FrancophonIA/ELRC3.0 huggingface dataset:
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Croatian: Ovaj zahtjev uključuje žene u reproduktivnoj dobi koje primjenjuju apsolutnu i neprekidnu apstinenciju.
English: • A fall in the number of red and white blood cells and platelets at the same time (pancytopenia).
Croatian: • pad broja crvenih i bijelih krvnih stanica te krvnih pločica u isto vrijeme (pancitopenija)
English: • cause sleepiness as thalidomide may increase their effects.
Croatian: • uzrokuju pospanost jer talidomid može pojačati njihove učinke.
English: • Brochure for male patients
Croatian: • brošura za muške bolesnike
English: • Pregnancy and any exposure during pregnancy must be avoided.
Croatian: • Mora se izbjegavati trudnoća i bilo kakvo izlaganje lijeku tijekom trudnoće.
English: MP - T
Croatian: MP MP-T
English: Thalidomide does not interact with digoxin.
Croatian: Talidomid ne stupa u interakcije s digoksinom.
English: Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks.
Croatian: Talidomid može također potencijalno pogoršati postojeću neuropatiju te se stoga ne smije primjenjivati u bolesnika s kliničkim znakovima ili simptomima periferne neuropatije, osim ako klinička dobrobit nadmašuje rizike.
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of thalidomide.
Croatian: • Potvrđuje da razumije rizike i nužne mjere opreza povezane s primjenom talidomida.
English: • Worsening of Parkinson's disease symptoms (such as tremor, depression or confusion).
Croatian: • pogoršanje simptoma Parkinsonove bolesti (poput nevoljnog drhtanja, depresije ili smetenosti)
English: Prior to starting treatment
Croatian: Prije početka liječenja
English: Thalidomide has a chiral centre and is used clinically as a racemate of (+)-(R)- and (-)-(S)-thalidomide.
Croatian: Talidomid sadrži kiralni centar te se upotrebljava u kliničke svrhe kao racemat (+)-(R)- i (-)-(S)-talidomida.
English: ≤ 75 < 1,500 but
Croatian: ≤ 75 < 1500 ali
English: • A spinning feeling in your head, making it difficult to stand up and move normally.
Croatian: • osjećaj vrtnje u glavi koji otežava normalno stajanje ili kretanje
English: Thalidomide must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the Pregnancy Prevention Programme are met.
Croatian: Talidomid ne smiju nikada upotrebljavati trudnice ili žene koje bi mogle zatrudnjeti, osim ako ispunjavaju sve uvjete iz Programa prevencije trudnoće.
English: Tell your doctor straight away if you notice any of the following serious side effects:
Croatian: Odmah se obratite svojem liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Do not take Thalidomide Celgene if any of the above applies to you.
Croatian: Nemojte uzimati Thalidomide Celgene ako se bilo što od prethodno navedenog odnosi na Vas.
English: Pharmacotherapeutic group: immunosuppressants, other immunosuppressants, ATC code: L04AX02.
Croatian: Farmakoterapijska skupina: imunosupresivi, ostali imunosupresivi, ATK oznaka: L04AX02.
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Croatian: Dijagnoza sindroma PRES/RPLS zahtijeva potvrdu snimanjem mozga.
English: Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis.
Croatian: Talidomid se metabolizira gotovo isključivo putem neenzimatske hidrolize.
English: • Do not break, open or chew the capsules.
Croatian: • Nemojte lomiti, otvarati ili žvakati kapsule.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine in the following situations:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek u sljedećim situacijama:
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Croatian: Idealno, testiranje na trudnoću, propisivanje lijeka i izdavanje lijeka treba obaviti istoga dana.
English: • Age  50 years and naturally amenorrhoeic for  1 year (Amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential).
Croatian: • Dob  50 godina te je prirodno amenoroična tijekom  1 godine (amenoreja nakon liječenja raka ili tijekom dojenja ne isključuje reproduktivni potencijal).
English: > 75 < 1,500 but
Croatian: > 75 < 1500 ali
English: A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
Croatian: Smatra se da je bolesnica ili partnerica bolesnika u reproduktivnoj dobi, osim ako ispunjava barem jedan od sljedećih kriterija:
English: There are in vitro data indicating that prednisone may give rise to enzyme induction which could reduce the systemic exposure of concomitantly used medicinal products.
Croatian: Postoje in vitro podaci koji upućuju na to da prednizon može pobuditi indukciju enzima koja može reducirati sistemsku izloženost istodobno primijenjenih lijekova.
English: The major route of excretion was via the urine (> 90 %) while faecal excretion was minor.
Croatian: Glavni način izlučivanja bio je mokraćom (> 90 %), dok je izlučivanje stolicom bilo manje zastupljeno.
English: This applies even if the man has had a vasectomy.
Croatian: To je primjenjivo čak i kada je muškarac podvrgnut vazektomiji.
English: Therefore, considering the seriousness of this risk, the PRAC considers that the risk should be reflected in the PI of thalidomide.
Croatian: Stoga, s obzirom na ozbiljnost toga rizika, PRAC smatra da je taj rizik potrebno navesti u Informacijama o lijeku za talidomid.
English: The plasma protein binding of the (+)-(R) and (-)-(S) enantiomers was found to be 55 % and 65 % respectively.
Croatian: Vezanje enantiomera (+)-(R) i (-)-(S) za proteine plazme iznosilo je 55 % odnosno 65 %.
English: The risk of intra-uterine death or severe birth defects, primarily phocomelia, is extremely high.
Croatian: Rizik od smrti ploda u maternici ili teških urođenih anomalija, prvenstveno fokomelije, iznimno je visok.
English: Continue to monitor the patient with clinical examination.
Croatian: Nastaviti pratiti bolesnika putem kliničkih pregleda.
English: This may be due to nerve damage (called ‘peripheral neuropathy'), which is a very common side effect.
Croatian: To može biti zbog oštećenja živca (nazvanog „periferna neuropatija“) što je vrlo česta nuspojava.
English: †, Abnormal coordination
Croatian: Konvulzije†, abnormalna koordinacija
English: The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each).
Croatian: Kapsule se isporučuju u kartonskim ovitcima koji sadrže 28 kapsula (2 blistera, svaki s 14 kapsula).
English: Make sure you tell your doctor if you are taking any medicines which:
Croatian: Ne zaboravite spomenuti svom liječniku ako uzimate bilo koje lijekove koji:
English: • are used for heart problems and complications (such as digoxin), or for thinning the blood (such as warfarin).
Croatian: • uzimaju se u slučaju tegoba i komplikacija sa srcem (kao što je digoksin) ili za razrjeđivanje krvi (kao što je varfarin).
English: In addition, the addition of interruption or discontinuation recommendations regarding the risk of severe skin reactions in general, in line with the one already approved for the structural analogues lenalidomide and pomalidomide, is supported.
Croatian: Nadalje, podupire dodavanje preporuke o privremenom ili trajnom prekidu primjene zbog rizika od teških kožnih reakcija općenito, u skladu s onom već odobrenom preporukom za njegove strukturne analoge lenalidomid i pomalidomid.
English: If no improvement or continued worsening of the neuropathy, discontinue treatment.
Croatian: Ako nema poboljšanja ili se neuropatija pogoršava, prekinuti liječenje.
English: Teratogenic effects
Croatian: Teratogeni učinci
English: The in vivo relevance of these findings is unknown.
Croatian: Relevantnost ovih podataka in vivo nije poznata.
English: • Low blood cell counts.
Croatian: • nizak broj krvnih stanica.
English: Thalidomide does not interact with hormonal contraceptives.
Croatian: Talidomid ne stupa u interakcije s hormonskim kontraceptivima.
English: Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Croatian: Rezultate testiranja korisnika lijeka treba predočiti nadležnom državnom tijelu, a konačne materijale vrednovati na državnoj razini.
English: The following can be considered to be examples of effective methods of contraception:
Croatian: Sljedeće metode kontracepcije mogu se smatrati učinkovitima:
English: It may harm them,
Croatian: Te će mjere spriječiti zlouporabu.
English: Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all.
Croatian: Simptomi se mogu pojaviti neko vrijeme nakon što je liječenje talidomidom prekinuto i mogu se povući sporo ili se uopće ne povući.
English: • by stimulating part of the immune system to attack the cancer cells.
Croatian: • poticanjem dijela imunološkog sustava da napada stanice raka.
English: Further to the per protocol analysis, an update was conducted for the IFM 99-06 study providing an additional 15 months follow-up data.
Croatian: Pored analiza definiranih protokolom, provedeno je ažuriranje ispitivanja IFM 99-06 podacima iz praćenja ispitanika tijekom dodatnih 15 mjeseci.
English: The mean elimination half-life of thalidomide in plasma following single oral doses between 50 mg and 400 mg was 5.5 to 7.3 hours.
Croatian: Srednja vrijednost poluvremena eliminacije talidomida u plazmi nakon pojedinačne oralne doze između 50 mg i 400 mg iznosila je od 5,5 do 7,3 sata.
English: Posterior reversible encephalopathy syndrome (PRES)/ Reversible posterior leukoencephalopathy syndrome (RPLS)
Croatian: Sindrom reverzibilne posteriorne encefalopatije (PRES)/Sindrom reverzibilne posteriorne leukoencefalopatije (RPLS)
English: All 4 cases involved other possible contributing factors preventing the establishment of a definite direct causal relationship between thalidomide and DRESS, but a link with thalidomide could also not be excluded.
Croatian: U sva 4 slučaja postojao je i mogući doprinos drugih čimbenika, zbog čega se nije mogla sigurno utvrditi izravna uzročna povezanost između talidomida i DRESS-a, ali se povezanost s talidomidom nije mogla ni isključiti.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Croatian: Bolesnicima i liječnicima se savjetuje da obrate pozornost na znakove i simptome tromboembolije.
English: Melphalan c,d,e
Croatian: Talidomida,b Melfalanc,d,e
English: Thalidomide must not be used at any time during pregnancy (see sections 4.4 and 4.6).
Croatian: Talidomid se uopće ne smije upotrebljavati tijekom trudnoće (vidjeti dijelove 4.4 i 4.6).
English: Syncope, bradycardia and atrioventricular block
Croatian: Sinkopa, bradikardija i atrioventrikularni blok
English: OR < 100,000 but
Croatian: ILI < 100 000 ali
English: Do not take thalidomide if you are pregnant or could become pregnant.
Croatian: Nemojte uzimati talidomid ako ste trudni ili biste mogli zatrudnjeti.
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Croatian: • procjenu usklađenosti sa zahtjevima nakon stavljanja lijeka u promet (kako je primjenjivo u državi članici)
English: • if you are able to become pregnant, unless you are able to follow or comply with the required contraceptive measures to prevent you from becoming pregnant (see section 2 “Warnings and precautions” and “Pregnancy and breast-feeding”).
Croatian: • ako možete zatrudnjeti, osim ako se možete pridržavati potrebnih mjera za sprječavanje trudnoće (opisanih u dijelu 2 pod naslovom „Upozorenja i mjere opreza“ i „Trudnoća i dojenje“)
English: Additional precautions
Croatian: Dodatne mjere opreza
English: Pack sizes: 28 capsules (two blisters) in a wallet card.
Croatian: Veličina pakiranja: 28 kapsula (dva blistera) u kartonskom ovitku.
English: Hepatitis B virus status should be established before initiating treatment with thalidomide.
Croatian: Status s obzirom na virus hepatitisa B treba ustanoviti prije započinjanja liječenja talidomidom.
English: Incidence of neuropathy events leading to discontinuation, dose reduction or interruption increases with cumulative dose and duration of therapy.
Croatian: Incidencija neuropatskih događaja koji su vodili do prekida liječenja, smanjenja doze ili pauze u liječenju povećava se s kumulativnom dozom i trajanjem terapije.
English: Modification of dose and regimen
Croatian: Promjene doze i režima doziranja
English: Allergic reactions and severe skin reactions
Croatian: Alergijske reakcije i teške kožne reakcije
English: • Premature ovarian failure confirmed by a specialist gynaecologist.
Croatian: • Prerano zatajivanje rada jajnika koje je potvrdio ginekolog.
English: Infections Patients should be monitored for severe infections including sepsis and septic shock.
Croatian: Infekcije Bolesnike treba nadzirati zbog moguće pojave teških infekcija uključujući sepsu i septički šok.
English: • Feeling weak, faint or unsteady, lack of energy or strength, low blood pressure.
Croatian: • osjećaj slabosti, nesvjestice ili nestabilnosti, gubitak energije ili snage, nizak krvni tlak
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
Croatian: U slučaju predoziranja potrebno je pratiti vitalne znakove bolesnika te poduzeti odgovarajuće potporne mjere kako bi se stabilizirali krvni tlak i disanje.
English: • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
Croatian: • Čak i ako žena u reproduktivnoj dobi ima amenoreju, mora se pridržavati svih savjeta za učinkovitu kontracepciju.
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors (see sections 4.4, 4.5 and 4.8).
Croatian: Odluku o primjeni antitrombotskih profilaktičkih mjera potrebno je donijeti nakon pažljive procjene podležećih čimbenika rizika za svakog pojedinog bolesnika (vidjeti dijelove 4.4, 4.5 i 4.8).
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia).
Croatian: Potrebno je poduzeti odgovarajuće mjere s ciljem smanjenja svih promjenjivih čimbenika rizika (npr. pušenje, hipertenzija i hiperlipidemija).
English: Treatment with Thalidomide Celgene may cause a virus to become active again in patients who carry it, resulting in a recurrence of the infection.
Croatian: Liječenje lijekom Thalidomide Celgene može uzrokovati ponovnu aktivaciju virusa u bolesnika koji ga nose, što rezultira ponovnom pojavom infekcije.
English: The MAH shall implement a Pregnancy Prevention Programme (PPP) in each Member State.
Croatian: Pregnancy Prevention Programme, PPP) u svakoj državi članici.
English: If you are in doubt, talk to your doctor.
Croatian: Ako niste sigurni, obratite se liječniku.
English: • Fall of blood pressure on standing which may lead to fainting.
Croatian: • pad krvnog tlaka pri ustajanju koji može izazvati nesvjesticu
English: • The patient has acknowledged the aforementioned conditions.
Croatian: • da bolesnik/ca potvrdi razumijevanje prethodno navedenih uvjeta.
English: It is very common that thalidomide causes somnolence.
Croatian: Vrlo često talidomid prouzročuje somnolenciju.
English: Your doctor may monitor your blood cell counts during treatment with Thalidomide Celgene.
Croatian: Liječnik može pratiti razine Vaših krvnih stanica tijekom liječenja lijekom Thalidomide Celgene.
English: Grade 3 (interfering with activities of daily living)
Croatian: Stupanj 3 (utjecaj na svakodnevne aktivnosti)
English: • The following information should also be provided in the appropriate educational brochure for patients: o Women of childbearing potential
Croatian: • sljedeće informacije također treba navesti u odgovarajućim edukacijskim brošurama za bolesnike: o za žene u reproduktivnoj dobi
English: If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/risk is favourable.
Croatian: Ako se neuropatija smanji na stupanj 1 ili stanje bude još bolje, može se ponovno započeti liječenje pod uvjetom da je odnos koristi i rizika povoljan.
English: • Bleeding or bruising in the absence of injury.
Croatian: • Krvarenje ili nastanak modrice bez ozljede.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Bolesnicima za koje se testom ustanovi da su pozitivni na infekciju HBV-om, preporučuje se da se posavjetuju s liječnikom specijalistom za liječenje hepatitisa B.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for thalidomide, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za talidomid, znanstveni zaključci CHMP-a su sljedeći:
English: No evidence of carcinogenicity was observed at exposures approximately 15, 13 and 39 times the estimated clinical AUC at the recommended starting dose in mice, male rats and female rats respectively.
Croatian: Nije bilo dokaza o kancerogenosti pri ekspozicijama od približno 15, 13 odnosno 39 puta većim od procijenjene kliničke AUC pri preporučenoj početnoj dozi u miševa te mužjaka odnosno ženki štakora.
English: • As little as one capsule taken by a pregnant woman can cause a baby to have serious birth defects.
Croatian: • Samo jedna kapsula lijeka koju uzme trudnica može prouzročiti teške urođene mane djeteta.
English: • The most appropriate strategies to monitor the off-label use within national territories
Croatian: • najprikladnije strategije za nadzor primjene lijeka izvan odobrenih indikacija unutar teritorija pojedine države
English: However, this has not formally been studied in patients with impaired renal or hepatic function; therefore patients with severe renal or hepatic impairment should be carefully monitored for any adverse events.
Croatian: Međutim, to nije službeno ispitivano u bolesnika s oštećenom funkcijom bubrega ili jetre; stoga je bolesnike s teškim oštećenjem funkcije bubrega ili jetre potrebno pomno nadzirati zbog moguće pojave bilo kakvih štetnih događaja.
English: Bradycardic effect
Croatian: Bradikardijski učinak
English: Co-administration of food delayed absorption but did not alter the overall extent of absorption.
Croatian: Istodobna primjena hrane odgađa apsorpciju, ali ne mijenja ukupni opseg apsorpcije.
English: • That if she needs to change or stop using her method of contraception she should inform: ▪ The physician prescribing her contraception that she is on thalidomide ▪ The physician prescribing thalidomide that she has stopped or changed her method of contraception
Croatian: • ako je potrebno da promijeni ili prestane upotrebljavati svoju metodu kontracepcije, žena mora obavijestiti: liječnika koji joj je propisao kontracepciju da uzima talidomid liječnika koji joj je propisao talidomid da je prestala uzimati ili da je promijenila svoju metodu kontracepcije
English: The MAH should agree on the implementation of the patient card system in each Member State.
Croatian: Nositelj odobrenja će dogovoriti uvođenje sustava kartica za bolesnike u svakoj državi članici.
English: Patients should be advised as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks (see section 4.7).
Croatian: Bolesnicima je potrebno objasniti moguća oštećenja mentalnih i/ili tjelesnih sposobnosti koje su potrebne za obavljanje rizičnih zadataka (vidjeti dio 4.7).
English: It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, especially haematological malignancies, and it is possible that this risk may be increased with Thalidomide Celgene treatment; therefore your doctor should carefully evaluate the benefit and risk when you are prescribed Thalidomide Celgene.
Croatian: Važno je napomenuti da se u malog broja bolesnika s multiplim mijelomom mogu razviti dodatne vrste raka, osobito zloćudne bolesti krvi, a moguće je da se taj rizik povećava uz lijek Thalidomide Celgene; stoga liječnik mora pažljivo procijeniti koje koristi i rizike za Vas uključuje propisivanje lijeka Thalidomide Celgene.
English: • Medroxyprogesterone acetate depot
Croatian: • depo preparat medroksiprogesteronacetata
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Croatian: Ako bolesnik iskusi bilo kakve tromboembolijske događaje, liječenje se mora prekinuti te započeti standardnu terapiju antikoagulansima.
English: These cells collect in the bone marrow and divide out of control.
Croatian: Te se stanice skupljaju u koštanoj srži i nekontrolirano dijele.
English: Thalidomide is present in the semen of male patients at levels similar to plasma concentrations (see section 4.4).
Croatian: Talidomid je prisutan u spermi muškaraca u razinama sličnim koncentracijama u plazmi (vidjeti dio 4.4).
English: If you are able to become pregnant, your doctor will record with each prescription that the necessary measures, as outlined above, have been taken
Croatian: Ako biste mogli zatrudnjeti, Vaš će liječnik uz svaki recept zabilježiti da su poduzete potrebne prethodno opisane mjere.
English: You must follow the contraception advice given to you by your doctor.
Croatian: Morate se pridržavati savjeta o zaštiti od začeća koje ste dobili od svog liječnika.
English: Peripheral neuropathy Dose modifications due to peripheral neuropathy are described in Table 2.
Croatian: Periferna neuropatija Promjene doze zbog periferne neuropatije prikazane su u tablici 2.
English: Prior to approval by the National Competent Authority and launch of the medicinal product, the MAH should ensure that the educational materials are provided to and reviewed by the national patients' organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.
Croatian: Prije odobrenja od nadležnog državnog tijela i stavljanja lijeka u promet, nositelj odobrenja će osigurati da se edukacijski materijali isporuče i da ih pregledaju državne organizacije bolesnika, ili ako takve organizacije ne postoje ili ih se ne može angažirati, da to učini odgovarajuća udruga bolesnika.
English: Cases of PRES/RPLS have been reported.
Croatian: Prijavljeni su slučajevi sindroma PRES/RPLS.
English: Oxidative metabolism does not contribute significantly to the overall metabolism of thalidomide.
Croatian: Oksidativni metabolizam ne pridonosi značajno ukupnom metabolizmu talidomida.
English: Pneumonia
Croatian: Pneumonija
English: • if you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
Croatian: • ako možete zatrudnjeti, liječnik će uz svaki recept zabilježiti da su poduzete sve potrebne mjere i dat će Vam tu potvrdu
English: • you experienced or have existing slow heart rate (this may be a symptom of bradycardia).
Croatian: • Ako ste prije opazili ili sada imate spore srčane otkucaje (to može biti simptom bradikardije).
English: • Sudden pain in your chest or difficulty in breathing.
Croatian: • Iznenadnu bol u prsnom košu ili otežano disanje.
English: These can happen during treatment, or after treatment has stopped.
Croatian: Događa se tijekom liječenja ili nakon završetka liječenja.