FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is 0.5 ml - 3.0 ml per patient.
Croatian: Preporučena doza iznosi 0,5 ml - 3,0 ml po bolesniku.
English: GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway
Croatian: GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norveška
English: In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies given in the table below: very common (≥1/10); common (≥1/100 to <1/10);
Croatian: U kliničkim ispitivanjima lijeka OPTISON, nuspojave su zabilježene kao štetni događaji s učestalošću navedenom u donjoj tablici: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do
English: - OPTISON will segregate in an undisturbed syringe and must be resuspended before use.
Croatian: - OPTISON će se izdvojiti u nepomičnoj štrcaljki i mora se ponovno suspendirati prije uporabe.
English: OPTISON contrast echocardiography should be accompanied by ECG monitoring.
Croatian: Kontrastna ehokardiografija pomoću lijeka OPTISON mora biti popraćena EKG nadzorom.
English: Therefore, the medicine should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the doctor.
Croatian: Zbog tog se razloga lijek ne smije koristiti tijekom trudnoće, osim ako su prednosti primjene veće od rizika te ako liječnik primjenu lijeka smatra nužnom.
English: OPTISON is injected during the ultrasound examination in order to allow the doctor to assess the function of your heart.
Croatian: OPTISON se ubrizgava tijekom ultrazvučnog pregleda kako bi liječnik mogao procijeniti funkciju srca.
English: • Ventricular tachycardia (a series of rapid heartbeats)
Croatian: • Ventrikularna tahikardija (niz brzih otkucaja srca)
English: • Dyspnoea (difficulty in breathing)
Croatian: • Dispneja (poteškoće s disanjem)
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Eozinofilija
English: In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed.
Croatian: Kod gravidnih kunića koji su tijekom organogeneze izloženi dnevnim dozama od 2,5 ml/kg (približno 15 puta više od maksimalno preporučene kliničke doze), primijećena je toksičnost za majku i embriofetalna toksičnost, uključujući blagu do ekstremnu dilataciju ventrikula mozga kod embrija kunića u razvojnom stadiju.
English: OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
Croatian: OPTISON se sastoji od mikrosfera toplinski obrađenog ljudskog albumina s perflutrenom suspendiranih u otopini ljudskog albumina, 1%.
English: Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration.
Croatian: Ultrazvuk se mora izvršiti tijekom injiciranja lijeka OPTISON, jer se najbolji kontrastni učinak postiže neposredno nakon primjene lijeka.
English: Vials are intended for single use only.
Croatian: Bočice su namijenjene samo za jednokratnu primjenu.
English: Reported side effects following the use of OPTISON:
Croatian: Zabilježene nuspojave nakon primjene lijeka OPTISON:
English: Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg.
Croatian: Plućna hipertenzija sa sistoličkim tlakom u plućnoj arteriji > 90 mm Hg.
English: OPTISON contains microspheres (tiny gas bubbles) that after injection travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualise and asses the function of the heart.
Croatian: OPTISON sadrži mikrosfere (malene mjehuriće plina) koje nakon ubrizgavanja prolaze venama do srca i pune komore lijeve strane srca, omogućavajući liječniku da jasno vidi i procijeni funkciju srca.
English: Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent thromboembolism, renal or hepatic end-stage disease.
Croatian: Ta klinička stanja uključuju sindrom respiratornog distresa kod odraslih, uporabu aparata za umjetno disanje s pozitivnim tlakom na kraju izdaha, teško zatajivanje srca (NYHA IV), endokarditis, akutni infarkt miokarda sa stabilnom ili nestabilnom anginom, umjetne srčane zaliske, akutna stanja sistemske upale ili sepse, poznata stanja hiperaktivnosti sustava koagulacije i/ili opetovane tromboembolije, krajnji stadij bolesti bubrega ili jetre.
English: OPTISON should only be used in patients where the study without contrast enhancement is inconclusive.
Croatian: OPTISON se smije primjenjivati samo kod bolesnika kod kojih ispitivanje bez poboljšanja kontrastom nije dalo jasne rezultate.
English: Dysgeusia (altered taste), headache Tinnitus, dizziness, paraesthesia
Croatian: Dizgeusija (poremećaj okusa), glavobolja Tinitus, omaglica, parestezija
English: No clinically important pulmonary haemodynamic, systemic haemodynamic, or ECG changes were observed.
Croatian: Nisu primijećene nikakve klinički značajne promjene plućne hemodinamike, sistemske hemodinamike ili EKG-a.
English: Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking effects with the possibility of obscuring important information.
Croatian: Za odgovarajuću opacifikaciju šupljina koristite najmanju dozu jer veće doze blokiraju učinak snimanja što može dovesti do zatamnjenja važnih podataka.
English: OPTISON improves the visualization of the inner cardiac walls in patients where the walls are difficult to see.
Croatian: OPTISON poboljšava vizualizaciju unutarnjih stijenki srca kod bolesnika čije je stijenke teško jasno prikazati.
English: This medicinal product is intended for left ventricular opacification after intravenous administration.
Croatian: Ovaj lijek je namijenjen opacifikaciji lijevog ventrikula nakon intravenske primjene.
English: The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg - The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Croatian: Približna količina perflutren plina u svakom ml lijeka OPTISON iznosi 0,19 mg - Pomoćne tvari su ljudski albumin, natrijev klorid, N-Acetiltriptofan, kaprilatna kiselina, natrijev hidroksid i voda za injekcije.
English: Immediately after OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the left ventricle.
Croatian: Odmah nakon ubrizgavanja lijeka OPTISON intravenska infuzija mora biti potpuno otvorena dok kontrast u lijevoj ventrikuli ne počne blijediti.
English: OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during an echocardiography (a procedure where an image of the heart is obtained by using ultrasound).
Croatian: OPTISON je ultrazvučno kontrastno sredstvo koje pomaže pri dobivanju jasnijih slika srca tijekom ehokardiografije (postupka snimanja srca ultrazvukom).
English: Side effects to OPTISON are rare and usually not serious.
Croatian: Nuspojave lijeka OPTISON rijetke su i obično nisu ozbiljne.
English: Store upright in a refrigerator (2oC - 8ºC).
Croatian: Čuvati u hladnjaku u uspravnom položaju (2 oC - 8 ºC).
English: Alternately, the flushing may be performed by infusion.
Croatian: Alternativno, moguće je provesti infuzijsko ispiranje.
English: • Warm sensation
Croatian: Osjećaj topline
English: Doses administered in one study were 0.2 ml above 25 kg body weight and 0.1ml under 25 kg, and in a second study 0.5ml above 20 kg body weight and 0.3 ml under 20 kg, by bolus peripheral intravenous injection followed by a saline flush.
Croatian: Doze primijenjene u jednom ispitivanju iznosile su 0,2 ml za ispitanike iznad 25 kg tjelesne težine i 0,1 ml do 25 kg, a u drugom ispitivanju 0,5 ml iznad 20 kg tjelesne težine i 0,3 ml ispod 20 kg, primijenjene u bolusu perifernom intravenskom injekcijom, nakon čega je slijedilo ispiranje fiziološkom otopinom.
English: The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full recovery.
Croatian: OPTISON u III. fazi kliničkih ispitivanja na ljudima bile su blage do umjerene s potpunim oporavkom.
English: OPTISON could be repeatedly administered, however, the clinical experience is limited.
Croatian: OPTISON se može višekratno primjenjivati, međutim, klinički su podaci ograničeni.
English: • Allergic type symptoms, for example, a severe allergic reaction or - shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria).
Croatian: • Alergijski simptomi, primjerice, teška alergijska reakcija ili šok (anafilaksa), oticanje lica (edem lica), svrbež kože (urtikarija).
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere sprječavanja infekcija do kojih može doći primjenom lijekova pripravljenih od ljudske krvi ili plazme uključuju odabir donora, pregled pojedinačnih uzoraka i pula plazme na specifične markere infekcije te primjenu učinkovitih proizvodnih koraka za inaktivaciju/uklanjanje virusa.
English: 5 x 3 ml presentation: EU/1/98/065/002
Croatian: Pakovanje od 5 x 3 ml: EU/1/98/065/002
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: Proizvođači ovih lijekova u postupak obrade krvi ili plazme također uključuju korake za inaktivaciju ili uklanjanje virusa.
English: Therefore, OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.
Croatian: Zbog tog se razloga OPTISON ne smije koristiti tijekom trudnoće, osim ako su prednosti primjene veće od rizika te ako liječnik primjenu lijeka smatra nužnom.
English: Store upright in a refrigerator.
Croatian: POSEBNE MJERE ČUVANJA Čuvati uspravno u hladnjaku.
English: OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber.
Croatian: OPTISON se daje putem intravenske injekcije kako bi mikrosfere mogle ući u srčanu komoru i ispuniti komoru lijeve strane srca.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane od ozbiljnih prema manje ozbiljnima.
English: Adverse reactions to OPTISON are rare and usually of a non-serious nature.
Croatian: Nuspojave vezane uz OPTISON rijetke su i obično nisu ozbiljne prirode.
English: • Tinnitus (noises in the ear)
Croatian: • Tinitus (šumovi u uhu)
English: GE Medical Systems Polska Sp. z o.o.
Croatian: GE Medical Systems Polska Sp. z o.o. Woloska St. 9
English: There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.
Croatian: Nema izvješća o virusnim infekcijama povezanih s albuminom proizvedenim utvrđenim postupcima prema specifikacijama Europske farmakopeje.
English: OPTISON consists of perflutren -containing microspheres.
Croatian: OPTISON se sastoji od mikrosfera koje sadrže perflutren.
English: GE International Inc. Konstitucijos pr. 7 LT-09308 Vilnius Tel.: + 370 68 723 753
Croatian: Konstitucijos pr. 7 LT-09308 Vilnius Tel.: + 370 68 723 753
English: GE International Inc. Meza 4
Croatian: GE International Inc.
English: There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Croatian: Nema izvješća o prijenosu virusa albuminom proizvedenim utvrđenim postupcima prema specifikacijama Europske farmakopeje.
English: There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease.
Croatian: Postoji ograničeno kliničko iskustvo s primjenom lijeka OPTISON kod bolesnika s određenim teškim stadijima srčane, plućne, bubrežne i jetrene bolesti.
English: - Immediately before injection a careful visual inspection of the syringe is mandatory in order to ensure complete suspension of the microspheres.
Croatian: Neposredno prije ubrizgavanja lijeka OPTISON obavezan je pažljiv vizualni pregled štrcaljke kako bi se osigurala potpuna suspenzija mikrosfera.
English: Microspheres in this size range contribute to the contrast effect by generating strongly enhanced echoes.
Croatian: U tom rasponu veličina, mikrosfere doprinose kontrastnom učinku jakim pojačanjem odjeka.
English: - The OPTISON vial must be inverted and gently rotated for approximately three minutes to completely resuspend the microspheres.
Croatian: - Bočicu s lijekom OPTISON morate preokrenuti i lagano zakretati približno tri minute kako bi se mikrosfere u potpunosti raspršile u suspenziju.
English: How to use OPTISON
Croatian: Kako primjenjivati OPTISON
English: - Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or precipitates before resuspension.
Croatian: - Pričekajte da se bočica zagrije na sobnu temperaturu i prije ponovne priprave suspenzije provjerite da se u tekućoj fazi ne nalaze čestice ili precipitat.
English: The safety of OPTISON for use during human pregnancy has not been fully established.
Croatian: Sigurnost primjene lijeka OPTISON tijekom trudnoće kod ljudi nije potpuno utvrđena.
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Croatian: Te mjere uključuju pažljiv odabir donora krvi i plazme kako bi se isključila opasnost od prijenosa infekcija te ispitivanje pojedinačnih uzoraka i pula plazme na prisutnost virusa/infekcija.
English: NO-0485 Oslo, Norway
Croatian: NO-0485 Oslo, Norveška
English: LIST OF EXCIPIENTS Excipients: Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Croatian: Pomoćne tvari: ljudski albumin, natrijev klorid, N-Acetiltriptofan, kaprilatna kiselina, natrijev hidroksid i voda za injekcije.
English: Attach a threeway stopcock to the cannula.
Croatian: Spojite trosmjerni zaustavni zatvarač na kanilu.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Croatian: Na lijekove dobivene iz ljudske krvi ili plazme primjenjuju se određene mjere za sprječavanje prijenosa infekcija na bolesnike.
English: How to store OPTISON
Croatian: Kako čuvati OPTISON
English: Clear solution with white microsphere layer on top.
Croatian: Prozirna otopina s bijelim slojem mikrosfera na vrhu.
English: The safety and efficacy of OPTISON in children and adolescents below 18 years has not been established.
Croatian: Sigurnost i djelotvornost OPTISONA u djece i adolescenata mlađih od 18 godina nije još ustanovljena.
English: OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml.
Croatian: OPTISON je dostupan u sljedećim pakovanjima: 1 bočica od 3 ml ili 5 bočica od 3 ml.
English: It is a clear solution with white microsphere layer on top.
Croatian: To je prozirna otopina s bijelim slojem mikrosfera na vrhu.
English: - Resuspend the microspheres in the syringe immediately before injection by holding the syringe horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds.
Croatian: Netom prije ubrizgavanja ponovno pripravite suspenziju mikrosfere u štrcaljki na način da vodoravno držite štrcaljku među dlanovima i brzo je protrljate naprijed-natrag najmanje 10 sekundi.
English: The experience of OPTISON in severely ill patients is limited - if you have an artificial valve in your heart - if you have acute severe inflammation or sepsis - if you have a known blood clotting problem
Croatian: - ako u srcu imate umjetni zalistak, - ako imate tešku akutnu upalu ili sepsu, - ako imate poznat problem sa zgrušavanjem krvi.
English: mmHg) and 11 with a normal PASP (≤35 mmHg; mean 29.3±4.6 mmHg; range 22.0-35.0 mmHg).
Croatian: 70,1±33,0 mmHg; raspon 36,0-176,0 mmHg) i 11 s normalnim PAST-om (≤35 mmHg; srednja vrijednost 29,3±4,6 mmHg; raspon 22,0-35,0 mmHg).
English: OPTISON should only be administered by doctors experienced in the field of diagnostic ultrasound imaging.
Croatian: OPTISON smiju davati samo liječnici koji imaju iskustva na području snimanja dijagnostičkim ultrazvukom.
English: It is not known whether OPTISON is excreted in human milk.
Croatian: Nije poznato izlučuje li se OPTISON u majčinom mlijeku.
English: Do not use OPTISON after the expiry date which is stated on the label, after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici lijeka iza teksta "EXP ".
English: Pharma-Cos Limited Pharma-Cos House, C. Portanier Street MT-Santa Venera SVR 1732 Tel: + 35 6 2144 1870
Croatian: Portanier Street MT-Santa Venera SVR 1732 Tel: + 35 6 2144 1870
English: OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation.
Croatian: OPTISON je transpulmonalno ehokardiografsko kontrastno sredstvo za primjenu u bolesnika s potvrđenom kardiovaskularnom bolesti ili kod kojih postoji sumnja na kardiovaskularnu bolest za opacifikaciju srčanih komora, poboljšanje obrisa endokardijalnog ruba lijevog ventrikula s poboljšanom vizualizacijom kretanja srčane stijenke.
English: Children and adolescents Efficacy and safety in patients below 18 years has not been established.
Croatian: Djeca i adolescenti Djelotvornost i sigurnost primjene lijeka kod bolesnika mlađih od 18 godina nije utvrđena.
English: The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been penetrated.
Croatian: Sadržaj bočice lijeka OPTISON mora se upotrijebiti unutar 30 minuta nakon probijanja gumenog zatvarača.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci dobiveni na temelju konvencionalnih ispitivanja sigurne farmakologije, akutne toksičnosti i toksičnosti ponovljene doze te genotoksičnosti nisu pokazali posebne opasnosti za ljude.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Usprkos tome, tijekom primjene lijekova pripravljenih od ljudske krvi ili plazme nije moguće u potpunosti isključiti mogućnost prijenosa zaraznih agensa.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Usprkos tim mjerama, tijekom primjene lijekova pripravljenih od ljudske krvi ili plazme nije moguće u potpunosti isključiti mogućnost prijenosa infekcije.
English: - OPTISON should be withdrawn with care into the syringe within 1 minute after resuspension.
Croatian: - OPTISON morate pažljivo uvući u štrcaljku unutar 1 minute nakon ponovne priprave suspenzije.
English: The safety of OPTISON for use during human pregnancy has not been established.
Croatian: Sigurnost primjene lijeka OPTISON tijekom trudnoće kod ljudi nije utvrđena.
English: The infusion should then be returned to a TKO rate.
Croatian: Infuziju potom morate vratiti na TKO brzinu protoka.
English: The effect of OPTISON on pulmonary haemodynamics was studied in a prospective, open-label study of 30 patients scheduled for pulmonary artery catheterisation, including 19 with an elevated baseline pulmonary arterial systolic pressure (PASP) (>35 mmHg; mean 70.1±33.0 mmHg; range 36.0-176.0
Croatian: Učinak OPTISONA na plućnu hemodinamiku proučavan je u prospektivnom otvorenom kliničkom ispitivanju u kojem je sudjelovalo 30 bolesnika naručenih za kateterizaciju plućne arterije, uključujući njih 19 s povišenim plućnim arterijskim sistoličkim tlakom (PAST) (>35 mmHg; srednja vrijednost
English: MARKETING AUTHORISATION NUMBERS 1 x 3 ml presentation: EU/1/98/065/001
Croatian: ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Pakovanje od 1 x 3 ml: EU/1/98/065/001
English: Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container.
Croatian: Kao i sve parenteralne proizvode, bočice s lijekom OPTISON treba vizualno pregledati kako bi se provjerilo je li spremnik oštećen.
English: It is strongly recommended that every time you receive a dose of OPTISON the name and batch number of the product are recorded in order to maintain a record of the batches used.
Croatian: Izričito je preporučljivo pri svakoj primjeni doze lijeka OPTISON zabilježiti naziv i serijski broj lijeka kako bi postojao zapis o korištenoj seriji lijeka.
English: It is strongly recommended that every time that OPTISON is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Croatian: Pri svakoj primjeni lijeka OPTISON bolesniku, izričito je preporučljivo zabilježiti naziv i serijski broj lijeka kako bi se održala veza između bolesnika i serije lijeka.
English: The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a ”to keep open” (TKO) rate.
Croatian: U tom slučaju, komplet za infuziju morate spojiti na trosmjerni zaustavni zatvarač i pokrenuti infuziju pri izravnom protoku (“to keep open”, TKO).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: POSEBNO UPOZORENJE DA SE LIJEK MORA ČUVATI IZVAN POGLEDA
English: Not applicable.
Croatian: LIJEKA Nije primjenjivo.
English: Excipient with known effect: Each ml contains 0.15 mmol (3.45 mg) of sodium.
Croatian: Svaki ml sadrži 0,15 mmol (3,45 mg) natrija.
English: GE Healthcare Buchler GmbH & Co. KG Gieselweg 1
Croatian: GE Healthcare Buchler GmbH & Co.
English: Your heart activity and rhythm will be monitored when you get OPTISON.
Croatian: Nakon dobivanja lijeka OPTISON pratit će se aktivnost i ritam Vašeg srca.
English: • Visual disturbances
Croatian: • Smetnje vida
English: Rare side effects (affects 1 to 10 users in 10,000):
Croatian: Rijetke nuspojave (pogađaju 1 do 10 na 10.000 korisnika):
English: Allergic type symptoms (e.g. anaphylactoid reaction or -shock, face oedema, urticaria)
Croatian: Poremećaji imunološkog sustava Alergijski simptomi (npr. anafilaktička reakcija ili šok, edem lica, urtikarija)
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: It is not known whether OPTISON passes into human milk.
Croatian: Nije poznato izlučuje li se OPTISON u majčino mlijeko.
English: Sodium hydroxide (pH adjustment) Water for injections
Croatian: N-Acetiltriptofan kaprilatna kiselina natrijev hidroksid (za podešavanje pH) voda za injekcije