FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Croatian: Iako za deksibuprofen nisu dostupni podaci, razumna je pretpostavka da slična interakcija može postojati između deksibuprofena (= S(+)-ibuprofen) (koji je farmakološki aktivan enantiomer ibuprofena) i niske doze acetilsalicilatne kiseline.
English: Anti-inflammatory/pain-killer medicines like dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.
Croatian: Protuupalni lijekovi / lijekovi protiv bolova poput deksibuprofena mogu biti povezani s blago povećanim rizikom od srčanog udara ili moždanog udara, naročito kada se upotrebljavaju u visokim dozama.
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Croatian: Iako za deksibuprofen nisu dostupni podaci, razumna je pretpostavka da slična interakcija može postojati između deksibuprofena (= S(+)-ibuprofen) (farmakološki aktivnog enantiomera ibuprofena) i niske doze acetilsalicilatne kiseline.
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording]
Croatian: Dio 4.5 - Interakcije s drugim lijekovima i drugi oblici interakcija
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.
Croatian: Temeljito razmatranje također je potrebno prije započinjanja dugotrajnog liječenja bolesnika s čimbenicima rizika za kardiovaskularne događaje (primjerice, hipertenzijom, hiperlipidemijom, šećernom bolesti, pušenjem), naročito ako su potrebne visoke doze deksibuprofena (1200 mg/dan).
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Croatian: Bolesnike s nekontroliranom hipertenzijom, kongestivnim zatajenjem srca (NYHA II-III), utvrđenom ishemijskom bolesti srca, bolesti perifernih arterija, i/ili cerebrovaskularnom bolešću smije se liječiti ibuprofenom samo nakon pažljivog razmatranja uz izbjegavanje davanja visokih doza (2400 mg/dan).
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording (if sub-sections exist this wording should be included in the relevant sub-section, e.g. concomitant use not recommended)]
Croatian: [Ovaj dio treba izmijeniti tako da sadrži sljedeći tekst (ako postoje pododjeljci, ti se opisi moraju uključiti u odgovarajući pododjeljak, primjerice, istodobna upotreba nije preporučena)]
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.
Croatian: Bolesnike s nekontroliranom hipertenzijom, kongestivnim zatajenjem srca (NYHA II-III), utvrđenom ishemijskom bolesti srca, bolesti perifernih arterija, i/ili cerebrovaskularnom bolešću smije se liječiti deksibuprofenom samo nakon pažljivog razmatranja uz izbjegavanje davanja visokih doza (1200 mg/dan).
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Croatian: Temeljito razmatranje također je potrebno prije započinjanja dugotrajnog liječenja bolesnika s čimbenicima rizika za kardiovaskularne događaje (primjerice, hipertenzijom, hiperlipidemijom, šećernom bolesti, pušenjem), naročito ako su potrebne visoke doze ibuprofena (2400 mg/dan).
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Croatian: Klinička ispitivanja upućuju na to da primjena ibuprofena, naročito u visokoj dozi (2400 mg/dan), može biti povezana s blago povećanim rizikom od arterijskih trombotičnih događaja (primjerice, infarkta miokarda ili moždanog udara) (vidjeti dio 4.4).
English: Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.
Croatian: Protuupalni lijekovi / lijekovi protiv bolova poput ibuprofena mogu biti povezani s blago povećanim rizikom od srčanog udara ili moždanog udara, naročito kada se upotrebljavaju u visokim dozama.
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).
Croatian: Smatra se da pri povremenom uzimanju ibuprofena klinički značajan učinak nije vjerojatan (vidjeti dio 4.5).
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Croatian: Klinička ispitivanja upućuju na to da primjena ibuprofena, naročito u visokoj dozi (2400 mg/dan), može biti povezana s blago povećanim rizikom od arterijskih trombotičnih događaja (primjerice, infarkta miokarda ili moždanog udara).
English: For all dexibuprofen-containing products
Croatian: Za sve lijekove koji sadrže deksibuprofen
English: Section 5.1 - Pharmacodynamic properties [The section should be amended to reflect the following wording]
Croatian: Dio 5.1 - Farmakodinamička svojstva
English: A. Summary of Products Characteristics Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Croatian: Sažetak opisa svojstava lijeka Dio 4.2 - Doziranje i način primjene
English: Warnings and precautions [The section should be amended to reflect the following wording]
Croatian: [Ovaj dio treba izmijeniti tako da sadrži sljedeći tekst]
English: Section 4.3 - Contraindications [The section should be amended to reflect the following wording]
Croatian: Dio 4.3 - Kontraindikacije
English: Further information on Buvidal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Buvidal.
Croatian: Više informacija o lijeku Buvidal nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Buvidal.
English: Buvidal (buprenorphine)
Croatian: Buvidal (buprenorfin)
English: Buvidal is used in adults and adolescents aged over 16 years who are also receiving medical, social and psychological support.
Croatian: Buvidal se primjenjuje u odraslih osoba i adolescenata starijih od 16 godina koji istodobno primaju zdravstvenu, socijalnu i psihološku potporu.
English: The main measure of effectiveness was based on the number of urine samples that tested negative for opioids.
Croatian: Glavna mjera učinkovitosti temeljila se na broju uzoraka urina koji su bili negativni na opioide.
English: Patients cannot take the medicine home or inject it themselves.
Croatian: Bolesnici ne smiju lijek ponijeti kući niti ga samostalno primjenjivati.
English: During the 25 weeks of treatment, 35% of patients given Buvidal had a negative urine test, compared with 28% of patients taking the comparator tablets.
Croatian: Tijekom 25 tjedana liječenja 35 % bolesnika koji su primali lijek Buvidal imalo je negativan nalaz urina u usporedbi s 28 % onih koji su primali usporedne tablete.
English: This means it can be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Croatian: To znači da se može kontrolirano primjenjivati u cilju sprječavanja simptoma ustezanja i smanjenja potrebe za pogrešnom primjenom drugih opioida.
English: What measures are being taken to ensure the safe and effective use of Buvidal?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Buvidal?
English: It can only be obtained with a prescription and can only be given by a healthcare professional.
Croatian: Izdaje se samo na liječnički recept i smije ga davati samo zdravstveni radnik.
English: Although information on the long-term safety of the new formulation was lacking, the Agency's view was that the benefit of Buvidal outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Iako nisu postojale informacije o dugoročnoj sigurnosti nove formulacije, mišljenje je Agencije da korist lijeka Buvidal nadmašuje s njim povezani rizik te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The reference medicine for Buvidal is Subutex.
Croatian: Referentni lijek za Buvidal je Subutex.
English: What is Buvidal and what is it used for?
Croatian: Što je Buvidal i za što se primjenjuje?
English: Buvidal is given as an injection under the skin, either once a week or once a month.
Croatian: Buvidal se primjenjuje injekcijom pod kožu jedanput tjedno ili jedanput mjesečno.
English: Weekly or monthly injections with Buvidal would offer an additional option for managing the condition.
Croatian: Tjedne ili mjesečne injekcije lijeka Buvidal omogućile bi dodatnu mogućnost kontrole tog stanja.
English: Side effects reported with Buvidal are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Buvidal pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Buvidal and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Buvidal i zašto je odobren u EU-u
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Buvidal is given in a different way.
Croatian: To znači da je sličan „referentnom lijeku” koji sadržava istu djelatnu tvar, ali Buvidal se primjenjuje na drugačiji način.
English: For patients dependent on short-acting opioids (e.g. morphine or heroin), the first dose is given at least 6 hours after the patient last used an opioid.
Croatian: U bolesnika ovisnih o kratkodjelujućim opioidima (npr. morfin ili heroin) prva se doza daje najmanje 6 sati nakon što je bolesnik zadnji put uzeo opioid.
English: The first dose of Buvidal is given when the patient shows clear signs of withdrawal.
Croatian: Prva doza lijeka Buvidal daje se kad bolesnik pokaže jasne znakove ustezanja.
English: The most common side effects with buprenorphine (which may affect more than 1 in 10 people) are headache, nausea (feeling sick), hyperhidrosis (excessive sweating), insomnia (difficulty sleeping), drug withdrawal syndrome and pain.
Croatian: Najčešće nuspojave buprenorfina (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, mučnina (osjećaj slabosti), hiperhidroza (prekomjerno znojenje), nesanica (poremećaj spavanja), sindrom ustezanja lijeka i bol.
English: The first dose of Buvidal is given at least 24 hours after the patient last used methadone.
Croatian: Prva doza lijeka Buvidal daje se najmanje 24 sata nakon što je bolesnik zadnji put uzeo metadon.
English: Patients who have never taken buprenorphine before should be given a 4 mg buprenorphine tablet and be monitored for one hour before being given Buvidal, to make sure they tolerate the medicine.
Croatian: Bolesnicima koji prethodno nikad nisu primali buprenorfin treba dati tabletu buprenorfina od 4 mg i pratiti ih jedan sat prije primjene lijeka Buvidal kako bi se potvrdilo da podnose lijek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Buvidal 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 Buvidal nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Buvidal are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Buvidal kontinuirano se prate.
English: What are the risks associated with Buvidal?
Croatian: Koji su rizici povezani s lijekom Buvidal?
English: Buvidal must not be used in patients with severe respiratory insufficiency (inability to breathe properly) and severe liver problems and in patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Croatian: Buvidal se ne smije primjenjivati u bolesnika s teškom respiratornom insuficijencijom (nesposobnost pravilnog disanja) i teškim oštećenjima jetre kao ni u bolesnika koji imaju intoksikaciju alkoholom ili simptome ustezanja od alkohola.
English: Buvidal is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Croatian: Buvidal je lijek koji se primjenjuje za liječenje ovisnosti o opioidima (narkoticima) kao što su heroin ili morfin.
English: While Subutex is available as sublingual tablets (tablets to be placed under the tongue), Buvidal is available as a solution for injection under the skin.
Croatian: Dok je lijek Subutex dostupan u obliku sublingvalnih tableta (tableta koje se stavljaju pod jezik), lijek Buvidal dostupan je u obliku otopine za injekciju pod kožu.
English: The European Medicines Agency concluded that Buvidal was at least as effective as buprenorphine tablets at treating opioid dependence.
Croatian: Europska agencija za lijekove zaključila je da je lijek Buvidal barem jednako učinkovit u liječenju ovisnosti o opioidima kao i tablete buprenorfina.
English: Why is Buvidal authorised in the EU?
Croatian: Zašto je lijek Buvidal odobren u EU-u?
English: For patients dependent on long-acting opioids (e.g. methadone), the dose of methadone is reduced to below 30 mg per day before starting Buvidal.
Croatian: U bolesnika ovisnih o dugodjelujućim opioidima (npr. metadon) doza metadona smanjuje se na razinu ispod 30 mg dnevno prije početka primjene lijeka Budival.
English: The active substance in Buvidal, buprenorphine, is a partial opioid agonist (it acts like an opioid drug but less powerfully).
Croatian: Djelatna tvar lijeka Buvidal, buprenorfin, parcijalni je agonist opioida (djeluje poput opioida, ali manje snažno).
English: For more information about using Buvidal, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Buvidal pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The dose of Buvidal can be adjusted and patients can be switched between weekly and monthly injections according to the patient's need and the judgement of the treating doctor.
Croatian: Doza lijeka Buvidal može se prilagoditi i bolesnici mogu prelaziti s tjednih na mjesečne injekcije i obratno u skladu s osobnim potrebama i procjeni ordinirajućeg liječnika.
English: Other information about Buvidal
Croatian: Ostale informacije o lijeku Buvidal
English: In this study, Buvidal was compared with sublingual tablets containing buprenorphine and another medicine, naloxone (which is used to prevent misuse).
Croatian: U tom ispitivanju lijek Buvidal bio je uspoređen sa sublingvalnim tabletama koje sadržavaju buprenorfin i drugi lijek, nalokson (koji se primjenjuje radi sprječavanja pogrešne primjene).
English: A study involving 428 patients with opioid dependence showed that Buvidal was effective at reducing patients' intake of opioid drugs.
Croatian: U ispitivanju kojim je bilo obuhvaćeno 428 ovisnika o opioidima utvrđeno je da se lijekom Buvidal učinkovito smanjuje njihov unos opioida.
English: These patients should be started on weekly doses of Buvidal before moving to monthly injections.
Croatian: U tih bolesnika treba početi s tjednim dozama lijeka Buvidal prije prelaska na injekcije jedanput mjesečno.
English: How does Buvidal work?
Croatian: Kako djeluje Buvidal?
English: What benefits of Buvidal have been shown in studies?
Croatian: Koje su koristi od lijeka Buvidal utvrđene u ispitivanjima?
English: Patients who have taken buprenorphine before may be switched directly to weekly or monthly Buvidal injections.
Croatian: Bolesnici koji su prethodno primali buprenorfin mogu odmah prijeći na tjedne ili mjesečne injekcije lijeka Budival.
English: Buvidal contains the active substance buprenorphine and is a ‘hybrid medicine'.
Croatian: Buvidal sadržava djelatnu tvar buprenorfin te je „hibridni lijek”.
English: For the full list of side effects and restrictions of Buvidal, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Buvidal potražite u uputi o lijeku.
English: How is Buvidal used?
Croatian: Kako se Buvidal primjenjuje?
English: Intravenous use vial (glass)
Croatian: Intravenska primjena bočica (staklena) 1 bočica
English: 1 vial
Croatian: Jačina
English: If you take more Plavix than you should
Croatian: Ako uzmete više Plavixa nego što ste trebali
English: Do not give this medicine to children because it does not work.
Croatian: Nemojte dati ovaj lijek djeci jer ne djeluje.
English: Other medicines and Plavix
Croatian: Drugi lijekovi i Plavix
English: Date of first authorisation: 15 July 1998 Date of latest renewal: 15 July 2008
Croatian: Datum prvog odobrenja: 15. srpanj 1998.
English: What Plavix is and what it is used for
Croatian: Što je Plavix i za što se koristi
English: 67019 Scoppito (AQ) - Italy or
Croatian: 67019 Scoppito (AQ) - Italija ili
English: The other ingredients are (see section 2 ‘Plavix contains lactose' and ‘Plavix contains hydrogenated castor oil'):
Croatian: Drugi sastojci su (vidjeti dio 2. „Plavix sadrži laktozu“ i „Plavix sadrži hidrogenirano ricinusovo ulje“):
English: You should take Plavix for as long as your doctor continues to prescribe it.
Croatian: Plavix trebate uzimati sve dok Vam ga liječnik propisuje.
English: Posology • Adults and elderly
Croatian: Doziranje • Odrasli i starije osobe
English: Some other medicines may influence the use of Plavix or vice versa.
Croatian: Neki lijekovi mogu utjecati na djelovanje Plavixa i obratno.
English: Strada Statale 17, Km 22 67019 Scoppito (AQ) Italy
Croatian: Strada Statale 17, Km 22 67019 Scoppito (AQ) - Italija
English: This leaflet was last revised in <Month YYYY>.
Croatian: Ova uputa je zadnji puta revidirana u <mjesec GGGG>.
English: Week 2 (for boxes of 14, 28 and 84 tablets) Week 3 (for boxes of 28 and 84 tablets) Week 4 (for boxes of 28 and 84 tablets)
Croatian: Tjedan 2 (za pakiranje od 14, 28 i 84 tablete) Tjedan 3 (za pakiranje od 28 i 84 tablete) Tjedan 4 (za pakiranje od 28 i 84 tablete)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Croatian: Tijekom nekliničkih ispitivanja na štakorima i babunima, najčešće zabilježeni učinci bile su promjene na jetri.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke vezane za trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3.).
English: Plavix contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Plavix sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: Do not use this medicine if you notice any visible sign of deterioration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove odstupanja u kakvoći.
English: While you are taking Plavix:
Croatian: Dok uzimate Plavix:
English: As a precautionary measure, breast-feeding should not be continued during treatment with Plavix.
Croatian: Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja Plavixom.
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Plavix by referring to the calendar printed on the blister.
Croatian: Za pakiranja od 7, 14, 28 i 84 tablete možete provjeriti dan kada ste zadnji put uzeli tabletu Plavixa pomoću kalendara otisnutog na blisteru.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Plavix and acetylsalicylic acid for this condition.
Croatian: Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene Plavixa i acetilsalicilatne kiseline.
English: What Plavix looks like and contents of the pack
Croatian: Kako Plavix izgleda i sadržaj pakiranja
English: If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Croatian: Ako se porežete ili ozlijedite, može trajati dulje nego obično da krvarenje prestane.
English: This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Croatian: To je povezano s načinom na koji djeluje Vaš lijek, jer spriječava mogućnost stvaranja krvnih ugrušaka.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Croatian: Farmakoterapijska skupina: inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC-04.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze ne bi trebali uzimati ovaj lijek.
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), kontaktirajte svog liječnika prije uzimanja ovog lijeka.
English: Your doctor should have prescribed Plavix plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Croatian: Liječnik Vam treba propisati Plavix i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
English: Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Croatian: Temeljeno na uključujućim kriterijima, liječnici su bolesnike uključivali u studiju ACTIVE-W ako su bili kandidati za terapiju antagonistima vitamina K (kao što je varfarin).
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Croatian: Njihova je učestalost definirana na sljedeći način: česte (≥1/100, <1/10); manje česte (≥1/1000, <1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Glomerulonephritis, blood creatinine increased
Croatian: Hematurija glomerulonefritis, povećanje kreatinina u krvi