FrancophonIA/ELRC3.0 huggingface dataset:
English: The company also looked at the way Triumeq was absorbed in the body in comparison with two separate tablets (dolutegravir and abacavir/lamivudine) containing the three medicines that make it up.
Croatian: Poduzeće je također istražilo način na koji se Triumeq apsorbira u tijelu u usporedbi s tri lijeka koji sadrže dvije zasebne tablete (dolutegravir i abakavir/lamivudin).
English: One of the active substances in Triumeq, dolutegravir, is an integrase inhibitor.
Croatian: Jedna od djelatnih tvari u lijeku Triumeq, dolutegravir, inhibitor je integraze.
English: What benefits of Triumeq have been shown in studies?
Croatian: Koje su koristi lijeka Triumeq utvrđene u ispitivanjima?
English: How does Triumeq work?
Croatian: Kako djeluje Triumeq?
English: How is Triumeq used?
Croatian: Kako se Triumeq koristi?
English: For the full list of restrictions with Triumeq, see the package leaflet.
Croatian: Potpuni popis ograničenja lijeka Triumeq potražite u uputi o lijeku.
English: For the full list of all side effects reported with Triumeq, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Triumeq potražite u uputi o lijeku.
English: <EMA procedure number> <MA (EU) number> (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging <Content (concentration)> Pack size
Croatian: <EMA broj postupka> <Broj (EU) odobrenja> (Zaštićeno) ime Jačina Farmaceutski oblik Put primjene Unutarnje pakiranje <Sadržaj (koncentracija)> Veličina pakiranja
English: From 50 kg
Croatian: Od 50 kg
English: 3 - How to take Keppra
Croatian: 3 - Kako uzimati Keppru
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzimite ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili ljekarnik.
English: Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Keppra se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Croatian: Kada prvi put počnete uzimati Keppru, liječnik će vam propisati manju dozu tijekom 2 tjedna prije davanja najmanje uobičajene doze.
English: Levetiracetam(oral solution) - Medication errors associated with accidental overdose (EPITT no 10519)
Croatian: Levetiracetam (oralna otopina) - Medikacijske pogreške povezane sa slučajnim predoziranjem (EPITT br. 10519)
English: Adopted at the 26-29 September 2016 PRAC
Croatian: Donesene na sjednici PRAC-a 26. - 29. rujna 2016.
English: In this population, metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available.
Croatian: Kod te bi se populacije metronidazol stoga trebao primjenjivati nakon pažljive procjene koristi i rizika te samo ako ne postoji drugi način liječenja.
English: After measuring the correct dose with an appropriate syringe, Keppra oral solution may be diluted in a glass of water or baby's bottle.
Croatian: Nakon mjerenja točne doze pomoću odgovarajuće štrcaljke, Keppra oralna otopina može se razrijediti u čaši vode ili u dječjoj bočici.
English: Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached.
Croatian: Potrebno je raditi testove funkcije jetre neposredno prije početka terapije, tijekom i nakon liječenja, sve dok funkcija jetre ne bude unutar normalnih vrijednosti ili dok se ne dostignu početne vrijednosti.
English: Package leaflet (except for products for external use on the skin) 2 - What you need to know before you use metronidazole Warnings and precautions
Croatian: Uputa o lijeku (osim za proizvode za vanjsku primjenu na koži) 2 - Što morate znati prije nego što počnete primjenjivati metronidazol
English: If the liver function tests become markedly elevated during treatment, the drug should be discontinued.
Croatian: Ako se vrijednosti u testovima funkcije jetre značajno povećaju tijekom liječenja, potrebno je prekinuti primjenu lijeka.
English: Metronidazole - Severe hepatic and neurologic toxicity in patients with Cockayne syndrome (EPITT no 18663)
Croatian: Metronidazol - teška jetrena i neurološka toksičnost u bolesnika s Cockayneovim sindromom (EPITT br. 18663)
English: Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
Croatian: Bolesnike s Cockayneovim sindromom treba savjetovati da sve simptome mogućeg oštećenja jetre odmah prijave svojem liječniku i prestanu uzimati metronidazol.
English: • Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Croatian: • bolovi u trbuhu, gubitak apetita, mučnina, povraćanje, vrućica, malaksalost, umor, žutica,
English: Summary of product characteristics (except for products for external use on the skin)
Croatian: Sažetak opisa svojstava lijeka (osim lijekova za vanjsku primjenu na koži)
English: Dose in children 6 months and older weighing less than 50 Kg Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Croatian: Doza u djece od navršenih 6 mjeseci nadalje koji imaju manje od 50 kg Doza u dojenčadi (6 do 23 mjeseca), djece (2 do 11 godina) i adolescenata (12 do 17 godina) koji imaju manje od 50 kg:
English: Tell your doctor immediately and stop taking metronidazole if you develop:
Croatian: U slučaju sljedećih nuspojava odmah obavijestite svojeg liječnika i prestanite uzimati metronidazol:
English: The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.
Croatian: Točnu količinu oralne otopine trebate dati uporabom štrcaljke koja se nalazi u kutiji.
English: If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with metronidazole and afterwards.
Croatian: Ako imate Cockayneov sindrom, vaš bi liječnik trebao često pratiti funkciju vaše jetre tijekom liječenja i nakon liječenja.
English: Take the oral solution following your doctor's instructions.
Croatian: Uzmite oralnu otopinu kako je liječnik propisao.
English: Dose in infants (1 month to less than 6 months): Weight
Croatian: Doza u dojenčadi (1 mjesec do manje od 6 mjeseci): Tjelesna težina
English: Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
Croatian: Odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja se nalazi u pakiranju za bolesnike od navršene 4 godine nadalje.
English: Dose in children 6 months and older weighing less than 50 kg: Weight
Croatian: Doza u djece od navršenih 6 mjeseci nadalječija je tjelesna težina manja od 50 kg: Tjelesna težina
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
Croatian: Doza za odrasle i adolescente od navršene (16. godine života): Odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja se nalazi u pakiranju za bolesnike od navršene 4 godine nadalje.
English: General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day.
Croatian: Uobičajena doza: između 0,14 ml (14 mg) i 0,42 ml (42 mg) na kg tjelesne težine svaki dan, podijeljeno u dvije doze na dan.
English: For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Croatian: Za dojenčad od navršenog 1. mjeseca do manje od 6 mjeseci odgovarajuću dozu izmjerite pomoću štrcaljke od 1 ml koja se nalazi u pakiranju.
English: General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day.
Croatian: Uobičajena doza: između 0,2 ml (20 mg) i 0,6 ml (60 mg) na kg tjelesne težine svaki dan, podijeljeno u dvije doze na dan.
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant.
Croatian: Uobičajena doza: Keppra se uzima dva puta na dan, u dvije jednake doze, pri čemu svaka pojedinačna doza iznosi između 0,07 ml (7 mg) i 0,21 ml (21 mg) po kilogramu tjelesne težine dojenčeta. (vidi tablicu ispod za primjere doze).
English: Add-on therapy
Croatian: Dodatna terapija
English: Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.
Croatian: Kod primjene lijekova koji sadrže metronidazol za sistemsku primjenu u bolesnika s Cockayneovim sindromom zabilježeni su slučajevi teške hepatotoksičnosti/akutnog zatajenja jetre, uključujući slučajeve sa smrtnim ishodom uz vrlo brzi nastup nakon početka liječenja.
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).
Croatian: Uobičajena doza: Keppra se uzima dva puta na dan, u dvije jednake doze, pri čemu svaka pojedinačna doza iznosi između 0,1 ml (10 mg) i 0,3 ml (30 mg) po kilogramu tjelesne težine djeteta.
English: For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.
Croatian: Za djecu od navršenih 6 mjeseci do manje od 4 godine odgovarajuću dozu izmjerite pomoću štrcaljke od 3 ml koja se nalazi u pakiranju.
English: Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.
Croatian: Kod primjene lijekova koji sadrže metronidazol, u bolesnika s Cockayneovim sindromom su zabilježeni slučajevi teškog oštećenja jetre (hepatotoksičnosti)/akutnog zatajenja jetre, uključujući slučajeve sa smrtnim ishodom.
English: Dose in adults and adolescents from (16 years of age):
Croatian: Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više:
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/130)
Croatian: Ishod arbitražnog postupka u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/130)
English: The European Commission issued a decision on 20 September 2019.
Croatian: Europska komisija donijela je odluku 20. rujna 2019.
English: 20 September 2019
Croatian: 20. rujna 2019.
English: The Committee concluded that the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site).
Croatian: Odbor je donio zaključak da injekciju treba podijeliti na dva mjesta primjene (najviše 2,5 ml volumena injekcije po mjestu primjene injekcije).
English: Which data has the CVMP reviewed?
Croatian: Koje je podatke preispitao CVMP?
English: The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'.
Croatian: Cjeloviti tekst izmjena informacija o VMP-u naveden je u Prilogu III. mišljenju CVMP-a u odjeljku „Svi dokumenti”.
English: Tylosin is a macrolide antibiotic used mainly to treat infections caused by bacteria known as Grampositive bacteria.
Croatian: Tilozin je makrolidni antibiotik koji se uglavnom koristi za liječenje infekcija uzrokovanih grampozitivnim bakterijama.
English: In addition, cattle may also be treated by injection given slowly into a vein.
Croatian: Osim toga, govedima se injekcija može polako ubrizgati u venu.
English: Why were veterinary medicines containing tylosin reviewed?
Croatian: Zašto su preispitivani veterinarsko-medicinski proizvodi koji sadrže tilozin?
English: Veterinary medicines containing tylosin are used in adult cattle, calves, pigs, sheep and goats and are given by injection into the muscle.
Croatian: Veterinarsko-medicinski proizvodi koji sadrže tilozin koriste se u odraslih goveda, teladi, svinja, ovaca i koza, a primjenjuju se injekcijom u mišić.
English: The CVMP reviewed available data on residue depletion, which indicates how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body.
Croatian: CVMP je preispitao raspoložive podatke o izlučivanju rezidua, koji pokazuju koliko je vremena potrebno da bi se koncentracija lijeka u tijelu životinje spustila ispod najviše dopuštene količine rezidua (MRL).
English: The Dutch authority considered that the withdrawal periods for sheep in the EU might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 8 to 42 days for sheep meat and offal and from 4 to 7 days for sheep milk.
Croatian: Nizozemsko nadležno tijelo smatralo je da razdoblja karencije za ovce u EU-u možda nisu primjerena kako bi zajamčila sigurnost potrošača te je napomenulo da se razdoblja karencije razlikuju unutar EUa: ona iznose od 8 do 42 dana za ovčje meso i iznutrice te od 4 do 7 dana za ovčje mlijeko.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that, for 49 out of 50 products, those containing benzyl alcohol and propylene glycol as a non-active ingredient, the withdrawal periods for meat and offal from treated sheep should be 42 days, while the withdrawal periods for milk from treated sheep should be 108 hours.
Croatian: Na temelju evaluacije trenutačno dostupnih podataka i znanstvene rasprave u Odboru, CVMP je donio zaključak da za 49 od 50 veterinarsko-medicinskih proizvoda, koji sadrže benzilni alkohol i propilen glikol kao pomoćne tvari, razdoblje karencije za meso i iznutrice liječenih ovaca treba biti 42 dana, dok razdoblje karencije za mlijeko liječenih ovaca treba biti 108 sati.
English: Therefore, the CVMP concluded that the benefit-risk balance for the veterinary medicine Tilocen is not favourable for sheep and recommended a change to its marketing authorisation to remove any reference to use in sheep.
Croatian: Stoga je CVMP zaključio da omjer koristi i rizika za veterinarsko-medicinski proizvod Tilocen nije povoljan za ovce i preporučio je izmjenu odobrenja za njegovo stavljanje u promet kako bi se izbrisala sva upućivanja na uporabu u ovaca.
English: The CVMP recommended the variation of the marketing authorisations for these veterinary medicines.
Croatian: CVMP je preporučio izmjenu odobrenja za stavljanje u promet tih veterinarsko-medicinskih proizvoda.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that for some of these medicines, the maximum injection volume per site and the withdrawal periods for sheep meat, offal and milk should be changed.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji donio je zaključak da je za neke od tih veterinarsko-medicinskih proizvoda potrebno izmijeniti najveći dopušteni volumen injekcije po mjestu primjene i razdoblja karencije za ovčje meso, iznutrice i mlijeko.
English: On 28 September 2018, the Dutch medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from sheep treated with injectable veterinary medicines containing tylosin.
Croatian: Dana 28. rujna 2018. nizozemsko nadležno tijelo za lijekove zatražilo je od CVMP-a preispitivanje svih raspoloživih podataka i preporuku o razdobljima karencije za mlijeko, meso i iznutrice ovaca liječenih injektabilnim veterinarsko-medicinskim proizvodima koji sadrže tilozin.
English: However, for one medicine, Tilocen, the Committee concluded that there were insufficient data to determine the withdrawal period and that it should therefore no longer be used in sheep.
Croatian: Međutim, za jedan od tih proizvoda, tj. Tilocen, Odbor je donio zaključak da ne postoji dovoljno podataka za utvrđivanje razdoblja karencije te da se on stoga više ne bi smio primjenjivati u ovaca.
English: The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.
Croatian: Karencija je najkraće vrijeme koja mora proteći prije klanja životinje liječene određenim lijekom odnosno korištenja mesa ili drugih proizvoda dobivenih od te životinje za prehranu ljudi.
English: For one medicine, Tilocen, which contains the non-active ingredient polyethylene glycol 400, there were no data available that could be used to set adequate withdrawal periods in sheep.
Croatian: Tilocen, koji kao pomoćnu tvar sadrži polietilen glikol 400, nije bilo dostupnih podataka koji bi se mogli upotrijebiti za utvrđivanje razdoblja karencije u ovaca.
English: On 20 June 2019, the European Medicines Agency completed a review of the withdrawal periods for injectable veterinary medicines containing tylosin when used in sheep.
Croatian: Europska agencija za lijekove završila je preispitivanje razdoblja karencije za injektabilne veterinarsko-medicinske proizvode koji sadrže tilozin kada se primjenjuju u ovaca.
English: This summary was last updated in 10-2014
Croatian: Sažetak je posljednji put ažuriran 10-2014.
English: Patients then lose their ability to control their movements reliably.
Croatian: Bolesnici potom gube sposobnost pouzdane kontrole pokreta.
English: This medicine is the same as Stalevo, which is already authorised in the European Union (EU).
Croatian: Ovaj je lijek isti kao i Stalevo, koji je već odobren u Europskoj uniji (EU).
English: Entacapone has been authorised in the European Union (EU) as Comtess/Comtan since 1998.
Croatian: Entakapon je odobren u Europskoj uniji (EU) kao Comtess/Comtan od 1998. godine.
English: Corbilta must not be used in patients with:
Croatian: Corbilta ne smije se koristiti u bolesnika sa:
English: Corbilta is used when these fluctuations cannot be treated with the standard combination alone.
Croatian: Corbilta koristi se kad se ove fluktuacije ne mogu liječiti samo standardnom kombinacijom.
English: A risk management plan has been developed to ensure that Corbilta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osiguralo da se Corbilta koristi što je sigurnije moguće.
English: • severely reduced liver function;
Croatian: • jako oštećenom funkcijom jetre;
English: Levodopa / carbidopa / entacapone
Croatian: Levodopa / karbidopa / entakapon
English: Other information about Corbilta
Croatian: Ostale informacije o lijeku Corbilta
English: The full EPAR for Corbilta 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 ocjeni dokumentacije o lijeku (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All of the tablets contain 200 mg entacapone.
Croatian: Sve tablete sadrže 200 mg entakapona.
English: Having all three substances in the same tablet can lower the number of tablets patients have to take and help them stick to their treatment.
Croatian: Sve tri supstance u istoj tableti mogu smanjiti broj tableta koje bolesnik uzima i pomoći im da se pridržavaju svog liječenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Corbilta on 11 November 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Corbilta vrijedi na prostoru Europske unije od 11. studenog 2013.
English: The strength of Corbilta that the patient should use is based on the amount of levodopa they need to control their symptoms.
Croatian: Jačina lijeka Corbilta koju bolesnik treba uzimati temelji se na količini levodope koju treba za kontrolu svojih simptoma.
English: What measures are being taken to ensure the safe and effective use of Corbilta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Corbilta?
English: What is Corbilta and what is it used for?
Croatian: Što je Corbilta i za što se koristi?
English: It is not intended to provide practical advice on how to use Corbilta.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Corbilta.
English: The use of combinations of levodopa and carbidopa is well established, having being in use since the mid1970s.
Croatian: Upotreba kombinacije levodope i karbidope je dobro poznata i u uporabi od sredine sedamdesetih godina.
English: Levodopa is converted into dopamine in the brain.
Croatian: Levodopa se pretvara u dopamin u mozgu.
English: The company that makes Stalevo has agreed that its scientific data can be used for Corbilta (‘informed consent').
Croatian: Farmaceutska tvrtka koja proizvodi Stalevo pristala je da se njeni znanstveni podaci koriste za Corbilta (tzv. „informirani pristanak”).
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Croatian: To pomaže poboljšavanju simptoma Parkinsonove bolesti poput ukočenosti i usporenih pokreta.
English: All of the active substances in Corbilta work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Croatian: Sve djelatne tvari u lijeku Corbilta djeluju u svrhu obnove razina dopamina u dijelovima mozga koji kontroliraju pokret i koordinaciju.
English: Corbilta must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Croatian: Corbilta ne smije se koristiti skupa s drugom lijekovima koji pripadaju skupini „inhibitora monoamino oksidaze” (vrsta antidepresiva).
English: The maximum daily dose of Corbilta is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Croatian: Maksimalna dnevna doza lijeka Corbilta je 10 tableta, osim za tablete koje sadrže 175 mg levodope i 43,75 mg karbidope za koju je maksimalna dnevna doza osam tableta i one koje sadrže 200 mg levodope te 50 mg karbidope za koju je maksimalna dnevna doza sedam tableta.
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Croatian: Povezane su sa smanjenim učinkom levodope kada bolesnik iskusi iznenadne promjene između „aktivnog” stanja i mogućnosti kretanja te „pasivnog” stanja i poteškoća s kretanjem.
English: What are the risks associated with Corbilta?
Croatian: Koji su rizici povezani s lijekom Corbilta?
English: • narrow-angle glaucoma (increased pressure within the eye);
Croatian: • glaukomom uskog kuta (povećanim tlakom unutar oka);
English: This is a summary of the European public assessment report (EPAR) for Corbilta.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Corbilta.
English: Corbilta is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Croatian: Corbilta je lijek koji sadrži tri djelatne tvari: levodopu, karbidopu i entakapon.
English: Corbilta is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Croatian: Corbilta dostupan je u rasponu tableta u sedam jakosti koje sadrže 50 do 200 mg levodope i 12,5 do 50 mg karbidope.
English: See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched to Corbilta and on how the dose is adjusted during treatment.
Croatian: Vidjeti Sažetak opisa svojstava lijeka (također dio EPAR-a) za potpune upute o tome kako se bolesnici prebacuju na Corbilta i o tome kako se doza prilagođava tijekom liječenja.