FrancophonIA/ELRC3.0 huggingface dataset:
English: OPTISON should only be used in patients where the study without contrast enhancement is inconclusive.
Slovenian: Kontrastno sredstvo OPTISON se sme uporabljati samo pri bolnikih, pri katerih preiskava brez kontrastne ojačitve ni uspešna.
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.
Slovenian: Nadzorovani odmerki v eni študiji so bili 0,2 ml pri telesni masi nad 25 kg in 0,1 ml pod 25 kg, v drugi študiji pa 0,5 ml pri telesni masi nad 20 kg in 0,3 ml pod 20 kg, z bolusno periferno intravensko injekcijo, ki ji je sledilo izpiranje s fiziološko raztopino.
English: Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration.
Slovenian: Ultrazvočno slikanje se mora izvajati med injiciranjem kontrastnega sredstva OPTISON, ker se najboljši kontrastni učinek doseže neposredno po dajanju.
English: GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway
Slovenian: GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norveška
English: Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg.
Slovenian: Pljučna hipertenzija s sistoličnim tlakom v pljučni arteriji > 90 mm Hg.
English: No such finding was observed in the rat embryotoxicity study.
Slovenian: V embriotoksikološki študiji na podganah takšnih izsledkov niso opazili.
English: 6.6 Special precautions for disposal and other handling Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Kot vsa parenteralna zdravila je treba tudi viale kontrastnega sredstva OPTISON vizualno pregledati na intaktnost vsebnika.
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.
Slovenian: Pri brejih kuncih, izpostavljenih dnevnim odmerkom 2,5 ml/kg (približno 15 x maksimalni priporočeni klinični odmerek) med organogenezo, so opazili škodljive učinke za mater in embrio-fetalno toksičnost vključno z blagim do ekstremnim širjenjem možganskih ventriklov razvijajočih se zajčjih zarodkov.
English: Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking effects with the possibility of obscuring important information.
Slovenian: Uporabljajte najmanjši odmerek, zadosten za dosego ustrezne opacifikacije votlin, ker lahko veliki odmerki blokirajo učinke slikanja z možnostjo zatemnitve pomembnih informacij.
English: The ultrasonic properties of microspheres containing perflutren are very different from that of soft tissue and will generate strong echoes.
Slovenian: Ultrazvočne lastnosti mikrosfer s perflutrenom se močno razlikujejo od lastnosti mehkih tkiv in tvorijo močan odboj.
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.
Slovenian: Zelo priporočljivo je, da se vsakič, ko prejmete kontrastno sredstvo OPTISON, zabeleži ime in številko serije izdelka, da se vodi evidenca o uporabljenih serijah.
English: In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Slovenian: V študijah na živalih je uporaba ultrazvočnih kontrastnih sredstev razkrila pojav bioloških neželenih učinkov (npr. poškodbo endotelijskih celic, rupturo kapilar) zaradi interakcije z ultrazvočnim valovanjem.
English: Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container.
Slovenian: Kot vsa parenteralna zdravila je treba tudi viale kontrastnega sredstva OPTISON vizualno pregledati na intaktnost vsebnika.
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.
Slovenian: Ultrazvočni odboj od krvi in bioloških mehkih tkiv, kot so maščobna tkiva in mišice, se zaradi majhnih razlik ultrazvočnih lastnosti tkiv tvori na mejni površini.
English: Information obtained from a preclinical study in rats with 125I-labelled albumin microspheres indicated that microspheres were rapidly cleared from the circulation, and radio-labelled microspheres, albumin shells and 125I were taken up primarily in the liver.
Slovenian: Podatki, pridobljeni iz predkliničnih študij na podganah z uporabo 125I- radioaktivno označenih mikrosfer albumina so pokazali hitro izstopanje mikrosfer iz krvnega obtoka in primarni privzem radioaktivno označenih mikrosfer, albuminskih ovojnic in 125I v jetrih.
English: 4.7 Effects on the ability to drive and use machines
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GE Healthcare AS, Nycoveien 1, 0485 Oslo, Norway 12.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GE Healthcare AS, Nycoveien 1, 0485 Oslo, Norveška 12.
English: OPTISON is a dispersion for injection.
Slovenian: Kontrastno sredstvo OPTISON je disperzija za injiciranje.
English: What OPTISON looks like and contents of the pack
Slovenian: Izgled kontrastnega sredstva OPTISON in vsebina pakiranja
English: Children and adolescents Efficacy and safety in patients below 18 years has not been established.
Slovenian: Otroci in mladostniki Učinkovitost in varnost pri bolnikih, mlajših od 18 let, nista dokazani.
English: Store upright in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C) v pokončnem položaju.
English: • Ventricular tachycardia (a series of rapid heartbeats)
Slovenian: • prekatna tahikardija (serija hitrih srčnih utripov).
English: Immediately after OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the left ventricle.
Slovenian: Takoj po injiciranju kontrastnega sredstva OPTISON je treba široko odpreti pretok intravenske infuzije, dokler ne začne kontrast v levem ventriklu izginjati.
English: Attach a threeway stopcock to the cannula.
Slovenian: Na kanilo pritrdite tripotni petelinček.
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.
Slovenian: Zelo priporočljivo je, da vsakič, ko daste bolniku kontrastno sredstvo OPTISON, zabeležite ime in številko serije izdelka, da tako ohranite povezavo med bolnikom in serijo kontrastnega sredstva.
English: OPTISON is injected during the ultrasound examination in order to allow the doctor to assess the function of your heart.
Slovenian: Kontrastno sredstvo OPTISON se injicira med ultrazvočno preiskavo, da zdravniku omogoči oceniti delovanje vašega srca.
English: It is not known whether OPTISON passes into human milk.
Slovenian: Ni znano, ali kontrastno sredstvo OPTISON pri ljudeh prehaja v materino mleko.
English: The clinical relevance of this finding is unknown.
Slovenian: Ni znano, ali so te ugotovitve klinično pomembne.
English: No clinically important pulmonary haemodynamic, systemic haemodynamic, or ECG changes were observed.
Slovenian: ja. Opažene niso bile nobene klinično pomembne spremembe pljučne hemodinamike, sistemske hemodinamike ali EKG-ja.
English: The recommended dose is 0.5 ml - 3.0 ml per patient.
Slovenian: Priporočeni odmerek je 0,5 ml - 3,0 ml na bolnika.
English: Therefore, OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.
Slovenian: Kontrastnega sredstva OPTISON se zato v nosečnosti ne sme uporabljati, razen če korist pretehta tveganje in je uporaba po presoji zdravnika nujna.
English: There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease.
Slovenian: Klinične izkušnje s kontrastnim sredstvom OPTISON so omejene pri bolnikih z določenimi hudimi stanji srčne, pljučne, ledvične ali jetrne bolezni.
English: Side effects to OPTISON are rare and usually not serious.
Slovenian: Neželeni učinki kontrastnega sredstva OPTISON so redki in običajno niso resni.
English: Do not use OPTISON after the expiry date which is stated on the label, after EXP.
Slovenian: Kontrastnega sredstva OPTISON ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
Slovenian: Kontrastno sredstvo OPTISON je sestavljeno iz perflutren vsebujočih mikrosfer toplotno obdelanega humanega albumina, ki so suspendirane v 1 % raztopini humanega albumina.
English: Alternately, the flushing may be performed by infusion.
Slovenian: Alternativno lahko spiranje izvedete z infuzijo.
English: - Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or precipitates before resuspension.
Slovenian: - Počakajte, da viala doseže sobno temperaturo in pred resuspendiranjem preglejte tekočo fazo na vsebnost delcev ali oborin.
English: - Immediately before injection a careful visual inspection of the syringe is mandatory in order to ensure complete resuspension of the microspheres.
Slovenian: - Tik pred injiciranjem morate obvezno natančno vizualno pregledati brizgo, da se prepričate o popolni resuspendiranosti mikrosfer.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: This medicinal product is intended for left ventricular opacification after intravenous administration.
Slovenian: To kontrastno sredstvo je namenjeno za opacifikacijo levega ventrikla po intravenski uporabi.
English: - OPTISON will segregate in an undisturbed syringe and must be resuspended before use.
Slovenian: - Kontrastno sredstvo OPTISON se bo v mirujoči brizgi ločilo in ga morate pred uporabo resuspendirati.
English: • Allergic type symptoms, for example, a severe allergic reaction or - shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria).
Slovenian: • simptomi alergijske vrste, na primer huda alergijska reakcija ali šok (anafilaksija), otekanje obraza (edem obraza), srbeč kožni izpuščaj (koprivnica),
English: The safety of OPTISON for use during human pregnancy has not been fully established.
Slovenian: Varnost uporabe kontrastnega sredstva OPTISON v nosečnosti pri človeku ni povsem potrjena.
English: The microspheres have a mean diameter of 2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ml.
Slovenian: Mikrosfere imajo povprečni premer 2,5 - 4,5 mikronov in koncentracijo 5-8 x 108 mikrosfer/ml.
English: In two uncontrolled studies including a total of 42 children and adolescents, aged 8 months to 19 years, the safety profile appeared to be similar to that seen in adults.
Slovenian: V dveh nenadzorovanih študijah, ki sta vključevali skupaj 42 otrok in mladostnikov, starih od 8
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: Do not use OPTISON - if you are allergic (hypersensitive) to perflutren or any of the other ingredients of OPTISON (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili kontrastno sredstvo OPTISON Ne uporabljajte kontrastnega sredstva OPTISON - če ste alergični na perflutren ali katero koli sestavino tega kontrastnega sredstva (navedeno vpoglavju 6).
English: The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Slovenian: Čas trajanja uporabnega slikanja je 2,5 - 4,5 minut za odmerek 0,5 - 3,0 ml.
English: NO-0485 Oslo, Norway
Slovenian: NO-0485 Oslo, Norveška
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.
Slovenian: Kontrastno sredstvo OPTISON vsebuje mikrosfere (majhne plinske mehurčke), ki po vbrizganju potujejo po venah v srce in napolnijo levi srčni votlini, kar zdravniku omogoči slikovno predstavo in ocenitev delovanja srca.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Slovenian: Pri zdravilih, ki so izdelana iz človeške krvi ali plazme, se z določenimi ukrepi preprečuje prenos okužbe na bolnike.
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
Slovenian: Učinek zdravila OPTISON na pljučno hemodinamiko so preučevali v perspektivni, odprti študiji na 30 bolnikih, naročenih na kateterizacijo pljučne arterije, vključno z 19 bolniki s povišanim sistolnim tlakom v pljučni arteriji (PASP) glede na izhodišče (>35 mmHg; povprečje 70,1 ± 33,0 mmHg; obseg 36,0-176,0 mmHg) in 11 bolniki z normalnim PASP (≤ 35 mmHg; povprečje 29,3 ± 4,6 mmHg; obseg
English: It is not known whether OPTISON is excreted in human milk.
Slovenian: Ni znano, ali se kontrastno sredstvo OPTISON pri ljudeh izloča v materino mleko.
English: 5 x 3 ml presentation: EU/1/98/065/002
Slovenian: 5 x 3 ml pakiranje: EU/1/98/065/002
English: It is a clear solution with white microsphere layer on top.
Slovenian: To je bistra raztopina z belo plastjo mikrosfer na vrhu.
English: • Dyspnoea (difficulty in breathing)
Slovenian: • dispnea (oteženo dihanje),
English: OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber.
Slovenian: Kontrastno sredstvo OPTISON se uporablja v obliki intravenske injekcije, ki omogoča, da mikrosfere vstopijo v srčno komoro in napolnijo levi srčni prekat.
English: OPTISON consists of perflutren -containing microspheres.
Slovenian: Kontrastno sredstvo OPTISON vsebuje mikrosfere s perflutrenom.
English: Clear solution with white microsphere layer on top.
Slovenian: Bistra raztopina z belo plastjo mikrosfer na vrhu.
English: LIST OF EXCIPIENTS Excipients: Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Slovenian: Pomožne snovi: humani albumin, natrijev klorid, N-acetiltriptofan, kaprilna kislina, natrijev hidroksid in voda za injekcije.
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);
Slovenian: V kliničnih preskušanjih s kontrastnim sredstvom OPTISON so o neželenih učinkih poročali z naslednjimi pogostnostmi, ki so navedene v spodnji preglednici: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000);
English: Paediatric population Efficacy and safety in patients below 18 years has not been studied.
Slovenian: Učinkovitost in varnost pri bolnikih, mlajših od 18 let, nista raziskani.
English: If injected otherwise OPTISON bubbles will be destroyed.
Slovenian: Če injicirate na drugačen način, bodo mikrosfere kontrastnega sredstva OPTISON uničene.
English: No interaction studies have been performed.
Slovenian: še nista bili proučeni.
English: Store upright in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v pokončnem položaju v hladilniku .
English: The safety of OPTISON for use during human pregnancy has not been established.
Slovenian: Varnost uporabe kontrastnega sredstva OPTISON v nosečnosti pri človeku ni bila dokazana.
English: OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml.
Slovenian: Kontrastno sredstvo OPTISON je na voljo v naslednjih velikostih pakiranja: 1 viala po 3 ml ali 5 vial po 3 ml.
English: MARKETING AUTHORISATION NUMBERS 1 x 3 ml presentation: EU/1/98/065/001
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM 1 x 3 ml pakiranje: EU/1/98/065/001
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.
Slovenian: Kontrastno sredstvo OPTISON je transpulmonalno ehokardiografsko kontrastno sredstvo, ki se uporablja pri bolnikih s sumom na srčnožilno bolezen ali z že potrjeno srčnožilno boleznijo za zagotavljanje opacifikacije srčnih komor, ojačitve orisa endokardialnega roba levega ventrikla, kar izboljša vizualizacijo gibanja srčne stene.
English: When used in conjunction with diagnostic ultrasound, OPTISON provides opacification of cardiac chambers, improvement in delineation of endocardial borders, enhancement of the Doppler signal, and visualisation of wall motion and blood flow within the heart.
Slovenian: omogoča opacifikacijo srčnih komor, izboljšanje orisov endokardialnih robov, ojačitev Dopplerjevega signala in vizualizacijo gibanja srčne stene in krvnega pretoka v srcu.
English: - OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension.
Slovenian: - Kontrastno sredstvo OPTISON je treba v največ 1 minuti po resuspendiranju previdno odvzeti v brizgo.
English: OPTISON should only be administered by doctors experienced in the field of diagnostic ultrasound imaging.
Slovenian: Kontrastno sredstvo OPTISON smejo uporabljati samo zdravniki, izkušeni na področju diagnostičnega slikanja z ultrazvokom.
English: NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection
Slovenian: IME ZDRAVILA OPTISON 0,19 mg/ml disperzija za injiciranje
English: What OPTISON contains - The active substance is perflutren-containing microspheres of heat treated human albumin 58 x 108/ml, suspended in human albumin solution 1%.
Slovenian: Kaj vsebuje kontrastno sredstvo OPTISON - Zdravilna učinkovina so mikrosfere s perflutrenom iz toplotno obdelanega humanega albumina v koncentraciji 5-8 x 108/ml, suspendirane v 1-odstotni raztopini humanega albumina.
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
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN
English: GE Healthcare Buchler GmbH & Co. KG Gieselweg 1
Slovenian: GE Healthcare Buchler GmbH & Co.
English: • Tinnitus (noises in the ear)
Slovenian: • tinitus (zvenenje v ušesih), • omotica,
English: The safety and efficacy of OPTISON in children and adolescents below 18 years has not been established.
Slovenian: Varnost in učinkovitost kontrastnega sredstva OPTISON pri otrocih in mladostnikih, mlajših od 18 let,
English: Rare side effects (affects 1 to 10 users in 10,000):
Slovenian: Redki neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov):
English: Allergic type symptoms (e.g. anaphylactoid reaction or -shock, face oedema, urticaria)
Slovenian: Bolezni imunskega sistema simptomi alergijske vrste (npr. anafilaktoidna reakcija ali šok, otekanje obraza, koprivnica)
English: Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml solution for injection or glucose 50 mg/ml solution for injection should be injected at a rate of 1 ml/s to optimise the effect of the contrast agent.
Slovenian: Takoj po injekciji kontrastnega sredstva OPTISON je treba injicirati 10 ml raztopine 9 mg/ml natrijevega klorida za injiciranje ali raztopine 50 mg/ml glukoze za injiciranje s hitrostjo 1 ml/s, da čimbolj izboljšamo učinek kontrastnega sredstva.
English: Sodium hydroxide (pH adjustment) Water for injections
Slovenian: N-acetiltriptofan kaprilna kislina natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih ter genotoksičnosti, ne kažejo posebnega tveganja za človeka.
English: Dysgeusia (altered taste), headache Tinnitus, dizziness, paraesthesia
Slovenian: Bolezni živčevja disgevzija (motnje okušanja), glavobol tinitus, omotica, parestezije pogosti redki
English: Package leaflet: Information for the user OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres
Slovenian: Navodilo za uporabo: informacije za uporabnika OPTISON 0,19 mg/ml disperzija za injiciranje mikrosfere s perflutrenom
English: Pharmacotherapeutic group: Ultrasound contrast medium, ATC Code: V08D A01
Slovenian: Farmakoterapevtska skupina: Ultrazvočna kontrastna sredstva, Oznaka ATC: V08D A01 Kadar se kontrastno sredstvo OPTISON uporablja v povezavi z ultrazvočno diagnostično preiskavo,
English: Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s.
Slovenian: Takoj po injiciranju kontrastnega sredstva OPTISON je treba injicirati 10 ml 0,9 % raztopine (9 mg/ml) natrijevega klorida za injiciranje ali 5 % raztopine (50 mg/ml) glukoze za injiciranje s hitrostjo 1 ml/s.
English: The infusion should then be returned to a TKO rate.
Slovenian: Takrat infuzijsko hitrost ponovno naravnajte na TKO.
English: The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a ”to keep open” (TKO) rate.
Slovenian: Takrat je treba pritrditi infuzijski set na tripotni petelinček in pričeti z intravenskim infundiranjem s hitrostjo, da je pretok ravno odprt (TKO - 'to keep open').
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/065/001 EU/1/98/065/002 13.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/98/065/001
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).
Slovenian: Kaj je kontrastno sredstvo OPTISON in za kaj ga uporabljamo Kontrastno sredstvo OPTISON je ultrazvočno kontrastno sredstvo, ki nam pomaga, da pri ehokardiografiji (postopek, pri katerem slikamo srce z ultrazvokom) dobimo razločnejše slike (sken) srca.
English: Common side effects (affects 1 to 10 users in 100):
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov):
English: In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Slovenian: Na splošno so uporabo humanega albumina povezovali s prehodnimi motnjami okušanja, navzeo, zardevanjem, izpuščajem, glavobolom, bruhanjem, mrazenjem in povišano telesno temperaturo.
English: The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
Slovenian: V enem ml kontrastnega sredstva OPTISON je približno 0,19 mg perflutren plina.
English: There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Slovenian: Trenutno v specifikacijah Evropske farmakopeje ni poročil o prenosu virusov preko albumina,