FrancophonIA/ELRC3.0 huggingface dataset:
English: Dafiro 10 mg/320 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Slovenian: Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
English: • abdominal discomfort
Slovenian: • slaba prebava
English: • dizziness
Slovenian: • zadihanost
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Slovenian: Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VHL” na drugi.
English: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Slovenian: Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) makrogol 4000 smukec titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
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), red iron oxide (E172).
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
English: Dafiro HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Slovenian: Pri bolnikih s hudo okvaro ledvic, z anurijo in pri bolnikih na dializi je uporaba zdravila Dafiro HCT kontraindicirana (glejte poglavje 4.3).
English: Caution required with concomitant use
Slovenian: Način uporabe peroralna uporaba
English: • dry mouth
Slovenian: • vročinski oblivi
English: • indigestion
Slovenian: • omotičnost
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
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.
Slovenian: Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Dafiro HCT 10 mg/160 mg/25 mg filmsko 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.
Slovenian: Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
English: • pain
Slovenian: • zadah
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.
Slovenian: Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
English: Talk to your doctor or pharmacist before taking Dafiro HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Slovenian: Pred začetkom jemanja zdravila Dafiro HCT se posvetujte z zdravnikom ali farmacevtom če imate v krvi nizke ravni kalija ali magnezija (s simptomi, kot so šibkost mišic, mišični krči in nepravilen srčni ritem, ali brez teh simptomov); če imate v krvi nizke ravni natrija (s simptomi, kot so utrujenost, zmedenost, trzanje mišic in napadi krčev, ali brez teh simptomov); če imate v krvi visoko raven kalcija (s simptomi, kot so slabost, bruhanje, zapeka, bolečine v trebuhu, pogosto uriniranje, žeja, šibkost in trzanje mišic, ali brez teh simptomov); če imate težave z ledvicami, če so vam presadili ledvico ali so vam povedali, da imate zoženje ledvičnih arterij; če imate težave z jetri; če imate ali ste imeli kdaj prej srčno popuščanje ali koronarno bolezen, zlasti če vam je zdravnik predpisal najvišji odmerek zdravila Dafiro HCT (10 mg/320 mg/25 mg); če ste preživeli srčni infarkt.
English: • fainting
Slovenian: • omedlevica
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).
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, rumeni železov oksid (E172).
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.
Slovenian: Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Dafiro HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: • hair loss
Slovenian: • srbeča koža
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).
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, titanov dioksid (E171).
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
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).
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, krospovidon (tipa A), brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza (substitucijski tip 2910 (3 mPa.s)), makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172).
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
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)
Slovenian: Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete EU/1/09/574/049-060
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: if you experience dizziness and/or fainting during treatment with Dafiro HCT, tell your doctor as soon as possible.
Slovenian: V tem primeru zdravila Dafiro HCT nikoli več ne smete več jemati; če med zdravljenjem z zdravilom Dafiro HCT pride do omotičnosti in/ali izgube zavesti, čimprej obvestite zdravnika; če se vam poslabša vid ali vas začne boleti oko.
English: • weight decrease
Slovenian: • zmanjšanje telesne mase
English: Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta tinitus vrtoglavica
English: • chest pain
Slovenian: • bolezen jeter
English: • anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia);
Slovenian: • mišičnih relaksantov (zdravil za sproščanje mišic, ki jih uporabljajo med operacijami); nitroglicerina in drugih nitratov ter učinkovin, ki jih imenujemo “vazodilatatorji”; drugih zdravil za zdravljenje visokega krvnega tlaka, vključno z metildopo; rifampicina (ki ga uporabljamo za zdravljenje npr. tuberkuloze), eritromicin, klaritromicin (antibiotiki); šentjanževke; dantrolen (zdravilo v infuziji pri hudih odstopanjih telesne temperature); vitamina D in kalcijevih soli.
English: Dafiro HCT should be discontinued if hypercalcaemia develops during treatment.
Slovenian: Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Dafiro HCT prekiniti.
English: Dafiro HCT with food, drink and alcohol
Slovenian: Shranjevanje zdravila Dafiro HCT Vsebina pakiranja in dodatne informacije
English: • anxiety
Slovenian: • nespečnost
English: Withdrawal period
Slovenian: Pakiranje
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pemetrexed Lilly sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Slovenian: Izdaja zdravila je le na recept, daje pa se lahko samo pod nadzorom zdravnika, ki je usposobljen za uporabo kemoterapije.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetrexed Lilly primerljivo z zdravilom Alimta.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Lilly.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetrexed Lilly.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Lilly?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetrexed Lilly?
English: Pemetrexed Lilly is a cancer medicine used to treat two types of lung cancer:
Slovenian: Pemetrexed Lilly je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
English: This means that Pemetrexed Lilly is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
English: The Committee recommended that Pemetrexed Lilly be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pemetrexed Lilly odobri za uporabo v EU.
English: Because Pemetrexed Lilly is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pemetrexed Lilly generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
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.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Pemetrexed Lilly in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What are the benefits and risks of Pemetrexed Lilly?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pemetrexed Lilly?
English: A risk management plan has been developed to ensure that Pemetrexed Lilly is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Pemetrexed Lilly je bil pripravljen načrt obvladovanja tveganj.
English: Pemetrexed Lilly is a ‘generic medicine'.
Slovenian: Zdravilo Pemetrexed Lilly je „generično zdravilo“.
English: For more information about treatment with Pemetrexed Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pemetrexed Lilly preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Pemetrexed Lilly
Slovenian: Druge informacije o zdravilu Pemetrexed Lilly
English: For practical information about using Pemetrexed Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pemetrexed Lilly naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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.
Slovenian: Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Pemetrexed Lilly jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
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'.
Slovenian: Zdravilna učinkovina v zdravilu Pemetrexed Lilly, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
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.
Slovenian: Kadar se zdravilo Pemetrexed Lilly daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem bolniku dati tudi „antiemetično“ zdravilo (za preprečevanje bruhanja) in tekočino (za preprečevanje dehidracije).
English: Pemetrexed Lilly pemetrexed
Slovenian: Pemetrexed Lilly pemetreksed
English: It is not intended to provide practical advice on how to use Pemetrexed Lilly.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What is Pemetrexed Lilly and what is it used for?
Slovenian: Kaj je zdravilo Pemetrexed Lilly in za kaj se uporablja?
English: Pemetrexed Lilly is available as a powder that is made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Pemetrexed Lilly je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
English: Why is Pemetrexed Lilly approved?
Slovenian: Zakaj je bilo zdravilo Pemetrexed Lilly odobreno?
English: How has Pemetrexed Lilly been studied?
Slovenian: Kako je bilo zdravilo Pemetrexed Lilly raziskano?
English: How is Pemetrexed Lilly used?
Slovenian: Kako se zdravilo Pemetrexed Lilly uporablja?
English: Pemetrexed Lilly contains the active substance pemetrexed.
Slovenian: Zdravilo Pemetrexed Lilly vsebuje zdravilno učinkovino pemetreksed.
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.
Slovenian: Ker je zdravilo Pemetrexed Lilly generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile potrebne nobene dodatne študije.
English: How does Pemetrexed Lilly work?
Slovenian: Kako zdravilo Pemetrexed Lilly deluje?
English: Patients are advised of the following:
Slovenian: Priporočila za bolnike so naslednja:
English: • Due to the risks associated with severe diarrhoea:
Slovenian: • Zaradi tveganj, povezanih s hudo drisko:
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.
Slovenian: Pregled zdravil, ki vsebujejo diacerein, se je začel dne 29. Novembra 2012 na zahtevo francoske agencije za zdravila v skladu s členom 31 Direktive 2001/83/ES.
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.
Slovenian: Zdravila, ki vsebujejo diacerein, se jemljejo peroralno in so trenutno odobrena v naslednjih državah članicah EU: v Avstriji, Češki republiki, Franciji, Grčiji, Italiji, na Portugalskem, Slovaškem in v Španiji.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Slovenian: Tel.: +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: In the majority of cases diacerein-induced diarrhoea started in the first weeks of treatment.
Slovenian: V večini primerov se je driska zaradi diacereina pojavila v prvih tednih zdravljenja.
English: The first beneficial effects of diacerein in these studies were seen after 2 to 4 weeks of continuous use.
Slovenian: Prve koristne učinke diacereina so v teh študijah opazili po 2 do 4 tednih neprekinjene uporabe.
English: The review of diacerein was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Pregled diacereina je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: It is also advised that patients start treatment on half the normal dose (i.e. 50 mg daily instead of 100 mg) and should stop taking diacerein if diarrhoea occurs.
Slovenian: Priporočljivo je tudi, da bolniki začnejo zdravljenje s polovico običajnega odmerka (tj. 50 mg na dan namesto 100 mg) in prenehajo jemati diacerein, če se pojavi driska.
English: The recommendations are based on a review of available data on the efficacy and safety of diacerein.
Slovenian: Priporočila temeljijo na pregledu razpoložljivih podatkov o učinkovitosti in varnosti diacereina.
English: Doctors should be monitoring their patients for early signs of liver problems and advising them how to recognise early symptoms.
Slovenian: Zdravniki morajo spremljati bolnike glede zgodnjih znakov težav z jetri in jim pojasniti, kako lahko prepoznajo zgodnje simptome.
English: • If you have any questions about your treatment, please contact your doctor or pharmacist.
Slovenian: • če imate dodatna vprašanja o vašem zdravljenju, se posvetujte z zdravnikom ali farmacevtom.
English: Restrictions intended to limit risks of severe diarrhoea and effects on the liver
Slovenian: Omejitve so namenjene zmanjšanju tveganj za hudo drisko in učinke na jetra
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.
Slovenian: Stališče skupine CMDh je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 4. septembra 2014 izdala pravno zavezujočo odločbo, ki velja za celotno EU.
English: The proportion of patients who develop drug-induced liver injury following treatment with diacerein is estimated to be 0.03%.
Slovenian: Delež bolnikov, pri katerih se po zdravljenju z diacereinom razvije poškodba jeter zaradi zdravila, po ocenah znaša 0,03 %.
English: The proportion of patients with diarrhoea in clinical trials ranged from 0% to 54.4%.
Slovenian: Delež bolnikov z drisko je v kliničnih preskušanjih znašal od 0 do 54,4 %.
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.
Slovenian: Končna priporočila odbora PRAC so bila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki jih je potrdila in sprejela stališče z večino glasov.
English: As the CMDh position on diacerein was adopted by majority vote, it was sent to the European Commission which endorsed it and issued a final legally binding decision valid throughout the European Union (EU) on 4 September 2014.
Slovenian: Ker je skupina CMDh stališče o diacereinu sprejela z večino, je bilo posredovano Evropski komisiji, ki ga je potrdila in 4. septembra 2014 izdala končen pravno zavezujoč sklep, ki velja za celotno Evropsko unijo (EU).
English: Restrictions to the use of diacerein-containing medicines
Slovenian: Omejitve pri uporabi zdravil, ki vsebujejo diacerein
English: It works by blocking the actions of interleukin-1 beta, a protein involved in the inflammation and destruction of cartilage that play a role in the development of symptoms of degenerative joint diseases such as osteoarthritis.
Slovenian: Deluje tako, da zavira delovanje interlevkina-1 beta, tj. beljakovine, ki sodeluje pri vnetju in propadanju hrustanca, ki imata vlogo pri razvoju simptomov degenerativne bolezni sklepov, kot je osteoartritis.
English: • You should not take diacerein if you have or have had liver problems.
Slovenian: • ne jemljite diacereina, če imate ali ste kdaj imeli težave z jetri.
English: In November 2013, the PRAC initially recommended the suspension of the marketing authorisations for diacerein-containing medicines.
Slovenian: Odbor PRAC je novembra 2013 najprej priporočil začasen umik dovoljenj za promet z zdravili, ki vsebujejo diacerein.
English: Doctors should also note that, based on available data, the use of diacerein is to be limited to treating symptoms of osteoarthritis affecting the hip or knee.
Slovenian: Zdravniki morajo prav tako upoštevati, da je glede na razpoložljive podatke uporabo diacereina treba omejiti na zdravljenje simptomov osteoartritisa, ki prizadene kolk ali koleno.
English: Due to the risks associated with severe diarrhoea, diacerein is no longer recommended in patients aged 65 years and above.
Slovenian: Zaradi tveganj, povezanih s hudo drisko, se diacerein ne priporoča več pri bolnikih, starih 65 let ali več.
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.
Slovenian: V kliničnih študijah je približno 0,5 % bolnikov, ki so uporabljali diacerein, imelo določeno vrsto jetrne reakcije, pri čemer je večinoma šlo za blaga in reverzibilna zvišanja ravni transaminaz v serumu.
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
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom