FrancophonIA/ELRC3.0 huggingface dataset:
English: The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and 4 mg/kg IV twice daily, respectively.
Croatian: Predviđena ukupna izloženost u djece nakon intravenske primjene doze održavanja od 4 mg/kg dvaput na dan bila je usporediva s onom u odraslih nakon intravenske primjene 3 mg/kg dvaput na dan, dok je izloženost u djece nakon intravenske primjene doze od 8 mg/kg dvaput na dan bila usporediva s onom u odraslih nakon intravenske primjene doze od 4 mg/kg dvaput na dan.
English: squamous cell carcinoma
Croatian: karcinom skvamoznih stanica*
English: Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID, (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Croatian: Fenitoin se može primjenjivati istodobno s vorikonazolom ako se doza održavanja vorikonazola povisi na 5 mg/kg BID intravenski, ili s 200 mg na 400 mg BID peroralno (sa 100 mg na 200 mg BID peroralno u bolesnika s manje od 40 kg) (vidjeti dio 4.2).
English: Voriconazole Cmax  4% Voriconazole AUCτ  32%
Croatian: Vorikonazol Cmax  4% Vorikonazol AUC  32%
English: Voriconazole Cmax  49% Voriconazole AUCτ  69%
Croatian: Vorikonazol Cmax  49% Vorikonazol AUC  69%
English: Other treated fungal infections (often with either partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus,
Croatian: Blastoschizomyces capitatus, vrstama iz roda Cladosporium, Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, vrstama iz roda Penicillium uključujući P.marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis i vrstama iz roda Trichosporon, uključujući T. beigelii.
English: Although not studied, voriconazole is likely to increase the plasma concentrations of vinca alkaloids and lead to neurotoxicity.
Croatian: Iako nije ispitivano, primjena vorikonazola vjerojatno će povećati koncentracije vinka alakloida u plazmi i dovesti do neurotoksičnosti.
English: Voriconazole Cmax 23% Voriconazole AUCτ  7%
Croatian: Vorikonazol Cmax  23% Vorikonazol AUC  7%
English: Voriconazole Cmax  18% Voriconazole AUCτ  23%
Croatian: Vorikonazol Cmax  18% Vorikonazol AUC  23%
English: [CYP3A4 substrate, P-gp substrate]
Croatian: [supstrat CYP3A4, supstrat P-glikoproteina]
English: [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Croatian: [inhibitor CYP2C19; supstrat CYP2C19 i CYP3A4]
English: Although not studied clinically, voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis.
Croatian: Preporuke za istodobnu primjenu povisiti plazmatske koncentracije statina koji se metaboliziraju putem CYP3A4, što može dovesti do rabdomiolize.
English: 2 weeks after EOT 125 (50%)
Croatian: Završetak liječenja 178 (72%) 2 tjedna po završetku liječenja 125 (50%)
English: When voriconazole is discontinued, ciclosporin levels must be carefully monitored and the dose
Croatian: Nakon prekida primjene vorikonazola moraju se pažljivo pratiti razine ciklosporina i po potrebi povećati doza.
English: 400 mg every 12 hours 200 mg every 12 hours
Croatian: 400 mg svakih 12 sati
English: [CYP2C9 and CYP3A4 substrates]
Croatian: [supstrati CYP2C9 i CYP3A4]
English: Voriconazole Accord 200 mg film-coated tablets Each tablet contains 200 mg voriconazole.
Croatian: Voriconazole Accord 200 mg filmom obložene tablete Jedna tableta sadrži 200 mg vorikonazola.
English: [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Croatian: [inhibitor CYP2C9, CYP2C19 i CYP3A4]
English: [CYP2C9 substrate and potentCYP450 inducer]
Croatian: [supstrat CYP2C9 i snažan induktor CYP450]
English: CARTON (Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (blister pakiranje za 200 mg filmom obložene tablete - pakiranje od 2, 10, 14, 20, 28,
English: Voriconazole Accord 200 mg film-coated tablets
Croatian: Voriconazole Accord 200 mg filmom obložene tablete
English: Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy).Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Croatian: Primijećeno je da se jetrene reakcije pojavljuju prvenstveno u bolesnika s teškim podležećim bolestima (pretežno s malignim hematološkim bolestima).
English: 100 mg twice a day
Croatian: 100 mg dvaput dnevno
English: 300 mg QD (coadministered with voriconazole 400 mg BID)*
Croatian: 300 mg QD (primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID)*
English: Investigations blood creatinine increased blood urea increased, blood cholesterol increased
Croatian: Pretrage povišene vrijednosti kreatinina povišene vrijednosti ureje u krvi, povišene vrijednosti kolesterola *Neželjeni događaji prijavljeni nakon stavljanja lijeka u promet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: and Fusarium spp.
Croatian: Vrsta iz roda Fusarium
English: [potent CYP450 inducer; CYP3A4 inhibitor and substrate]
Croatian: [snažan induktor CYP450; inhibitor i supstrat CYP3A4]
English: , leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Croatian: Poremećaji krvi i limfnog sustava agranulocitoza1, pancitopenija, trombocitopenija 2, leukopenija, anemija zatajenje koštane srži, limfadenopatija, eozinofilija diseminirana intravaskularna koagulacija
English: Voriconazole AUC0-∞  59% Contraindicated (see section 4.3)
Croatian: Vorikonazol AUC0-  59%
English: [CYP450 inducer; CYP3A4 inhibitor and substrate]
Croatian: [induktor CYP450; inhibitor i supstrat CYP3A4]
English: It is therefore recommended to use the oral suspension formulation in children aged
Croatian: Stoga se u djece u dobi od 2 do < 12 godina preporučuje primjenjivati ovaj lijek u obliku oralne suspenzije.
English: [CYP3A4 inhibitor]
Croatian: [supstrati i inhibitori CYP3A4]
English: - Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract causing antibiotic associated diarrhoea, inflammation of the lymphatic vessels - Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ - Enlarged lymph glands (sometimes painful), failure of blood marrow, increased eosinophil - Depressed function of the adrenal gland, underactive thyroid gland - Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain,
Croatian: - simptomi nalik gripi, nadraženost i upala probavnog trakta, upala probavnog sustava koja uzrokuje proljev povezan s antibioticima, upala limfnih žila - upala tankog tkiva kojim je obložena unutarnja stijenka trbuha i koja prekriva trbušne organe - povećani limfni čvorovi (ponekad bolni), zatajenje koštane srži, povećani broj eozinofila - smanjena funkcija nadbubrežne žlijezde, smanjena aktivnost štitnjače - poremećaj moždane funkcije, simptomi slični Parkinsonovoj bolesti, ozljeda živca s posljedičnom utrnulošću, boli, trncima ili žarenjem u šakama ili stopalima - smetnje ravnoteže ili koordinacije - oticanje mozga - dvoslike, ozbiljna stanja oka uključujući: bol i upala oka i vjeđa, neuobičajeni očni pokreti,
English: IFI while on study drug * Primary endpoint of the study ** Difference in proportions, 95% CI and p-values obtained after adjustment for randomization
Croatian: Nastala dokazana ili vjerojatna invazivna gljivična infekcija tijekom uzimanja ispitivanog lijeka * Primarni ishod ispitivanja ** Razlika u udjelima, 95%-tni CI i p-vrijednosti dobivene nakon prilagodbe za randomizaciju
English: High dose (400 mg BID) Low dose (100 mg BID)*
Croatian: Visoka doza (400 mg BID)
English: Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets voriconazole
Croatian: Voriconazole Accord 50 mg filmom obložene tablete Voriconazole Accord 200 mg filmom obložene tablete vorikonazol
English: [CYP3A4 substrates]
Croatian: [supstrati CYP3A4]
English: 4 mg/kg twice daily
Croatian: 4 mg/kg dvaput na dan
English: • Patient Alert Card for Phototoxicity and SCC:
Croatian: • Kartica s upozorenjima za bolesnika o fototoksičnosti i SCC-u: - Podsjeća bolesnike na rizik od fototoksičnosti i SCC-a kože.
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.When multiple doses of voriconazole are administered with high fat meals, Cmax and AUCτ are reduced by 34 % and 24 %, respectively.
Croatian: Nakon višekratne primjene vorikonazola s punomasnim obrokom Cmax se smanjuje za 34%, a AUCτ za 24%.
English: Magnesium stearate
Croatian: Gospina trava
English: Other Candida spp.4
Croatian: Druge vrste iz roda Candida4
English: Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUCτ  17%
Croatian: Efavirenz Cmax ↔ Efavirenz AUC  17%
English: loss of part of the usual field of vision, spots before the eyes) - Fever - Rash - Nausea, vomiting, diarrhoea - Headache - Swelling of the extremities - Stomach pains - Breathing difficulties - Elevated liver enzymes
Croatian: - oticanje udova - bolovi u trbuhu - otežano disanje - povišeni jetreni enzimi
English: Short-acting Opiates
Croatian: Mijeloablativni postupci liječenja
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO ROK VALJANOSTI Rok valjanosti POSEBNE MJERE ČUVANJA 10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU OD LIJEKA, AKO JE POTREBNO 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Study endpoints
Croatian: Ishodi ispitivanja
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets
Croatian: Voriconazole Accord 50 mg filmom obložene tablete Voriconazole Accord 200 mg filmom obložene tablete
English: Voriconazole Accord 50 mg film-coated tablets voriconazole
Croatian: Voriconazole Accord 50 mg filmom obložene tablete vorikonazol
English: Acute renal failure has been observed in severely ill patients undergoing treatment with voriconazole.
Croatian: U bolesnika s teškom osnovnom bolešću liječenje vorikonazolom se povezivalo sa slučajevima teške hepatotoksičnosti.
English: • Health Care Professional (HCP) Question and Answer Brochure for Phototoxicity, SCC and Hepatic toxicity;
Croatian: • Brošura za zdravstvenog radnika s pitanjima i odgovorima o fototoksičnosti, SCC-u te o toksičnosti za jetru; - Upozorava zdravstvene radnike na rizik od fototoksičnosti, karcinoma skvamoznih stanica kože (SCC) te toksičnosti za jetru povezanih uz primjenu vorikonazola.
English: - Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below - Small dry scaly skin patches, sometimes thick with spikes or ‘horns'
Croatian: - prekomjerna aktivnost štitnjače - propadanje moždane funkcije koja je ozbiljna komplikacija jetrene bolesti - gubitak većine vlakana vidnog živca i zamagljenje rožnice, nevoljni pokreti oka - povećana osjetljivost na svjetlost popraćena mjehurićima - poremećaj u kojem imunosni sustav tijela napada dio perifernog živčanog sustava - problemi s ritmom ili provođenjem otkucaja srca (ponekad opasni po život) - alergijska reakcija opasna po život - poremećaji u zgrušavanju krvi - alergijska reakcija kože (katkad ozbiljna), uključujući brzo oticanje (edem) kože, potkožnog tkiva, sluznice i podsluznice, svrab ili bolna područja zadebljale, crvene kože sa srebrnastim kožnim ljuskicama, nadraženost kože i sluznice, kožna stanja opasna po život koja uzrokuju odvajanje velikih površina epidermisa, gornjeg sloja kože, od donjih dijelova kože - male suhe ljuskaste mrlje na koži, katkad debele sa šiljcima ili „rogovima“
English: Voriconazole Accord 200 mg film-coated tablets voriconazole
Croatian: Voriconazole Accord 200 mg filmom obložene tablete vorikonazol
English: Fusarium spp
Croatian: Pvrijedno st
English: Medicinal product
Croatian: FARMACEUTSKI
English: Penicillium spp.
Croatian: Scedosporium.
English: Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔
Croatian: Indinavir Cmax ↔ Indinavir AUC ↔ Vorikonazol Cmax ↔ Vorikonazol AUC ↔
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, angioedema, actinic keratosis*, pseudoporphyri a erythema multiforme, psoriasis, drug eruption, drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: Johnsonov sindrom, fototoksičnost, purpura, urtikarija, alergijski dermatitis, papularni osip, makularni osip,
English: Lactose monohydrate Pregelatinized starch Croscarmellose sodium Povidone
Croatian: Jezgra tablete laktoza hidrat, škrob, prethodno geliran karmelozanatrij, umrežena povidon magnezijev stearat
English: Phenytoin Cmax  67% Phenytoin AUCτ  81%
Croatian: Fenitoin Cmax  67% Fenitoin AUC  81% U usporedbi s dozom vorikonazola od 200 mg BID:
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 50 mg film-coated tablets voriconazole NAME OF THE MARKETING AUTHORISATION HOLDER Accord EXPIRY DATE
Croatian: NAZIV LIJEKA Voriconazole Accord 50 mg filmom obložene tablete vorikonazol NAZIV NOSITELJA
English: 200 mg twice daily
Croatian: 200 mg dvaput dnevno
English: Advises HCPs on the risks of phototoxicity, skin SCC and liver toxicity associated with voriconazole use.
Croatian: Preporučuje se nadzor zbog nuspojava povezanih s oralnim kontraceptivima, koje mogu nastupiti uz one povezane s primjenom vorikonazola.
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 200 mg film-coated tablets voriconazole NAME OF THE MARKETING AUTHORISATION HOLDER Accord EXPIRY DATE
Croatian: NAZIV LIJEKA Voriconazole Accord 200 mg filmom obložene tablete vorikonazol NAZIV NOSITELJA
English: red area on the skin that is covered with small confluent bumps, redness of the skin - Itchiness - Hair loss - Back pain - Kidney failure, blood in the urine, changes in kidney function tests
Croatian: nakupljanje tekućine u plućima - zatvor, probavne tegobe, upala usana - žutica, upala jetre i oštećenje jetre - kožni osipi koji mogu dovesti do jakog stvaranja mjehurića i ljuštenja kože karakterizirani ravnim, crvenim područjem kože koje je prekriveno malim izraslinama koje se spajaju, crvenilo kože - svrbež - gubitak kose - bol u leđima - zatajenje bubrega, krv u mokraći, promjene u testovima funkcije bubrega
English: The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment.
Croatian: Vezivanje vorikonazola za proteine plazme bilo je podjednako u ispitanika s različitim stupnjevima bubrežnog oštećenja (vidjeti dijelove 4.2 i 4.4).
English: Although not studied, voriconazole is likely to increase the plasma
Croatian: Iako ova interakcija nije klinički ispitana, vorikonazol će vjerojatno
English: Monitoring for adverse reactions related to oral contraceptives, in addition to those for voriconazole, is recommended ol (1 mg/0.035 mg QD)
Croatian: Noretisteron/etinilestradiol (1 mg/0,035 mg QD)
English: Itraconazo le
Croatian: Prijavljivanje nuspojava
English: EU/1/18/1348
Croatian: EU/1/18/1348 Mulpleo
English: Mulpleo
Croatian: Doza
English: Oral use blister OPA/alu/PVC/alu 7 tablets
Croatian: Blister OPA/Al/PVC/Al
English: Pack size
Croatian: Vitekta
English: Route of Administration
Croatian: Doza Farmaceutski oblik
English: Lutathera lutetium (
Croatian: Lutathera lutecijev (
English: Lu) oxodotreotide
Croatian: Lu) oksodotreotid
English: The patient cannot leave the controlled areas until told to do so by the doctor.
Croatian: Bolesnik ne smije napustiti kontrolirana područja sve dok mu liječnik to ne kaže.
English: It is a radiopharmaceutical (a medicine that emits a small amount of radioactivity).
Croatian: Lijek je radiofarmaceutik (emitira malu količinu radioaktivnosti).
English: Lutathera must not be given to women who are pregnant or in whom pregnancy has not been excluded.
Croatian: Lijek Lutathera ne smije se davati trudnicama i ženama u kojih se trudnoća ne može isključiti.
English: It must also not be given to patients with severely reduced kidney function.
Croatian: Također se ne smije davati bolesnicima s teškim oštećenjem funkcije bubrega.
English: The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects.
Croatian: Uobičajena terapija uključuje četiri infuzije u razmaku od osam tjedana, no taj se razmak između infuzija može povećati na najviše 16 tjedana ako se u bolesnika pojave teške nuspojave.
English: Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite.
Croatian: Ostale česte nuspojave koje se javljaju u više od 1 na 10 bolesnika jesu trombocitopenija (niska razina trombocita), limfopenija (niska razina limfocita, vrste bijelih krvnih stanica), anemija (niska razina crvenih krvnih stanica), pancitopenija (niska razina svih vrsta krvnih stanica), umor i smanjeni apetit.
English: What measures are being taken to ensure the safe and effective use of Lutathera?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lutathera?
English: The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them.
Croatian: Tvrtka koja lijek Lutathera stavlja na tržište organizirat će edukativni program za bolesnike kako bi se zajamčilo da razumiju rizik od radioaktivnosti i mjere opreza koje trebaju poduzeti radi ograničavanja vlastite izloženosti te izloženosti osoba oko njih.
English: Other information about Lutathera
Croatian: Ostale informacije o lijeku Lutathera
English: What is Lutathera and what is it used for?
Croatian: Što je Lutathera i za što se koristi?
English: Lutathera is used is to treat GEP-NETs that cannot be removed by surgery, have spread to other parts of the body or are not responding to treatment.
Croatian: Lijek Lutathera primjenjuje se za liječenje GEP-NET-ova koji se ne mogu ukloniti kirurškim putem, koji su se proširili na druge dijelove tijela ili koji ne reagiraju na terapiju.
English: The radioactivity it emits then kills the tumour cells it is attached to but has little effect on neighbouring cells.
Croatian: Radioaktivnost koju emitira zatim ubija stanice tumora na koje se pričvršćuje, pri čemu ima slab učinak na susjedne stanice.
English: The European Medicines Agency considered that the benefits seen with Lutathera outweigh its risks and recommended it be approved in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Lutathera nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja u EU-u.
English: The patient should also be given an infusion of an amino acid solution which helps protect their kidneys.
Croatian: Bolesniku je također potrebno dati infuziju otopine aminokiselina koja pomaže u zaštiti bubrega.
English: This is a summary of the European public assessment report (EPAR) for Lutathera.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Lutathera.
English: It is not intended to provide practical advice on how to use Lutathera.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Lutathera.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutathera have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Lutathera također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel.
Croatian: Lijek Lutathera emitira određenu razinu radioaktivnosti i stoga se primjenjuje samo u posebnim kontroliranim područjima te njime smije rukovati i davati ga bolesnicima kvalificirano osoblje.
English: What are the risks associated with Lutathera?
Croatian: Koji su rizici povezani s lijekom Lutathera?
English: For further information, including information on the precise method for giving the infusions, see the package leaflet.
Croatian: Dodatne informacije, uključujući informacije o točnom načinu davanja infuzije, potražite u uputi o lijeku.
English: Because the number of patients with GEP-NETs is low, they are considered ‘rare', and Lutathera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 January 2008.
Croatian: Budući da postoji mali broj bolesnika s GEP-NET-ovima, ta se bolest smatra „rijetkom” te se lijek Lutathera označava kao lijek za liječenje rijetkih bolesti od 31. siječnja 2008.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Lutathera nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion.
Croatian: Najčešće nuspojave zabilježene kod liječenja lijekom Lutathera jesu mučnina i povraćanje, koje se javljaju na početku davanja infuzije u otprilike polovice bolesnika te se mogu povezati s infuzijom otopine aminokiselina.
English: Before starting treatment, the doctor will have checked that the patient's tumours have somatostatin receptors on their cell surfaces.
Croatian: Prije početka terapije liječnik provjerava imaju li bolesnikovi tumori somatostatinske receptore na površini stanica.
English: Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Croatian: Lutathera je lijek za liječenje raka koji se primjenjuje za liječenje tumora u crijevima koji su poznati pod nazivom gastroenteropankreatični neuroendokrini tumori (GEP-NET-ovi).
English: The full EPAR for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni (EPAR) za lijek Lutathera nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.