natgillin/translations-raw huggingface dataset:
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.  The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
1 ml vsebuje 330, 9 mg gadoversetamida, kar ustreza 500 mikromolom.  Pomožne snovi so: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid in/ ali klorovodikova kislina, voda za injekcije.
What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Izgled zdravila Optimark in vsebina pakiranja Brizge zdravila Optimark vsebujejo prozorno, brezbarvno do svetlo rumeno raztopino.
Optimark pre-filled syringes are supplied in the following package sizes:
Napolnjene brizge zdravila Optimark so na voljo v naslednjih velikostih pakiranja:
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml 1 x 30 ml 10 x 30 ml Not all package sizes may be marketed.
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml 1 x 30 ml 10 x 30 ml Na trgu ni vseh navedenih pakiranj.
Marketing Authorisation Holder For any information about this medicine, please contact the Marketing Authorisation Holder:
Imetnik dovoljenja za promet z zdravilom Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom:
Manufacturer Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart, Dublin 15 Ireland
Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart, Dublin 15 Irska
This leaflet was last approved in:
Navodilo je bilo odobreno.
Detailed information on this product is available on the European Medicines Agency (EMEA) web site http: / /www. emea. europa. eu/
38 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
38 The following information is intended for medical or healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
Therapeutic indications Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Terapevtske indikacije Zdravilo Optimark je indicirano za uporabo pri magnetnoresonančnem slikanju (magnetic resonance imaging – MRI) osrednjega živčevja in jeter.
It provides contrast enhancement and facilitates visualization and helps with characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Omogoča krepitev kontrasta ter izboljša prikaz in pomaga pri karakterizaciji fokalnih lezij in nenormalnih struktur v osrednjem živčevju in jetrih bolnikov z znano patologijo ali močnim sumom nanjo.
Special warnings and precautions for use As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions.
Posebna opozorila in previdnostni ukrepi Kot pri vseh drugih paramagnetnih kontrastnih sredstvih lahko krepitev kontrasta pri magnetnoresonančnem slikanju z zdravilom Optimark okvari vidnost obstoječih lezij.
The usual contraindications of MR examinations must be applied, such as exclusion of patients with infusion pumps, pacemakers, ferro-magnetic clips etc.  Hypersensitivity Allergoid and other idiosyncratic reactions may occur with all contrast media for intravenous application, also with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
Treba je upoštevati običajne kontraindikacije za magnetnoresonančno slikanje, kot so izključitev bolnikov z infuzijskimi črpalkami, spodbujevalniki, sponkami iz feromagnetnih snovi itn.
Premedication with antihistamines and/ or glucocorticoids may be considered.  Patients taking beta-blockers It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.  Patients with cardiovascular disease In this group of patients hypersensitivity reactions may be severe.
Treba je pretehtati možnost priprave z uporabo antihistaminikov in/ ali glukokortikoidov.  Bolniki, ki jemljejo blokatorje beta Treba je biti pozoren na to, da ni nujno, da se bolniki, ki uporabljajo blokatorje beta, odzovejo na agoniste beta, ki se po navadi uporabljajo pri zdravljenju preobčutljivostnih reakcij.  Bolniki s kardiovaskularnimi boleznimi Pri tej skupini bolnikov so lahko preobčutljivostne reakcije hude.
However, these were not evident from clinical trials with Optimark.  Central nervous system disorders In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Vendar pa teh reakcij v kliničnih preskušanjih z zdravilom Optimark ni bilo.  Bolezni osrednjega živčevja Pri bolnikih z epilepsijo ali lezijami v možganih se lahko verjetnost konvulzij med preiskavo poveča.
Precautions are necessary when examining these patients (e. g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.  Renal impairment and liver transplant patients There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2), and in those who have had or are undergoing liver transplantation.
Pri pregledu teh bolnikov je treba biti previden (npr. bolnika nadzorovati), na voljo pa morajo biti oprema in zdravila za hitro zdravljenje morebitnih konvulzij.  Ledvična okvara in bolniki, pri katerih so opravili presaditev jeter Pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/ min/ 1, 73 m2) in pri bolnikih, pri katerih opravljajo presaditev jeter, so poročali o nefrogeni sistemski fibrozi (NSF), povezani z uporabo nekaterih kontrastnih sredstev, ki vsebujejo gadolinij.
Therefore, Optimark should not be used in these populations.
Zato se zdravilo Optimark pri teh skupinah bolnikov ne
Optimark should be used in these patients with caution.
Pri bolnikih z zmerno ledvično okvaro (GFR < 60 ml/ min/ 1, 73 m2) so tudi poročali o primerih NSF pri uporabi kontrastnih sredstev, ki vsebujejo gadolinij, zato je treba pri teh bolnikih zdravilo Optimark uporabljati previdno.
Pregnancy and Lactation There is no clinical experience with the use of gadoversetamide during pregnancy.
Nosečnost in dojenje Kliničnih izkušenj z uporabo gadoversetamida med nosečnostjo ni.
Posology and method of administration The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/ kg (0.1 mmol/ kg) body weight.
Odmerjanje in način uporabe Sredstvo je treba uporabiti v obliki bolusne periferne intravenske injekcije z odmerkom 0, 2 ml/ kg (0, 1 mmol/ kg) telesne mase.
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.1 mmol/ kg may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Pri magnetnoresonančnem slikanju lobanje se lahko, če močan klinični sum na lezijo ne izgine kljub enkratnem odmerku kontrastnega sredstva ali kadar lahko natančnejša informacija o številu, velikosti ali obsegu lezij vpliva na obravnavanje ali zdravljenje bolnika, pri osebah z normalnim delovanjem ledvic v 30 minutah po prvem injiciranju uporabi druga bolusna injekcija z odmerkom 0, 1 mmol/ kg, ker lahko poveča diagnostični izkoristek pregleda.
The safety of repeat doses has not been established in children and adolescents, in patients with impaired renal function, or the elderly.
Varnost ponavljajočih se odmerkov pri otrocih in mladostnikih, pri bolnikih z ledvično okvaro ali starejših bolnikih ni bila ugotovljena.
Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of 0.3 mmol/ kg body weight of Optimark may lead to higher diagnostic confidence.
Omejeni podatki z drugimi kontrastnimi sredstvi, ki vsebujejo gadolinij, kažejo, da lahko pri izločanju kranialnih metastaz pri bolnikih z znano posamezno resektabilno metastazo magnetnoresonančno slikanje z injiciranjem odmerka 0, 3 mmol/ kg telesne mase zdravila Optimark poveča zanesljivost diagnoze.
40 Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
40 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja niso izvedli.
Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.
Pokazalo se je, da gadoversetamid povzroča motnje pri merjenju kalcija v serumu s kolorimetrično metodo s kompleksonom orto- krezolftaleina (OCP).
Optimark pre-filled syringes should be used immediately.
Napolnjene injekcijske brizge Optimark je treba uporabiti takoj.
Pre-filled syringes:
Sestava in pregled:
Assembly and Inspection Inspect the syringe for signs of leakage.
Preverite, ali obstajajo kakršnikoli znaki uhajanja raztopine iz brizge.
41 PACKAGE LEAFLET:
41 NAVODILO ZA UPORABO
42 Tell your doctor, if:  you are feeling thirsty and/ or if you have only had small quantities or nothing to drink before the examination  you have a cardiac pacemaker or any ferromagnetic implant (vascular clips, etc.) or a metallic stent in your body  you are taking a special kind of antihypertensive medicine, i. e. a beta-blocker  you have heart disease  you suffer from epilepsy or brain lesions  you are or your child is on a controlled sodium diet If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Če za vas velja karkoli od naštetega, se bo zdravnik odločil, ali bo nameravani pregled opravil.
Most of the undesirable effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
43 Neželeni učinki, ki so jih opazili po uporabi zdravila Optimark, so bili večinoma blagi do zmerni in prehodni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
44 Če kateri koli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
 The active substance is gadoversetamide.
Kaj vsebuje zdravilo Optimark  Zdravilna učinkovina je gadoversetamid.
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromoles.  The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
1 ml vsebuje 330, 9 mg gadoversetamida, kar ustreza 500 mikromolom.  Pomožne snovi so: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid in/ ali klorovodikova kislina, voda za injekcije.
Optimark vials contain a clear, colourless to pale yellow solution.
Izgled zdravila Optimark in vsebina pakiranja Viale zdravila Optimark vsebujejo prozorno, brezbarvno do svetlo rumeno raztopino.
Optimark vials are supplied in the following package sizes:
Viale zdravila Optimark so na voljo v naslednjih velikostih pakiranja:
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml Not all package sizes may be marketed.
1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml Na trgu ni vseh navedenih pakiranj.
45 The following information is intended for medical or healthcare professionals only:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu / 45 Naslednje informacije so namenjene samo zdravstvenemu osebju:
The usual contraindications of MR examinations must be applied, such as exclusion of patients with infusion pumps, pacemakers, ferro-magnetic clips etc.  Hypersensitivity Allergoid and other idiosyncratic reactions may occur with all contrast media for intravenous application, also with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
Te reakcije se lahko pokažejo v obliki kardiovaskularnih, respiratornih ali kožnih reakcij.
Cases of NSF have also been reported in patients
Zato se zdravilo Optimark pri teh skupinah bolnikov ne sme uporabljati (glejte poglavje 4. 3).
Optimark should be used in these patients with caution.
46 Pri bolnikih z zmerno ledvično okvaro (GFR < 60 ml/ min/ 1, 73 m2) so tudi poročali o primerih NSF pri uporabi kontrastnih sredstev, ki vsebujejo gadolinij, zato je treba pri teh bolnikih zdravilo Optimark uporabljati previdno.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na sposobnost razmnoževanja (glejte poglavje 5. 3).
47 Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
47 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja niso izvedli.
What is OPTISON?
Kaj je zdravilo OPTISON?
OPTISON is a suspension for injection.
Zdravilo OPTISON je suspenzija za injiciranje.
It contains microspheres (tiny bubbles) of heat-treated human albumin containing perflutren gas as the active substance.
Vsebuje mikrosfere (majhne mehurčke) toplotno obdelanega humanega albumina, ki vsebuje aktivno učinkovino perflutren plin.
What is OPTISON used for?
Za kaj se zdravilo OPTISON uporablja?
OPTISON is for diagnostic use only.
Zdravilo OPTISON je samo za diagnostične namene.
It is a ‘ contrast agent’, which helps make internal body structures easier to see during imaging tests.
To je „ kontrastno sredstvo “, ki med testi s slikanjem olajša vpogled v notranje telesne strukture.
OPTISON is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Zdravilo OPTISON se uporablja za jasnejše slikanje srčnih komor, še posebej levega prekata, med ehokardiografijo (diagnostični test pri katerem dobijo sliko srca s pomočjo ultrazvoka).
OPTISON is used in patients with suspected or known cardiovascular disease, when scans without a contrast agent have not been conclusive.
Zdravilo OPTISON se uporablja pri bolnikih s sumom na bolezen ali z znano boleznijo srca in žil, pri kateri slikanje brez kontrastnih sredstev ne daje dokončnih izsledkov.
How is OPTISON used?
Kako se zdravilo OPTISON uporablja?
OPTISON should only be used by doctors who have experience in diagnostic ultrasound imaging.
Zdravilo OPTISON smejo uporabljati le zdravniki, ki imajo izkušnje z diagnostičnim ultrazvočnim slikanjem.
The ultrasound scan must be carried out during the injection of OPTISON, as the best effect is within the first 2.5 to 4.5 minutes after dosing.
Ultrazvočno slikanje je treba opraviti med injiciranjem zdravila OPTISON, ker se najboljši učinek doseže v prvih 2, 5 do 4, 5 minutah po dajanju odmerka.
OPTISON is slowly injected into a vein, usually in the right arm.
OPTISON se počasi injicira v veno, navadno v desni roki.
The recommended dose is 0.5 to 3.0 ml per patient.
Priporočen odmerek na bolnika znaša 0, 5 do 3, 0 ml.
The total dose should not exceed 8.7 ml per patient.
Celoten odmerek na bolnika ne sme preseči 8, 7 ml.
The patient’ s heart should be monitored with an electrocardiogram (ECG) during an ultrasound scan with OPTISON.
Srce bolnika je treba med ultrazvočnim pregledom s pomočjo zdravila OPTISON spremljati z elektrokardiogramom (EKG).
For more information, see the Package Leaflet.
Več podatkov je na voljo v Navodilu za uporabo.
How does OPTISON work?
Kako zdravilo OPTISON deluje?
OPTISON is an ultrasound contrast medium.
OPTISON je ultrazvočno kontrastno sredstvo.
Ultrasound uses high-frequency sound waves to create images of certain areas inside the body.
Ultrazvok uporablja visoko frekvenčne zvočne valove za proizvajanje slik izbranih predelov v telesu.
The sound waves produced by the ultrasound equipment can be reflected by different parts of the body, such as the heart.
Različni deli telesa, kakršno je srce, odbijajo zvočne valove, ki jih proizvaja ultrazvočna oprema.
OPTISON contains gas-filled albumin microspheres (tiny bubbles) that generate echoes very differently from the surrounding tissues when used during an ultrasound scan.
Zdravilo OPTISON vsebuje s plinom napolnjene mikrosfere (majhne mehurčke) albumina, ki med ultrazvočnim pregledom ustvarjajo ultrazvočne odmeve, ki se zelo razlikujejo od tistih, ki jih ustvarjajo okoliška tkiva.
When OPTISON is injected, it travels in the veins to the heart.
Ko se OPTISON injicira, ta potuje po venah do srca.
This helps to obtain better contrast between the area where the gas bubbles are (such as the chambers of the heart) and the surrounding tissue during the echocardiography.
To med ehokardiografijo pomaga izboljšati kontrast med območji, kjer so plinski mehurčki (kakršni so srčne komore) in okoliškim tkivom.
The gas is then cleared through the lungs.
Plin se na koncu izčisti skozi pljuča.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged medicine.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo OPTISON raziskano?
The injections were on different days, with a delay of between 2 and 10 days between the two medicines.
Injicirali so jih na različne dni, med uporabo posameznega zdravila pa so počakali od 2 do 10 dni.
The main measures of effectiveness were the length of the endocardium (inner surface) of the left ventricle of the heart that could be seen before and after injection of OPTISON and the reference medicine, and the observer’ s assessment of the change in the ability to see the endocardium of the left ventricle before and after each injection.
Glavni merili učinkovitosti sta bili dolžina endokardija (notranja površina srca) levega prekata srca, ki jo je bilo mogoče videti pred in po injiciranju zdravila OPTISON in referenčnega zdravila, ter ocena opazovalca o spremembi vidnosti levega ventrikla pred in po injekciji.
What benefit has OPTISON shown during the studies?
Kakšne koristi je zdravilo OPTISON izkazalo med raziskavami?
OPTISON was more effective than the reference medicine at increasing the ability to see the endocardium of the left ventricle.
OPTISON je bil bolj učinkovit od referenčnega zdravila pri večanju vidnosti endokardija levega prekata.
In the first study, the length of endocardium that could be seen increased by 7.8 cm with OPTISON, compared with 3.7 cm with the reference medicine.
V prvi študiji se je dolžina endokardija, ki jo je bilo mogoče videti, pri uporabi zdravila OPTISON povečala za 7, 8 cm, pri referenčnemu sredstvu pa le za 3, 7 cm.
In the other study, the increases were 7.1 cm for OPTISON and 3.1 cm for the reference medicine.
V drugi študiji je povečanje znašalo 7, 1 pri uporabi zdravila OPTISON in 3, 1 cm pri uporabi referenčnega zdravila.
In both studies, the observer reported that the ability to see the endocardium improved for more patients after injection of OPTISON than after injection of the reference medicine.
V obeh študijah so opazovalci poročali o tem, da se je vidnost endokardija izboljšala pri večjem številu bolnikov v primeru injiciranja zdravila OPTISON kot pri injiciranju referenčnega zdravila.
What is the risk associated with OPTISON?
Kakšna tveganja so povezana z zdravilom OPTISON?
The most common side effects with OPTISON (seen in between 1 and 10 patients in 100) are dysgeusia (altered taste), headache, flushing, and a warm sensation.
Najpogostejši neželeni učinki zdravila OPTISON (opaženi pri 1 do 10 izmed 100 bolnikov) so disgevzija (motnje okušanja), glavobol, rdečica in občutek toplote.
For the full list of all side effects reported with OPTISON, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila OPTISON, glejte Navodilo za uporabo.
OPTISON should not be used in patients who may be hypersensitive (allergic) to any of the ingredients, particularly human albumin, or in patients with pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs).
Zdravila OPTISON ne smejo uporabljati bolniki, ki utegnejo biti preobčutljivi za (alergični na) katero koli sestavino, posebej humani albumin, ali bolniki s pulmonalno hipertenzijo (visok krvni tlak v pljučni arteriji, ki vodi od srca v pljuča).
Why has OPTISON been approved?
Zakaj je bilo zdravilo OPTISON odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that OPTISON’ s benefits are greater than its risks to help diagnose patients with suspected or established cardiovascular disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristi zdravila OPTISON pri pomoči diagnosticiranja bolnikov s sumom na bolezen ali z ugotovljeno boleznijo srca in ožilja, večje od z njimi povezanih tveganj.
The committe recommended that OPTISON be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom OPTISON.
Other information about OPTISON:
Druge informacije o zdravilu OPTISON:
The European Commission granted a marketing authorisation valid throughout the European Union, for OPTISON on 18 May 1998.
Evropska Komisija je dovoljenje za promet z zdravilom OPTISON, veljavno po vsej Evropski uniji, odobrila dne 18. maja 1998.
The marketing authorisation was renewed 15 May 2003.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 15. maja 2003.
The marketing authorisation holder is GE Healthcare AS.
Imetnik dovoljenja za promet je družba GE Healthcare AS.
The full EPAR for OPTISON is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo OPTISON je na voljo tukaj.
Package sizes
Viala (iz stekla)
8 5 – 8 x 10 perflutren-containing microspheres with a mean diameter range of 2.5 – 4.5 μ m; equivalent to 0.19 mg perflutren gas per ml
Ustreza 0, 19 mg perflutren plina na ml.
Dispersion for injection
Disperzija za injiciranje
Vial (glass)
Viala (iz stekla)
5 – 8 x 108 perflutren-containing microspheres with a mean diameter range of 2.5 – 4.5 μ m; equivalent to 0.19 mg perflutren gas per ml
8 5 - 8 x 10 mikrosfer s perflutrenom, s povprečnim premerom v razponu 2, 5 – 4, 5 µm.
Dispersion for injection
Ustreza 0, 19 mg perflutren plina na ml.
Intravenous use
Disperzija za injiciranje
Vial (glass)
Intravenska uporaba
OPTISON 0.19 mg/ ml dispersion for injection
OPTISON 0, 19 mg/ ml disperzija za injiciranje
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
OPTISON sestoji iz perflutren vsebujočih mikrosfer toplotno obdelanega humanega albumina, ki so suspendirane v 1% raztopini humanega albumina.
Perflutren -containing microspheres, 5-8 x 108/ ml with a mean diameter range of 2.5 - 4.5 µm.
5- 8 x 108/ ml mikrosfer humanega albumina s perflutrenom, s povprečnim premerom v razponu 2, 5 – 4, 5 µm.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
Približna količina perflutren plina v vsakem ml zdravila OPTISON je 0, 19 mg.
Excipient Each ml contains 0.15 mmol (3.45 mg) of sodium.
Pomožna snov En mililiter vsebuje 0, 15 mmola (3, 45 mg) natrija.