FrancophonIA/ELRC3.0 huggingface dataset:
English: Autoimmune diseases
Slovenian: Avtoimunske bolezni
English: Warnings and precautions Talk to your doctor or pharmacist before taking Slenyto if you or your child:
Slovenian: Pred začetkom jemanja zdravila Slenyto se posvetujte z zdravnikom ali farmacevtom, če imate vi ali vaš otrok:
English: There was a significant improvement with Slenyto over placebo in Composite Sleep Disturbance Index (CSDI)assessed parent satisfaction in child sleep pattern (p=0 .005) and in caregivers' well-being as assessed by the WHO-5 after 13 weeks of double-blind treatment (p=0.01) (Table 2).
Slovenian: Pri zdravilu Slenyto sta se po 13-tedenskem dvojno slepem zdravljenju v primerjavi s placebom zelo izboljšala sestavljeni indeks motenj spanja (CSDI) - s katerim se oceni zadovoljstvo staršev z otrokovim spalnim vzorcem (p = 0,005), in dobro počutje skrbnikov, ocenjeno z indeksom WHO-5 (p = 0,01) (preglednica 2).
English: 60 prolonged-release tablets
Slovenian: 60 tablet s podaljšanim sproščanjem
English: • thioridazine (used for the treatment of schizophrenia)
Slovenian: • tioridazinom (ki se uporablja za zdravljenje shizofrenije);
English: Two liver-mediated metabolic pathways account for around 90% of melatonin metabolism.
Slovenian: Približno 90 % melatonina se presnovi po dveh metaboličnih poteh prek jeter.
English: What Slenyto looks like and contents of the pack 1 mg strength
Slovenian: Izgled zdravila Slenyto in vsebina pakiranja jakost 1 mg
English: CARTON (BOTTLE AND BLISTER PACKS) AND LABEL (HDPE BOTTLE) - 5 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA (PLASTENKA IN PRETISNI OMOTI) IN NALEPKA (PLASTENKA HDPE) - 5 mg
English: Therefore, melatonin is not recommended for use in patients with hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z jetrno okvaro zato uporaba melatonina ni priporočljiva (glejte poglavje 5.2).
English: Slenyto is a medicine that contains the active ingredient, melatonin.
Slovenian: Zdravilo Slenyto vsebuje zdravilno učinkovino melatonin.
English: There is no experience of the use of melatonin in patients with liver impairment.
Slovenian: Izkušenj z uporabo melatonina pri bolnikih z jetrno okvaro ni.
English: There is no relevant use of melatonin in children aged 0 to 2 years for the treatment of insomnia.
Slovenian: Pediatrična populacija (do dveh le starosti) Melatonin ni namenjen za zdravljenje nespečnosti pri otrocih, starih od 0 do 2 leti.
English: • benzodiazepines and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone
Slovenian: • benzodiazepinskimi in nebenzodiazepinskimi hipnotiki, kot so zaleplon, zolpidem in zopiklon (ki se uporabljajo za uspavanje);
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/003: 30 prolonged-release tablets (blister pack) EU/1/18/1318/004: 30 prolonged-release tablets (bottle)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1318/003: 30 tablet s podaljšanim sproščanjem (pretisni omot) EU/1/18/1318/004: 30 tablet s podaljšanim sproščanjem (plastenka)
English: Slenyto is for oral use.
Slovenian: Zdravilo Slenyto je namenjeno peroralni uporabi.
English: - If you or your child gets any side effects, talk to your doctor or pharmacist.
Slovenian: - Če pri sebi ali otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Ammonio methacrylate copolymer type A Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
Slovenian: Jedro tablete amonijev metakrilat kopolimer vrste A kalcijev hidrogenfosfat dihidrat monohidrat laktoze brezvodni koloidni silicijev dioksid magnezijev stearat
English: Fluvoxamine
Slovenian: Fluvoksamin
English: How to take Slenyto
Slovenian: Kako jemati zdravilo Slenyto
English: Drowsiness
Slovenian: Zaspanost
English: In the paediatric population comprising 16 ASD children ages 7-15 years old suffering from insomnia, following Slenyto 2 mg (2 x 1 mg mini-tablets) administration after a standardized breakfast,
Slovenian: Pri pediatrični populaciji, sestavljeni iz 16 otrok z ASD, starih od 7 do 15 let, ki so imeli težave z nespečnostjo, ki je po standardnem zajtrku prejela 2 mg zdravila Slenyto (2 x 1 mg mini tabletko), so bile koncentracije melatonina najvišje v dveh urah po prejemu in so ostale povišane šest ur potem, pri čemer je Cmax (SD) v slini znašal 410 pg/ml (210).
English: No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases.
Slovenian: V zvezi z uporabo melatonina pri posameznikih z avtoimunskimi boleznimi ni na voljo kliničnih podatkov.
English: If you or your child gets any side effects, talk to your doctor or pharmacist.
Slovenian: Če pri sebi ali otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Tablets can be put into food such as yoghurt, orange juice or ice-cream to facilitate swallowing and improve compliance.
Slovenian: Za lažje požiranje in izboljšanje skladnosti se tablete lahko dajo v hrano, na primer v jogurt, pomarančni sok ali sladoled.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BLISTER PACK) - 1 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PRETISNI OMOT) - 1 mg
English: Fidia Farmaceutici S.p.A. Tel: +39 049 8232355 e-mail: info@fidiapharma.it
Slovenian: Tel: +39 049 8232355 e-mail: info@fidiapharma.it
English: - The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc, magnesium stearate, carmellose sodium (E466), maltodextrin, glucose monohydrate, lecithin (E322),
Slovenian: - Druge sestavine so amonijev metakrilat kopolimer vrste A, kalcijev hidrogenfosfat dihidrat, monohidrat laktoze, silicijev dioksid (brezvodni koloidni), magnezijev stearat, natrijev karmelozat (E466), maltodekstrin, monohidrat glukoze, lecitin (E322), titanov dioksid (E171) in rumeni železov oksid (E172).
English: Iberfar - Indústria Farmacêutica, S.A.
Slovenian: Fidia Farmaceutici S.p.A.
English: Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc
Slovenian: Jedro tablete amonijev metakrilat kopolimer vrste B kalcijev hidrogenfosfat dihidrat monohidrat laktoze brezvodni koloidni silicijev dioksid smukec magnezijev stearat
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: (only applicable for outer carton, not applicable for bottle label) SN: (only applicable for outer carton, not applicable for bottle label) NN: (only applicable for outer carton, not applicable for bottle label)
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: (Uporablja se samo za zunanjo škatlo, ne uporablja se za nalepko na plastenki.)
English: Slenyto contains lactose.
Slovenian: Zdravilo Slenyto vsebuje laktozo.
English: • Visual impairment
Slovenian: • poslabšanje vida
English: • Decreased appetite
Slovenian: • zmanjšan tek
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/005: 30 prolonged-release tablets
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1318/005: 30 tablet s podaljšanim sproščanjem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1318/002: 60 prolonged-release tablets
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1318/002: 60 tablet s podaljšanim sproščanjem
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER STRIP OF 30 TABLETS - 5 MG
Slovenian: PRETISNI OMOT DVOJNI TRAK S 30 TABLETAMI - 5 mg
English: Table 2: PARENTS WELL BEING (13 weeks Double- blind)
Slovenian: Preglednica 2: DOBRO POČUTJE STARŠEV (13-tedensko dvojno slepo zdravljenje) Spremenljivka Skupina Prilagojeno povprečje zdravljenja (SE) [95 % CI]
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 30 TABLETS - 1 MG
Slovenian: PRETISNI OMOT S 30 TABLETAMI - 1 mg
English: CARTON AND LABEL (HDPE BOTTLE) - 1 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA (PLASTENKA HDPE) - 1 mg
English: NAME OF THE MEDICINAL PRODUCT Slenyto 5 mg prolonged-release tablets melatonin
Slovenian: IME ZDRAVILA Slenyto 5 mg tablete s podaljšanim sproščanjem melatonin
English: Glucose monohydrate Lecithin (E322) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Slovenian: Filmska obloga natrijev karmelozat (E466) maltodekstrin monohidrat glukoze lecitin (E322) titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
English: The rate of participants attaining clinically meaningful responses in TST (increase of 45 minutes from baseline) and/or SL (decrease of 15 minutes from baseline) was significantly higher with Slenyto than with placebo
Slovenian: Odstotek udeležencev, ki so dosegli klinično pomembne odzive glede skupnega časa spanja (TST) (podaljšanje za 45 minut glede na izhodišče) in/ali latence uspavanja (SL) (skrajšanje za 15 minut glede na izhodišče), je bil pri zdravilu Slenyto veliko večji kot pri placebu (68,9 % oziroma 39,3 %; p = 0,001).
English: NAME OF THE MEDICINAL PRODUCT Slenyto 1 mg prolonged-release tablets melatonin
Slovenian: IME ZDRAVILA Slenyto 1 mg tablete s podaljšanim sproščanjem melatonin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Slenyto 1 mg prolonged-release tablets
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Slenyto 1 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 1 mg melatonina.
English: Glucose monohydrate Lecithin (E322) Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Filmska obloga natrijev karmelozat (E466) maltodekstrin monohidrat glukoze lecitin (E322) titanov dioksid (E171) rumeni železov oksid (E172)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 5 mg melatonin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Vsaka tableta s podaljšanim sproščanjem vsebuje 5 mg melatonina.
English: Slenyto 5 mg prolonged-release tablets
Slovenian: Slenyto 5 mg tablete s podaljšanim sproščanjem
English: Slenyto 1 mg prolonged-release tablets
Slovenian: Slenyto 1 mg tablete s podaljšanim sproščanjem
English: • methoxypsoralens (used in the treatment of skin disorders e.g. psoriasis)
Slovenian: • metoksipsoraleni (ki se uporabljajo za zdravljenje kožnih bolezni, npr. luskavice);
English: B. PACKAGE LEAFLET
Slovenian: • zabuhel obraz
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Iberfar Indústria Farmacêutica S.A.,
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovorih) za sproščanje serij
English: Sinusitis
Slovenian: Vnetje sinusov
English: NAME OF THE MARKETING AUTHORISATION HOLDER RAD Neurim Pharmaceuticals EEC SARL
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM RAD Neurim Pharmaceuticals EEC SARL
English: - Keep this leaflet.
Slovenian: Pogoltnite cele.
English: PVC/PVDC opaque blister with aluminium foil backing.
Slovenian: Neprozorni pretisni omot PVC/PVDC s hrbtno stranjo iz aluminija Velikost pakiranja: 30 tablet.
English: If you or your child stops taking Slenyto
Slovenian: Če ste vi ali vaš otrok prenehali jemati zdravilo Slenyto Preden vi/vaš otrok prenehate jemati zdravilo Slenyto, se posvetujte z zdravnikom.
English: Slenyto 5 mg prolonged-release tablets are yellow, film coated, round, biconvex, 3 mm diameter tablets.
Slovenian: Slenyto 5 mg tablete s podaljšanim sproščanjem so rumene barve, filmsko obložene, okrogle, bikonveksne, s premerom 3 mm.
English: Slenyto 5 mg prolonged-release tablets Yellow, film coated, round, biconvex, 3 mm diameter tablets with no imprint.
Slovenian: Slenyto 5 mg tablete s podaljšanim sproščanjem Rumene, filmsko obložene, okrogle, bikonveksne, s premerom 3 mm in brez vtisa.
English: DATE OF REVISION OF THE TEXT {DD month YYYY}
Slovenian: DATUM REVIZIJE BESEDILA
English: Slenyto 1 mg prolonged-release tablets are pink, film coated, round, biconvex, 3 mm diameter tablets.
Slovenian: Slenyto 1 mg tablete s podaljšanim sproščanjem so roza barve, filmsko obložene, okrogle, bikonveksne, s premerom 3 mm.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 1 mg melatonin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s podaljšanim sproščanjem vsebuje 1 mg melatonina.
English: If any of the following side effects get serious or are troublesome, contact your doctor or seek medical advice:
Slovenian: Posvetujte se z zdravnikom, če kateri koli od naslednjih neželenih učinkov postane resen ali neprijeten:
English: Slenyto 1 mg prolonged-release tablets Pink, film coated, round, biconvex, 3 mm diameter tablets with no imprint.
Slovenian: Slenyto 1 mg tablete s podaljšanim sproščanjem Roza, filmsko obložene, okrogle, bikonveksne, s premerom 3 mm in brez vtisa.
English: Concomitant use to be considered with caution
Slovenian: Previdna sočasna uporaba z drugimi zdravili
English: Alcohol
Slovenian: Kajenje
English: Caution should be used when melatonin is administered to patients with renal impairment.
Slovenian: Pri dajanju melatonina bolnikom z ledvično okvaro je potrebna previdnost.
English: LIST OF EXCIPIENTS Contains lactose monohydrate See leaflet for further information
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje monohidrat laktoze.
English: Slenyto 1 mg prolonged-release tablets Slenyto 5 mg prolonged-release tablets melatonin
Slovenian: Slenyto 1 mg tablete s podaljšanim sproščanjem Slenyto 5 mg tablete s podaljšanim sproščanjem
English: Group
Slovenian: Skupna ocena
English: Slenyto contains lactose
Slovenian: Shranjevanje zdravila Slenyto
English: Nervous system disorders
Slovenian: Nesteroidna protivnetna zdravila
English: Prolonged- release tablet.
Slovenian: Tableta s podaljšanim sproščanjem.
English: Each prolonged-release tablet contains 5 mg melatonin.
Slovenian: Slenyto 5 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 5 mg melatonina.
English: Variable
Slovenian: Odmerjanje
English: 1 mg strength - The active substance is melatonin.
Slovenian: - Zdravilna učinkovina je melatonin.
English: The dose can be repeated.
Slovenian: Odmerek se lahko ponovi.
English: Side-effects were generally minor.
Slovenian: Neželeni učinki so bili v splošnem manjši.
English: The main measure of effectiveness was how clear the images obtained in the test were.
Slovenian: Glavno merilo učinkovitosti je bila jasnost slik, pridobljenih pri preiskavi.
English: The full EPAR for SonoVue can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo SonoVue je na voljo na spletni strani agencije: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for SonoVue on 26 March 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom SonoVue, veljavno po vsej Evropski uniji, izdala 26. marca 2001.
English: What measures are being taken to ensure the safe and effective use of SonoVue?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila SonoVue?
English: It is a contrast agent (it helps make internal body structures visible during imaging tests).
Slovenian: Je kontrastno sredstvo (omogoča vidnost notranjih telesnih struktur med slikanjem).
English: The European Medicines Agency therefore decided that SonoVue's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je tako sklenila, da so koristi zdravila SonoVue večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: This helps to enhance the results of tests that rely on measuring ultrasound.
Slovenian: To pomaga izboljšati rezultate preiskav, ki temeljijo na merjenju ultrazvoka.
English: SonoVue sulphur hexafluoride
Slovenian: SonoVue žveplov heksafluorid
English: It is only used when the results of the test without a contrast agent are inconclusive.
Slovenian: Uporablja se samo takrat, kadar je preiskava brez kontrastnega sredstva neuspešna.
English: It is not intended to provide practical advice on how to use SonoVue.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This is a summary of the European public assessment report (EPAR) for SonoVue.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo SonoVue.
English: Pooled analysis of the studies suggested that SonoVue identified children with vesicoureteral reflux in 89% of cases, and correctly distinguished patients who did not have the condition in 81% of cases.
Slovenian: Zbirna analiza študij kaže, da je zdravilo SonoVue odkrilo otroke z refluksom sečnega mehurja v 89 % primerih in da je v 81 % primerov pravilno razločilo bolnike, pri katerih tega stanja ni bilo.
English: Other information about SonoVue
Slovenian: Druge informacije o zdravilu SonoVue
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SonoVue have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila SonoVue upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the ‘gold standard', such as angiography (X-rays of blood vessels).
Slovenian: V teh študijah zdravila SonoVue niso primerjali z nobenim drugim zdravilom, vendar so rezultate preizkusa s tem zdravilom primerjali z zlatim standardom, kot je na primer angiografija (rentgensko slikanje krvnih žil).
English: SonoVue is used in:
Slovenian: Zdravilo SonoVue se uporablja pri:
English: • Doppler (a diagnostic test that measures the speed of blood flow).
Slovenian: • Dopplerjevi sonografiji (diagnostični preiskavi, pri kateri se meri hitrost pretoka krvi).
English: The company also presented results from the literature of 4 main studies involving over 500 children given SonoVue before ultrasound scans of the bladder to detect vesicoureteral reflux.
Slovenian: Družba je predstavila tudi rezultate iz literature 4 glavnih študij, v katere je bilo vključenih več kot 500 otrok, ki so pred ultrazvočnimi preiskavami mehurja za odkrivanje refluksa sečnega mehurja prejeli zdravilo SonoVue.
English: The company will carry out a study to confirm the effectiveness of SonoVue in detecting vesicoureteral reflux in children and its impact on the way patients are managed.
Slovenian: Družba bo izvedla študijo za potrditev učinkovitosti zdravila SonoVue pri odkrivanju refluksa sečnega mehurja pri otrocih in njegovega vpliva na način obravnave bolnikov.
English: For more information about treatment with SonoVue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom SonoVue preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with SonoVue?
Slovenian: Kakšna tveganja so povezana z zdravilom SonoVue?
English: Why is SonoVue approved?
Slovenian: Zakaj je bilo zdravilo SonoVue odobreno?
English: SonoVue must also not be used together with the medicine dobutamine (used for heart failure) in patients for whom dobutamine is not suitable.
Slovenian: Prav tako se zdravilo ne sme uporabljati sočasno z dobutaminom (zdravilom za zdravljenje srčnega popuščanja) pri bolnikih, za katere slednji ni primeren.
English: What benefits of SonoVue have been shown in studies?
Slovenian: Kakšne koristi je zdravilo SonoVue izkazalo v študijah?
English: The active substance in SonoVue, sulphur hexafluoride, is a gas that is not soluble in body fluids or water.
Slovenian: Zdravilna učinkovina v zdravilu SonoVue, žveplov heksafluorid, je plin, ki v telesnih tekočinah ali vodi ni topen.
English: What is SonoVue and what is it used for?
Slovenian: Kaj je zdravilo SonoVue in za kaj se uporablja?
English: SonoVue can only be obtained with a prescription and should only be used by doctors who have experience in diagnostic ultrasound imaging.
Slovenian: Predpisovanje in izdaja zdravila SonoVue je le na recept, zdravljenje z njim pa smejo izvajati samo zdravniki, ki imajo izkušnje z diagnostičnim ultrazvočnim slikanjem.
English: • ultrasound scans of the bladder and urinary tract in children and adolescents to detect vesicoureteral reflux, a condition in which urine flows backward from the bladder to the kidneys, leading to scarring and kidney infections.
Slovenian: • ultrazvočnih preiskavah mehurja in sečil pri otrocih in mladostnikih za odkrivanje refluksa sečnega mehurja, stanja, pri katerem urin teče iz mehurja nazaj v ledvice, kar povzroča brazgotine in okužbe ledvic.
English: After injection, the microbubbles travel in the blood or disperse throughout the bladder, where they reflect ultrasound waves more than the surrounding tissues.
Slovenian: Po injiciranju mikromehurčki potujejo po krvi ali pa se razpršijo po mehurju, kjer odbijajo ultrazvočne valove bolj kot obdajajoča tkiva.
English: For use in echocardiography, SonoVue was investigated in 3 main studies.
Slovenian: Zdravilo SonoVue so za uporabo v ehokardiografiji proučevali v 3 glavnih študijah.
English: For use in Doppler scans, a further 3 main studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels.
Slovenian: Za uporabo pri preiskavah z Dopplerjevo sonografijo je bilo v dodatne 3 glavne študije vključenih 361 bolnikov, pri katerih so proučevali nepravilnosti v velikih krvnih žilah, in 217 bolnikov, pri katerih so proučevali nepravilnosti v manjših žilah.
English: The ultrasound scan of the bladder and kidneys is carried out during filling and emptying of the bladder.
Slovenian: Ultrazvočna preiskava mehurja in ledvic se izvaja med polnjenjem in praznjenjem mehurja.
English: The medicine contains the active substance sulphur hexafluoride (a gas).
Slovenian: Zdravilo vsebuje zdravilno učinkovino žveplov heksafluorid (plin).
English: These involved a total of 317 patients, and compared SonoVue with another contrast agent and placebo (a dummy treatment).
Slovenian: Vanje je bilo vključenih skupno 317 bolnikov, primerjale pa so učinke zdravila SonoVue z učinki drugega kontrastnega sredstva in placeba (zdravila brez zdravilne učinkovine).
English: It is available as a kit including one vial of gas and powder and one pre-filled syringe containing 5 ml of solvent.
Slovenian: Na voljo je v kompletu, ki vsebuje eno vialo plina in eno napolnjeno injekcijsko brizgo, v kateri je 5 ml vehikla.
English: The most common side effects when SonoVue is injected into a vein (seen in up to 1 in 100 patients) are headache, nausea (feeling sick) and reactions at the injection site.
Slovenian: Najpogostejši neželeni učinki pri injiciranju zdravila SonoVue v veno (ki se pojavijo pri največ 1 od 100 bolnikov) so glavobol, navzeja (siljenje na bruhanje) in reakcije na mestu injiciranja.
English: When used with ultrasound of the heart or for measuring blood flow, SonoVue is injected intravenously (into a vein) before the test is carried out, as a 2 or 2.4 ml dose depending on which test is being carried out.
Slovenian: Zdravilo SonoVue je pri ultrazvoku srca ali merjenju pretoka krvi injicirano intravensko (v veno) pred izvedbo preiskave v odmerku 2 ali 2,4 ml, odvisno od vrste preiskave.
English: Ultrasound with SonoVue was compared with the standard method using X-rays with an X-ray contrast agent.
Slovenian: Ultrazvok z zdravilom SonoVue so primerjali s standardno metodo rentgenskih žarkov, uporabljenih skupaj s kontrastnim sredstvom zanje.
English: SonoVue is a medicine for diagnostic use only.
Slovenian: Zdravilo SonoVue se uporablja samo v diagnostične namene.