FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency decided that Procoralan's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi lijeka Procoralan nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: In a fourth study in 889 patients, Procoralan was more effective than placebo, when both were added to atenolol.
Croatian: U četvrtom ispitivanju na 889 bolesnika kombinacija lijeka Procoralan i atenolola bila je djelotvornija od kombinacije placeba i atenolola.
English: Procoralan was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Croatian: Lijek Procoralan uspoređen je s placebom u jednom glavnom ispitivanju koje je uključivalo više od 6 500 bolesnika s kroničnim umjerenim do ozbiljnim zatajenjem srca.
English: How is Procoralan used?
Croatian: Kako se Procoralan primjenjuje?
English: For the treatment of angina, Procoralan was originally authorised for patients whose heart rate is at least 60 beats per minute.
Croatian: Procoralan je izvorno odobren za bolesnike čija je srčana frekvencija barem 60 otkucaja u minuti.
English: Procoralan contains the active substance ivabradine.
Croatian: Procoralan sadržava djelatnu tvar ivabradin.
English: Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Croatian: Procoralan je lijek za srce koji se primjenjuje za simptomatsko liječenje kronične stabilne angine (bolova u prsima, vilici i leđima uzrokovanih fizičkim naporom) u odraslih osoba s koronarnom arterijskom bolesti (bolest srca koju uzrokuje opstrukcija krvnih žila koje opskrbljuju srčani mišić krvlju).
English: How does Procoralan work?
Croatian: Kako djeluje Procoralan?
English: For the full list of restrictions with Procoralan, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Procoralan potražite u uputi o lijeku.
English: What benefits of Procoralan have been shown in studies?
Croatian: Koje su koristi lijeka Procoralan utvrđene u ispitivanjima?
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Croatian: Česta nuspojava (koja se može javiti u manje od 1 na 10 osoba) jest bradikardija (niska srčana frekvencija).
English: Results showed that the medicine was more effective than placebo in one of the studies in 360 patients.
Croatian: Rezultati jednog ispitivanja na 360 bolesnika pokazali su da je Procoralan bio djelotvorniji od placeba.
English: For the full list of all side effects reported with Procoralan, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Procoralan potražite u uputi o lijeku.
English: What is Zubsolv and what is it used for?
Croatian: Što je Zubsolv i za što se koristi?
English: The tablets are taken once a day by placing them under the tongue and allowing them to dissolve for up to 10 minutes.
Croatian: Tablete se uzimaju jedanput dnevno tako da se stave pod jezik kako bi se omogućilo njihovo otapanje koje traje do 10 minuta.
English: Zubsolv is a ‘hybrid medicine'.
Croatian: Zubsolv je „hibridni lijek”.
English: The full EPAR for Zubsolv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni (EPAR) lijeka Zubsolv nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zubsolv is available as tablets of various strengths (0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, 11.4 mg/2.9 mg).
Croatian: Zubsolv je dostupan u obliku tableta različitih jačina (od 0,7 mg/0,18 mg, 1,4 mg/0,36 mg, 2,9 mg/0,71 mg, 5,7 mg/1,4 mg, 8,6 mg/2,1 mg, 11,4 mg/2,9 mg).
English: Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990s for the treatment of opioid addiction.
Croatian: Sublingvalne tablete koje sadržavaju samo buprenorfin dostupne su u EU-u od sredine 1990-ih godina za liječenje ovisnosti o opioidima.
English: Zubsolv is used in individuals who are also receiving medical, social and psychological support and who have agreed to be treated for their addiction.
Croatian: Zubsolv se primjenjuje u pojedinaca koji također primaju medicinsku, socijalnu i psihološku potporu i koji su pristali na liječenje od ovisnosti.
English: Once the patient has been stabilised, the maintenance dose may be reduced gradually if the patients agrees, and eventually treatment may be stopped.
Croatian: Kada se bolesnik stabilizira, doza održavanja može se postupno smanjivati ako se bolesnik slaže, te se terapija s vremenom može prekinuti.
English: What measures are being taken to ensure the safe and effective use of Zubsolv?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zubsolv?
English: The study also showed that Zubsolv tablets dissolved faster and had a better taste than the reference medicine.
Croatian: Ispitivanje je također pokazalo da su se tablete Zubsolv brže otapale i da su imale bolji okus od referentnog lijeka.
English: Zubsolv is a medicine used in adults and adolescents aged over 15 years to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Croatian: Zubsolv je lijek koji se koristi u odraslih i adolescenata starijih od 15 godina za liječenje ovisnosti o opioidima (narkoticima) kao što su heroin ili morfij.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Zubsolv contains these at different strengths.
Croatian: To znači da je sličan „referentnom lijeku” koji sadržava jednake djelatne tvari, ali ih on sadržava u drugačijim jačinama.
English: What are the risks associated with Zubsolv?
Croatian: Koji su rizici povezani s lijekom Zubsolv?
English: A study involving 125 healthy volunteers showed that some strengths of the Zubsolv tablets produced a lower level of the active substances in the body than the reference product and therefore the two medicines cannot be used interchangeably.
Croatian: Ispitivanje koje je uključivalo 125 zdravih dobrovoljaca pokazalo je da su neke jačine tableta Zubsolv proizvele nižu razinu djelatnih tvari u tijelu od referentnog proizvoda, te se stoga ta dva lijeka ne smiju koristiti kao zamjena jedan za drugog.
English: As for Suboxone, the European Medicines Agency decided that Zubsolv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: U pogledu lijeka Suboxone, Europska agencija za lijekove zaključila je da koristi od lijeka Zubsolv nadmašuju s njim povezane rizike i preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: This is a summary of the European public assessment report (EPAR) for Zubsolv.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Zubsolv.
English: Because Zubsolv can be misused or cause addiction, it can only be obtained by ‘special' prescription and must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Croatian: S obzirom na to da se lijek Zubsolv može zloupotrijebiti ili da može uzrokovati ovisnost, izdaje se samo na „poseban” liječnički recept i mora se koristiti samo pod nadzorom liječnika koji je iskusan u liječenju ovisnosti o opioidima.
English: Zubsolv buprenorphine / naloxone
Croatian: Zubsolv buprenorfin/nalokson
English: It is not intended to provide practical advice on how to use Zubsolv.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Zubsolv.
English: It must also not be used with the medicines naltrexone and nalmefene, other opioid antagonists used for the treatment of alcohol or opioid dependence.
Croatian: Ne smije se primjenjivati s lijekovima naltreksonom i nalmefenom, drugim opiodnim antagonistima koji se koriste za liječenje ovisnosti o alkoholu ili opiodima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zubsolv have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zubsolv nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Serious side effects include seizures (fits), vomiting, diarrhoea and abnormal results of blood tests for liver function.
Croatian: Ozbiljne nuspojave uključuju napadaje (grčeve), povraćanje, proljev i abnormalne vrijednosti testova funkcije jetre.
English: Zubsolv contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug but less powerfully), and naloxone, an opioid antagonist (it counteracts the effects of opioid drugs).
Croatian: Zubsolv sadržava dvije djelatne tvari: buprenorfin, djelomično opioidni agonist (djeluje kao opioid, ali ne tako snažno) i nalokson, opioidni antagonist (poništava djelovanje opioida).
English: Why is Zubsolv approved?
Croatian: Zašto je lijek Zubsolv odobren?
English: The company provided data from studies with the reference medicine Suboxone and from the published literature showing the benefits of buprenorphine and naloxone in the treatment of opioid dependence.
Croatian: Tvrtka je dostavila podatke iz ispitivanja s referentnim lijekom Suboxone i podatke iz objavljene literature koji pokazuju koristi buprenorfina i naloksona u liječenju ovisnosti o opioidima.
English: The addition of naloxone helps prevent the misuse of the medicine.
Croatian: Dodavanje naloksona pomaže u sprječavanju zlouporabe lijeka.
English: Other information about Zubsolv
Croatian: Ostale informacije o lijeku Zubsolv
English: Since Zubsolv does not produce the same amounts of buprenorphine and naloxone in the blood as the reference medicine, the medicines cannot be used interchangeably.
Croatian: S obzirom na to da Zubsolv ne proizvodi jednake količine buprenorfina i naloksona u krvi kao referentni lijek, ti lijekovi ne smiju biti zamjena jedan za drugog.
English: For more information about treatment with Zubsolv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Zubsolv pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The most common side effects with Zubsolv (which may affect more than 1 in 10 people) are constipation and symptoms of drug withdrawal such as insomnia (difficulty sleeping), headache, nausea (feeling sick), hyperhidrosis (excessive sweating) and pain.
Croatian: Najčešće nuspojave zabilježene pri uporabi lijeka Zubsolv (koje se mogu javiti u više od 1 na 10 osoba) jesu zatvor i simptomi ustezanja od lijeka kao što su nesanica (nemogućnost spavanja), glavobolja, mučnina (osjećaj slabosti), hiperhidroza (pojačano znojenje) i bol.
English: Zubsolv must not be used in patients with severe respiratory insufficiency (inability to breathe properly), severe liver problems, acute alcoholism (excessive alcohol consumption) or delirium tremens (a condition caused by alcohol withdrawal).
Croatian: Lijek Zubsolv ne smije se primjenjivati u bolesnika s teškom respiratornom insuficijencijom (poteškoće s disanjem), teškim oštećenjem jetre, akutnim alkoholizmom (pretjerana konzumacija alkohola) ili delirium tremensom (stanje koje je uzrokovano ustezanjem od alkohola).
English: How is Zubsolv used?
Croatian: Kako se Zubsolv koristi?
English: On the first day of treatment, the recommended daily dose is one or two tablets of Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg. During the next days, the doctor may increase the dose depending on the patient's response, but the daily dose should not be higher than 17.2 mg buprenorphine.
Croatian: Na prvi dan liječenja, preporučuje se jedna ili dvije tablete lijeka Zubsolv od 1,4 mg/0,36 mg ili 2,9 mg/0,71 mg kao dnevna doza.
English: For practical information about using Zubsolv, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Zubsolv bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Croatian: Razlog tomu je činjenica da nalokson prilikom ubrizgavanja suzbija djelovanje opioida te uzrokuje akutne simptome ustezanja kod bolesnika.
English: What benefits of Zubsolv have been shown in studies?
Croatian: Koje su koristi lijeka Zubsolv utvrđene u ispitivanjima?
English: However, buprenorphine tablets have been misused by drug addicts who dissolve the tablets and inject themselves with the resulting solution.
Croatian: Međutim, ovisnici o drogama zloupotrebljavali su tablete koje sadržavaju buprenorfin otapajući ih i ubrizgavajući si nastalu otopinu.
English: Combining buprenorphine and naloxone is an established strategy for managing opioid dependence which prevents misuse of the medicine.
Croatian: Kombiniranje buprenorfina i naloksona utvrđena je strategija za liječenje ovisnosti o opiodima kojom se sprječava zlouporaba lijeka.
English: How does Zubsolv work?
Croatian: Kako djeluje Zubsolv?
English: The reference medicine for Zubsolv is Suboxone.
Croatian: Referentni lijek za lijek Zubsolv jest Suboxone.
English: It contains the active substances buprenorphine and naloxone.
Croatian: Sadržava djelatne tvari buprenorfin i nalokson.
English: For the full list of side effects reported with Zubsolv, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Zubsolv potražite u uputi o lijeku.
English: 90 capsules blister (PVC/Aclar/alu)
Croatian: Peroralna primjena Blister (PVC/Aclar/alu)
English: Annex A_en
Croatian: Annex A_hr
English: MA (EU) Number
Croatian: Broj EU odobrenja
English: Further information on Fiasp can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fiasp.
Croatian: Više informacija o lijeku Fiasp dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/fiasp.
English: However, it is unclear whether this changes the risk of diabetic complications.
Croatian: Međutim, nije jasno mijenja li se time rizik od komplikacija dijabetesa.
English: Fiasp (insulin aspart)
Croatian: Fiasp (aspart inzulin)
English: Fiasp received a marketing authorisation valid throughout the EU on 9 January 2017.
Croatian: Lijek Fiasp dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 9. siječnja 2017.
English: It is usually injected under the skin of the belly or upper arm immediately before a meal, although it may be given up to 20 minutes after starting a meal if necessary.
Croatian: Obično se ubrizgava pod kožu trbuha ili nadlaktice neposredno prije jela, iako se može dati i unutar 20 minuta od početka obroka ako je potrebno.
English: Although Fiasp was not studied in children below 2 years of age, it is also expected to have a beneficial effect in younger children.
Croatian: Premda nisu provedena ispitivanja lijeka Fiasp u djece mlađe od dvije godine, očekuje se da on ima povoljne učinke i kod mlađe djece.
English: What is Fiasp and what is it used for?
Croatian: Što je Fiasp i za što se koristi?
English: Other information about Fiasp
Croatian: Ostale informacije o lijeku Fiasp
English: What measures are being taken to ensure the safe and effective use of Fiasp?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fiasp?
English: Diabetes is a disease in which blood glucose is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Croatian: Dijabetes je bolest pri kojoj bolesnik ima visoku razinu šećera u krvi zbog toga što tijelo ne može proizvoditi inzulin (dijabetes tipa 1) ili zbog toga što tijelo ne proizvodi dovoljno inzulina ili ga ne može učinkovito iskoristiti (dijabetes tipa 2).
English: This controls the level of blood glucose and reduces the symptoms and complications of diabetes.
Croatian: Time se postiže kontrola razine glukoze u krvi i ublažavaju simptomi i komplikacije dijabetesa.
English: Insulin aspart enters the bloodstream faster than human insulin after injection and therefore works more quickly.
Croatian: Aspart inzulin ulazi u krvotok brže od ljudskog inzulina nakon injektiranja i stoga brže djeluje.
English: The European Medicines Agency therefore decided that Fiasp's benefits outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Fiasp nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Side effects reported with Fiasp are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Fiasp pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The overall rate and severity of side effects was comparable with NovoRapid, although hypoglycaemia occurred more often in the first 2 hours after a dose of Fiasp.
Croatian: Cjelokupna stopa i težina nuspojava bila je usporediva s lijekom NovoRapid, premda je hipoglikemija nastupala češće u prva dva sata nakon doze lijeka Fiasp.
English: Both Fiasp and NovoRapid contain insulin aspart but Fiasp contains some different ingredients intended to help it to be absorbed rapidly.
Croatian: I Fiasp i NovoRapid sadrže aspart inzulin, ali Fiasp sadrži neke druge sastojke koji doprinose njegovoj bržoj apsorpciji.
English: Fiasp is a medicine that is used to treat children from one year of age and adults with diabetes.
Croatian: Fiasp je lijek za liječenje djece starije od godinu dana i odraslih osoba oboljelih od dijabetesa.
English: The dose depends on the patient's blood glucose, which should be tested regularly to find the dose that gives good control of blood sugar.
Croatian: Doza ovisi o razini glukoze u krvi bolesnika, što se treba redovito provjeravati kako bi se pronašla doza kojom se postiže dobra kontrola šećera u krvi.
English: When injected under the skin, Fiasp should be used in combination with an intermediate- or long-acting insulin that is given at least once a day.
Croatian: Kada se daje kao injekcija pod kožu, Fiasp treba kombinirati s inzulinom srednjeg ili dugog djelovanja koji se daje barem jednom dnevno.
English: (There was no direct comparison between Fiasp and another mealtime insulin in this study.)
Croatian: (U ovom ispitivanju nije bilo izravne usporedbe lijeka Fiasp i drugog inzulina koji se daje uz obrok.)
English: In two studies Fiasp was at least as effective as another insulin, NovoRapid.
Croatian: U dvama ispitivanjima lijek Fiasp pokazao se barem jednako djelotvoran kao drugi inzulin NovoRapid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fiasp have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Fiasp nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Compared with the already authorised insulin aspart medicine NovoRapid, the lowering of blood glucose develops earlier in adults given Fiasp, although the total extent of the lowering effect is similar.
Croatian: U usporedbi s već odobrenim lijekom NovoRapid koji sadrži aspart inzulin, snižavanje razine glukoze u krvi nastupa prije u odraslih osoba koje primaju lijek Fiasp, premda je cjelokupni opseg učinka smanjenja sličan.
English: The slightly higher risk of hypoglycaemia at night in children treated with Fiasp is addressed in the product information and is considered manageable.
Croatian: Neznatno veći rizik od hipoglikemije po noći u djece koja su liječenja lijekom Fiasp naveden je u informacijama o lijeku i može se kontrolirati.
English: As for all medicines, data on the use of Fiasp are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Fiasp kontinuirano se prate.
English: The main measure of effectiveness was the medicine's ability to decrease the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled over time.
Croatian: Glavna mjera djelotvornosti bila je sposobnost lijeka da smanji razinu glikoziliranog hemoglobina u krvi (HbA1c), tvari koja pokazuje koliko se dobro dugoročno kontrolira razina glukoze u krvi.
English: The most common side effect with Fiasp (which may affect more than 1 in 10 people) is hypoglycaemia (excessively low blood sugar).
Croatian: Najčešća nuspojava lijeka Fiasp (koja se može javiti u više od 1 na 10 osoba) jest hipoglikemija (preniska razina glukoze u krvi).
English: What are the risks associated with Fiasp?
Croatian: Koji su rizici povezani s lijekom Fiasp?
English: Why is Fiasp authorised in the EU?
Croatian: Zašto je lijek Fiasp odobren u EU-u?
English: An overview of Fiasp and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Fiasp i zašto je odobren u EU-u
English: Fiasp can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be injected into a vein but only by a doctor or a nurse.
Croatian: Fiasp se može primjenjivati i sustavom pumpe za kontinuiranu infuziju inzulina supkutano ili injekcijom u venu, koju smiju davati samo liječnik ili medicinska sestra.
English: For more information about using Fiasp, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Fiasp pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The replacement insulin in Fiasp acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Croatian: Lijek Fiasp zamjenski je inzulin koji djeluje na isti način kao inzulin samog tijela i pomaže u tome da glukoza iz krvi uđe u stanice.
English: Hypoglycaemia can occur more quickly with Fiasp than with other mealtime insulins.
Croatian: Hipoglikemija se može pojaviti brže s lijekom Fiasp nego s drugim inzulinima koji se daju uz obrok.
English: The benefits of Fiasp were also shown in children.
Croatian: Koristi od lijeka Fiasp utvrđene su i u djece.
English: It contains the active substance insulin aspart, a rapid-acting insulin.
Croatian: Sadrži djelatnu tvar aspart inzulin, koji je zapravo brzodjelujući inzulin.
English: How does Fiasp work?
Croatian: Kako djeluje Fiasp?
English: In this study, Fiasp was at least as effective as the comparator: there was almost no change in HbA1c in patients given Fiasp at mealtime (0.05 percentage points) and a similar slight increase in those given Fiasp after a meal or NovoRapid at mealtime (0.35 and 0.23 percentage points respectively).
Croatian: U tom je ispitivanju lijek Fiasp bio barem jednako djelotvoran kao usporedni lijek: HbA1c ostao je gotovo nepromijenjen u bolesnika koji su primali lijek Fiasp uz obrok (0,05 postotnih bodova), a došlo je do sličnog blagog povećanja u bolesnika koji su primali lijek Fiasp nakon obroka ili lijek NovoRapid uz obrok (0,35 i 0,23 postotna boda).
English: Fiasp is a solution for injection available in vials, cartridges or pre-filled pens and can only be obtained with a prescription.
Croatian: Fiasp je otopina za injekciju koja je dostupna u bočicama, ampulama ili napunjenim brizgalicama i izdaje se samo na recept.
English: What benefits of Fiasp have been shown in studies?
Croatian: Koje su koristi od lijeka Fiasp utvrđene u ispitivanjima?