FrancophonIA/ELRC3.0 huggingface dataset:
English: On 19 March 2014, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed recommendations to restrict the use of diacerein-containing medicines in order to manage the risks of severe diarrhoea and effects on the liver.
Croatian: Koordinacijska skupina za međusobno prepoznavanje i decentralizirane postupke za humane lijekove (CMDh) 19. ožujka 2014. godine1 potvrdila je preporuke za ograničavanje uporabe lijekova koji sadrže diacerein kako bi se upravljalo rizicima od teškog proljeva i učinaka na jetru.
English: Doctors should be monitoring their patients for early signs of liver problems and advising them how to recognise early symptoms.
Croatian: Liječnici trebaju nadzirati svoje bolesnike na rane znakove problema s jetrom i savjetovati ih kako prepoznati rane simptome.
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.
Croatian: S obzirom da je većina usvojila stajalište CMDh o diacereinu, isto je poslano u Europsku komisiju koja ga je preporučila i izdala konačnu, pravno obvezujuću odluku koja vrijedi širom Europske unije (EU) od 4. rujna 2014.
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.
Croatian: Djeluje blokadom djelovanja interleukina1 beta, proteina koji je uključen u upalu i razaranje hrskavice koja igra ulogu u razvoju simptoma degenerativne bolesti zglobova poput osteoartritisa.
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.
Croatian: Liječnici također trebaju imati na umu, a na temelju dostupnih podataka, da uporabu diacereina treba ograničiti kod liječenja simptoma osteoartritisa koji utječe na kuk ili koljeno.
English: Efficacy in the symptomatic treatment of osteoarthritis of the hip or knee was shown in published studies where diacerein was superior to placebo in relieving pain1-5.
Croatian: Djelotvornost u simptomatskom liječenju osteoartritisa kuka ili koljena dokazana je u objavljenim ispitivanjima gdje je diacerein bio superioran placebu u olakšavanju boli1-5.
English: These recommendations are based on the review of the benefits and risks of diacerein conducted by the EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) and follow concerns raised by the French medicines agency (ANSM) about diacerein's gastro-intestinal and liver effects.
Croatian: Te se preporuke temelje na procjeni koristi i rizika diacereina koja je provedena od strane Odbora Europske agencije za lijekove za ocjenu rizika u farmakovigilanciji te slijede bojazni koje je iznijela Francuska agencija za lijekove (ANSM) o učincima diacereina na jetru i probavni sustav.
English: − it is advisable to start treatment with half the normal dose (i.e. 50 mg per day) for the first 2
Croatian: − savjetuje se da započnete liječenje polovicom normalne doze (tj. 50 mg na dan) tijekom prvih
English: • If you are taking diacerein and you are 65 years or above, contact your doctor to discuss your treatment.
Croatian: • Ako uzimate diacerein i ako ste stari 65 godina ili više obratite se svom liječniku kako biste raspravili svoje liječenje.
English: • Diacerein should only be used to treat symptoms of osteoarthritis of the hip or knee and it is not recommended for rapidly progressive hip osteoarthritis.
Croatian: • Diacerein se smije koristiti samo za liječenje simptoma osteoartritisa kuka i koljena i ne preporučuje se za rapidno progresivni osteoartritis kuka.
English: • You should not take diacerein if you have or have had liver problems.
Croatian: • Ne smijete uzimati diacerein ako imate ili ste imali probleme s jetrom.
English: In addition, diacerein-containing medicines must now not be used in any patient with liver disease or a history of liver disease, and doctors should be monitoring their patients for early signs of liver problems.
Croatian: Pored toga, lijekovi koji sadrže diacerein ne smiju se sada koristiti kod bilo kojeg bolesnika s bolešću jetre ili anamnezom bolesti jetre i liječnici moraju nadzirati svoje bolesnike na rane znakove problema s jetrom.
English: The proportion of patients who develop drug-induced liver injury following treatment with diacerein is estimated to be 0.03%.
Croatian: Udio bolesnika koji razvijaju jatrogenu ozljedu jetre nakon liječenja diacereinom procjenjuje se na 0,03%.
English: The CMDh endorsed the PRAC's final recommendations to address these concerns and ensure that diacerein's benefits continue to outweigh its known risks.
Croatian: CMDh potvrdi je konačne preporuke PRAC-a za rješavanje tih bojazni i daljnje osiguravanje da će koristi diacereina nadmašiti njegove poznate rizike.
English: Following an EU-wide review of diacerein, its use has been restricted in order to minimise the risks of severe diarrhoea and liver problems.
Croatian: Nakon procjene diacereina širom Europske unije njegova je uporaba ograničena kako bi se smanjili rizici od teškog proljeva i problem s jetrom.
English: In November 2013, the PRAC initially recommended the suspension of the marketing authorisations for diacerein-containing medicines.
Croatian: PRAC je stoga prvotno preporučio suspenziju odobrenja za stavljanje u promet za lijekove koji sadrže diacerein.
English: Pelletier JP, Yaron M, Haraoui B, Cohen P, Nahir M A, Choquette D, et al. Efficacy and Safety of Diacerein in Osteoarthritis of the Knee.
Croatian: 4. Pelletier JP, Yaron M, Haraoui B, Cohen P, Nahir M A, Choquette D, et al.
English: Treatment should only be started by doctors experienced in treating osteoarthritis.
Croatian: Liječenje smiju započeti samo liječnici iskusni u liječenju osteoartritisa.
English: • Diacerein should only be used for treating symptoms of osteoarthritis affecting the hip or knee.
Croatian: • diacerein treba koristiti samo za liječenje simptoma osteoartritisa koji zahvaća kuk ili koljeno.
English: − treatment should be stopped if diarrhoea occurs.
Croatian: − liječenje treba prekinuti u slučaju pojave proljeva.
English: • Treatment should only be started by doctors experienced in treating osteoarthritis.
Croatian: • Liječenje smiju započeti samo liječnici iskusni u liječenju osteoartritisa.
English: • Diacerein must not be used in any patient with liver disease or a history of liver disease.
Croatian: • Diacerein se ne smije koristiti ni u jednog bolesnika s bolešću jetre ili anamnezom bolesti jetre.
English: Elevated serum liver enzymes and cases of symptomatic acute hepatic injury have been reported in the post-marketing phase with diacerein.
Croatian: Povišene razine jetrenih enzima u serumu i slučajevi simptomatske ozljede jetre prijavljeni su s diacereinom kao suspektnim lijekom nakon stavljanja lijeka u promet.
English: The review of diacerein was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Odbor za ocjenu rizika u farmakovigilanciji (PRAC) proveo je pregled podataka za diacerein.
English: Diacerein is a medicine used to treat joint diseases such as osteoarthritis (swelling and pain in the joints).
Croatian: Diacerein je lijek koji se koristi za liječenje bolesti zglobova poput osteoartritisa (oticanja i boli u zglobovima).
English: Diacerein is a slow-acting medicine of the class ‘anthraquinones' used to treat joint diseases such as osteoarthritis (swelling and pain in the joints).
Croatian: Diacerein je lijek sporog djelovanja klase „antrakinona” koji se koristi za liječenje bolesti zglobova poput osteoartritisa (oticanja i boli u zglobovima).
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.
Croatian: 50 mg dnevno umjesto 100 mg), a u slučaju proljeva treba prestati uzimati diacerein.
English: 1994 Apr;37(4):529-36.
Croatian: Diacerhein in the treatment of osteoarthritis of the hip. Arthritis Rheum. 1994 Apr;37(4):529-36.
English: Nguyen M, Dougados M, Berdah L, Amor B. Diacerhein in the treatment of osteoarthritis of the hip.
Croatian: 5. Nguyen M, Dougados M, Berdah L, Amor B.
English: Singh K, Sharma R, Rai J. Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee.
Croatian: Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee.
English: Lequesne M, Berdah L, Gérentes I. Efficacy and Safety of Diacerein for the treatment of Knee and Hip Osteoarthritis [Efficacité et tolérance de la diacerhéine dans le traitment de la gonarthrose et de la coxarthrose].
Croatian: [Efficacité et tolérance de la diacerhéine dans le traitment de la gonarthrose et de la coxarthrose].
English: (Invented)name Strength Pharmaceutical Form
Croatian: Farmaceutski oblik
English: Pack size l t o r
Croatian: Veličina pakovanja vrećica (papir/folija/Bar ex® laminat)
English: The full EPAR for Bortezomib Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Bortezomib Sun nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is calculated using the patient's height and weight).
Croatian: Preporučena doza izračunava se na osnovi visine i tjelesne težine bolesnika.
English: If a patient develops severe side effects, treatment must be discontinued, delayed or the dose adjusted.
Croatian: Ako se u bolesnika pojave ozbiljne nuspojave, liječenje se mora prekinuti, odgoditi ili se doza mora prilagoditi.
English: At least 72 hours must pass between two doses of Bortezomib Sun.
Croatian: Mora proći najmanje 72 sata između dvije uzastopne doze lijeka Bortezomib Sun.
English: Patients with moderate or severe liver problems should be treated with lower doses.
Croatian: Bolesnici s umjerenim ili ozbiljnim problemima jetre trebaju se liječiti manjim dozama.
English: This means that Bortezomib Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Croatian: To znači da je Bortezomib Sun sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Velcade.
English: It blocks proteasome, which is a system in cells that breaks down proteins that are no longer needed.
Croatian: Ta tvar onemogućuje djelovanje proteazoma, sustava unutar stanica koji razgrađuje proteine koji više nisu potrebni.
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje se mora započeti i provoditi pod nadzorom liječnika specijalista s iskustvom u primjeni kemoterapije.
English: When given into a vein, the solution is injected through a catheter (a thin sterile tube).
Croatian: Kada se primjenjuje u venu, otopina se injicira kroz kateter (tanka sterilna cjevčica).
English: Blocking the proteasome system causes the cell to die.
Croatian: Onemogućivanje djelovanja sustava proteazoma uzrokuje smrt stanica.
English: Bortezomib Sun must not be given by other routes.
Croatian: Lijek Bortezomib Sun ne smije se davati drugim putovima.
English: When injected under the skin, it is given in the thigh or abdomen (tummy).
Croatian: U slučaju ubrizgavanja ispod kože, lijek se daje u bedro ili abdomen (trbuh).
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, blood stem-cell transplantation.
Croatian: • u odraslih osoba čija se bolest pogoršava nakon najmanje jednog liječenja i koje su već bile podvrgnute, ili se ne mogu podvrgnuti, transplantaciji hematopoetskih matičnih stanica.
English: Because Bortezomib Sun is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Bortezomib Sun generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Sun.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Bortezomib Sun.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Sun has been shown to be comparable to Velcade.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, lijek Bortezomib Sun usporediv s lijekom Velcade.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Sun have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Bortezomib Sun nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: No additional studies were needed as Bortezomib Sun is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.
Croatian: Dodatna ispitivanja nisu bila potrebna jer je lijek Bortezomib Sun generički lijek koji se daje injekcijom i koji sadrži istu djelatnu tvar kao i referentni lijek, Velcade.
English: Bortezomib Sun is a ‘generic medicine'.
Croatian: Bortezomib Sun je „generički lijek”.
English: It is not intended to provide practical advice on how to use Bortezomib Sun.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Bortezomib Sun.
English: Doses of Bortezomib Sun are given with rest periods between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Sun is given alone or in combination with other medicines.
Croatian: Doze lijeka Bortezomib Sun daju se u razmacima s razdobljima odmora među dozama, i to u ciklusima liječenja od tri do šest tjedna ovisno o tome primjenjuje li se lijek kao monoterapija ili u kombinaciji s drugim lijekovima.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Sun?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bortezomib Sun?
English: Bortezomib Sun is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin.
Croatian: Lijek Bortezomib Sun dostupan je u bočicama od 3,5 mg kao prašak za pripremu otopine za injekciju u venu ili pod kožu.
English: Bortezomib Sun is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Croatian: Lijek Bortezomib Sun koristi se za liječenje multiplog mijeloma, raka krvi, u sljedećim skupinama bolesnika:
English: Other information about Bortezomib Sun
Croatian: Ostale informacije o lijeku Bortezomib Sun
English: The company that markets Bortezomib Sun will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.
Croatian: Tvrtka koja stavlja na tržište lijek Bortezomib Sun mora zdravstvenim radnicima dostaviti edukativne materijale u kojima se objašnjava način pripreme i primjene injekcije, izračunavanja doze i propisivanja i primjene odgovarajućeg liječenja u primatelja transplantacije hematopoetskih matičnih stanica.
English: Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors like bortezomib.
Croatian: Stanice raka osjetljivije su na učinke inhibitora proteazoma u odnosu na normalne stanice.
English: The active substance in Bortezomib Sun, bortezomib, is a proteasome inhibitor.
Croatian: Djelatna tvar u lijeku Bortezomib Sun, bortezomib, inhibitor je proteazoma.
English: What is Bortezomib Sun and what is it used for?
Croatian: Što je Bortezomib Sun i za što se koristi?
English: What are the benefits and risks of Bortezomib Sun?
Croatian: Koje su koristi i rizici lijeka Bortezomib Sun?
English: The Committee recommended that Bortezomib Sun be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Bortezomib Sun u EU-u.
English: The company provided data from the published literature on bortezomib.
Croatian: Tvrtka je priložila podatke o bortezomibu iz objavljene literature.
English: For more information on the use of Bortezomib Sun see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o korištenju lijeka Bortezomib Sun pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: • previously untreated adults who cannot have high-dose chemotherapy with blood stem-cell transplantation.
Croatian: • u odraslih osoba koje prethodno nisu liječene i za koje nije prikladna kemoterapija u visokim dozama s transplantacijom hematopoetskih matičnih stanica.
English: For more information about treatment with Bortezomib Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Bortezomib Sun pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Velcade, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za lijek Velcade.
English: Bortezomib Sun is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Croatian: Lijek Bortezomib Sun također se koristi za liječenje limfoma plaštenih stanica, drugog oblika raka krvi, u odraslih osoba koje prethodno nisu primile terapiju, a za koje nije prikladna transplantacija hematopoetskih matičnih stanica.
English: In these patients, Bortezomib Sun is used in combination with melphalan and prednisone;
Croatian: U ovih se bolesnika lijek Bortezomib Sun koristi u kombinaciji s melfalanom i prednizonom;
English: For practical information about using Bortezomib Sun, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Bortezomib Sun pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Why is Bortezomib Sun approved?
Croatian: Zašto je Bortezomib Sun odobren?
English: Bortezomib Sun contains the active substance bortezomib.
Croatian: Bortezomib Sun sadrži djelatnu tvar bortezomib.
English: For mantle cell lymphoma, Bortezomib Sun is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Croatian: U bolesnika s limfomom plaštenih stanica lijek Bortezomib Sun koristi se u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom.
English: • previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
Croatian: • u bolesnika koji prethodno nisu liječeni i koji trebaju primiti kemoterapiju u visokim dozama te potom biti podvrgnuti transplantaciji hematopoetskih matičnih stanica.
English: Bortezomib Sun is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone;
Croatian: Lijek Bortezomib Sun koristi se kao monoterapija ili u kombinaciji s pegiliranim liposomalnim doksorubicinom ili deksametazonom;
English: In this group of patients, Bortezomib Sun is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Croatian: U ovoj skupini bolesnika, lijek Bortezomib Sun koristi se u kombinaciji s deksametazonom ili s deksametazonom i talidomidom.
English: How does Bortezomib Sun work?
Croatian: Kako djeluje Bortezomib Sun?
English: How is Bortezomib Sun used?
Croatian: Kako se koristi Bortezomib Sun?
English: How has Bortezomib Sun been studied?
Croatian: Kako je Bortezomib Sun ispitivan?
English: By 25th November 2013 at the latest
Croatian: Najkasnije do 25. studenog 2013.
English: Within 30 days after CMDh agreement
Croatian: Unutar 30 dana nakon usvajanja sporazuma CMDh-a
English: The products with only obstetric indications and for which revocation is applicable (instead of variation to the terms of the marketing authorisation) should be recalled from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Croatian: Lijekovi koji se primjenjuju samo u opstetričnim indikacijama i za koje je primjenjivo ukidanje (umjesto izmjena u uvjetima odobrenja za stavljanje lijeka u promet) trebaju biti povučeni iz prometa od strane nositelja odobrenja najkasnije do 25. studenog 2013.
English: National Competent Authorities (NCAs) of Member States or Reference Member States (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela države članice (država članica) ili referente države članice (referentnih država članica), ako je primjenjivo, pobrinut će se da nositelj(i) odobrenja ispuni(e) sljedeće uvjete:
English: DHPC Communication circulation according to the CMDh agreed communication plan and conditions.
Croatian: Pismo liječnicima u skladu s komunikacijskim planom i uvjetima usuglašenim s CMDh-om.
English: Annex IV Conditions to the marketing authorisation
Croatian: Dodatak IV Uvjeti odobrenja za stavljanje lijeka u promet
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Croatian: Nakon odluke Komisije, nadležno tijelo država članica, u suradnji s referentnom zemljom, ažurirat će podatke o proizvodu, po potrebi.
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Croatian: Stoga, ovaj SPC, označavanje i uputa ne mora nužno predstavljati trenutni tekst.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Croatian: Važeći Sažetak opisa svojstava, označavanje i uputa su konačne verzije postignute tijekom postupka Koordinacijske skupine.
English: Note: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Croatian: Primjedba: Ovaj SPC, označavanje i uputa su važeće verzije u vrijeme odluke Komisije.
English: Summary of product characteristics, labelling and package leaflet
Croatian: Sažetak opisa svojstava lijeka, označavanje i uputa
English: Further information on Steglujan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Steglujan možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Steglujan and what is it used for?
Croatian: Što je Steglujan i za što se koristi?
English: The most common side effects with Steglujan (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Croatian: Najčešće nuspojave lijeka Steglujan (koje se mogu javiti u više od 1 na 10 osoba) jesu vaginalne gljivične infekcije i druge infekcije ženskog reproduktivnog sustava.
English: What measures are being taken to ensure the safe and effective use of Steglujan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Steglujan?
English: For more information about using Steglujan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Steglujan pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: What are the risks associated with Steglujan?
Croatian: Koji su rizici povezani s lijekom Steglujan?