FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregelatinised starch (maize) Maize starch
Croatian: Jezgra tablete manitol škrob, prethodno geliran (kukuruzni) kukuruzni škrob kopovidon magnezijev stearat
English: Linagliptin provided significant improvements in HbA1c (-0.64 % change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c (promjena od -0,64% u usporedbi s placebom nakon 24 tjedna), u odnosu na prosječnu početnu vrijednost HbA1c od 7,8%.
English: In the placebo-controlled studies 4.9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Croatian: U placebom kontroliranim ispitivanjima 4,9% bolesnika imalo je „hipoglikemiju” kao nuspojavu uz linagliptin, od čega je ona u 4,0% slučajeva bila blagog, u 0,9% umjerenog, a u 0,1% jakog intenziteta.
English: Linagliptin also showed significant improvements in patients fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG), compared to placebo.
Croatian: Linagliptin je također pokazao značajna poboljšanja nalaza glukoze u plazmi natašte i 2-satne postprandijalne glukoze kod bolesnika u usporedbi s placebom.
English: Linagliptin provided significant improvements in HbA1c, (-0.57% change compared to placebo), from a mean baseline HbA1c of 8.09%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c (-0,57% promjene u usporedbi s placebom), u odnosu na prosječnu početnu vrijednost HbA1c od 8,09%.
English: Linagliptin as add-on therapy in patients with severe renal impairment, 12 week placebo-controlled data (stable background) and 40 week placebo-controlled extension (adjustable background) The efficacy and safety of linagliptin was also evaluated in type 2 diabetes patients with severe renal impairment in a double-blind study versus placebo for 12 weeks duration, during which background glycaemic therapies were kept stable.
Croatian: Linagliptin kao dodatna terapija kod bolesnika s teškim oštećenjem bubrega, podaci za 12-tjednu kontrolnu primjenu placeba (stabilna osnovna terapija) i 40-tjedno produljenje kontrolne primjene placeba (prilagodljiva osnovna terapija)
English: Linagliptin
Croatian: • Djelatna tvar je linagliptin
English: Linagliptin provided significant improvements in HbA1c (-0.65% compared to placebo) from a mean baseline HbA1c of 8.3%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c (-0,65% u usporedbi s placebom) u odnosu na prosječan početni HbA1c od 8,3%.
English: Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c (-0,62% promjena u usporedbi s placebom) u odnosu na prosječan početni HbA1c od 8,14%.
English: Linagliptin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c, (-0,64% promjene u usporedbi s placebom) u odnosu na prosječan početni HbA1c od 8 %.
English: Magnesium stearate
Croatian: Bulozni pemfigoid
English: • Trajenta 5 mg tablets are 8 mm diameter round, light red film-coated tablets debossed with
Croatian: • Trajenta 5 mg tablete su okrugle, svijetlocrvene filmom obložene tablete, promjera 8 mm s utisnutom oznakom “D5” na jednoj te logom Boehringer Ingelheim na drugoj strani.
English: Elderly No dose adjustment is necessary based on age.
Croatian: Nije potrebno prilagođavanje doze prema dobi.
English: Copovidone
Croatian: OBLIK
English: Treatment should be stopped if liver function does not improve within three months.
Croatian: Liječenje treba prekinuti ako se jetrena funkcija ne poboljša unutar tri mjeseca.
English: Orphacol has been authorised under ‘exceptional circumstances'.
Croatian: Orphacol je odobren pod „iznimnim okolnostima”.
English: A risk management plan has been developed to ensure that Orphacol is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Orphacol koristi što je sigurnije moguće.
English: Orphacol is available as capsules and should be taken every day at approximately the same time, with a meal.
Croatian: Orphacol je dostupan u obliku kapsula i treba ga uzimati svaki dan u približno isto vrijeme, uz obrok.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi obnavlja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orphacol on 12 September 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Orphacol vrijedi na prostoru Europske unije od 12. rujna 2013.
English: The daily dose is between 5 and 15 mg per kg body weight, adjusted for each patient according to the state of their bile acid, with a minimum daily dose of 50 mg and a maximum of
Croatian: Dnevna doza je između 5 i 15 mg po kg tjelesne težine prilagođena za svakog bolesnika u skladu sa stanjem njegove žučne kiseline s minimalnom dnevnom dozom od 50 mg i maksimalnom dozom od 500 mg.
English: It must not be taken by patients already taking phenobarbital, a medicine used to treat epilepsy.
Croatian: Ne smiju ga uzimati bolesnici koji već uzimaju fenobarbital, lijek za liječenje epilepsije.
English: It is used to treat adults and children from one month of age who have a genetic abnormality that makes them unable to produce bile.
Croatian: Koristi se za liječenje odraslih i djece u dobi od mjesec dana koja imaju genetički poremećaj koji ih sprječava da proizvode žuč.
English: 500 mg. For small children who cannot swallow capsules, the contents can be mixed in with infant formula or juice.
Croatian: Za malu djecu koja ne mogu gutati kapsule, sadržaj se može promiješati s dječjom hranom ili sokom.
English: Orphacol cholic acid
Croatian: Orphacol kolna kiselina
English: Because cholic acid is a well-known substance, and its use in these enzyme deficiencies is well established, the applicant presented data from the scientific literature.
Croatian: S obzirom na to da je kolna kiselina dobro poznata tvar te je njezina upotreba u nedostacima ovih enzima dobro utvrđena, predlagatelj je prezentirao podatke iz znanstvene literature.
English: Orphacol should not be used in people who may be hypersensitive (allergic) to cholic acid or any of the other ingredients.
Croatian: Orphacol se ne smije koristiti kod osoba koje bi mogle biti preosjetljive (alergične) na kolnu kiselinu ili na bilo koji od sastojaka.
English: This is a summary of the European public assessment report (EPAR) for Orphacol.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije lijeka (EPAR) za Orphacol.
English: It is not intended to provide practical advice on how to use Orphacol.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Orphacol.
English: The side effects seen with Orphacol were diarrhoea, pruritus (itching), increases in transaminases (liver enzymes) and possibly gallstones, although their frequency could not be reliably estimated from the available limited data.
Croatian: Nuspojave uočene s Orphacolom bili su proljev, pruritus (svrbež), porast u razinama transaminaza (jetreni enzima) i mogućih žučnih kamenaca, iako se njihova učestalost ne može pouzdano procijeniti iz dostupnih ograničenih podataka.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that the use of cholic acid to treat inborn errors in primary bile acid synthesis was well established in medical practice and documented in the scientific literature, although the number of documented cases was low due to the rarity of the condition.
Croatian: Povjerenstvo za humane lijekove (CHMP) napomenulo je da je upotreba kolne kiseline za liječenje urođenih grešaka u sintezi primarne žučne kiseline dobro utvrđena u medicinskoj praksi i dokumentirana u znanstvenoj literaturi, iako je broj dokumentiranih slučajeva bio nizak zbog rijetkosti bolesti.
English: What is Orphacol and what is it used for?
Croatian: Što je Orphacol i za što se koristi?
English: Other information about Orphacol
Croatian: Druge informacije o lijeku Orphacol
English: Orphacol is used in patients who do not have enough of two specific liver enzymes (3β-Hydroxy-Δ5-C27-steroid oxidoreductase or Δ4-3-Oxosteroid-5β-reductase).
Croatian: Orphacol se koristi kod bolesnika koji nemaju dovoljno dva specifična jetrena enzima (3β-hidroksi-Δ5-C27-steroid oksidoreduktaze ili Δ4-3-oksosteroid-5β-reduktaza).
English: What measures are being taken to ensure the safe and effective use of Orphacol?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Orphacol?
English: The company that makes Orphacol will also provide doctors in all Member States who will use Orphacol with a pack containing product literature and information regarding the correct diagnosis of these disease conditions, the risks of side effects and how to use the medicine properly.
Croatian: Tvrtka koja proizvodi Orphacol također će snabdjeti liječnike u svim državama članicama koji će koristiti Orphacol s paketom koji sadrži literaturu o proizvodu i informacije u vezi ispravne dijagnoze ovih bolesti, rizika od nuspojava i kako ispravno koristiti lijek.
English: Why is Orphacol approved?
Croatian: Zašto je Orphacol odobren?
English: The medicine can only be obtained with a prescription and treatment with Orphacol should be started and supervised by a doctor specialised in liver disease.
Croatian: Lijek se može dobiti samo na recept i liječenje Orphacolom treba započeti i nadzirati liječnik specijaliziran za bolesti jetre.
English: It compared the outcomes of 28 patients who received cholic acid with others who were given different bile acids or did not receive bile acid treatment.
Croatian: Usporedio je ishode 28 bolesnika koji su primali kolnu kiselinu s drugima koji su primali različite žučne kiseline ili nisu bili liječeni žučnom kiselinom.
English: The applicant presented data on 49 patients with inborn errors in primary bile acid synthesis, taken from the scientific literature (38 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency and 11 patients with Δ4-3-Oxosteroid-5β-reductase deficiency).
Croatian: Predlagatelj je predao podatke za 49 bolesnika s urođenim greškama u sintezi primarne žučne kiseline, dobivene iz znanstvene literature (38 bolesnika s manjkom 3β-hidroksi-Δ5-C27-steroidne oksidoreduktaze i 11 bolesnika s manjkom Δ4-3-oksosteroid-5β-reduktaze).
English: Cholic acid is the main primary bile acid produced by the liver.
Croatian: Kolna kiselina je glavna primarna žučna kiselina koju proizvodi jetra.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Orphacol možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Orphacol is a medicine containing cholic acid, a substance found in the bile which is used to digest fats.
Croatian: Orphacol je lijek koji sadrži kolnu kiselinu, tvar koja se nalazi u žuči i koja se koristi za probavljanje masnoća.
English: The full EPAR for Orphacol 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: Since Orphacol has been approved under exceptional circumstances, the company that markets Orphacol will establish a database of patients treated with Orphacol to monitor the safety and effectiveness of the treatment, and will submit the results to the CHMP at regular, specified intervals.
Croatian: S obzirom da je Orphacol odobren pod iznimnim okolnostima, tvrtka koja trži Orphacol uspostavit će bazu podataka bolesnika liječenih Orphacolom kako bi nadzirala sigurnost i djelotvornost terapije te će predati rezultate CHMP-u u redovitim, određenim intervalima.
English: It decided that based on the evidence from the scientific literature Orphacol's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo je odlučilo da su na temelju dokaza iz znanstvene literature koristi lijeka Orphacol veće od njegovih rizika i preporučilo izdavanje odobrenja za stavljanje lijeka Orphacol u promet.
English: What are the risks associated with Orphacol?
Croatian: Koji su rizici povezani s lijekom Orphacol?
English: In the scientific literature, cholic acid treatment was shown to reduce the amount of abnormal bile acids in patients, to restore the normal functions of the liver and to help delay or prevent the need for a liver transplant.
Croatian: U znanstvenoj literaturi dokazano je da liječenje kolnom kiselinom smanjuje količinu nenormalnih žučnih kiselina u bolesnika kako bi se povratile normalne funkcije jetre i pomoglo odgoditi ili spriječiti potrebu za transplantacijom jetre.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orphacol, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju ovog plana sigurnosne informacije uključene su u Sažetak opisa svojstava lijeka i Uputu o lijeku za Orphacol uključujući i odgovarajuće mjere opreza kojih se trebaju pridržavati zdravstveni djelatnici i bolesnici.
English: Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Orphacol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Croatian: Budući da je broj bolesnika s urođenim pogreškama u sintezi primarnih žučnih kiselina, dotična se bolest smatra „rijetkom” te se Orphacol od 18. prosinca 2002. označava kao lijek za liječenje rijetkih i teških bolesti.
English: This helps to decrease the production of abnormal bile acids and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the condition.
Croatian: To pomaže smanjivanju produkcije nenormalnih žučnih kiselina i pridonosi normalnoj aktivnosti žuči u probavnom sustavu olakšavajući tako simptome stanja.
English: The cholic acid contained in Orphacol replaces the patient's missing cholic acid.
Croatian: Kolna kiselina u Orphacolu zamjenjuje kolnu kiselinu koja nedostaje bolesniku.
English: When these primary bile acids are lacking, the body produces abnormal bile acids instead which can damage the liver, potentially leading to life-threatening liver failure.
Croatian: Kad ove primarne žučne kiseline manjkaju, tijelo proizvodi nenormalne žučne kiseline koje mogu oštetiti jetru i uzrokovati po život opasno zatajenje jetre.
English: This makes their liver unable to produce enough of the main components of bile, called primary bile acids, such as cholic acid.
Croatian: To čini njihovu jetru nesposobnom za produkciju dovoljne količine žuči zvanih primarne žučne kiseline poput kolne kiseline.
English: For more information about treatment with Orphacol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Orphacol pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Orphacol.
Croatian: Razlog za navedeno je nemogućnost dobivanja potpunih informacija o Orphacolu zbog male učestalosti bolesti.
English: What information is still awaited for Orphacol?
Croatian: Koje se još informacije očekuju o lijeku Orphacol?
English: For practical information about using Orphacol, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Orphacol bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: How does Orphacol work?
Croatian: Kako djeluje Orphacol?
English: What benefits of Orphacol have been shown in studies?
Croatian: Koje su koristi lijeka Orphacol dokazane u ispitivanjima?
English: How is Orphacol used?
Croatian: Kako se Orphacol koristi?
English: The effects last for at least 12 hours.
Croatian: Učinci traju najmanje 12 sati.
English: Relative Risk (95% confidence intervals)
Croatian: Relativni rizik (95% intervali pouzdanosti)
English: Do not take more than the recommended dose.
Croatian: Nemojte uzeti više od preporučene doze.
English: Plasma protein binding is 91%.
Croatian: Vezanje za proteine plazme iznosi 91%.
English: Number of primary endpoint events /number of patients
Croatian: Broj događaja primarnog ishoda/ broj bolesnika
English: It is not known if this was due to pharmacogenetic or other factors.
Croatian: Nije poznato jesu li razlog tome bili farmakogenetički ili drugi čimbenici.
English: There are no data in humans.
Croatian: Nema podataka u ljudi.
English: Depression, aggression (predominantly in children)
Croatian: depresija, agresivnost (pretežno u djece)
English: After opening the foil wrap: 3 months.
Croatian: Nakon otvaranja folije: 3 mjeseca.
English: • For inhalations remaining from 20 downwards to ‘8', ‘6', ‘4', ‘2' the numbers are displayed in red on a white background.
Croatian: • Za preostale udahe od broja 20 na niže do ‘8', ‘6', ‘4', ‘2' brojevi su prikazani crvenim znamenkama na bijeloj podlozi.
English: Frequency not known, but may also occur:
Croatian: Nepoznata učestalost, ali također mogu nastati:
English: However, these animal experimental results do not seem to be relevant for man given recommended doses.
Croatian: Međutim, čini se da ti rezultati pokusa na životinjama nisu važni za ljude kojima se daju preporučene doze.
English: The secondary endpoints in the table above reached statistical significance in the whole population.)
Croatian: Sekundarni ishodi u gornjoj tablici postigli su statističku značajnost u cijeloj populaciji.)
English: A 4-unit decrease is considered clinically relevant.
Croatian: Sniženje za 4 jedinice smatra se klinički značajnim.
English: Take care not to block the air vents.
Croatian: Pazite da ne zatvorite otvore za zrak.
English: Lactose is a type of sugar found in milk.
Croatian: Laktoza je vrsta šećera koja se nalazi u mlijeku.
English: This includes other medicines for asthma or any medicines obtained without a prescription.
Croatian: To uključuje druge lijekove za astmu ili bilo koje lijekove koje ste nabavili bez recepta.
English: Keep taking it until your doctor tells you to stop.
Croatian: Nastavite ga uzimati sve dok Vam liječnik ne kaže da prestanete.
English: For pharmacokinetic purposes each component can be considered separately.
Croatian: U farmakokinetičke svrhe, svaka će se komponenta razmatrati zasebno.
English: Both non-selective and selective β blockers should be avoided unless there are compelling reasons for their use.
Croatian: Potrebno je izbjegavati i neselektivne i selektivne β-blokatore osim ako postoje opravdani razlozi za njihovu primjenu.
English: Caution is recommended and long-term treatment with such drugs should if possible be avoided.
Croatian: Preporučuje se oprez, a dugotrajno liječenje takvim lijekovima treba, ako je moguće, izbjegavati.
English: You may notice your heart beating faster than usual and that you feel shaky.
Croatian: Možete opaziti da Vam srce radi brže nego obično i da drhtite.
English: Packs of 1 and 3 inhalers.
Croatian: Pakiranja od 1 i 3 inhalatora.
English: Note that it is important that you breathe in forcefully.
Croatian: Napominjemo da je važno da snažno udahnete.
English: A risk to breastfed newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za dojeno novorođenče/dojenče.
English: Breathe in through your mouth as deeply and as forcefully as you can.
Croatian: Udahnite kroz usta što dublje i što jače možete.
English: • Tuberculosis (TB) now or have had in the past, or have other lung infections
Croatian: • tuberkulozu (TBC) sada ili u prošlosti ili druge plućne infekcije.
English: • Diuretics, also known as ‘water tablets' used to treat high blood pressure.
Croatian: • diuretike, također poznate kao ‘tablete za izmokravanje' koji se primjenjuju za liječenje visokog tlaka.
English: These are often used to treat asthma.
Croatian: Oni se često primjenjuju za liječenje astme.
English: Hold your breath for 10 seconds or as long as you comfortably can.
Croatian: Zadržite dah na 10 sekundi ili onoliko dugo koliko možete a da Vam je ugodno.
English: Tell your doctor or pharmacist if you are taking or, have recently taken or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli primijeniti bilo koje druge lijekove.
English: If your asthma or breathing gets worse tell your doctor straight away.
Croatian: Ako Vam se astma ili disanje pogoršavaju, odmah obavijestite liječnika.
English: The incidence in placebo was not taken into account.
Croatian: Pojava uz placebo nije se uzela u obzir.
English: See section 4.4: “Adrenal function”.
Croatian: Vidjeti dio 4.4: „Funkcija nadbubrežnih žlijezda“.
English: • Corticosteroids (by mouth or by injection).
Croatian: • kortikosteroide (kroz usta ili injekcijom).
English: In general inhaled corticosteroids remain the first line treatment for most patients.
Croatian: Inhalacijski kortikosteroidi općenito ostaju prva linija liječenja za većinu bolesnika.
English: • Headache - this usually gets better as treatment continues.
Croatian: • glavobolja - obično se poboljšava s nastavkom liječenja
English: This study was not designed to investigate the effect on exacerbations.
Croatian: Ovo ispitivanje nije bilo osmišljeno da ispita učinak na
English: Beta adrenergic blockers may weaken or antagonise the effect of salmeterol.
Croatian: Beta adrenergički blokatori mogu oslabiti ili imati antagonistički učinak salmeterolu.
English: However, it should be noted that children and adolescents less than 16 years taking high doses of fluticasone propionate (typically ≥ 1000 micrograms/day) may be at particular risk.
Croatian: Međutim, treba napomenuti da djeca i adolescenti mlađi od 16 godina koji uzimaju visoke doze flutikazonpropionata (obično ≥1000 mikrograma/dan) mogu biti pod osobitim rizikom.
English: This training is important to ensure you receive the dose you require.
Croatian: To je važno uvježbati kako biste bili sigurni da primate dozu koja Vam je potrebna.
English: Survival status at 3 years was determined for all patients regardless of withdrawal from study medication.
Croatian: Status s obzirom na preživljenje nakon 3 godine bio je utvrđen za sve bolesnike bez obzira na prestanak uzimanja ispitivanog lijeka.
English: It is not known whether this medicine can pass into breast milk.
Croatian: Nije poznato može li ovaj lijek prijeći u mačino mlijeko.
English: Fluticasone propionate is cleared very rapidly from the systemic circulation.
Croatian: Flutikazonpropionat vrlo se brzo uklanja iz sistemske cirkulacije.
English: These side effects may include any of the following:
Croatian: Te nuspojave mogu uključivati nešto od sljedećeg:
English: Latvija Sicor Biotech filiāle Latvijā
Croatian: Sicor Biotech filiāle Latvijā
English: Other unidentified metabolites are also found in the faeces.
Croatian: Drugi neutvrđeni metaboliti također se pronalaze u stolici.
English: The secondary endpoints of combined all cause death or life-threatening experience, all cause death, or all cause hospitalisation did not reach statistical significance in the whole population.
Croatian: Sekundarni ishodi kombinirane smrti svih uzroka ili životno ugrožavajućeg događaja, smrt svih uzroka, ili hospitalizacija svih uzroka nisu postigli statističku značajnost u cijeloj