FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Besponsa (which may affect more than 1 in 5 people) are thrombocytopenia (low blood platelet counts), neutropenia and leucopenia (low white blood cell counts), infection, anaemia (low red blood cell counts), tiredness, haemorrhage (bleeding), fever, nausea (feeling sick), headache, febrile neutropenia (low white cell count with fever), abdominal pain (stomach ache), increased levels of liver enzymes called transaminases and gammaglutamyltransferase, and hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells).
Croatian: Najčešće nuspojave lijeka Besponsa (koje se mogu javiti u više od 1 na 5 osoba) jesu trombocitopenija (nizak broj trombocita u krvi), neutropenija i leukopenija (nizak broj bijelih krvnih stanica u krvi), infekcija, anemija (nizak broj crvenih krvnih stanica u krvi), umor, hemoragija (krvarenje), vrućica, mučnina (osjećaj slabosti), glavobolja, febrilna neutropenija (nizak broj bijelih krvnih stanica praćen vrućicom), bol u abdomenu (bol u trbuhu), povećane razine jetrenih enzima pod nazivom transaminaze i gama-glutamiltransferaze te hiperbilirubinemija (visoke razine bilirubina, proizvoda razgradnje crvenih krvnih stanica).
English: Besponsa must not be used in patients who have VOD/SOS or have had severe VOD/SOS or have other serious liver diseases.
Croatian: Lijek Besponsa ne smije se primjenjivati u bolesnika koji boluju od VOD-a/SOS-a ili su bolovali od teškog oblika VOD-a/SOS-a ili koji boluju od druge teške bolesti jetre.
English: The main study showed that Besponsa was better than other commonly used chemotherapy medicines at inducing a response in patients and allowing them to have a curative stem cell transplant.
Croatian: U glavnom ispitivanju lijek Besponsa pokazao se boljim od drugih najčešće upotrebljavanih kemoterapijskih lijekova u postizanju odgovora u bolesnika, pri čemu im omogućuje ljekovitu transplantaciju matičnih stanica.
English: Besponsa was shown to be more effective than other chemotherapy (medicines to treat cancer) in one main study involving 326 adults with CD22-positive B-cell precursor ALL, which had come back or had not responded to previous treatment.
Croatian: Lijek Besponsa pokazao se učinkovitijim od drugih kemoterapija (lijekovi za liječenje raka) u jednom glavnom ispitivanju u kojem je sudjelovalo 326 odraslih osoba s CD22-pozitivnom akutnom limfoblastičnom leukemijom prekursora B-limfocita koja se ponovno javila ili kod koje nije bilo pozitivnog odgovora na prethodno liječenje.
English: Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare', and Besponsa was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 June 2013.
Croatian: Budući da je broj bolesnika s akutnom limfoblastičnom leukemijom prekursora B-limfocita nizak, dotična se bolest smatra „rijetkom” te je lijek Besponsa dobio status „lijeka za rijetke bolesti” 7. lipnja 2013.
English: The CHMP considered that although there have been recent advances in the treatment of B-cell precursor ALL, treatment options for patients remain limited.
Croatian: CHMP je smatrao da su unatoč nedavnim napredcima u liječenju akutne limfoblastične leukemije prekursora B-limfocita, mogućnosti liječenja za bolesnike i dalje ograničene.
English: Once attached, the medicine is taken up by the cell where calicheamicin becomes active, causing breaks in the cell's DNA and thereby killing the cancer cell.
Croatian: Nakon vezivanja lijek se apsorbira u stanicu u kojoj kalikeamicin postaje djelatan, uzrokuje lomove u DNK-u stanice te time ubija stanicu raka.
English: Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL).
Croatian: Besponsa je lijek protiv raka koji se primjenjuje u liječenju vrste raka krvi koja pogađa B-limfocite (vrsta bijelih krvnih stanica) pod nazivom akutna limfoblastična leukemija (ALL) prekursora B-limfocita.
English: Besponsa is used on its own in adults whose cancer has come back or did not respond to previous treatment.
Croatian: Besponsa se primjenjuje kao monoterapija u odraslih osoba u kojih se rak ponovno vratio ili u kojih nije bilo pozitivnog odgovora na prethodno liječenje.
English: For practical information about using Besponsa, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Besponsa bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: This means that patients' have a particular protein (CD22) on the surface of their white blood cells.
Croatian: To znači da bolesnici na površini svojih bijelih krvnih stanica imaju posebnu bjelančevinu (CD22).
English: The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells.
Croatian: Monoklonsko protutijelo prepoznaje i veže se za CD22 na B-limfocitima zahvaćenima rakom.
English: The most serious side effects are infection, febrile neutropenia, haemorrhage, abdominal pain, fever, tiredness and veno-occlusive liver disease/sinusoidal obstruction syndrome (VOD/SOS, a serious liver disease).
Croatian: Najteže nuspojave jesu infekcija, febrilna neutropenija, hemoragija, bol u abdomenu, vrućica, umor i venookluzivna bolest jetre / sindrom sinusoidalne opstrukcije (VOD/SOS, teška bolest jetre).
English: Other information aboutBesponsa
Croatian: Ostale informacije o lijeku Besponsa
English: Besponsa contains the active substance inotuzumab ozogamicin.
Croatian: Besponsa sadrži djelatnu tvar inotuzumab ozogamicin.
English: How is Besponsa used?
Croatian: Kako djeluje Besponsa?
English: Patients were considered to have responded if they had no remaining cancerous B cells in their blood and bone marrow after treatment.
Croatian: Smatralo se da je u bolesnika došlo do pozitivnog odgovora na liječenje ako nakon liječenja u krvi i koštanoj srži nisu imali nijedan B-limfocit zahvaćen rakom.
English: The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule, N-acetyl-gamma-calicheamicin dimethylhydrazide.
Croatian: Djelatna tvar u lijeku Besponsa, inotuzumab ozogamicin, monoklonsko je protutijelo (vrsta bjelančevine) vezano na malu molekulu, N-acetil-gama-kalikeamicindimetilhidrazid.
English: How does Besponsa work?
Croatian: Kako se Besponsa koristi?
English: Besponsa is only used in patients with ‘CD22-positive B-cell precursor ALL'.
Croatian: Besponsa se primjenjuje samo u bolesnika s „CD22-pozitivnom akutnom limfoblastičnom leukemijom prekursora B-limfocita”.
English: For the full list of all side effects and restrictions reported with Besponsa, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Besponsa potražite u uputi o lijeku.
English: Patients who responded to treatment could proceed to have a stem cell transplant.
Croatian: Bolesnicima s pozitivnim odgovorom na liječenje mogle su se transplantirati matične stanice u nastavku liječenja.
English: In patients who do not respond to treatment, Besponsa should be stopped after 3 cycles.
Croatian: Liječenje lijekom Besponsa potrebno je zaustaviti nakon tri ciklusa u bolesnika u kojih nema pozitivnog odgovora na liječenje.
English: Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja EU/1/19/1390/001 Inbrija
English: MA (EU) number
Croatian: EU/1/19/1390/002 Inbrija
English: 3 bottles
Croatian: 3 bočice
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: Package size
Croatian: Način primjene Pakovanje Veličina pakovanja
English: Most of them occurred during the first months of treatment.
Croatian: Većina slučajeva odnosila se na prve mjesece liječenja.
English: How to take [Invented Name]
Croatian: Kako uzimati [zaštićeno ime]
English: Patients with such form of the disease may derive less benefit from treatment.
Croatian: Bolesnici s takvim oblikom bolesti mogu imati manje koristi od liječenja.
English: It takes some time for [Invented Name] to have its effect.
Croatian: Potrebno je neko vrijeme da [zaštićeno ime] počne djelovati.
English: Your doctor may ask you to undergo blood tests to check your liver function.
Croatian: Liječnik može zatražiti da obavite pretrage krvi kako bi se provjerila funkcija jetre.
English: As some patients may experience loose stools or diarrhoea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily.
Croatian: Budući da se u nekih bolesnika može pojaviti meka stolica ili dijareja, u prva 2 do 4 tjedna liječenja preporučena početna doza je 50 mg jedanput na dan uz večernji obrok, a nakon toga preporučena dnevna doza je 50 mg dvaput na dan.
English: The treatment should be taken with food, one with breakfast and the other with evening meal.
Croatian: Terapiju treba uzimati s hranom, jednu kapsulu uz doručak, a drugu uz večernji obrok.
English: The capsules must be swallowed intact, without opening them, with a glass of water.
Croatian: Kapsule se mora progutati cijele, neotvorene, s čašom vode.
English: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Croatian: POREMEĆAJI KOŽE I POTKOŽNOG TKIVA
English: Concomitant intake of laxatives should be avoided.
Croatian: Treba izbjegavati istodobnu uporabu laksativa.
English: If you have diarrhoea while taking this medicine, stop taking [Invented Name] and contact your doctor to discuss which other treatments you can take.
Croatian: Ako imate proljev dok uzimate ovaj lijek, prestanite uzimati [zaštićeno ime] i obratite se liječniku kako biste razmotrili koje druge terapije možete uzimati.
English: As a rule, these effects abate with continuing treatment.
Croatian: U pravilu, ovi se učinci smanjuju s nastavkom liječenja.
English: [The dose recommendation for adults should be as follows]
Croatian: [Preporuka za doziranje za odrasle treba glasiti kako slijedi]
English: The treatment should be initiated by specialists experienced in the treatment of osteoarthritis.
Croatian: Liječenje treba započeti specijalist s iskustvom u liječenju osteoartritisa.
English: Treatment with [Invented Name] is therefore not recommended for a specific form of hip osteoarthritis called rapidly progressive (worsening) hip osteoarthritis.
Croatian: Stoga se [zaštićeno ime] ne preporučuje za liječenje specifičnog oblika osteoartritisa kuka koji se naziva brzo napredujućim (pogoršavajućim) osteoartritisom kuka.
English: Treatment of symptoms in patients with osteoarthritis of the hip or knee, with delayed effect.
Croatian: Liječenje simptoma u bolesnika s osteoartritisom kuka ili koljena, s odgođenim djelovanjem.
English: In some cases, diarrhoea was severe with complications such as dehydration and disorders of fluid and electrolyte balance.
Croatian: U nekim slučajevima dijareja je bila teška, s komplikacijama kao što su dehidracija i poremećaji ravnoteže tekućina i elektrolita.
English: Tell your doctor immediately if you have abdominal pain, jaundice (yellow discolouration of the eyes or skin), impaired consciousness or itching of the skin, as these may indicate serious conditions such as liver disease.
Croatian: Odmah se obratite liječniku ako osjetite bol u trbuhu, imate žuticu (žuta boja očiju ili kože), poremećaj svijesti ili svrbež kože jer to može ukazivati na ozbiljna stanja poput bolesti jetre.
English: Talk to your doctor before taking [Invented Name] if you have ever suffered from liver disease.
Croatian: [U ovom dijelu treba navesti sljedeći tekst:] Razgovarajte s liječnikom prije nego što uzmete [zaštićeno ime] ako ste ikada bolovali od bolesti jetre.
English: Intake of diacerein frequently leads to diarrhoea (see section 4.8) that can consequently lead to dehydration and hypokalaemia.
Croatian: Unos diacereina često dovodi do dijareje (vidjeti dio 4.8) što posljedično može dovesti do dehidracije i hipokalijemije.
English: [The wording below should be added at the top of this section]
Croatian: [Tekst ispod treba dodati na početak ovog dijela]
English: You should limit your alcohol consumption while you are undergoing treatment with [Invented Name].
Croatian: Morate ograničiti konzumaciju alkohola dok se liječite [zaštićeno ime].
English: Uncommon (≥ 1/1000 and < 1/100): Cases of elevated hepatic enzymes in serum.
Croatian: Manje često (≥ 1/1000 i < 1/100): slučajevi povišenih jetrenih enzima u serumu.
English: 4.4 Special warnings and precautions for use [The wording on diarrhoea and hepatotoxicity in this section should be presented and read as follows]
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi [U ovom dijelu, tekst koji se odnosi na dijareju i hepatotoksičnost treba izgledati i glasiti kako slijedi:] Dijareja
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Dodatak III Izmjene u relevantnim dijelovima Sažetka opisa svojstava lijeka i Upute o lijeku
English: Contraindications
Croatian: 4.3. Kontraindikacije
English: Before treatment with diacerein is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease.
Croatian: Prije nego što se započne liječenje diacereinom, bolesnika treba pitati o mogućim komorbidnim stanjima te prošloj ili sadašnjoj bolesti jetre i testirati na glavne uzroke aktivne bolesti jetre.
English: Intake of diacerein can lead to diarrhoea and hypokalaemia.
Croatian: Uzimanje diacereina može dovesti do dijareje i hipokalijemije.
English: Some patients may experience loose stools or diarrhoea after the intake of [Invented Name].
Croatian: U nekih se bolesnika može pojaviti meka stolica ili proljev nakon uzimanja [zaštićeno ime].
English: Treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Croatian: Liječenje diacereinom ne preporučuje se bolesnicima u kojih osteoartritis kuka brzo napreduje, jer mogu imati slabiji odgovor na diacerein.
English: Caution should be exercised in patients receiving diuretics, because dehydration and hypokalaemia may occur.
Croatian: U bolesnika koji primaju diuretike potreban je oprez, jer mogu nastupiti dehidracija i hipokalijemija.
English: The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate
Croatian: Izmjene i dopune Sažetka opisa svojstava lijeka i Upute o lijeku možda će trebati naknadno dopuniti nadležna nacionalna tijela, u suradnji s referentnom državom članicom ako je primjenjivo.
English: Patients should be monitored for signs and symptoms of hepatic injury (see section 4.4).
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma ozljede jetre (vidjeti dio 4.4).
English: From post-marketing surveillance
Croatian: Nakon stavljanja lijeka u promet
English: Patients should be advised about the signs and symptoms of hepatotoxicity and must be advised to immediately contact their physician in case of appearance of symptoms suggestive of liver damage.
Croatian: Bolesnike treba upozoriti na znakove i simptome hepatotoksičnosti, i mora im se savjetovati da se u slučaju pojave simptoma koji upućuju na oštećenje funkcije jetre odmah obrate liječniku.
English: [The following wording should be reflected in this section] It is recommended that you start treatment with one capsule in the evening for the first 2-4 weeks, after which the dose can be increased to two capsules per day.
Croatian: Preporučuje se da liječenje počnete jednom kapsulom uvečer prva 2 do 4 tjedna, a nakon toga dozu možete povećati na dvije kapsule na dan.
English: Treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected.
Croatian: Liječenje diacereinom treba prekinuti ako se ustanovi povišenje vrijednosti jetrenih enzima ili posumnja na znakove ili simptome oštećenja funkcije jetre.
English: Caution must be exercised in the concomitant administration of diuretics (high-ceiling loop and thiazides) and/or cardiac glycosides (digitoxin, digoxin), as the risk of arrhythmia is increased (see section 4.4).
Croatian: Potreban je oprez pri istodobnoj primjeni diuretika (diuretici uzlaznog kraka Henleove petlje i tiazidi) i/ili srčanih glikozida (digitoksin, digoksin), jer se povećava rizik od aritmije (vidjeti dio 4.4).
English: • Current and/or history of liver disease
Croatian: • Bolest jetre, postojeća i/ili u anamnezi
English: Signs of hepatic injury should be monitored and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury.
Croatian: Potrebno je nadzirati znakove ozljede jetre i postupati s oprezom kada se diacerein primjenjuje istodobno s drugim lijekovima povezanim s ozljedom jetre.
English: Particular caution should also be exercised in case of hypokalaemia in patients treated with cardiac glycosides (digitoxin, digoxin) (see section 4.5).
Croatian: Posebno oprezno treba postupati u slučaju hipokalijemije u bolesnika liječenih srčanim glikozidima (digitoksin, digoksin) (vidjeti dio 4.5).
English: Common (> 1/100 and < 1/10): pruritus, rash, eczema.
Croatian: Često (> 1/100 i < 1/10): pruritus, osip, ekcem.
English: [The following side effects should be inserted in this paragraph] Very common side effects (may affect more than 1 in 10 people treated): - diarrhoea, - abdominal pain
Croatian: [U ovaj odjeljak treba umetnuti sljedeće nuspojave:] Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 liječenih osoba): - proljev - bol u trbuhu
English: Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported in the post-marketing phase with diacerein.
Croatian: Slučajevi akutne ozljede jetre, uključujući povišene jetrene enzime u serumu i slučajeve hepatitisa, zabilježeni su u fazi nakon stavljanja diacereina u promet.
English: [The following wording should also be reflected in this section] Diacerein is not recommended in patients older than 65 years.
Croatian: [U ovom dijelu treba također navesti sljedeći tekst:] Diacerein se ne preporučuje u bolesnika starijih od 65 godina.
English: What [Invented Name] is and what it is used for [This section should be read as follows] [Invented Name] contains diacerein and is used to relieve symptoms of osteoarthritis of the hip or knee.
Croatian: [Ovaj dio treba glasiti kako slijedi:] [Zaštićeno ime] sadrži diacerein i koristi se za ublažavanje simptoma osteoartritisa kuka ili koljena.
English: Very common (> 1/10): diarrhoea, abdominal pain.
Croatian: Vrlo često (> 1/10): dijareja, bol u trbuhu
English: [In addition, any existing dose recommendation in case of hepatic impairment should be deleted from this section as diacerein is now contraindicated in patients with liver disease.]
Croatian: [Nadalje, iz ovog dijela treba izbrisati svaku postojeću preporuku za doziranje u slučaju oštećenja funkcije jetre, jer je sada diacerein kontraindiciran u bolesnika s bolešću jetre.]
English: Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase (see section 4.8).
Croatian: Povišene vrijednosti jetrenih enzima u serumu i simptomatsko akutno oštećenje funkcije jetre zabilježeno je uz diacerein u fazi nakon stavljanja lijeka u promet (vidjeti dio 4.8).
English: [The following contraindication should be added in this section and replace any existing wording on hepatic insufficiency]
Croatian: [Ovom dijelu treba dodati sljedeću kontraindikaciju i zamijeniti tekst o insuficijenciji jetre, ako ikakav postoji.]
English: Liver problems including raised liver enzymes in the blood and hepatitis (inflammation in the liver) have been reported in some patients taking diacerein.
Croatian: Tegobe s jetrom, uključujući povišene vrijednosti jetrenih enzima u krvi te hepatitis (upala jetre), zabilježene su u nekih bolesnika koji su uzimali diacerein.
English: [In addition, any existing dose recommendation for patients with hepatic impairment should be deleted from this section as diacerein is now contraindicated in patients with liver disease.]
Croatian: [Nadalje, iz ovog dijela treba izbrisati svaku postojeću preporuku za doziranje u bolesnika s oštećenjem funkcije jetre, jer je sada diacerein kontraindiciran u bolesnika s bolešću jetre.]
English: Common (> 1/100 and < 1/10): frequent bowel movements, flatulence.
Croatian: Često (> 1/100 i < 1/10): česta pražnjenja crijeva, flatulencija.
English: [Invented Name] with food, drink and alcohol [The following wording should be reflected in this section] Drinking alcohol while taking [Invented Name] may increase the risk of liver damage.
Croatian: [Zaštićeno ime] s hranom, pićem i alkoholom [U ovom dijelu treba navesti sljedeći tekst:]
English: Patients should be advised to stop diacerein treatment in case of diarrhoea and contact their physician to discuss treatment alternatives.
Croatian: Bolesnicima treba savjetovati da u slučaju dijareje prekinu liječenje diacereinom te da se obrate liječniku kako bi razmotrili druge moguće terapije.
English: [The following side effects should be inserted in this paragraph] Common side effects (may affect up to 1 in 10 people treated): - frequent bowel movements, - flatulence - pruritus (itching), rash, eczema (itchy, red rash).
Croatian: [U ovaj odjeljak treba umetnuti sljedeće nuspojave:] Česte nuspojave (mogu se pojaviti u 1 na 10 liječenih osoba): - česta pražnjenja crijeva - nadutost - pruritus (svrbež), osip, ekcem (svrbljiv, crveni osip).
English: Other medicines and [Invented Name] [The following wording should be reflected in this section] Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: A diagnosis of liver disease is a contraindication to diacerein use (see section 4.3).
Croatian: Dijagnoza bolesti jetre kontraindicirana je primjeni diacereina (vidjeti dio 4.3).
English: Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Croatian: Bolesnike treba upozoriti da za vrijeme liječenja diacereinom ograniče unos alkohola.
English: [The following text should be reflected in this section] Tell your doctor immediately and stop taking [Invented Name] if you experience unusually frequent liquid or watery stools.
Croatian: Odmah se obratite liječniku i prekinite uzimanje [zaštićeno ime] ako Vam se pojave neobično česte vodene ili vodenaste stolice.
English: Warnings and precautions [The following wording should be reflected in this section]
Croatian: Drugi lijekovi i [zaštićeno ime] [U ovom dijelu treba navesti sljedeći tekst:]
English: 4.8 Undesirable effects [The following text should be reflected in this section] GASTROINTESTINAL DISORDERS
Croatian: 4.8 Nuspojave [U ovom dijelu treba navesti sljedeći tekst:]
English: You should not take laxatives during your treatment with [Invented Name].
Croatian: Tijekom liječenja [zaštićeno ime] ne smijete uzimati lijekove za liječenje zatvora stolice (laksative).
English: [The following wording should be reflected in this section] In some cases, diarrhoea can be severe with life threatening complications such as fluid loss and electrolyte disturbances.
Croatian: U nekim slučajevima proljev može biti težak, uz komplikacije opasne po život, kao što su gubitak tekućine i poremećaji elektrolita.
English: [The following wording should be reflected in this section]
Croatian: [Ovaj dio treba glasiti kako slijedi]
English: [Invented Name] should be taken with food, one with breakfast and the other with the evening meal.
Croatian: [Zaštićeno ime] treba uzimati s hranom, jednu kapsulu uz doručak, a drugu uz večernji obrok.