natgillin/translations-raw huggingface dataset:
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.
Zdravilo 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.
OPTISON should only be used in patients where the study without contrast enhancement is inconclusive.
Zdravilo OPTISON smemo uporabljati samo pri bolnikih, kjer je preiskava brez kontrastne ojačitve neuspešna.
OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging.
Zdravilo OPTISON smejo uporabljati samo zdravniki, izkušeni na področju diagnostičnega slikanja z ultrazvokom.
Before administering OPTISON, please see section 6.6 for instructions for use/ handling.
Pred dajanjem zdravila OPTISON, preberite poglavje 6. 6 za navodila za pripravo in ravnanje.
This medicinal product is intended for left ventricular opacification after intravenous administration.
To zdravilo je namenjeno za opacifikacijo levega ventrikla po intravenski uporabi.
Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration.
Ultrazvočno slikanje se mora izvajati med injiciranjem zdravila OPTISON, ker se najboljši kontrastni učinek doseže neposredno po dajanju.
Dosage The recommended dose is 0.5 ml - 3.0 ml per patient.
Odmerjanje Priporočeni odmerek je 0, 5 ml – 3, 0 ml na bolnika.
A dose of 3.0 ml is usually sufficient, but some patients may need higher doses.
Običajno zadošča odmerek 3, 0 ml, vendar nekateri bolniki lahko potrebujejo višje odmerke.
The total dose should not exceed 8.7 ml per patient.
Skupni odmerek na bolnika ne sme preseči 8, 7 ml.
2 the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Trajanje uporabnega časa za slikanje je 2, 5 – 4, 5 minut pri odmerku 0, 5 – 3, 0 ml.
OPTISON could be repeatedly administered, however, the clinical experience is limited.
Zdravilo OPTISON se lahko uporablja večkrat, vendar so klinične izkušnje omejene.
Paediatric patients OPTISON is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
2 Otroci Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila OPTISON pri otrocih pod 18 leti ni priporočljiva.
Care should therefore be exercised.
Zato moramo biti previdni.
A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur.
Vnaprej mora biti izdelan postopek ukrepanja, in na voljo nujna zdravila ter oprema za takojšnje zdravljenje, v primeru nastopa hude reakcije.
The experience of OPTISON in severely ill patients is limited.
Izkušnje z zdravilom OPTISON pri hudo bolnih bolnikih so omejene.
There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease.
Klinične izkušnje z zdravilom OPTISON so omejene pri bolnikih z določenimi hudimi stanji srčne, pljučne, ledvične ali jetrne bolezni.
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.
Takšna klinična stanja obsegajo sindrom dihalne stiske pri odraslih, uporabo umetne ventilacije s pozitivnim tlakom na koncu izdiha, hudo srčno odpoved (NYHA IV), endokarditis, akutni miokardni infarkt s trajajočo angino pektoris ali nestabilno angino pektoris, srce z umetnimi srčnimi zaklopkami, akutna stanja sistemskih vnetij ali sepsa, znana stanja hiperaktivnega koagulacijskega sistema in/ ali rekurentni tromboembolizem, zadnja faza ledvične ali jetrne bolezni.
OPTISON should be used in these categories of patients only after careful consideration, and monitored closely during and after administration.
V teh skupinah bolnikov smemo uporabljati zdravilo OPTISON samo po skrbnem tehtnem premisleku in ob stalnem nadzoru med in po dajanju.
Other routes of administration not specified in section 4.2 above (e. g. intracoronary injection) are not recommended.
Druge poti uporabe, ki niso navedene v zgornjem poglavju 4. 2 (npr. intrakoronarno injiciranje), niso priporočljive.
When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded.
Pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ne moremo popolnoma izključiti okužb zaradi prenosa infektivnih agensov.
This applies also to pathogens of hitherto unknown origin.
To velja tudi za patogene dosedaj neznanega izvora.
To reduce the risk of transmission of infective agents, stringent controls are applied to the selection of blood donors and donations.
Za zmanjševanje tveganja prenosa infektivnih agensov, velja za zbiranje krvi in donacije strog nadzor.
In addition, virus removal and/ or inactivation procedures are included in the production process.
Poleg tega vključuje proizvodni proces postopke za odstranjevanje in/ ali inaktiviranje virusov.
The current procedures applied in the manufacture of medicinal products derived from human blood or plasma are effective against enveloped viruses such as HIV, hepatitis B and hepatitis C viruses.
Sedanji postopki, ki se uporabljajo pri izdelavi zdravil, pridobljenih iz človeške krvi ali plazme, so učinkoviti proti virusom z ovojnico, kot so HIV, hepatitis B in hepatitis C virusi.
These procedures are of limited value against non-enveloped viruses such as hepatitis A virus.
Ti postopki imajo omejen pomen pri virusih brez ovojnice, kot je virus hepatitisa A.
OPTISON contrast echocardiography should be accompanied by ECG monitoring.
Kontrastno ultrazvočno preiskavo srca z zdravilom OPTISON moramo spremljati s snemanjem EKG.
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.
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.
3 The safety of OPTISON for use during human pregnancy has not been established.
Varnost uporabe zdravila OPTISON v nosečnosti pri človeku ni potrjena.
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.
Pri brejih zajkljah, 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.
The clinical relevance of this finding is unknown.
3 Ni znano, ali so te ugotovitve klinično pomembne.
Therefore OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.
Zdravilo OPTISON se zato v nosečnosti ne sme uporabljati, razen če korist pretehta tveganje in je uporaba nujna po presoji zdravnika.
It is not known whether OPTISON is excreted in human milk.
Ni znano, ali se zdravilo OPTISON izloča z mlekom pri človeku.
Therefore, caution should be exercised when OPTISON is administered to breast-feeding women.
Zato je potrebna previdnost pri dajanju zdravila OPTISON doječim materam.
Adverse reactions to OPTISON are rare and usually of a non-serious nature.
Neželeni učinki zdravila OPTISON so redki in običajno nenevarni.
In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Na splošno so uporabo humanega albumina povezovali s prehodnimi motnjami okušanja, slabostjo, rdečico, izpuščajem, glavobolom, bruhanjem, mrazenjem in povišano telesno temperaturo.
The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full recovery.
Neželeni učinki po uporabi zdravila OPTISON v III fazi kliničnih študij pri človeku so bili blagi do zmerni s kasnejšim popolnim okrevanjem.
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); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare < 1/ 10,000, not known (cannot be estimated from the available data)).
V kliničnih preskušanjih z zdravilom OPTISON so o neželenih učinkih poročali z naslednjimi pogostnostmi, ki so navedene v spodnji preglednici (zelo pogosto ≥1/ 10; pogosto (≥1/ 100 do < 1/ 10); občasno (≥1/ 1. 000 do < 1/ 100); redko (≥1/ 10. 000 do < 1/ 1. 000); zelo redko < 1/ 10. 000), neznano (ni mogoče oceniti iz razpoložljivih podatkov)).
Tinnitus, dizziness, paraesthesia
tinitus, vrtoglavost, parestezije
Eye disorders Respiratory, thoracic and mediastinal disorders
Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Visual disturbances Dyspnoea
motnje vida Dispnea
Not known* Uncommon
neznano * občasni
Flushing Warm sensation
napadi rdečice občutek toplote
Chest pain
bolečine v prsih
Allergic type symptoms (e. g. anaphylactoid reaction or -shock, face oedema, urticaria)
simptomi alergijske vrste (npr. anafilaktoidna reakcija ali šok, otekanje obraza, koprivnica)
Not known*
neznano *
* Reactions for which no frequency rate can be provided due to lack of clinical trial data, have been classified as “ Not known”.
* Reakcije, za katere pogostost ni na voljo zaradi pomanjkanja podatkov iz kliničnih preskušanj, so bile razvrščene kot “ neznano ”.
In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.
V preskušanju I faze so zdravi prostovoljci prejemali odmerke do 44, 0 ml zdravila OPTISON in niso doživeli nobenih pomembnih neželenih dogodkov.
5.1 Pharmacodynamic properties
4 5. 1 Farmakodinamične lastnosti
Ultrasound contrast medium, ATC Code:
Ultrazvočna kontrastna sredstva, Oznaka ATC:
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.
Kadar se zdravilo OPTISON uporablja v povezavi z ultrazvočno diagnostično preiskavo, omogoča opacifikacijo srčnih komor, izboljšanje orisov endokardialnih robov, ojačitev Dopplerjevega signala in vizualizacijo gibanja srčne stene in krvnega pretoka v srcu.
OPTISON consists of perflutren -containing microspheres.
Zdravilo OPTISON vsebuje mikrosfere s perflutrenom.
The microspheres have a mean diameter of 2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ ml.
Mikrosfere imajo povprečni premer 2, 5 – 4, 5 mikronov in koncentracijo 5- 8 x 108 mikrosfer/ ml.
As OPTISON consists of microspheres that are stable and small enough for transpulmonary passage, it will also give enhanced echo signals in the left heart cavities.
Zdravilo OPTISON povzroča tudi ojačitve ultrazvočnega signala v votlini levega srca, ker sestoji iz mikrosfer, ki so zadosti obstojne in majhne za transpulmonalni prehod.
As a consequence of the complex relationship between the concentration of the microspheres and the ultrasound signal, data processing within the ultrasound equipment and the fact that each individual responds differently due to variability in cardiac and pulmonary function, a strict dose/ response relationship cannot be defined.
Zaradi kompleksnosti povezave med koncentracijo mikrosfer in ultrazvočnega signala, obdelave podatkov v opremi za ultrazvočno slikanje in dejstva, da se vsak posameznik odzove drugače zaradi variabilnosti srčnega in pljučnega delovanja, natančnega razmerja med odmerkom/ in odzivom ni mogoče določiti.
The dose of OPTISON will therefore have to be adjusted individually, although clinical studies have shown that an initial dose of 0.5 - 3.0 ml per patient can be recommended for left heart opacification.
Zato se mora odmerek zdravila OPTISON individualno prilagajati, čeprav so klinične študije pokazale, da lahko za opacifikacijo levega srca priporočimo začetni odmerek 0, 5 do 3, 0 ml na bolnika.
Higher doses produce greater contrast effect of longer duration.
Višji odmerki povzročijo večji kontrastni učinek z daljšim trajanjem.
Following intravenous injection of 0.21 to 0.33 ml/ kg of OPTISON to healthy volunteers, the perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 minutes with a dominating pulmonary elimination half life of 1.3±0.7 minutes.
Po intravenski injekciji 0, 21 do 0, 33 ml/ kg zdravila OPTISON zdravim prostovoljcem se perflutrenska sestavina zdravila OPTISON hitro in skoraj popolno izloči v manj kot 10 minutah, z vodilnim pljučnim eliminacijskim razpolovnim časom 1, 3±0, 7 minut.
The perflutren levels detected in blood following this dosage were too low and transient to accurately determine pharmacokinetic parameters.
Izmerjena raven perflutrena v krvi po teh odmerkih je bila premajhna in prehodna, da bi lahko določili farmakokinetične parametre.
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
Podatki, dobljeni 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.
35% in liver).
Visoki odmerki radioaktivnosti so se tudi precej dolgo zadrževali v pljučih, približno 10% celokupnega odmerka še 40 minut po dajanju odmerka (oziroma 35% v jetrih).
In the rabbit embryotoxicity study, a significant increase in the number of fetuses with dilated ventricles in the brain was observed (see section 4.6).
V embriotoksikološki študiji na zajcih so opazili pomembno širjenje možganskih ventriklov pri številnih fetusih (glejte poglavje 4. 6).
Human albumin Sodium chloride N-acetyltryptophan Caprylic acid Sodium hydroxide (pH adjustment) Water for injections
Humani albumin Natrijev klorid N- acetiltriptofan Kaprilna kislina Natrijev hidroksid (za uravnavanje pH) Voda za injekcije
OPTISON must not be mixed with other medicinal products.
Zdravila OPTISON ne smemo mešati z drugimi zdravili.
A separate syringe should be used.
Uporabljati moramo ločeno injekcijsko brizgo.
Unopened vial in the outer packaging:
Neodprta viala v zunanji ovojnini:
Finished product after rubber stopper perforation:
Pripravljeno zdravilo po predrtju gumijastega zamaška:
3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top.
3- mililitrska viala iz stekla tipa I, zaprta z bromobutilnim gumijastim zamaškom, prevlečenim z aluminijasto kapico z barvnim plastičnim vrhom, ki se odtrga.
OPTISON is supplied as:
Zdravilo OPTISON je na voljo v naslednjih velikostih pakiranja:
1 vial of 3 ml or 5 vials of 3 ml.
1 viala po 3 ml ali 5 vial po 3 ml.
Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container.
Kot vsa parenteralna zdravila, moramo viale zdravila OPTISON vizualno pregledati na intaktnost vsebnika.
6 Vials are intended for single use only.
Viale so namenjene samo za enkratno uporabo.
Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded.
Po predrtju gumijastega zamaška moramo vsebino uporabiti v 30 minutah in ves neuporabljeni ostanek zavreči.
OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use.
Zdravilo OPTISON ima v ne- resuspendirani obliki na vrhu tekoče faze belo plast mikrosfer, ki jih je treba pred uporabo resuspendirati.
Homogenous white suspension after resuspension.
Homogena bela suspenzija po re- suspendiranju.
The following instructions should be followed:
Upoštevati morate naslednja navodila:
- Cold solutions taken directly from the refrigerator should not be injected.
- Hladnih raztopin, vzetih direktno iz hladilnika, ne smete injicirati.
- Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or
- Počakajte, da viala doseže sobno temperaturo in pred resuspendiranjem preglejte tekočo fazo na
precipitates before resuspension.
vsebnost delcev ali oborin.
Attach a
Pritrdite
three-way stopcock to the cannula.
tripotni petelinček na kanilo.
- The OPTISON vial must be inverted and gently rotated for approximately three minutes to
- Vialo zdravila OPTISON morate obrniti navzdol in nežno vrteti približno tri minute, da se
completely resuspend the microspheres.
mikrosfere popolnoma resuspendirajo.
- Complete resuspension is indicated by a uniformly opaque white suspension and absence of any
- Popolno resuspendiranje označuje enakomerno bela motna suspenzija in odsotnost kakršnekoli
material on stopper and vial surfaces.
snovi na površini zamaška in viale.
- OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension.
- Zdravilo OPTISON morate previdno odvzeti v brizgo v času do 1 minute po resuspendiranju.
- Any pressure instability within the vial should be avoided since it may cause disruption of
- Kakršni koli nestabilnosti tlaka v viali se morate izogibati, ker lahko povzroči predrtje mikrosfer
microspheres and loss of contrast effect.
in izgubo kontrastnega učinka.
Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe.
Tako v viali napravite luknjo s sterilno konico ali sterilno 18 G iglo, preden izvlečete suspenzijo v injekcijsko brizgo.
Do not inject air into the vial as this will damage the product.
Ne injicirajte zraka v vialo, ker to poškoduje zdravilo.
- Use the suspension within 30 minutes after withdrawal.
- Suspenzijo uporabite v času do 30 minut po tem, ko ste jo odvzeli.
- OPTISON will segregate in an undisturbed syringe and must be resuspended before use.
- Zdravilo OPTISON se bo poleglo v mirujoči brizgi in ga morate pred uporabo resuspendirati.
- Resuspend the microspheres in the syringe immediately before injection by holding the syringe
- Mikrosfere resuspendirajte v brizgi tik pred injiciranjem tako, da držite brizgo vodoravno med
horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds.
dlanmi in jih hitro obračate naprej in nazaj najmanj 10 sekund.
- Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection
- Injicirajte suspenzijo skozi plastično kanilo, ki ni manjša od 20 G, pri maksimalni hitrosti
Never use any other type of route but the open flow connection.
Nikoli ne uporabljajte katerekoli druge poti razen povezave z direktnim pretokom.
If injected otherwise OPTISON bubbles will be destroyed.
Če injicirate na drugačen način, bodo mikrosfere zdravila OPTISON uničene.
- Immediately before injection a careful visual inspection of the syringe is mandatory in order to
- Tik pred injiciranjem morate obvezno natančno vizualno pregledati brizgo, da se prepričate o
ensure complete suspension of the microspheres.
popolni resuspendiranosti mikrosfer.
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.
Takoj po injiciranju zdravila OPTISON morate 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.
The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a “ to keep open” (TKO) rate.
Takrat morate pritrditi infuzijski set na tripotni petelinček in pričeti z intravenskim infundiranjem s hitrostjo, da je pretok ravno odprt (TKO - 'to keep open').
Immediately after OPTISON injection, the intravenous infusion should be wide open until contrast begins to fade from the left ventricle.
Takoj po injiciranju zdravila OPTISON morate široko odpreti pretok intravenske infuzije, dokler ne začne kontrast v levem ventriklu izginjati.
7 GE Healthcare AS Nycoveien 1-2 P. O. BOX 4220 Nydalen NO-0401 OSLO, Norway
GE Healthcare AS Nycoveien 1- 2 P. O. BOX 4220 Nydalen NO- 0401 OSLO, Norveška
1 x 3 ml presentation:
1 x 3 ml pakiranje:
EU/ 1/ 98/ 065/ 001 5 x 3 ml presentation:
EU/ 1/ 98/ 065/ 001 5 x 3 ml pakiranje:
Date of first authorisation:
7 Datum pridobitve dovoljenja za promet:
18/ 05/ 1998 Date of latest renewal:
18/ 05/ 1998 Datum zadnjega podaljšanja:
CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI ZA DOVOLJENJE ZA PROMET
Box 4220 Nydalen NO-0401 Oslo Norway
Box 4220 Nydalen NO- 0401 Oslo Norveška
Medicinal product subject to restricted medical prescription (See Annex I:
Zdravilo se izdaja le na recept z omejenim režimom izdajanja (Glejte Dodatek I:
The Marketing Authorisation Holder will continue to submit yearly Periodic Safety Update Reports (PSURs), unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet z zdravilom bo nadaljeval z oddajanjem letnih periodičnih poročil o varnosti zdravila (PSUR), če CHMP ne bo določila drugače.
1 ml contains:
IME ZDRAVILA
Perflutren-containing microspheres 5 - 8 x 108, with a mean diameter range of 2.5 - 4.5 µm, equivalent to 0.19 mg perflutren gas per ml.
1 ml vsebuje 5 - 8 x 108 mikrosfer s perflutrenom, s povprečnim premerom v razponu 2, 5 – 4, 5 µm, kar ustreza 0, 19 mg perflutren plina na ml.
Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Pomožne snovi: humani albumin, natrijev klorid, N- acetiltriptofan, kaprilna kislina, natrijev hidroksid in voda za injekcije.
Discard any unused portion.
Zavrzite ves neuporabljeni ostanek.
SPECIAL STORAGE CONDITIONS
13 Shranjujte v pokončnem položaju v hladilniku.
GE Healthcare AS, Nycoveien 1-2, 0401 Oslo, Norway
GE Healthcare AS, Nycoveien 1- 2, 0401 Oslo, Norveška
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
OPTISON 0.19 mg/ ml dispersion for injection Perflutren-containing microspheres
OPTISON 0, 19 mg/ ml disperzija za injiciranje mikrosfere s perflutrenom
16 PACKAGE LEAFLET:
16 NAVODILO ZA UPORABO:
OPTISON 0.19 mg/ ml dispersion for injection Perflutren-containing microspheres
OPTISON 0, 19 mg/ ml disperzija za injiciranje Mikrosfere s perflutrenom
What OPTISON is and what it is used for 2.
Kaj je zdravilo OPTISON in za kaj ga uporabljamo 2.
Before you use OPTISON 3.
Kaj morate vedeti, preden boste uporabili zdravilo OPTISON 3.
How to use OPTISON 4.
Kako uporabljati zdravilo OPTISON 4.
How to store OPTISON 6.
Shranjevanje zdravila OPTISON 6.
WHAT OPTISON IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO OPTISON IN ZA KAJ GA UPORABLJAMO
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).
Zdravilo OPTISON je ultrazvočno kontrastno sredstvo, ki nam pomaga, da pri ehokardiografiji (postopek, pri katerem slikamo srce z ultrazvokom) dobimo razločnejše slike (sken) srca.