FrancophonIA/ELRC3.0 huggingface dataset:
English: They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.
Slovenian: Zdravilo Vivanza vsebuje vardenafil, učinkovino iz skupine t.i. zaviralcev fosfodiesteraze tipa 5, ki se uporabljajo za zdravljenje erektilne disfunkcije pri odraslih moških, tj. z nezmožnostjo doseči in ohraniti erekcijo.
English: Vivanza may be administered at any time with tamsulosin or alfuzosin.
Slovenian: Med zdravljenjem s tamsulozinom ali alfuzosinom se lahko zdravilo Vivanza vzame kadar koli.
English: - Aspartame: This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Vivanza 10 mg orodisperzibilne tablete - Aspartam: To zdravilo vsebuje 1,80 mg aspartama v vsaki 10-mg orodisperzibilni tableti.
English: - Erythromycin or clarithromycin, macrolide antibiotics.
Slovenian: - ketokonazol ali itrakonazol - protiglivični zdravili, - eritromicin ali klaritromicin - makrolidna antibiotika, - zaviralci adrenergičnih receptorjev alfa - vrsta zdravil za zdravljenje visokega krvnega tlaka in povečane prostate (benigne hiperplazije prostate), - riociguat.
English: Talk to your doctor or pharmacist before taking Vivanza.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Vivanza se posvetujte z zdravnikom ali farmacevtom.
English: Dyspepsia Gastro-oesophag eal reflux disease Gastritis
Slovenian: Bolezni prebavil dispepsija gastroezofagealna refluksna bolezen gastritis bolečina v želodcu in trebuhu driska bruhanje navzea suha usta
English: It may be risky for you to have sex. - If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Vivanza - če imate težave s srcem; spolni odnosi so za vas lahko tvegani.
English: EU/1/03/249/016 4 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/249/016 4 tablete
English: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Slovenian: Bolezni jeter, žolčnika in žolčevodov povečane vrednosti transaminaz povečane vrednosti gamaglutamil transferaze
English: 2x (1 vial + 1 syringe + 1 needle + 1 vial adapter + 2 alcohol pads)
Slovenian: 2x (1 viala + 1 brizga + 1 igla + 1 adapter za vialo + 2 alkoholna zloženca)
English: 40 mg/0.8 ml
Slovenian: 40 mg/ 0,8 ml raztopina za injiciranje viala (steklena)
English: I) are listed below according to ICRP 128.
Slovenian: I) so navedeni spodaj, skladno z ICRP 128.
English: Appropriate aseptic precautions should be taken.
Slovenian: Treba je uporabljati ustrezne aseptične previdnostne ukrepe.
English: You will need to be careful with the water (urine) that you pass - your doctor will tell you what to do.
Slovenian: Previdni boste morali biti pri izločanju vode (urina) - zdravnik vam bo povedal, kaj morate storiti.
English: Changes in this area of the brain occur in:
Slovenian: Do sprememb v tem delu možganov pride pri:
English: It will be the smallest quantity necessary to get the desired information.
Slovenian: To bo najmanjša količina, ki še zadošča za pridobitev želenih informacij.
English: I) which is used to help identify (diagnose) conditions in the brain.
Slovenian: I), ki se uporablja za odkrivanje (diagnosticiranje) bolezni v možganih.
English: also a drug of abuse)
Slovenian: uporablja se tudi za zlorabo drog),
English: Each dose contains up to 197 mg alcohol.
Slovenian: En odmerek vsebuje do 197 mg alkohola.
English: Tell your doctor if any of these apply to you.
Slovenian: Obvestite zdravnika, če kar koli od naštetega velja za vas.
English: Some medicines or substances can affect the way that this medicine works.
Slovenian: Nekatera zdravila ali snovi lahko vplivajo na delovanje tega zdravila.
English: Ioflupane is a cocaine analogue.
Slovenian: Joflupan je analog kokaina.
English: Bq/mmol) at reference time.
Slovenian: Bq/mmol) ob referenčnem času.
English: Do not exceed 185 MBq and do not use when the activity is below 110 MBq.
Slovenian: Ne presezite 185 MBq in zdravila ne uporabljajte pri aktivnosti, manjši od 110 MBq.
English: When this medicine is injected into a patient, it is carried around the body in the blood and collects in a small area of your brain.
Slovenian: Ko to zdravilo injicirajo bolniku, se to s krvjo prenaša po telesu in se nabere v majhnem delu možganov.
English: The rest is assumed to be distributed uniformly in the remaining organs and tissues.
Slovenian: Za preostanek se predpostavlja, da se enakomerno porazdeli po preostalih organih in tkivih.
English: I) at reference time.
Slovenian: I) ob referenčnem času aktivnosti.
English: Not known: frequency cannot be estimated from the available data.
Slovenian: Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
English: I) at reference time (0.07 to 0.13 µg/mL of ioflupane).
Slovenian: I) ob referenčnem času (0,07 do 0,13 μg/ml joflupana).
English: • Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras.
Slovenian: • Ker vsebuje majhno količino radioaktivnosti, ga lahko zaznamo s posebnimi kamerami zunaj telesa.
English: It belongs to a group of medicines called “radiopharmaceuticals”, which contain a small amount of radioactivity.
Slovenian: Sodi v skupino zdravil, ki jim rečemo »radiofarmaki« in vsebujejo majhno količino radioaktivnosti.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Slovenian: Prevzem, shranjevanje, uporaba, prenos in odstranjevanje radiofarmakov so urejeni s predpisi in/ali ustreznimi dovoljenji pristojnih uradnih organizacij.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki od skupin pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
English: Common: may affect up to 1 in 10 people - Headache
Slovenian: Pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov - glavobol.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Slovenian: Vsako žensko, ki ji je izostala menstruacija, je treba obravnavati kot nosečo, dokler ni dokazano nasprotno.
English: Striascan is contraindicated in pregnancy (see section 4.3).
Slovenian: Zdravilo Striascan je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: The camera pictures are usually taken 3 to 6 hours after the injection of this product.
Slovenian: Slikanje s kamero se ponavadi opravi v 3 do 6 urah po injiciranju tega zdravila.
English: This scan will show exactly where the radioactivity is inside the organ and the body.
Slovenian: Ta slika pokaže, kje točno je radioaktivnost v organu ali telesu.
English: I) adopted by ICRP 128 ((International Commission on Radiological Protection ,2015) assumes initial uptake of 31% of the administered activity in the liver, 11% in the lungs, and 4% in the brain.
Slovenian: I), ki ga je sprejela ICRP 128 (Mednarodna komisija za radiološko zaščito, 2015), predpostavlja začetni privzem 31 % aplicirane aktivnosti v jetrih, 11 % v pljučih in 4 % v možganih.
English: A scan will give your doctor information about any changes in this area of your brain.
Slovenian: Slika bo vašemu zdravniku dala podatek o morebitnih spremembah v tem delu možganov.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Slovenian: Pri apliciranju radiofarmakov nastane tveganje za druge osebe zaradi zunanjega sevanja ali kontaminacije zaradi razlitja urina, bruhanja itd.
English: Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.
Slovenian: Nenormalne slike so bodisi nesimetrične bodisi simetrične, vendar z neenako intenzivnostjo in/ali izgubo srpaste oblike.
English: Striascan is used only to identify illness.
Slovenian: Zdravilo Striascan se uporablja samo za odkrivanje bolezni.
English: Symbol of radioactivity
Slovenian: simbol za radioaktivnost
English: Clinical efficacy has been demonstrated across the range 110 to 185 MBq.
Slovenian: Klinična učinkovitost je bila dokazana v razponu od 110 do 185 MBq.
English: If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.
Slovenian: Če je bila kadar koli v času priprave ogrožena neoporečnost viale, se je ne sme uporabiti.
English: • In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer's disease.
Slovenian: • Pri odraslih bolnikih za pomoč pri razlikovanju verjetne demence z Lewyjevimi telesci od Alzheimerjeve bolezni.
English: Ioflupane also binds to the serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
Slovenian: Joflupan se veže tudi na serotoninske prenašalce na nevronih 5-HT, vendar z manjšo afiniteto (približno 10-krat).
English: I): 74 MBq/mL at reference time
Slovenian: I) 74 MBq/ml ob referenčnem času
English: Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been performed.
Slovenian: Študije o vplivu na sposobnost razmnoževanja in za ocenitev karcinogenega potenciala joflupana niso bile izvedene.
English: • You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.
Slovenian: • Tako morate ravnati zaporedne tri dni, dokler se radioaktivne snovi ne izločijo iz telesa.
English: - Pregnancy (see section 4.6).
Slovenian: - Nosečnost (glejte poglavje 4.6).
English: The safety and efficacy of Striascan in children and adolescents aged 0 to 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Striascan pri otrocih in mladostniki, starih od 0 do 18 let, nista bili dokazani.
English: Children and adolescents Striascan is not recommended for children and adolescents aged 0 to 18 years.
Slovenian: Otroci in mladostniki Zdravilo Striascan se ne priporoča za otroke in mladostnike, stare od 0 do 18 let.
English: Absorbed radiation dose µGy/MBq
Slovenian: Absorbirani odmerek sevanja μGy/MBq
English: Very rare Not known (cannot be estimated from the available data)
Slovenian: zelo redki Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: The vial is placed into a lead container for protective shielding and packed in a metal box.
Slovenian: Viala je nameščena v zaščitni svinčen vsebnik in zapakirana v kovinsko škatlo.
English: This is about the same as 5 mL beer, or 2 mL wine.
Slovenian: To je približno enakovredno 5 ml piva ali 2 ml vina.
English: Angular sampling should preferably be not less than 120 views over 360 degrees.
Slovenian: Kotno vzorčenje naj bi bilo opravljeno z vsaj 120 pogledi v območju 360 stopinj.
English: This medicinal product contains 39.5 g/L (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 mL beer or 2 mL wine.
Slovenian: To zdravilo vsebuje 39,5 g/l (5 volumskih odstotkov) etanola (alkohola), do 197 mg na odmerek, kar je enakovredno 5 ml piva ali 2 ml vina.
English: After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with the conditions specified by the local competent authority.
Slovenian: Po uporabi se mora ves material, uporabljen pri pripravi in uporabi radiofarmakov, vključno z neuporabljenim izdelkom in njegovo ovojnino, dekontaminirati in z njim ravnati kot z radioaktivnim odpadkom ter ga odstraniti v skladu s pogoji, ki jih določa lokalni pristojni organ.
English: • cocaine (sometimes used as an anaesthetic for nose surgery; also a drug of abuse)
Slovenian: • kokain (včasih se uporablja kot anestetik za operacijo nosu; uporablja se tudi za zlorabo drog).
English: Adequate shielding is mandatory.
Slovenian: Obvezna je primerna zaščita.
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of Striascan to be used in your case.
Slovenian: Zdravnik nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila Striascan, ki se uporabi v vašem primeru.
English: The complete Summary of Product Characteristics (SmPC) of Striascan is provided as a separate document in the product packaging, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Slovenian: Celoten povzetek glavnih značilnosti zdravila Striascan je priložen kot ločen dokument v pakiranju zdravila, da se zdravstvenemu osebju zagotovijo dodatne znanstvene in praktične informacije o dajanju in uporabi tega radiofarmaka.
English: Please refer to section 2 “Striascan contains ethanol.”
Slovenian: Glejte poglavje 2 "Zdravilo Striascan vsebuje etanol".
English: For patient preparation, see section 4.4.
Slovenian: Za navodila za pripravo bolnika glejte poglavje 4.4.
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Slovenian: Za takojšnje ukrepanje v nujnih primerih morajo biti na voljo nujna zdravila in oprema, kot sta endotrahealna cevka in aparat za predihavanje.
English: • In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.
Slovenian: • Pri odraslih bolnikih, pri katerih obstaja sum parkinsonskih sindromov, kot na primer tistih z zgodnjimi simptomi, za pomoč pri ločevanju esencialnega tremorja od parkinsonskih sindromov, povezanih z idiopatsko Parkinsonovo boleznijo, multiple sistemske atrofije in progresivne supranuklearne paralize.
English: For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15 cm).
Slovenian: Pri kolimatorjih visoke ločljivosti mora biti polmer obračanja stalen in nastavljen na najmanjšo možno vrednost (praviloma 11-15 cm).
English: The doctor may ask you to stop taking them for a short time before you receive Striascan.
Slovenian: Zdravnik vas bo morda prosil, da jih za kratek čas, preden prejmete zdravilo Striascan, nehate jemati.
English: Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with Striascan imaging and can therefore be continued if desired.
Slovenian: Za agoniste in antagoniste dopamina, ki delujejo na postsinaptične dopaminske receptorje, se ne pričakuje, da bodo vplivali na slikanje z zdravilom Striascan, zato jih lahko bolniki po potrebi še naprej jemljejo.
English: There is no experience in types of tremor other than essential tremor.
Slovenian: Izkušenj z drugimi vrstami tremorja, razen esencialnega, ni.
English: • When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a short time.
Slovenian: • Radiofarmak se po injiciranju za kratek čas nakopiči v določenem organu ali delu telesa.
English: To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Slovenian: To upoštevajte pri visoko rizičnih skupinah, kot so bolniki s poškodbo jeter ali epilepsijo.
English: Route Nationale 306
Slovenian: CIS bio international Route Nationale 306
English: The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation.
Slovenian: Bolnik mora biti pred začetkom preiskave dobro hidriran in treba ga je spodbujati, da v prvih urah po preiskavi čim pogosteje izprazni mehur in tako zmanjša sevanje.
English: The frequency of side effects is:
Slovenian: Pogostnost neželenih učinkov je:
English: I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection.
Slovenian: I) se po intravenskem injiciranju zelo hitro izloči iz krvi; 5 minut po injiciranju ostane v celi krvi le 5 % aktivnosti.
English: In a clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB) (144 subjects), Alzheimer's disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects), the results of an independent, blinded visual assessment of the ioflupane (
Slovenian: Klinične študije pri bolnikih z demenco z Lewyjevimi telesci V kliničnem preskušanju, ki je vključevalo oceno 288 bolnikov z demenco, in sicer demenco z Lewyjevimi telesci (DLB) (144 bolnikov), Alzheimerjevo boleznijo (124 bolnikov), vaskularno demenco (9 bolnikov) ali drugo (11 bolnikov), so rezultate slepe neodvisne vizualne ocene slik joflupana (
English: The quantity to be administered usually recommended for an adult ranges from 110 to 185 MBq (megabecquerel or MBq, the unit used to measure radioactivity).
Slovenian: Uporabljena količina, ki se ponavadi priporoča za odrasle, je od 110 do 185 MBq (megabekerel je enota, ki se uporablja za izražanje radioaktivnosti).
English: This medical product is for use in hospitals or in designated nuclear medicine facilities only.
Slovenian: Zdravilo se lahko uporablja le v bolnišnicah ali odobrenih ustanovah za nuklearno medicino.
English: The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter)
Slovenian: Pri izračunu vrednosti sta bila predpostavljena praznjenje mehurja v 4,8-urnih presledkih in ustrezno blokiranje ščitnice (jod-123 je znan Augerjev oddajnik elektronov).
English: The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value from 86.1% to 88.7%.
Slovenian: Pozitivna napovedna vrednost je bila med 78,9 % in 84,4 %, negativna napovedna vrednost pa med 86,1 % in 88,7 %.
English: Activity in the liver is excreted according to the Publication 53 gallbladder model (ICRP, 1987), where 30% is eliminated via the gallbladder and the remainder passes directly into the small intestine.
Slovenian: Aktivnost v jetrih se izloča skladno z modelom žolčnika iz Publikacije št. 53 (ICRP, 1987), kjer se 30 % aktivnosti izloči v žolčnik, preostanek pa preide neposredno v tanko črevo.
English: Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Slovenian: Pred uporabo radiofarmaka pri doječi materi morate ugotoviti, ali je možno uporabo radionuklida odložiti, dokler mati ne preneha z dojenjem, in ali je bil izbran najprimernejši radiofarmak ob upoštevanju izločanja aktivnosti v materino mleko.
English: The effective dose (E) resulting from administration of 185 MBq of Striascan injection is 4.6 mSv (per 70 kg individual).
Slovenian: Efektivni odmerek (E), ki nastane z injiciranjem 185 MBq zdravila Striascan, je 4,6 mSv (pri osebi, ki tehta 70 kg).
English: Fertility No fertility studies have been performed.
Slovenian: Plodnost Študij plodnosti niso opravili.
English: Contaminated material must be disposed of as radioactive waste via an authorised route.
Slovenian: Kontaminirani material se mora na odobren način odstraniti kot radioaktivni odpadek.
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmake je treba pripravljati v skladu z zahtevami radiološke varnosti in farmacevtske kakovosti.
English: It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV.
Slovenian: Med razpadom oddaja sevanje gama s prevladujočo energijo 159 keV in rentgenske žarke z energijo 27 keV.
English: If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding.
Slovenian: Če je uporaba radiofarmaka nujna, je treba dojenje prekiniti za 3 dni in nadomestiti z umetnim mlekom.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Radiofarmake lahko sprejmejo, uporabljajo in aplicirajo le pooblaščene osebe v temu namenjenih kliničnih oddelkih.
English: I) images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
Slovenian: I) primerjali s kliničnimi diagnozami, ki so jih postavili zdravniki, izkušeni v vodenju in diagnosticiranju demenc.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Slovenian: Možnost za preobčutljivostne ali anafilaktične reakcije Če pride do preobčutljivostne ali anafilaktične reakcije, je treba takoj prekiniti dajanje zdravila in po potrebi začeti intravensko zdravljenje.
English: Before administration of Striascan you should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.
Slovenian: Pred uporabo zdravila Striascan morate piti zadostne količine vode pred začetkom preiskave, da boste v prvih urah po preiskavi lahko čim pogosteje urinirali.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Slovenian: Uporabljena aktivnost mora biti v vsakem primeru najmanjša možna, ki še zagotavlja pridobivanje potrebnih diagnostičnih informacij.
English: Precautions with respect to environmental hazard see section 6.6.
Slovenian: Za previdnostne ukrepe v zvezi s tveganjem za okolje glejte poglavje 6.6.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden vzamete to zdravilo.
English: 25.0 µSv/MBq
Slovenian: 25,0 μSv/MBq
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Slovenian: To zdravilo je radiofarmak samo za diagnostične namene.
English: Striascan has no known influence on the ability to drive and use machines.
Slovenian: Za zdravilo Striascan ni znano, da bi imelo vpliv na sposobnost vožnje in upravljanja strojev.
English: Method of administration Striascan is for intravenous use.
Slovenian: Način uporabe Zdravilo Striascan je za intravensko uporabo.
English: After administration of Striascan, you should urinate frequently in order to eliminate the product from your body.
Slovenian: Po uporabi zdravila Striascan morate pogosto urinirati, da se zdravilo izloči iz telesa.
English: As the effective dose is 4.6 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.
Slovenian: Ker je efektivni odmerek pri uporabi največje priporočene aktivnosti 185 MBq enak 4,6 mSv, se pričakuje, da je verjetnost pojava teh neželenih učinkov majhna.
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Slovenian: Kadar se načrtuje uporaba radiofarmakov pri ženski v rodni dobi, je treba predhodno ugotoviti, ali je noseča.
English: Alternative techniques which do not involve radioactivity should be considered.
Slovenian: Treba je razmisliti o drugih možnostih zdravljenja, pri katerih se ne uporablja radioaktivnosti.