FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel Acino is a medicine that contains the active substance clopidogrel.
Croatian: Acino je lijek koji sadrži djelatnu tvar Clopidogrel.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđeni rizik, kao i u slučaju lijeka Plavix.
English: How is Clopidogrel Acino used?
Croatian: Kako se Clopidogrel Acino koristi?
English: How has Clopidogrel Acino been studied?
Croatian: Kako je Clopidogrel Acino ispitivan?
English: How does Clopidogrel Acino work?
Croatian: Kako djeluje Clopidogrel Acino?
English: Cholib fenofibrate / simvastatin
Croatian: Cholib fenofibrat / simvastatin
English: The recommended dose is one tablet a day to be swallowed whole with a glass of water.
Croatian: Preporučena doza je jedna tableta dnevno, koja se treba progutati cijela s čašom vode.
English: Fenofibrate is a ‘PPARα agonist'.
Croatian: Fenofibrat je „agonist PPARα“.
English: The full EPAR for Cholib 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) za lijek Cholib može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Cholib vrijedi na prostoru Europske unije od 26. kolovoza 2013.
English: A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se lijek Cholib koristi što je sigurnije moguće.
English: Other information about Cholib
Croatian: Druge informacije o lijeku Cholib
English: Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
Croatian: Cholib se izdaje samo na liječnički recept i dostupan je kao tablete (145/20 mg i 145/40 mg).
English: What is Cholib and what is it used for?
Croatian: Što je Cholib i za što se koristi?
English: It is not intended to provide practical advice on how to use Cholib.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Cholib.
English: The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Croatian: Kolesterol izvučen iz krvi na ovaj način jest „loš“ kolesterol.
English: What measures are being taken to ensure the safe and effective use of Cholib?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cholib?
English: Why is Cholib approved?
Croatian: Zašto je Cholib odobren?
English: It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Croatian: Također se ne smije upotrebljavati u trudnica ili dojilja, u osoba za koje je poznato da imaju fototoksične reakcije na fibrate ili ketoprofen, ili osobe koje boluju od bolesti jetre ili žučnog mjehura, pankreatitisa, odnosno umjereno ili ozbiljno smanjene funkcije bubrega, ili koje su prethodno imale poteškoća s mišićima prilikom uzimanja statina ili fibrata.
English: What are the risks associated with Cholib?
Croatian: Koji su rizici povezani s lijekom Cholib?
English: This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
Croatian: To znači da aktivira tip receptora naziva „peroksisomski proliferator aktivirajućih receptora alfa" (PPARα), koji je uključen u razgradnju masti iz prehrane, posebice triglicerida.
English: The second active substance, simvastatin, belongs to the group called ‘statins'.
Croatian: Druga djelatna tvar, simvastatin, ubraja se u grupu naziva „statini“.
English: With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns.
Croatian: S obzirom na sigurnost lijeka Cholib, nuspojave prijavljene u ispitivanjima bile su konzistentne s nuspojavama koje su poznate za dvije djelatne tvari, te ne postoje veći razlozi za zabrinutost.
English: In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin.
Croatian: U glavnom ispitivanju u kojem je uspoređen lijek Cholib 145/20 mg sa simvastatinom 40 mg u 1.050 bolesnika koji nisu na primjeren način liječeni samo s 20 mg simvastatina, razine triglicerida smanjile su se za otprilike 36% s lijekom Cholib nakon 12 tjedana u usporedbi s 12% sa simvastatinom.
English: The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Croatian: Djelatne tvari u lijeku Cholib, fenofibrat i simvastatin, djeluju na različite načine, a njihovo djelovanje ima komplementaran učinak.
English: The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
Croatian: Povjerenstvo je također odlučilo da se kombinacija fenofibrata i simvastatina već koristi u dobroj kliničkoj praksi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective at improving blood fat levels.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji smatra da se kombinacija fenofibrata i simvastatina pokazala djelotvornom u poboljšavanju razina masti u krvi.
English: Two further studies compared Cholib with other statins (atorvastatin and pravastatin) and showed Cholib to be more effective than those statins given alone.
Croatian: Dva daljnja ispitivanja usporedila su Cholib s drugim statinima (atorvastatinom i pravastatinom) i dokazala da je Cholib djelotvorniji od primjene samo statina.
English: It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Croatian: Pokazalo se da je Cholib rezultirao većim smanjenjem razina triglicerida (33% u odnosu na 7%), te povišenom razinom dobrog kolesterola (6% povećanje u odnosu na 1% smanjenja).
English: In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Croatian: Nadalje, razine dobrog kolesterola povećale su se za otprilike 7% s lijekom Cholib u usporedbi s otprilike 2% sa simvastatinom.
English: Cholib is a medicine for improving blood fat levels.
Croatian: Cholib jest lijek za poboljšavanje razina masti u krvi.
English: Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad' cholesterol (LDL cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
Croatian: Cholib je indiciran za uporabu u odraslih osoba koje su izložene riziku od srčanih bolesti čije se razine „lošeg“ kolesterola (LDL kolesterola) već kontroliraju samo odgovarajućom dozom simvastatina.
English: When these receptors are activated, the breakdown of fats speeds up, which helps clear the blood of ‘bad' cholesterol and triglycerides.
Croatian: Nakon što su ovi receptori aktivirani, razgradnja masti se ubrzava, što pomaže pri čišćenju krvi od „lošeg“ kolesterola i triglicerida.
English: This is a summary of the European public assessment report (EPAR) for Cholib.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Cholib.
English: The Committee therefore concluded that Cholib's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo je stoga zaključilo da koristi lijeka Cholib nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone.
Croatian: Drugo ispitivanje usporedilo je Cholib 145/40 mg sa simvastatinom 40 mg u 450 bolesnika koji nisu na primjeren način liječeni samo sa 40 mg simvastatina.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Cholib uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine.
Croatian: Cholib se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na kikiriki, soja lecitin ili bilo koju drugu pomoćnu tvar.
English: What benefits of Cholib have been shown in studies?
Croatian: Koje koristi lijeka Cholib su dokazane u ispitivanjima?
English: As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Croatian: S obzirom da je jetri potreban kolesterol za proizvodnju žući, smanjena razina kolesterola u krvi uzrokuje da stanice jetre proizvode receptore koji privlače kolesterol iz krvi, te još više smanjuju njegovu razinu.
English: The most common side effects with Cholib are raised blood creatinine levels, upper respiratory tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme).
Croatian: Najčešće nuspojave s lijekom Cholib su povišene razine kreatinina u krvi, upala gornjeg respiratornog trakta (prehlade), povećanje broja trombocita, gastroenteritis (proljev i povraćanje) i povišene razine alanin-aminotransferaze (enzima jetre).
English: It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Croatian: Smanjuje ukupan kolesterol u krvi tako što inhibira djelovanje HMG-CoA reduktaze, enzima u jetri uključenog u proizvodnju kolesterola.
English: In all studies the reductions in triglycerides and the increases in good cholesterol were higher with Cholib than with a statin alone.
Croatian: U svim je ispitivanjima smanjenje triglicerida i povećanje dobrog kolesterola bilo veće s lijekom Cholib nego samo sa statinom.
English: For practical information about using Cholib, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Cholib bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Grapefruit juice should be avoided during Cholib treatment as this is known to alter the amount of simvastatin in the blood.
Croatian: Tijekom liječenja lijekom Cholib treba izbjegavati sok od grejpa s obzirom da je poznato da mijenja količinu simvastatina u krvi.
English: For more information about treatment with Cholib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Cholib pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
Croatian: Cholib se pokazao djelotvornijim od samog statina u smanjivanju razina triglicerida i u povećavanju razina dobrog kolesterola.
English: It contains two active substances, fenofibrate and simvastatin, and is used together with a low fat diet and exercise with the aim of reducing patients' levels of triglycerides (a type of fat) and increasing their levels of ‘good' cholesterol (HDL cholesterol).
Croatian: Sadrži dvije djelatne tvari, fenofibrat i simvastatin te se primjenjuje se zajedno s dijetom siromašnom mastima i tjelovježbom sa ciljem smanjivanja razina triglicerida (tipa masti) u bolesnika i povećavanja razina „dobrog“ kolesterola (HDL kolesterol).
English: How does Cholib work?
Croatian: Kako Cholib djeluje?
English: How is Cholib used?
Croatian: Kako se Cholib koristi?
English: Before starting treatment with Cholib, possible causes of the abnormal levels of blood fats should be adequately treated and patients should be placed on a standard fat-lowering diet.
Croatian: Mogući uzroci abnormalnih razina masti u krvi moraju se odgovarajuće liječiti prije početka terapije lijekom Cholib, a bolesnici se moraju staviti na odgovarajuću dijetu za snižavanje razine masti u krvi.
English: For the full list of all side effects reported with Cholib, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Cholib potražite u uputi o lijeku.
English: Intravenous use ampoule (glass) 10 ml
Croatian: Ampula (staklo) 10 ml
English: 10 ampoules
Croatian: 10 ampula
English: 6 ml
Croatian: Bočica (staklo) 6 ml
English: * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Croatian: * Relativna jedinica djelovanja određena ELISA antigenom kvantifikacije (in vitro test) u odnosu na referentna cjepiva.
English: --1 Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Croatian: --1 Inaktivirani rekombinantni himerni cirkovirus svinja, tipa 1 koji sadrži cirkovirus svinja, tipa 2 ORF2 protein 2,3-12,4 RP * Inaktivirana Mycoplasma hyopneumoniae, soj P-5722-3 (inaktivirani)
English: Inactivated Mycoplasma hyopneumoniae strain P-5722-3 (inactivated)
Croatian: 1,5-3,8 RP *
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Croatian: • Ovo Povjerenstvo razmotrilo upućivanje sukladno članku 30 Direktive 2001/83/EC
English: A harmonised Module 3 was also adopted.
Croatian: Prihvaćen je i usklađen Modul 3.
English: Measurement of serum concentration
Croatian: Mjerenje koncentracije u serumu
English: • Bacteraemia/ Septicaemia / Sepsis
Croatian: • Bakteremija/ septikemija / sepsa
English: Section 4.1 of the SmPC does not include the paediatric population in all Member States.
Croatian: Odjeljak 4.1 SmPC-a ne uključuje u svim državama članicama pedijatrijsku populaciju.
English: • Infective endocarditis
Croatian: • Infektivni endokarditis
English: The study protocol of this non-interventional PASS shall be submitted within 2 months as of the Commission Decision.
Croatian: Ovaj protokol istraživanja neintervencijskog PASS-a mora se predati unutar 2 mjeseca od Odluke povjerenstva.
English: Risk minimisation activities
Croatian: Aktivnosti za smanjenje rizika
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of the Commission Implementing Regulation (EC) No 520/2012.
Croatian: Protokoli, sažeci i konačna izvješća istraživanja moraju se predati u obliku zadanom u Dodatku III dokumenta Commission Implementing Regulation (EU) br. 520/2012.
English: Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3.
Croatian: Neke potkomponente su zapravo skupine manjih vršnih vrijednosti (A2-1, A2-3, A2-5 i A3).
English: Additionally, as mentioned above, the MAH has been requested to perform an appropriate PASS to evaluate the safety of this higher dosage.
Croatian: Pored toga, kao što je spomenuto i gore, od nositelja odobrenja se tražilo da provede odgovarajući PASS kako bi se provjerila sigurnost ovih viših doza.
English: Targocid is not administered by the intraventricular route and is mentioned as a special warning in section 4.4.
Croatian: Targocid se ne daje intraventrikularnim putem, što je kao posebno upozorenje spomenuto u odjeljku 4.4.
English: Information on development, manufacture and control of the finished product has been presented in a satisfactory manner.
Croatian: Na zadovoljavajući su način predstavljene informacije o razvoju, proizvodnji i kontroli gotovog proizvoda.
English: • Clinical issues
Croatian: • Klinička pitanja
English: Risk management plan (RMP)
Croatian: Plan upravljanja rizicima (engl. kratica: RMP)
English: Simplified dosing regimens of teicoplanin for patient groups stratified by renal function and weight using Monte Carlo simulation.
Croatian: Simplified dosing regimens of teikoplanin for patient groups stratified by renal function and weight using Monte Carlo simulation.
English: The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that these products should have a satisfactory and uniform performance.
Croatian: Rezultati provedenih ispitivanja pokazuju zadovoljavajuću postojanost i jednolikost važnih kvalitativnih svojstava proizvoda, što bi trebalo voditi zaključku da bi ovi proizvodi trebali imati zadovoljavajuće i jednoliko djelovanje.
English: The PASS protocol should also be included in the RMP.
Croatian: U RMP se mora uključiti i protokol navedenog PASS-a.
English: In keeping with the adult studies, the clinical cure was > 80%.
Croatian: Sukladno istraživanjima na odraslim osobama kliničko je izlječenje iznosilo > 80%.
English: Chemother 1997 ; 39: 789-96.
Croatian: J Antimicrob Chemother 1997 ; 39: 789-96.
English: However due to its limited spectrum of antibacterial activity, a crossreference to section 4.4 commenting on the limited spectrum of antibacterial use and its rational use has been included.
Croatian: Ipak, zbog njegova ograničenog spektra antibakterijskog djelovanja, bila je uključena i unakrsna referenca na odjeljak 4.4 u kojemu se govori o ograničenu spektru antibakterijske upotrebe i njegovoj racionalnoj upotrebi.
English: Whereas
Croatian: Pri tome je
English: Four clinical studies provided data in children treated with specific paediatric protocols, and one study that included 7 neonates.
Croatian: Četiri su klinička ispitivanja pružila podatke o djeci liječenoj specifičnim pedijatrijskim protokolima, a jedno je istraživanje uključivalo 7 novorođenčadi.
English: In most of them the posology for children, neonates and new-borns is mentioned in section 4.2.
Croatian: U većini njih je doziranje za djecu i novorođenčad spomenuto u odjeljku 4.2.
English: • Quality issues
Croatian: • Pitanja kvalitete
English: The clinical cure and improvement rate was about 90% and bacteriological success rate was 76%.
Croatian: Stopa kliničkog poboljšanja i izlječenja iznosila je približno 90%, a stopa uspješnog bakteriološkog djelovanja 76%.
English: The shelf-life of the product is supported by relevant stability data.
Croatian: Rok trajanja ovog proizvoda u skladu je s relevantnim podacima o stabilnosti.
English: It can be concluded that batch results prove good consistency of the manufacturing process.
Croatian: Može se zaključiti da skupni rezultati dokazuju dobru dosljednost postupka proizvodnje.
English: Nevertheless a warning has been added in this section that “Teicoplanin should not be administered by intraventricular route”.
Croatian: Svejedno je u ovaj odjeljak bilo dodano upozorenje da se „teikoplanin ne smije davati intraventrikularnim putem”.
English: The study protocol shall be entered in the EU electronic register of postauthorisation studies (EU PAS Register) before the start of data collection.
Croatian: Protokol ovoga istraživanja mora se unijeti u elektronički registar istraživanja nakon izdavanja odobrenja EU-a (engl. EU PAS Register), a prije početka sakupljanja podataka.
English: agitation and vomiting are confounded by concomitant treatments or clinical situation.
Croatian: Uznemirenost i povraćanje možda su izazvala usporedna liječenja ili klinička situacija.
English: Measurement of trough serum concentrations is also recommended at least once a week during the maintenance treatment.
Croatian: Mjerenje najnižih koncentracija u serumu ujedno se preporuča i tijekom terapije održavanja, najmanje jednom tjedno.
English: The loading dose of 12mg/kg bid is in line with what is currently recommended in the SmPCs in France and Finland.
Croatian: Početna doza od 12 mg/kg bid sukladna je aktualnim preporukama iz SmPC-a u Francuskoj i Finskoj.
English: Harmonisation of the active substance specification was needed as tighter limits for the individual subcomponents were approved in some Member States, compared to the current Ph. Eur.
Croatian: Usklađivanje specifikacija djelatne tvari bilo je potrebno jer su, u usporedbi s aktualnom Ph. Eur., u nekim državama članicama bila odobrena stroža ograničenja za pojedine potkomponente.
English: • Skin and soft tissue infections (SSTI)
Croatian: • Infekcije kože i mekih tkiva (SSTI)
English: As ‘Sepsis' is generally a secondary condition to a primary site infection, it was not considered to be acceptable as a stand-alone indication, and was therefore deleted from the list of indications.
Croatian: Budući da je „sepsa” kao takva sekundarno stanje, nastalo zbog infekcije na nekom primarnome mjestu, ona se nije smatrala prihvatljivom kao samostalna indikacija pa je stoga bila izbrisana s popisa indikacija.
English: The data was not considered to be sufficiently robust as they were open labelled comparative studies that did not demonstrate that teicoplanin was better than the comparators.
Croatian: Predočene se podatke nije smatralo dovoljno čvrstima jer je riječ o otvorenim usporednim istraživanjima koja nisu pokazala da je teikoplanin bio bolji od tvari s kojima je uspoređivan.
English: The pharmacokinetics of teicoplanin in infants and children.
Croatian: The pharmacokinetics of teikoplanin in infants and children.
English: 4 Reed MD, Yamashita TS, Myers CM, et al.
Croatian: Reed MD, Yamashita TS, Myers CM i sur.
English: The pharmacokinetics of teicoplanin for the treatment of Clostridium difficile was investigated in study DRC342-DLI073.
Croatian: Farmakokinetička svojstva teikoplanina u liječenju infekcija s Clostridium difficile bila su predmetom istraživanja DRC342-DLI073.
English: The clinical development focussed on the susceptibility of gram-positive bacteria to teicoplanin and not on specific indications.
Croatian: Klinički je razvoj usmjeren na osjetljivost gram-pozitivnih bakterija na teikoplanin, a ne na specifične indikacije.
English: For infective endocarditis, the CHMP considered that 21 days would be the minimum period of use, and that treatment beyond 4 months should be avoided.
Croatian: Kod infektivnog endokarditisa CHMP je smatrao da bi najkraće trajanje primjene bilo 21 dan, te da bi se trebalo izbjegavati liječenje duže od 4 mjeseca.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Croatian: Dodatak II Znanstveni zaključci i temelji za izmjenu uvjeta
English: The finished product dossier was updated to include compatibility studies with various types of diluents, PVC bags and syringes, together with in-use stability data.
Croatian: Dosje gotovog proizvoda bio je ažuriran kako bi uključio istraživanja kompatibilnosti s različitim vrstama otapala, PVC vrećicama i štrcaljkama, zajedno s podacima o stabilnosti prilikom upotrebe.
English: Since teicoplanin is already used in children in most member states and clinical guidelines recommend its use in children, the indication for the use of teicoplanin in children, as well as in neonates and infants was supported by the CHMP.
Croatian: Budući da se teikoplanin već upotrebljava za liječenje djece u većini država članica, te da kliničke smjernice preporučuju njegovu upotrebu kod djece, CHMP je podupirao indikaciju upotrebe teikoplanina kod djece, kao i kod novorođenčadi.