FrancophonIA/ELRC3.0 huggingface dataset:
English: * Withdrawal period (milk): - Zero hours after calving (when the dry period length is 32 days or more) - 4 days (8 milkings) after calving (when the dry period length is less than 32 days)
Croatian: * Karencija (mlijeko): - nula sati nakon telenja (ako je suhostaj trajao 32 dana ili dulje) - 4 dana (8 mužnji) nakon telenja (ako je suhostaj trajao kraće od 32 dana)
English: Cattle (dairy cows)
Croatian: Goveda (muzne krave)
English: Target species
Croatian: Ciljne vrste životinja
English: Solution for injection
Croatian: Otopina za injekciju
English: Packaging Content Package size
Croatian: Put primjene Pakovanje Sastav Veličina pakovanja
English: EU/2/15/192/001 Velactis 1.12 mg/ml
Croatian: Karencija mg/ml
English: Withdrawal period
Croatian: EU broj odobrenja
English: Annex A EU (MA) Number Invented name
Croatian: Izmišljeno ime
English: 1 April 2016
Croatian: 1. travnja 2016.
English: Outcome of re-examination
Croatian: Ishod ponovnog pregleda
English: More information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Ovdje možete pronaći dodatne informacije o lijekovima za rijetke bolesti: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The applicant requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva zatražio je ponovni pregled mišljenja.
English: What is Dropcys?
Croatian: Što je Dropcys?
English: During the re-examination, the CHMP looked again at the data from the company.
Croatian: Tijekom ponovnog pregleda, CHMP je ponovno pregledao podatke tvrtke.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje posljedice ovo odbijanje zahtjeva ima za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: What were the CHMP's main concerns that led to the refusal?
Croatian: Koji su glavni razlozi za zabrinutost CHMP-a rezultirali odbijanjem?
English: The Committee confirmed the opinion that the effectiveness of Dropcys in the treatment of corneal deposits had not been sufficiently demonstrated and that there were unresolved issues regarding the formulation and long-term safety and sterility of the medicine.
Croatian: Odbor je potvrdio mišljenje da djelotvornost lijeka Dropcys u liječenju taloženja u rožnici nije dovoljno dokazana i da postoje neriješena pitanja u vezi s formulacijom i dugoročnom sigurnosti i sterilnosti lijeka.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 1 April 2016.
Croatian: Nakon razmatranja razloga za ovaj zahtjev, CHMP je ponovno ispitao prvotno mišljenje i potvrdio odbijanje davanja odobrenja za stavljanje lijeka u promet dana 1. travnja 2016.
English: The build-up of cystine crystals inside corneal cells can damage the eyes and cause serious vision problems.
Croatian: Nagomilavanje cistinskih kristala unutar stanica rožnice može oštetiti oči i izazvati ozbiljne probleme s vidom.
English: In addition, the CHMP had concerns regarding other ingredients of the medicine, their impact on long-term safety, particularly in children, and how stable and sterile the solution would be once prepared.
Croatian: Osim toga, CHMP je bio zabrinut u vezi s ostalim sastojcima lijeka, njihovim utjecajem na dugoročnu sigurnost, osobito kod djece, te u kojoj bi mjeri otopina ostala stabilna i sterilna nakon pripreme.
English: Dropcys is a medicine that contains the active substance mercaptamine hydrochloride (also known as cysteamine hydrochloride).
Croatian: Dropcys je lijek koji sadrži djelatnu tvar merkaptamin hidroklorid (također poznat pod nazivom cisteamin hidroklorid).
English: What did the company present to support its application?
Croatian: Koju je dokumentaciju tvrtka priložila zahtjevu?
English: Because mercaptamine has been used for many years to treat cystinosis and its use is well established, the applicant presented data from the medical literature to support its application for Dropcys.
Croatian: Budući da je merkaptamin dugi niz godina korišten za liječenje cistinoze i njegova je uporaba ustaljena, podnositelj zahtjeva iznio je podatke iz medicinske literature koji podupiru njegov zahtjev za Dropcys.
English: Cystinosis is a rare inherited disease caused by the accumulation of a substance called cystine, which forms crystals inside cells, particularly cells in the cornea and kidneys.
Croatian: Cistinoza je rijetka nasljedna bolest uzrokovana nakupljanjem tvari koja se zove cistin, koja tvori kristale unutar stanica, posebno stanica u rožnici i bubrezima.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Dropcys.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ili programa milosrdnog davanja lijeka Dropcys koji su u tijeku.
English: How was Dropcys expected to work?
Croatian: Kako je Dropcys trebao djelovati?
English: The active substance in Dropcys, mercaptamine hydrochloride, was expected to react with cystine to dissolve it and to form substances that could be removed from the cells.
Croatian: Očekivalo se da će djelatna tvar u lijeku Dropcys, merkaptamin hidroklorid, reagirati s cistinom tako da ga otopi i da nastanu tvari koje mogu biti uklonjene iz stanice.
English: The CHMP considered that the studies from the medical literature presented to support the application were insufficient.
Croatian: CHMP je zaključio da su ispitivanja iz medicinske literature priložena kao potpora zahtjevu bila nedostatna.
English: Ophthalmic (eye) formulations of mercaptamine are made up locally and used for the management of eye symptoms.
Croatian: Oftalmološke formulacije (formulacije za oči) merkaptamina napravljene su za lokalnu uporabu i koriste se za tretiranje simptoma na očima.
English: What was Dropcys expected to be used for?
Croatian: Za što se Dropcys trebao koristiti?
English: Medicines containing mercaptamine hydrochloride are authorised in the EU for use by mouth in the treatment of cystinosis.
Croatian: Lijekovi koji sadrže merkaptamin hidroklorid odobreni su u EU-u za oralnu primjenu u liječenju cistinoze.
English: Therefore, the CHMP was of the opinion that the benefits of Dropcys did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP smatrao da koristi od lijeka Dropcys ne nadmašuju s njime povezane rizike te je preporučio da se odbije davanje odobrenja za stavljanje lijeka u promet.
English: Although the role of mercaptamine eye drops in the treatment of corneal deposits appears sufficiently supported by the literature, current clinical recommendations and its routine use in hospital preparations, there were few data supporting the effectiveness of the concentration of mercaptamine used in Dropcys (0.1% solution).
Croatian: Iako se čini da literatura, postojeće kliničke preporuke i rutinsko korištenje u bolničkim pripravcima u dovoljnoj mjeri podupiru ulogu kapi za oko s merkaptaminom u liječenju taloženja u rožnici, priloženo je malo podataka koji podupiru djelotvornost koncentracije merkaptamina koja se nalazi u lijeku Dropcys (otopina u koncentraciji od 0,1 %).
English: Thus, the CHMP reaffirmed its previous recommendation that the medicine be refused marketing authorisation.
Croatian: Stoga je CHMP potvrdio svoju prethodnu preporuku da se odbije davanje odobrenja za stavljanje lijeka u promet.
English: Dropcys was expected to be used to prevent and treat cystinosis affecting the cornea.
Croatian: Dropcys se trebao koristiti za sprječavanje i liječenje cistinoze koja pogađa rožnicu.
English: It was to be available as a powder and a solvent, to make a solution for eye drops.
Croatian: Trebao je biti dostupan u obliku praška i otapala, za izradu otopina za kapi za oko.
English: Dropcys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 October 2014 for the treatment of cystinosis.
Croatian: Dropcys je 15. listopada 2014. označen kao lijek za rijetku bolest za liječenje cistinoze.
English: When the medicine is applied to the eye, the amount of cystine in the cells of the cornea was expected to be reduced, limiting the amount of eye damage.
Croatian: Očekivalo se da će se količina cistina u stanicama rožnice smanjiti pri primjeni lijeka u oko, što bi ograničilo stupanj oštećenja oka.
English: On 17 December 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dropcys, intended to prevent and treat the build-up of the amino acid cystine in the cornea (the transparent layer in front of the eye).The company that applied for authorisation in the EU is Lucane Pharma.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje, uz preporuku za odbijanje odobrenja za stavljanje u promet lijeka Dropcys, koji je namijenjen za sprječavanje i liječenje nagomilavanja aminokiseline cistina u rožnici (prozirni sloj ispred oka).
English: MA (EU) number (Invented) name Strength
Croatian: Broj (EU) odobrenja
English: Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Whereas
Croatian: Budući da:
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for metformin containing medicinal products.
Croatian: • CHMP je razmotrio postupak u skladu sa člankom 31. Direktive 2001/83/EZ za lijekove koji sadrže metformin.
English: Overall summary of the scientific evaluation
Croatian: Cjelokupan sažetak znanstvene ocjene
English: Grounds for CHMP opinion
Croatian: Obrazloženje mišljenja CHMP-a
English: On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Croatian: Stoga je Nizozemska 25. siječnja 2016. pokrenula postupak upućivanja u skladu s člankom 31. Direktive 2001/83/EZ te je zatražila od CHMP-a da ocijeni utjecaj navedenih razmatranja na omjer koristi i rizika od lijekova koji sadrže metformin te da izda mišljenje o tome treba li odgovarajuća odobrenja za stavljanje u promet zadržati, izmijeniti, obustaviti ili opozvati.
English: Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Croatian: Metformin, u monoterapiji ili kombinaciji s drugim lijekovima, smatra se prvim odabirom u liječenju dijabetesa tipa 2 (T2DM) i u širokoj je primjeni u EU-u
English: The risk of lactic acidosis is very rare in clinical practice and in the majority of cases only observed in emergency care.
Croatian: Rizik od laktacidoze vrlo je rijedak u kliničkoj praksi i u većini je slučajeva zabilježen samo u hitnoj medicinskoj skrbi.
English: These patients form a large population which currently may have not access to the benefits of metformin across the Union.
Croatian: Ti bolesnici čine veliku populaciju bolesnika kojima koristi od metformina trenutačno možda nisu dostupne diljem Unije.
English: Moreover, metformin treatment slows the further deterioration of renal function and provides additional significant micro-and macrovascular benefits in this patient population.
Croatian: Štoviše, liječenje metforminom usporava daljnje pogoršanje funkcije bubrega i pruža značajne dodatne mikrovaskularne i makrovaskularne koristi za navedenu populaciju bolesnika.
English: It is considered in the interest of the Union that the adequacy of the current recommendations for metformin containing products is re-evaluated with respect to the use in patients with moderate renal failure, taking into account the available information on the risk of lactic acidosis.
Croatian: Smatra se da je u interesu Unije da se provede ponovna procjena prikladnosti postojećih preporuka za lijekove koji sadrže metformin u bolesnika s umjerenim zatajenjem bubrega, uzimajući u obzir dostupne informacije o riziku od laktacidoze.
English: In addition, although causality cannot be ruled out, other factors rather than metformin are most likely the causes of lactic acidosis.
Croatian: Osim toga, iako se uzročnost ne može isključiti, vrlo je vjerojatno da laktacidozu uzrokuju drugi čimbenici, a ne metformin.
English: In addition, published epidemiological studies indicate that metformin is often used in clinical practice in patients with moderate renal impairment as reflected in current clinical guidelines without a marked increase in risk of lactic acidosis or other serious side effects.
Croatian: Osim toga, objavljene epidemiološke studije ukazuju na to da se metformin često primjenjuje u kliničkoj praksi u bolesnika s umjerenim oštećenjem bubrega, što je vidljivo u postojećim kliničkim smjernicama, i to bez značajnog većeg rizika od laktacidoze ili drugih ozbiljnih nuspojava.
English: As there is a clear relationship between renal function and metformin exposure, a recommendation for a daily dose of 2000 mg/day and 1000 mg/day dose in patients with moderate renal impairment stages 3a and 3b, respectively, can be concluded from the data provided.
Croatian: S obzirom na jasan odnos između funkcije bubrega i izloženosti metforminu, iz dostavljenih podataka može se zaključiti da je u bolesnika s umjerenim oštećenjem bubrega faze 3a i 3b preporučena dnevna doza od 2 000 mg, odnosno od 1 000 mg dnevno.
English: Currently the use of metformin in patients with renal failure is not harmonised across the EU, being contraindicated in patients with different stages of moderate renal failure depending on the member state and product.
Croatian: Primjena metformina u bolesnika sa zatajenjem bubrega trenutačno nije usklađena u EU-u s obzirom na to da je lijek kontraindiciran u bolesnika s različitim fazama umjerenog zatajenja bubrega, ovisno o državi članici i proizvodu.
English: Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Croatian: Ako izuzmemo laktacidozu, ukupni sigurnosni profil metformina u bolesnika s umjerenim oštećenjem bubrega sličan je sigurnosnom profilu u bolesnika s normalnom funkcijom bubrega.
English: The most common side-effects observed in association with metformin use in diabetic individuals are mild to moderate gastrointestinal events including diarrhea, nausea, vomiting, abdominal pain, and decreased appetite.
Croatian: Najčešće zabilježene nuspojave povezane s primjenom metformina u osoba s dijabetesom jesu gastrointestinalne pojave blagog do umjerenog stupnja koje uključuju proljev, mučninu, povraćanje, abdominalnu bol i smanjeni apetit.
English: In addition, routine pharmacovigilance activities will be extended to include a cumulative review and a targeted follow up questionnaire on lactic acidosis cases to be submitted in subsequent PSURs.
Croatian: Osim toga, rutinske farmakovigilancijske aktivnosti proširit će se uvrštavanjem kumulativnog ocjenjivanja i ciljanog kontrolnog upitnika o slučajevima laktacidoze u sljedeće PSUR-ove.
English: • The CHMP considered that publications in the medical literature have shown that metformin at reduced dose may be safely used in patients with moderate renal impairment.
Croatian: • CHMP je zaključio da su publikacije u medicinskoj literaturi pokazale da se metformin može sigurno primjenjivati u manjim dozama u bolesnika s umjerenim oštećenjem bubrega.
English: Based on the review of all available data on safety and efficacy, the benefit-risk balance of medicinal products containing metformin remains favourable and it is recommended that the marketing authorisations are varied regarding the use in renal impairment.
Croatian: Na temelju pregleda svih dostupnih podataka o sigurnosti i djelotvornosti, omjer koristi i rizika lijekova koji sadrže metformin ostaje povoljan te se preporučuje izmjena odobrenja za stavljanje lijeka u promet za primjenu kod oštećenja bubrega.
English: • The CHMP reviewed the totality of the data submitted by the MAHs on the safety and efficacy of metformin containing medicinal products for the treatment of Type 2 diabetes mellitus in subjects with moderate renal impairment (GFR 30-59 ml/min) with a focus on the risk of lactic acidosis.
Croatian: • CHMP je pregledao sve podatke koje su dostavili nositelji odobrenja za stavljanje lijeka u promet o sigurnosti i djelotvornosti lijekova koji sadrže metformin za liječenje dijabetesa tipa 2 u bolesnika s umjerenim oštećenjem bubrega (GFR 30 - 59 ml/min) uz usredotočenost na rizik od laktacidoze.
English: • The CHMP considered the evidence from epidemiological studies, which have shown that lactic acidosis is a very rare condition that occurs most often in patients with acute renal or cardiorespiratory illness or sepsis.
Croatian: • CHMP je razmotrio dokaze iz epidemioloških ispitivanja koja su pokazala da je laktacidoza vrlo rijetko stanje do kojeg najčešće dolazi u bolesnika s akutnim oboljenjem bubrega, kardiorespiratornom bolesti ili sepsom.
English: The benefits of metformin in the treatment of T2DM in patients with moderate renal impairment have been demonstrated in terms of the reduction of cardiovascular risk and all-cause mortality.
Croatian: Dokazano je da postoje koristi od metformina u liječenju dijabetesa tipa 2 u bolesnika s umjerenim oštećenjem bubrega, u smislu da lijek smanjuje kardiovaskularni rizik i sve uzroke smrtnosti.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for metformin containing products
Croatian: CHMP stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet za lijekove koji sadrže metformin.
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Croatian: Konačno, mogućnost povećanog rizika od laktacidoze može se dostatno smanjiti na najmanju moguću mjeru u bolesnika s umjerenim oštećenjem bubrega (GFR veći od 30 ml/min) jasnim preporukama o doziranju, dodatnim praćenjem razine GFR-a prije i tijekom liječenja te ažuriranjem upozorenja i mjera opreza u sažetku opisa svojstava lijeka i uputi o lijeku.
English: Overall, metformin has been used safely in patients with moderate renal impairment at reduced doses without causing significant metformin or lactate plasma elevations.
Croatian: Ukupno razmatrajući, primjena metformina u bolesnika s umjerenim oštećenjem bubrega bila je sigurna pri smanjenim dozama i nije uzrokovala značajno povišenje metformina ili laktata u plazmi.
English: • The CHMP considered that there is evidence from clinical and epidemiological studies indicating the benefits of the use of metformin containing medicinal products in patients with moderate renal impairment (GFR 30-59 ml/min).
Croatian: • CHMP je zaključio da dokazi iz kliničkih i epidemioloških ispitivanja upućuju na koristi od primjene lijekova koji sadrže metformin u bolesnika s umjerenim oštećenjem bubrega (GFR 30 - 59 ml/min).
English: In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Croatian: Osim toga, rutinsko smanjivanje rizika na najmanju moguću mjeru proširit će se tako da se kumulativno ocjenjivanje laktacidoze uključi u PSUR-ove i ciljani upitnik.
English: Moreover, recent clinical guidelines in the treatment of T2DM recommend the use of metformin in moderate renal impairment.
Croatian: Štoviše, u najnovijim kliničkim smjernicama za liječenje dijabetesa tipa 2 preporučuje se primjena metformina kod umjerenog oštećenja bubrega.
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Croatian: • CHMP je bio mišljenja da se rizik od laktacidoze može smanjiti na najmanju moguću mjeru u bolesnika s umjerenim oštećenjem bubrega jasnim preporukama o doziranju, dodatnim praćenjem razine GFR-a prije i tijekom liječenja te ažuriranjem upozorenja i mjera opreza u sažetku opisa svojstava lijeka i uputi o lijeku.
English: Recent scientific data have concluded that the main causes of lactic acidosis are cardiogenic or hypovolemic shock, severe heart failure, severe trauma, and sepsis; therefore lactic acidosis is not primarily caused by metformin treatment.
Croatian: Zaključak na osnovi novih znanstvenih podataka jest da su glavni uzroci laktacidoze kardiogeni ili hipovolemijski šok, teško zatajenje srca, teška ozljeda i sepsa.
English: In view of the above, the CHMP concluded that the benefit-risk balance of metformin containing medicinal products is favourable subject to changes to the product information as described above.
Croatian: S obzirom na sve prethodno navedeno, CHMP je zaključio da omjer koristi i rizika lijekova koji sadrže metformin ostaje povoljan, što je podložno izmjenama u informacijama o lijeku kako je gore opisano.
English: The CHMP, as a consequence, considers that the benefit-risk balance of metformin containing products remains favourable subject to the amendments to the product information.
Croatian: CHMP slijedom toga zaključuje da omjer koristi i rizika za lijekove koji sadrže metformin ostaje povoljan, pod uvjetom da se uvedu izmjene u informacije o lijeku.
English: Date of latest renewal: 20 July 2012
Croatian: Datum posljednje obnove: 20. srpnja 2012.
English: 3 years
Croatian: 3 godine
English: 10 DATE OF REVISION OF THE TEXT
Croatian: 10 DATUM REVIZIJE TEKSTA
English: REVERSE {number} {YYYY MM}
Croatian: POLEĐINA {broj} {GGGG MM}
English: The educational programme is aimed:
Croatian: Cilj edukacijskog programa je:
English: Your surgeon will know which bones to avoid.
Croatian: Kirurg će znati koje kosti treba izbjegavati.
English: • adequate fracture reduction and stabilization to ensure mechanical stability
Croatian: • odgovarajućom redukcijom prijeloma i stabilizacijom kako bi se osigurala mehanička stabilnost
English: See section 5.1.
Croatian: Vidjeti dio 5.1.
English: The selected pieces can be further cut as required.
Croatian: Odabrani dijelovi mogu se dalje rezati po potrebi.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Croatian: Ovaj se lijek ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: The product must be used within 2 hours after preparation.
Croatian: Lijek se mora upotrijebiti unutar 2 sata nakon pripreme.
English: Talk to your doctor if you have any of the following:
Croatian: Razgovarajte sa svojim liječnikom ako imate išta od sljedećeg:
English: Additional educational materials for healthcare professionals are available on the following URL: [URL to be included] <and the <Member State> website>.
Croatian: Dodatni edukacijski materijali za zdravstvene djelatnike dostupni su na sljedećem URL: [URL će biti upisan] <i <zemlja članica> web-stranica>.
English: While no harmful effects have been noted, the long-term effects are unknown.
Croatian: Iako nisu uočeni štetni učinci, dugoročni učinci nisu poznati.
English: No clinical data are available; potential risk for human is unknown.
Croatian: Nema dostupnih kliničkih podataka; mogući rizik za ljude nije poznat.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove uključujući i one dobivene bez recepta.