FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with moderate to severe hepatic or severe renal impairment should be monitored carefully for symptoms of sufentanil overdose (see section 4.9).
Croatian: Bolesnici s umjerenim do teškim oštećenjem jetre ili teškim oštećenjem bubrega moraju se pažljivo nadzirati u pogledu simptoma predoziranja sufentanilom (vidjeti dio 4.9).
English: Zalviso is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Zalviso tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Therefore, Zalviso should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Croatian: Stoga se Zalviso mora upotrebljavati s oprezom u bolesnika s bolešću žučovoda, uključujući akutni pankreatitis.
English: Population pharmacokinetic analysis with a BMI as covariate showed that patients with a BMI > 30 kg/m2 dosed more frequently.
Croatian: Populacijska farmakokinetička analiza s indeksom tjelesne mase kao kovarijantom pokazala je da su bolesnici s indeksom tjelesne mase > 30 kg/m češće uzimali lijek.
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).
Croatian: Učinci sufentanila na probavni sustav obuhvaćaju smanjene propulzivnih kretnji, smanjenu sekreciju i povećani mišićni tonus (sve do spazma) sfinktera gastrointestinalnog trakta (vidjeti dio 4.4).
English: Taking the sublingual tablets with the device
Croatian: Uzimanje sublingvalnih tableta pomoću naprave
English: Sufentanil is excreted in human milk when applied intravenously; therefore caution is advised when Zalviso is administered to breast-feeding women.
Croatian: Sufentanil se izlučuje u majčino mlijeko kada se primjenjuje intravenski; stoga se preporučuje oprez kada se Zalviso primjenjuje u dojilja.
English: No pharmacokinetic data exist for the Zalviso in paediatric patients.
Croatian: Ne postoje farmakokinetički podaci za Zalviso u pedijatrijskih bolesnika.
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).
Croatian: Ipak, budući da je u ispitivanju bio uključen ograničen broj bolesnika s teškim oštećenjem bubrega, Zalviso se mora upotrebljavati s oprezom u takvih bolesnika (vidjeti dio 4.4).
English: You should only drive and use machines if sufficient time as elapsed after your last dose of Zalviso.
Croatian: Smijete upravljati vozilima i raditi sa strojevima samo ako je prošlo dovoljno vremena od posljednje doze Zalvisa.
English: After your treatment the medical staff will take the Zalviso administration device and dispose of any unused tablets accordingly.
Croatian: Medicinsko osoblje će nakon Vašeg liječenja uzeti Zalviso napravu za primjenu lijeka i odgovarajuće zbrinuti sve neupotrijebljene tablete.
English: For instructions on the setup and handling of the Zalviso administration device before administration, see section 6.6.
Croatian: Za uputu o pripremi i rukovanju Zalviso napravom za primjenu lijeka prije same primjene lijeka vidjeti dio 6.6.
English: Zalviso sublingual tablets of 3 mm diameter are orange-coloured flat-faced tablets with rounded edges.
Croatian: Zalviso sublingvalne tablete promjera 3 mm su narančasto obojene plosnate tablete zaobljenih rubova.
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.
Croatian: Populacijska farmakokinetička analiza koncentracija sufentanila u plazmi nakon primjene Zalvisa u bolesnika i zdravih dobrovoljaca (N = 700), koja je uključivala 75 bolesnika s umjerenim i 7 bolesnika s teškim oštećenjem bubrega, nije identificirala funkciju bubrega kao značajnu kovarijantu za klirens.
English: 800 sublingual tablets (20 cartridges of 40 sublingual tablets each).
Croatian: 800 sublingvalnih tableta (20 uložaka od po 40 sublingvalnih tableta).
English: How to store Zalviso
Croatian: Kako čuvati Zalviso
English: Before use, the health-care professional should ensure that the patients have been appropriately instructed on how to operate the Zalviso administration device to self-administer tablets as needed to manage their pain post-operatively.
Croatian: Zdravstveni radnici se prije primjene lijeka moraju pobrinuti da su bolesnici odgovarajuće upućeni u način rukovanja Zalviso napravom za primjenu lijeka kako bi bolesnici sami i prema potrebi primijenili tablete za kontroliranje svoje boli nakon operacije.
English: * see “Description of selected adverse reactions”
Croatian: “Opis odabranih nuspojava”
English: Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Croatian: Jedna sublingvalna tableta sadrži 15 mikrograma sufentanila (u obliku sufentanilcitrata).
English: Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances
Croatian: Rizik od istodobne primjene lijekova za smirenje poput benzodiazepina ili srodnih lijekova
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.
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): alergijske reakcije, izostanak interesa ili emocija, nervoza, pospanost, abnormalni osjećaji na koži, problemi s koordinacijom mišićnih pokreta, mišićne kontrakcije, izraženi refleksi, poremećaji vida, usporeni puls, suha usta, pojačano znojenje, osip, suha koža, zimica, slabost.
English: Patients should only drive and use machines if sufficient time has elapsed after the last administration of Zalviso.
Croatian: Bolesnici smiju upravljati vozilima i raditi sa strojevima samo ako je prošlo dovoljno vremena od posljednje primjene Zalvisa.
English: Interaction with cytochrome P450-3A4 enzyme
Croatian: Interakcije s enzimom citokroma P450-3A4
English: Sublingual use
Croatian: Sublingvalna primjena
English: Grünenthal Italia S.r.l.I Tel: +39 02 4305 1
Croatian: Grünenthal Italia S.r.l. Tel: +39 02 4305 1
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.
Croatian: Učestalost nije poznata (učestalost se ne može procijeniti iz dostupnih podataka): teške alergijske reakcije (anafilaktički šok), konvulzije (napadaji), koma, mala veličina zjenice, crvenilo kože, sindrom ustezanja.
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.
Croatian: Njihove učestalosti utvrđene su na temelju podataka iz intravenske primjene sufentanila: često - trzanje mišića; manje čestopreosjetljivost, apatija, nervoza, ataksija, distonija, hiperrefleksija, usporena srčana frekvencija i suha koža.
English: Zalviso is used to treat acute moderate to severe pain after an operation in adults.
Croatian: Zalviso se koristi za liječenje akutne umjerene do teške boli u odraslih nakon kirurškog zahvata.
English: Sufentanil is mainly metabolised in humans by the cytochrome P450-3A4 enzyme system (see section 4.5).
Croatian: Sufentanil se uglavnom metabolizira u ljudi pomoću enzimskog sustava citokroma P450-3A4 (vidjeti dio 4.5).
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.
Croatian: Zalviso naprava za primjenu lijeka dizajnirana je tako da dostavi pojedinačne sufentanil sublingvalne tablete od 15 mikrograma, pri čemu bolesnik kontrolira primjenu lijeka prema potrebi, s minimalnim vremenom koje mora proći između doza od 20 minuta (engl. lockout interval), tijekom razdoblja do 72 sata, što je maksimalno preporučeno trajanje liječenja.
English: Sufentanil as a µ-opioid receptor agonist may cause spasm of the sphincter of Oddi.
Croatian: Sufentanil kao agonist µ-opioidnog receptora može prouzročiti spazam Oddijevog sfinktera.
English: Mean absolute bioavailability after a single sublingual administration of Zalviso relative to a oneminute intravenous sufentanil infusion of 15 micrograms was 59 %.
Croatian: Srednja apsolutna bioraspoloživost nakon jednokratne sublingvalne primjene Zalvisa iznosila je 59% u odnosu na intravensku infuziju sufentanila od 15 mikrograma u trajanju od jedne minute.
English: Sedating medicinal products such as benzodiazepines or related substances
Croatian: Lijekovi za smirenje poput benzodiazepina ili srodni lijekovi
English: See section “Method of administration”.
Croatian: “Način primjene”.
English: Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Croatian: Zalviso je indiciran za zbrinjavanje akutne umjerene do teške postoperativne boli u odraslih bolesnika.
English: These medicines must not be taken in the 2 weeks before or at the same time as Zalviso is given.
Croatian: Ti se lijekovi ne smiju uzimati dva tjedna prije početka uzimanja lijeka Zalviso ni tijekom uzimanja lijeka Zalviso.
English: Not known
Croatian: * vidjeti
English: If these start to develop, tell a doctor or nurse immediately.
Croatian: Ako se ti simptomi počnu pojavljivati, odmah obavijestite liječnika ili medicinsku sestru.
English: EU/1/15/1042/001 1 cartridge of 40 sublingual tablets EU/1/15/1042/002 10 cartridges of 40 sublingual tablets each EU/1/15/1042/003 20 cartridges of 40 sublingual tablets each
Croatian: EU/1/15/1042/001 1 uložak od 40 sublingvalnih tableta EU/1/15/1042/002 10 uložaka od po 40 sublingvalnih tableta EU/1/15/1042/003 20 uložaka od po 40 sublingvalnih tableta
English: Sufentanil acts as a full agonist in µ-opioid receptors.
Croatian: Sufentanil djeluje kao potpuni agonist µ-opioidnih receptora.
English: Only limited data are available for the use of sufentanil in such patients.
Croatian: Dostupni su samo ograničeni podaci o upotrebi sufentanila u tih bolesnika.
English: Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme.
Croatian: Sufentanil se primarno metabolizira pomoću humanog enzima citokroma P450-3A4.
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.
Croatian: Bolesnici su bili liječeni režimom doziranja Zalvisa od 15 mikrograma sufentanila sublingvalno prema potrebi s minimalnim vremenom koje mora proći između dvije doze (engl. lockout interval) od 20 minuta, tijekom razdoblja od 72 sata.
English: EU/1/15/1042/004 2 x 20 cartridges of 40 sublingual tablets each EU/1/15/1042/005 3 x 20 cartridges of 40 sublingual tablets each EU/1/15/1042/006 5 x 20 cartridges of 40 sublingual tablets each
Croatian: EU/1/15/1042/004 2 x 20 uložaka od po 40 sublingvalnih tableta EU/1/15/1042/005 3 x 20 uložaka od po 40 sublingvalnih tableta EU/1/15/1042/006 5 x 20 uložaka od po 40 sublingvalnih tableta
English: Somnolence Paraesthesia Ataxia* Dystonia* Hyperreflexia*
Croatian: Poremećaji živčanog sustava omaglica glavobolja sedacija somnolencija parestezija ataksija* distonija* hiperrefleksija*
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.
Croatian: smetenost, omaglica, glavobolja, omamljenost, ubrzani puls, visoki krvni tlak, niski krvni tlak, zatvor, probavne smetnje, svrbež kože, nevoljni grčevi mišića, trzanje mišića, poteškoće s mokrenjem.
English: Other CNS effects
Croatian: Drugi učinci na SŽS
English: Zalviso is placed under the tongue using the Zalviso administration device.
Croatian: Zalviso se stavlja ispod jezika pomoću Zalviso naprave za primjenu lijeka.
English: The cartridge should be used only with the Zalviso administration device, consisting of a controller and a dispenser to ensure the proper use of this system.
Croatian: Uložak se smije upotrijebiti samo pomoću Zalviso naprave za primjenu lijeka, koja se sastoji od regulatora i dozatora kako bi se osigurala ispravna primjena sustava.
English: No special population studies were performed using sufentanil sublingual tablets in elderly patients.
Croatian: Nisu provedena ispitivanja na posebnim populacijama primjenjujući sufentanil sublingvalne tablete u starijih bolesnika.
English: Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium Lake (E110).
Croatian: Jedna sublingvalna tableta sadrži 0,074 mg boje sunset yellow FCF Aluminium Lake (E110).
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.
Croatian: U placebom kontroliranim ispitivanjima faze III približno 20% uključenih bolesnika je bilo starije dobi (≥ 75 godina), a približno 30% uključenih bolesnika je bilo u dobi između 65 i 75 godina.Populacijska farmakokinetička analiza je pokazala učinak dobi s 27%-tnim smanjenjem klirensa u starijih osoba (starijih od 65 godina).
English: The sublingual tablets measure 3 mm in diameter.
Croatian: Sublingvalne tablete su promjera 3 mm.
English: EXP see page 1 EXP see reverse
Croatian: EXP vidjeti stranicu
English: Sufentanil as a µ-opioid receptor agonist may slow the gastrointestinal motility.
Croatian: Sufentanil kao agonist µ-opioidnog receptora može usporiti gastrointestinalnu pokretljivost.
English: 1 cartridge of 40 sublingual tablets 10 cartridges of 40 sublingual tablets each 20 cartridges of 40 sublingual tablets each
Croatian: 1 uložak od 40 sublingvalnih tableta 10 uložaka od po 40 sublingvalnih tableta 20 uložaka od po 40 sublingvalnih tableta
English: No special population studies were performed using Zalviso in the elderly.
Croatian: Nisu provedena ispitivanja na posebnim populacijama pomoću Zalvisa u starijih bolesnika.
English: Concomitant use of Zalviso and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.
Croatian: Istodobna primjena Zalvisa i lijekova za smirenje poput benzodiazepina ili srodnih lijekova mogu rezultirati u sedaciji, respiratornoj depresiji, komi i smrti.
English: Two local tolerance studies were conducted in the hamster cheek pouch with the sufentanil sublingual tablets.
Croatian: Dva ispitivanja lokalne podnošljivosti provedena su sa sufentanil sublingvalnim tabletama na obraznim vrećicama hrčka.
English: Hypersensitivity* Anaphylactic shock
Croatian: Poremećaji imunološkog sustava preosjetljivost* anafilaktički šok
English: Heart rate increased Heart rate decreased*
Croatian: Srčani poremećaji ubrzana srčana frekvencija usporena srčana frekvencija*
English: Zalviso sublingual tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Croatian: Zalviso sublingvalne tablete sadrže manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: In the Phase III active-controlled trial, the magnitude of decrease in oxygen saturation was comparable between Zalviso and i.v.
Croatian: U aktivno kontroliranom ispitivanju faze III veličina smanjenja saturacije kisikom bila je usporediva između skupine liječene Zalvisom i bolesnika koji su kontrolirali bol intravenskim morfinom.
English: Zalviso 15 micrograms sublingual tablets
Croatian: Zalviso 15 mikrograma sublingvalne tablete
English: Zalviso 15 micrograms sublingual tablets Sufentanil
Croatian: Zalviso 15 mikrograma sublingvalne tablete sufentanil
English: After removing from the sachet, the cartridge should be placed into the Zalviso administration device immediately.
Croatian: Nakon uklanjanja vrećice potrebno je odmah staviti uložak u Zalviso napravu za primjenu lijeka.
English: The instructions for setting up the Zalviso administration device by a healthcare professional must be followed carefully.
Croatian: Zdravstveni radnici moraju pažljivo slijediti upute za pripremu Zalviso naprave za primjenu lijeka.
English: Sufentanil crosses the placenta.
Croatian: Sufentanil prolazi kroz posteljicu.
English: Place immediately into the Zalviso administration device after removal from sachet.
Croatian: Staviti u Zalviso napravu za primjenu lijeka odmah nakon što se izvadi iz vrećice.
English: Zalviso sublingual tablets are to be self-administered by the patient in response to pain using the Zalviso administration device.
Croatian: Bolesnici sami primjenjuju Zalviso sublingvalne tablete kao odgovor na bol upotrebom Zalviso naprave za primjenu lijeka.
English: Zalviso sublingual tablets contain the azo colouring agent sunset yellow FCF Aluminium Lake (E110), which may cause allergic reactions.
Croatian: Zalviso sublingvalne tablete sadrže azo boju sunset yellow FCF Aluminium Lake (E110) koje može prouzročiti alergijske reakcije.
English: Serotonergic agents
Croatian: Serotoninergički lijekovi
English: No special population studies were performed using sufentanil sublingual tablets in hepatic and renal impaired patients.
Croatian: Nisu provedena ispitivanja na posebnim populacijama primjenjujući sufentanil sublingvalne tablete u bolesnika s oštećenjem bubrega i jetre.
English: This compares to a substantially lower bioavailability of 9 % after oral intake (swallowed).
Croatian: U usporedbi s time bioraspoloživost nakon unosa kroz usta (progutano) bila je znatno niža i iznosila je 9%.
English: Zalviso should be administered with caution to patients with moderate to severe hepatic or severe renal impairment (see section 4.4).
Croatian: Zalviso se mora s oprezom primijeniti u bolesnika s umjerenim do teškim oštećenjem jetre ili teškim oštećenjem bubrega (vidjeti dio 4.4).
English: Impaired hepatic or renal function
Croatian: Oštećena funkcija jetre ili bubrega
English: The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related substances increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
Croatian: Istodobna primjena opioida s lijekovima za smirenje poput benzodiazepina ili srodnih lijekova povećava rizik od sedacije, respiratorne depresije, kome i smrti zbog aditivnog učinka depresora središnjeg živčanog sustava.
English: Zalviso is to be administered in a hospital setting only.
Croatian: Zalviso se smije primijenjivati samo u bolničkom okruženju.
English: Zalviso sublingual tablets are available in pack sizes of 1, 10 and 20 cartridges and in multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Croatian: Zalviso sublingvalne tablete su dostupne u pakiranjima od 1, 10 i 20 uložaka te višestrukim pakiranjima koja sadrže 40 (2 pakiranja od 20), 60 (3 pakiranja od 20) i 100 (5 pakiranja od 20) uložaka što odgovara 40, 400, 800, 1600, 2400 odnosno 4000 sublingvalnih tableta.
English: Concomitant use of Zalviso and sedating medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.
Croatian: Istodobna primjena lijeka Zalviso i lijekova za smirenje poput benzodiazepina ili srodnih lijekova povećava rizik od omamljenosti, poteškoća u disanju (respiratorne depresije), kome te može biti opasno za život.
English: Zalviso is available in pack sizes of 1 and 10, 20 cartridges and multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Croatian: Zalviso je dostupan u pakiranjima od 1, 10 i 20 uložaka te višestrukim pakiranjima koja sadrže 40 (2 pakiranja od 20), 60 (3 pakiranja od 20) i 100 (5 pakiranja od 20) uložaka što odgovara 40, 400, 800, 1600, 2400 odnosno 4000 sublingvalnih tableta.
English: 1 cartridge of 40 sublingual tablets
Croatian: 1 uložak od 40 sublingvalnih tableta
English: Zalviso contains sodium Zalviso contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Croatian: Zalviso sadrži natrij Zalviso sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: Contains sunset yellow FCF Aluminium Lake (E110), contains sodium.
Croatian: Sadrži boju sunset yellow FCF Aluminium Lake (E110), sadrži natrij.
English: Alameda Fernão Lopes, 12-8.º A P-1495 - 190 Algés Tel: +351 / 214 72 63 00
Croatian: A P-1495 - 190 Algés Tel: +351 / 214 72 63 00
English: Sufentanil passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended when you take Zalviso.
Croatian: Sufentanil prolazi u majčino mlijeko i može uzrokovati nuspojave u dojenom djetetu.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva svrbež hiperhidroza osip suha koža*
English: What Zalviso looks like and contents of the pack Zalviso sublingual tablets are orange-coloured flat-faced tablets with rounded edges.
Croatian: Zalviso sublingvalne tablete su narančasto obojene plosnate tablete sa zaobljenim rubovima.
English: Chills Asthenia
Croatian: Stariji bolesnici
English: Very rare Not known Cannot be estimated from the available data
Croatian: ≥ 1/10 000 i < 1/1000 vrlo rijetko (< 1/10 000) nepoznato ne može se procijeniti iz dostupnih podataka
English: Posology
Croatian: ULOŽAK
English: EU/1/15/1042/004
Croatian: EU/1/15/1042/001 EU/1/15/1042/002 EU/1/15/1042/003 EU/1/15/1042/004 EU/1/15/1042/005 EU/1/15/1042/006
English: Multipack: 1600 sublingual tablets [40 (2 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 2400 sublingual tablets [60 (3 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 4000 sublingual tablets [100 (5 packs of 20) cartridges of 40 sublingual tablets each]
Croatian: Višestruko pakiranje: 1600 sublingvalnih tableta [40 (2 pakiranja od 20) uložaka od po 40 sublingvalnih tableta]
English: To be used only with the Zalviso administration device.
Croatian: Samo za primjenu pomoću Zalviso naprave za primjenu lijeka.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja respiracijska depresija apneja respiracijski arest
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva nevoljni grčevi mišića trzanje mišića*
English: Calcium hydrogen phosphate, anhydrous Hypromellose
Croatian: 6.1 Popis pomoćnih tvari manitol (E421) kalcijev hidrogenfosfat, bezvodni hipromeloza karmelozanatrij, umrežena stearatna kiselina magnezijev stearat
English: Nervous system disorders
Croatian: Poremećaji bubrega i mokraćnog sustava zadržavanje mokraće
English: Involuntary muscle spasms
Croatian: Poremećaji oka poremećaji vida mioza
English: Gastrointestinal effects
Croatian: Učinci na probavni sustav
English: Nausea Vomiting
Croatian: Prijavljivanje nuspojava
English: • Summary of Product Characteristics (SmPC) and Package Leaflet
Croatian: • Sažetak opisa svojstava lijeka i Uputa o lijeku
English: LABELLING AND PACKAGE LEAFLET
Croatian: Kako Zalviso izgleda i sadržaj pakiranja
English: What are the steps?
Croatian: Koji su koraci?
English: Date of first authorisation: 12 May 2016
Croatian: Datum prvog odobrenja: 12. svibnja 2016
English: The relevance for humans is not known.
Croatian: Važnost za ljude nije poznata.