FrancophonIA/ELRC3.0 huggingface dataset:
English: Dzuveo is to be administered by a healthcare professional from a disposable single-dose applicator (see section 6.6).
Croatian: Dzuveo treba davati zdravstveni radnik isključivo iz jednokratnog aplikatora za jednu dozu (vidjeti dio 6.6.).
English: Following either a single dose or multiple doses hourly over 12 hours, the median CST½ remained 2.3 hours: the sublingual delivery route thus substantially extends the duration of action associated with intravenous sufentanil administration (CST½ of 0.1 hours).
Croatian: Nakon jednokratne doze ili višestrukih doza svaki sat tijekom 12 sati, medijan CST½ -a ostao je 2,3 sata: stoga, sublingvalni način primjene doza znatno produljuje trajanje djelovanja povezanog s intravenskom primjenom sufentanila (CST½ od 0,1 sati).
English: Do not chew or swallow the tablet.
Croatian: Nemojte žvakati niti progutati tabletu.
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: Kardiovaskularni učinci Male doze intravenskog sufentanila povezana s vjerojatnošću vagalne (kolinergičke) aktivnosti uzrokuju blagu bradikardiju i blago smanjenu sistemsku vaskularnu otpornost bez značajnog snižavanja krvnog tlaka (vidjeti dio 4.4.).
English: - Other medicines which are also taken sublingually (placed under the tongue where they dissolve) or medicines which 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 Dzuveo has not been studied.
Croatian: Drugi lijekovi koji se uzimaju sublingvalno (stavljeni pod jezik gdje se otapaju) ili lijekovi koji djeluju u ustima (npr. nistatin, tekućina ili pastile koje držite u ustima radi liječenja gljivičnih infekcija), jer nije ispitan učinak na Dzuveo.
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Croatian: Sufentanil može uzrokovati respiratornu depresiju čiji je stupanj/težina povezan s dozom.
English: The duration of activity may be prolonged in patients with severe hepatic and renal impairment.
Croatian: Trajanje aktivnosti može se produžiti u bolesnika s teškim oštećenjem funkcije jetre i bubrega.
English: Analgesic doses of sufentanil resulted in respiratory depressive effects in some patients in the clinical trials, however, no patient treated with Dzuveo required use of an opioid reversal drug (e.g. naloxone).
Croatian: Analgezijske doze sufentanila rezultirale su učincima respiratorne depresije u nekih bolesnika u kliničkim ispitivanjima, međutim kod nijednog bolesnika liječenog lijekom Dzuveo nije bila potrebna primjena lijeka za reverziju opioidnog učinka (npr. naloksona).
English: Agitation Apathy Conversion disorder Disorientation Euphoric mood Hallucination Mental status changes Nervousness
Croatian: Agitacija Apatija Konverzivni poremećaj Dezorijentacija Euforično raspoloženje Halucinacija Promjene mentalnog stanja
English: Administer product immediately after opening pouch.
Croatian: Primijenite lijek odmah nakon otvaranja vrećice.
English: Do not use if the Single Dose Applicator (SDA) is damaged Instruct the patient to not chew or swallow the tablet.
Croatian: Ne upotrebljavajte ako je aplikator za jednu dozu oštećen Uputite bolesnika da ne žvače i ne proguta tabletu.
English: Dzuveo should only be prescribed and administered by healthcare professionals who are experienced in the management of opioid therapy; particularly opioid adverse reactions, such as respiratory depression (see section 4.4).
Croatian: Dzuveo smiju propisivati i davati samo zdravstveni radnici s iskustvom upravljanja opioidnom terapijom, posebice nuspojavama opioida, kao što je respiratorna depresija (vidjeti dio 4.4).
English: In a study of a sufentanil 15 microgram sublingual tablet (with the same formulation as the 30 microgram tablet), a substantially lower bioavailability of 9% after oral intake (swallowed) was observed.
Croatian: U ispitivanju sa sublingvalnom tabletom sufentanila od 15 mikrograma (s jednakom formulacijom kao i u tableti od 30 mikrograma), uočena je znatno manja bioraspoloživost od 9 % nakon peroralnog unosa (gutanja).
English: Lower pregnancy rates were noted following treatment of males suggesting the potential for an adverse effect on fertility in males.
Croatian: Niže stope trudnoće zabilježene su nakon liječenja muških jedinki što upućuje na mogućnost štetnog učinka na plodnost u muških jedinki.
English: Sufentanil may obscure the clinical course of patients with head injury.
Croatian: Sufentanil može prikriti klinički tijek u bolesnika s ozljedom glave.
English: Store in original package to protect from light and oxygen.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti i kisika.
English: Therefore, it should be used with caution in patients with previous or pre-existing bradyarrhythmias.
Croatian: Stoga se savjetuje oprez pri primjeni u bolesnika s prethodnim ili postojećim bradiaritmijama.
English: Increased resorption of foetuses and reduced litter size was noted in the high dose females suggesting the potential for foetotoxicity, likely due to maternal toxicity.
Croatian: Povišena resorpcija fetusa i smanjena veličina legla zabilježena je u ženki koje su primale velike doze, što upućuje na mogućnost fetotoksičnosti, vjerojatno zbog toksičnosti za majku.
English: Dzuveo is packaged in a polypropylene single-dose applicator, which is packaged in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.
Croatian: Dzuveo se pakira u polipropilenski aplikator za jednu dozu, koji se pakira u vrećicu od poliesterske folije/LDPE/aluminijske folije/LDPE s apsorberom kisika.
English: The most commonly reported adverse reactions seen in clinical trials and from post marketing experience with sufentanil containing products were nausea, vomiting and pyrexia (≥1/10 patients) (see section 4.4).
Croatian: Najčešće zabilježene nuspojave lijekova koji sadržavaju sufentanil u kliničkim ispitivanjima i na temelju iskustva nakon stavljanja na tržište su mučnina, povraćanje i pireksija (≥ 1/10 bolesnika) (vidjeti dio 4.4.).
English: - Decreased heart rate, irregular heartbeat, angina or other chest discomfort.
Croatian: - Smanjena brzina srca, nepravilni otkucaji srca, angina ili druga nelagoda u prsnom košu.
English: - Any medicines which might make you sleepy (have a sedative effect), such as sleeping pills, medicines to treat anxiety (e.g. benzodiazipines), tranquillisers or other opioid medicines, as they can increase the risk of severe breathing problems, coma and may be life-threatening.
Croatian: - Bilo koji lijek koji vas može učiniti pospanima (ima sedativni učinak), kao što su tablete za spavanje, lijekovi za liječenje tjeskobe (npr. benzodiazepini), trankvilizatori ili drugi opioidni lijekovi jer mogu povećati rizik od teških problema s disanjem, uzrokovati komu te mogu biti opasni po život.
English: The applicator is used as a placement aid for the healthcare professional to deliver the tablet under the tongue, on an as needed basis, per patient request, with a minimum of 1 hour between doses.
Croatian: Aplikator zdravstvenom radniku služi kao pomagalo za stavljanje tablete pod jezik, prema potrebi i zahtjevu bolesnika, pri čemu između doza treba proći najmanje jedan sat.
English: Concomitant use of sufentanil and sedative medicines such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Croatian: Istodobna uporaba sufentanila i sedativnih lijekova, kao što su benzodiazepini ili srodni lijekovi, može dovesti do sedacije, respiratorne depresije, kome i smrti.
English: It is not recommended to use these medicines at the same time as Dzuveo.
Croatian: Ne preporučuje se istodobna primjena tih lijekova i lijeka Dzuveo.
English: Monoamine Oxidase Inhibitors must not be taken in the 2 weeks before or at the same time as Dzuveo is given.
Croatian: Inhibitori monoaminooksidaze ne smiju se uzimati dva tjedna prije primjene lijeka Dzuveo ni tijekom primjene lijeka Dzuveo.
English: The most serious adverse reaction of sufentanil is respiratory depression, which occurred at a rate of 0.6% in sufentanil clinical trials.
Croatian: Najozbiljnija nuspojava sufentanila je respiratorna depresija, koja je u kliničkim ispitivanjima sufentanila bila prisutna u stopi od 0,6 %.
English: Blue-coloured flat-faced tablet with round edges and a diameter of 3 mm.
Croatian: Plosnata tableta plave boje sa zaobljenim rubovima i promjerom 3 mm.
English: The pharmacokinetics of sufentanil after administration of Dzuveo can be described as a twocompartment model with first-order absorption.
Croatian: Farmakokinetika sufentanila nakon primjene lijeka Dzuveo može se opisati kao dvodijelni model s apsorpcijom prvog reda.
English: The frequencies are defined as:
Croatian: Učestalost se određuje kako slijedi:
English: Management of sufentanil overdose should be focused on treating symptoms of μ-opioid receptor agonism, including administration of oxygen.
Croatian: Liječenje predoziranja sufentanilom treba biti usmjereno na liječenje simptoma agonizma μopioidnih receptora, uključujući davanje kisika.
English: Contents of the pouch are shown below:
Croatian: Sadržaj vrećice prikazan je u nastavku:
English: Analgesia
Croatian: Analgezija
English: Common side effects (may affect up to 1 in 10 people): - Inability or difficulty sleeping, feeling anxious or confused, dizziness.
Croatian: Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba): - Nemogućnost spavanja ili poteškoće pri spavanju, osjećaj tjeskobe ili zbunjenosti, omaglica.
English: Patients requested dosing with Dzuveo to maintain plasma sufentanil concentrations averaging 40- 50 pg/ml at 12 hours, with no effect based on age or body mass index (BMI), or mild to moderate renal or liver impairment.
Croatian: Bolesnici su tražili doziranje lijekom Dzuveo koje održava koncentraciju sufentanila u plazmi u prosjeku od 40 - 50 pg/ml u 12 sati, bez učinka utemeljenog na dobi ili indeksu tjelesne mase (ITM) ili blagom do umjerenom oštećenju funkcije bubrega ili jetre.
English: Dzuveo should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Croatian: Dzuveo se ne smije uzimati tijekom trudnoće niti ga smiju koristiti žene reproduktivne dobi koje ne upotrebljavaju učinkovitu kontracepciju.
English: This route of administration results in higher absolute bioavailability than oral (swallowed) administration by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Croatian: Ovim putem primjene dolazi do veće apsolutne bioraspoloživosti nego peroralnom primjenom (gutanjem), izbjegavanjem intestinalnog metabolizma i metabolizma prvog prolaska kroz jetru putem enzima CYP3A4.
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 središnjeg živčanog sustava kako bi se izmijenili procesi koji utječu na percepciju i odgovor na bol.
English: Only limited data are available for the use of sufentanil in such patients.
Croatian: Dostupni su samo ograničeni podatci o primjeni sufentanila u tih bolesnika.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Propak Health Ltd
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Propak Health Ltd.
English: Sufentanil is a synthetic, potent opioid with highly selective binding to μ-opioid receptors.
Croatian: Sufentanil je sintetički, snažan opioid s izrazito selektivnim vezivanjem na μ-opioidne receptore.
English: Instruct the patient to not chew or swallow the tablet.
Croatian: Uputite bolesnika da ne žvače i ne proguta tabletu.
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 funkcije jetre, možda nije bio zabilježen potencijalni učinak disfunkcije jetre kao kovarijate za klirens.
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 krutost mišića, vjerojatno kao posljedica utjecaja na crnu tvar i striatnu jezgru.
English: Patients should not eat or drink and should minimise talking for 10 minutes after each dose of sufentanil 30 mcg sublingual tablet.
Croatian: Bolesnici ne smiju jesti niti piti te trebaju što manje govoriti tijekom 10 minuta nakon svake doze sufentanila u obliku sublingvalne tablete od 30 μg.
English: The respiratory effects of sufentanil should be assessed by clinical monitoring, e.g. respiratory rate, sedation level and oxygen saturation.
Croatian: Respiratorne učinke sufentanila potrebno je procijeniti kliničkim praćenjem, npr. brzine disanja, razine sedacije i zasićenosti kisikom.
English: Patients on chronic opioid therapy or opioid addicts may require higher analgesic doses than contained in Dzuveo.
Croatian: U bolesnika s kroničnom opioidnom terapijom ili ovisnika o opioidima mogu biti potrebne veće analgetske doze od one koju sadrži lijek Dzuveo.
English: Sufentanil is excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.
Croatian: Sufentanil se izlučuje u majčino mlijeko do te mjere da su izgledni učinci na novorođenčad/dojenčad.
English: With administration of Dzuveo, clinical duration of analgesia is largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50% of Cmax after discontinuation of dosing (context sensitive half-time or CST½) rather than by the terminal half-life.
Croatian: Uz primjenu lijeka Dzuveo, kliničko trajanje analgezije je u velikoj mjeri određeno vremenom koje je potrebno da se koncentracija sufentanila u plazmi smanji od Cmax do 50 % Cmax-a nakon prekida doziranja (poluvijek ovisan o kontekstu ili CST½, engl. context sensitive half-time), a ne terminalnim poluvijekom.
English: - The other ingredient(s) are mannitol (E421), dicalcium phosphate, hypromellose, croscarmellose sodium, Indigo Carmine (E132), stearic acid, and magnesium stearate.
Croatian: - Drugi sastojci su manitol (E421), kalcijev hidrogenfosfat, hipromeloza, karmelozanatrij, umrežena, boja Indigo Carmine (E132), stearinska kiselina i magnezijev stearat.
English: Convulsions Coma
Croatian: Konvulzije Koma
English: Sufentanil is primarily metabolised in the liver and excreted in the urine and faeces.
Croatian: Sufentanil se prvenstveno metabolizira u jetri te se izlučuje u urinu i izmetu.
English: Analgesic plasma concentrations of sufentanil may provoke nausea and vomiting by irritation of the chemoreceptor trigger zone.
Croatian: Analgezijske koncentracije sufentanila u plazmi mogu izazvati mučninu i povraćanje iritacijom kemoreceptorske okidačke zone.
English: No pharmacokinetic data exist for sufentanil in paediatric patients.
Croatian: Nema farmakokinetičkih podataka za sufentanil u pedijatrijskih bolesnika.
English: The efficacy of Dzuveo was evaluated in two double-blind, placebo-controlled trials involving 221 patients with moderate-to-severe acute postoperative pain (pain intensity of ≥ 4 on a 0-10 scale) after abdominal (studied up to 48-hours) or orthopedic (bunionectomy) surgery (studied up to 12 hours).
Croatian: Djelotvornost lijeka Dzuveo procijenjena je u dva dvostruko slijepa, placebom kontrolirana ispitivanja koja su uključivala 221 bolesnika s umjerenom do teškom akutnom postoperativnom boli (intenzitet boli ≥ 4 na ljestvici od 0 do 10) nakon operacije abdomena (praćena do 48 sati) ili ortopedske operacije (operacija čukljeva) (praćena do 12 sati).
English: Instruct the patient to not eat or drink and minimize talking for 10 minutes after receiving the tablet.
Croatian: Uputite bolesnika da ne jede i ne pije te da što manje govori tijekom 10 minuta nakon uzimanja tablete.
English: The incidence and degree of bradycardia and hypotension with sufentanil may be greater in patients on chronic calcium channel and/or beta blocker therapy.
Croatian: Incidencija i stupanj bradikardije i hipotenzije sa sufentanilom mogu biti veći u bolesnika s kroničnom terapijom blokatorima kalcijevih kanala ili beta blokatorima.
English: Place the SDA tip under the tongue and aim at the floor of the patient's mouth.
Croatian: Postavite aplikator za jednu dozu ispod jezika i ciljajte dno usta bolesnika.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih se radnika traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog
English: Population pharmacokinetic analysis with weight as a covariate showed that patients with a higher BMI dosed more frequently.
Croatian: Analiza populacijske farmakokinetike s težinom kao kovarijatom pokazala je da su bolesnici s višim ITM-om primali učestalije doze.
English: Direct effects of sufentanil on myocardial function were not observed.
Croatian: Nisu zapaženi izravni učinci sufentanila na funkciju miokarda.
English: Sufentanil is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se primjena sufentanila tijekom trudnoće i u žena u reproduktivnoj dobi koje ne upotrebljavaju kontracepciju.
English: Do not use if the Single Dose Applicator (SDA) is damaged.
Croatian: Ne upotrebljavajte ako je aplikator za jednu dozu oštećen.
English: Therefore, Dzuveo should be used with caution in such patients (see section 4.4).
Croatian: Stoga Dzuveo treba oprezno primjenjivati u takvih bolesnika (vidjeti dio 4.4.).
English: How to store Dzuveo
Croatian: Kako čuvati Dzuveo
English: Very rare <1/10,000 Not known Cannot be estimated from the available data.
Croatian: Nije poznato Ne može se procijeniti iz dostupnih podataka
English: 1 single-dose applicator containing 1 sublingual tablet.
Croatian: 1 aplikator za jednu dozu koji sadržava 1 sublingvalnu tabletu.
English: Rescue analgesia was allowed in both studies, with a higher proportion of patients in the placebo group requiring rescue medication due to inadequate analgesia (64.8%, 100%; abdominal, bunionectomy) than in the sufentanil group (27.1%, 70.0%;.
Croatian: U oba ispitivanja dopuštena je analgezija za hitno ublažavanje boli, s većim udjelom bolesnika u skupini koja je uzimala placebo kojima je bio potreban lijek za hitno ublažavanje boli zbog neodgovarajuće analgezije (64,8 %, 100 %, operacija abdomena, operacija čukljeva) nego u skupini koja je primala sufentanil (27,1 %, 70,0 %; operacija abdomena, operacija čukljeva).
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: However, elderly patients should be observed closely for adverse reactions of sufentanil (see section 5.2).
Croatian: Međutim, starije bolesnike treba pomno promatrati radi nuspojava sufentanila (vidjeti dio 5.2).
English: Insomnia Anxiety Confusional state
Croatian: Nesanica Anksioznost Stanje konfuzije
English: Each pouch contains one applicator and one sufentanil 30 micrograms tablet.
Croatian: Svaka vrećica sadržava jedan aplikator i jednu tabletu sufentanila od 30 mikrograma.
English: In both trials, the primary efficacy endpoint was the time-weighted sum of pain intensity difference (SPID) to baseline (measured on an 11-point NRS) over 12 hours (SPID12).
Croatian: U oba je ispitivanja primarna mjera ishoda djelotvornosti bio vremenski ponderirani zbroj razlike intenziteta boli (engl. sum of pain intensity difference, SPID) prema početnoj vrijednosti (izmjeren na brojčanoj ljestvici s 11 točaka) tijekom 12 sati (SPID12).
English: - Swelling, uncomfortable sensations in your chest, chills, and weakness (lack of energy).
Croatian: - Oticanje, neugodni osjećaji u prsnom košu, zimica i slabost (nedostatak energije).
English: - Developing blisters, excessive sweating, rash, dry skinnumbness of mouth or face.
Croatian: - Nastajanje plikova, pretjerano znojenje, osip, suha koža, utrnulost usta ili lica.
English: The concomitant use of CNS depressants including barbiturates, benzodiazepines, neuroleptics or other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance respiratory depression.
Croatian: Istodobna primjena depresora središnjeg živčanog sustava, uključujući barbiturate, benzodiazepine, neuroleptike ili druge opioide, halogene plinove ili druge neselektivne depresore središnjeg živčanog sustava (npr. alkohol) može pojačati respiratornu depresiju.
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 u kliničkim ispitivanjima ili nakon stavljanja na tržište s drugim lijekovima koji sadržavaju sufentanil nalaze se u tablici u nastavku.
English: Talk to your doctor or nurse before using Dzuveo.
Croatian: Upozorenja i mjere opreza Obratite se svojem liječniku ili medicinskoj sestri prije nego primijenite Dzuveo.
English: Keep out of reach and sight of children.
Croatian: Čuvati izvan pogleda i dohvata djece.
English: Hypotension Hypertension
Croatian: Hipotenzija Hipertenzija
English: The active substance of Dzuveo is sufentanil, which belongs to a group of strong painkillers called opioids.
Croatian: Djelatna tvar lijeka Dzuveo je sufentanil, koji se ubraja u skupinu snažnih lijekova protiv bolova pod nazivom opioidi.
English: Respiratory Depression
Croatian: Respiratorna depresija
English: INFORMATION IN BRAILLE
Croatian: 16. PODATCI NA BRAILLEOVOM PISMU
English: Interaction with cytochrome P450-3A4 enzyme
Croatian: Interakcije s enzimom citokrom P450-3A4
English: Electrocardiogram abnormal
Croatian: Elektrokardiogram Tvala abnormalan Elektrokardiogram abnormalan
English: For sublingual use only.
Croatian: Samo za sublingvalnu primjenu.
English: When considering the use of sufentanil in a patient taking a CNS depressant, the duration of use of the CNS depressant and the patient's response should be assessed, including the degree of tolerance that has developed to CNS depression.
Croatian: Pri razmatranju primjene sufentanila u bolesnika koji uzimaju depresor središnjeg živčanog sustava, potrebno je procijeniti trajanje primjene depresora središnjeg živčanog sustava i odgovor bolesnika na lijek, uključujući stupanj tolerancije koja se razvila na depresiju središnjeg živčanog sustava.
English: If the decision to begin sufentanil is made, the patient should be closely monitored and a lower dose of the concomitant CNS depressant should be considered.
Croatian: Ako se donese odluka o početku primjene sufentanila, potrebno je pažljivo pratiti bolesnika i razmotriti propisivanje manje doze istodobno primijenjenog depresora središnjeg živčanog sustava.
English: Patients should only drive and use machines if sufficient time has elapsed after the last administration of sufentanil.
Croatian: Bolesnici smiju voziti i raditi sa strojevima samo ako je proteklo dovoljno vremena od posljednje primjene sufentanila.