FrancophonIA/ELRC3.0 huggingface dataset:
English: Analyses of all these data showed a consistent pattern whereby generally a larger proportion of patients treated with Raxone had vision improvement compared with untreated or placebo-treated patients.
Croatian: Analize svih ovih podataka pokazale su konzistentan uzorak u skladu s kojim je načelno veći udio bolesnika liječenih lijekom Raxone doživio poboljšanje vida u usporedbi s neliječenim ili placebom liječenim bolesnicima.
English: Raxone has been investigated in one main study involving 85 patients with LHON, in which it was compared with placebo (a dummy treatment) over 24 weeks.
Croatian: Raxone je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 85 bolesnika s LHON-om i usporedilo ga s placebom (lažnim liječenjem) tijekom 24 tjedna.
English: The active substance in Raxone, idebenone, is an anti-oxidant agent that acts on mitochondria (the structures inside cells that produce the energy necessary for cells to function).
Croatian: Idebenon, djelatna tvar lijeka Raxone, antioksidantno je sredstvo koje djeluje na mitohondrije (strukturalne unutarnje stanice koje proizvode energiju potrebnu za funkcioniranje stanica).
English: Raxone contains the active substance idebenone.
Croatian: Raxone sadrži djelatnu tvar idebenon.
English: What are the risks associated with Raxone?
Croatian: Koji su rizici povezani s lijekom Raxone?
English: Why is Raxone approved?
Croatian: Zašto je lijek Raxone odobren?
English: Since Raxone has been approved under exceptional circumstances, the company that markets Raxone will conduct additional studies on the long-term effects and safety of Raxone, and will establish and maintain a registry of LHON patients treated with Raxone.
Croatian: Budući da je lijek Raxone odobren u iznimnim okolnostima, tvrtka koja lijek Raxone stavlja u promet mora provesti dodatna ispitivanja o dugoročnom djelovanju i sigurnoj primjeni lijeka Raxone te utvrditi i održavati registar bolesnika s LHON-om liječenih lijekom Raxone.
English: Additional supportive data on the benefits of Raxone came from an expanded access program through which Raxone was made available to individual patients not participating in a clinical study, and from a case record survey, which included data from patients with LHON who did not receive any treatment.
Croatian: Dodatni podaci o koristima lijeka Raxone potječu iz programa proširenog ispitivanja kojim je lijek Raxone učinjen dostupnim pojedinim bolesnicima koji nisu sudjelovali u kliničkom ispitivanju te iz pregleda evidencije slučajeva, kojim su obuhvaćeni podaci bolesnika s LHON-om koji nisu primili nikakvo liječenje.
English: For practical information about using Raxone, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Raxone bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The results of the main study showed an improvement in vision in patients treated with Raxone, and this trend towards a beneficial effect was confirmed by additional data from an expanded access program and a case record survey.
Croatian: Rezultati glavnog ispitivanja pokazali su poboljšanje vida bolesnika liječenih lijekom Raxone te je trend u smjeru korisnog djelovanja potvrđen dodatnim podacima iz programa proširenog ispitivanja i pregleda evidencije slučajeva.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Raxone, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Raxone nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Raxone can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in LHON.
Croatian: Raxone se izdaje samo na liječnički recept te liječenje treba započeti i provoditi liječnik s iskustvom u liječenju LHON-a.
English: What information is still awaited for Raxone?
Croatian: Koje se još informacije očekuju o lijeku Raxone?
English: How does Raxone work?
Croatian: Kako djeluje Raxone?
English: With regard to the safety of Raxone, the majority of side effects seen with the medicine were mild or moderate in intensity.
Croatian: Uzimajući u obzir sigurnu primjenu lijeka Raxone, većina nuspojava zabilježenih pri primjeni ovog lijeka bila je blagog ili umjerenog intenziteta.
English: Raxone is a medicine used to treat visual impairment in adults and adolescents aged 12 years and over with Leber's hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight.
Croatian: Raxone je lijek koji se koristi za liječenje oštećenja vida u odraslih osoba i adolescenata u dobi od 12 godina i starijih s Leberovom nasljednom optičkom neuropatijom (engl.
English: How is Raxone used?
Croatian: Kako se Raxone koristi?
English: What benefits of Raxone have been shown in studies?
Croatian: Koje su koristi lijeka Raxone utvrđene u ispitivanjima?
English: The full EPAR and risk management plan summary for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Raxone kao i sažetak plana upravljanja rizikom za taj lijek možete pronaći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Raxone pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: For the full list of all side effects and restrictions with Raxone, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Raxone potražite u uputi o lijeku.
English: 10 (2 x 5) pre-filled pens
Croatian: 10 (2 x 5) napunjenih brizgalica
English: EU Procedure number Invented name Strength Pharmaceutical Form
Croatian: Doza Farmaceutski oblik
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 15 July 2016
Croatian: Datum prvog odobrenja: 20. rujna 2006 Datum posljednje obnove odobrenja: 15. srpanj 2016
English: They will calculate the right dose for you.
Croatian: Izračunat će koja je odgovarajuća doza za Vas.
English: Tell your doctor if you are taking or have recently taken any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, ili ste nedavno uzeli bilo koje druge lijekove.
English: • altered taste,
Croatian: • promijenjeni okus,
English: No interaction studies have been performed and no other forms of interaction have been identified.
Croatian: Nisu provedena ispitivanja interakcija i nisu utvrđeni nikakvi drugi oblici interakcija.
English: In the case of overdose the doctor will take appropriate action.
Croatian: U slučaju predoziranja liječnik će poduzeti odgovarajuće radnje.
English: In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
Croatian: U nekim slučajevima liječnik može odlučiti upotrijebiti dvije injekcije da bi dovršio pregled ultrazvukom.
English: If you are given more Luminity than you should
Croatian: Ako dobijete više Luminityja nego što ste trebali
English: Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied in these groups
Croatian: Luminity se ne smije koristiti u djece i adolescenata (mlađih od 18 godina) jer nije ispitan u tim skupinama.
English: Other medicines and Luminity
Croatian: Drugi lijekovi i Luminity
English: The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans.
Croatian: Farmakokinetika i metabolizam MPEG5000 DPPE nisu ocjenjivani u ljudi.
English: Contents of the pack and other information What Luminity contains
Croatian: Sadržaj pakiranja i druge informacije Što Luminity sadrži
English: - The active substance is perflutren.
Croatian: - Djelatna tvar je perflutren.
English: For perflutren, no clinical data on exposed pregnancies are available.
Croatian: Za perflutren nisu dostupni klinički podaci o izloženim trudnoćama.
English: • feeling hot and
Croatian: • osjećaj vrućine i
English: What Luminity is and what it is used for
Croatian: Što je Luminity i za što se koristi
English: The safety and efficacy of Luminity in children and adolescents below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Luminityja u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests).
Croatian: On je kontrastno sredstvo (lijek koji pomaže učiniti unutarnje tjelesne strukture vidljivijima tijekom pretraga snimanjem).
English: • increased blood pressure,
Croatian: • povišeni krvni tlak,
English: If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.
Croatian: Ako ste u prošlosti imali alergijsku reakciju na Luminity ili neko drugo ultrazvučno kontrastno sredstvo obavijestite svog liječnika.
English: A strict dose/response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
Croatian: Ne može se definirati precizan odnos između doze i odgovora, iako se pokazalo da više doze proizvode učinak kontrasta duljeg trajanja.
English: In addition, some patients may experience convulsions, which may be associated with these allergic reactions.
Croatian: Osim toga, neki bolesnici mogu osjetiti konvulzije, koje mogu biti povezane s tim alergijskim reakcijama.
English: Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds.
Croatian: Luminity se aktivira korištenjem Vialmixa koji ima programirano vrijeme miješanja od 45 sekundi.
English: These levels are substantially above the recommended maximal clinical dose.
Croatian: Te su razine znatno iznad preporučene najveće kliničke doze.
English: It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Croatian: Nužno je slijediti upute za uporabu i rukovanje Luminityjem te se pridržavati strogih aseptičkih postupaka tijekom pripreme.
English: Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.
Croatian: Liječenje predoziranja treba biti usmjereno na potporu svih vitalnih funkcija i brzo uvođenje simptomatske terapije.
English: The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute.
Croatian: Brzina infuzije na početku treba biti 4 ml/minuta, ali se zatim titrira prema potrebi da bi se postiglo optimalno pojačanje slike, pri čemu ne smije premašiti 10 ml/minuta.
English: EU/1/06/361/001 4 single-dose vials EU/1/06/361/002 1 single-dose vial
Croatian: EU/1/06/361/001 4 jednodozne bočice EU/1/06/361/002 1 jednodozna bočica
English: Resuscitation equipment and trained personnel must always be readily available.
Croatian: Oprema za reanimaciju i osposobljeno osoblje uvijek moraju biti na raspolaganju.
English: Pack sizes of 1 or 4 vials.
Croatian: Veličine pakiranja od 1 ili 4 bočice.
English: Luminity should only be administered to such patients after careful risk/benefit assessment.
Croatian: Luminity se takvim bolesnicima smije primjenjivati samo nakon pažljive procjene rizika/koristi.
English: Some patients may experience allergic type reactions such as swelling of the face.
Croatian: Neki bolesnici mogu doživjeti alergijske reakcije poput oticanja lica.
English: What Luminity looks like and contents of the pack
Croatian: Kako Luminity izgleda i sadržaj pakiranja
English: The contents of the vial are intended for single use only.
Croatian: Sadržaj bočice namijenjen je samo za jednokratnu uporabu.
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Potreban je oprez kod propisivanja trudnicama.
English: This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
Croatian: Time se osigurava da se lijek miješa ispravno i dovoljno dugo da bi se napravila ‘disperzija'mikrosfera plina perflutrena odgovarajuće veličine da bi se dobila snimka dobre kvalitete.
English: These side effects usually go away quickly without any treatment.
Croatian: Ove se nuspojave obično brzo povuku bez ikakve terapije.
English: No air should be injected into the vial.
Croatian: U bočicu se ne smije ubrizgati zrak.
English: Further information
Croatian: Druge informacije
English: The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Croatian: Vialmix će upozoriti rukovatelja ako se frekvencija miješanja promijeni za 5% ili više ispod ciljane frekvencije.
English: Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
Croatian: Trudnoća i dojenje Recite svom liječniku ako ste trudni ili dojite i obratite se svom liječniku ili ljekarniku za savjet prije nego što dobijete Luminity.
English: Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management.
Croatian: Kontrastna ehokardiografija smije se razmatrati u takvih bolesnika samo ako je vjerojatno da će rezultati dovesti do promjene u liječenju pojedinačnog bolesnika.
English: Higher doses of the product, typically ≥ 1 ml/kg, resulted in more severe signs including unresponsiveness and occasionally death.
Croatian: Više doze lijeka, obično ≥ 1 ml/kg, rezultirale su težim znakovima, uključujući izostanak odgovora i povremeno smrt.
English: It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Croatian: Programiran je i da se ugasi te će dati vidljiva i čujna upozorenja ako frekvencija miješanja premaši ciljanu frekvenciju za 5%, ili padne ispod ciljane frekvencije za 10%.
English: Patients with unstable cardiopulmonary status
Croatian: Bolesnici s nestabilnim kardiopulmonalnim statusom
English: Fertility Animal studies do not indicate direct or indirect harmful effects on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na plodnost.
English: There is however a risk that these allergic type reactions become severe and may include anaphylactic shock (a serious, potentially life-threatening allergic response).
Croatian: Postoji, međutim, rizik da te alergijske reakcije postanu teške i mogu uključivati anafilaktički šok (ozbiljna, po život opasna alergijska reakcija).
English: Luminity is for intravenous use (direct injection into the vein).
Croatian: Luminity je namijenjen za intravensku primjenu (izravnu injekciju u venu).
English: The ultrasonic properties of the product are very different from those of soft tissue and will generate strong echoes.
Croatian: Ultrazvučna svojstva lijeka vrlo su različita od svojstava mekog tkiva i stvorit će snažne odjeke.
English: When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial.
Croatian: Kada se koristi igla, ona mora biti postavljena tako da izvlači materijal iz sredine tekućine u preokrenutoj bočici.
English: The percentage of the perflutren dose excreted in expired air was approximately 50% of the administered dose due to the small quantities of perflutren given and the inability to quantify low levels of perflutren by gas chromatography.
Croatian: Postotak doze perflutrena koja se izlučuje u izdahnutom zraku bio je otprilike 50% primijenjene doze zbog malih količina perflutrena koje su bile primijenjene i nemogućnosti kvantificiranja niskih razina perflutrena plinskom kromatografijom.
English: Pharmacokinetics in special population groups
Croatian: Farmakokinetika u posebnim skupinama bolesnika
English: The way Luminity is given and the dose depend on the technique used for the echocardiography.
Croatian: Način na koji se primjenjuje Luminity i doza ovise o tehnici koja se koristi za ehokardiografiju.
English: Immediately after activation, Luminity appears as a milky white dispersion.
Croatian: Neposredno nakon aktivacije Luminity izgleda kao mliječno bijela disperzija.
English: All lipids are metabolised to free fatty acids.
Croatian: Svi se lipidi metaboliziraju u slobodne masne kiseline.
English: Note: if the product is allowed to stand for more than 5 minutes after activation, it should be resuspended with 10 seconds of hand agitation prior to syringe withdrawal from the vial.
Croatian: Napomena: ako lijek odstoji više od 5 minuta nakon aktivacije, treba ponovno napraviti suspenziju mućkajući ga rukom 10 sekundi, prije izvlačenja suspenzije štrcaljkom iz bočice.
English: What you need to know before you use Luminity 3.
Croatian: Što morate znati prije nego počnete primjenjivati Luminity
English: The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Croatian: Vialmix nije uključen u pakiranje Luminityja, ali će ga zdravstveni radnici dobiti kada naruče pakiranje.
English: Luminity contains sodium.
Croatian: Luminity sadrži natrij.
English: The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
Croatian: Najučestalije zabilježene nuspojave su: glavobolja (2,0%), navale crvenila (1,0%) te bolovi u leđima (0,9%).
English: As Luminity has no pharmacologic effect, and on the basis of its pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of this product on the ability to drive or use machines.
Croatian: Budući da Luminity nema farmakološki učinak te na temelju njegovog farmakokinetičkog i farmakodinamičkog profila, očekuje se da ne utječe ili da zanemarivo utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions, which might require resuscitation.
Croatian: Bolesnike je potrebno pažljivo motriti, a primjena treba biti pod nadzorom liječnika s iskustvom u zbrinjavanju reakcija preosjetljivosti, uključujući teške alergijske reakcije, koje bi mogle zahtijevati reanimaciju.
English: • reduced blood pressure,
Croatian: • sniženi krvni tlak,
English: Microspheres in the 1 to < 10 µm diameter size range contribute to the contrast effect by generating strongly enhanced echoes.
Croatian: Mikrosfere u rasponu promjera od 1 do < 10 µm doprinose učinku kontrasta stvaranjem snažno pojačanih odjeka.
English: Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood.
Croatian: Intenzitet Doppler signala dobro je odgovarao izmjerenim i ekstrapoliranim koncentracijama perflutrena u krvi.
English: Luminity has no effect on the ability to drive and use machines.
Croatian: Luminity ne utječe na sposobnost upravljanja vozilima i strojevima.
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 odjeci iz krvi i bioloških mekih tkiva kao što su masnoća i mišići stvaraju se na graničnoj površini zbog malih razlika u ultrazvučnim svojstvima tkiva.
English: The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Croatian: Pokazalo se da je vrijeme do najvećeg intenziteta Doppler signala tmax slično vrijednosti tmax perflutrena u krvi (1,13 naspram 1,77 minuta).
English: These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects.
Croatian: Ovi rezultati upućuju na to da je cjelokupna sistemska eliminacija perflutrena brza i nije značajno smanjena u bolesnika s KOPB-om u usporedbi sa zdravim ispitanicima.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću, razvoj embrija/fetusa, porođaj ili postporođajni razvoj (vidjeti dio 5.3).
English: Adverse reactions were reported with the following frequencies (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), not known (cannot be estimated from the available data).
Croatian: Manje često ≥ 1/1000 i < 1/100; Rijetko ≥ 1/10 000 i < 1/1000; Vrlo rijetko < 1/10 000), nepoznato
English: Use in this patient group should be on the basis of a benefit risk assessment by the physician.
Croatian: Primjena lijeka u ovoj skupini bolesnika treba se temeljiti na liječnikovoj procjeni koristi i rizika.
English: Emergency equipment and personnel trained in its use must be readily available.
Croatian: Oprema za hitnu pomoć i osposobljeno osoblje moraju biti na raspolaganju.
English: Luminity is an ultrasound contrast agent that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Croatian: Luminity je ultrazvučno kontrastno sredstvo koje sadrži mikrosfere (sitne mjehuriće) plina perflutrena kao djelatnu tvar.
English: If Luminity is administered directly to the patient without undergoing the mechanical activation procedure using the Vialmix (see section 6.6), the product will not produce its intended effect.
Croatian: Ako se Luminity primjenjuje bolesniku izravno bez prethodno provedenog postupka mehaničke aktivacije pomoću Vialmixa (vidjeti dio 6.6), lijek neće imati planirani učinak.
English: Rare: Bradycardia, Tachycardia, Palpitations
Croatian: Rijetko: bradikardija, tahikardija, palpitacije
English: It is available in a pack containing one or four single-use 1.5 ml vials.
Croatian: Dostupan je u pakiranju koje sadrži jednu ili četiri jednodozne bočice od 1,5 ml.
English: The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored under refrigeration or at room temperature.
Croatian: Lijek se može reaktivirati do 48 sati nakon početne aktivacije te koristiti do 12 sati nakon druge aktivacije, bez obzira na to čuva li se u hladnjaku ili na sobnoj temperaturi.
English: Luminity is given to you before or during your ultrasound examination by healthcare professionals such as doctors who are experienced in this type of examination.
Croatian: Luminity će Vam prije ili tijekom pregleda ultrazvukom dati zdravstveni radnik kao što je liječnik koji ima iskustva s takvom vrstom pregleda.
English: Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of perflutren.
Croatian: Mjerenja Doppler ultrazvukom s Luminityjem provedena su zajedno s farmakokinetičkom evaluacijom perflutrena.
English: Penn Pharmaceutical Services Ltd 23-24 Tafarnaubach Ind. Est. Tredegar, Wales NP22 3AA.
Croatian: Penn Pharmaceutical Services Ltd 23-24 Tafarnaubach Ind.
English: The product should be used immediately after its withdrawal from the vial.
Croatian: Lijek se mora upotrijebiti odmah nakon izvlačenja iz bočice.
English: In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation.
Croatian: U tih bolesnika fosfolipidno inkapsulirane mikrosfere mogu zaobići pluća i izravno ući u arterijski krvotok.
English: Overdose is not likely to happen since the medicine is administered by a doctor.
Croatian: Vrlo je mala vjerojatnost da se to dogodi zato što lijek primjenjuje liječnik.