FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information What Luminity contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Luminity
English: The way Luminity is given and the dose depend on the technique used for the echocardiography.
Slovenian: Način dajanja zdravila Luminity in njegov odmerek sta odvisna od tehnike, ki se uporabi pri ehokardiografiji,
English: - The active substance is perflutren.
Slovenian: Učinkovina je perflutren.
English: Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.
Slovenian: Previdnost je potrebna pri bolnikih s klinično pomembno boleznijo pljuč, vključno z difuzno intersticijsko pljučno fibrozo in hudo kronično obstruktivno pljučno boleznijo, saj študije pri teh bolnikih niso bile izvedene.
English: It is available in a pack containing one or four single-use 1.5 ml vials.
Slovenian: Na voljo je v pakiranjih, ki vsebujejo eno in štiri 1,5-ml viale za enkratno uporabo.
English: The clinical consequences of overdose with Luminity are not known.
Slovenian: Klinične posledice prevelikega odmerka zdravila Luminity niso znane.
English: The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Slovenian: Vialmix ni priložen pakiranju zdravila Luminity, a ga bodo zdravniki dobili, ko bodo naročili pakiranje.
English: The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute.
Slovenian: Potem jo prilagodite, kot je potrebno za optimalno ojačitev slike, ne sme pa preseči 10 ml/minuto.
English: Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of perflutren.
Slovenian: Dopplerske ultrazvočne meritve z zdravilom Luminity so opravili hkrati s farmakokinetično analizo perflutrena.
English: Before use, this medicine must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
Slovenian: To zdravilo je treba aktivirati s stresanjem v mehaničnem pripomočku, imenovanem Vialmix, ki se dobavi zdravnikom, ki ga potrebujejo za pripravo zdravila.
English: This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
Slovenian: To zdravilo vsebuje 103,5 mg/ml propilenglikola, kar ustreza 182,2 mg propilenglikola na vialo.
English: Immediately after activation, Luminity appears as a milky white dispersion.
Slovenian: Takoj po aktiviranju je zdravilo Luminity videti kot mlečno bela disperzija.
English: Rare: Abnormal electrocardiogram
Slovenian: Preiskave redki: nenormalen elektrokardiogram
English: Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Slovenian: Zdravilo Luminity se ne sme uporabljati pri osnovnih načinih slikanja med obremenitveno ehokardiografijo, saj učinkovitost in varnost nista bili dokazani.
English: Luminity contains propylene glycol.
Slovenian: Luminity vsebuje propilenglikol.
English: In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation.
Slovenian: Pri takšnih bolnikih lahko fosfolipidno inkapsulirane mikrosfere obidejo pljuča in pridejo neposredno v arterijski obtok.
English: Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management.
Slovenian: Kontrastna ehokardiografija se sme izvesti le pri bolnikih, pri katerih bi rezultati tovrstne preiskave lahko bistveno vplivali na potek zdravljenja posameznega bolnika.
English: Activation process and administration
Slovenian: Postopek aktiviranja in apliciranja
English: 1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.
Slovenian: 1,5 ml tekočine v viali iz bistrega borosilikatnega stekla tipa I, zaprti s klorobutilnim elastomernim liofilizacijskim zamaškom, zapečateni z aluminijsko obrobo in pokriti s plastičnim dvižnim gumbom.
English: If Luminity is administered directly to the patient without undergoing the mechanical activation procedure using the Vialmix (see section 6.6), the product will not produce its intended effect.
Slovenian: Če zdravilo Luminity aplicirate, ne da bi ga pred tem mehanično aktivirali z Vialmixom (glejte poglavje 6.6), ne bo imel želenega učinka.
English: • and abnormal electrocardiogram.
Slovenian: • nenormalen elektrokardiogram.
English: The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored under refrigeration or at room temperature.
Slovenian: Zdravilo lahko reaktivirate do 48 ur po prvem aktiviranju in ga uporabite do 12 ur po drugem aktiviranju, ne glede na to, ali je shranjeno v hladilniku ali pri sobni temperaturi.
English: Heart or breathing problems including cardiac arrest have occurred in some patients.
Slovenian: Pri nekaterih bolnikih so se pojavile težave s srcem ali dihanjem, vključno z zastojem srca.
English: - The vial should be activated using the Vialmix.
Slovenian: - Vialo morate aktivirati z Vialmixom.
English: When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial.
Slovenian: Če uporabljate iglo, mora biti zabodena tako, da disperzijo vlečete iz sredine tekočine v viali, obrnjeni na glavo.
English: Luminity is used in adults 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).
Slovenian: Zdravilo Luminity se uporablja pri odraslih za jasnejše slikanje srčnih votlin, predvsem levega prekata, med ehokardiografijo (diagnostično preiskavo, pri kateri se slika srca pridobi z ultrazvokom).
English: Talk to your doctor before using Luminity - if you have been told you have a heart shunt - if you have severe heart or lung diseases or if you need mechanical help to breathe - if you have an artificial valve in your heart - if you have an acute severe inflammation/sepsis - if you have known hyperactive coagulation system (blood clotting issues) or recurrent thromboembolism (blood clots) - if you have a liver disease - if you have a kidney disease
Slovenian: - če so vam povedali, da imate srčni spoj (šant), - če imate hudo bolezen srca ali pljuč ali če za dihanje potrebujete mehanično podporo, - če imate umetno srčno zaklopko, - če imate hujše akutno vnetje/sepso, - če je znano, da imate hiperaktivni koagulacijski sistem (težave s strjevanjem krvi) ali ponavljajočo se trombembolijo (krvne strdke),
English: - The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile needle or attached to a sterile non-siliconised mini-spike.
Slovenian: - Disperzijo morate izvleči iz viale z brizgo, ki ima nameščeno sterilno iglo številka 18 do 20 ali sterilno nesilikonizirano mini-konico.
English: Rats treated with Luminity for 1 month exhibited dose-related, reversible perivascular and peribronchiolar eosinophil infiltration, alveolar macrophage accumulation and increased goblet cell size and number in the lungs.
Slovenian: Pri podganah, ki so 1 mesec dobivale Zdravilo Luminity, so ugotovili z odmerkom povezano, reverzibilno perivaskularno in peribronhiolarno infiltracijo z eozinofilci, alveolarno kopičenje makrofagov ter povečanje velikosti in števila čašastih celic v pljučih.
English: Luminity is given to you before or during your ultrasound examination by healthcare professionals such as doctors who are experienced in this type of examination.
Slovenian: Zdravilo Luminity boste dobili pred preiskavo z ultrazvokom ali med njo; dal vam ga bo zdravstveni delavec, npr. zdravnik, ki ima izkušnje s takšnimi preiskavami.
English: • increased sweating,
Slovenian: • srbenje, • močnejše znojenje,
English: The ultrasonic properties of the product are very different from those of soft tissue and will generate strong echoes.
Slovenian: Luminity se zelo razlikujejo od lastnosti mehkih tkiv in povzročijo močan odboj.
English: The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.
Slovenian: Zdravilo lahko reaktivirate do 48 ur po prvem aktiviranju in ga uporabite do 12 ur po drugem aktiviranju.
English: How to use Luminity
Slovenian: Kako uporabljati zdravilo Luminity
English: Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:
Slovenian: Intravensko infundiranje z uporabo nelinearnega načina kontrastnega slikanja (mirovanje in obremenitev) ali osnovnih načinov slikanja v mirovanju:
English: This product must only be administered intravenously.
Slovenian: To zdravilo se sme dajati samo intravensko.
English: Luminity is for diagnostic use only.
Slovenian: Zdravilo Luminity je samo za diagnostične namene.
English: Luminity should only be administered to such patients after careful risk/benefit assessment.
Slovenian: Pri teh bolnikih se sme zdravilo Luminity uporabljati le po skrbnem ovrednotenju razmerja med koristjo in tveganjem.
English: • loss of consiousness,
Slovenian: • izguba zavesti,
English: Luminity is an ultrasound contrast agent that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Slovenian: Zdravilo Luminity je kontrastno sredstvo za ultrazvočne preiskave, ki vsebuje mikrosfere (drobne mehurčke) s plinom perflutren kot učinkovino.
English: Fundamental and non-linear imaging techniques (second harmonic, multipulse phase and/or amplitude modulation) using both continuous and triggered acquisition were utilised in clinical studies with Luminity.
Slovenian: V kliničnih študijah z zdravilom Luminity so bile uporabljene osnovne in nelinearne preiskovalne metode (“second harmonic”, “multipulse phase” in/ali “amplitude modulation”) pri čemer je bil uporabljen tako kontinuiran kot pulzirajoč signal.
English: The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied.
Slovenian: Varnost zdravila Luminity ni raziskana pri bolnikih z desno-levimi, dvosmernimi ali prehodnimi desno-levimi srčnimi spoji (šanti).
English: • pain at the site of injection.
Slovenian: • občutek vročine in • bolečina na mestu injiciranja.
English: Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Slovenian: Kot velja za vsa parenteralna zdravila, morate viale pred uporabo pregledati in preveriti glede delcev in nepoškodovanosti viale.
English: All lipids are metabolised to free fatty acids.
Slovenian: Vsi lipidi se presnovijo v proste maščobne kisline.
English: Luminity is a gas and solvent for dispersion for injection or infusion.
Slovenian: Zdravilo Luminity je plin in vehikel za disperzijo za injiciranje ali infundiranje.
English: What Luminity looks like and contents of the pack
Slovenian: Izgled zdravila Luminity in vsebina pakiranja
English: During contrast-enhanced echocardiography, serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes of Luminity administration in patients including those with severe cardiac and pulmonary diseases (see section 4.8).
Slovenian: Bolniki z nestabilnim kardiopulmonalnim stanjem Med izvajanjem kontrastne ehokardiografije ali v 30 minutah po uporabi zdravila Luminity so pri bolnikih, vključno z bolniki s hudo boleznijo srca in pljuč, poročali o pojavu hudih kardiopulmonalnih reakcij, tudi s smrtnimi izidi (glejte poglavje 4.8).
English: The dispersion should be given to you within 12 hours of activation (shaking).
Slovenian: Disperzijo morate dobiti v 12 urah po aktiviranju (stresanju).
English: Not known: Abnormal vision
Slovenian: Očesne bolezni neznana: nenormalen vid
English: Luminity should be used within 12 hours following activation.
Slovenian: Zdravilo Luminity morate uporabiti v 12 urah po aktiviranju.
English: If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.
Slovenian: Če ste že kdaj prejeli zdravilo Luminity ali katero koli drugo kontrastno sredstvo, ki ga uporabljamo pri ultrazvočnih preiskavah, in se je pri tem pojavila alergijska reakcija, o tem obvestite svojega zdravnika.
English: Luminity contains sodium.
Slovenian: Zdravilo Luminity vsebuje natrij.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree' .
Slovenian: Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar dejansko pomeni, da je “brez natrija”.
English: - if you are allergic to perflutren or any of the other ingredients of Luminity.
Slovenian: - če ste alergični na perflutren ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Gas and solvent for dispersion for injection/infusion 1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
Slovenian: plin in vehikel za disperzijo za injiciranje/infundiranje 1 x 1,5-ml viala z enim odmerkom
English: As Luminity has no pharmacologic effect, and on the basis of its pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of this product on the ability to drive or use machines.
Slovenian: Glede na farmakokinetične in farmakodinamične lastnosti ni pričakovati vpliva na sposobnost vožnje in upravljanja s stroji oz. je pričakovani vpliv zanemarljiv.
English: Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
Slovenian: Preden dobite zdravilo Luminity, morate zdravniku ali farmacevtu povedati, če ste noseči ali če dojite,
English: The product consists of lipid encapsulated perflutren microspheres.
Slovenian: Zdravilo sestavljajo mikrosfere perflutrena, inkapsulirane z lipidom.
English: The product should be used within 12 hours of activation.
Slovenian: Zdravilo je treba uporabiti v 12 urah po aktiviranju.
English: • rash, redness of the skin,
Slovenian: • izpuščaj, pordelost kože,
English: Rare side effects (may affect up to 1 in 1000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu,
English: Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.
Slovenian: Pred uporabo je treba zdravilo Luminity aktivirati z uporabo mehanskega stresalnika Vialmix, glejte poglavje 6.6.
English: Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions, which might require resuscitation.
Slovenian: Zdravilo se sme uporabljati le pod neposrednim nadzorom zdravnika, ki ima izkušnje z ukrepanjem v primeru pojava preobčutljivostnih reakcij, vključno s hudimi alergijskimi reakcijami,
English: The approximate amount of perflutren gas in each ml is 150 microlitres (μl).
Slovenian: Približna količina plina perflutrena je 150 mikrolitrov (μl) na mililiter.
English: Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity, fertility, embryo/foetal development, parturition or post-natal development, and local tolerance.
Slovenian: Predklinični podatki na osnovi običajnih študij genotoksičnosti, plodnosti, embrio-fetalnega razvoja, porajanja ali postnatalnega razvoja in lokalnega prenašanja ne kažejo posebnega tveganja za človeka.
English: The total dose of perflutren should not exceed 1.6 ml.
Slovenian: Celotni odmerek perflutrena ne sme preseči
English: The systemic clearance of perflutren was similar in healthy and COPD subjects.
Slovenian: Sistemski očistek perflutrena je bil pri zdravih osebah in bolnikih s KOPB podoben.
English: Caution must be exercised when considering the administration of Luminity to these patients.
Slovenian: Zato se morate za uporabo zdravila Luminity pri takšnih bolnikih odločiti previdno.
English: Gas and solvent for dispersion for injection/infusion Colourless, uniformly clear to translucent liquid.
Slovenian: plin in vehikel za disperzijo za injiciranje/infundiranje brezbarvna, enakomerno bistra do prosojna tekočina
English: • increased blood pressure,
Slovenian: • omedlevica, • zvišan krvni tlak,
English: • altered heart rate, palpitations (you feel your heart beats harder or in an irregular way),
Slovenian: • otrplost, mravljinčenje ali pekoč občutek, • spremenjen srčni utrip, palpitacije (občutek močnejšega ali nerednega bitja srca),
English: Overdose is not likely to happen since the medicine is administered by a doctor.
Slovenian: Verjetnost prevelikega odmerjanja tega zdravila je majhna, saj vam ga bo injiciral zdravnik.
English: Not known: Cardiac arrest, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contactions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia
Slovenian: Srčne bolezni redki: bradikardija, tahikardija, palpitacije neznana: srčni zastoj, ventrikularne aritmije (ventrikularna fibrilacija, ventrikularna tahikardija, prezgodnje krčenje prekatov), asistolija, atrijska fibrilacija, srčna ishemija,
English: In most subjects after 4-5 minutes, perflutren was undetectable in blood and expired air. Perflutren concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects and 1.9 minutes in COPD subjects.
Slovenian: Ugotovljeno je, da koncentracija perflutrena v krvi upada monoeksponentno, in sicer s povprečnim razpolovnim časom, ki je pri zdravih preiskovancih 1,3 minute in pri preiskovancih s KOPB 1,9 minute.
English: The pharmacokinetic properties of Luminity were evaluated in normal healthy subjects and subjects with chronic obstructive pulmonary disease (COPD) following intravenous administration of a 50 µl/kg dose of the product.
Slovenian: Farmakokinetične lastnosti zdravila Luminity so ocenili pri normalnih zdravih preiskovancih in pri preiskovancih s kronično obstruktivno pljučno boleznijo (KOPB) po intravenski aplikaciji odmerka
English: Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status, for example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart failure (NYHA IV) or respiratory failure.
Slovenian: Pri bolnikih z nestabilnim kardiopulmonalnim stanjem je treba zdravilo Luminity uporabljati izjemno previdno, npr. pri bolnikih z nestabilno angino pektoris, akutnim miokardnim infarktom, s hudo ventrikularno aritmijo, hudim srčnim popuščanjem
English: The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
Slovenian: bolnikih) so se pojavili v nekaj minutah po aplikaciji in so ponavadi v 15 minutah minili brez terapevtskega ukrepanja.
English: - The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before withdrawing the dispersion.
Slovenian: - Preden izvlečete disperzijo, zabodite v vialo sterilno injekcijsko iglo ali sterilno, nesilikonizirano mini-konico, da bo viala odzračena.
English: • breathing problems, cough, dry throat, difficulty in swallowing,
Slovenian: • težave z dihanjem, kašelj, suho žrelo, težave s požiranjem,
English: The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
Slovenian: Približna količina plina perflutrena je 150 mikrolitrov na mililiter zdravila Luminity.
English: • fatigue,
Slovenian: • utrujenost,
English: After activation: Do not store above 30°C.
Slovenian: Po aktiviranju: Shranjujte pri temperaturi do 30 °C.
English: After activation (shaking), the product appears as a milky white liquid.
Slovenian: Po aktiviranju (stresanju) ima videz mlečno bele disperzije.
English: Uncommon: Hypotension Rare: Syncope, hypertension, peripheral coldness
Slovenian: Žilne bolezni pogosti: zardevanje občasni: hipotenzija redki: sinkopa, hipertenzija, hladne okončine
English: • abdominal pain, diarrhoea, nausea (feeling sick), vomiting,
Slovenian: • bolečina v trebuhu, driska, navzea (siljenje na bruhanje), bruhanje,
English: After activation (shaking), do not store above 30°C.
Slovenian: Po aktiviranju (stresanju) shranjujte pri temperaturi do 30 °C.
English: • difficulty in breathing, throat irritation,
Slovenian: • težko dihanje, draženje žrela,
English: Elderly Pharmacokinetics has not been specifically studied in the elderly.
Slovenian: Farmakokinetike pri starostnikih niso posebej preučevali.
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
Slovenian: En mililiter vsebuje največ 6,4 x 109 lipidnih mehurčkov, ki vsebujejo perflutren; povprečni razpon njihovega premera je od 1,1 do 2,5 mikrometra.
English: • joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness
Slovenian: • bolečina v sklepih, bolečina ob strani/ob straneh, bolečine v vratu, mišični krč, zvišana telesna temperatura, mišična togost in
English: Administration and mechanical activation procedure Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).
Slovenian: Zdravila Luminity se ne sme aplicirati na noben drug način (npr. intraarterijsko injiciranje).
English: • back pain, chest pain,
Slovenian: • bolečina v hrbtu, bolečina v prsih,
English: Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Slovenian: (pri projekciji “štirih” ali “dveh votlin” vsaj dveh od šestih segmentov prekatne stene ni bilo možno ovrednotiti), da bi tako dosegli opacifikacijo srčnih votlin in boljšo zamejitev endokardialne meje levega prekata tako v mirovanju kot med obremenitvijo.
English: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride
Slovenian: 1,2-dipalmitoil-sn-glicero-3-fosfatidilholin (DPPC) 1,2-dipalmitoil-sn-glicero-3-fosfatidilna kislina, mononatrijeva sol (DPPA) N-(metoksipolietilenglikol 5000 karbamoil)-1,2-dipalmitoil-sn-glicero-3fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE) natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid propilenglikol glicerol voda za injekcije
English: Do not use Luminity after the expiry date which is stated on the carton and label after EXP. Before activation (shaking), store in a refrigerator (2°C - 8°C).
Slovenian: Pred aktiviranjem (stresanjem) shranjujte v hladilniku (2 °C - 8 °C).