FrancophonIA/ELRC3.0 huggingface dataset:
English: In the circumstance in which commencing with oral opioids is not considered possible and DUROGESIC is considered to be the only appropriate treatment option for opioid-naïve patients, only the lowest starting dose (ie, 12 mcg/h) should be considered.
Croatian: U okolnostima kada se smatra da nije moguće započeti liječenje oralnim opioidima i DUROGESIC se smatra jedinom prikladnom terapijskom opcijom za bolesnike koji prethodno nisu primali opioide,
English: Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section 4.5).
Croatian: Ne preporučuje se istodobna primjena buprenorfina, nalbufina ili pentazocina (vidjeti i dio 4.5).
English: • Some medicines used to treat heartburn or ulcers (such as cimetidine).
Croatian: • neke lijekove koji se koriste za liječenje žgaravice ili želučanog vrijeda (npr. cimetidin)
English: If concomitant use of DUROGESIC with a CYP3A4 inhibitor cannot be avoided, close monitoring for signs or symptoms of increased or prolonged therapeutic effects and adverse effects of fentanyl (in particular respiratory depression) is warranted, and the DUROGESIC dosage must be reduced or interrupted as deemed necessary (see section 4.5).
Croatian: Ako se istodobna primjena lijeka DUROGESIC i inhibitora CYP3A4 ne može izbjeći, potreban je pažljiv nadzor zbog mogućih znakova ili simptoma pojačanih ili produljenih terapijskih učinaka i nuspojava fentanila (osobito depresije disanja), te se doza lijeka DUROGESIC
English: Fold the sachet at the notch, then carefully tear the sachet material.
Croatian: Vrećicu treba presavinuti na mjestu zareza i zatim pažljivo otrgnuti preklopljeni dio.
English: It also crosses the placenta and is excreted in breast milk.
Croatian: Osim toga, prolazi i kroz posteljicu te se izlučuje u majčino mlijeko.
English: • Some medicines used to treat nausea or motion sickness (such as phenothiazines).
Croatian: • neke lijekove koji se koriste za liječenje mučnine ili bolesti vožnje (npr. fenotiazine)
English: After coadministration of weak, moderate or strong CYP3A4 inhibitors with short term intravenous fentanyl administration, decreases in fentanyl clearance were generally ≤25%,
Croatian: Nakon istodobne primjene slabih, umjerenih ili snažnih inhibitora CYP3A4 s kratkotrajnom intravenskom primjenom fentanila, klirens fentanila općenito se smanjio za ≤ 25%; međutim, uz ritonavir (snažan inhibitor CYP3A4), klirens fentanila u prosjeku se smanjio za 67%.
English: Tables 1, 2, and 3 should only be used to convert from other opioids to DUROGESIC and not from DUROGESIC to other therapies to avoid overestimating the new analgesic dose and potentially causing overdose.
Croatian: Kako bi se izbjeglo precjenjivanje nove analgetske doze i potencijalno predoziranje, Tablice 1, 2 i 3 smiju se koristiti samo pri prelasku s drugih opioida na DUROGESIC, a ne pri prelasku s lijeka DUROGESIC na druge lijekove.
English: The safety of DUROGESIC was evaluated in 1565 adult and 289 paediatric subjects who participated in 11 clinical studies (1 double-blind, placebo-controlled; 7 open-label, active-controlled; 3 open-label, uncontrolled) used for the management of chronic malignant or non-malignant pain.
Croatian: Sigurnost lijeka DUROGESIC ocjenjivala se kod 1565 odraslih i 289 pedijatrijskih ispitanika koji su sudjelovali u 11 kliničkih ispitivanja (1 dvostruko slijepo ispitivanje kontrolirano placebom;
English: • Nausea, vomiting, constipation
Croatian: • mučnina, povraćanje, zatvor
English: • Feeling extremely happy (euphoria)
Croatian: • osjećaj uznemirenosti ili dezorijentiranosti • osjećaj iznimne sreće (euforija)
English: • Muscle tremors or spasms
Croatian: • nevoljno drhtanje ili grčenje mišića
English: Some patients may experience significant respiratory depression with DUROGESIC; patients must be observed for these effects.
Croatian: Kod nekih bolesnika koji primjenjuju DUROGESIC može se razviti značajna depresija disanja te ih se zbog toga mora pažljivo nadzirati.
English: Application site reaction, Influenzalike illness, Feeling of body temperature change,
Croatian: osjećaj hladnoće reakcija na mjestu primjene, bolest nalik gripi, osjećaj promjene temperature tijela, preosjetljivost na mjestu primjene, sindrom ustezanja od lijeka, vrućica*
English: Use of DUROGESIC in the opioid-naïve patient has been associated with very rare cases of significant respiratory depression and/or fatality when used as initial opioid therapy, especially in patients with non-cancer pain.
Croatian: Bolesnici koji prethodno nisu primali opioide i bolesnici koji nisu tolerantni na opioide Primjena lijeka DUROGESIC kod bolesnika koji prethodno nisu primali opioide u vrlo je rijetkim slučajevima bila povezana sa značajnom depresijom disanja i/ili smrtnim ishodom kada se DUROGESIC koristio kao početna opioidna terapija, osobito u bolesnika s nekarcinomskom boli.
English: (see Table 2).
Croatian: (vidjeti dio 4.4).
English: Moreover, because fentanyl passes through the placenta, the use of DUROGESIC during childbirth might result in respiratory depression in the newborn infant.
Croatian: pa primjena lijeka DUROGESIC tijekom poroda može dovesti do depresije disanja kod novorođenčeta.
English: Insomnia, Depression, Anxiety,
Croatian: Psihijatrijski poremećaji nesanica, depresija, tjeskoba, smeteno stanje, halucinacije agitacija, dezorijentiranost
English: • Being short of breath (dyspnoea)
Croatian: • nedostatak zraka (dispneja)
English: You should not breastfeed for 3 days after removing your DUROGESIC patch.
Croatian: Ne smijete dojiti 3 dana nakon uklanjanja
English: Rare side effects (may affect up to 1 in 1000 people)
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba):
English: 0.4b tapentadol oral parenteral tramadol oral parenteral a The oral/IM potency for morphine is based on clinical experience in patients with chronic pain.
Croatian: Omjer jačine oralnog i intramuskularnog morfina temelji se na kliničkom iskustvu kod bolesnika s kroničnom boli.
English: Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Croatian: Ne preporučuje se istodobna primjena buprenorfina, nalbufina ili pentazocina.
English: This delay is due to the gradual increase in serum fentanyl concentration in the 24 hours following initial patch application.
Croatian: To je zato što nakon početne primjene flastera serumske koncentracije fentanila postupno rastu tijekom 24 sata.
English: • Inspect the patch for any damage
Croatian: • Provjerite da flaster nije oštećen
English: Marketing Authorization Holder and Manufacturer [See Annex I - To be completed nationally]
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač [Vidjeti Prilog I.
English: (frequency cannot be estimated from the available data.)
Croatian: To mogu biti znakovi teške alergijske reakcije. (učestalost se ne može procijeniti na temelju dostupnih podataka)
English: DUROGESIC is not recommended for use in patients who require the concomitant administration of an MAOI.
Croatian: Ne preporučuje se primjena lijeka DUROGESIC kod bolesnika kojima je potrebna istodobna primjena MAO inhibitora.
English: Then wash hands with clean water.
Croatian: Ne smiju se upotrijebiti flasteri koji su razrezani,
English: 30b pethidine oral parenteral
Croatian: 30b petidin peroralni parenteralni
English: How to use DUROGESIC
Croatian: Kako primjenjivati DUROGESIC
English: Eczema, Dermatitis allergic, Skin disorder,
Croatian: Poremećaji kože i potkožnog tkiva hiperhidroza, pruritus, osip, eritem ekcem, alergijski dermatitis, kožni poremećaj,
English: More about using DUROGESIC
Croatian: Više informacija o uporabi lijeka DUROGESIC
English: Table 2: Recommended starting dosage of DUROGESIC based upon daily oral morphine dose (for patients who have a need for opioid rotation or for clinically less stable patients: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 150:1) 1
Croatian: Tablica 2: Preporučena početna doza lijeka DUROGESIC koja se temelji na dnevnim dozama oralnog morfina (za bolesnike kod kojih postoji potreba za promjenom opioida ili koji su manje klinički stabilni: omjer konverzije oralnog morfina u transdermalni fentanil iznosi približno
English: Do no sunbathe, have long hot baths or saunas.
Croatian: Nemojte se sunčati, dugo se kupati u vrućoj vodi ni odlaziti u saunu.
English: Take special care with DUROGESIC
Croatian: Budite posebno oprezni s lijekom DUROGESIC
English: Calculate the 24-hour dose (mg/day) of the opioid currently being used.
Croatian: DUROGESIC treba slijediti korake u nastavku: 1. Izračunajte 24-satnu dozu (mg/dan) opioida koji se trenutno koristi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Transdermal Use
Croatian: NAČIN I PUT(OVI) PRIMJENE LIJEKA
English: Where to apply the patch
Croatian: Na koje mjesto treba primijeniti flaster Odrasli
English: PHARMACEUTICAL FORM Transdermal patch.
Croatian: OBLIK Transdermalni flaster.
English: • Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or verapamil).
Croatian: • lijekove koji se koriste za liječenje HIV infekcije (npr. ritonavir) • lijekove koji se koriste za liječenje nepravilnih otkucaja srca (npr. amiodaron, diltiazem ili verapamil)
English: Additional restrictions apply to opioid-naïve patients with renal impairment (see section 4.2).
Croatian: Dodatna ograničenja primjenjuju se u bolesnika s oštećenjem funkcije bubrega koji prethodno nisu primali opioide (vidjeti dio 4.2).
English: hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Croatian: • lijekove koji Vam pomažu da se smirite (trankvilizatore, kao što su alprazolam, klonazepam, diazepam, hidroksizin ili lorazepam) i lijekove za psihička stanja (antipsihotike, kao što su aripiprazol, haloperidol, olanzapin, risperidon ili fenotiazini)
English: Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (eg, hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhoea).
Croatian: komu), autonomnu nestabilnost (npr. tahikardiju, nestalan krvni tlak, hipertermiju), neuromuskularne poremećaje (npr. hiperrefleksiju, nekoordiniranost, rigidnost) i/ili gastrointestinalne simptome (npr. mučninu, povraćanje, proljev).
English: Abdominal pain, Abdominal pain upper, Dyspepsia
Croatian: konstipacija proljev, suha usta, bol u abdomenu, bol u gornjem dijelu abdomena, dispepsija ileus subileus
English: Anaphylactic reaction, Anaphylactoid reaction
Croatian: anafilaktička reakcija, anafilaktoidn a reakcija
English: To derive the DUROGESIC dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows: a. Table 2 is for adult patients who have a need for opioid rotation or who are less clinically stable (conversion ratio of oral morphine to transdermal fentanyl approximately equal to b. Table 3 is for adult patients who are on a stable, and well-tolerated, opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 100:1).
Croatian: Tablica 2 odnosi se na odrasle bolesnike kod kojih postoji potreba za promjenom opioida ili koji su manje klinički stabilni (omjer konverzije oralnog morfina u transdermalni fentanil iznosi približno 150:1) b. Tablica 3 odnosi se na odrasle bolesnike koji su na stabilnom i dobro podnošljivom režimu liječenja opioidima (omjer konverzije oralnog morfina u transdermalni fentanil iznosi približno 100:1)
English: All patients should be advised to avoid exposing the DUROGESIC application site to direct external heat sources such as heating pads, electric blankets, heated water beds, heat or tanning lamps, sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths.
Croatian: izravnim vanjskim izvorima topline, kao što su jastučići za zagrijavanje, električni pokrivači, zagrijani vodeni kreveti, lampe za grijanje ili sunčanje, sunčanje, termofori, dugotrajne vruće kupke, saune i vruće hidromasažne kade.
English: Table 4: Recommended DUROGESIC dosage for paediatric patients1 based upon daily oral morphine dose2
Croatian: Tablica 4: Preporučena doza lijeka DUROGESIC za pedijatrijske bolesnike1, koja se temelji na dnevnim dozama oralnog morfina2 24-satna doza oralnog morfina (mg/dan)
English: Elderly patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see section 4.4).
Croatian: Starije bolesnike treba pažljivo nadzirati zbog moguće pojave znakova toksičnosti fentanila te smanjiti dozu ako je potrebno (vidjeti dio 4.4).
English: • It may take some time for your first patch to have its maximum effect.
Croatian: • Možda će trebati neko vrijeme prije nego prvi flaster postigne maksimalan učinak • Liječnik će Vam možda propisati dodatne lijekove protiv boli za prvi dan
English: How to store DUROGESIC
Croatian: Kako čuvati DUROGESIC
English: Side effects and DUROGESIC
Croatian: Nuspojave i DUROGESIC
English: Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Croatian: Slično kao i drugi opioidni analgetici, fentanil je inducirao mutagene učinke u stanicama sisavaca in vitro.
English: What DUROGESIC is and what it is used for What you need to know before you use DUROGESIC How to use DUROGESIC
Croatian: Što je DUROGESIC i za što se koristi Naziv Vašeg lijeka je DUROGESIC.
English: Therefore, the product information of the CYP3A4 inhibitor must be consulted for the active substance's half-life and duration of the inhibitory effect before applying the first DUROGESIC patch.
Croatian: Stoga se prije primjene prvog DUROGESIC flastera moraju pročitati informacije o lijeku za inhibitor CYP3A4 kako bi se utvrdilo koliki su poluvijek i trajanje inhibicijskog učinka te djelatne tvari.
English: Table 3: Recommended starting dosage of DUROGESIC based upon daily oral morphine dosage (for patients on stable and well tolerated opioid therapy: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 100:1)
Croatian: Tablica 3: Preporučena početna doza lijeka DUROGESIC koja se temelji na na dnevnim dozama oralnog morfina (za bolesnike koji su na stabilnom i dobro podnošljivom režimu liječenja opioidima: omjer konverzije oralnog morfina u transdermalni fentanil iznosi približno 24-satna doza oralnog morfina (mg/dan)
English: The release liner for the patch is slit.
Croatian: Zaštitna folija na flasteru je prerezana napola.
English: DUROGESIC should not be administered to opioid-naïve paediatric patients (see section 4.2).
Croatian: Pedijatrijska populacija DUROGESIC se ne smije primjenjivati kod pedijatrijskih bolesnika koji prethodno nisu primali opioide (vidjeti dio 4.2).
English: If you, or your partner or carer, notice that the person wearing the patch is unusually drowsy, with slow or shallow breathing: - Take the patch off - Call a doctor, or go to your nearest hospital straight away - Keep the person moving and talking as much as possible
Croatian: Ako Vi, Vaš partner ili njegovatelj primijetite da je osoba koja nosi flaster neuobičajeno omamljena i da diše sporo ili plitko:
English: Do not use DUROGESIC if:
Croatian: Nemojte primjenjivati DUROGESIC
English: Palpitations, Tachycardia
Croatian: Srčani poremećaji palpitacije, tahikardija bradikardija, cijanoza
English: Patients with hepatic impairment should be observed carefully for signs of fentanyl toxicity and the dose of DUROGESIC should be reduced if necessary (see section 4.4).
Croatian: Bolesnike s oštećenjem jetrene funkcije treba pažljivo nadzirati zbog moguće pojave znakova toksičnosti fentanila te smanjiti dozu lijeka DUROGESIC ako je potrebno (vidjeti dio 4.4).
English: Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids.
Croatian: Kod opetovane primjene opioida mogu se razviti tolerancija te fizička i psihička ovisnost.
English: 15b methadone oral parenteral
Croatian: 15b metadon peroralni parenteralni b oksikodon peroralni parenteralni
English: Discontinuation of DUROGESIC
Croatian: Prekid primjene lijeka DUROGESIC
English: The polymer matrix and the diffusion of fentanyl through the layers of the skin ensure that the release rate is relatively constant.The concentration gradient existing between the system and the lower concentration in the skin drives drug release.
Croatian: Koncentracijski gradijent koji postoji između sustava i niže koncentracije u koži potiče otpuštanje lijeka.
English: How to dispose of used patches or patches you no longer use A used or unused patch accidentally sticking to another person, especially a child, may be fatal.
Croatian: Ako se upotrijebljeni i neupotrijebljeni flaster slučajno zalijepi na drugu osobu, osobito dijete, to može dovesti do smrtnog ishoda.
English: Do not use DUROGESIC after the expiry date which is stated on the carton and sachet.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici.
English: If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using DUROGESIC.
Croatian: Obavijestite svog liječnika ili stomatologa da uzimate DUROGESIC ako mislite da ćete primiti anesteziju.
English: Several days should elapse before a new patch is applied to the same area of the skin.
Croatian: Flaster se može ponovno primijeniti na isto područje na koži tek nakon nekoliko dana.
English: Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths.
Croatian: Izbjegavajte sunčanje, dugotrajne tople kupke, saune ili vruće hidromasažne kade jer u protivnom se može povećati količina lijeka koja se otpušta iz flastera.
English: If patients with renal impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Croatian: Ako se DUROGESIC primjenjuje kod bolesnika s oštećenjem bubrežne funkcije, treba ih pažljivo nadzirati zbog mogućih znakova toksičnosti fentanila te po potrebi smanjiti dozu.
English: • Swollen hands, ankles or feet (peripheral oedema)
Croatian: • oticanje šaka, gležnjeva ili stopala (periferni edem) Manje često (mogu se javiti u manje od 1 na 100 osoba)
English: If elderly patients receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see section 5.2).
Croatian: Ako stariji bolesnici koriste DUROGESIC, treba ih pažljivo nadzirati zbog moguće pojave znakova toksičnosti fentanila te po potrebi smanjiti dozu (vidjeti dio 5.2).
English: DUROGESIC contains {name the excipient(s)
Croatian: DUROGESIC sadrži {naziv pomoćne tvari}
English: • You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
Croatian: • ako ste alergični na fentanil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) • ako bol koju osjećate traje kratko, poput iznenadne boli ili boli poslije operacije
English: Opioid-naïve patients
Croatian: Dosadašnji opioid
English: • Stomach pain or indigestion
Croatian: • bolovi u trbuhu ili probavne tegobe
English: Examples of active substances that may increase fentanyl concentrations include: amiodarone, cimetidine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, ritonavir, verapamil and voriconazole (this list is not exhaustive).
Croatian: Primjeri djelatnih tvari koje bi mogle povećati koncentracije fentanila uključuju: amiodaron, cimetidin, klaritromicin, diltiazem, eritromicin,
English: • Depression
Croatian: • pospanost
English: Initial dosage selection
Croatian: Za izračun odgovarajuće početne doze lijeka
English: A new patch should be applied to a different skin site after removal of the previous transdermal patch.
Croatian: Nakon skidanja prethodnog transdermalnog flastera, novi treba primijeniti na drugo mjesto na koži.
English: To convert paediatric patients from oral or parenteral opioids to DUROGESIC, refer to Equianalgesic potency conversion (Table 1) and Recommended DUROGESIC dosage based upon daily oral morphine dose (Table 4).
Croatian: Za prijelaz s oralnih ili parenteralnih opioida na DUROGESIC kod pedijatrijskih bolesnika koristite tablicu za preračun ekvianalgetske jačine (Tablica 1) i tablicu s preporučenim dozama lijeka
English: Anaphylactic shock,
Croatian: Poremećaji imunološkog sustava preosjetljivos t anafilaktički šok,
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Croatian: NAVOĐENJE DJELATNE(IH) TVARI [Ispunjava država članica]
English: This may result in increased serum concentrations (see section 5.2) and the patient should be monitored closely.
Croatian: (vidjeti dio 5.2), pa bolesnika treba pažljivo nadzirati.
English: DUROGESIC Dosage (mcg/h)
Croatian: Doza lijeka DUROGESIC (µg/h)
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mišićni spazam mišićni trzaji
English: SACHET LABEL NAME OF THE MEDICINAL PRODUCT
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of DUROGESIC during pregnancy.
Croatian: Kod novorođenčadi čije su majke kronično koristile DUROGESIC u trudnoći prijavljen je neonatalni sindrom ustezanja.
English: 6.2 Incompatibilities
Croatian: [Ispunjava država članica] 6.2 Inkompatibilnosti
English: PHARMACEUTICAL FORM AND CONTENTS Transdermal patch [To be completed nationally]
Croatian: OBLIK I SADRŽAJ Transdermalni flaster
English: If patients with hepatic impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose of DUROGESIC reduced if necessary (see section
Croatian: Ako bolesnici s oštećenjem jetrene funkcije primaju DUROGESIC, treba ih pažljivo nadzirati zbog mogućih znakova toksičnosti fentanila te po potrebi smanjiti dozu lijeka DUROGESIC (vidjeti dio 5.2).
English: • Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Croatian: • neke antibiotike koji se koriste za liječenje infekcije (npr. eritromicin ili klaritromicin) • lijekove koji se koriste za liječenje gljivične infekcije (npr. itrakonazol, ketokonazol, flukonazol ili vorikonazol)
English: - Common (may affect up to 1 in 10 people)
Croatian: Česte (mogu se javiti u manje od 1 na 10 osoba):
English: Not applicable [To be completed nationally]
Croatian: - Ispunjava država članica]
English: The adverse reactions reported with the use of DUROGESIC from these clinical studies, including the above-mentioned adverse reactions, and from post-marketing experiences are listed below in Table 5.
Croatian: (uključujući i prethodno spomenute nuspojave) i nakon stavljanja lijeka u promet navedene su u nastavku, u Tablici 5.
English: • Feeling anxious or confused
Croatian: • depresija • tjeskoba ili smetenost
English: - see below for more information
Croatian: Sadržaj pakiranja i druge informacije
English: Some patients may require additional or alternative methods of opioid administration when the DUROGESIC dose exceeds 300 mcg/h.
Croatian: Kada doza lijeka DUROGESIC prijeđe 300 µg/h, nekim bolesnicima može biti potreban i dodatni ili neki drugi način primjene opioida.
English: Subileus
Croatian: • proljev
English: LIST OF EXCIPIENTS [To be completed nationally]
Croatian: POPIS POMOĆNIH TVARI [Ispunjava država članica]
English: Immune system disorders
Croatian: • Probavni sustav
English: Bradypnoea
Croatian: • omaglica
English: Uncommon (may affect up to 1 in 100 people)
Croatian: • napadaje. (manje često, može se javiti u manje od 1 na 100 osoba)
English: Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Croatian: Nakon prelaska na drugi lijek ili prilagodbe doze kod nekih se bolesnika mogu javiti simptomi ustezanja od opioida.
English: • Feeling dizzy
Croatian: • suha usta