FrancophonIA/ELRC3.0 huggingface dataset:
English: Imnovid is available as capsules (1, 2, 3 and 4 mg).
Croatian: Lijek Imnovid dostupan je u obliku kapsula (od 1, 2, 3 i 4 mg).
English: This overview was last updated in 04-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 4. 2019.
English: It must not be used in women who could become pregnant, unless they take all the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment.
Croatian: Ne smiju ga uzimati ni žene koje bi mogle zatrudnjeti, osim ako poduzmu sve potrebne mjere kako bi bile sigurne da nisu trudne prije početka liječenja odnosno kako ne bi zatrudnjele tijekom ili ubrzo nakon liječenja.
English: Further information on the orphan designation can be found on ema.europa.eu/medicines/human/orphan-designations/EU309672.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete pronaći ovdje: ema.europa.eu/medicines/human/orphan-designations/EU309672.
English: Each Member State will also ensure that educational materials and patient cards are provided to prescribers and patients.
Croatian: Svaka država članica osigurat će i da se edukativni materijali i kartice za bolesnike isporuče propisivačima lijeka i bolesnicima.
English: What measures are being taken to ensure the safe and effective use of Imnovid?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imnovid?
English: Imnovid received a marketing authorisation valid throughout the EU on 5 August 2013.
Croatian: Lijek Imnovid dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 5. kolovoza 2013.
English: As the medicine can pass into semen, the medicine must also not be used in men who are unable to comply with the required contraceptive measures.
Croatian: Budući da se lijek može izlučiti u sjemenu tekućinu, ne smije se primjenjivati u muškaraca koji se ne mogu pridržavati obveznih mjera kontracepcije.
English: Further information on Imnovid can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
Croatian: Više informacija o lijeku Imnovid nalazi se na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
English: Treatment with Imnovid may need to be interrupted or stopped, or the dose reduced, if the disease gets worse or certain side effects occur.
Croatian: Možda će biti potrebno prekinuti ili obustaviti liječenje lijekom Imnovid ili smanjiti dozu ako se bolest pogorša ili nastupe određene nuspojave.
English: The company that makes Imnovid will set up a pregnancy-prevention programme in each Member State.
Croatian: Tvrtka koja lijek Imnovid stavlja u promet utvrdit će program sprječavanja trudnoće u svakoj državi članici.
English: Pomalidomide is expected to be harmful to the unborn child, causing severe and life-threatening birth defects.
Croatian: Očekuje se da će pomalidomid biti štetan za nerođeno dijete i uzrokovati teške i po život opasne prirođene mane.
English: Side effects reported with Imnovid are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Imnovid pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Imnovid
Croatian: Ostale informacije o lijeku Imnovid
English: What are the risks associated with Imnovid?
Croatian: Koji su rizici povezani s lijekom Imnovid?
English: It will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining that the medicine is expected to be harmful to the unborn child and detailing the steps needed to use the medicine safely.
Croatian: Dostavit će pismo i edukativne komplete za zdravstvene radnike te brošure za bolesnike s objašnjenjem kako se očekuje da će lijek biti štetan za nerođeno dijete i iscrpnim opisom potrebnih mjera za sigurnu primjenu lijeka.
English: Treatment with Imnovid must be started and supervised by a doctor experienced in treating multiple myeloma.
Croatian: Liječenje lijekom Imnovid mora započeti i nadzirati liječnik s iskustvom u liječenju multiplog mijeloma.
English: Therefore, Imnovid must not be used in women who are pregnant.
Croatian: Stoga lijek Imnovid ne smiju uzimati trudnice.
English: Why is Imnovid authorised in the EU?
Croatian: Zašto je lijek Imnovid odobren u EU-u?
English: It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient.
Croatian: Osim toga, bolesnicima će dostaviti kartice kako bi se osiguralo da svaki bolesnik poduzima sve odgovarajuće mjere za sigurnu primjenu.
English: An overview of Imnovid and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Imnovid i zašto je odobren u EU-u
English: Multiple myeloma is rare, and Imnovid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Croatian: Multipli mijelom je rijetka bolest, a lijek Imnovid dobio je status „lijeka za rijetku bolest” 8. listopada 2009.
English: The medicine packs containing Imnovid capsules will carry a warning on the risk of severe birth defects.
Croatian: Na kutijama s kapsulama lijeka Imnovid bit će istaknuto upozorenje o riziku od teških prirođenih mana.
English: As for all medicines, data on the use of Imnovid are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Imnovid kontinuirano se prate.
English: A further study included 559 patients with multiple myeloma who had received at least one treatment including lenalidomide, and whose disease got worse during or after their last treatment.
Croatian: Dodatnim ispitivanjem bilo je obuhvaćeno 559 bolesnika s multiplim mijelomom koji su prethodno primili najmanje jednu terapiju koja je uključivala lenalidomid i čija se bolest pogoršala tijekom ili nakon njihova posljednjeg liječenja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imnovid have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Imnovid također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The Agency concluded that Imnovid is effective at delaying the progression of multiple myeloma in patients whose disease has not got better or has come back after previous treatment, who have very limited treatment options.
Croatian: Agencija je zaključila da Imnovid učinkovito odgađa pogoršanje multiplog mijeloma u bolesnika u kojih se nakon prethodnog liječenja stanje nije poboljšalo ili se bolest vratila i čije su mogućnosti liječenja vrlo ograničene.
English: The European Medicines Agency decided that Imnovid's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Imnovid nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The disease worsened after 16 weeks on average in patients taking Imnovid plus low-dose dexamethasone, compared with 8 weeks in those taking high-dose dexamethasone.
Croatian: Bolest se pogoršala nakon prosječno 16 tjedana u bolesnika koji su primali lijek Imnovid u kombinaciji s niskom dozom deksametazona, u usporedbi s osam tjedana u onih koji su primali visoku dozu deksametazona.
English: It is taken in the first 2 weeks of 3-week treatment cycles, when given in combination with bortezomib and dexamethasone, and in the first 3 weeks of 4-week treatment cycles when given in combination with dexamethasone only.
Croatian: Uzima se tijekom prva dva tjedna trotjednih ciklusa liječenja kad se daje u kombinaciji s bortezomibom i deksametazonom, te tijekom prva tri tjedna četverotjednih ciklusa liječenja kad se daje u kombinaciji samo s deksametazonom.
English: The company will also set up a registry of patients treated with Imnovid to monitor the side effects reported and whether the medicine is used for its approved indication and in compliance with the pregnancy-prevention programme.
Croatian: Tvrtka će uspostaviti registar bolesnika liječenih lijekom Imnovid kako bi se omogućilo praćenje prijavljenih nuspojava kao i to primjenjuje li se lijek za odobrenu indikaciju i u skladu s programom za sprječavanje trudnoće.
English: Imnovid contains the active substance pomalidomide.
Croatian: Imnovid sadržava djelatnu tvar pomalidomid.
English: It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened.
Croatian: Primjenjuje se i u kombinaciji s deksametazonom u odraslih osoba koje su prethodno primile najmanje dvije terapije koje su uključivale i lenalidomid i bortezomib i čija se bolest pogoršala.
English: Patients treated with Imnovid, bortezomib and low-dose dexamethasone lived on average 11.2 months before their disease got worse, compared with 7.1 months for patients treated with bortezomib and low dose dexamethasone.
Croatian: Bolesnici liječeni lijekom Imnovid, bortezomibom i niskom dozom deksametazona živjeli su prosječno 11,2 mjeseca bez pogoršanja bolesti, dok je to razdoblje trajalo 7,1 mjesec u bolesnika liječenih bortezomibom i niskom dozom deksametazona.
English: Imnovid is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow).
Croatian: Imnovid je lijek protiv raka koji se primjenjuje za liječenje multiplog mijeloma (raka koštane srži).
English: The Agency also noted that Imnovid's side effects were acceptable for these patients, with side effects similar to those of other medicines of this type.
Croatian: Agencija je napomenula i da su nuspojave lijeka Imnovid prihvatljive za te bolesnike te su slične nuspojavama drugih lijekova te vrste.
English: The most common side effects with Imnovid (which affect more than 1 in 10 patients), some of which can be serious, include anaemia (low red blood cell counts), neutropenia (low white blood cell count), tiredness, thrombocytopenia (low platelet counts), fever, peripheral oedema (swelling of the limbs due to fluid retention), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet) and infections including pneumonia (infection of the lungs).
Croatian: Najčešće nuspojave lijeka Imnovid (koje se javljaju u više od 1 na 10 bolesnika), od kojih neke mogu biti ozbiljne, jesu anemija (niska razina crvenih krvnih stanica), neutropenija (niska razina bijelih krvnih stanica), umor, trombocitopenija (niska razina krvnih pločica), vrućica, periferni edem (oticanje udova uslijed zadržavanja tekućine), periferna neuropatija (oštećenje živaca koje uzrokuje trnce, bol i utrnulost u rukama i stopalima) te infekcije, uključujući pneumoniju (upalu pluća).
English: Pomalidomide works in a number of ways in multiple myeloma, similarly to other immunomodulating medicines such as lenalidomide and thalidomide: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some specialised cells of the immune system to attack the tumour cells.
Croatian: U slučaju multiplog mijeloma pomalidomid djeluje na niz različitih načina, slično drugim imunomodulatornim lijekovima kao što su lenalidomid i talidomid: inhibira razvoj tumorskih stanica, sprječava rast krvnih žila u tumorima i potiče neke posebne stanice imunosnog sustava da napadaju tumorske stanice.
English: It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).
Croatian: Primjenjuje se u kombinaciji s bortezomibom (drugim lijekom protiv raka) i deksametazonom (protuupalnim lijekom) u odraslih osoba koje su prethodno primile najmanje jednu terapiju koja je uključivala lenalidomid (drugi lijek protiv raka).
English: For more information about using Imnovid, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Imnovid pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The company will also provide final results from a study with Imnovid in combination with bortezomib and dexamethasone in patients with multiple myeloma who had received at least one treatment including lenalidomide, to confirm the medicine's effect on overall survival.
Croatian: Tvrtka će dostaviti i konačne rezultate ispitivanja primjene lijeka Imnovid u kombinaciji s bortezomibom i deksametazonom u bolesnika s multiplim mijelomom koji su prethodno primili najmanje jednu terapiju koja je uključivala lenalidomid kako bi se potvrdio učinak lijeka na ukupno preživljenje.
English: Serious side effects, which affect up to 1 in 10 patients, include blood disorders (such as neutropenia, anaemia and thrombocytopenia), lower respiratory tract infection (such as bronchitis or pneumonia), pulmonary embolism (clot in a blood vessel in the lungs), flu, and acute kidney injury.
Croatian: Ozbiljne nuspojave, koje se javljaju u najviše 1 na 10 bolesnika, uključuju krvne poremećaje (kao što su neutropenija, anemija i trombocitopenija), infekcije donjeg dijela dišnog sustava (kao što su bronhitis ili upala pluća), plućnu emboliju (ugrušak u krvnoj žili u plućima), gripu i akutnu ozljedu bubrega.
English: How does Imnovid work?
Croatian: Kako djeluje Imnovid?
English: Imnovid plus low-dose dexamethasone was more effective than high-dose dexamethasone alone at delaying the worsening of multiple myeloma.
Croatian: Lijek Imnovid u kombinaciji s niskom dozom deksametazona bio je učinkovitiji od monoterapije visokom dozom deksametazona s obzirom na odgađanje pogoršanja multiplog mijeloma.
English: What benefits of Imnovid have been shown in studies?
Croatian: Koje su koristi od lijeka Imnovid utvrđene u ispitivanjima?
English: The active substance in Imnovid, pomalidomide, is an immunomodulating agent.
Croatian: Djelatna tvar u lijeku Imnovid, pomalidomid, imunomodulatorni je agens.
English: Imnovid has been studied in one main study involving 455 adults with multiple myeloma whose disease did not get better or came back after previous treatments.
Croatian: Lijek Imnovid ispitan je u jednom glavnom ispitivanju kojim je bilo obuhvaćeno 455 odraslih osoba s multiplim mijelomom u kojih se nakon prethodnih liječenja stanje nije poboljšalo ili se bolest vratila.
English: How is Imnovid used?
Croatian: Kako se Imnovid primjenjuje?
English: For the full list of side effects and restrictions with Imnovid, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Imnovid potražite u uputi o lijeku.
English: It may harm them,
Croatian: NAVOĐENJE DJELATNE (IH) TVARI
English: Date of first authorisation: 15 October 2015.
Croatian: Datum prvog odobrenja: 15 listopad 2015
English: Take the capsules as soon as you remember.
Croatian: Uzmite kapsulu čim se sjetite.
English: Usual dose after the first two days
Croatian: Uobičajena doza nakon prva dva dana
English: 48 months
Croatian: 48 mjeseca
English: Median treatment duration was 45 days.
Croatian: Medijan trajanja liječenja iznosio je 45 dana.
English: This is because it is not known if it may affect or harm your unborn baby.
Croatian: To je zato što nije poznato može li lijek utjecati ili štetiti nerođenom djetetu.
English: Capsules length: 24.2 mm.
Croatian: Duljina kapsule: 24,2 mm.
English: Susceptibility data were available in only a small subset of cases.
Croatian: Podaci o osjetljivosti bili su dostupni samo za malu podskupinu slučajeva.
English: (Mechanism unknown)
Croatian: (Nepoznat mehanizam)
English: The protocol-defined maximum treatment duration was 84 days.
Croatian: Maksimalno trajanje liječenja definirano protokolom iznosilo je 84 dana.
English: If this happens, do not drive or use machines.
Croatian: Ako se to dogodi, nemojte upravljati vozilima niti rukovati strojevima.
English: Take the medicine pack with you so the doctor knows what you have taken.
Croatian: Ponesite kutiju lijeka sa sobom kako bi liječnik znao što ste uzeli.
English: This leaflet was last revised in
Croatian: Ova je uputa zadnji puta revidirana
English: Delirium includes reactions of confusional state.
Croatian: Delirij uključuje reakcije konfuznog stanja.
English: It can also make you pass out.
Croatian: Također može izazvati nesvjesticu.
English: Cresemba can sometimes affect your liver function.
Croatian: Cresemba može ponekad utjecati na funkciju jetre.
English: This is started 12 to 24 hours after your last starting dose.
Croatian: Započinje 12 do 24 sata nakon zadnje početne doze.
English: CRESEMBA is indicated in adults for the treatment of
Croatian: CRESEMBA je indicirana u odraslih za liječenje
English: A stable response was observed in an additional 10/35 patients (28.6%).
Croatian: Stabilan odgovor primijećen je u još 10/35 bolesnika (28,6%).
English: The duration of treatment with Cresemba may be longer than 6 months if your doctor considers this necessary.
Croatian: Terapija lijekom Cresemba može trajati i dulje od 6 mjeseci ako Vaš liječnik smatra da je to potrebno.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Croatian: Budući da ćete lijek dobivati pod strogom liječničkim nadzorom, malo je vjerojatno da ćete propustiti dozu.
English: No carcinogenicity studies have been performed.
Croatian: Ispitivanja kancerogenosti nisu provedena.
English: A risk to newborns and infants cannot be excluded.
Croatian: Rizik za novorođenčad i dojenčad ne može se isključiti.
English: However, if it is nearly time for the next dose, skip the missed dose.
Croatian: Međutim, ako se već približava vrijeme za sljedeću dozu, preskočite propuštenu dozu.
English: Your doctor may carry out blood tests while you are taking this medicine.
Croatian: Liječnik može zatražiti krvne pretrage tijekom uzimanja ovog lijeka.
English: Elevated liver transaminases or hepatitis
Croatian: Povišene jetrene transaminaze ili hepatitis
English: Do not chew, crush, dissolve or open the capsules.
Croatian: Nemojte žvakati, drobiti, otapati ili otvarati kapsule.
English: Cresemba is available in cartons that contain 14 capsules.
Croatian: Cresemba je dostupna u kutijama koje sadrže 14 kapsula.
English: The safety and efficacy of CRESEMBA in children aged below 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka CRESEMBA u djece mlađe od 18 godina nisu ustanovljene.
English: Other medicines and Cresemba
Croatian: Drugi lijekovi i Cresemba
English: For individual Mucorales species, the clinical efficacy data are very limited, often to one or two patients (see section 5.1).
Croatian: Za pojedinačne vrste gljivica Mucorales, podaci o kliničkoj djelotvornosti su vrlo ograničeni, često na jednog ili dva bolesnika (vidjeti dio 5.1).
English: ^ Indicates that grouping of appropriate preferred terms into a single medical concept occurred.
Croatian: ^ označava grupiranje odgovarajućih preporučenih pojmova u jedan medicinski pojam.
English: Store in a refrigerator (2 °C to 8 °C).
Croatian: Čuvati u hladnjaku (2°C do 8°C).
English: Other statins were not studied.
Croatian: Drugi statini nisu ispitivani.
English: Cresemba should not be used in children or adolescents younger than 18 years because there is no information on use in this age group.
Croatian: Lijek Cresemba ne smiju uzimati djeca i adolescenti mlađi od 18 godina jer nema informacija o primjeni u toj dobnoj skupini.
English: Following single doses of [cyano
Croatian: Nakon jednokratnih doza [cijano
English: Environmental risk assessment has shown that Cresemba may pose a risk for the aquatic environment.
Croatian: Procjena rizika za okoliš pokazala je da Cresemba može predstavljati rizik za vodeni okoliš.
English: Some medicines may affect the way Cresemba works or Cresemba may affect the way they work, if they are taken at the same time.
Croatian: Neki lijekovi mogu utjecati na način na koji Cresemba djeluje ili bi Cresemba mogla utjecati na način njihova djelovanja, ako se uzimaju istodobno.
English: CRESEMBA capsules should be swallowed whole.
Croatian: Kapsule CRESEMBA treba progutati cijele.
English: What Cresemba is and what it is used for 2.
Croatian: Što je Cresemba i za što se koristi 2.
English: CRESEMBA must only be given as an intravenous infusion.
Croatian: CRESEMBA se smije davati samo kao intravenska infuzija.
English: Effect of food on absorption
Croatian: Učinak hrane na apsorpciju
English: Reconstituted concentrate should be clear and free of visible particulate.
Croatian: Rekonstituirani koncentrat treba biti bistar i bez vidljivih čestica.
English: Bupropion: dose increase if required.
Croatian: Bupropion: povećanje doze ako je potrebno.
English: Except for the active moiety isavuconazole, no individual metabolite was observed with an AUC > 10% of total radio-labelled material.
Croatian: Osim za aktivni oblik izavukonazol, nije primijećen niti jedan pojedinačni metabolit s AUC > 10% ukupnog radioaktivno obilježenog materijala.
English: No dose adjustment is necessary for elderly patients; however the clinical experience in elderly patients is limited.
Croatian: Dozu nije potrebno prilagođavati u starijih bolesnika; međutim klinička iskustva sa starijim bolesnicima su ograničena.
English: Treatment of mucormycosis
Croatian: Liječenje mukormikoze
English: Unnecessary vibration or vigorous shaking of the solution should be avoided.
Croatian: Treba izbjegavati nepotrebne vibracije ili snažno protresanje otopine.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika i u normalnim okolnostima ne smiju biti duži od 24 sata na temperaturi od 2°C do 8°C, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: Chemical and physical in-use stability after reconstitution and dilution has been demonstrated for 24 hours at 2 °C to 8 °C, or 6 hours at room temperature.
Croatian: Kemijska i fizikalna stabilnost pri uporabi nakon rekonstitucije i razrjeđivanja dokazana je za 24 sata na temperaturi od 2°C do 8°C ili 6 sati na sobnoj temperaturi.
English: If you take more Cresemba than you should
Croatian: Ako uzmete više lijeka Cresemba nego što ste trebali
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzimati dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: This is to make sure that the fungal infection has gone.
Croatian: To je potrebno kako bi se osiguralo da se gljivična infekcija potpuno povukla.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100).
Croatian: Učestalost nuspojava definirana je na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); i manje često (≥1/1000 i <1/100).
English: There is no specific antidote for isavuconazole.
Croatian: Ne postoji specifični antidot za izavukonazol.
English: Your doctor should monitor you for possible side effects,
Croatian: Vaš liječnik Vas treba pratiti zbog mogućih nuspojava,
English: Isavuconazole has no discernible mutagenic or genotoxic potential.
Croatian: Izavukonazol nema nikakav vidljiv mutageni niti genotoksični potencijal.
English: The pharmacokinetics in paediatric patients (< 18 years) have not yet been evaluated.
Croatian: Farmakokinetika u pedijatrijskih bolesnika (<18 godina) još nije ocijenjena.
English: Precautions to be taken before handling or administering the medicinal product
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka