FrancophonIA/ELRC3.0 huggingface dataset:
English: A reduction in the ocular surface inflammation assessed with Human Leukocyte Antigen-DR (HLADR) expression (an exploratory endpoint), was observed at Month 6 in favour of IKERVIS (p=0.021).
Croatian: U 6. mjesecu je zabilježeno smanjenje upale površine oka procijenjeno ekspresijom ljudskog leukocitnog antigena-DR (HLA-DR) (izviđajna ciljna točka) u korist IKERVISA (p=0,021).
English: It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.
Croatian: Dokazano je da produljuje preživljenje alogenih transplantata u životinja i signifikantno poboljšava preživljenje presatka u svim vrstama transplantacija čvrstih organa u čovjeka.
English: One pouch contains five single-dose containers.
Croatian: Jedna vrećica sadrži pet jednodoznih spremnika.
English: Eye drops, emulsion.
Croatian: Kapi za oko, emulzija.
English: Santen UK Limited Tel: + 44 (0) 845 075 4863
Croatian: United Kingdom Santen UK Limited Tel: +44 (0) 845 075 4863
English: Effects in non-clinical studies were observed only with systemic administration or at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri sustavnoj primjeni ili pri izloženosti dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time.
Croatian: Kontaktne leće je, prije kapanja kapi u oko prije spavanja, potrebno ukloniti, a mogu se ponovno umetnuti nakon buđenja.
English: No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section
Croatian: U životinja koje su primale ciklosporin intravenski nije zabilježeno oštećenje plodnosti (vidjeti dio
English: How to use IKERVIS
Croatian: Kako primjenjivati IKERVIS
English: Ocular or peri-ocular malignancies or premalignant conditions Active or suspected ocular or peri-ocular infection.
Croatian: Aktivna ili suspektna infekcija oka ili periokularnog područja.
English: Following oral administration, ciclosporin is excreted in breast milk.
Croatian: Nakon oralne primjene ciklosporin se izlučuje u majčino mlijeko.
English: Percentage of patients who experienced a severe keratitis recurrence was 35% and 48% in patients treated 12 months and 6 months with IKERVIS respectively in the SANSIKA study.
Croatian: Postotak bolesnika u kojih je došlo do ponovne pojave teškog keratitisa bio je 35% u bolesnika koji su liječeni IKERVISOM 12 mjeseci i 48% u bolesnika liječenih IKERVISOM
English: A topical overdose is not likely to occur after ocular administration.
Croatian: Nije vjerojatno da će doći do topikalnog predoziranja nakon očne primjene.
English: Excipients: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Croatian: Pomoćne tvari: srednjelančani trigliceridi, cetalkonijev klorid, glicerol, tiloksapol, poloksamer 188, natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: - The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol,
Croatian: - Drugi sastojci su srednjelančani trigliceridi, cetalkonijev klorid, glicerol, tiloksapol, poloksamer
English: Women of childbearing potential/contraception in females IKERVIS is not recommended in women of childbearing potential not using effective contraception.
Croatian: Ne preporučuje se koristiti lijek IKERVIS u žena reproduktivne dobi koje ne koriste djelotvornu kontracepciju.
English: • Take one single-dose container from the aluminium pouch.
Croatian: • Uzmite jedan jednodozni spremnik iz aluminijske vrećice.
English: Therefore, you should remove your contact lenses at bedtime before using IKERVIS; you can reinsert them when you wake up.
Croatian: Zbog toga, prije nego što primijenite IKERVIS prije spavanja, trebate izvaditi kontaktne leće; možete ih ponovo staviti kada se probudite.
English: IKERVIS is supplied in 0.3 mL single-dose, low-density polyethylene (LDPE) containers presented in a sealed laminate aluminium pouch.
Croatian: IKERVIS se isporučuje u jednodoznim spremnicima volumena 0,3 ml od polietilena niske gustoće (LDPE) u zatvorenoj višeslojnoj aluminijskoj vrećici.
English: The majority of adverse reactions reported in clinical studies with the use of IKERVIS were ocular and mild to moderate in severity.
Croatian: Većina nuspojava zabilježenih uz primjenu IKERVISA u kliničkim ispitivanjima javljala se na oku/očima te je bila blage do umjerene težine.
English: SantenPharma AB Tlf: +45 78737843
Croatian: Danmark SantenPharma AB Tlf: +45 78737843
English: It is used in those patients who have dry eye disease, which has not improved despite treatment with tear substitutes (artificial tears).
Croatian: Primjenjuje se u onih bolesnika sa sindromom suhog oka koji se ne poboljšava unatoč liječenju umjetnim suzama.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Prije uporabe izvadite kontaktne leće.
English: Santen GmbH Tel: +49 (0) 3030809610
Croatian: Deutschland Santen GmbH Tel: +49 (0) 3030809610
English: Co-administration of Ikervis with eye drops containing corticosteroids may potentiate the effects of Ikervis on the immune system.
Croatian: Istodobna primjena IKERVISA s kapima za oči koje sadrže kortikosteroide može pojačati učinke IKERVISA na imunološki sustav.
English: Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye), eye allergy, tear disorder, eye discharge, inflammation of the iris (coloured part of the eye) or eyelid, deposits in the eye, bacterial infection or inflammation of the cornea (transparent front part of the eye), abrasion to the outer layer of the cornea, whitish patches on the cornea, cyst in the eyelid, itching in the eyelid, painful rash around the eye caused by the herpes zoster virus.
Croatian: Nadraženost ili oticanje konjunktive (tanke opne koja prekriva prednji dio oka), očna alergija, poremećaji suza, iscjedak iz oka, upala šarenice (obojeni dio oka) ili vjeđe, depoziti u oku, bakterijska infekcija ili upala rožnice (prozirni prednji dio oka), abrazija vanjskog sloja rožnice, bijelkaste mrlje na rožnici, cista u vjeđi, svrbež vjeđe, bolan osip oko oka uzrokovan herpes zoster virusom.
English: Infections and infestations
Croatian: Infekcije i infestacije Manje često
English: Santen Oy Tél/Tel : +32 (0) 24019172
Croatian: Tél/Tel : +32 (0) 24019172
English: Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when Ikervis is used for years.
Croatian: Zbog toga se, kada se IKERVIS primjenjuje godinama, preporučuju redoviti pregledi oka (očiju) (npr. najmanje svakih 6 mjeseci).
English: Santen Oy Tel: +421 (01) 23 332 5519
Croatian: Tel: +421 (01) 23 332 5519
English: Santen Oy Tél/Tel: +352 (0) 27862006
Croatian: Tél/Tel: +352 (0) 27862006
English: Santen Oy Tel.: +36 (06) 16777305
Croatian: Tel.: +36 (06) 16777305
English: A small but statistically significant difference in CFS improvement was observed between the treatment groups at Month 6 in favour of IKERVIS (mean change from baseline in CFS -1.05 with IKERVIS and -0.82 with vehicle, p=0.009).
Croatian: Došlo je do malog, ali statistički signifikantnog poboljšanja nalaza CFS-a u 6. mjesecu u skupini liječenoj IKERVISOM (srednja vrijednost promjene od početne CFS uz IKERVIS bila je -1,05; a uz vehikulum -0,82; p=0,009).
English: time to relapse (back to CFS grade 4) was ≤224 days and ≤175 days in patients previously treated 12
Croatian: Na temelju prve kvartile (medijan se nije mogao procijeniti zbog malog broja relapsa) vrijeme do relapsa (povratak na 4. stupanj CFS-a) iznosilo je ≤224 dana u bolesnika prethodno liječenih IKERVISOM 12 mjeseci te ≤175 dana u bolesnika prethodno liječenih IKERVISOM
English: Package leaflet: Information for the patient IKERVIS 1 mg/mL, eye drops, emulsion ciclosporin
Croatian: Uputa o lijeku: Informacije za bolesnika IKERVIS 1 mg/ml kapi za oko, emulzija ciklosporin (ciclosporin)
English: It is likely to be attributable to ciclosporin.
Croatian: To je vjerojatno pripisivo ciklosporinu.
English: The mean change from baseline in ocular discomfort score (assessed using a Visual Analogic Scale) was -12.82 with IKERVIS and -11.21 with vehicle (p=0.808).
Croatian: Srednja vrijednost promjene od početne procjene očne nelagode (procijenjeno vizalno-analognom skalom) bila je -12,82 uz IKERVIS te -11,21 uz vehikulum (p=0,808).
English: Santen Oy Tel: +371 677 917 80
Croatian: Tel: +371 677 917 80
English: The effect of IKERVIS has not been studied in patients with hepatic or renal impairment.
Croatian: Djelovanje IKERVISA nije ispitano na bolesnicima s oštećenjem funkcije jetre ili bubrega.
English: Santen Oy Puh/Tel: +358 (0) 974790211
Croatian: Puh/Tel: +358 (0) 974790211
English: Santen Oy Tel: +420 234 102 170
Croatian: Tel: +420 234 102 170
English: Uncommon Instillation site reaction, instillation site discomfort, instillation site pruritus, instillation site foreign body sensation.
Croatian: Reakcija na mjestu ukapavanja, nelagoda na mjestu ukapavanja, svrbež na mjestu ukapavanja, osjećaj stranog tijela na mjestu ukapavanja.
English: Only use IKERVIS for dropping in your eye(s).
Croatian: Upozorenja i mjere opreza IKERVIS primjenjujte samo za kapanje u oko (oči).
English: Santen Oy Tel.: +48 (0) 221168608
Croatian: Tel.: +48 (0) 221168608
English: This study was an open-label, non-randomized, one-arm, 24-month study extension of the Sansika Study.
Croatian: Ovo ispitivanje bilo je produžetak ispitivanja SANSIKA , trajalo je 24 mjeseca i bilo je otvoreno, nerandomizirano ispitivanje s jednom skupinom ispitanika.
English: - if you are allergic to ciclosporin or to any of the other ingredients of this medicine (listed in section 6).
Croatian: NEMOJTE primjenjivati IKERVIS - ako ste alergični na ciklosporin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste imali ili imate rak oka ili područja oko oka.
English: In the 6 month, double-masked, vehicle controlled, supportive clinical trial (SICCANOVE study), 492 DED patients with moderate to severe keratitis (defined as a CFS score of 2 to 4) were also randomised to IKERVIS or vehicle daily at bedtime for 6 months.
Croatian: U dvostruko slijepom, vehikulumom kontroliranom, suportivnom kliničkom ispitivanju (SICCANOVE ispitivanje) koje je trajalo 6 mjeseci, 492 bolesnika sa sindromom suhog oka i umjerenim do teškim keratitisom (definiran kao 2-4 boda CFS-a) također su randomizirana u 2 skupine od kojih je jedna primala IKERVIS, a druga vehikulum svakodnevno, prije spavanja, tijekom 6 mjeseci.
English: In the 12 month, double-masked, vehicle controlled, pivotal clinical trial (SANSIKA study), 246 Dry Eye Disease (DED) patients with severe keratitis (defined as a corneal fluorescein staining (CFS) score of 4 on the modified Oxford scale) were randomised to one drop of IKERVIS or vehicle daily at bedtime for 6 months.
Croatian: U dvostruko slijepom, vehikulumom kontroliranom, pivotalnom kliničkom ispitivanju (SANSIKA ispitivanje) koje je trajalo 12 mjeseci, 264 bolesnika sa sindromom suhog oka i teškim keratitisom (definiran kao 4 boda modificirane Oksfordske skale nakon bojanja fluoresceinom (CFS, engl. corneal fluorescein staining)), randomizirana su u 2 skupine od kojih je jedna primala jednu kap IKERVISA dnevno, a druga jednu kap vehikuluma dnevno, prije spavanja, tijekom 6 mjeseci.
English: The recommended dose is one drop of IKERVIS once daily to be applied to the affected eye(s) at bedtime.
Croatian: Preporučena doza je jedna kap IKERVISA u zahvaćeno oko (zahvaćene oči) jednom dnevno prije spavanja.
English: IKERVIS 1 mg/mL eye drops, emulsion
Croatian: IKERVIS 1 mg/ml kapi za oko, emulzija
English: Santen Oy Tel: +370 37 366628
Croatian: Tel: +370 37 366628
English: Discard any opened individual single-dose container with any remaining emulsion immediately after use.
Croatian: Odmah nakon uporabe bacite svaki otvoreni jednodozni spremnik s preostalom emulzijom.
English: Santen Oy Tel: + 351 308 805 912
Croatian: Tel: +351 308 805 912
English: The mean change from baseline in the 100-point OSDI score was -13.6 with IKERVIS and -14.1 with vehicle at Month 6 (p=0.858).
Croatian: Srednja vrijednost promjene bodova na OSDI ljestvici od 100 bodova od početka do 6. mjeseca ispitivanja bila je -13,6 uz IKERVIS, a -14,1 uz vehikulum (p=0,858).
English: The following adverse reactions listed below were observed in clinical studies.
Croatian: U kliničkim ispitivanjima zabilježene su niže navedene nuspojave.
English: EXCELVISION Rue de la Lombardière ZI la Lombardière
Croatian: Rue de la Lombardière ZI la Lombardière F-07100 Annonay
English: Santen Oy Tel: +31 (0) 207139206
Croatian: Tel: +31 (0) 207139206
English: How to store IKERVIS
Croatian: Kako čuvati IKERVIS
English: - if you have had or have a cancer in or around your eye. - if you have an eye infection.
Croatian: - ako imate infekciju oka.
English: Irritation, redness, and increase in tears when the drops are put into the eye, redness of the eyelid, watery eyes, eye redness, blurred vision.
Croatian: Nadraženost, crvenilo i pojačano suzenje pri kapanju kapi u oko, crvenilo vjeđe, suzne oči, crvenilo oka, zamagljen vid.
English: The severity of keratitis, assessed using CFS, improved significantly from baseline at Month 6 with IKERVIS compared to vehicle (mean change from baseline was -1.764 with IKERVIS vs. -1.418 with vehicle, p=0.037).
Croatian: Došlo je do signifikantnog poboljšanja težine keratitisa od početka do 6. mjeseca ispitivanja uz IKERVIS u usporedbi s vehikulumom (srednja vrijednost promjene od početka za IKERVIS je bila1,764; a za vehikulum -1,418, p=0,037) procijenjeno CFS-om.
English: Santen Oy Tel: +40 (0) 316300603
Croatian: Tel: +40 (0) 316300603
English: One millilitre of IKERVIS contains 1 mg of ciclosporin.
Croatian: Jedan mililitar IKERVISA sadrži 1 mg ciklosporina.
English: One mL of emulsion contains 1 mg of ciclosporin.
Croatian: Jedan ml emulzije sadrži 1 mg ciklosporina (ciclosporin).
English: Santen Oy Tel: +43 (0) 720116199
Croatian: Tel: +43 (0) 720116199
English: ikervis
Croatian: Dojenje
English: Uncommon Conjunctival oedema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis.
Croatian: Edem konjunktive, poremećaj suzenja, iscjedak iz oka, svrbež oka, iritacija konjunktive, konjunktivitis, osjećaj stranog tijela u očima, depoziti u oku, keratitis, blefaritis, dekompenzacija rožnice, halacion, infiltracija rožnice, ožiljak na rožnici, svrbež vjeđe, iridociklitis.
English: Suomi/Finland
Croatian: Suomi/Finland Santen Oy
English: IKERVIS 1 mg/mL eye drops, emulsion ciclosporin
Croatian: IKERVIS 1 mg/ml kapi za oko, emulzija ciklosporin
English: IKERVIS is a milky white eye drops emulsion.
Croatian: Kako IKERVIS izgleda i sadržaj pakiranja IKERVIS je mliječno bijela emulzija u obliku kapi za oko.
English: Your vision may be blurred immediately after using IKERVIS eye drops.
Croatian: Neposredno nakon primjene kapi za oči IKERVIS vid bi Vam mogao biti zamagljen.
English: Santen Oy Tel: + 353 (0) 16950008
Croatian: Tel: +353 (0) 16950008
English: IKERVIS contains the active ingredient, ciclosporin.
Croatian: IKERVIS sadrži djelatnu tvar ciklosporin.
English: Common Instillation site irritation, instillation site erythema, instillation site lacrimation.
Croatian: Iritacija na mjestu ukapavanja, eritem na mjestu ukapavanja, suzenje na mjestu ukapavanja.
English: Common Erythema of eyelid, lacrimation increased, ocular hyperaemia, vision blurred, eyelid oedema, conjunctival hyperaemia, eye irritation, eye pain.
Croatian: Eritem vjeđe, pojačano suzenje, hiperemija očiju, zamagljen vid, edem vjeđe, hiperemija konjunktive, iritacija oka, bol u oku.
English: Santen Oy Τηλ: + 358 (0) 3 284 8111
Croatian: Τηλ: +358 (0) 3 284 8111
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Ikervis
English: months and 6 months with IKERVIS, respectively.
Croatian: 6 mjeseci u ispitivanju SANSIKA.
English: Swelling of the eyelid, redness of the conjunctiva (thin membrane covering the front part of the eye), eye irritation, eye pain.
Croatian: Oticanje vjeđa, crvenilo konjunktive (tanke opne koja prekriva prednji dio oka), nadraženost oka, bol u oku.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET SANTEN Oy
English: Pain when the drops are put into the eye.
Croatian: Bol pri kapanju kapi u oko.
English: How to store IKERVIS 6.
Croatian: 3. Kako primjenjivati IKERVIS
English: Method of administration Ocular use.
Croatian: Način primjene Okularno.
English: Ocular use.
Croatian: Za oko.
English: • Gently squeeze one drop of the medicine onto your eye. Make sure you do not touch your eye with the tip of the single-dose container.
Croatian: • Nježno istisnite jednu kap lijeka u oko.
English: Santen Oy Sími: + 358 (0) 3 284 8111
Croatian: Sími: +358 (0) 3 284 8111
English: 1 mL of emulsion contains 1 mg of ciclosporin.
Croatian: NAVOĐENJE DJELATNE TVARI 1 ml emulzije sadrži 1 mg ciklosporina.
English: • Gently shake the single dose container prior to use
Croatian: • Prije primjene nježno protresite jednodozni spremnik.
English: Deutschland
Croatian: Francuska
English: Cases of infections have been reported uncommonly in association with the use of IKERVIS.
Croatian: Slučajevi infekcija povezani s primjenom IKERVISA zabilježeni su manje često.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET SANTEN Oy
English: Tel: +39 0236009983
Croatian: Santen Italy S.r.l. Tel: +39 0236009983
English: Concomitant therapy
Croatian: Konkomitantno liječenje
English: LIST OF EXCIPIENTS
Croatian: Proizvođač EXCELVISION
English: Lot
Croatian: Santen
English: • Risk Management Plan ( RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: It may harm them, even if their symptoms are the same as yours.
Croatian: Može im naškoditi, čak i ako imaju simptome jednake Vašima.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo za zdravstvene radnike:
English: Date of latest renewal: 24 April 2006
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2006.
English: - This medicine has been prescribed for you.
Croatian: - Ovaj je lijek propisan samo Vama.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovaj lijek, jer sadrži Vama važne podatke.
English: This leaflet was last revised on
Croatian: Uputa je zadnji puta revidirana u
English: This dose might be repeated if needed up to 4.8 mL.
Croatian: Ta doza može se ponovno po potrebi ubrizgati do najviše 4,8 ml.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim s onima spomenutim u dijelu 6.6.
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba upotrijebiti odmah.
English: The mean terminal half-life was 12 minutes (range 2 to 33 minutes).
Croatian: Srednji terminalni poluvijek je 12 minuta (raspon od 2 do 33 minute).
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Croatian: Ako ste trudni i dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: Technical recommendation
Croatian: Tehničke preporuke
English: In the case of overdose the doctor will take appropriate action.
Croatian: U slučaju predoziranja liječnik će poduzeti odgovarajuće korake.
English: Not known Cannot be estimated from available data
Croatian: Ne može se procijeniti iz dostupnih podataka
English: Although these biological side effects have not been reported in humans, the use of a low mechanical index is recommended.
Croatian: Iako te biološke nuspojave nisu zapažene kod ljudi, preporučuje se uporaba niskog mehaničkog indeksa.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme čuvanja i uvjeti čuvanja prije uporabe odgovornost su korisnika.
English: Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified.
Croatian: Budući da do sada nije bilo zabilježenih slučajeva predoziranja, znakovi i simptomi predoziranja nisu identificirani.
English: Other medicines and SonoVue
Croatian: Drugi lijekovi i SonoVue
English: The recommended dose is 2 or 2.4 mL per patient.
Croatian: Preporučena doza je 2 ili 2,4 ml po bolesniku.
English: Emergency equipment and personnel trained in its use must be readily available.
Croatian: Oprema za hitne slučajeve i osoblje obučeno za njezinu primjenu moraju biti u pripravnosti.
English: Animal studies do not indicate harmful effects on fertility .
Croatian: Ispitivanja na životinjama ne upućuju na štetne učinke na plodnost.
English: NL - 1077 ZX Amsterdam The Netherlands
Croatian: NL - 1077 ZX Amsterdam Nizozemska
English: However you must stop breastfeeding for two to three hours after your ultrasound examination.
Croatian: Međutim, morate prekinuti dojenje na dva do tri sata nakon ultrazvučnog pregleda.
English: For the limitation in the interpretation of a negative urosonography, see section 4.4. and 5.1.
Croatian: Za ograničenja u interpretaciji negativne urosonografije, vidjeti dio 4.4 i 5.1.
English: The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows:
Croatian: Bočica se potom snažno protrese dvadeset sekundi, nakon čega se željeni volumen disperzije može uvući u štrcaljku kako slijedi:
English: Any unused liquid remaining at the end of an examination must be discarded.
Croatian: Sva neupotrijebljena tekućina preostala na kraju pregleda mora se baciti.
English: In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.
Croatian: Kod svih tih bolesnika postojao je visok podležeći rizik od većih srčanih komplikacija koje su mogle dovesti do fatalnog ishoda.
English: In the event of overdose occurring, the patient should be observed and treated symptomatically.
Croatian: U slučaju predoziranja, bolesnika treba promatrati i liječiti simptomatski.
English: Intravesical local tolerance for SonoVue was also assessed.
Croatian: Također je procijenjena intravezikalna lokalna tolerancija za SonoVue.
English: White powder
Croatian: Bijeli prašak
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti te reproduktivne toksičnosti.
English: Do not use SonoVue:
Croatian: Nemojte primjenjivati SonoVue:
English: Reconstitution instructions:
Croatian: Upute za rekonstituciju: