FrancophonIA/ELRC3.0 huggingface dataset:
English: Thalidomide shows immunomodulatory, anti-inflammatory and potential anti-neoplastic activities.
Croatian: Talidomid pokazuje imunomodulatorne, protuupalne te potencijalno antineoplastične učinke.
English: • A hole in part of your large bowel (colon) which can cause infection.
Croatian: • pukotina u dijelu debelog crijeva što može uzrokovati infekciju
English: • you have or have had injury to the liver (hepatic disorders) including abnormal liver test results.
Croatian: • Ako imate ili ste imali oštećenje jetre (poremećaj jetre) uključujući poremećene rezultate pretrage jetre.
English: If thalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Croatian: Ako talidomid dođe u kontakt sa sluznicama, treba ih temeljito isprati vodom.
English: You will have been given specific instructions by your doctor, particularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).
Croatian: Što morate znati prije nego počnete uzimati Thalidomide Celgene Vaš će Vam liječnik dati posebne upute, osobito o učincima talidomida na nerođenu djecu (opisano u Programu prevencije trudnoće za Thalidomide Celgene).
English: The patient should continue anticoagulation therapy during the course of thalidomide treatment.
Croatian: Bolesnik mora nastaviti uzimati antikoagulantne lijekove tijekom liječenja talidomidom.
English: Digoxin
Croatian: Digoksin
English: • you have experienced fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (these may be symptoms of severe infections).
Croatian: • Ako ste imali vrućicu, zimicu ili jaku tresavicu uz moguću komplikaciju u obliku niskog krvnog tlaka i smetenosti (to mogu biti simptomi teških infekcija).
English: A medically supervised pregnancy test should be performed during the consultation, when thalidomide is prescribed or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Croatian: Potrebno je napraviti test na trudnoću pod liječničkim nadzorom prilikom konzultacija tijekom kojih se propisuje talidomid ili 3 dana prije posjeta liječniku propisivaču kada bolesnica primjenjuje učinkovitu kontracepciju najmanje 4 tjedna.
English: Neutropenia, Leukopenia, Anaemia, Lymphopenia, Thrombocytopenia
Croatian: Neutropenija, leukopenija, anemija, limfopenija, trombocitopenija
English: A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Croatian: Testove na trudnoću pod liječničkim nadzorom potrebno je ponavljati svaka 4 tjedna, uključujući i razdoblje od 4 tjedna nakon završetka liječenja, osim u slučaju potvrđenog podvezivanja jajovoda.
English: • Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection.
Croatian: • Vrućica, zimica, grlobolja, kašalj, ranice u ustima ili neki drugi simptomi infekcije.
English: Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment, and until at least 4 weeks after thalidomide treatment and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Croatian: Žene u reproduktivnoj dobi moraju upotrebljavati jednu učinkovitu metodu kontracepcije najmanje 4 tjedna prije početka liječenja, tijekom trajanja liječenja i još najmanje 4 tjedna nakon završetka liječenja talidomidom te čak u slučaju pauza u uzimanju lijeka, osim ako se bolesnik obveže na apsolutnu i neprekidnu apstinenciju koja će se potvrđivati mjesečno.
English: • Irregularities of the heartbeat (heart block or atrial fibrillation), feeling faint or fainting.
Croatian: • nepravilnosti u srčanim otkucajima (srčani blok ili treperenje pretklijetki), osjećaj da ćete se onesvijestiti ili nesvjestica.
English: Somnolence
Croatian: Somnolencija
English: Thromboembolic events
Croatian: Tromboembolijski događaji
English: Thalidomide causes severe birth defects or death to an unborn baby.
Croatian: Trudnoća Talidomid uzrokuje teške urođene mane ili smrt nerođenog djeteta.
English: • Numbness, tingling, abnormal coordination or pain in your hands and feet.
Croatian: • Utrnulost, trnce, poremećaj koordinacije ili bol u šakama i stopalima.
English: • Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting.
Croatian: • Bol u prsnom košu koja se širi u ruke, vrat, čeljust, leđa ili trbuh, osjećaj oznojenosti i nedostatka zraka, osjećaj mučnine ili povraćanje.
English: • Injury to the liver (hepatic disorder) including abnormal liver test results.
Croatian: • ozljeda jetre (hepatički poremećaj) uključujući poremećene rezultate pretraga jetre
English: Platelet Count (/µL)
Croatian: Broj trombocita (/µl)
English: Table 4: Comparison of haematological disorders for the melphalan, prednisone (MP) and melphalan, prednisone, thalidomide (MPT) combinations in study IFM 99-06 (see section 5.1) n (% of patients)
Croatian: Tablica 4: Usporedba hematoloških poremećaja za melfalan, prednizon (MP) i kombinaciju melfalana, prednizona i talidomida (MPT) u ispitivanju IFM 99-06 (vidjeti dio 5.1)
English: Do not take Thalidomide Celgene
Croatian: Nemojte uzimati Thalidomide Celgene
English: EU/1/08/443/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/443/001
English: Some of the cases of HBV reactivation progressed to acute hepatic failure and resulted in discontinuation of thalidomide.
Croatian: Neki slučajevi reaktivacije HBV-a napredovali su u akutno zatajenje funkcije jetre i rezultirali prekidom primjene talidomida.
English: Hearing impaired or deafness
Croatian: • oslabljen sluh ili gluhoća
English: Therefore breast-feeding should be discontinued during treatment with thalidomide.
Croatian: Stoga dojenje treba prekinuti za vrijeme liječenja talidomidom.
English: • you have had an allergic reaction whilst taking Thalidomide Celgene such as rash, itching, swelling, dizziness or trouble breathing.
Croatian: • Ako Vam se za vrijeme uzimanja lijeka Thalidomide Celgene pojavila alergijska reakcija kao što je osip, svrbež, oticanje, omaglica ili otežano disanje.
English: • Convulsions.
Croatian: • konvulzije
English: The initial dose of melphalan is reduced for elderly > 75 years of age considering baseline bone marrow reserve and renal function.
Croatian: Početna doza melfalana za osobe starije od 75 godina snižena je s ozbirom na početnu rezervu koštane srži i funkciju bubrega.
English: Data from patients with end-stage renal disease suggest no impact of kidney function on thalidomide pharmacokinetics.
Croatian: Podaci od bolesnika u terminalnom stadiju bolesti bubrega upućuju na to da funkcija bubrega ne utječe na farmakokinetiku talidomida.
English: What Thalidomide Celgene is and what it is used for
Croatian: Što je Thalidomide Celgene i za što se koristi
English: Dispensing of thalidomide should occur within a maximum of 7 days of the prescription.
Croatian: Talidomid je potrebno izdati u roku od najviše 7 dana od propisivanja.
English: Previously infected patients should be closely monitored for signs and symptoms of viral reactivation, including active HBV infection, throughout therapy.
Croatian: Tijekom cijele terapije bolesnike koji su prije bili zaraženi je potrebno pomno pratiti zbog mogućih znakova i simptoma reaktivacije virusa, uključujući aktivnu infekciju HBV-om.
English: • The need to avoid foetal exposure
Croatian: • potrebu za izbjegavanjem fetalne izloženosti
English: Patients treated with thalidomide have an increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) (see section 4.8).
Croatian: Bolesnici liječeni talidomidom imaju povećani rizik za razvoj venske tromboembolije (poput duboke venske tromboze i plućne embolije) i arterijske tromboembolije (poput infarkta miokarda i cerebrovaskularnog događaja) (vidjeti dio 4.8).
English: An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4).
Croatian: Povećani rizik od venske tromboembolije (poput duboke venske tromboze i plućne embolije) i arterijske tromboembolije (poput infarkta miokarda i cerebrovaskularnog događaja) prijavljen je u bolesnika liječenih talidomidom (vidjeti dio 4.4).
English: • Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including o The need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of thalidomide o Need to provide patients with the appropriate patient educational material o Report any pregnancy, or adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “Educational Healthcare Professional's Kit”
Croatian: • obveze zdravstvenih radnika koji namjeravaju propisivati ili izdavati Thalidomide Celgene uključujući o potrebu za obuhvatnim objašnjenjima i savjetovanjem bolesnika o zahtjev da bolesnici trebaju biti sposobni pridržavati se zahtjeva za sigurnu primjenu talidomida o potrebu da se bolesnika opskrbi odgovarajućim edukacijskim materijalima koji su namijenjeni bolesnicima o prijavljivanje svake trudnoće ili štetnih događaja tvrtki Celgene i lokalnom tijelu nadležnom za zdravstvo (ako je to primjenjivo u državi članici) uporabom obrazaca koji se nalaze u „Edukacijskom materijalu za zdravstvene radnike“
English: • Fever, feeling generally unwell.
Croatian: • vrućica, opće loše osjećanje
English: A clear mechanism by which thalidomide can induce amenorrhea is not elucidated.
Croatian: Nije razjašnjen točan mehanizam kojim talidomid prouzročuje amenoreju.
English: • Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional's Kit containing the following: o Educational healthcare professional booklet o Educational brochures for patient o Patient cards o Summary of product characteristics, package leaflet and labelling
Croatian: • Prije propisivanja lijeka svi zdravstveni radnici koji namjeravaju propisivati Thalidomide Celgene (te ga izdavati u dogovoru s nadležnim državnim tijelom) dobiti edukacijski materijal za zdravstvene radnike koji će sadržavati sljedeće: o edukacijsku knjižicu za zdravstvene radnike o edukacijske brošure za bolesnike o kartice za bolesnike o sažetak opisa svojstava lijeka, uputu o lijeku i označivanje.
English: Myelodysplastic syndrome*
Croatian: Mijelodisplastični sindrom*,^
English: • The active substance is thalidomide.
Croatian: • Djelatna tvar je talidomid.
English: Always use a condom: o during treatment o for at least 7 days after stopping treatment
Croatian: Uvijek upotrebljavajte prezervativ: o tijekom liječenja o još najmanje 7 dana nakon završetka liječenja.
English: The most clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Croatian: Klinički najvažnije nuspojave povezane s uporabom talidomida u kombinaciji s melfalanom i prednizonom ili deksametazonom uključuju: duboku vensku trombozu i plućnu emboliju, perifernu neuropatiju, teške kožne reakcije uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, sinkopu, bradikardiju i omaglicu (vidjeti dijelove 4.2, 4.4 i 4.5).
English: • Pregnancy reporting requirements o Instruction to stop thalidomide immediately upon suspicion of pregnancy, if female patient o Need to refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation o Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit” o Local contact details for reporting of any suspected pregnancy
Croatian: • zahtjeve za prijavljivanjem trudnoće o upute za prekid uzimanja talidomida čim se pojavi sumnja na trudnoću, kada je bolesnik žena o potreba za upućivanjem bolesnice liječniku specijaliziranom ili iskusnom u teratologiji za savjet i procjenu o popuniti obrazac za prijavljivanje trudnoće kako je prikazano u „Edukacijskom materijalu za zdravstvene radnike“ o lokalni kontakt-podaci za prijavljivanje svake sumnje na trudnoću
English: Grades 3 and 4*
Croatian: MPT (n=124) Stupnjevi 3 i 4*
English: You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, “What you need to know before you take Thalidomide Celgene”).
Croatian: Ako ste žena koja bi mogla zatrudnjeti, morate upotrebljavati jednu učinkovitu metodu zaštite od začeća (vidjeti dio 2 „Što morate znati prije nego počnete uzimati Thalidomide Celgene“).
English: The MAH shall notify the EMA and the appropriate national patients and victims representatives of the proposed launch date before launch in each Member State.
Croatian: Nositelj odobrenja će obavijestiti EMA-u i odgovarajuće državne udruge za zaštitu bolesnika i žrtava liječenja talidomidom, o predloženom datumu stavljanja lijeka u promet prije samog stavljanja lijeka u promet u svakoj državi članici.
English: It is unknown whether thalidomide is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se talidomid u majčino mlijeko u ljudi.
English: • you have a fall in the number of white blood cells (neutropenia) accompanied by fever and infection.
Croatian: • Ako imate pad broja bijelih krvnih stanica (neutropenija) popraćen vrućicom i infekcijom.
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening and institute treatment as indicated.
Croatian: Prije i tijekom liječenja, liječnici trebaju pažljivo procijeniti bolesnike standardnim testovima probira na rak i započeti liječenje prema indikaciji.
English: Cardiovascular disorders
Croatian: Kardiovaskularni poremećaji
English: It can also happen sometime after treatment has stopped.
Croatian: Ta se nuspojava može javiti i neko vrijeme nakon završetka liječenja.
English: Black iron oxide (E172) Propylene glycol
Croatian: Tinta za označivanje šelak željezov oksid, crni (E172) propilenglikol
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (mogu se javiti u do 1 od 100 osoba)
English: For women of childbearing potential, prescriptions of thalidomide should be limited to a maximum of 4 weeks of treatment and continuation of treatment requires a new prescription.
Croatian: Za žene u reproduktivnoj dobi, propisivanje talidomida potrebno je ograničiti na terapiju dostatnu za najviše 4 tjedna liječenja, tako da nastavak liječenja zahtijeva novi recept.
English: Increase of sedative effects of other medicinal products Thalidomide has sedative properties, thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives, barbiturates and alcohol.
Croatian: Talidomid ima sedativna svojstva, pa može povećati sedaciju induciranu anksioliticima, hipnoticima, antipsihoticima, H1 antihistaminicima, derivatima opijata, barbituratima i alkoholom.
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Croatian: • tablete samog progesterona koje inhibiraju ovulaciju (tj. dezogestrel).
English: • you have kidney or liver problems (see also section 4 “Possible side effects”).
Croatian: • Ako imate tegobe s bubrezima ili jetrom (vidjeti također dio 4 „Moguće nuspojave”).
English: Dose delay, reduction or discontinuation, dependent upon the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade, may be necessary.
Croatian: Može biti potrebna odgoda doze, smanjivanje doze ili prekid liječenja, ovisno o rezultatima procjene prema općim kriterijima toksičnosti američkog Nacionalnog instituta za rak (NCI CTC).
English: • Pregnancy initial and outcome reporting forms
Croatian: • obrasce za prijavljivanje početka i ishoda trudnoće
English: WARNING: Thalidomide causes birth defects and foetal death.
Croatian: UPOZORENJE: Talidomid uzrokuje urođene mane i smrt fetusa.
English: Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se javiti u do 1 od 10 osoba)
English: ANC (/µL)
Croatian: ABN* (/µl)
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Croatian: • Dodatne mjere minimizacije rizika Nositelj odobrenja dogovorit će pojedinosti kontrolirane distribucije lijeka s nadležnim državnim tijelima te provoditi taj program na državnoj razini kako bi osigurao da će:
English: • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom
Croatian: • da mora odmah obavijestiti svog liječnika ako partnerica zatrudni te uvijek upotrebljavati prezervativ
English: If pregnancy occurs in a woman treated with thalidomide, treatment must be stopped immediately and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Croatian: Ako žena liječena talidomidom zatrudni, liječenje se mora odmah prekinuti, a bolesnicu uputiti liječniku specijaliziranom ili iskusnom u teratologiji na pregled i savjetovanje.
English: Myocardial infarction
Croatian: Infarkt miokarda
English: • you have or have ever had previous viral infection, particularly varicella zoster, hepatitis B infection, or HIV.
Croatian: • Ako imate ili ste prije imali virusnu infekciju, posebice infekciju virusom varičele zoster,
English: A cumulative search of DRESS cases with thalidomide from spontaneous sources and clinical trials retrieved 8 cases among which 4 cases were assessed as probable or possible drug reaction with eosinophilia and systemic symptoms (DRESS) as per Regiscar criteria.
Croatian: Pretraživanjem kumulativnih slučajeva DRESS-a kao posljedice talidomida, prijavljenih iz spontanih izvora i kliničkih ispitivanja, ustanovljeno je 8 slučajeva od kojih su prema Regiscar kriterijima 4 slučaja procijenjena kao vjerojatna ili moguća reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS).
English: Frequencies given are based on the observations during a pivotal comparative clinical study investigating the effect of thalidomide in combination with melphalan and prednisone in previously untreated multiple myeloma patients.
Croatian: Prikazane učestalosti temelje se na zapažanjima tijekom pivotalnog usporednog kliničkog ispitivanja kojim je ispitivan učinak talidomida u kombinaciji s melfalanom i prednizonom u bolesnika s multiplim mijelomom koji nisu bili prethodno liječeni.
English: Patients should be monitored for: thromboembolic events, peripheral neuropathy, severe skin reactions, bradycardia, syncope, somnolence, neutropenia and thrombocytopenia (see sections 4.4 and 4.8).
Croatian: Bolesnike je potrebno nadzirati zbog mogućnosti pojave tromboembolijskih događaja, periferne neuropatije, teških kožnih reakcija, bradikardije, sinkope, somnolencije, neutropenije i trombocitopenije (vidjeti dijelove 4.4 i 4.8).
English: Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage (see section 4.4).
Croatian: Periferna neuropatija je vrlo česta, potencijalno teška nuspojava liječenja talidomidom koja može rezultirati ireverzibilnim oštećenjem (vidjeti dio 4.4).
English: • Rash, dryness of the skin.
Croatian: • osip, suhoća kože
English: An increased incidence of second primary malignancies (SPM) has also been observed in patients with newly diagnosed MM receiving lenalidomide.
Croatian: Povećana incidencija drugih primarnih zloćudnih bolesti opažena je također u bolesnika s novodijagnosticiranim multiplim mijelomom koji su primali lenalidomid.
English: • Brochure for women of childbearing potential Brochure for women patients who are not of childbearing potential
Croatian: • brošura za bolesnice koje nemaju reproduktivni potencijal
English: In addition to the adverse reactions outlined above, thalidomide in combination with dexamethasone in other clinical studies led to the very common adverse reaction of fatigue; common adverse reactions of transient ischaemic event, syncope, vertigo, hypotension, mood altered, anxiety, blurred vision, nausea and dyspepsia; and uncommon adverse reactions of cerebrovascular accident, diverticular perforation, peritonitis, orthostatic hypotension and bronchitis.
Croatian: Pored prethodno opisanih nuspojava, talidomid u kombinaciji s deksametazonom prouzročio je u drugim kliničkim ispitivanjima kao vrlo čestu nuspojavu umor; česte nuspojave kao što su tranzitorna ishemijska ataka, sinkopa, vrtoglavica, hipotenzija, promjene raspoloženja, anksioznost, zamućeni vid, mučnina i dispepsija i manje česte nuspojave poput cerebrovaskularnog inzulta, perforacije divertikula, peritonitisa, ortostatske hipotenzije i bronhitisa.
English: • A fall in the number of white blood cells (neutropenia) accompanied by fever and infection.
Croatian: • pad broja bijelih krvnih stanica (neutropenija) popraćen vrućicom i infekcijom
English: Marketing Authorisation Holder Celgene Europe B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Celgene Europe B.V.
English: As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential who is not using effective contraception.
Croatian: Budući da se talidomid može naći u spermi, kao mjera opreza, svi muški bolesnici moraju upotrebljavati prezervative tijekom liječenja, tijekom pauza u uzimanju lijeka i najmanje 7 dana nakon završetka liječenja kada imaju spolne odnose s trudnicom ili ženom u reproduktivnoj dobi koja ne upotrebljava učinkovitu metodu kontracepcije.
English: * see section 4.8 description of selected adverse reactions identified from post marketing data ^ Acute myeloid leukaemia and Myelodysplastic syndrome were reported in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT)
Croatian: * vidjeti dio 4.8 za opis odabranih nuspojava † rezultati izvedeni iz podataka nakon stavljanja lijeka u promet ^ akutna mijeloična leukemija i mijelodisplastični sindrom prijavljeni su u jednom kliničkom ispitivanju u bolesnika s prethodno neliječenim MM koji su dobivali kombinaciju melfalana, prednizona i talidomida (MPT)
English: Each capsule contains 50 mg of thalidomide.
Croatian: Jedna kapsula sadrži 50 mg talidomida.
English: As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception.
Croatian: S obzirom na činjenicu da se talidomid može naći u spermi, kao mjera opreza, svi muški bolesnici moraju upotrebljavati prezervative tijekom liječenja, tijekom pauza u uzimanju lijeka i još najmanje 7 dana nakon završetka liječenja ako je njihova partnerica trudna ili je u reproduktivnoj dobi, a ne upotrebljava učinkovitu kontracepciju.
English: Severity of neuropathy
Croatian: Težina neuropatije
English: There is minimal cytochrome P450 catalysed hepatic metabolism of thalidomide.
Croatian: Prisutan je minimalni jetreni metabolizam talidomida kataliziran citokromom P450.