FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Posebice obavijestite svog liječnika ako uzimate bilo što od sljedećeg: - Bilo koje lijekove koji mogu utjecati na način na koji Vaše tijelo razgrađuje Zalviso npr. ketokonazol, koji se upotrebljava za liječenje gljivičnih infekcija.
English: Immeuble Eurêka 19 rue Ernest Renan CS 90001
Croatian: Laboratoires Grünenthal SAS Immeuble Eurêka 19 rue Ernest Renan CS 90001
English: Sufentanil is rapidly metabolised to a number of inactive metabolites, with oxidative N- and O-dealkylation being the major routes of elimination.
Croatian: Sufentanil se vrlo brzo metabolizira u brojne neaktivne metabolite pri čemu su oksidativna N- i O-dealkilacija glavni putevi eliminacije.
English: Abuse potential and tolerance
Croatian: Potencijal za zloupotrebu i podnošljivost lijeka
English: Prior to launch of Zalviso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja Zalvisa u promet u svakoj državi članici nositelj odobrenja mora s nacionalnim nadležnim tijelom usuglasiti sadržaj i oblik edukacijskog programa, uključujući medije komunikacije, načine distribucije i sve druge aspekte programa.
English: Do not crush, chew, or swallow the tablet.
Croatian: Nemojte drobiti, žvakati ili progutati tabletu.
English: Tell your doctor or nurse before treatment if you: - are suffering from any condition that affects your breathing (such as asthma, wheezing, or shortness of breath).
Croatian: Obavijestite svog liječnika ili medicinsku sestru prije liječenja ako: - patite od bilo kojeg stanja koje utječe na Vaše disanje (poput astme, piskanja u plućima ili nedostatka zraka).
English: Patients at higher risk are those with respiratory impairment or reduced respiratory reserve.
Croatian: Bolesnici s višim rizikom su oni koji imaju oštećenje dišnog sustava ili smanjenu respiratornu rezervu.
English: Very common side effects (may affect more than 1 in 10 people): nausea, vomiting, fever.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): mučnina, povraćanje, vrućica.
English: Lot see page 1 Lot see reverse
Croatian: Lot vidjeti stranicu 1 Lot vidjeti na poleđini.
English: The embryolethal effect was considered secondary to the toxicity for the mother animal.
Croatian: Embrioletalni učinak se smatrao sekundarnim naspram toksičnosti za skotnu ženku.
English: There are no data on the effects of sufentanil on fertility in women or men.
Croatian: Nema podataka o učincima sufentanila na plodnost u žena ili muškaraca.
English: The health-care professional should take into consideration the ability (e. g. visual or cognitive) of the patient to use the device appropriately.
Croatian: Nužno je da zdravstveni radnik uzme u obzir sposobnost bolesnika (npr. vizualnu ili kognitivnu) da odgovarajuće upotrijebi napravu.
English: It can increase the risk of experiencing severe breathing problems.
Croatian: To može povećati rizik od nastanka teških problema s disanjem.
English: Because of this, concomitant use should only be considered when other treatment options are not possible.
Croatian: Zbog toga istodobnu primjenu treba razmatrati samo kada nisu moguće alternativne metode liječenja.
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).
Croatian: Svaka promjena u djelotvornosti/podnošljivosti povezanoj s povećanom izloženošću kompenzirat će se u praksi promjenom u učestalosti doziranja (vidjeti dio 4.2).
English: Before you start using Zalviso, your doctor or nurse will show you how to use the Zalviso administration device.
Croatian: Prije nego počnete uzimati Zalviso, Vaš liječnik ili medicinska sestra pokazat će Vam kako upotrebljavati Zalviso napravu za primjenu lijeka.
English: The total plasma clearance after single intravenous administration is about 917 l/min.
Croatian: Ukupni klirens plazme nakon jednokratne intravenske primjene iznosi oko 917 l/min.
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Croatian: Ovisno o osjetljivosti bolesnika klinička slika je određena stupnjem respiracijske depresije.
English: In humans the potency is 7 to 10-fold higher than fentanyl and 500 to 1,000-fold higher than morphine (per oral).
Croatian: U ljudi je potentnost 7 do 10 puta veća u odnosu na fentanil, a 500 do 1000 puta veća u odnosu na morfin (kroz usta).
English: The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
Croatian: Bolesnike je potrebno pomno nadzirati na znakove i simptome respiratorne depresije i sedacije.
English: Pharmacotherapeutic group: Opioid anaesthetics, ATC Code: N01AH03
Croatian: Farmakoterapijska skupina: Opioidni anestetici, ATK oznaka: N01AH03
English: The shorter duration of activity of the opiate antagonist compared to sufentanil should be taken into account.
Croatian: Potrebno je razmotriti kraće trajanje aktivnosti opijatnog antagonista u usporedbi sa sufentanilom.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: There is insufficient data on the use of sufentanil during human pregnancy to evaluate its potential harmful effects.
Croatian: Nema dovoljno podataka o primjeni sufentanila tijekom trudnoće kako bi se procijenili njegovi potencijalni štetni učinci.
English: In the event of repeated maximal usage by the patient, one cartridge will last for a period of 13 hours 20 minutes.
Croatian: U slučaju ponovljene maksimalne upotrebe od strane bolesnika, jedan uložak pokriva razdoblje od 13 sati i 20 minuta.
English: All effects of sufentanil can immediately and completely be blocked by administration of a specific antagonist such as naloxone.
Croatian: Svi učinci sufentanila mogu se neposredno i potpuno blokirati primjenom specifičnog antagonista poput naloksona.
English: Maximum concentrations of sufentanil are achieved approximately 50 minutes after a single dose; this is shortened to approximately 20 minutes following repeat dosing.
Croatian: Maksimalne koncentracije sufentanila se postižu približno 50 minuta nakon jednokratne doze; to se skraćuje na približno 20 minuta nakon ponovljenog doziranja.
English: OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY
Croatian: VANJSKA NALJEPNICA (S PLAVIM OKVIROM) SAMO VIŠESTRUKA PAKIRANJA
English: Approximately 80 % of the intravenously administered dose of sufentanil is excreted within 24 hours.
Croatian: Približno 80% intravenski primijenjene doze sufentanila izlučuje se unutar 24 sata.
English: Repeat antagonist administration may be required as the duration of respiratory depression may last longer than the duration of the effect of the antagonist (see section 4.9).
Croatian: Može biti potrebna ponovljena primjena antagonista budući da respiracijska depresija može trajati duže od trajanja učinka antagonista (vidjeti dio 4.9).
English: The fully charged Zalviso administration device will operate without recharging for up to 72 hours.
Croatian: Potpuno napunjena Zalviso naprava za primjenu lijeka radit će bez punjenja u trajanju do 72 sata.
English: INTERMEDIATE CARTON COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: UNUTARNJA KUTIJA KAO DIO VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Please tell your doctor about all sedating medicines you are taking, and follow your doctor's dose recommendation closely.
Croatian: Obavijestite svog liječnika o svim lijekovima za smirenje koje uzimate te se pomno pridržavajte preporuka za doziranje svog liječnika.
English: In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Croatian: U tom smislu snažno preporučujemo da obavijestite bolesnike i njihove njegovatelje kako bi bili svjesni tih simptoma (vidjeti dio 4.5).
English: Respiratory depression caused by sufentanil can be reversed by opioid antagonists.
Croatian: Respiracijska depresija uzrokovana sufentanilom može se poništiti opioidnim antagonistima.
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.
Croatian: Budući da je smanjenje povezano s dobi manje od uočene interindividualne varijabilnosti od 30-40% u parametrima izloženosti za sufentanil, ovaj učinak se ne smatra klinički značajnim, naročito s obzirom na to da se Zalviso primjenjuje samo prema potrebi.
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.
Croatian: Središnji volumen distribucije nakon intravenske primjene sufentanila iznosi približno 14 litara, a volumen distribucije u stanju dinamičke ravnoteže iznosi približno 350 litara.
English: The Ames test revealed no mutagenic activity of sufentanil.
Croatian: Amesov test nije otkrio mutagenu aktivnost sufentanila.
English: Any other waste material must be discarded in accordance to the institutional policies and local requirements.
Croatian: Sav preostali otpadni materijal mora se zbrinuti sukladno pravilnikom ustanove i lokalnim propisima.
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.
Croatian: - Druge lijekove koji se također uzimaju sublingvalno (lijekove koji se stavljaju ispod jezika gdje se otapaju) ili lijekove koji se razrjeđuju ili djeluju u Vašim ustima (npr. nistatin, tekući ili pastile koje držite u ustima kako bi se liječile gljivične infekcije), jer nije ispitan učinak na Zalviso.
English: Similar CST½ values were observed following both single and repeated administration demonstrating that there is a predictable and consistent duration of action after multiple dosing of the sublingual tablet.
Croatian: Slične vrijednosti CST½ uočene su nakon jednokratne i ponovljene primjene što pokazuje da postoji predvidivo i postojano trajanje djelovanja nakon višekratnog doziranja sublingvalne tablete.
English: Therefore, it should be used with caution in patients with previous or pre-existing bradyarrhythmias.
Croatian: Stoga se mora koristiti s oprezom u bolesnika s prethodnim ili postojećim bradiaritmijama.
English: Carcinogenicity studies have not been conducted on sufentanil.
Croatian: Ispitivanja karcinogenosti nisu provedena na sufentanilu.
English: You should not drive or operate machinery if you experience any of these symptoms whilst or after being treated with Zalviso.
Croatian: Ne smijete upravljati vozilima ili strojevima ako iskusite bilo koji od tih simptoma tijekom ili nakon liječenja Zalvisom.
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.
Croatian: Zalviso je dostupan u polikarbonatnom ulošku, koji sadrži po 40 sublingvalnih tableta i pakiran je u vrećici od poliesterskog filma/LDPE/aluminijske folije/LDPE sa sredstvom za apsorpciju kisika.
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 %.
Croatian: Ketokonazol, potentni inhibitor enzima CYP3A4, može značajno povećati sistemsku izloženost sublingvalnom sufentanilu (povećanje maksimalne razine u plazmi (Cmax) od 19%, povećanje ukupne izloženosti djelatnoj tvari (AUC) od 77%) i produljiti vrijeme za postizanje maksimalne koncentracije za 41%.
English: How to take Zalviso
Croatian: Kako uzimati Zalviso
English: There is limited pharmacokinetic data available in children after intravenous sufentanil administration.
Croatian: Dostupni su ograničeni farmakokinetički podaci u djece nakon intravenske primjene sufentanila.
English: Respiratory depression
Croatian: Respiracijska depresija
English: As demonstrated in the active-controlled trial, the average time between Zalviso doses was approximately double as long as compared to intravenous morphine patient-controlled analgesia (approximately 80 minutes compared to approximately 45 minutes) over the first 48 hours.
Croatian: Kao što je pokazano u aktivno kontroliranom ispitivanju, prosječno vrijeme između doza lijeka Zalviso bilo je približno dvostruko duže u odnosu na analgeziju koju bolesnici kontroliraju intravenskim morfinom (približno 80 minuta u usporedbi s približno 45 minuta) tijekom prvih 48 sati.
English: The tablets dissolve under your tongue and should not be crushed, chewed, or swallowed.
Croatian: Tablete se otapaju ispod Vašeg jezika i ne smiju se drobiti, žvakati ili progutati.
English: Each sublingual tablet contains 0.013 mg sodium.
Croatian: Jedna sublingvalna tableta sadrži 0,013 mg natrija.
English: Buccal administration study showed an increased bioavailability of 78 % when the tablets were placed in front of the front lower teeth.
Croatian: Ispitivanje bukalne primjene pokazalo je povećanu bioraspoloživost od 78% kada su se tablete stavile ispred prednjih donjih zubiju.
English: Only patients who are able to understand and follow the instructions to operate the administration device should use Zalviso.
Croatian: Samo bolesnici koji mogu razumijeti i slijediti upute za rukovanje napravom za primjenu lijeka smiju primijeniti Zalviso.
English: Other symptoms that may occur are loss of consciousness, coma, cardiovascular shock and muscle rigidity.
Croatian: Drugi simptomi koji se mogu pojaviti su gubitak svijesti, koma, kardiovaskularni šok i ukočenost mišića.
English: The duration of the concomitant use should be limited (see section 4.4).
Croatian: Potrebno je ograničiti trajanje istodobne primjene (vidjeti dio 4.4).
English: Sufentanil caused embryolethality in rats and rabbits who were treated for 10-30 days during pregnancy with 2.5 times the maximum human dose by intravenous administration.
Croatian: Sufentanil je uzrokovao embrioletalnost u štakora i kunića u kojih je tijekom 10-30 dana tijekom gravidnosti intravenski primjenjena doza 2,5 puta veća od maksimalne doze u ljudi.
English: Zalviso should not be used during pregnancy or if you are a woman of childbearing potential not using contraception.
Croatian: Zalviso se ne smije uzimati tijekom trudnoće ili ako ste žena u reproduktivnoj dobi koja ne koristi kontracepciju.
English: In the micronucleus test in female rats, single intravenous doses of sufentanil as high as 80 µg/kg (approximately 2.5 times the upper human intravenous dose) produced no structural chromosome mutations.
Croatian: U mikronukleusnom testu u ženki štakora jednokratna intravenska doza sufentanila u visini od 80 µg/kg (približno 2,5 puta vrijednosti gornje intravenske doze u ljudi) nije proizvela strukturalne mutacije kromosoma.
English: After a single dose, the median CST½ was 2.2 hours, increasing to a median value of 2.5 h after multiple dosing: the sublingual delivery route thus substantially extends the duration of action associated with intravenous sufentanil administration (CST½ of 0.14 hours).
Croatian: Nakon jednokratne doze medijan CST½ je iznosio 2,2 sata povećavajući se do vrijednosti medijana od 2,5 sati nakon višekratnog doziranja: sublingvalni put dostave se stoga značajno povećava tijekom djelovanja povezanog s intravenskom primjenom sufentanila (CST½ od 0,14 sati).
English: Clearance is not affected by race, sex, renal parameters, hepatic parameters, or concomitant CYP3A4 substrates.
Croatian: Na klirens ne utječu rasa, spol, bubrežni parametri, jetreni parametri ili istodobni supstrati enzima CYP3A4.
English: Sufentanil has been shown to induce opioid-like effects in a variety of laboratory animals (dogs, rats, guinea pigs, hamsters) at doses above those inducing analgesia and in two repeat-dose studies with sufentanil sublingual tablets administered buccally in Golden Syrian hamster.
Croatian: Pokazano je da sufentanil inducira učinke nalik opioidnim učincima u raznovrsnim laboratorijskim životinjama (psima, štakorima, zamorcima, hrčcima) pri dozama iznad onih koje induciraju analgeziju te u dva ispitivanja ponovljenih doza sufentanil sublingvalnih tableta koje su se bukalno primijenile u zlatnom sirijskom hrčku.
English: If a decision is made to prescribe Zalviso concomitantly with sedating medicinal products the duration of the concomitant treatment should be as short as possible.
Croatian: Ako je donesena odluka o propisivanju lijeka Zalviso istodobno s drugim lijekovima za smirenje, trajanje istodobnog liječenja treba biti što je kraće moguće.
English: Sufentanil may cause hypotension, especially in hypovolemic patients.
Croatian: Sufentanil može prouzročiti hipotenziju, naročito u bolesnika s hipovolemijom.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance while taking or after the treatment with Zalviso.
Croatian: Bolesnike je potrebno savjetovati da ne voze niti upravljaju strojevima ako osjećaju somnolenciju, omaglicu ili vizualnu smetnju tijekom uzimanja ili nakon liječenja Zalvisom.
English: Central nervous system (CNS) depressants
Croatian: Depresori središnjeg živčanog sustava (SŽS)
English: The maximum amount of sublingual sufentanil that can be delivered via the Zalviso administration device over an hour is 45 micrograms (3 doses).
Croatian: Maksimalna količina sublingvalnog sufentanila koja se može dostaviti pomoću Zalviso naprave za primjenu lijeka tijekom jednog sata iznosi 45 mikrograma (3 doze).
English: This should be considered when prescribing or administering sufentanil where there is concern about an increased risk of misuse, abuse or diversion.
Croatian: To je potrebno uzeti u obzir pri propisivanju ili primjeni sufentanila kada postoji zabrinutost zbog povećanog rizika od pogrešne primjene, zloupotrebe ili primjene u nedopuštene svrhe.
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).
Croatian: Ovaj lijek smiju propisati samo liječnici koji imaju iskustva u primjeni jakih lijekova protiv bolova poput Zalvisa i znaju koje učinke lijek može imati na Vas, naročito na Vaše disanje (vidjeti prethodno navedena „Upozorenja i mjere opreza“).
English: After treatment discontinuation the health-care professional has to remove the cartridge from the device and any unused and/or not completely empty cartridges have to be disposed by the health-care professional in accordance with local laws and requirements for controlled substances.
Croatian: Nakon prekida liječenja zdravstveni radnik mora ukloniti uložak iz naprave i zbrinuti svaki neupotrijebljen i/ili potpuno neispražnjen uložak sukladno lokalnim zakonima i zahtjevima za kontrolirane tvari.
English: Management of overdose should be focused on treating symptoms of µ-opioid receptor agonism including administration of oxygen.
Croatian: Zbrinjavanje predoziranja mora biti usmjereno na liječenje simptoma agonizma µ-opioidnih receptora uključujući primjenu kisika.
English: Zalviso affects your ability to drive or use machines as it may cause sleepiness, dizziness or visual disturbances.
Croatian: Zalviso utječe na Vašu sposobnost upravljanja vozilima ili rada sa strojevima jer može uzrokovati pospanost, omaglicu ili vizualne smetnje.
English: Pharmacokinetic data from intravenous sufentanil administration did not reveal age related differences.
Croatian: Farmakokinetički podaci iz intravenske primjene sufentanila nisu otkrili razlike povezane s dobi.
English: The pharmacokinetics of sufentanil after sublingual administration can be described as a threecompartment model with first-order absorption.
Croatian: Farmakokinetika sufentanila nakon sublingvalne primjene može se opisati kao model s tri odjeljka i apsorpcijom prvog reda.
English: Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza oznake EXP.
English: Due to the limited number of patients with moderate to severe hepatic impairment, a potential effect of hepatic dysfunction as covariate on clearance may not have been detected.
Croatian: Zbog ograničenog broja bolesnika s umjerenim do teškim oštećenjem jetre, potencijalan učinak disfunkcije jetre kao kovarijante na klirens možda nije bio otkriven.
English: What Zalviso contains - The active substance is sufentanil.
Croatian: Što Zalviso sadrži - Djelatna tvar je sufentanil.
English: An opiate antagonist (e.g. naloxone) should be administered in the event of respiratory depression.
Croatian: Opijatni antagonisti (npr. nalokson) moraju se primijeniti u slučaju respiracijske depresije.
English: It is not recommended to use these medicines at the same time as Zalviso.
Croatian: Ne preporučuje se istodobna primjena tih lijekova i lijeka Zalviso.
English: - Any medicines to treat anxiety, tranquillisers or other opioid medicines, as they can increase the risk of severe breathing problems.
Croatian: - Bilo koje lijekove za liječenje tjeskobe, lijekova za smirenje ili drugih opioidnih lijekova, jer mogu povećati rizik od nastanka teških problema s disanjem.
English: Do not take Zalviso: - if you are allergic to sufentanil or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Zalviso: - ako ste alergični na sufentanil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate teških problema s disanjem.
English: The most serious side effects are severe breathing problems like slow and shallow breathing, which may even lead to stopping breathing or inability to breathe.
Croatian: Najozbiljnije nuspojave su teški problemi s disanjem poput usporenog i plitkog disanja, koje može dovesti i do prestanka disanja ili nemogućnosti disanja.
English: Sufentanil should be used with caution in patients who may be particularly susceptible to the cerebral effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
Croatian: Sufentanil je potrebno koristiti s oprezom u bolesnika koji mogu biti naročito podložni učincima na mozgu uslijed zadržavanja CO2 poput bolesnika s dokazanim povećanim intrakranijalnim tlakom ili smanjenom sviješću.
English: Sufentanil may increase plasma serotonin level and its concomitant use with other serotoninergic agents may increase the risk of serotonin syndrome.
Croatian: Sufentanil može povisiti razinu serotonina u plazmi te njegova istodobna primjena s drugim serotoninergičkim lijekovima može povećati rizik od serotoninskog sindroma.
English: Some adverse reactions were not observed in the clinical trials with Zalviso.
Croatian: Neke nuspojave nisu bile uočene u kliničkim ispitivanjima Zalvisa.
English: 52078 Aachen Germany
Croatian: 52078 Aachen