FrancophonIA/ELRC3.0 huggingface dataset:
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
Croatian: • informirana je i shvaća moguće posljedice trudnoće i potrebu za hitnim savjetovanjem u slučaju rizika od trudnoće
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of pomalidomide.
Croatian: • potvrđuje da razumije rizike i nužne mjere opreza povezane s primjenom pomalidomida.
English: • A spinning feeling in your head, making it difficult to stand up and move normally.
Croatian: • osjećaj vrtnje u glavi što stvara teškoće pri ustajanju i normalnom kretanju
English: Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell').
Croatian: Multipli mijelom je vrsta raka koja pogađa određene vrste bijelih krvnih stanica (zvane „plazma stanice“).
English: • Flu-like symptoms (influenza).
Croatian: • simptomi slični gripi (influenca)
English: A decision to take prophylactic measures should be made after a careful assessment of the individual patient's underlying risk factors.
Croatian: Odluku o primjeni profilaktičkih mjera treba donijeti nakon pažljive procjene rizičnih čimbenika kod pojedinog bolesnika.
English: Blood donation and blood tests
Croatian: Darivanje krvi i krvne pretrage
English: Uterine examination on Gestation Day 13 showed a decrease in mean number of viable embryos and an increase in postimplantation loss at all dosage levels.
Croatian: Pregled uterusa 13. dana gestacije pokazao je smanjenje prosječnog broja živih embrija i povećanje postimplantacijskih gubitaka pri svim razinama doze.
English: A dose modification may be required (see section 4.2).
Croatian: Može biti potrebna prilagodba doze (vidjeti dio 4.2).
English: A female patient or a female partner of a male patient is considered of non-childbearing potential if she meets at least one of the following criteria:
Croatian: Smatra se da bolesnica ili partnerica bolesnika nije u reproduktivnoj dobi ako ispunjava barem jedan od sljedećih kriterija:
English: There was no maternal toxicity observed in this study.
Croatian: U tom ispitivanju nije opažena toksičnost za majku.
English: If you take more Imnovid than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više Imnovida nego što ste trebali, odmah se obratite liječniku ili otiđite u bolnicu.
English: • by stimulating the immune system to attack the cancer cells
Croatian: • poticanjem imunosnog sustava da napada stanice raka
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Croatian: Rizik od venske tromboembolije nastavlja se još 4 do 6 tjedana nakon prekida liječenja kombiniranim oralnim kontraceptivima.
English: Dizziness and confusion
Croatian: Omaglica i konfuzija
English: • some antibiotics (for example ciprofloxacin, enoxacin)
Croatian: • neke antibiotike (primjerice ciprofloksacin, enoksacin)
English: • Guidance on handling pomalidomide for patients, caregivers and family members
Croatian: • smjernice za rukovanje pomalidomidom za bolesnike, njegovatelje i članove obitelji
English: Close monitoring of warfarin concentration is advised during treatment.
Croatian: Savjetuje se pozorno nadzirati koncentracije varfarina tijekom liječenja.
English: Died n (%)
Croatian: umrli n (%)
English: Women of childbearing potential should use effective method of contraception.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije.
English: This is because Imnovid can affect the way some other medicines work.
Croatian: To je potrebno zbog toga što Imnovid može utjecati na djelovanje nekih drugih lijekova.
English: Hepatitis B virus status should be established before initiating treatment with pomalidomide.
Croatian: Status infekcije virusom hepatitisa B treba ustanoviti prije započinjanja liječenja pomalidomidom.
English: The effect of dexamethasone on warfarin is unknown.
Croatian: Učinak deksametazona na varfarin nije poznat.
English: This is because this medicine is expected to harm the unborn baby.
Croatian: To je zato što se očekuje da će taj lijek naškoditi nerođenom djetetu.
English: Do not take Imnovid:
Croatian: Nemojte uzimati Imnovid:
English: How much Imnovid to take with other medicines
Croatian: Koliko Imnovida uzeti s drugim lijekovima
English: As a precaution, and taking into account special populations with potentially prolonged elimination time such as hepatic impairment, all male patients taking pomalidomide must meet the following conditions:
Croatian: Kao mjera opreza i uzimajući u obzir posebne populacije s potencijalno produljenim vremenom eliminacije, primjerice u slučaju oštećenja funkcije jetre, svi muški bolesnici koji uzimaju pomalidomid moraju ispuniti sljedeće uvjete:
English: 2 D bar code carrying the unique identifier
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom
English: Doses were reduced and treatment was temporarily interrupted or stopped as needed to manage toxicity (see section
Croatian: Doze su smanjivane i liječenje je privremeno prekinuto ili zaustavljeno prema potrebi kako bi se liječila toksičnost (vidjeti dio 4.2).
English: In vitro binding of pomalidomide enantiomers to proteins in human plasma ranges from 12% to 44% and is not concentration dependent.
Croatian: In vitro vezanje enantiomera pomalidomida za proteine ljudske plazme kreće se u rasponu od 12% do 44% i ne ovisi o koncentraciji.
English: Staphylococcal infection was observed in 4 monkeys; 3 of these animals responded to antibiotic treatment and 1 died without treatment.
Croatian: Stafilokokna infekcija javila se u 4 majmuna od kojih su 3 odgovorila na antibiotsko liječenje, dok je jedan uginuo bez liječenja.
English: Your doctor will advise you of how and when to take Imnovid if you have kidney problems and are receiving dialysis treatment.
Croatian: Liječnik će Vam reći kako i kada morate uzimati Imnovid ako imate tegoba s bubrezima i liječite se dijalizom.
English: The capsules should be swallowed whole, preferably with water, with or without food.
Croatian: Kapsule treba progutati cijele, po mogućnosti s vodom, s hranom ili bez nje.
English: Imnovid contains the active substance ‘pomalidomide'.
Croatian: Imnovid sadrži djelatnu tvar „pomalidomid“.
English: Decrease dose by one dose level.
Croatian: Smanjiti dozu za jednu razinu.
English: CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O ZAHTJEVU ZA JEDNOGODIŠNJU ZAŠTITU STAVLJANJA LIJEKA U PROMET
English: The most frequently reported adverse reaction was peripheral sensory neuropathy (47.8%).
Croatian: Najčešće zabilježena nuspojava bila je periferna senzorna neuropatija (47,8%).
English: Pomalidomide is present in human semen.
Croatian: Pomalidomid je prisutan u ljudskom sjemenu.
English: • Documentation of childbearing potential status
Croatian: • dokumentaciju o statusu reproduktivnog potencijala
English: Pomalidomide (4 mg) Bortezomib (1.3 mg/m2) Dexamethasone (20 mg) * • •
Croatian: Pomalidomid (4 mg) Bortezomib (1,3 mg/m2) • Deksametazon (20 mg)* • •
English: • Brief background on pomalidomide and its licensed indication
Croatian: • osnovna saznanja o pomalidomidu i njegove odobrene indikacije
English: As a result of these tests, your doctor may change your dose of Imnovid or stop your treatment.
Croatian: Na temelju rezultata tih pretraga, liječnik će Vam možda promijeniti dozu Imnovida ili prekinuti liječenje.
English: Interrupt dose until symptoms are controlled.
Croatian: Prekinuti dozu dok se simptomi ne stave pod kontrolu.
English: • Weight loss.
Croatian: • gubitak težine
English: • Infections of the nose, sinuses and throat, caused by bacteria or viruses.
Croatian: • infekcija nosa, sinusa i grla prouzročena bakterijama ili virusima
English: For male patients taking pomalidomide, pharmacokinetic data has demonstrated that pomalidomide is present in human semen during treatment.
Croatian: Za muške bolesnike koji uzimaju pomalidomid, farmakokinetički podaci su pokazali da je pomalidomid prisutan u ljudskoj spermi tijekom liječenja.
English: If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above.
Croatian: Ako bolesnica trenutačno primjenjuje kombiniranu oralnu kontracepciju, treba je zamijeniti nekom od prethodno navedenih djelotvornih metoda.
English: Pomalidomide must be discontinued permanently for angioedema.
Croatian: Pomalidomid se mora trajno ukinuti u slučaju angioedema.
English: Pomalidomide has minor or moderate influence on the ability to drive and use machines.
Croatian: Pomalidomid malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical studies.
Croatian: Bolesnici s ukupnim bilirubinom u serumu >1,5 x GGN (gornja granica normale) bili su isključeni iz kliničkih ispitivanja.
English: • Pregnancy test dates and results
Croatian: • datume i rezultate testova na trudnoću
English: Patients may require use of blood product support and /or growth factors.
Croatian: Bolesnicima može biti potrebna potpora primjenom krvnih preparata i/ili čimbenika rasta.
English: Kaplan-Meier Curve of Overall Survival (ITT Population)
Croatian: Kaplan-Meierova krivulja ukupnog preživljenja (analiza ITT populacije)
English: • you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels.
Croatian: • Ako ste imali srčani udar, imate zatajenje srca, otežano dišete ili ako pušite, imate povišeni krvni tlak ili visoke razine kolesterola.
English: Treatment continued until patients had disease progression.
Croatian: S liječenjem bolesnika nastavilo se sve do progresije bolesti.
English: Anticoagulation therapy (unless contraindicated) is recommended (see section 4.4).
Croatian: Preporučuje se antikoagulantna terapija (osim ako je kontraindicirana) (vidjeti dio 4.4).
English: • Swelling of the body, including swelling of the arms or legs.
Croatian: • oticanje tijela, uključujući oticanje ruku i nogu.
English: When to take Imnovid with other medicines
Croatian: Kada uzeti Imnovid s drugim lijekovima
English: Therefore, pomalidomide can be administered without regard to food intake.
Croatian: Stoga se pomalidomid može primjenjivati bez obzira na unos hrane.
English: The MAH should agree on the implementation of the patient card system in each Member State.
Croatian: 4. Nositelj odobrenja treba dogovoriti uvođenje sustava kartica za bolesnike u svakoj državi članici.
English: The PFS advantage was more pronounced in patients who received only one prior line of therapy.
Croatian: Produljenje PFS-a bilo je izraženije u bolesnika koji su primili samo jednu prethodnu liniju terapije.
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Croatian: U suradnji s nacionalnim nadležnim tijelom uveden je nacionalni sustav kontrolirane distribucije.
English: The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil.
Croatian: Kapsule su pakirane u blisterima od polivinilklorida (PVC) / poliklorotrifluoroetilena (PCTFE) s aluminijskom folijom.
English: • The need to avoid foetal exposure due to teratogenicity of pomalidomide in animals and the expected teratogenic effect of pomalidomide in humans
Croatian: • potrebu za izbjegavanjem fetalne izloženosti zbog teratogenosti pomalidomida u životinja i očekivanog teratogenog učinka pomalidomida u ljudi
English: • if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see “Pregnancy, contraception and breast-feeding - information for women and men”).
Croatian: • Ako možete zatrudnjeti, osim ako ste poduzeli sve potrebne mjere za sprječavanje trudnoće (vidjeti „Trudnoća, kontracepcija i dojenje - obavijesti za žene i muškarce“).
English: Pomalidomide is eliminated with a median plasma half-life of approximately 9.5 hours in healthy subjects and approximately 7.5 hours in patients with multiple myeloma.
Croatian: Pomalidomid se eliminira uz medijan poluvijeka u plazmi približno 9,5 sati u zdravih ispitanika i približno 7,5 sati u bolesnika s multiplim mijelomom.
English: Censored n (%)
Croatian: cenzurirani n (%)
English: Effect of other medicinal products on pomalidomide
Croatian: Učinak drugih lijekova na pomalidomid
English: Regular monitoring of liver function is recommended for the first 6 months of treatment with pomalidomide and as clinically indicated thereafter.
Croatian: Preporučuje se redovito pratiti funkciju jetre u prvih 6 mjeseci liječenja pomalidomidom, a nakon toga, kako je klinički indicirano.
English: Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5.
Croatian: Pomalidomid se djelomično metabolizira preko CYP1A2 i CYP3A4/5.
English: Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored.
Croatian: Bolesnike s poznatim čimbenicima rizika za tromboemboliju - uključujući prethodnu trombozu - treba pomno nadzirati.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Croatian: Bolesnike treba uputiti da potraže liječničku pomoć ako osjete simptome poput nedostatka zraka, bolova u prsima, oticanja ruku ili nogu.
English: • If your partner is pregnant or able to become pregnant, you must use condoms for the whole time you are taking treatment and for 7 days after the end of treatment.
Croatian: • Ako je Vaša partnerica trudna ili je u mogućnosti zatrudnjeti, morate upotrebljavati prezervative cijelo vrijeme dok se liječite i 7 dana dana nakon završetka liječenja.
English: What Imnovid is used for Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma'.
Croatian: Za što se Imnovid koristi Imnovid se koristi za liječenje odraslih s vrstom raka koji se naziva multipli mijelom.
English: Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of Imnovid to reduce the chance that you get blood clots.
Croatian: Liječnik Vam može preporučiti uzimanje dodatnih lijekova (npr. varfarin) ili sniženje doze Imnovida kako bi se smanjila mogućnost nastanka krvnih ugrušaka.
English: If adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be discontinued.
Croatian: Ako nuspojave nastupe nakon smanjenja doze na 1 mg, potrebno je prekinuti primjenu lijeka.
English: Such patients may be at higher risk of hypersensitivity reactions and should not receive pomalidomide.
Croatian: Za takve bolesnike može postojati veći rizik od reakcija preosjetljivosti i ne smiju primati pomalidomid.
English: • A core text as agreed by the CHMP.
Croatian: • od osnovnog teksta kao što je dogovoreno s CHMP-om
English: Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the Pom + LD-Dex arm.
Croatian: Na temelju rezultata ishoda PFS-a i ukupnog preživljenja, odbor za nadzor podataka uspostavljen za ovo ispitivanje preporučio je da se ispitivanje dovrši i da se bolesnici iz skupine HD-Dex prebace u skupinu Pom+LD-Dex.
English: These patients should be monitored closely and appropriate precautions taken.
Croatian: Te bolesnike treba pomno nadzirati te poduzimati odgovarajuće mjere opreza.
English: Women and men taking Imnovid must not become pregnant or father a child.
Croatian: Žene koje uzimaju Imnovid ne smiju zatrudnjeti ni muškarci začeti dijete.
English: • Even if a woman of childbearing potential has amenorrhoea 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 djelotvornu kontracepciju
English: Before and during the treatment with Imnovid you will have regular blood tests.
Croatian: Prije i tijekom liječenja Imnovidom podvrgavat ćete se redovitim pretragama krvi.
English: Your doctor will advise if you should stop or continue breast-feeding.
Croatian: Liječnik će Vas uputiti trebate li prekinuti ili nastaviti s dojenjem.
English: The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model.
Croatian: d p-vrijednost temelji se na nestratificiranom log-rang testu s istim stratifikacijskim čimbenicima kao i u gornjem Coxovom modelu.
English: NE = Not Estimable.
Croatian: NP = ne može se procijeniti.
English: In vitro, CYP1A2 and CYP3A4 were identified as the primary enzymes involved in the CYP-mediated hydroxylation of pomalidomide, with additional minor contributions from CYP2C19 and CYP2D6.
Croatian: In vitro, CYP1A2 i CYP3A4 bili su utvrđeni kao primarni enzimi uključeni u hidroksilaciju pomalidomida posredovanu CYP-om, uz dodatni manji doprinos CYP2C19 i CYP2D6.
English: • A fast and irregular heartbeat (atrial fibrillation).
Croatian: • brzi i nepravilni otkucaji srca (fibrilacija atrija)
English: o Some days, you take both medicines, some days just 1 medicine, and some days none at all.
Croatian: o Nekih dana uzet ćete oba lijeka, nekih dana samo 1 lijek, a nekih dana nijedan.
English: Prophylaxis with acetylsalicylic acid (and other anticoagulants in high risk patients) was mandatory for all patients in clinical studies.
Croatian: Profilaksa acetilsalicilatnom kiselinom (i drugim antikoagulansima u visokorizičnih bolesnika) bila je u kliničkim ispitivanjima obavezna za sve bolesnike.
English: • The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m2 body surface area).
Croatian: • Preporučenu početnu dozu bortezomiba odredit će Vam liječnik, a temeljit će se na Vašoj visini i težini (1,3 mg/m tjelesne površine).
English: If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is expected (see section 4.4).
Croatian: Ako se pomalidomid uzima tijekom trudnoće, očekuje se teratogeni učinak pomalidomida na ljude (vidjeti dio 4.4).
English: • Swallow the capsules whole, preferably with water.
Croatian: • Progutajte kapsule cijele, po mogućnosti s vodom.
English: o Some days, you take all 3 medicines, some days just 2 or 1 medicines, and some days none at all.
Croatian: o Nekih dana uzet ćete sva 3 lijeka, nekih dana samo 2 lijeka ili 1 lijek, a nekih dana nijedan.
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure.
Croatian: To može dovesti do stanja u kojem se tumori razgrađuju i prouzročiti pojavu neuobičajenih razina kemikalija u krvi, što može dovesti do zatajenja bubrega.
English: The doctor may also change the dose or stop the medicine because of your general health.
Croatian: Dozu može promijeniti ili prekinuti primjenu lijeka i zbog Vašega općeg zdravlja.
English: This is because pomalidomide is expected to harm the unborn baby.
Croatian: To je zato što se očekuje da će pomalidomid naškoditi nerođenom djetetu.
English: • you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet).
Croatian: • Ako imate ili ste imali neuropatiju (oštećenje živca koje uzrokuje žarenje ili bol u šakama i stopalima).
English: • He understands the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential
Croatian: • razumiju očekivani teratogeni rizik ako stupaju u spolne odnose s trudnicom ili ženom reproduktivne dobi
English: Following a single oral administration of [
Croatian: Nakon jednokratne peroralne primjene [
English: During the treatment with Imnovid you have an increased risk of getting blood clots in your veins and arteries.
Croatian: Tijekom liječenja Imnovidom imate povećan rizik od stvaranja krvnih ugrušaka u venama i arterijama.
English: Because of the potential for adverse reactions in breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the woman.
Croatian: Zbog mogućih nuspojava od pomalidomida u dojenčadi, mora se odlučiti da li prekinuti dojenje ili prekinuti liječenje, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: • Decreased number of lymphocytes (one type of white blood cells) often caused by infection (lymphopenia).
Croatian: • smanjen broj limfocita (jedna vrsta bijelih krvnih stanica) što je često prouzročeno infekcijom (limfopenija)
English: Also some other medicines can affect the way Imnovid works.
Croatian: Isto tako, neki drugi lijekovi mogu utjecati na djelovanje Imnovida.
English: Each pack contains 14 or 21 capsules.
Croatian: Jedno pakiranje sadrži 14 ili 21 kapsulu.
English: These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy.
Croatian: U tih bolesnika treba pomno pratiti pojavu znakova i simptoma aktivne infekcije virusom hepatitisa B tijekom cijele terapije.
English: Imnovid is expected to cause severe birth defects and may lead to the death of an unborn baby.
Croatian: Očekuje se da će Imnovid prouzročiti teška prirođena oštećenja i može izazvati smrt nerođenog djeteta.
English: Celgene Distribution B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Croatian: Winthontlaan 6 N 3526 KV Utrecht Nizozemska
English: Median OS time from Kaplan-Meier estimates has not been reached for the Pom + LD-Dex, but would be expected to be at least 48 weeks, which is the lower boundary of the 95% CI.
Croatian: Medijan razdoblja ukupnog preživljenja prema Kaplan-Meierovoj procjeni u skupini koja je primala Pom+LD-Dex nije bio postignut, ali očekuje se da bi iznosio najmanje 48 tjedana, što je donja granica 95% CI.
English: • Infections of the lungs (pneumonia and bronchitis).
Croatian: • infekcija u plućima (upala pluća i bronhitis)
English: • Maximum duration of prescription o 4 weeks for women with childbearing potential o 12 weeks for men and women without childbearing potential
Croatian: • maksimalno trajanje propisane terapije o 4 tjedna za žene reproduktivne dobi o 12 tjedana za muškarce i žene koje nisu u reproduktivnoj dobi
English: Increased cardiac anomalies were seen at all doses with significant increases at 250 mg/kg/day.
Croatian: Opažen je povećan broj srčanih anomalija pri svim dozama uz značajna povećanja pri dozi od 250 mg/kg na dan.
English: In particular, tell your doctor, pharmacist or nurse before taking Imnovid if you are taking any of the following medicines:
Croatian: Posebice recite svojemu liječniku, ljekarniku ili medicinskoj sestri prije uzimanja Imnovida ako uzimate bilo koji od sljedećih lijekova:
English: What Imnovid is
Croatian: Što je Imnovid
English: If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with pomalidomide.
Croatian: Ako se u bolesnika pojavi takav utjecaj lijeka, treba ga upozoriti da ne upravlja vozilima, ne rukuje strojevima ili ne obavlja rizične zadatke za vrijeme liječenja pomalidomidom.
English: • Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to a serious type of allergic reaction called angioedema).
Croatian: • oticanje lica, usana, jezika i grla, što može prouzročiti otežano disanje (zbog ozbiljne vrste alergijske reakcije pod nazivom angioedem)
English: There have also been cases of hepatitis that resulted in discontinuation of pomalidomide.
Croatian: Bilo je i slučajeva hepatitisa koji su rezultirali ukidanjem primjene pomalidomida.
English: Pomalidomide should be interrupted pending investigation of these symptoms and if ILD is confirmed, appropriate treatment should be initiated.
Croatian: Pomalidomid treba prekinuti sve dok se ne ispitaju ovi simptomi, i ako se potvrdi IBP potrebno je započeti odgovarajuće liječenje.