FrancophonIA/ELRC3.0 huggingface dataset:
English: Component 1: 2 ml of human fibrinogen (80 mg/ml) Component 2: 2 ml of human thrombin (500 IU/ml)
Croatian: Komponenta 1: 2 ml ljudskog fibrinogena (80 mg/ml) Komponenta 2: 2 ml ljudskog trombina (500 IU/ml)
English: Remove the Airless Spray Tip portion of the spray and drip tip by unscrewing the Airless Spray Tip.
Croatian: Bezračni nastavak za raspršivanje odvrnite s nastavka za primjenu raspršivanjem i kapanjem i uklonite ga.
English: Solutions for sealant.
Croatian: Primjena kapanjem
English: 22 May 2015 EMA/324341/2015
Croatian: 16 July 2015 EMA/466132/2015
English: Patients and healthcare professionals are advised of the following:
Croatian: Bolesnici i zdravstveni radnici obavješćuju se o sljedećem:
English: • Patients should continue to take their medicines as prescribed and contact their doctor or pharmacist if they have any questions.
Croatian: • Bolesnici trebaju nastaviti uzimati svoje lijekove kako su im propisani i obratiti se svojem liječniku ili ljekarniku ako imaju bilo kakvih pitanja.
English: For medicines that are considered critical, companies are given 12 months to submit additional data.
Croatian: Za lijekove koji se smatraju izuzetno važnima, tvrtkama se daje 12 mjeseci za dostavljanje dodatnih podataka.
English: Some of these medicines may remain on the market in some countries if they are of critical importance for patients because alternatives cannot meet patients' needs.
Croatian: Neki od tih lijekova mogu ostati u prometu u pojedinim državama ako su izuzetno važni za bolesnika budući da alternativni lijekovi ne mogu udovoljiti potrebama bolesnika.
English: For around 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU.
Croatian: Za otprilike 300 drugih farmaceutskih oblika i jačina dostavljeni su dostatni podaci iz drugih izvora koji podržavaju njihovu primjenu; stoga ti lijekovi ostaju u prometu unutar EU-a.
English: 1 Bivolet (nebivolol) 5 mg tablets (marketing authorisation holder: Neo Balkanika EOOD); the product has now been removed from the list of medicines recommended for suspension.
Croatian: 1 Bivolet (nebivolol) tablete od 5 mg (nositelj odobrenja za stavljanje lijeka u promet: Neo Balkanika EOOD); lijek je uklonjen s popisa lijekova za koje se preporuča suspenzija.
English: Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated.
Croatian: Njihova sustavnost, dugo razdoblje tijekom kojeg su se događale i broj članova osoblja koji su u njih bili uključeni baca sjenu na integritet provođenja ispitivanja na toj lokaciji općenito, kao i na pouzdanost dobivenih podataka.
English: This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.
Croatian: Komisija je donijela svoju odluku koja se primjenjuje na sve države članice bez obzira jesu li one poduzele privremene mjere za suspenziju lijekova.
English: The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years.
Croatian: Inspekcijom su otkrivene manipulacije podacima elektrokardiograma (EKG-ova) tijekom provođenja pojedinih ispitivanja generičkih lijekova, a čini se da su se odvijale tijekom razdoblja od pet godina.
English: National authorities will decide if some of the medicines recommended for suspension are critical in their countries.
Croatian: Nacionalna tijela donijet će odluku jesu li pojedini lijekovi koji su preporučeni za suspenziju izuzetno važni u njihovim državama.
English: EMA and national authorities work closely with international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that the companies involved comply fully with all aspects of Good Clinical Practice (GCP).
Croatian: EMA i nacionalna tijela usko surađuju s međunarodnim partnerima kako bi osigurali da su ispitivanja na kojima se temelje odobrenja za stavljanje lijeka u promet unutar EU-a provedena u skladu s najvišim standardima te da tvrtke uključene u ova ispitivanja u potpunosti udovoljavaju svim aspektima dobre kliničke prakse (GCP-a).
English: The updated list of medicines for which the CHMP recommends suspension is available on the EMA website.
Croatian: Ažurirani popis lijekova za koje je CHMP preporučio suspenziju dostupan je na internetskim stranicama EMA-e.
English: The CHMP's recommendation will now be sent to the European Commission for a legally binding decision.
Croatian: Preporuka CHMP-a dostavljena je Europskoj komisiji kako bi ona donijela pravno obvezujuću odluku.
English: This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned.
Croatian: To je ishod zahtjeva za ponovni pregled koji su zatražili nositelji odobrenja za sedam predmetnih lijekova.
English: Medicines considered critically important for patients to remain available
Croatian: Lijekovi koji se smatraju izuzetno važnima za bolesnike ostat će dostupni
English: • National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
Croatian: • Nacionalna tijela unutar EU-a razmotrit će koliko su važni pojedini ti lijekovi u njihovim državama i donijeti konačne odluke o tome treba li ove lijekove suspendirati ili dopustiti da ostanu dostupni do dostavljanja dodatnih podataka.
English: During the re-examination, the CHMP concluded that concerns about reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available.
Croatian: Tijekom ponovnog pregleda CHMP je zaključio da su zabrinutosti vezane uz pouzdanost kliničkih ispitivanja opravdane i stoga je ostao pri preporuci iz siječnja 2015. kojom se suspendiraju lijekovi za koje ne postoje podaci iz drugih ispitivanja koji bi podržavali njihovu primjenu.
English: This is with the exception of one medicine included in the re-examination for which concerns about studies were addressed.
Croatian: Iznimku predstavlja jedan lijek uključen u ponovno ispitivanje za koji su uklonjene zabrinutosti u vezi s ispitivanjima.
English: Following a request from some marketing authorisation holders, the CHMP re-examined its January 2015 opinion.
Croatian: Po zahtjevu pojedinih nositelja odobrenja za stavljanje lijeka u promet, CHMP je ponovno pregledao svoje mišljenje iz siječnja 2015.
English: • There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by GVK Biosciences.
Croatian: • nema dokaza o štetnosti ili nedostatku djelotvornosti bilo kojeg lijeka povezanog s ispitivanjima koja je provela tvrtka GVK Biosciences.
English: As a result of the CHMP's January 2015 opinion and the re-examination, around 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension.
Croatian: Kao rezultat mišljenja CHMP-a iznesenog u siječnju 2015. i ponovnog pregleda, za suspenziju je preporučeno otprilike 700 farmaceutskih oblika i jačina lijekova koji su ispitivani na lokaciju u Hyderabadu.
English: The review was initiated on 25 September 2014 at the request of the European Commission, under Article 31 of Directive 2001/83/EC, in relation to findings by the French medicines agency (ANSM) of non-compliance with Good Clinical Practice (GCP) at the GVK Biosciences' site in Hyderabad, India.
Croatian: Pregled je započet 25. rujna 2014. na zahtjev Europske Komisije u skladu s člankom 31. Direktive 2001/83/EZ u vezi s nalazima francuske agencije za lijekove (ANSM-a) o nesukladnosti s dobrom kliničkom praksom (GCP-om) na lokaciji tvrtke GVK Biosciences u Hyderabadu, Indija.
English: • Some medicines considered critical for patients will remain on the market in some countries pending the submission of new data.
Croatian: • Pojedini lijekovi koji se smatraju izuzetno važnima za bolesnike ostaju u prometu u pojedinim državama članicama do dostavljanja novih podataka.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted in January 2015 an opinion on the marketing authorisation of these medicines.
Croatian: Odbor za lijekove za humanu uporabu (CHMP), tijelo odgovorno za pitanja u vezi s lijekovima za humanu uporabu, proveo je pregled i u siječnju 2015. donio mišljenje o odobrenju za stavljanje u promet tih lijekova.
English: This medicine is now no longer recommended for suspension.1
Croatian: Taj je lijek uklonjen s liste lijekova koji su preporučeni za suspenziju.1
English: The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country.
Croatian: Odluku o tome je li lijek izuzetno važan za bolesnike trebaju donijeti nacionalna tijela država članica EU-a.
English: The CHMP noted that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad.
Croatian: CHMP je zaključio da ne postoje dokazi o štetnosti ili nedostatku djelotvornosti u vezi s ispitivanjima koja je provela tvrtka GVK Biosciences u Hyderabadu.
English: The CHMP has now adopted its final opinion, which will be forwarded to the European Commission, for a legally binding decision applicable in all EU Member States.
Croatian: Konačno mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je donijela konačnu pravno obvezujuću odluku primjenjivu u svim državama članicama EU-a dana
English: EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted its original recommendation in January 2015 following an inspection of GVK Biosciences' site at Hyderabad by the French medicines agency (ANSM) that raised concerns about how GVK Biosciences conducted studies at the site on behalf of marketing authorisation holders.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji donio je svoju izvornu preporuku u siječnju 2015. nakon što je francuska agencija za lijekove (ANSM-a) provela inspekciju lokacije tvrtke GVK Biosciences u Hyderabadu i iznijela svoju zabrinutost o načinu na koji je tvrtka GVK Biosciences provela ispitivanja na toj lokaciji u ime nositelja odobrenja.
English: The European Medicines Agency (EMA) has confirmed its recommendation to suspend a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.
Croatian: Dana 21. svibnja 2015. Europska agencija za lijekove (EMA) potvrdila je svoju preporuku za suspenziju niza lijekova čije se odobrenje u Europskoj uniji (EU) prvenstveno temeljilo na kliničkim ispitivanjima provedenima na lokaciji tvrtke GVK Biosciences u Hyderabadu, u Indiji.
English: The review covered nationally authorised medicines whose marketing authorisation applications included clinical data from studies conducted by GVK Biosciences at its Hyderabad site.
Croatian: Pregledom su bili obuhvaćeni nacionalno odobreni lijekovi čiji su zahtjevi za izdavanje odobrenja za stavljanje lijeka u promet obuhvaćali kliničke podatke iz ispitivanja provedenih na lokaciji tvrtke GVK Biosciences u Hyderabadu.
English: Information to patients and healthcare professionals A number of medicines are being considered for suspension in EU countries following concerns about how studies had been conducted at GVK Biosciences' site in Hyderabad, India.
Croatian: Razmatra se suspenzija niza u državama EU-a nakon što je izražena zabrinutost o ispitivanjima provedenima na lokaciji tvrtke GVK Biosciences u Hyderabadu, u Indiji.
English: • At the request of the European Medicines Agency;
Croatian: • na zahtjev Europske agencije za lijekove,
English: Date of first authorisation: 22 March 2016
Croatian: Datum prvog odobrenja: 22 Ožujak 2016
English: Distribution: Volume of distribution is approximately 21 L/kg.
Croatian: Distribucija: Volumen distribucije je otprilike 21 l/kg.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower strength.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik Vam može predložiti višu ili nižu jačinu.
English: * Based on patient weight of 50 kg
Croatian: * na temelju tjelesne težine bolesnika od 50 kg
English: 10 10.3 NA NA 9.0 9.5
Croatian: 10,3 ND ND 9,0 9,5
English: PVC/PCTFE blisters.
Croatian: PVC/PCTFE blisteri.
English: 117 Allée des parcs 69800 Saint Priest France
Croatian: 117 Allée des parcs 69800 Saint Priest Francuska
English: For Bottle packs: After first opening use within 100 days.
Croatian: Za boce: nakon otvaranja iskoristiti u roku od 100 dana.
English: Additional information on the combination
Croatian: Dodatne informacije o kombinaciji
English: Absolute bioavailability has been calculated as between 64 % and 80 %.
Croatian: Apsolutna bioraspoloživost je izračunata između 64% i 80%.
English: Swelling of the tongue and throat which causes great difficulty breathing.
Croatian: - Oticanje jezika i grla koje uzrokuje velike teškoće pri disanju.
English: A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
Croatian: Nekoliko bolesnika je imalo ove ozbiljne nuspojave (mogu se javiti u do 1 na 1000 osoba).
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Croatian: Nemojte koristiti ovaj lijek ako primijetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
English: Rare (may affect up to 1 in 1,000 people): Confusion.
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba): Smetenost.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107c stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Mylan Hungary Kft. Mylan utca 1, Komárom - 2900 Hungary
Croatian: Mylan utca 1, Komárom - 2900 Mađarska
English: if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na valsartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Carcinogenesis, mutagenesis
Croatian: Kancerogeneza, mutageneza
English: Valsartan is highly bound to serum proteins (94-97 %), mainly serum albumin.
Croatian: Valsartan se u velikoj mjeri veže na serumske proteine (94-97%), uglavnom na serumski albumin.
English: Mean absolute bioavailability is 23 %.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti je 23%.
English: Clarithromycin is an inhibitor of CYP3A4.
Croatian: Klaritromicin je inhibitor CYP3A4.
English: Swelling of eyelids, face or lips.
Croatian: - Oticanje očnih kapaka, lica ili usnica.
English: Valsartan is primarily eliminated in faeces (about 83 % of dose) and urine (about 13 % of dose), mainly as unchanged drug.
Croatian: Valsartan se primarno eliminira stolicom (oko 83% doze) i mokraćom (oko 13% doze), uglavnom kao nepromijenjen lijek.
English: (It is also better to avoid Amlodipine/Valsartan Mylan in early pregnancy, see Pregnancy section).
Croatian: (Također je bolje izbjegavati Amlodipin/Valsartan Mylan u ranoj trudnoći, vidjeti dio Trudnoća).
English: CARTON FOR BOTTLE AND BLISTER BOTTLE LABEL
Croatian: KUTIJA ZA BOCU I BLISTER NALJEPNICA NA BOCI
English: In vitro studies with amlodipine have shown that approximately 97.5 % of circulating drug is bound to plasma proteins.
Croatian: In vitro ispitivanja s amlodipinom pokazala su da se u otprilike 97,5% cirkulirajućeg lijeka veže na proteine plazme.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%.
Croatian: Procijenjen je udio majčine doze koju primi dojenče, i njegov interkvartilni raspon iznosio je 3 - 7%, uz maksimum od 15%.
English: Biotransformation: Amlodipine is extensively (approximately 90 %) metabolised in the liver to inactive metabolites.
Croatian: Biotransformacija: Amlodipin se u velikoj mjeri (otprilike 90%) metabolizira u jetri do inaktivnih metabolita.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10 % of the valsartan AUC).
Croatian: U plazmi je identificiran hidroksi-metabolit u niskoj koncentraciji (manje od 10% AUC valsartana).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Mean systemic AUC of valsartan is higher by 70 % in the elderly than in the young, therefore caution is required when increasing the dosage.
Croatian: Srednja sistemska vrijednost AUC valsartana viša je za 70% u starijih osoba nego u mladih osoba, te je stoga nužan oprez pri povećavanju doze.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to amlodipine/valsartan.
Croatian: Dob, spol, rasa ili indeks tjelesne mase (≥30 kg/m 2, <30 kg/m 2) nisu utjecali na odgovor na amlodipin/valsartan.
English: Amlodipine/Valsartan Mylan is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Amlodipin/Valsartan Mylan se ne preporučuje u ranoj trudnoći (prva 3 mjeseca) te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and angiotensin II receptor blockers (ARBs).
Croatian: S obzirom na njihova slična farmakodinamička svojstva, ti su rezultati relevantni i za druge ACE inhibitore i blokatore angiotenzin II receptora (ARB-ove).
English: In two long-term follow-up studies the effect of amlodipine/valsartan was maintained for over one year.
Croatian: U dva dugotrajna ispitivanja praćenja, učinak amlodipina/valsartana bio je održan tijekom više od jedne godine.
English: Over 1,400 hypertensive patients received amlodipine/valsartan once daily in two placebo-controlled trials.
Croatian: Više od 1400 hipertenzivnih bolesnika primalo je amlodipin/valsartan jednom dnevno u dva placebo kontrolirana klinička ispitivanja.
English: (calculations assume an oral dose of 320 mg/day and a 60 kg patient).
Croatian: (u izračunima je korištena pretpostavka da je peroralna doza 320 mg/dan i da je tjelesna težina bolesnika 60 kg).
English: The safety of amlodipine in human pregnancy has not been established.
Croatian: Sigurnost amlodipina u ljudskoj trudnoći nije ustanovljena.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with amlodipine/valsartan.
Croatian: Ako se diuretik također koristi, rizik od toksičnosti litija vjerojatno se može povećati i više s amlodipinom/valsartanom.
English: At the time of Commission Decision
Croatian: U vrijeme donošenj a Odluke Komisije
English: In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine.
Croatian: U marmoseta su pri usporedivim dozama promjene bile slične iako teže, osobito u bubrezima, gdje su se promjene razvile u nefropatiju uključujući povišenu ureju u krvi i kreatinin.
English: Amlodipine/Valsartan Mylan and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Croatian: Amlodipin/Valsartan Mylan i starije osobe (u dobi od 65 ili više godina) Vaš liječnik treba oprezno postupati kod povećavanja doze.
English: Biotransformation: Valsartan is not transformed to a high extent as only about 20 % of dose is recovered as metabolites.
Croatian: Biotransformacija: Valsartan se ne transformira u većoj mjeri, budući da se svega 20% doze može naći u obliku metabolita.
English: Correction of this condition prior to administration of amlodipine/valsartan or close medical supervision at the start of treatment is recommended.
Croatian: Preporučuje se korigiranje ovog stanja prije primjene amlodipina/valsartana ili pažljiv liječnički nadzor na početku liječenja.
English: The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Croatian: Sigurnost i djelotvornost amlodipina u hipertenzivnoj krizi nisu ustanovljene.
English: If you forget to take Amlodipine/Valsartan Mylan If you forget to take this medicine, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti Amlodipin/Valsartan Mylan Ako zaboravite uzeti ovaj lijek, uzmite ga čim se sjetite.
English: To date there is no experience of the safe use of amlodipine/valsartan in patients who have had a recent kidney transplantation.
Croatian: Do danas ne postoji iskustvo o sigurnoj primjeni amlodipina/valsartana u bolesnika kojima je nedavno transplantiran bubreg.
English: Max. daily dose (mg)
Croatian: Maksimaln a dnevna doza (mg)
English: Not all pack sizes may be available in your country.
Croatian: Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja.
English: Pack sizes: 28, 56 or 98 film-coated tablets.
Croatian: Veličine pakiranja: 28, 56 ili 98 filmom obloženih tableta.
English: Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77 % increase in exposure to simvastatin compared to simvastatin alone.
Croatian: Istodobna primjena višestrukih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
English: See also information under the heading “Do not take Amlodipine/Valsartan Mylan”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Amlodipin/Valsartan Mylan“.
English: As expected for a compound where renal clearance accounts for only 30 % of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Croatian: Kao što se i očekuje za lijek čiji bubrežni klirens iznosi samo 30% ukupnog klirensa iz plazme, nije uočena korelacija između funkcije bubrega i sistemske izloženosti valsartanu.
English: Your doctor will normally advise you to stop taking Amlodipine/Valsartan Mylan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amlodipine/Valsartan Mylan.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Amlodipin/Valsartan Mylan prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto lijeka Amlodipin/Valsartan Mylan.
English: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Croatian: Poluvijek amlodipina je produljen i vrijednosti AUC-a su više u bolesnika s oštećenom jetrenom funkcijom; preporuke za doziranje nisu ustanovljene.