FrancophonIA/ELRC3.0 huggingface dataset:
English: Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid, Solvent: sodium chloride 9 mg/mL
Croatian: Makrogol 4000, distearilfosfatidilkolin, natrijev fosfatidilglicerildipalmitat, palmitatna kiselina, Otapalo: natrijev klorid 9 mg/ml
English: In animal studies, the application of echo-contrast agents revealed biological adverse reactions (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Croatian: Ispitivanja na životinjama pokazala su da je primjena eho-kontrastnog sredstva dovela do bioloških nuspojava (npr. oštećenje endotelnih stanica, puknuće kapilara) u interakciji s ultrazvučnim valovima.
English: PHARMACEUTICAL FORM AND CONTENTS 1 powder vial, 1 pre-filled syringe of solvent, 1 transfer system
Croatian: OBLIK I SADRŽAJ 1 bočica s praškom,1 napunjena štrcaljka s otapalom, 1 sustav za prijenos
English: Immediately following the first voiding, the bladder may be refilled with saline for a second cycle of voiding and imaging, without the need of a second SonoVue administration.
Croatian: Odmah nakon prvog pražnjenja, mjehur se može ponovno napuniti fiziološkom otopinom za drugi ciklus pražnjenja i oslikavanja, bez potrebe ponovne primjene lijeka SonoVue.
English: • In paediatric patients the recommended dose of SonoVue is 1mL.
Croatian: Intravezikalna primjena • U pedijatrijskih bolesnika preporučena doza za SonoVue je 1 ml.
English: Intravenous use of SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
Croatian: Intravenska primjena lijeka SonoVue je kontraindicirana u bolesnika s poznatim desno-lijevim šantovima, teškom plućnom hipertenzijom (tlak plućne arterije > 90 mmHg), nekontroliranom sistemskom hipertenzijom i kod bolesnika s respiratornim distres sindromom odraslih.
English: For ultrasonography of the excretory urinary tract in paediatric patients, after intravesical administration, SonoVue increases the signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis, and facilitates the detection of reflux of fluid from the bladder into the ureters.
Croatian: Za ultrasonografiju ekskretornog urinarnog trakta u pedijatrijskih bolesnika, nakon intravezikalne primjene, SonoVue povećava intenzitet signala tekućina unutar mokraćne cijevi, mjehura, mokraćovoda i bubrežne nakapnice, te olakšava otkrivanje refluksa tekućine iz mjehura u mokraćovode.
English: SonoVue must not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
Croatian: SonoVue se ne smije koristiti u kombinaciji s dobutaminom kod bolesnika sa stanjima koja ukazuju na vaskularne nestabilnosti kada je dobutamin kontraindiciran.
English: This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Ultrasound imaging of the bladder and kidneys is performed during filling and voiding of the bladder.
Croatian: Ultrazvučno oslikavanje mjehura i bubrega izvodi se tijekom punjenja i pražnjenja mjehura.
English: Not known (frequency cannot be estimated from the available data): - Faintness - In some of the cases of allergic reactions, in patients with cardiac blood vessel disease, lack of oxygen supply of the heart or cardiac arrest were reported - Vomiting
Croatian: Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka): - nesvjestica; - u nekim slučajevima alergijskih reakcija, u bolesnika s bolešću srčanih krvnih žila prijavljen je prekid dostave kisika u srce ili srčani zastoj; - povraćanje.
English: The sulphur hexafluoride dissolves in the blood and is subsequently exhaled.
Croatian: Sumporov heksafluorid otapa se u krvi, a potom se izlučuje u izdahnutom zraku.
English: No clinical data are available.
Croatian: Plodnost Nisu dostupni klinički podaci.
English: SonoVue helps to obtain clearer pictures of the urinary tract in children .
Croatian: SonoVue omogućava dobivanje jasnijih snimaka mokraćnog sustava kod djece.
English: The vial is for a single use only.
Croatian: Bočica je samo za jednokratnu uporabu.
English: How to store SonoVue
Croatian: Kako čuvati SonoVue
English: It was therefore concluded that SonoVue is well tolerated in the urinary tract in the rat.
Croatian: Stoga je zaključeno da se SonoVue dobro podnosi u urinarnom traktu kod štakora.
English: Use caution when treating anaphylaxis with epinephrine in patients on beta blockers since response may be poor or promote undesired alpha-adrenergic and vagotonic effects (hypertension, bradycardia).
Croatian: Potreban je oprez kod liječenja anafilaksije s epinefrinom u bolesnika koji uzimaju beta-blokatore budući da odgovor može biti slab ili može potaknuti neželjene alfa-adrenergičke i vagotoničke učinke
English: Overdose is not likely to happen since SonoVue is given by a doctor.
Croatian: Malo je vjerojatno da će doći do predoziranja lijekom SonoVue jer Vam ga daje liječnik.
English: For patients under 18 years of age SonoVue can be used only for ultrasound of the urinary tract.
Croatian: Za bolesnike mlađe od 18 godina SonoVue se smije koristiti samo za ultrazvučno oslikavanje mokraćnog sustava.
English: Remove the protective disk from the vial.
Croatian: Uklonite zaštitni poklopac s bočice.
English: Nausea, Abdominal pain
Croatian: Mučnina, bol u abdomenu
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the dispersion contains 8 µL sulphur hexafluoride microbubbles, equivalent to 45 micrograms.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml disperzije sadrži 8 µl mikromjehurića sumporovog heksafluorida, što odgovara 45 mikrograma.
English: SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux.
Croatian: SonoVue je indiciran za uporabu u ultrasonografiji ekskretornog urinarnog trakta u pedijatrijskih bolesnika od novorođenačke dobi do 18 godina za otkrivanje vezikoureteralnog refluksa.
English: It is not known if SonoVue passes into breast milk.
Croatian: Nije poznato izlučuje li se SonoVue u majčino mlijeko.
English: It is not known if sulphur hexafluoride is excreted in human milk .
Croatian: Nije poznato izlučuje li se sumporov heksafluorid u majčino mlijeko.
English: SonoVue dispersion should be administered within six hours of its preparation.
Croatian: SonoVue disperzija treba biti primijenjena unutar šest sati od pripreme.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous or intravesical use Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena u venu ili intravezikalna primjena Prije uporabe pročitajte uputu o lijeku.
English: SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
Croatian: SonoVue je transpulmonalno ehokardiografsko kontrastno sredstvo koje se koristi kod odraslih bolesnika sa sumnjom na ili s dokazanom kardiovaskularnom bolešću kako bi se omogućila opacifikacija srčanih komora i poboljšalo određivanje endokardijalnih kontura lijevog ventrikula.
English: Justification for not including Braille accepted
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Use extreme caution when considering the administration of Sonvue in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders because in these patients allergy like and/or vasodilatory reactions may lead to life threatening conditions.
Croatian: Primjenu lijeka SonoVue u bolesnika s nedavnim akutnim koronarnim sindromom ili klinički nestabilnom ishemijskom bolesti srca, uključujući: infarkt miokarda u razvoju ili u tijeku, tipičnu anginu u mirovanju u zadnjih 7 dana, značajno pogoršanje srčanih simptoma u zadnjih 7 dana, nedavne intervencije na koronarnim arterijama ili druge čimbenike koji ukazuju na kliničku nestabilnost (primjerice, nedavno pogoršanje EKG-a, laboratorijskih ili kliničkih nalaza), akutno zatajenje srca, zatajenje srca klase III/IV ili teške poremećaje ritma, potrebno je razmotriti uz veliki oprez jer kod takvih bolesnika, alergijske i/ili vazodilatacijske reakcije mogu dovesti do stanja opasnih po život.
English: Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an aluminium crimp seal with a flip-off disc. A transfer system ( MiniSpike ).
Croatian: I koja sadrži 25 mg suhog, liofiliziranog praška u atmosferi sumporovog heksafluorida zatvorena sa sivim butilnim gumenim čepom i zapečaćena aluminijskim zatvaračem sa flip-off poklopcem.
English: Uncommon side effects (may affect up to 1 in 100 people): - Headache - Numbness - Dizziness - Strange taste in the mouth - Redness - Chest discomfort - Feeling sick (nausea) - Abdominal pain - Skin rash - Feeling hot - Local reactions where the injection was given such as: pain or an unusual sensation at the injection site
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): - glavobolja; - utrnulost; - omaglica; - čudan okus u ustima; - crvenilo; - nelagoda u prsnom košu; - mučnina; - bol u trbuhu; - osip kože; - osjećaj vrućine; - lokalne reakcije na mjestu primjene injekcije kao što su: bol ili neobičan osjećaj na mjestu primjene injekcije
English: Caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease, as the numbers of patients with those conditions who were exposed to SonoVue in the clinical trials were limited.
Croatian: Savjetuje se oprez kod uporabe ovog lijeka kod bolesnika s: akutnim endokarditisom, umjetnim zaliscima, akutnom sistemskom upalom i/ili sepsom, hiperkoagulacijskim stanjima i/ili nedavnom tromboembolijom te završnim stadijima bolesti bubrega ili jetre, s obzirom da je broj bolesnika s ovim stanjima koji su bili izloženi lijeku SonoVue tijekom kliničkih ispitivanja ograničen.
English: In a Phase I study doses up to 52 mL of SonoVue were administered to normal volunteers without serious adverse events being reported.
Croatian: U ispitivanju faze 1 zdravi dobrovoljci su primili doze do 52 ml lijeka SonoVue i nisu prijavili ozbiljne nuspojave.
English: If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe.
Croatian: Ako se SonoVue ne upotrijebi odmah nakon rekonstitucije, morate ponovno protresti disperziju mikromjehurića prije uvlačenja u štrcaljku.
English: After introduction of a sterile 6F-8F urinary catheter into the bladder under sterile conditions, the bladder is emptied of urine and then filled with saline (normal sterile 0.9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL.
Croatian: Ispraznite urin iz mjehura, te ispunite mjehur fiziološkom otopinom (normalna sterilna 0,9% otopina natrijevog klorida) do otprilike jedne trećine ili polovine njegovog predviđenog ukupnog volumena [(dob u godinama +2) x 30] ml.
English: SonoVue contains sodium
Croatian: SonoVue sadrži natrij
English: SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation.
Croatian: SonoVue poboljšava prikaz vaskularnosti lezija jetre i dojki pri Doppler sonografiji u odraslih bolesnika, vodeći do specifičnije karakterizacije lezije.
English: Paediatric population-Intravesical use
Croatian: Pedijatrijska populacija-Intravezikalna primjena
English: Doppler of microvasculature
Croatian: Doppler malih žila
English: Talk to your doctor before you are given SonoVue if: - you had a recent myocardial infarction or a recent surgery on your coronary arteries, - you suffer from angina or chest pain or severe cardiac disease, - you suffer from severe heart rhythm disorders, - your cardiac disease has worsened recently, - you have an acute inflammation of the cardiac envelope (endocarditis), - you have artificial heart valves, - you have an acute general inflammation or infection, - you have known blood clotting problem, - you have severe kidney or liver diseases,
Croatian: - ste nedavno imali srčani udar ili ste nedavno operirali koronarne arterije, - imate anginu ili bol u prsnom košu ili tešku srčanu bolest, - imate teške poremećaje srčanog ritma, - je nedavno došlo do pogoršanja bolesti srca, - imate akutnu upalu srčane ovojnice (endokarditis), - imate umjetne srčane zaliske, - imate akutnu opću upalu ili infekciju, - imate utvrđeni poremećaj zgrušavanja krvi, - imate tešku bolest bubrega ili jetre
English: SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment in adult patients.
Croatian: SonoVue povećava kvalitetu dopplerskog prikaza protoka i trajanje klinički korisnog poboljšanja signala u prikazu portalne vene u odraslih bolesnika.
English: SonoVue should be administered immediately by injection into a peripheral vein for use in echocardiography and in vascular Doppler imaging in adults or by intravesical administration for use in ultrasonography of the excretory urinary tract in paediatric patients.
Croatian: SonoVue treba odmah primijeniti injekcijom u perifernu venu za uporabu u ehokardiografiji i Doppler prikazu krvnih žila u odraslih ili primijeniti intravezikalno za uporabu u ultrasonografiji ekskretornog urinarnog trakta u pedijatrijskih bolesnika.
English: For the full list of excipients, see section 6.1
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.
Croatian: SonoVue treba ubrizgati u perifernu venu odmah nakon uvlačenja u štrcaljku.
English: ECG monitoring should be performed in high-risk patients as clinically indicated.
Croatian: Bolesnici s nestabilnim kardiopulmonalnim statusom Kod visoko rizičnih bolesnika potrebno je EKG praćenje kao što je klinički indicirano.
English: Doppler of macrovasculature
Croatian: Doppler velikih žila
English: Empty the contents of the syringe into the vial by pushing on the plunger rod.
Croatian: Ispraznite sadržaj štrcaljke u bočicu pritišćući potisnik klipa.
English: Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date which is stated on the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici.
English: SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.
Croatian: SonoVue povećava točnost pri otkrivanju ili isključivanju anomalija u cerebralnim arterijama i ekstrakranijalnim karotidnim ili perifernim arterijama u odraslih bolesnika poboljšavajući dopplerski omjer signala i šuma.
English: False negative cases can occur with voiding ultrasonography with SonoVue and have not been clarified (see section 5.1).
Croatian: Interpretacija mikcijske urosonografije s lijekom SonoVue i ograničenja u primjeni Lažno negativni slučajevi mogu se pojaviti tijekom mikcijske urosonografije s lijekom SonoVue i oni nisu razjašnjeni (vidjeti dio 5.1).
English: Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
Croatian: Potisnite bočicu u prozirnu cijev sustava za prijenos i čvrsto pritisnite da bočica sjedne na svoje mjesto.
English: METHOD OF ADMINISTRATION Intravenous or intravesical use
Croatian: NAČIN PRIMJENE LIJEKA Primjena u venu ili intravezikalna primjena
English: Rare (may affect up 1 in 1,000 people): - Blurred vision - Decrease in blood pressure - Itching - Back pain - Pain in general - Chest pain - Fatigue - Severe and less severe allergic reaction (including redness of the skin, decrease in heart rate,
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba): - zamagljen vid; - snižavanje krvnog tlaka; - svrbež; - bol u leđima; - bol općenito; - bol u prsnom košu; - umor; - teške i manje teške alergijske reakcije (uključujući crvenilo kože, usporen puls, sniženje krvnog tlaka, nedostatak zraka, gubitak svijesti, srčani/srčano-dišni zastoj, ili teža reakcija s otežanim disanjem i omaglicom).
English: If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
Croatian: Ako se lijek SonoVue ne primijeni neposredno nakon rekonstitucije disperziju treba ponovno protresti prije uvlačenja u štrcaljku.
English: - The other ingredients are: macrogol 4000, distearoylphosphatidylcholine,
Croatian: - Drugi sastojci su: makrogol 4000, distearilfosfatidilkolin, natrijev fosfatidilglicerildipalmitat,
English: Unscrew the syringe from the transfer system.
Croatian: Odvijte štrcaljku sa sustava za prijenos.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).
Croatian: Osim toga, tijekom primjene lijeka SonoVue u ehokardiografiji s farmakološkim stresorom (npr. s dobutaminom), potrebno je provoditi praćenje EKG-a i krvnog tlaka.
English: SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to the contents of the vial.
Croatian: SonoVue se prije uporabe mora pripremiti ubrizgavanjem 5 ml 0,9%-tne (9 mg/ml) otopine natrijevog klorida za injekciju kroz čep u sadržaj bočice.
English: The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam .The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhancing blood echogenicity and increasing contrast between the blood and the surrounding tissues .
Croatian: Granica između mjehurića sumporovog heksafluorida i vodenog medija djeluje kao reflektor ultrazvučnih valova i tako povećava ehogenost krvi te pojačava kontrast između krvi i okolnih tkiva.
English: Chest pain, pain, fatigue
Croatian: Bol u prsištu, bol, umor
English: Intravesical use
Croatian: Intravezikalna primjena
English: SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.
Croatian: SonoVue je namijenjen za primjenu uz ultrazvučno oslikavanje kako bi povećao ehogenost krvi ili tekućina u urinarnom traktu, što dovodi do poboljšanog omjera signala i šuma (smetnji).
English: Administration of SonoVue is followed by completion of bladder filling with saline until patient has the urge to micturate or there is the first slight sign of back pressure to the infusion.
Croatian: Ubrizgajte SonoVue kroz urinarni kateter, te nastavite puniti mjehur sa fiziološkom otopinom dok bolesnik ne osjeti potrebu za mokrenjem ili dok se ne pojavi prvi blagi znak povratnog pritiska u infuziju.
English: Open the MiniSpike transfer system blister and remove syringe tip cap. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
Croatian: Otvorite blister MiniSpike sustava za prijenos i uklonite zatvarač s vrha štrcaljke.
English: The following side effects have been reported with SonoVue:
Croatian: Za lijek SonoVue prijavljene su sljedeće nuspojave:
English: SonoVue 8 microlitres/mL powder and solvent for dispersion for injection sulphur hexafluoride
Croatian: SonoVue 8 mikrolitara/ml prašak i otapalo za disperziju za injekciju sumporov heksafluorid
English: Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Nakon svake injekcije treba slijediti ispiranje s 5 ml 9 mg/ml (0,9%) otopine natrijevog klorida za injekciju.
English: Connect the plunger rod by screwing it clockwise into the syringe.
Croatian: Pričvrstite klip uvijajući ga na štrcaljku u smjeru kazaljke na satu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of the dispersion contains 8 µLsulphur hexafluoride microbubbles, equivalent to 45 micrograms.
Croatian: Jedan ml disperzije sadrži 8 µl mikromjehurića sumporovog heksafluorida, što odgovara 45 mikrograma.
English: Other concomitant diseases
Croatian: Ostale prateće bolesti
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sodium chloride 9 mg/mL solution for injection Solvent for SonoVue
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA 9 mg/ml otopina natrijevog klorida za injekciju Otapalo za SonoVue
English: There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy.The addition of sodium chloride 9 mg/mL (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride.
Croatian: Dodatak otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju u liofilizirani prašak nakon kojeg slijedi snažno protresanje dovodi do stvaranja mikromjehurića sumporovog heksafluorida.
English: A low mechanical index (≤ 0.4) is recommended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast.
Croatian: Za oslikavanje mjehura, mokraćovoda i bubrega tijekom ultrasonografije urinarnog trakta s kontrastom, preporučuje se niski mehanički indeks (≤ 0,4).
English: SonoVue will then be administered through the thin tube and will be followed by administration of saline to continue filling the bladder.
Croatian: Nakon toga će se kroz tanku cjevčicu primijeniti SonoVue te će potom uslijediti primjena fiziološke otopine kako bi se nastavio puniti mjehur.
English: After emptying the bladder, a saline solution will be introduced into the bladder via a thin tube.
Croatian: Nakon pražnjenja mjehura, u mjehur će se kroz tanku cjevčicu ubrizgati fiziološka otopina.
English: Musculoskeletal, connective tissue and bone disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Otapalo: 9 mg/ml (0,9%) otopina natrijevog klorida za injekciju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SonoVue 8 microlitres/mL powder for dispersion for injection sulphur hexafluoride
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA SonoVue 8 mikrolitara/ml prašak za disperziju za injekciju sumporov heksafluorid
English: NAME OF THE MEDICINAL PRODUCT SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
Croatian: NAZIV LIJEKA SonoVue 8 mikrolitara/ml prašak i otapalo za disperziju za injekciju.
English: The glass syringe contains sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Staklena štrcaljka sadrži 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za injekciju.
English: Bracco Imaging S.p.A.
Croatian: Bracco International B.V.