FrancophonIA/ELRC3.0 huggingface dataset:
English: Intravenous use
Slovenian: gadobutrol intravenska uporaba
English: In healthy persons renal clearance of gadobutrol is 1.1 to 1.7 ml min kg and thus comparable to the renal clearance of inulin, pointing to the fact that gadobutrol is eliminated primarily by glomerular filtration.
Slovenian: , torej je primerljiv ledvičnemu očistku inulina, kar kaže, da se gadobutrol v prvi vrsti izloča z glomerularno filtracijo.
English: Short-lasting mild to moderate feelings of coldness, warmth or pain at the injection site have been uncommonly observed during or after the injection of Gadovist.
Slovenian: Med injiciranjem zdravila Gadovist ali po njem so občasno opazili kratkotrajne blage do zmerne občutke mraza, toplote ali bolečine na mestu injiciranja.
English: 1 prefilled syringe with 20 ml of the solution contains 12094 mg gadobutrol.
Slovenian: 1 napolnjena injekcijska brizga z 20 ml raztopine vsebuje 12.094 mg gadobutrola.
English: This medicinal product is a clear, colourless to pale yellow solution.
Slovenian: To zdravilo je bistra, brezbarvna do bledo rumena raztopina.
English: Delayed anaphylactoid reactions (after hours to days) have been observed rarely (see section
Slovenian: Redko so opazili pozne anafilaktoidne reakcije (po več urah ali dneh) (glejte poglavje 4.4).
English: Gadovist should not be used in case of severe discoloration, the occurrence of particulate matter or a defective container.
Slovenian: Če je zdravilo Gadovist močno razbarvano, vsebuje delce ali ima poškodovan vsebnik, se ne sme uporabiti.
English: Face edema, Hyperhidrosis, Pruritus, Erythema
Slovenian: Bolezni kože in podkožja urtikarija, izpuščaj edem obraza, hiperhidroza, pruritus, eritem
English: HOW TO STORE GADOVIST
Slovenian: Shranjevanje zdravila GADOVIST
English: 1 or 5 prefilled syringes with 5, 7.5, 10 ml solution for injection (in 10-ml prefilled syringe) 1 or 5 prefilled syringes with 15 ml solution for injection (in 17-ml prefilled syringe) 1 or 5 prefilled syringes with 20 ml solution for injection
Slovenian: 1 ali 5 napolnjenih injekcijskih brizg s 5, 7,5 ali 10 ml raztopine za injiciranje(v 10-mililitrski napolnjeni injekcijski brizgi)
English: Solution for Injection in prefilled syringe
Slovenian: Raztopina za injiciranje v napolnjeni intravensko
English: One 17-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 15 ml solution for injection.
Slovenian: Ena 17-mililitrska napolnjena injekcijska brizga (steklo hidrolitične odpornost tip I) z vsajenim zamaškom (klorobutilni elastomer) in koničastim zamaškom (klorobutilni elastomer) vsebuje 15 ml raztopine za injiciranje.
English: Anaphylactoid shock
Slovenian: Bolezni prebavil navzea bruhanje
English: Gadovist not used in one examination must be discarded.
Slovenian: Zdravilo Gadovist, ki ga pri pregledu ne porabite, morate zavreči.
English: What GADOVIST is and what it is used for Before you are given GADOVIST How to use GADOVIST Possible side effects
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo GADOVIST 3.
English: Loss of consciousness,
Slovenian: Neželeni učinki iz podatkov,
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection
Slovenian: IME ZDRAVILA Gadovist 1,0 mmol/ml raztopina za injiciranje
English: Headache, Dizziness, Paresthesia,
Slovenian: Bolezni živčevja glavobol, vrtoglavica, parestezija, disgevzija parosmija izguba zavesti, konvulzije
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gadovist 1.0 mmol/ml solution for injection in prefilled syringe Gadobutrol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Gadovist 1,0 mmol/ml raztopina za injiciranje v napolnjenih injekcijskih brizgah.
English: “Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant”.
Slovenian: „MRI jeter ali ledvic z izboljšanim kontrastom pri bolnikih, pri katerih obstaja močan sum ali dokaz za fokalne lezije, z namenom opredelitve benignosti ali malignosti teh lezij.“
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom in odlaganje (če so potrebna)
English: MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Breathing difficulties (bronchospasm, swelling of the throat), Breathing arrest, Blueness of the lips, Cough, Sneezing
Slovenian: Redki srčni zastoj, pospešen srčni utrip izguba zavesti, konvulzije konjunktivitis, otekanje (edem) očesnih vek težave pri dihanju (bronhospazem, otekanje grla), dihalni zastoj, pomodrelost ustnic, kašelj, kihanje otekanje (edem) obraza, povečano potenje, srbenje, rdečica kože omedlevica, vročinski obliv občutek vročine, splošno slabo počutje hude reakcije, podobne alergijam (šok)
English: Dizziness
Slovenian: Jakost
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection Gadobutrol
Slovenian: NAVODILO ZA UPORABO Gadovist 1,0 mmol/ml raztopina za injiciranje gadobutrol
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection in prefilled syringe
Slovenian: IME ZDRAVILA Gadovist 1,0 mmol/ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: • Dosage
Slovenian: • Odmerjanje
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection in prefilled syringe Gadobutrol
Slovenian: NAVODILO ZA UPORABO Gadovist 1,0 mmol/ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadobutrol
English: Gadovist is a clear, colourless to pale yellow solution.
Slovenian: Zdravilo Gadovist je prozorna, brezbarvna do svetlo rumena raztopina.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Gadovist 1.0 mmol/ml solution for injection
Slovenian: IME ZDRAVILA IN POT UPORABE Gadovist 1,0 mmol/ml raztopina za injiciranje.
English: Circulatory collapse, Flushing
Slovenian: Žilne bolezni vazodilatacija hipotenzija cirkulatorni kolaps, vročinski obliv
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla/zunanja ovojnina
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Očesne bolezni konjunktivitis, edem na veki
English: The device is constructed so that you will not be able to open it.
Slovenian: Pripomoček je narejen tako, da ga ne boste mogli odpreti.
English: Appropriate measures should be taken to maintain stable arterial pressure.
Slovenian: Za ohranjanje stabilnega arterijskega tlaka je treba uvesti ustrezne ukrepe.
English: Only 2 % of the dose is excreted in unchanged form.
Slovenian: Le 2% odmerka se izločita v nespremenjeni obliki.
English: Very rare Not known Cannot be estimated from the available data
Slovenian: Zelo redki Neznana pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
English: • Educational materials for the healthcare professionals
Slovenian: • Izobraževalno gradivo za zdravstvenim delavcem
English: Mannitol (E421)
Slovenian: Manitol (E421)
English: Any other waste material must be discarded in accordance to the institutional policies and local requirements.
Slovenian: Ves drugi odpadni material zavrzite v skladu s politikami ustanove in lokalnimi predpisi.
English: Abuse potential and tolerance
Slovenian: Možnost zlorabe in tolerance
English: Follow the instructions carefully.
Slovenian: Natančno upoštevajte navodila.
English: What Zalviso is and what it is used for
Slovenian: Kaj je zdravilo Zalviso in za kaj ga uporabljamo
English: Patients with BMI > 30 kg/m
Slovenian: Bolniki z ITM> 30 kg/m
English: Primary attention should be given to obstruction of airways and the necessity of assisted or controlled ventilation.
Slovenian: Primarno pozornost je treba nameniti obstrukciji dihalnih poti in potrebi po asistirani ali nadzorovani ventilaciji.
English: The device will work for 3 days (72 hours), which is also the maximum recommended duration of your treatment.
Slovenian: Pripomoček deluje tri dni (72 ur), ki je tudi najdaljše priporočeno trajanje zdravljenja.
English: It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above.
Slovenian: Koristno bi bilo o tem obvestiti tudi prijatelje ali sorodnike, da bi lahko prepoznali zgoraj navedene znake in simptome.
English: The safety and efficacy in elderly patients was similar to that observed in younger adults (see section 5.2).
Slovenian: Varnost in učinkovitost pri starejših bolnikih je bila podobna, kot so jo opazili pri mlajših odraslih (glejte poglavje 5.2).
English: - if you have severe breathing problems.
Slovenian: - če imate hude težave z dihanjem.
English: Blood pressure increased Blood pressure decreased
Slovenian: Zvišan krvni tlak Znižan krvni tlak
English: Children and adolescents Zalviso should not be used in children and adolescents below 18 years.
Slovenian: Otroci in mladostniki Zdravilo Zalviso se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
English: Patients at higher risk are those with respiratory impairment or reduced respiratory reserve.
Slovenian: Bolniki z večjim tveganjem so tisti z respiratorno okvaro ali zmanjšano respiratorno rezervo.
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Slovenian: Odvisno od občutljivosti posameznika klinično sliko določa stopnja respiratorne depresije.
English: OUTER CARTON for 1, 10 and 20 cartridges
Slovenian: ZUNANJA ŠKATLA za 1, 10 in 20 vložkov
English: See section “Method of administration”.
Slovenian: Glejte poglavje »Način uporabe«.
English: Zalviso was also considered to be easier to use by healthcare professionals (P = 0.017).
Slovenian: Tudi za zdravstvene delavce je uporaba zdravila Zalviso bolj preprosta (P = 0,017).
English: * see “Description of selected adverse reactions”
Slovenian: * glejte »Opis izbranih neželenih učinkov«
English: EXP see page 1 EXP see reverse
Slovenian: EXP glejte stran 1 EXP glejte hrbtno stran
English: You can control your treatment and should only activate the device when in need of pain relief.
Slovenian: Svoje zdravljenje lahko nadzorujete, zato pripomoček aktivirajte le, če želite ublažiti bolečino.
English: Do not use the device if any component is visibly damaged.
Slovenian: Pripomočka ne uporabljajte, če je kateri koli del vidno poškodovan.
English: Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible.
Slovenian: Zaradi teh tveganj je sočasno predpisovanje tega zdravila s sedativnimi zdravili dovoljeno le za bolnike, pri katerih alternativne možnosti zdravljenja niso možne.
English: This should be considered when prescribing or administering sufentanil where there is concern about an increased risk of misuse, abuse or diversion.
Slovenian: To je treba upoštevati pri predpisovanju in dajanju sufentanila, ko obstajajo pomisleki glede večjega tveganja napačne rabe, zlorabe ali preusmerjanja.
English: It can increase the risk of experiencing severe breathing problems.
Slovenian: To lahko poveča tveganje za pojav hudih težav z dihanjem.
English: Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazol, ritonavir) cannot be excluded.
Slovenian: Podobnih učinkov z drugimi močnimi zaviralci CYP3A4 (npr. itrakonazol, ritonavir) ni mogoče izključiti.
English: Hypnotic activity can be demonstrated by EEG alterations.
Slovenian: Hipnotično aktivnost se lahko vidi kot spremembe na EEG-ju.
English: The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
Slovenian: Pri bolnikih je treba pozorno spremljati znake in simptome respiratorne depresije in sedacije.
English: Because of this, concomitant use should only be considered when other treatment options are not possible.
Slovenian: Zaradi tega je sočasna uporaba dovoljena le, če druge možnosti zdravljenja niso možne.
English: Sufentanil has major influence on the ability to drive and use machines.
Slovenian: Sufentanil ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: After receiving a dose you will not be able to release another dose for 20 minutes and you will not be able to take more than 3 doses in one hour.
Slovenian: Ko prejmete odmerek, novega odmerka ni mogoče aplicirati naslednjih 20 minut, tako da v eni uri ne boste mogli vzeti več kot treh odmerkov.
English: The total plasma clearance after single intravenous administration is about 917 l/min.
Slovenian: Skupni očistek v plazmi po enkratni intravenski aplikaciji je približno 917 l/min.
English: Any change in efficacy/tolerability associated with the increased exposure would be compensated in practice by an alteration in dosing frequency (see section 4.2).
Slovenian: Vsakršno spremembo v učinkovitosti/prenašanju, povezano z večjo izpostavljenostjo, je treba v praksi kompenzirati s spremenjeno pogostnostjo odmerjanja (glejte poglavje 4.2).
English: Do not take Zalviso: - if you are allergic to sufentanil or any of the other ingredients of this medicine (listed in section
Slovenian: Ne jemljite zdravila Zalviso: - če ste alergični na sufentanil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Reproductive toxicity has been shown in animal studies (see section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5.3).
English: The duration of the concomitant use should be limited (see section 4.4).
Slovenian: Trajanje sočasne uporabe je treba omejiti (glejte poglavje 4.4).
English: Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici poleg oznake EXP.
English: Approximately 80 % of the intravenously administered dose of sufentanil is excreted within 24 hours.
Slovenian: Približno 80% intravensko apliciranega odmerka sufentanila se izloči v 24 urah.
English: Please tell your doctor about all sedating medicines you are taking, and follow your doctor's dose recommendation closely.
Slovenian: Svojega zdravnika obvestite o vseh sedativnih zdravilih, ki jih jemljete, in natančno upoštevajte priporočeni odmerek.
English: Confusional state Apathy* Nervousness*
Slovenian: Stanje zmedenosti Apatija* Živčnost*
English: Additional Zalviso cartridges may be utilized if needed.
Slovenian: Po potrebi se lahko uporabijo dodatni vložki zdravila Zalviso.
English: The duration of activity may be prolonged in patients with severe hepatic and renal impairment.
Slovenian: Trajanje aktivnosti se lahko podaljša pri bolnikih s hudo jetrno in ledvično okvaro.
English: Immeuble Eurêka 19 rue Ernest Renan CS 90001
Slovenian: Laboratoires Grünenthal SAS Immeuble Eurêka 19 rue Ernest Renan CS 90001
English: What you need to know before you take Zalviso
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zalviso
English: - Significant respiratory depression.
Slovenian: Pomembna respiratorna depresija.
English: Component of multipack, can't be sold separately.
Slovenian: Sestavni del skupnega pakiranja, ni za posamično prodajo.
English: In clinical trials during repeated administrations the bioavailability decreased to 37.6 %.
Slovenian: V kliničnih preskušanjih je biološka uporabnost po ponavljajočem dajanju upadla na 37,6%.
English: There are no indications to date that the use of sufentanil during pregnancy increases the risk of congenital abnormalities.
Slovenian: Doslej še ni nobenih dokazov, da uporaba sufentanila med nosečnostjo zveča tveganje za kongenitalne anomalije.
English: The safety and efficacy of Zalviso in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Zalviso pri otrocih, starih do 18 let, nista bili dokazani.
English: Sufentanil may cause hypotension, especially in hypovolemic patients.
Slovenian: Sufentanil lahko povzroči hipotenzijo, zlasti pri hipovolemičnih bolnikih.
English: After prolonged use of other substances with µ-opioid receptor activity, symptoms of withdrawal were observed after abrupt interruption of the treatment.
Slovenian: Po podaljšani uporabi drugih učinkovin z aktivnostjo na µ-opioidnih receptorjih so po nenadni prekinitvi zdravljenja opazili odtegnitvene simptome.
English: The health-care professional should take into consideration the ability (e. g. visual or cognitive) of the patient to use the device appropriately.
Slovenian: Zdravstveni delavec mora presoditi bolnikovo sposobnost (npr. vizualno ali kognitivno) za ustrezno uporabo pripomočka.
English: All effects of sufentanil can immediately and completely be blocked by administration of a specific antagonist such as naloxone.
Slovenian: Vse učinke sufentanila je možno takoj in popolno zavreti z dajanjem specifičnega antagonista, kot je nalokson.
English: - Any medicines to treat anxiety, tranquillisers or other opioid medicines, as they can increase the risk of severe breathing problems.
Slovenian: - Vsa zdravila za zdravljenje tesnobnosti, pomirjevala ali druga opioidna zdravila, saj lahko povečajo tveganje za hude težave z dihanjem.
English: OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY
Slovenian: ZUNANJA NALEPKA (Z BLUE BOX-OM) SAMO SKUPNA PAKIRANJA
English: In humans the potency is 7 to 10-fold higher than fentanyl and 500 to 1,000-fold higher than morphine (per oral).
Slovenian: Pri ljudeh je učinek 7- do 10-krat večji od fentanila in 500- do 1.000-krat večji od morfina (peroralnega).
English: Since this decrease related to age is smaller than the observed inter-subject variability of 30-40 % in exposure parameters for sufentanil, this effect is not considered to be of clinical relevance, particularly given that Zalviso is only used on an ‘as-needed' basis.
Slovenian: Ker je zmanjšanje, povezano s starostjo, manjše od opažene variabilnosti med osebami, ki pri parametrih izpostavljenosti za sufentanil znaša 30 do 40%, ta učinek ne velja za klinično pomembnega, zlasti glede na to, da se zdravilo Zalviso uporablja le na podlagi potrebe.
English: INTERMEDIATE CARTON COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA KOT DEL SKUPNEGA PAKIRANJA (BREZ MODREGA POLJA)
English: Each sublingual tablet contains 0.013 mg sodium.
Slovenian: Ena podjezična tableta vsebuje 0,013 mg natrija.
English: The population pharmacokinetic analysis showed an effect of age with a 27 % decrease in clearance in the elderly people (above 65 years of age).
Slovenian: Analiza populacijske farmakokinetike je pokazala, da ima starost vpliv na zmanjšanje očistka za 27% pri starejših bolnikih (nad 65 let starosti).
English: Sufentanil is rapidly metabolised to a number of inactive metabolites, with oxidative N- and O-dealkylation being the major routes of elimination.
Slovenian: Sufentanil se hitro presnovi v številne neaktivne presnovke, pri čemer je oksidativna N- in O-dealkilacija glavna pot izločanja.
English: The central volume of distribution after intravenous application of sufentanil is approximately 14 litres and the volume of distribution at steady state is approximately 350 litres.
Slovenian: Centralni porazdelitveni volumen po intravenskem apliciranju sufentanila je približno 14 litrov in porazdelitveni volumen v stanju dinamičnega ravnovesja je približno 350 litrov.
English: Sufentanil does not induce histamine release.
Slovenian: Sufentanil ne povzroča sproščanje histamina.
English: Adverse reactions identified either from clinical studies or from post-marketing experience with other medicinal products containing sufentanil are summarised in the table below.
Slovenian: Neželeni učinki, ki so jih opredelili v kliničnih študijah ali izkušnjah v obdobju trženja z drugimi zdravili, ki vsebujejo sufentanil, so povzeti v spodnji preglednici.
English: Lot see page 1 Lot see reverse
Slovenian: Lot glejte stran 1 Lot glejte hrbtno stran
English: Pharmacotherapeutic group: Opioid anaesthetics, ATC Code: N01AH03
Slovenian: Farmakoterapevtska skupina: opioidni analgetiki, oznaka ATC: N01AH03
English: It is only prescribed by physicians who are experienced in the use of strong pain killers like Zalviso and know the effects it may have on you, in particular on your breathing (see “Warnings and precautions” above).
Slovenian: Predpisujejo ga lahko le zdravniki z izkušnjami z močnimi zdravili proti bolečinam, kot je zdravilo Zalviso, ki poznajo učinke, ki jih lahko ima na vas, zlasti na vaše dihanje (glejte »Opozorila in previdnostni ukrepi« zgoraj).
English: Zalviso is provided in a polycarbonate cartridge, each of which contains 40 sublingual tablets and is packed in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.
Slovenian: Zdravilo Zalviso so na voljo v polikarbonatnem vložku, vsak vsebuje 40 podjezičnih tablet in je pakiran v vrečico iz poliestrskega filma/LDPE/aluminijaste folije/LDPE z absorbentom kisika.
English: In that case, the opioid antagonist can be administered repeatedly or by infusion.
Slovenian: V tem primeru je treba opioidne antagoniste dati večkrat ali z infundiranjem.
English: The device should be used as recommended in the information provided by the device manufacturer.
Slovenian: Pripomoček je treba uporabljati v skladu z navodili izdelovalca pripomočka.
English: - Other medicines which are also taken sublingually (medicines that are placed under the tongue where they dissolve) or medicines which dilute or take effect in your mouth (e.g. nystatin, a liquid or pastilles you hold in your mouth to treat fungus infections), as the effect on Zalviso has not been studied.
Slovenian: - Druga zdravila, ki se tudi jemljejo podjezično (zdravila, ki se namestijo pod jezik, da se raztopijo) ali zdravila, ki se v ustih raztopijo ali učinkujejo (npr. nistatin, tekočina ali pastile, ki jih zadržite v ustih za zdravljenje glivičnih okužb), saj vpliva na zdravilo Zalviso niso preučili.
English: Zalviso with alcohol
Slovenian: Zdravilo Zalviso skupaj z alkoholom
English: This may range from hypoventilation to respiratory arrest.
Slovenian: Lahko sega od hipoventilacije do zastoja dihanja.
English: Population pharmacokinetic analysis with a BMI as covariate showed that patients with a BMI > 30 kg/m2 dosed more frequently.
Slovenian: Analiza populacijske farmakokinetike z BMI kot sospremenljivko je pokazala, da so bolniki z ITM> 30 kg/m2 zdravilo odmerjali pogosteje.
English: The preclinical effects were only observed following administrations of levels significantly above the maximum human dose, which are therefore of little relevance for clinical use.
Slovenian: Predklinične učinke so opažali samo, ko so dani odmerki močno presegali največji odmerek za človeka, zato niso pomembni za klinično uporabo.
English: Ketoconazole, a potent CYP3A4 inhibitor, can significantly increase the systemic exposure to sublingual sufentanil (maximal plasma levels (Cmax) increase of 19 %, overall exposure to the active substance (AUC) increase of 77 %) and prolong the time to reach maximum concentration by 41 %.
Slovenian: Ketokonazol, močan zaviralec CYP3A4, lahko pomembno poveča sistemsko izpostavljenost podjezičnemu sufentanilu (največje ravni v plazmi (Cmax) se povečajo za 19%, celokupna izpostavljenost zdravilni učinkovini (AUC) se poveča za 77%) in podaljša čas do dosežene največje koncentracije za 41%.
English: After 48 hours more than half of the subjects in the Zalviso group had a relevant pain reduction (30 % responder rate) in these trials (visceral pain 60 %, nociceptive pain 54.9 %).
Slovenian: Po 48 urah se je pri več kot polovici oseb v skupini z zdravilom Zalviso pojavilo pomembno zmanjšanje bolečine (30% stopnja odziva) v teh preskušanjih (visceralna bolečina 60%, nociceptivna bolečina 54,9%).
English: In clinical trials approximately 30 % of enrolled patients were 65 to 75 years of age.
Slovenian: V kliničnih preskušanjih je bilo približno 30% vključenih bolnikov starih 65 do 75 let.