FrancophonIA/ELRC3.0 huggingface dataset:
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, decreasing ability of the kidneys to work properly) or other kidney problems;
Croatian: Silapo je lijek koji se primjenjuje za: liječenje anemije (niskog broja crvenih krvnih stanica) koja uzrokuje simptome u bolesnika s kroničnim zatajenjem bubrega (dugoročnim, smanjenjem sposobnosti bubrega da ispravno funkcioniraju) ili drugim problemima s bubrezima; liječenje anemije u odraslih osoba koje primaju kemoterapiju za liječenje određenih tipova raka i za smanjenje potrebe za transfuzijama krvi; povećanje količine krvi koju bolesnici s umjerenom anemijom mogu sami sebi donirati prije operacije kako bi im se njihova vlastita krv mogla vratiti tijekom ili nakon operacije; smanjenje potrebe za transfuzijama krvi u odraslih osoba s umjerenom anemijom koji trebaju ići na veći ortopedski (koštani) kirurški zahvat, poput operacije kuka.
English: How does Silapo work?
Croatian: Kako djeluje Silapo
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Croatian: Obavijestite liječnika ako imate (ili ste imali) ili razvijete bilo koja medicinska stanja ili simptome, a osobito sljedeće:
English: Talk to your doctor before taking <product name>.
Croatian: Obratite se svom liječniku prije nego uzmete <naziv lijeka>.
English: Special warnings and precautions for use Dyskinesia
Croatian: Posebna upozorenja i mjere opreza pri uporabi Diskinezija
English: Pramipexole - Dystonia (EPITT no 18866)
Croatian: Pramipeksol - distonija (EPITT br. 18866)
English: Adopted at the 29 August-1 September 2017 PRAC
Croatian: Usvojeno na sjednici PRAC-a 29. kolovoza - 1. rujna 2017.
English: Rare side effects • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
Croatian: Rijetke nuspojave • Povećana osjetljivost kože na sunce i ultraljubičasto zračenje (fotoosjetljivost).
English: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Croatian: Teže reakcije zabilježene su u bolesnika s postojećim kožnim bolestima kao što su atopijski dermatitis i atopijski ekcem.
English: - Dystonia2 (inability of keeping your body and neck straight and upright (axial dystonia)).
Croatian: - distonija2 (nemogućnost držanja tijela i vrata ravno i uspravno (aksijalna distonija)).
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/406998/2017
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/600963/2017
English: Mesalazine - Risk of photosensitivity reactions (EPITT no
Croatian: Mesalazin - rizik od reakcija fotoosjetljivosti (EPITT br. 18869)
English: Undesirable effects Skin and subcutaneous tissue disorders Frequency ‘rare': Photosensitivity* *see section c)
Croatian: Učestalost „rijetko”: Fotoosjetljivost* *vidjeti dio Opis odabranih nuspojava
English: Dystonia
Croatian: Distonija
English: - Dyskinesia
Croatian: Nuspojave
English: Package leaflet
Croatian: Opis odabranih nuspojava
English: Package leaflet 4.
Croatian: Uputa o lijeku 4. Moguće nuspojave
English: The European Commission issued a decision on this opinion on 22/9/16.
Croatian: Europska Komisija objavila je odluku o tom mišljenju dana 22/9/16.
English: The patch should be replaced every 3 days.
Croatian: Flaster treba mijenjati svaka tri dana.
English: The age and general condition of the patient should also be taken into account.
Croatian: Dob i opće stanje bolesnika također se moraju uzeti u obzir.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway
Croatian: CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU), Island, Lihtenštajn i Norvešku
English: What is Durogesic?
Croatian: Što je Durogesic?
English: Therefore, the patches must be kept out of the sight and reach of children, before and after use.
Croatian: Stoga je potrebno čuvati flastere izvan pogleda i dohvata djece, i prije i nakon uporabe.
English: 4.3 Contra-indications
Croatian: 4.3. Kontraindikacije
English: The company that markets these medicines is Janssen-Cilag and associated companies.
Croatian: Te lijekove stavlja u promet tvrtka Janssen-Cilag i povezane tvrtke.
English: The dose should be re-assessed regularly during treatment and the lowest effective dose should be used.
Croatian: Tijekom liječenja treba redovito procjenjivati dozu i primjenjivati najnižu djelotvornu dozu.
English: This section also contains other warnings, including warnings about the risk of respiratory depression, dependence and potential for abuse, and use in children and elderly patients.
Croatian: Ovaj odjeljak također sadrži ostala upozorenja, uključujući upozorenja o riziku od respiratorne depresije, ovisnosti i moguće zlouporabe te o primjeni u djece i starijih bolesnika.
English: EMA/680946/2016 Rev. 1 EMEA/H/A-30/1413
Croatian: EMA/681615/2016 Rev.
English: The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 4.9 (overdose).
Croatian: Odbor je također uskladio druge odjeljke Sažetka opisa svojstava lijeka, uključujući i odjeljke 4.6. (plodnost, trudnoća i dojenje), 4.8. (nuspojave) i 4.9. (predoziranje).
English: Durogesic is available in the EU under various trade names including Durogesic DTrans and Durogesic Matrix.
Croatian: Durogesic je dostupan u EU-u pod raznim trgovačkim nazivima, među ostalim pod nazivima Durogesic DTrans i Durogesic Matrix.
English: Durogesic has been authorised in the EU via national procedures.
Croatian: Lijek Durogesic odobren je u EU-u nacionalnim postupcima.
English: Why was Durogesic reviewed?
Croatian: Zašto je Durogesic ponovno ocjenjivan?
English: Patients who have serious side effects with Durogesic should be monitored for at least 24 hours after removal of the patch, depending on their symptoms, because the active substance fentanyl remains in the blood for some time and its level only declines slowly (by about half after 24 hours).
Croatian: Bolesnike s ozbiljnim nuspojavama lijeka Durogesic potrebno je, ovisno o simptomima, promatrati najmanje 24 sata nakon uklanjanja flastera jer se djelatna tvar fentanil neko vrijeme zadržava u krvi i njegova razina postupno se smanjuje (otprilike za pola nakon 24 sata).
English: Fentanyl is an opioid (a pain medicine related to morphine).
Croatian: Fentanil je opioid (lijek protiv bolova srodan morfinu).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Durogesic in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija o propisivanju lijeka Durogesic u Europskoj uniji (EU).
English: Also, it must not be used in patients with severe respiratory depression (breathing problems), or in those allergic to fentanyl or any other ingredients of Durogesic.
Croatian: Također, ne smije se primjenjivati u bolesnika s jakom respiratornom depresijom (problemima disanja) ili u bolesnika koji su alergični na fentanil ili bilo koje druge sastojke lijeka.
English: However, adult patients who cannot take opioids by mouth and for whom Durogesic is considered the only option could be given the patch with the lowest dose.
Croatian: Međutim, odraslim bolesnicima koji ne mogu uzimati opioide na usta ili za koje se smatra da im je lijek Durogesic jedina moguća terapija, može se dati flaster s najnižom dozom.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je rezultiralo razlikama među državama članicama u pogledu načina primjene lijeka što je vidljivo u razlikama u sažecima opisa svojstava lijeka, označivanju i uputama o lijeku u državama u kojima se lijek stavlja u promet.
English: Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Durogesic.
Croatian: Nakon usklađivanja indikacija, CHMP je također uskladio preporuke o načinu primjene lijeka Durogesic.
English: The appropriate starting dose should be chosen according to the patient's current use of opioid medicines.
Croatian: Prikladna početna doza mora se odabrati uzimajući u obzir bolesnikovu trenutačnu uporabu opioidnih lijekova.
English: The use of Durogesic is not recommended in patients who have not taken opioid medicines before.
Croatian: Primjena lijeka Durogesic ne preporučuje se u bolesnika koji ranije nisu primali opioide.
English: On 15 September 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Durogesic in the EU2.
Croatian: Europska je komisija 15. rujna 2015. uputila predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Durogesic u EU-u2.
English: It contains the active substance fentanyl and is available as a transdermal patch (a patch that gradually delivers the medicine through the skin).
Croatian: Sadrži djelatnu tvar fentanil i dostupan je u obliku transdermalnog flastera (flaster koji postupno otpušta lijek kroz kožu).
English: In children treated with Durogesic, the patch should be applied on the upper back to prevent the child from removing the patch.
Croatian: U djece koja se liječe lijekom Durogesic potrebno je primijeniti flaster na gornjem dijelu leđa kako bi se spriječilo da ga dijete ukloni.
English: 2 This referral procedure did not cover other fentanyl formulations such as tablets, nasal sprays or solutions for injection
Croatian: U ovaj postupak upućivanja nisu uključene druge formulacije fentanila kao što su tablete, nazalni sprejevi ili otopine za injekcije
English: These patients should be closely monitored for side effects.
Croatian: Te bolesnike potrebno je pomno motriti zbog mogućnosti nuspojava.
English: The CHMP agreed that Durogesic can be used in adults to treat severe long-term pain that requires continuous treatment with opioid medicines, whether or not the pain is caused by cancer.
Croatian: CHMP se usuglasio oko toga da se lijek Durogesic smije primjenjivati u odraslih za liječenje jakih dugotrajnih bolova za koje je potrebna kontinuirana terapija opioidnim lijekovima neovisno o tome je li uzrok boli rak.
English: Durogesic is a medicine used to relieve severe long-term pain in adults and children from 2 years of age.
Croatian: Durogesic je lijek koji se koristi za ublažavanje jakih dugotrajnih bolova u odraslih i djece u dobi od 2 ili više godina.
English: Durogesic must not be used to relieve severe short-term pain or pain resulting from an operation.
Croatian: Lijek Durogesic ne smije se koristiti za ublažavanje jakih kratkotrajnih bolova ili bolova koji su rezultat operativnog zahvata.
English: On 21 July 2016, the European Medicines Agency completed a review of Durogesic.
Croatian: Europska agencija za lijekove dovršila je ocjenjivanje lijeka Durogesic 21. srpnja 2016.
English: Durogesic can also be used to treat severe long-term pain in children from 2 years of age who are already being treated with opioids.
Croatian: Lijek Durogesic također se može koristiti za liječenje dugotrajnih jakih bolova u djece u dobi od dvije ili više godina koja već primaju opioide.
English: Tables to work out the appropriate dose of Durogesic when switching from other opioids taken by mouth or given by injection have been included in the harmonised SmPC.
Croatian: U usklađeni sažetak opisa svojstava lijeka uvrštene su tablice za utvrđivanje prikladne doze lijeka Durogesic prilikom prelaska s drugih opioida koji se primjenjuju kroz usta ili injekcijom.
English: Durogesic patches release enough fentanyl to be fatal if not used appropriately, especially for a child; sufficient fentanyl remains in the patch to cause severe effects even after it has been used.
Croatian: Flasteri Durogesic otpuštaju fentanil u količinama koje mogu biti smrtonosne ako se ne koriste ispravno, posebno za djecu.
English: Durogesic was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1.
Croatian: Koordinacijska skupina za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh)1 utvrdila je da je u pogledu lijeka Durogesic potrebno provesti usklađivanje.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Pakovanje
English: • Other medicines you are taking.
Croatian: • drugim lijekovima koje uzimate.
English: These are signs of a serious condition.
Croatian: To su znakovi ozbiljnog stanja.
English: Most of these symptoms were reversible.
Croatian: Većina tih simptoma bila je reverzibilna.
English: How much medicine will you be given
Croatian: Koliko ćete lijeka primiti
English: Iceland, Norway, Sweden:
Croatian: Island, Norveška, Švedska:
English: Severe allergic reaction that may include:
Croatian: Teška alergijska reakcija, koja može uključivati:
English: • You are less aware of things around you or your reactions become unusually slow
Croatian: • ako ste manje svjesni stvari koje Vas okružuju ili su Vam reakcije postale neobično spore
English: It is used for illnesses affecting the way you think, feel or behave.
Croatian: Koristi se za bolesti koje utječu na to na koji način razmišljate, kako se osjećate ili ponašate.
English: This list is not exhaustive.
Croatian: Ovaj popis nije sveobuhvatan.
English: This means you should be careful how much alcohol you drink.
Croatian: To znači da morate paziti na količinu alkohola koju unosite.
English: An increased risk cannot be excluded for other patient populations.
Croatian: Ne može se isključiti povećan rizik za druge populacije bolesnika.
English: • Lack of normal facial expression that sometimes looks like a mask.
Croatian: • izostanak normalne izražajnosti lica, koje ponekad izgleda poput maske
English: Adults aged 18 years and above
Croatian: Odrasli u dobi od 18 ili više godina
English: Consequently, it is recommended that newborn infants be monitored carefully.
Croatian: Stoga se preporučuje pažljivo praćenje novorođenčadi.
English: Treatment is supportive.
Croatian: Liječenje je potporno.
English: You may need urgent medical treatment.
Croatian: Možda će Vam biti potrebno hitno liječenje.
English: Patients must always be maintained on the lowest effective dose.
Croatian: Bolesnike se uvijek mora održavati na minimalnoj učinkovitoj dozi.
English: cannot be estimated from the available data.
Croatian: ne može se procijeniti iz dostupnih podataka
English: • You will not be given more than 300 mg every 4 weeks.
Croatian: • Nećete primiti više od 300 mg svaka 4 tjedna.
English: Examples include:
Croatian: Primjeri uključuju:
English: Pregnancy - if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice.
Croatian: Trudnoća - ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet.
English: • Believe things that are not true (delusions)
Croatian: • možete vjerovati u stvari koje nisu stvarne (deluzije)
English: There is no specific antidote.
Croatian: Ne postoji specifičan protulijek.
English: This leaflet was last revised in {month YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {mjesec YYYY}.
English: • High or low body temperature
Croatian: • visoka ili niska tjelesna temperatura
English: • Feel very aggressive, hostile or violent.
Croatian: • možete biti vrlo agresivni, neprijateljski nastrojeni ili nasilni
English: Hyperthermia is often an early sign of this syndrome.
Croatian: Hipertermija je često rani znak tog sindroma.
English: Blood clots can be very serious, so tell your doctor straight away if you notice any of these problems.
Croatian: Krvni ugrušci mogu biti vrlo ozbiljni, pa stoga odmah obavijestite svog liječnika ako primijetite bilo koju od tih tegoba.
English: • See, hear, feel or smell things that are not there (hallucinations)
Croatian: • možete vidjeti, čuti, osjećati ili namirisati stvari kojih nema (halucinacije)
English: It can also cause severe allergic reactions and blood clots.
Croatian: Također može izazvati teške alergijske reakcije i krvne ugruške.
English: The following side effects have also been reported, but their exact frequency is unknown:
Croatian: Prijavljene su i sljedeće nuspojave, ali je njihova točna učestalost nepoznata:
English: As the administration of volumes greater than 3 ml is uncomfortable for the patient, such large volumes are not recommended.
Croatian: Budući da je primjena volumena većih od 3 ml neugodna za bolesnika, ne preporučuju se tako veliki volumeni.
English: It remains unclear whether this represents a distinct clinical entity.
Croatian: Ostaje nejasno predstavljaju li oni zaseban klinički entitet.
English: This belongs to a group of medicines called ‘antipsychotics'.
Croatian: On pripada skupini lijekova koji se zovu ‘antipsihotici'.
English: • Depression (‘tricyclic antidepressants')
Croatian: • depresiju (‘tricikličke antidepresive')
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ove informacije o lijeku ishod su arbitražnog posupka na koji se odnosi ova Odluka Komisije.
English: • Fever you can't explain or movements you can't control
Croatian: • vrućica koju ne možete objasniti ili kretnje koje ne možete kontrolirati
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria:
Croatian: Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod sljedećim nazivima:
English: • Bupropion (for depression or to help you stop smoking)
Croatian: • bupropion (za depresiju ili za pomoć pri prestanku pušenja)
English: Mean haloperidol plasma protein binding in adults is approximately 88 to 92%.
Croatian: Srednja vrijednost vezivanja haloperidola za proteine u plazmi odraslih osoba iznosi približno 88 - 92%.
English: This medicine must not be used if any of the above applies to you.
Croatian: Ne smijete primiti ovaj lijek ako se nešto od navedenoga odnosi na Vas.
English: Enzyme induction may be observed after a few days of treatment.
Croatian: Indukcija enzima može se primijetiti nakon nekoliko dana liječenja.
English: The mechanism for this increased risk is not known.
Croatian: Mehanizam u pozadini tog povećanja rizika nije poznat.
English: The plasma concentrations rise gradually, usually peaking within 3 to 9 days after injection.
Croatian: Plazmatske koncentracije postupno se povećavaju i obično dosežu vršnu vrijednost unutar 3 - 9 dana nakon injekcije.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of local tolerability, repeat dose toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja lokalne podnošljivosti, toksičnosti ponovljenih doza i genotoksičnosti.
English: • A swollen face, lips, mouth, tongue or throat
Croatian: • oticanje lica, usana, usta, jezika ili grla
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Croatian: U bolesnika u kojih se razviju ti simptomi povećanje doze može biti štetno.
English: • Difficulty getting and keeping an erection (impotence)
Croatian: • otežano postizanje i održavanje erekcije (impotencija)
English: Increased mortality in elderly people with dementia
Croatian: Povećana smrtnost u starijih bolesnika s demencijom
English: If you get any of these effects, you may be given an additional medicine.
Croatian: Ako se pojavi bilo koja od tih nuspojava, možda ćete dobiti još jedan lijek.
English: The manifestations may be permanent in some patients.
Croatian: U nekih bolesnika te manifestacije mogu biti trajne.
English: Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Croatian: Iako su uzroci smrti bili raznoliki, čini se da je većina smrtnih slučajeva bila kardiovaskularne (npr. zatajenje srca, iznenadna smrt) ili infektivne (npr. pneumonija) prirode.
English: This is most likely to occur within the first few weeks of treatment.
Croatian: Ona se najčešće javlja u prvih nekoliko tjedana liječenja.
English: Tell your doctor straight away and stop taking both medicines if you get:
Croatian: Odmah obavijestite svog liječnika i prestanite primjenjivati oba lijeka ako se pojavi:
English: • Muscle spasms, twitching or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side
Croatian: • grčenje, trzanje ili stezanje mišića koje ne možete kontrolirati, uključujući grč u vratu zbog kojeg se glava okreće u jednu stranu
English: Cerebrovascular events
Croatian: Cerebrovaskularni događaji
English: Animal studies have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na reproduktivnu toksičnost (vidjeti dio 5.3).
English: • Dementia with Lewy bodies.
Croatian: • Demencija s Lewyjevim tjelešcima
English: This is because small amounts of the medicine may pass into the mother's milk and on to the baby.
Croatian: Naime, male količine lijeka mogu se izlučiti u majčino mlijeko i tako prijeći na dijete.
English: • You have progressive supranuclear palsy (PSP)
Croatian: • ako imate progresivnu supranuklearnu paralizu (PSP)
English: A moderate amount of data on pregnant women (more than 400 pregnancy outcomes) indicate no malformative or foeto/ neonatal toxicity of haloperidol.
Croatian: Umjerena količina podataka o primjeni u trudnica (više od 400 ishoda trudnoće) ne ukazuje na malformacijsku ni fetalnu/neonatalnu toksičnost haloperidola.
English: If you miss an appointment, contact your doctor right away to make a new appointment.
Croatian: Ako propustite zakazani pregled, odmah se javite liječniku kako biste dogovorili novi.
English: • Feel confused (delirium)
Croatian: • možete se osjećati smeteno (delirij)
English: • Serious mental health problem, such as believing things that are not true (delusions) or seeing, feeling, hearing or smelling things that are not there (hallucinations)
Croatian: • ozbiljna psihička tegoba, poput vjerovanja u stvari koje nisu istinite (deluzije) ili stanja kod kojeg vidite, osjećate, čujete ili možete namirisati stvari kojih nema (halucinacije)
English: • A maximum dose of 300 mg every 4 weeks must not be exceeded because the safety concerns outweigh the clinical benefits of treatment.
Croatian: • Ne smije se premašiti maksimalna doza od 300 mg svaka 4 tjedna jer potencijalni sigurnosni problemi nadmašuju kliničku korist od liječenja.
English: The ECG measures the electrical activity of your heart.
Croatian: EKG mjeri električnu aktivnost srca.
English: The exact frequency of these problems is unknown.
Croatian: Točna učestalost tih tegoba nije poznata.
English: • You have a type of dementia called ‘Lewy body dementia'
Croatian: • ako imate jednu vrstu demencije koja se zove ‘demencija s Lewyjevim tjelešacima'
English: Your doctor will adjust the dose to suit you, and may also give you a type of haloperidol that you take by mouth.
Croatian: Liječnik će prilagoditi dozu tako da odgovara Vama, a možda Vam dati i jedan oblik haloperidola koji se uzima kroz usta.
English: Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (14%), tremor (8%), parkinsonism (7%), muscle rigidity (6%) and somnolence (5%).
Croatian: Prema objedinjenim podacima o sigurnosti iz tih kliničkih ispitivanja, najčešće prijavljene nuspojave bile su: ekstrapiramidni poremećaj (14%), tremor (8%), parkinsonizam (7%), mišićna ukočenost (6%) i somnolencija (5%).
English: Neuroleptic malignant syndrome
Croatian: Neuroleptički maligni sindrom