje Prialt?
English: How has Prialt been studied?
Croatian: Kako se Prialt ispitivao?
English: How is Prialt used?
Croatian: Kako se Prialt koristi?
English: For the full list of all side effects and restrictions with Prialt, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Prialt potražite u uputi o lijeku.
English: Prialt was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Croatian: Prialt je odobren u „iznimnim okolnostima”.
English: The primary route of elimination of radioactivity was the urine.
Croatian: Primarni put eliminacije radioaktivnosti bio je urin.
English: This dose might be repeated if needed.
Croatian: Ova se doza po potrebi može ponavljati.
English: Homogenous white suspension after resuspension.
Croatian: Homogena bijela suspenzija nakon ponovne suspenzije.
English: Unopened vial in the outer packaging: 2 years.
Croatian: Neotvorena bočica u vanjskom pakovanju: 2 godine.
English: However, because OPTISON is based on human albumin (the main protein in our blood), it is highly unlikely that it will have any harmful effects in pregnancy.
Croatian: Međutim, budući da se OPTISON temelji na ljudskom albuminu (najčešći protein u našoj krvi), nije vjerojatno da će imati bilo kakve štetne učinke tijekom trudnoće.
English: A dose of 3.0 ml is usually sufficient, but some patients may need higher doses.
Croatian: Obično je dovoljna doza od 3,0 ml, ali nekim bolesnicima mogu biti potrebne veće doze.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u odjeljku 5.1, međutim nije moguće dati preporuku o doziranju.
English: OPTISON must not be mixed with other medicinal products.
Croatian: OPTISON se ne smije miješati s drugim lijekovima.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Samo za jednokratnu primjenu.
English: The clinical relevance of this finding is unknown.
Croatian: Klinički značaj ovih nalaza nije poznat.
English: Other routes of administration not specified in section 4.2 above (e.g. intracoronary injection) are not recommended.
Croatian: Ostali putevi primjene lijeka koji nisu navedeni u odjeljku 4.2 (npr. intrakoronarna injekcija) nisu preporučeni.
English: This leaflet is available in all EU/EEA languages on the European Agency website.
Croatian: Ova Uputa o lijeku je dostupna na svim EU/EEA jezicima na web stranicama Europske agencije za lijekove.
English: * Reactions for which no frequency rate can be provided due to lack of clinical trial data have been classified as “Not known”.
Croatian: * Reakcije za koje nije moguće odrediti učestalost zbog nedostatka podataka kliničkih ispitivanja klasificirane su kao "nepoznato".
English: In two uncontrolled studies including a total of 42 children and adolescents, aged 8 months to 19 years, the safety profile appeared to be similar to that seen in adults.
Croatian: U dva nekontrolirana ispitivanja provedena na 42 djece i adolescenata u dobi od 8 mjeseci do 19 godina, sigurnosni profil bio je sličan onom kod odraslih osoba.
English: Higher doses produce greater contrast effect of longer duration.
Croatian: Veće doze stvaraju veći kontrastni učinak dužeg trajanja.
English: - If you have any further questions, ask your doctor.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku.
English: A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur.
Croatian: Postupak primjene mora biti isplaniran unaprijed, a potrebni lijekovi i oprema moraju biti dostupni za hitan medicinski postupak u slučaju nastanka ozbiljne reakcije.
English: Before administering OPTISON, please see section 6.6 for instructions for use/handling.
Croatian: Prije primjene lijeka OPTISON, u odjeljku 6.6 potražite upute o uporabi/rukovanju.
English: Do not use OPTISON - if you are allergic (hypersensitive) to perflutren or any of the other ingredients of OPTISON (listed in section 6).
Croatian: Nemojte primjenjivati OPTISON - ako ste alergični (preosjetljivi) na perflutren ili neki drugi sastojak lijeka OPTISON (naveden u dijelu 6).
English: What OPTISON is and what it is used for
Croatian: Što je OPTISON i za što se koristi
English: What OPTISON looks like and contents of the pack
Croatian: Kako OPTISON izgleda i sadržaj pakovanja
English: Resuspend before use.
Croatian: Promućkajte prije uporabe.
English: Date of latest renewal: 12 June 2008
Croatian: Datum prvog odobrenja: 18. svibnja 1998 Datum posljednje obnove odobrenja: 12. lipnja 2008
English: Use during anaesthesia with halothane and oxygen has not been studied.
Croatian: Primjena tijekom anestezije halotanom i kisikom nije ispitana.
English: The total dose should not exceed 8.7 ml per patient.
Croatian: Ukupna doza ne smije prijeći 8,7 ml po bolesniku.
English: Do not inject air into the vial as this will damage the product.
Croatian: Ne ubrizgavajte zrak u bočicu jer će to dovesti do oštećenja proizvoda.
English: Finished product after rubber stopper perforation: 30 minutes.
Croatian: Pripremljeni proizvod nakon perforacije gumenog zatvarača: 30 minuta.
English: OPTISON is a dispersion for injection.
Croatian: OPTISON je disperzija za injekciju.
English: Do not inject air into the vial.
Croatian: Ne ubrizgavajte zrak u bočicu.
English: A separate syringe should be used.
Croatian: Mora se koristiti zasebna štrcaljka.
English: • Eosinophilia (increased number of a type of white blood cells in the blood)
Croatian: • Eozinofilija (povećan broj bijelih krvnih stanica u krvi)
English: Systemic haemodynamic parameters and ECGs were also evaluated.
Croatian: Sistemski hemodinamički parametri i EKG-ovi također su razmotreni.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti lijeka podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: This study did not assess the effect of OPTISON on visualisation of cardiac or pulmonary structures.
Croatian: Ovo ispitivanje nije proučavalo učinak OPTISONA na vizualizaciju srčanih ili plućnih struktura.
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na nepoznate ili nove viruse ili druge vrste infekcija.
English: Duration of useful contrast effect at the recommended dose is adequate to perform a complete echocardiographic examination including Doppler assessment.
Croatian: Trajanje korisnog kontrastnog učinka pri preporučenoj dozi dovoljno je za izvođenje potpunog ehokardiografskog pregleda, uključujući Doppler snimanje.
English: PHARMACEUTICAL FORM Dispersion for injection.
Croatian: OBLIK Disperzija za injekciju.
English: - Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm.
Croatian: - Uvedite 20 G plastičnu kanilu u veliku antekubitalnu venu, po mogućnosti na desnoj ruci.
English: The following instructions should be followed: - Cold solutions taken directly from the refrigerator should not be injected.
Croatian: Morate se pridržavati sljedećih uputa: - Ne ubrizgavajte hladne otopine izvađene izravno iz hladnjaka.
English: Although these biological side effects have not been reported in humans, the use of a low mechanical index and enddiastolic triggering is recommended.
Croatian: Iako ovi biološki štetni učinci nisu zabilježeni kod ljudi, preporučena je uporaba niskog mehaničkog indeksa i ciljani prikaz na kraju dijastole.
English: If injected otherwise OPTISON bubbles will be destroyed.
Croatian: Ako se ubrizga na drugi način, mjehurići lijeka OPTISON biti će uništeni.
English: OPTISON should be used in these categories of patients only after careful consideration and monitored closely during and after administration.
Croatian: OPTISON se smije primjenjivati u ovim kategorijama bolesnika samo nakon pažljivog razmatranja, a bolesnici se moraju strogo nadzirati tijekom i nakon primjene lijeka.
English: What OPTISON is and what it is used for What you need to know before you use OPTISON How to use OPTISON
Croatian: Što je OPTISON i za što se koristi Što morate znati prije nego počnete primjenjivati OPTISON
English: High levels of radioactivity were also retained in lungs for a considerable time, approx. 10% of the total dose 40 minutes after dose administration (cf. 35% in liver).
Croatian: Visoke razine radioaktivnosti također su se zadržale u plućima znatno vrijeme, približno 10% ukupne doze 40 minuta nakon primjene doze (u usporedbi s 35% u jetri).
English: - Any pressure instability within the vial should be avoided since it may cause disruption of microspheres and loss of contrast effect.
Croatian: - Izbjegavajte bilo kakve promjene tlaka unutar bočice jer to može dovesti do raskida mikrosfera i gubitka kontrastnog efekta.
English: In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.
Croatian: U I. fazi kliničkih ispitivanja, zdravi dobrovoljci primili su do 44,0 ml lijeka OPTISON i nisu zabilježeni značajni štetni događaji.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na nepoznate ili nove viruse i ostale patogene.
English: Care should therefore be exercised.
Croatian: Stoga treba postupati oprezno.
English: The experience of OPTISON in severely ill patients is limited.
Croatian: Iskustvo primjene lijeka OPTISON kod teško bolesnih pacijenata je ograničeno.
English: The perflutren levels detected in blood following this dosage were too low and transient to accurately determine pharmacokinetic parameters.
Croatian: Razine perflutrena otkrivene u krvi nakon primjene te doze bile su preniske i kratkotrajne da bi se farmakokinetički parametri mogli točno utvrditi.
English: - Complete resuspension is indicated by a uniformly opaque white suspension and absence of any material on stopper and vial surfaces.
Croatian: - Završetak ponovne priprave suspenzije označava jednolična neprozirna bijela suspenzija i odsustvo bilo kojeg materijala na zatvaraču i površinama bočice.
English: Storage at room temperature (up to 25°C) for 1 day is acceptable.
Croatian: Može se čuvati pri sobnoj temperaturi (do 25 °C) tijekom 1 dana.
English: You can also report side effects directly via the national reporting system.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known
Croatian: <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti na temelju raspoloživih podataka).
English: Following intravenous injection of 0.21 to 0.33 ml/kg of OPTISON to healthy volunteers, the perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 minutes with a dominating pulmonary elimination half-life of 1.3±0.7 minutes.
Croatian: Nakon intravenskog injiciranja 0,21 do 0,33 ml/kg lijeka OPTISON zdravim dobrovoljcima, perflutrenska komponenta lijeka OPTISON brzo se i gotovo potpuno eliminirala za manje od 10 minuta, s dominantnim pulmonalnim poluvijekom eliminacije od 1,3±0,7 minuta.
English: Unknown frequency (side effects where frequency cannot be estimated from the available data):
Croatian: Nepoznata učestalost (nuspojave čiju učestalost nije moguće procijeniti na temelju raspoloživih podataka):
English: Low mechanical index was used for ultrasound imaging.
Croatian: Za ultrazvučno snimanje korišten je niski mehanički indeks.
English: - Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate of 1.0 ml/s.
Croatian: - Ubrizgajte suspenziju kroz plastičnu kanilu, ne manju od 20 G, uz maksimalnu brzinu ubrizgavanja od 1,0 ml/s.
English: OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use.
Croatian: OPTISON u nesuspendiranom obliku ima bijeli sloj mikrosfera na vrhu tekuće faze koji zahtijeva ponovnu pripravu suspenzije prije uporabe.
English: Store upright in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku u uspravnom položaju (2 °C -8 °C).
English: The dose of OPTISON will therefore have to be adjusted individually, although clinical studies have shown that an initial dose of 0.5 - 3.0 ml per patient can be recommended for left heart opacification.
Croatian: Zbog toga se doza lijeka OPTISON mora prilagoditi ovisno o osobi, iako su klinička ispitivanja pokazala da se početna doza od 0,5 - 3,0 ml po bolesniku može preporučiti za opacifikaciju lijeve strane srca.
English: - if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg).
Croatian: - ako imate tešku plućnu hipertenziju (sistolički tlak u plućnoj arteriji > 90 mm Hg).
English: The ultrasound echoes from blood and biological soft tissues such as fat and muscles are generated at interfaces due to small differences in the ultrasonic properties of the tissues.
Croatian: Ultrazvučni odjek iz krvi i bioloških mekih tkiva, kao što su masti i mišići, stvaraju se na granicama površina zbog malih razlika u ultrazvučnim svojstvima tkiva.
English: - Use the suspension within 30 minutes after withdrawal.
Croatian: - Suspenziju upotrijebite unutar 30 minuta nakon uvlačenja u štrcaljku.
English: The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
Croatian: Približna količina perflutren plina u svakom ml lijeka OPTISON iznosi 0,19 mg.
English: What you need to know before you use OPTISON
Croatian: Što morate znati prije nego počnete primjenjivati OPTISON
English: OPTISON contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Croatian: OPTISON sadrži manje od 1 mmol natrija (23 mg) po dozi, što znači da u biti “ne sadrži natrij”.
English: In the rabbit embryotoxicity study, a significant increase in the number of foetuses with dilated ventricles in the brain was observed (see section 4.6).
Croatian: U embriotoksikološkom ispitivanju na kunićima primijećen je povećan broj fetusa s dilatiranim ventrikulima mozga (vidi odjeljak 4.6).
English: The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Croatian: Korisno vrijeme snimanja iznosi 2,5 - 4,5 minute za dozu 0,5 - 3,0 ml.
English: The disposition and elimination of the albumin microspheres have not been studied in humans.
Croatian: Nisu provedena ispitivanja razmještaja i eliminacije albuminskih mikrosfera kod ljudi.
English: Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded.
Croatian: Nakon probijanja gumenog zatvarača, sadržaj bočice mora se upotrijebiti unutar 30 minuta, a sav neiskorišteni lijek zbrinuti.
English: If you are given more OPTISON than you should Effects suspected to be due to overdose have not been reported.
Croatian: Ako ste primili veće doze lijeka OPTISON nego što ste trebali Učinci kod kojih postoji sumnja da su nastali predoziranjem nisu zabilježeni.
English: As a consequence of the complex relationship between the concentration of the microspheres and the ultrasound signal, data processing within the ultrasound equipment and the fact that each individual responds differently due to variability in cardiac and pulmonary function, a strict dose/response relationship cannot be defined.
Croatian: Zbog složenog odnosa koncentracije mikrosfera i ultrazvučnog signala, obrade podataka u opremi za ultrazvučno snimanje i činjenice da svaki pojedinac reagira na drugačiji način ovisno o razlikama u radu srca i pluća, nije moguće utvrditi jasno određen odnos doze i odgovora tijela.
English: Like all medicines, OPTISON can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi drugi lijekovi, OPTISON može uzrokovati nuspojave, iako se one ne pojavljuju kod svih.
English: Other medicines and OPTISON Tell your doctor if you are taking or have recently taken any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste ih nedavno uzeli bilo koje druge lijekove.
English: The ultrasonic properties of microspheres containing perflutren are very different from that of soft tissue and will generate strong echoes.
Croatian: Ultrazvučna svojstva mikrosfera s perflutrenom znatno se razlikuju od svojstava mekih tkiva i stvarati će snažnije odjeke.
English: Information obtained from a preclinical study in rats with 125I-labelled albumin microspheres indicated that microspheres were rapidly cleared from the circulation, and radio-labelled microspheres, albumin shells and 125I were taken up primarily in the liver.
Croatian: Podaci dobiveni nekliničkim ispitivanjima na štakorima s primjenom 125I-označenim albuminskim mikrosferama pokazali su da su se mikrosfere brzo uklanjale iz krvotoka, dok su se radioaktivno označene mikrosfere, albuminske ovojnice i 125I primarno apsorbirali u jetri.
English: 3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top.
Croatian: Staklena bočica od 3 ml vrste I, zatvorena bromobutilnim gumenim zatvaračem, zapečaćena aluminijskim čepom i obojenom plastičnom ”flip off” kapicom.
English: Warning: Never use any other type of route but the open flow connection.
Croatian: Upozorenje: Nikad ne upotrebljavajte nijedan drugi put za ubrizgavanje osim priključka s izravnim protokom.
English: Hypersensitivity has been reported.
Croatian: Zabilježeni su slučajevi preosjetljivosti.