FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/574/044 56 x 1 film-coated tablet (unit dose) EU/1/09/574/045 98 x 1 film-coated tablet (unit dose) EU/1/09/574/046 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/574/044 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/045 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/046 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/574/028 56 film-coated tablets
Croatian: EU/1/09/574/028 56 filmom obloženih tableta
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: EU/1/09/574/050 28 film-coated tablets
Croatian: EU/1/09/574/050 28 filmom obloženih tableta
English: Coordination abnormal
Croatian: • poremećaj koordinacije
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: EU/1/09/574/008 56 x 1 film-coated tablet (unit dose) EU/1/09/574/009 98 x 1 film-coated tablet (unit dose) EU/1/09/574/010 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/574/008 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/009 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/010 280 x 1 filmom obloženih tableta (jedinična doza)
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, žuti željezov oksid (E172).
English: EU/1/09/574/056 56 x 1 film-coated tablet (unit dose) EU/1/09/574/057 98 x 1 film-coated tablet (unit dose) EU/1/09/574/058 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/574/056 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/057 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/058 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/574/032 56 x 1 film-coated tablet (unit dose) EU/1/09/574/033 98 x 1 film-coated tablet (unit dose) EU/1/09/574/034 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/574/032 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/033 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/034 280 x 1 filmom obloženih tableta (jedinična doza)
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: fever (toxic epidermal necrolysis)
Croatian: Johnsonov sindrom, toksičnu epidermalnu nekrolizu) ili druge alergijske reakcije
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: EU/1/09/574/020 56 x 1 film-coated tablet (unit dose) EU/1/09/574/021 98 x 1 film-coated tablet (unit dose) EU/1/09/574/022 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/574/020 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/021 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/022 280 x 1 filmom obloženih tableta (jedinična doza)
English: • skin reddening
Croatian: • promjena boje kože
English: • anxiety
Croatian: • pospanost
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172).
English: EU/1/09/574/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/574/060 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/059 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171).
Croatian: Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171).
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
English: EU/1/09/574/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/574/048 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/047 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
English: • stiffness
Croatian: • drhtanje
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
English: EU/1/09/574/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/574/012 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/011 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: EU/1/09/574/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/574/036 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/035 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
English: Renal dysfunction
Croatian: Bubrežna disfunkcija
English: EU/1/09/574/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/574/024 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/023 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: • feeling unwell
Croatian: • loše osjećanje
English: No dose adjustment of Dafiro HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m 2) dozu Dafiro
English: Constipation
Croatian: Konstipacija
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (mogu se javiti u do1 na 10 osoba):
English: EU (MA) number Invented name
Croatian: EU broj odobrenja Izmišljeno ime
English: Pemetrexed Lilly is a cancer medicine used to treat two types of lung cancer:
Croatian: Pemetrexed Lilly je lijek protiv raka koji se koristi za liječenje dva tipa raka pluća:
English: This means that Pemetrexed Lilly is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Croatian: To znači da je Pemetrexed Lilly sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: U tijelu pemetreksed se konvertira u djelatni oblik koji blokira djelovanje enzima koji su uključeni u proizvodnju „nukleotida” (stanica koje grade DNK i RNK, genetski materijal stanica).
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Croatian: Ovaj se lijek izdaje samo na liječnički recept i smije se primjenjivati samo pod nadzorom liječnika koji ima iskustva u primjeni kemoterapije.
English: Because Pemetrexed Lilly is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Pemetrexed Lilly generički lijek, smatra se da su njegovi koristi i rizici isti kao i oni referentnog lijeka.
English: Pemetrexed Lilly is a ‘generic medicine'.
Croatian: Pemetrexed Lilly je „generički lijek”.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Lilly has been shown to be comparable to Alimta.
Croatian: Odbor za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, potvrđeno da je lijek Pemetrexed Lilly usporediv s lijekom Alimta.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Lilly.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Pemetrexed Lilly.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Lilly?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pemetrexed Lilly?
English: For practical information about using Pemetrexed Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pemetrexed Lilly bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: A risk management plan has been developed to ensure that Pemetrexed Lilly is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pemetrexed Lilly.
English: Pemetrexed Lilly is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Pemetrexed Lilly dostupan je kao prašak koji se koristi za pripremu otopine za infuziju (drip) u venu.
English: No additional studies were needed as Pemetrexed Lilly is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Pemetrexed Lilly generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: It is not intended to provide practical advice on how to use Pemetrexed Lilly.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pemetrexed Lilly.
English: The full EPAR and risk management plan summary for Pemetrexed Lilly 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) kao i sažetak plana upravljanja rizikom za lijek Pemetrexed Lilly nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Pemetrexed Lilly pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: When Pemetrexed Lilly is given with cisplatin, an ‘antiemetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se Pemetrexed Lilly primjenjuje s cisplatinom, prije ili nakon doze cisplatinom bolesniku također treba dati „antiemetik” (za sprječavanje povraćanja) i tekućinu (za sprječavanje dehidracije).
English: Other information about Pemetrexed Lilly
Croatian: Ostale informacije o lijeku Pemetrexed Lilly
English: What is Pemetrexed Lilly and what is it used for?
Croatian: Što je Pemetrexed Lilly i za što se koristi?
English: What are the benefits and risks of Pemetrexed Lilly?
Croatian: Koje su koristi i rizici lijeka Pemetrexed Lilly?
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Lilly.
Croatian: Kako bi se ublažile nuspojave lijeka, bolesnici tijekom terapije lijekom Pemetrexed Lilly trebaju uzimati kortikosteroid (tip lijeka koji smanjuje upalu) i folnu kiselinu (tip vitamina) te primati injekcije vitamina B12.
English: Pemetrexed Lilly pemetrexed
Croatian: Pemetrexed Lilly pemetreksed
English: The Committee recommended that Pemetrexed Lilly be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Pemetrexed Lilly u EU-u.
English: Why is Pemetrexed Lilly approved?
Croatian: Zašto je Pemetrexed Lilly odobren?
English: The active substance in Pemetrexed Lilly, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar lijeka Pemetrexed Lilly, pemetreksed, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, kao što su stanice karcinoma), a ubraja se u grupu „antimetabolita”.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Lilly, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Lilly nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: How is Pemetrexed Lilly used?
Croatian: Kako se Pemetrexed Lilly koristi?
English: Pemetrexed Lilly contains the active substance pemetrexed.
Croatian: Pemetrexed Lilly sadrži djelatnu tvar pemetreksed.
English: How has Pemetrexed Lilly been studied?
Croatian: Kako je Pemetrexed Lilly ispitivan?
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Pemetrexed Lilly, kao i kod lijeka Alimta, koristi nadmašuju utvrđene rizike.
English: How does Pemetrexed Lilly work?
Croatian: Kako djeluje Pemetrexed Lilly?
English: References
Croatian: Reference
English: Patients are advised of the following:
Croatian: Bolesnicima se savjetuje sljedeće:
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Obratite se našim dužnosnicima za tisak Monika Benstetter ili Martin Harvey
English: Diacerein-containing medicines are taken by mouth and are currently authorised in the following EU Member States: Austria, Czech Republic, France, Greece, Italy, Portugal, Slovakia and Spain.
Croatian: Lijekovi koji sadrže diacerein uzimaju se kroz usta i trenutno su odobreni u sljedećim državama članicama EU-a: Austrija, Češka Republika, Francuska, Grčka, Italija, Portugal, Slovačka i Španjolska.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 1 CMDh je regulatorno tijelo za lijekove koje predstavlja države članice Europske unije (EU) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: • Due to the risks associated with severe diarrhoea:
Croatian: • Zbog rizika povezanih s teškim proljevom:
English: The review of diacerein-containing medicines was initiated on 29 November 2012 at the request of the French medicines agency under Article 31 of Directive 2001/83/EC.
Croatian: Procjena lijekova koji sadrže diacerein započela je 29. studenog 2012. godine na zahtjev francuske Agencije za lijekove u skladu s člankom 31. Direktive 2001/83/EZ.
English: 4 September 2014 EMA/544268/2014
Croatian: EMA/544268/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Croatian: Telefon +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: to 4 weeks, after which the recommended dose is 50 mg twice a day.
Croatian: 2 do 4 tjedna nakon čega preporučena doza iznosi 50 mg dva puta na dan.
English: Contact your doctor if you have symptoms of liver problems.
Croatian: Obratite se svom liječniku ako imate simptome problema s jetrom.
English: The first beneficial effects of diacerein in these studies were seen after 2 to 4 weeks of continuous use.
Croatian: Prvi korisni učinci diacerein u ovim ispitivanjima uočeni su nakon 2 do 4 tjedna neprekidne uporabe.
English: • If you have any questions about your treatment, please contact your doctor or pharmacist.
Croatian: • Ako imate pitanja o liječenju, obratite se svom liječniku ili ljekarniku.
English: In the majority of cases diacerein-induced diarrhoea started in the first weeks of treatment.
Croatian: U većini slučajeva proljev izazvan diacereinom započeo je u prvim tjednima terapije.
English: The recommendations are based on a review of available data on the efficacy and safety of diacerein.
Croatian: Preporuke se temelje na pregledu dostupnih podataka o djelotvornosti i sigurnosti diacereina.
English: • If you have diarrhoea while taking diacerein, stop taking your medicine and contact your doctor to discuss which other treatments you can take.
Croatian: • Ako imate proljev dok uzimate diacerein prekinite uzimati svoj lijek i obratite se svom liječniku kako biste raspravili koje druge lijekove možete uzimati.
English: Your doctor will monitor your liver function on a regular basis and advise about the symptoms of liver problems (such as pruritus
Croatian: Vaš liječnik će redovito nadzirati funkciju Vaše jetre i savjetovati Vas o simptomima problema s jetrom (kao što je pruritus
English: (itching) and jaundice).
Croatian: (svrbež) i žutica).
English: However, following re-examination, the PRAC considered additional proposals to manage diacerein's risks and was satisfied that with new restrictions diacerein's benefits would outweigh its risks.
Croatian: Međutim, nakon ponovne procjene, PRAC je razmatrao dodatne prijedloge za upravljanje rizicima diacereina i bio je zadovoljan što s novim ograničenjima koristi diacereina nadmašuju njegove rizike.
English: In clinical studies, around 0.5% of patients on diacerein had some kind of liver reaction, with most cases being mild, reversible increases in serum transaminases.
Croatian: U kliničkim ispitivanjima približno 0,5% bolesnika na diacereinu imalo je neku vrstu jetrene reakcije dok su najčešći slučajevi bili blagi, prolazni porasti u razinama serumskih transaminaza.
English: Due to the risks associated with severe diarrhoea, diacerein is no longer recommended in patients aged 65 years and above.
Croatian: Zbog rizika povezanih s teškim proljevom, diacerein se više ne preporučuje u bolesnika u dobi od 65 godina i više.
English: The PRAC's final recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which endorsed the recommendations and adopted a position by majority vote.
Croatian: Konačne preporuke PRAC-a poslane su Koordinacijskoj skupini za međusobno prepoznavanje i decentralizirane postupke za humane lijekove (CMDh) koja je potvrdila preporuke i većinski usvojila stajalište.
English: The proportion of patients with diarrhoea in clinical trials ranged from 0% to 54.4%.
Croatian: Udio bolesnika s proljevom u kliničkom ispitivanju kretao se u rasponu od 0 do 54,4%.
English: Restrictions intended to limit risks of severe diarrhoea and effects on the liver
Croatian: Ograničenja su namijenjena za ograničavanje rizika od teškog proljeva i učinaka na jetru
English: The CMDh position was sent to the European Commission which endorsed it and issued an EU-wide legally binding decision on 4 September 2014.
Croatian: Mišljenje CMDh poslano je Europskoj komisiji koja ga je potvrdila i izdala konačnu, pravno obvezujuću odluku za EU 4. rujna 2014.
English: − diacerein is not recommended in patients aged 65 years or above.
Croatian: − diacerein se ne preporučuje kod bolesnika u dobi od 65 godina i više.
English: With regard to safety, loose stools or diarrhoea were the most frequently reported adverse events in clinical studies with diacerein at a dose of 100 mg per day.
Croatian: S obzirom na sigurnost, vodenaste stolice ili proljev bile su najčešće prijavljivanje nuspojave u kliničkim ispitivanjima s diacereinom pri dozi od 100 mg po danu.