FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Zdravilo Zalviso smejo predpisovati le zdravniki z izkušnjami pri nadzorovanju opioidnega zdravljenja, zlasti opioidnih neželenih učinkov, kot je respiratorna depresija (glejte poglavje 4.4).
English: It was concluded from these studies that Zalviso sublingual tablets have no or minimal potential for local irritation.
Slovenian: Na podlagi teh študij je bilo zaključeno, da Zalviso podjezične tablete nimajo potenciala za lokalno draženje oz. je ta potencial minimalen.
English: The sublingual tablets are taken using the Zalviso administration device, which is a system that delivers a single dose upon activation.
Slovenian: Podjezične tablete se jemljejo s pomočjo pripomočka za aplikacijo zdravila Zalviso, ki je sistem, ki ob aktivaciji aplicira enkratni odmerek.
English: The instructions for setting up the Zalviso administration device by a healthcare professional must be followed carefully.
Slovenian: Navodila zdravstvenega delavca za nastavitev pripomočka za aplikacijo zdravila Zalviso je treba natančno upoštevati.
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Slovenian: Sufentanil lahko povzroči respiratorno depresijo s stopnjo/resnostjo, odvisno od odmerka.
English: What Zalviso is and what it is used for What you need to know before you take Zalviso How to take Zalviso
Slovenian: Kaj je zdravilo Zalviso in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zalviso Kako jemati zdravilo Zalviso Možni neželeni učinki
English: In the event of repeated maximal usage by the patient, one cartridge will last for a period of 13 hours 20 minutes.
Slovenian: Ob bolnikovi ponavljajoči največji uporabi en vložek zadostuje za 13 ur in 20 minut.
English: Direct effects of sufentanil on myocardial function were not observed.
Slovenian: Neposrednih učinkov sufentanila na delovanje miokarda niso opazili.
English: When Zalviso was administered every 20 minutes, steady state plasma concentrations were achieved after 13 doses.
Slovenian: Pri dajanju zdravila Zalviso vsakih 20 minut so bile plazemske koncentracije v dinamičnem ravnovesju dosežene po 13 odmerkih.
English: In the placebo-controlled Phase 3 trials, approximately 20 % of enrolled patients were elderly (≥ 75 years of age) and approximately 30 % of enrolled patients were 65 to 75 years of age.
Slovenian: V preskušanjih 3. faze je bilo približno 20% vključenih bolnikov starejših (≥ 75 let starosti) in približno 30% vključenih bolnikov je bilo starih od 65 do 75 let.
English: For sublingual use only.
Slovenian: Le za sublingvalno uporabo.
English: - Medicines for the treatment of depression known as Monoamine Oxidase Inhibitors (MAOIs).
Slovenian: - Zdravila za zdravljenje depresije, imenovana zaviralci monoaminooksidaz (MAOI).
English: If these start to develop, tell a doctor or nurse immediately.
Slovenian: Če se začnejo pojavljati, to takoj povejte z zdravniku ali medicinski sestri.
English: Other medicines and Zalviso Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The Zalviso administration device should not be used if any component is visibly damaged.
Slovenian: Pripomočka za aplikacijo zdravila Zalviso se ne sme uporabiti, če je kateri del vidno poškodovan.
English: What Zalviso contains - The active substance is sufentanil.
Slovenian: Kaj vsebuje zdravilo Zalviso - Zdravilna učinkovina je sufentanil.
English: Monoamine Oxidase Inhibitors must not be taken in the 2 weeks before or at the same time as Zalviso is given.
Slovenian: Zaviralcev monoaminooksidaz se ne sme uporabljati 2 tedna pred začetkom jemanja zdravila Zalviso ali sočasno z njim.
English: The high lipophilicity of sufentanil allows it to be administered sublingually and achieve a rapid onset of analgesic effect.
Slovenian: Velika lipofilnost sufentanila omogoča, da ga lahko damo podjezično in da hitro nastopi analgetični učinek.
English: Patients were treated using the Zalviso dosing regimen of 15 micrograms sufentanil sublingually as needed with a minimum 20 minute lock-out interval over a period of 72 hours.
Slovenian: Bolniki so bili zdravljeni z režimom odmerjanja zdravila Zalviso 15 mikrogramov sufentanila podjezično po potrebi z vsaj 20-minutnim intervalom premora v 72-urnem obdobju.
English: Clearance is not affected by race, sex, renal parameters, hepatic parameters, or concomitant CYP3A4 substrates.
Slovenian: Etična pripadnost, spol, ledvični parametri, jetrni parametri ali sočasni substrati CYP3A4 ne vplivajo na očistek.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Marketing Authorisation Holder and Manufacturer Grünenthal GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Grünenthal GmbH
English: Calcium hydrogen phosphate, anhydrous Hypromellose
Slovenian: Kalcijev hidrogenfosfat, brezvodni Hipromeloza
English: Do not crush, chew, or swallow the tablet.
Slovenian: Tablet ne lomite, žvečite in ne pogoltnite.
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.
Slovenian: Na podlagi populacijske farmakokinetične analize za zdravilo Zalviso pri bolnikih in zdravih prostovoljcih (N = 700), ki je vključevala 13 bolnikov z zmerno in 6 bolnikov s hudo jetrno okvaro, delovanje jeter ni bilo potrjeno kot pomembna sospremenljivka za očistek.
English: Sufentanil was not teratogenic in rats and rabbits.
Slovenian: Teratogenega učinka sufentanila pri podganah in kuncih ni bilo.
English: ≥1/100 and <1/10
Slovenian: ≥ 1/100 in < 1/10
English: Analgesic plasma concentrations of sufentanil may provoke nausea and vomiting by irritation of the chemoreceptor trigger zone.
Slovenian: Analgetične koncentracije sufentanila v plazmi lahko povzročijo navzeo in bruhanje zaradi draženja kemoreceptorske sprožilne cone.
English: Ask the medical staff how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: However if your doctor prescribes Zalviso together with sedating medicines the duration of concomitant treatment should be limited by your doctor.
Slovenian: Če zdravnik predpiše zdravilo Zalviso skupaj s sedativnimi zdravili, vam mora zdravnik omejiti trajanje sočasnega zdravljenja.
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.
Slovenian: Boljši učinek od placeba je bil dokazan v s placebom nadzorovanih preskušanjih 3. faze za primarni opazovani dogodek, glede na čas uteženo vsoto razlik v intenzivnosti bolečine od izhodišča v 48 urah (SPID48; P 0,001), in sekundarne opazovane dogodke, glede na čas utežene vsote razlik v intenzivnosti bolečine (P 0,004), celotno ublažitev bolečine (TOTPAR; P 0,004) in globalne ocene bolnika (P 0,007) v 24, 48 in 72 urah.
English: The dispensed sublingual tablet should dissolve under the tongue and should not be crushed, chewed, or swallowed.
Slovenian: Aplicirana podjezična tableta se mora pod jezikom razpustiti; ne sme se je lomiti, žvečiti ali pogoltniti.
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.
Slovenian: Simptomi prevelikega odmerjanja vključujejo hude težave z dihanjem, kot so počasno in plitko dihanje, izguba zavesti, izjemno nizek krvni tlak, kolaps in togost mišic.
English: ≥1/10,000 and <1/1,000
Slovenian: ≥ 1/10.000 in < 1/1.000
English: Only limited data are available for the use of Zalviso in such patients.
Slovenian: Na voljo so le omejeni podatki glede uporabe zdravila Zalviso pri teh bolnikih.
English: This route of administration results in higher absolute bioavailability by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Slovenian: Ta način uporabe povzroči višjo absolutno biološko uporabnost, saj preskoči presnovo v prebavilih in presnovo prvega prehoda v jetrih z encimom 3A4.
English: The Zalviso administration device is designed to deliver a single sufentanil 15 micrograms sublingual tablet, on a patient-controlled as needed basis, with a minimum of 20 minutes (lockout interval) between doses, over a period of up to 72 hours, which is the maximum recommended treatment duration.
Slovenian: Pripomoček za aplikacijo zdravila Zalviso je zasnovan tako, da aplicira eno podjezično tableto s 15 mikrogrami sufentanila po potrebi in nadzoru bolnika, z najmanj 20 minutami (zaklepni interval) med odmerki, v obdobju do 72 ur, ki predstavlja najdaljše priporočeno obdobje zdravljenja.
English: In particular, tell your doctor if you are taking any of the following: - Any medicines that might have an effect on the way in which your body breaks down Zalviso e.g. ketoconazole, which is used for the treatment of fungal infections.
Slovenian: Zdravniku še posebno povejte, če jemljete kaj od naslednjega: - Vsa zdravila, ki lahko vplivajo na način, kako vaše telo razgrajuje zdravilo Zalviso, npr.
English: Frequency not known (frequency cannot be estimated from the available data): severe allergic reactions (anaphylactic shock), convulsion (fits), coma, small pupil size, redness of the skin, withdrawal syndrome.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): hude alergijske reakcije (anafilaktični šok), konvulzije (epileptični krči), koma, majhne zenice, rdečina kože, odtegnitveni sindrom.
English: Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: - Medicines for the treatment of depression known as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
Slovenian: - Zdravila za zdravljenje depresije, imenovana selektivni zaviralci privzema serotonina (SSRI) in zaviralci privzema serotonina in noradrenalina (SNRI).
English: Sufentanil is a synthetic, potent opioid with highly selective binding to µ-opioid receptors.
Slovenian: Sufentanil je močan sintetični opioid z visoko selektivno vezavo na µ-opioidne receptorje.
English: Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Slovenian: Ena podjezična tableta vsebuje 15 mikrogramov sufentanila (v obliki citrata).
English: However, due to the limited number of patients with severe renal impairment studied, Zalviso should be used with caution in such patients (see section 4.4).
Slovenian: Vendar je treba zaradi omejenega števila preiskovanih bolnikov s hudo ledvično okvaro zdravilo Zalviso pri teh bolnikih uporabljati previdno (glejte poglavje 4.4).
English: A population pharmacokinetic analysis of plasma sufentanil concentrations following usage of Zalviso in patients and healthy volunteers (N = 700), which included 75 patients with moderate and 7 patients with severe renal impairment, did not identify renal function as a significant covariate for clearance.
Slovenian: Populacijska farmakokinetična analiza koncentracij sufentanila v plazmi po uporabi zdravila Zalviso pri bolnikih in zdravih prostovoljcih (N = 700), vključno s 75 bolniki z zmerno in 7 bolniki s hudo ledvično okvaro, ni potrdila delovanja ledvic kot pomembne sospremenljivke za očistek.
English: Sufentanil is excreted in human milk when applied intravenously; therefore caution is advised when Zalviso is administered to breast-feeding women.
Slovenian: Sufentanil se pri intravenski uporabi izloča v materino mleko; zato je pri dajanju zdravila Zalviso doječim ženskam potrebna previdnost.
English: Taking the sublingual tablets with the device
Slovenian: Jemanje podjezičnih tablet s pripomočkom
English: Hypersensitivity* Anaphylactic shock
Slovenian: Preobčutljivost* Anafilaktični šok
English: In case you experience any of the above mentioned side effects, stop taking Zalviso and tell your doctor or nurse immediately.
Slovenian: Če opazite kateri koli zgoraj navedeni neželeni učinek, takoj prenehajte jemati zdravilo Zalviso in se posvetujte z zdravnikom ali medicinsko sestro.
English: Interaction with cytochrome P450-3A4 enzyme
Slovenian: Interakcije z encimom citokroma P450-3A4
English: Zalviso is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Zalviso ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Uncommon side effects (may affect up to 1 in 100 people): allergic reactions, lack of interest or emotion, nervousness, sleepiness, abnormal sensation of the skin, problems coordinating muscle movements, muscle contractions, exaggeration of reflexes, vision disturbances, decreased heart rate, dry mouth, excessive sweating, rash, dry skin, chills, weakness.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikih): alergijske reakcije, pomanjkanje interesa ali čustev, živčnost, zaspanost, nenormalni občutki na koži, težave s koordinacijo mišičnih gibov, krčenje mišic, pretirano povečanje refleksov, motnje vida, zmanjšan srčni utrip, suha usta, pretirano znojenje, izpuščaj, suha koža, mrzlica, šibkost.
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.
Slovenian: Pri titraciji odmerka zdravila Zalviso do analgetičnega učinka s strani bolnikov samih so bile povprečne koncentracije sufentanila v plazmi 60 do 100 pg/ml v dveh dneh uporabe, na kar starost, indeks telesne mase (ITM) ali blaga do zmerna okvara ledvic ali jeter niso imele vpliva.
English: Therefore, Zalviso should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Slovenian: Zato je treba zdravilo Zalviso previdno uporabljati pri bolnikih z boleznijo žolčnika in žolčevodov, vključno z akutnim pankreatitisom.
English: In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Slovenian: V zvezi s tem je zelo priporočljivo obveščanje bolnikov in njihovih skrbnikov, da se zavedajo teh simptomov
English: Patients with moderate to severe hepatic or severe renal impairment should be monitored carefully for symptoms of sufentanil overdose (see section 4.9).
Slovenian: Bolnike z zmerno do hudo jetrno ali hudo ledvično okvaro je treba skrbno spremljati glede možnega pojava simptomov prevelikega odmerjanja sufentanila (glejte poglavje 4.9).
English: Zalviso affects your ability to drive or use machines as it may cause sleepiness, dizziness or visual disturbances.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zalviso vpliva na vašo sposobnost vožnje ali uporabe strojev, saj lahko povzroči zaspanost, omotico ali motnje vida.
English: Zalviso is only to be taken in a hospital setting.
Slovenian: Zalviso se sme jemati samo v bolnišničnem okolju.
English: Patients should only drive and use machines if sufficient time has elapsed after the last administration of Zalviso.
Slovenian: Bolnikom sta vožnja in upravljanje s stroji dovoljena samo, če je od zadnjega dajanja zdravila Zalviso minilo dovolj časa.
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).
Slovenian: Bistveno višji delež bolnikov (78,5%) je ocenil, da je način obvladovanja bolečine z zdravilom Zalviso v primerjavi z intravensko analgezijo z morfinom, ki jo nadzirajo bolniki (65,5%) (primarni opazovani dogodek pri 48 urah; P = 0,007), »dober« ali »odličen«.
English: The active substance of Zalviso is sufentanil, which belongs to a group of strong pain-relieving medicines called opioids.
Slovenian: Zdravilna učinkovina v zdravilu Zalviso je sufentanil, ki sodi v skupino močnih zdravil za blaženje bolečine, imenovanih opioidi.
English: Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances
Slovenian: Tveganje zaradi sočasne uporabe sedativnih zdravil, kot so benzodiazepini ali sorodne učinkovine
English: confusion, dizziness, headache, drowsiness, increased heart rate, high blood pressure, low blood pressure, constipation, indigestion, itching of the skin, involuntary muscle cramps, muscle twitching, difficulty passing urine.
Slovenian: zmedenost, omotica, glavobol, dremavost, zvišan srčni utrip, visok krvni tlak, nizek krvni tlak, zaprtost, prebavne motnje, srbenje kože, nehoteni mišični krči, trzanje mišic, težave pri izločanju urina.
English: Gastrointestinal effects of sufentanil comprise decreased propulsive motility, reduced secretion and increased muscle tone (up to spasms) of the sphincters of the gastrointestinal tract (see section 4.4).
Slovenian: Učinki sufentanila na prebavila obsegajo zmanjšanje propulzivne gibljivosti, zmanjšano sekrecijo in povečan mišični tonus (do spazmov) sfinktrov prebavil (glejte poglavje 4.4).
English: The most serious adverse reaction of sufentanil is respiratory depression, potentially leading to apnoea and respiratory arrest (see section 4.4).
Slovenian: Najbolj resen neželeni učinek sufentanila je respiratorna depresija, ki lahko povzroči apnejo in zastoj dihanja (glejte poglavje 4.4).
English: Only limited data are available for the use of sufentanil in such patients.
Slovenian: Na voljo so le omejeni podatki glede uporabe sufentanila pri teh bolnikih.
English: Nervous system disorders
Slovenian: Zaviralci osrednjega živčnega sistema
English: Mean absolute bioavailability after a single sublingual administration of Zalviso relative to a oneminute intravenous sufentanil infusion of 15 micrograms was 59 %.
Slovenian: Povprečna absolutna biološka uporabnost enkratne podjezične aplikacije zdravila Zalviso v primerjavi z enominutnim intravenskim infundiranjem sufentanila 15 mikrogramov je bila 59%.
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.
Slovenian: Analgezija, ki jo povzroči sufentanil, je verjetno povezana z aktivacijo µ-opioidnih receptorjev, primarno v osrednjem živčnem sistemu, kjer spremeni procese, ki vplivajo na zaznavanje bolečine in na odziv nanjo.
English: The sublingual tablets are supplied in cartridges; each cartridge contains 40 sublingual tablets.
Slovenian: Podjezične tablete so na voljo v vložkih; en vložek vsebuje 40 podjezičnih tablet.
English: Sufentanil is mainly metabolised in humans by the cytochrome P450-3A4 enzyme system (see section 4.5).
Slovenian: Sufentanil pri ljudeh pretežno presnavlja encimski sistem citokroma P450-3A4 (glejte poglavje 4.5).
English: Sublingual use
Slovenian: Sublingvalna uporaba
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.
Slovenian: Sočasna uporaba zaviralcev osrednjega živčnega sistema, vključno z barbiturati, nevroleptiki ali drugimi opioidi, halogenimi plini in drugimi neselektivnimi depresivi osrednjega živčnega sistema (npr. alkohola) lahko poveča respiratorno depresijo.
English: Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Slovenian: Zdravilo Zalviso je indicirano za nadzorovanje zmerne do hude akutne pooperativne bolečine pri odraslih bolnikih.
English: These medicines must not be taken in the 2 weeks before or at the same time as Zalviso is given.
Slovenian: Teh zdravil ne smete uporabljati 2 tedna pred začetkom jemanja zdravila Zalviso ali sočasno z njim.
English: Therefore, Zalviso should be used with caution in such patients (see section 4.4).
Slovenian: Zdravilo Zalviso je treba pri teh bolnikih uporabljati previdno (glejte poglavje 4.4).
English: How to take Zalviso
Slovenian: Kako jemati zdravilo Zalviso
English: Patients should not eat or drink and minimize talking for 10 minutes after each dose of Zalviso.
Slovenian: Bolniki 10 minut po vsakem odmerku zdravila Zalviso ne smejo jesti ali piti in naj čim manj govorijo.
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.
Slovenian: Pri drugi študiji pri podganah, ki so med organogenezo ploda prejemale 20-kratnik največjega odmerka pri človeku, ni bilo opaženih nobenih negativnih učinkov.
English: Annex IV
Slovenian: PRILOGA IV
English: Sufentanil passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended when you take Zalviso.
Slovenian: Sufentanil prehaja v materino mleko in lahko povzroči neželene učinke pri dojenem otroku.
English: 40 sublingual tablets
Slovenian: 40 podjezičnih tablet
English: Dizziness Headache Sedation
Slovenian: Omotica Glavobol Sedacija
English: Sufentanil as a µ-opioid receptor agonist may cause spasm of the sphincter of Oddi.
Slovenian: Sufentanil kot agonist µ-opioidnih receptorjev lahko povzroči spazme Oddijevega sfinktra.
English: Zalviso sublingual tablets of 3 mm diameter are orange-coloured flat-faced tablets with rounded edges.
Slovenian: Zalviso podjezične tablete imajo premer 3 mm in so ploske oranžne tablete z zaobljenimi robovi.
English: Sufentanil acts as a full agonist in µ-opioid receptors.
Slovenian: Sufentanil deluje kot polni agonist µ-opioidnih receptorjev.
English: Co-administration of sufentanil with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), or Monoamine Oxidase Inhibitors (MAOIs), may increase the risk of serotonin syndrome, a potentially life threatening condition.
Slovenian: Sočasna uporaba sufentanila s serotoninergičnimi zdravili, kot so selektivni zaviralci privzema serotonina (SSRI), zaviralci privzema serotonina in noradrenalina (SNRI) ali zaviralci monoaminooksidaz (MAOI), lahko poveča tveganje za nastanek serotoninskega sindroma, ki je lahko življenje ogrožajoče stanje.
English: This compares to a substantially lower bioavailability of 9 % after oral intake (swallowed).
Slovenian: Za primerjavo je biološka uporabnost po peroralni uporabi (zaužitju) pomembno nižja - 9%.
English: Warnings and precautions Talk to your doctor or nurse before taking Zalviso.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Zalviso se posvetujte z zdravnikom ali medicinsko sestro.
English: Their frequencies were established based on data from intravenous administration of sufentanil: common - muscle twitching; uncommon - hypersensitivity, apathy, nervousness, ataxia, dystonia, hyperreflexia, heart rate decreased and dry skin.
Slovenian: Pogostnosti so bile določene na osnovi podatkov iz intravenskega dajanja sufentanila: pogosti - trzanje mišic; občasni - preobčutljivost, apatija, živčnost, ataksija, distonija, hiperrefleksija, upočasnjen srčni utrip in suha koža.