FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are mannitol (E421), calcium hydrogen phosphate (anhydrous), hypromellose, croscarmellose sodium, stearic acid, magnesium stearate, sunset yellow FCF Aluminium Lake (E110) (see section 2 “What you need to know before you take Zalviso”)
Croatian: - Drugi sastojci su manitol (E421), kalcijev hidrogenfosfat (bezvodni), hipromeloza, umrežena karmelozanatrij, stearatna kiselina, magnezijev stearat, sunset yellow FCF Aluminium Lake (E110) (vidjeti dio 2 „Što morate znati prije nego počnete uzimati Zalviso“).
English: Clinical trials have shown that sufentanil administered intravenously causes less respiratory depression when compared with equianalgesic doses of fentanyl.
Croatian: Klinička ispitivanja su pokazala da sufentanil primijenjen intravenski manje uzrokuje respiracijsku depresiju kada se usporedi s ekvianalgetičkim dozama fentanila.
English: After multiple administrations, a longer mean terminal half-life of up to 18 hours was determined, owing to the higher plasma concentrations of sufentanil achieved after repeated dosing and due to the possibility to quantify these concentrations over a longer time period.
Croatian: Nakon višestrukih primjena određen je dulji srednji terminalni poluvijek do 18 sati zbog većih plazmatskih koncentracija sufentanila postignutih nakon ponovljenog doziranja te zbog mogućnosti kvantifikacije tih koncentracija tijekom duljeg vremenskog razdoblja.
English: Therefore, Zalviso should be used with caution in patients at risk of ileus.
Croatian: Stoga se Zalviso mora upotrebljavati s oprezom u bolesnika s rizikom od ileusa.
English: Interaction with other sublingually administered products or products intended to dilute/establish an effect in the oral cavity were not evaluated and simultaneous administration should be avoided.
Croatian: Interakcije s drugim sublingvalno primijenjenim lijekovima ili proizvodima namijenjenim za razrjeđivanje/uspostavljanje učinka u usnoj šupljini nisu procijenjene, a istodobnu primjenu je potrebno izbjegavati.
English: Analgesia induced by sufentanil is thought to be mediated via activation of µ-opioid receptors primarily within the CNS to alter processes affecting both the perception of and the response to pain.
Croatian: Smatra se da je analgezija inducirana sufentanilom posredovana aktivacijom µ-opioidnih receptora prvenstveno unutar SŽS-a kako bi se promijenili procesi koji utječu kako na percepciju tako i na odgovor na bol.
English: High doses of intravenously administered sufentanil are known to cause muscle rigidity, probably as a result of an effect on the substantia nigra and the striate nucleus.
Croatian: Poznato je da visoke doze intravenski primijenjenog sufentanila uzrokuju ukočenost mišića, vjerojatno kao rezultat učinka na crnu tvar (substantia nigra) i striatum.
English: Patients should not eat or drink and minimize talking for 10 minutes after each dose of Zalviso.
Croatian: Bolesnici ne smiju jesti niti piti te moraju što manje govoriti 10 minuta nakon svake doze Zalvisa.
English: This route of administration results in higher absolute bioavailability by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Croatian: Ovaj put primjene rezultira većom apsolutnom bioraspoloživošću izbjegavanjem intestinalnog metabolizma i metabolizma prvog prolaza putem jetrenog enzima 3A4.
English: Sufentanil may cause respiratory depression (see section 4.4) and also suppresses the cough reflex.
Croatian: Sufentanil može prouzročiti respiracijsku depresiju (vidjeti dio 4.4), a ujedno suprimira refleks kašlja.
English: Patients on chronic opioid therapy or opioid addicts may require higher analgesic doses than the Zalviso administration device can deliver.
Croatian: Bolesnici na kroničnoj opioidnoj terapiji ili ovisnici o opioidima mogu zahtijevati više analgetičke doze od one koju može dostaviti Zalviso naprava za primjenu lijeka.
English: Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazol, ritonavir) cannot be excluded.
Croatian: Ne mogu se isključiti slični učinci s drugim potentnim inhibitorima enzima CYP3A4 (npr. itrakonazolom, ritonavirom).
English: Patients who were treated with Zalviso between 48 and 72 hours in the three controlled trials used a wide range of the available 216 doses, with a mean of 49 doses/patient (range of 8-153 doses) with the majority of patients (69.7 %) using between 24 to 72 doses.
Croatian: Bolesnici koji su se liječili Zalvisom između 48 i 72 sata u tri kontrolirana ispitivanja koristili su široki raspon dostupnih 216 doza uz srednju vrijednost od 49 doza/bolesniku (raspon od 8-153 doze) pri čemu je većina bolesnika (69,7%) koristila između 24 i 72 doze.
English: Direct effects of sufentanil on myocardial function were not observed.
Croatian: Nisu uočeni direktni učinci sufentanila na funkciju miokarda.
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.
Croatian: Neklinički učinci uočili su se samo nakon primjena razina značajno iznad maksimalne doze u ljudi te su stoga od malog značaja za kliničku upotrebu.
English: After prolonged use of other substances with µ-opioid receptor activity, symptoms of withdrawal were observed after abrupt interruption of the treatment.
Croatian: Nakon produljene primjene drugih tvari koje imaju aktivnost µ-opioidnog receptora, uočeni su simptomi ustezanja nakon naglog prekida liječenja.
English: Breastfeeding is not recommended when sufentanil is administered, due to the risk of opioid effects or toxicity in the breastfed newborns/infants (see section 4.9).
Croatian: Dojenje se ne preporučuje pri primjeni sufentanila zbog rizika od opioidnih učinaka ili toksičnosti u dojene novorođenčadi/doječadi (vidjeti dio 4.9).
English: When Zalviso was administered every 20 minutes, steady state plasma concentrations were achieved after 13 doses.
Croatian: Kada se Zalviso primjenjivao svakih 20 minuta, koncentracije u plazmi u stanju dinamičke ravnoteže postigle su se nakon 13 doza.
English: Efficacy of Zalviso for patient-controlled analgesia was demonstrated in 3 Phase III clinical trials in acute post-surgical nociceptive and visceral pain (post-surgical pain following major abdominal or orthopaedic surgery): 2 trials were double-blind placebo-controlled (Zalviso N = 430 patients; placebo N = 161 patients) and 1 was an open-label active-controlled (Zalviso N = 177 patients; morphine N = 180 patients) trial.
Croatian: Djelotvornost Zalvisa u analgeziji koju kontrolira bolesnik bila je demonstrirana u 3 klinička ispitivanja faze III akutne postkirurške nociceptivne i visceralne boli (postkirurška bol nakon velikog abdominalnog ili ortopedskog kirurškog zahvata): 2 ispitivanja su bila dvostruko slijepa placebom kontrolirana (Zalviso N = 430 bolesnika; placebo N = 161 bolesnik), a 1 ispitivanje je bilo otvoreno aktivno kontrolirano (Zalviso N = 177 bolesnika; morfin N = 180 bolesnika).
English: Cardiovascular stability is also the result of minimal effects on cardiac preload, cardiac flow rate and myocardial oxygen consumption.
Croatian: Kardiovaskularna stabilnost je također rezultat minimalnih učinaka na volumno opterećenje srca, brzinu protoka krvi kroz srce i potrošnju kisika u miokardu.
English: No negative effects were observed in another study in rats that were treated with 20times the maximum human dose in the period of organogenesis.
Croatian: Nisu uočeni negativni učinci u drugom ispitivanju na štakorima u kojih je u razdoblju organogeneze primijenjena doza 20 puta veća od maksimalne doze u ljudi.
English: As Zalviso may affect your breathing, your doctor or nurse will check your breathing during treatment; - have a head injury or brain tumour; - have problems with your heart and circulation, especially slow heart rate, irregular heart beats, low blood volume or low blood pressure; - have moderate to severe liver or severe kidney problems, as these organs have an effect on the way in which your body breaks down and eliminates the medicine; - have a history of medicine or alcoholabuse; - are regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone,
Croatian: Budući da Zalviso može utjecati na Vaše disanje, liječnik ili medicinska sestra provjeravat će Vaše disanje tijekom liječenja; - imate ozljedu glave ili tumor mozga; - imate problema sa srcem i cirkulacijom, naročito usporeni puls, nepravilne otkucaje srca, nizak volumen krvi ili nizak krvni tlak; - imate umjerene do teške probleme s jetrom ili teške probleme s bubrezima, jer ti organi utječu na način na koji Vaše tijelo razgrađuje i uklanja ovaj lijek; - imate zloupotrebu lijekova ili alkohola u anamnezi; - redovito primjenjujete propisani opioidni lijek (npr. kodein, fentanil, hidromorfon, oksikodon); - imate nenormalno sporo kretanje crijeva; - imate bolest žučnog mjehura ili gušterače.
English: On the basis of the scientific conclusions for sufentanil the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing sufentanil is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za sufentanil, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) sufentanil nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Marketing Authorisation Holder and Manufacturer Grünenthal GmbH
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Grünenthal GmbH
English: Very common
Croatian: vrlo često često
English: Low doses of intravenous sufentanil associated with likely vagal (cholinergic) activity cause mild bradycardia and mildly reduced systemic vascular resistance without significantly lowering blood pressure (see section 4.4).
Croatian: Niske doze intravenskog sufentanila povezane s vjerojatnom vagalnom (kolinergičkom) aktivnošću uzrokuju blagu bradikardiju i blago smanjeni sistemski krvožilni otpor bez značajnog snižavanja krvnog tlaka (vidjeti dio 4.4).
English: However if your doctor prescribes Zalviso together with sedating medicines the duration of concomitant treatment should be limited by your doctor.
Croatian: Međutim, ako Vaš liječnik propisuje Zalviso zajedno s lijekovima za smirenje, on mora ograničiti trajanje istodobnog liječenja.
English: Monoamine Oxidase Inhibitors must not be taken in the 2 weeks before or at the same time as Zalviso is given.
Croatian: Inhibitori monoaminooksidaze ne smiju se uzimati dva tjedna prije primjene lijeka Zalviso ni tijekom primjene lijeka Zalviso.
English: Sufentanil overdose is manifested by an exaggeration of its pharmacological effects.
Croatian: Predoziranje sufentanilom manifestira se pojačanjem njegovih farmakoloških učinaka.
English: The Zalviso administration device should not be used if any component is visibly damaged.
Croatian: Zalviso naprava za primjenu lijeka ne smije se upotrijebiti ako je bilo koji sastavni dio vidljivo oštećen.
English: The dispensed sublingual tablet should dissolve under the tongue and should not be crushed, chewed, or swallowed.
Croatian: Oslobođenu sublingvalnu tabletu je potrebno otopiti ispod jezika, a ne smije se drobiti, žvakati ili progutati.
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.
Croatian: Nuspojave koje su identificirane bilo iz kliničkih ispitivanja ili iz iskustva nakon stavljanja lijeka u promet s drugim lijekovima koji sadrže sufentanil, sažete su u tablici u nastavku.
English: D-52078 Aachen GERMANY
Croatian: 52078 Aachen Njemačka
English: Sufentanil should be used with caution in patients with brain tumours.
Croatian: Sufentanil je potrebno koristiti s oprezom u bolesnika s tumorom mozga.
English: The sublingual tablets are taken using the Zalviso administration device, which is a system that delivers a single dose upon activation.
Croatian: Sublingvalne tablete se uzimaju pomoću Zalviso naprave za primjenu lijeka, a to je sustav koji dostavlja jednokratnu dozu nakon aktivacije.
English: Based on the combined safety data from these clinical studies, nausea and vomiting were the most frequently reported adverse reactions (≥1/10 frequency).
Croatian: Na temelju kombiniranih podataka o sigurnosti primjene iz kliničkih ispitivanja najčešće (učestalost ≥ 1/10) prijavljene nuspojave bile su mučnina i povraćanje.
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Croatian: Sufentanil može prouzročiti respiracijsku depresiju čiji su stupanj/težina povezani s dozom.
English: A significantly higher proportion of patients (78.5 %) rated the method of pain control as “good” or “excellent” with Zalviso than with intravenous morphine patient-controlled analgesia method (65.5 %) (primary endpoint at 48 hours; P = 0.007).
Croatian: Značajno veći udio bolesnika (78,5%) ocijenio je metodu kontrole boli Zalvisom kao „dobru“ ili „izvrsnu“ u odnosu na metodu analgezije koju bolesnik kontrolira intravenskim morfinom (65,5%) (primarni ishod u 48. satu; P = 0,007).
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 %).
Croatian: Nakon 48 sati više od polovice ispitanika u Zalviso skupini imali su relevantno smanjenje boli (30%-tna stopa ispitanika koji su odgovorili na liječenje) u ovim ispitivanjima (visceralna bol 60%, nociceptivna bol
English: The device should be used as recommended in the information provided by the device manufacturer.
Croatian: Napravu je potrebno upotrijebiti sukladno uputama dostavljenim od strane proizvođača.
English: Clinically relevant plasma levels are largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50 % of Cmax after discontinuation of dosing (context sensitive halftime or CST½) rather than by the terminal half-life.
Croatian: Klinički značajne razine u plazmi većinom su određene vremenom potrebnim da plazmatska koncentracija sufentanila s Cmax padne na 50% Cmax nakon prekida doziranja (poluvijek ovisan o kontekstu ili od engl. context sensitive half-time, CST½), a ne terminalnim poluvijekom.
English: However, symptoms of overdose include severe breathing problems like slow and shallow breathing, loss of conciousness, extreme low blood pressure, collapse and muscle rigidity.
Croatian: Međutim, simptomi predoziranja uključuju teške probleme s disanjem poput usporenog i plitkog disanja, gubitka svijesti, ekstremno niskog krvnog tlaka, kolapsa i ukočenosti mišića.
English: In case you experience any of the above mentioned side effects, stop taking Zalviso and tell your doctor or nurse immediately.
Croatian: Ako iskusite bilo koju od prethodno navedenih nuspojava, prestanite uzimati Zalviso i odmah obavijestite liječnika ili medicinsku sestru.
English: The sublingual tablets are supplied in cartridges; each cartridge contains 40 sublingual tablets.
Croatian: Sublingvalne tablete dostupne su u ulošcima; svaki uložak sadrži 40 sublingvalnih tableta.
English: However, there was a statistically significant lower percentage of patients who experienced oxygen desaturation episodes following the administration of Zalviso sublingual tablets (19.8 %) with the administration device than in the IV PCA morphine group (30.0 %).
Croatian: Međutim, postojao je statistički značajno niži postotak bolesnika koji su iskusili epizode desaturacije kisikom nakon primjene Zalviso sublingvalnih tableta (19,8%) pomoću naprave za primjenu lijeka nego u skupini bolesnika koji su kontrolirali analgeziju i.v. morfinom (30,0%).
English: Zalviso is only to be taken in a hospital setting.
Croatian: Zalviso se smije uzimati samo u bolničkom okruženju.
English: The duration of activity may be prolonged in patients with severe hepatic and renal impairment.
Croatian: Trajanje aktivnosti može biti produljeno u bolesnika s teškim oštećenjem bubrega i jetre.
English: Confusional state Apathy* Nervousness*
Croatian: Psihijatrijski poremećaji stanje smetenosti apatija* nervoza*
English: Grünenthal Norway AS C.J. Hambros Plass 2C 0164 Oslo
Croatian: Hambros Plass 2C 0164 Oslo
English: See leaflet for further information.
Croatian: Za daljnje informacije vidjeti uputu.
English: When patients titrated themselves to analgesic effect with Zalviso, plasma sufentanil concentrations averaged 60-100 pg/ml over two days of use, with no effect based on age or body mass index (BMI), or mild to moderate renal or liver impairment.
Croatian: Kada su se bolesnici sami titrirali na analgetički učinak pomoću Zalvisa, plazmatske koncentracije sufentanila u prosjeku su iznosile 60-100 pg/ml tijekom dva dana primjene bez učinka na bazi dobi ili indeksa tjelesne mase ili blagog do umjerenog oštećenja bubrega ili jetre.
English: In that case, the opioid antagonist can be administered repeatedly or by infusion.
Croatian: U tom se slučaju opioidni antagonist može opetovano primijeniti ili dati putem infuzije.
English: Sufentanil is primarily metabolised in the liver and excreted in the urine and faeces.
Croatian: Sufentanil se primarno metabolizira u jetri i izlučuje u mokraći i stolici.
English: Sufentanil may obscure the clinical course of patients with head injury.
Croatian: Sufentanil može otežati praćenje kliničkog tijeka bolesnika s ozljedom glave.
English: Therefore, Zalviso should be used with caution in such patients (see section 4.4).
Croatian: Stoga se Zalviso mora upotrebljavati s oprezom u takvih bolesnika (vidjeti dio 4.4).
English: One cartridge is packed in a sachet including an oxygen absorber.
Croatian: Jedan uložak je pakiran u vrećici u kojoj se nalazi i sredstvo za apsorpciju kisika.
English: Analgesic plasma concentrations of sufentanil may provoke nausea and vomiting by irritation of the chemoreceptor trigger zone.
Croatian: Analgetičke koncentracije sufentanila u plazmi mogu izazvati mučninu i povraćanje iritacijom kemoreceptorske zone okidanja.
English: The active substance of Zalviso is sufentanil, which belongs to a group of strong pain-relieving medicines called opioids.
Croatian: Djelatna tvar Zalvisa je sufentanil koji pripada skupini jakih lijekova za ublažavanje boli koji se nazivaju opioidima.
English: After single administration of a 15 micrograms sufentanil sublingual tablet, mean terminal phase halflives in the range of 6 to 10 hours have been observed.
Croatian: Nakon jednokratne primjene sufentanil sublingvalne tablete od 15 mikrograma, uočeni su srednji poluvijekovi terminalne faze u rasponu od 6 do 10 sati.
English: The respiratory effects of sufentanil should be assessed by clinical monitoring, e. g. respiratory rate, sedation level and oxygen saturation.
Croatian: Respiracijske učinke sufentanila je potrebno procijeniti pomoću kliničkog praćenja, npr. brzine disanja, razine sedacije i zasićenja kisikom.
English: Only limited data are available for the use of Zalviso in such patients.
Croatian: Dostupni su samo ograničeni podaci o upotrebi Zalvisa u tih bolesnika.
English: Convulsions Coma
Croatian: konvulzije koma
English: The Zalviso sublingual tablets are to be self-administered using the Zalviso administration device which should only be actuated by the patient in response to pain (see section 6.6).
Croatian: Zalviso sublingvalne tablete su namijenjene za primjenu od strane samog bolesnika pomoću Zalviso naprave za primjenu lijeka, koju bolesnik smije aktivirati samo kao odgovor na bol (vidjeti dio 6.6).
English: The most serious adverse reaction of sufentanil is respiratory depression, potentially leading to apnoea and respiratory arrest (see section 4.4).
Croatian: Najozbiljnija nuspojava sufentanila je respiracijska depresija, koja može dovesti do apneje i respiracijskog aresta (vidjeti dio 4.4).
English: The concomitant use of CNS depressants including barbiturates, neuroleptics or other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance respiratory depression.
Croatian: Istodobna upotreba depresora SŽS-a, uključujući barbiturate, neuroleptike ili druge opioide, halogene plinove ili druge neselektivne depresore SŽS-a (npr. alkohol), mogu pojačati respiracijsku depresiju.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Zalviso is launched all healthcare professionals who are expected to prescribe Zalviso are informed through an information letter on having access to / are provided with the following items:
Croatian: Nakon rasprava i postizanja suglasnosti s nacionalnim nadležnim tijelima u svakoj državi članici gdje se Zalviso stavlja u promet, nositelj odobrenja će osigurati da su svi zdravstveni radnici, za koje se očekuje da će propisivati Zalviso, informirani putem pisma o pristupu sljedećim materijalima ili će im isti biti dostavljeni:
English: The high lipophilicity of sufentanil allows it to be administered sublingually and achieve a rapid onset of analgesic effect.
Croatian: Velika lipofilnost sufentanila omogućuje da se on primjenjuje sublingvalno te postigne brzo nastupanje analgetičkog učinka.
English: Sufentanil is a synthetic, potent opioid with highly selective binding to µ-opioid receptors.
Croatian: Sufentanil je sintetski potentni opioid s visoko selektivnim vezivanjem na µ-opioidne receptore.
English: - Medicines for the treatment of depression known as Monoamine Oxidase Inhibitors (MAOIs).
Croatian: Lijekove za liječenje depresije koji se zovu inhibitori monoaminoksidaze (MAO inhibitori).
English: Analgesic doses of Zalviso resulted in respiratory depressive effects in some patients in the clinical trials.
Croatian: Analgetičke doze Zalvisa u kliničkim ispitivanjima rezultirale su učincima respiracijske depresije u nekih bolesnika.
English: Uncommon ≥1/1,000 and <1/100 Rare
Croatian: ≥ 1/100 i < 1/10 manje često ≥ 1/1000 i < 1/100 rijetko
English: Patients reported in all the 3 Phase III trials a clinically meaningful pain relief within the first hour of treatment with Zalviso (pain intensity difference to baseline and total pain response >1 NRS).
Croatian: Bolesnici su u sva 3 ispitivanja faze III prijavili klinički značajno ublažavanje boli unutar prvog sata liječenja Zalvisom (razlika u intenzitetu boli u odnosu na početne vrijednosti i ukupni odgovor na bol > 1 numeričke ocjenske skale, engl. numeric rating skale, NRS).
English: Superiority over placebo was demonstrated in the Phase III placebo-controlled trials for the primary endpoint time-weighted sum of pain intensity difference from baseline over 48 hours (SPID48; P 0.001), and the secondary endpoints, time-weighted SPID (P 0.004), total pain relief (TOTPAR; P 0.004), and patients global assessment (P 0.007) over 24, 48 and 72 hours.
Croatian: Superiornost u odnosu na placebo bila je pokazana u placebom kontroliranim ispitivanjima faze III za primarni ishod vremenski ponderiranog zbroja razlika u intenzitetu boli u odnosu na početnu vrijednost tijekom 48 sati (engl. sum of pain intensity difference ,SPID48; P 0,001), a za sekundarne ishode, vremenski ponderirani SPID (P 0,004), potpuno ublažavanje boli (engl. total pain relief, TOTPAR, P 0,004) i procjena općeg stanja bolesnika (P0,007) tijekom 24, 48 i 72 sata.
English: 40 sublingual tablets
Croatian: 40 sublingvalnih tableta
English: Zalviso should only be prescribed by physicians who are experienced in the management of opioid therapy, particularly opioid adverse reactions such as respiratory depression (see section 4.4).
Croatian: Zalviso smiju propisivati samo liječnici koji imaju iskustva u primjeni opioidne terapije, naročito zbrinjavanju nuspojava opioidne terapije poput respiracijske depresije (vidjeti dio 4.4).
English: Based on the population pharmacokinetic analysis for Zalviso in patients and healthy volunteers (N = 700), which included 13 patients with moderate and 6 patients with severe hepatic impairment, hepatic function was not identified as a significant covariate for clearance.
Croatian: Na temelju populacijske farmakokinetičke analize za Zalviso u bolesnika i zdravih dobrovoljaca (N = 700), koja je uključivala 13 bolesnika s umjerenim i 6 bolesnika s teškim oštećenjem jetre, funkcija jetre nije identificirana kao značajna kovarijanta za klirens.