FrancophonIA/ELRC3.0 huggingface dataset:
English: Aripiprazole Sandoz 30 mg tablets
Croatian: Sandoz 30 mg tablete
English: Aripiprazole Sandoz 30mg tablets
Croatian: Sandoz 30 mg tablete aripiprazol
English: Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Sandoz tablets for patients who have difficulty swallowing Aripiprazole Sandoz tablets (see section 5.2).
Croatian: Sandoz tablete u bolesnika kojima je teško progutati Aripiprazol
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Croatian: Sandoz 30 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat crveni željezov oksid (E172)
English: Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
Croatian: EU/1/15/1029/021 (56 tableta) EU/1/15/1029/022 (70 tableta) EU/1/15/1029/023 (14 x 1 tableta) EU/1/15/1029/024 (28 x 1 tableta) EU/1/15/1029/025 (49 x 1 tableta) EU/1/15/1029/026 (56 x 1 tableta) EU/1/15/1029/027 (98 x 1 tableta) EU/1/15/1029/028 (100 tableta)
English: The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Croatian: Liječnik može odlučiti da bolesnici ili njegovi njegovatelj mogu sami injicirati lijek nakon što su prošli odgovarajuću obuku.
English: This compared with 2 attacks per month for patients on placebo (a dummy treatment).
Croatian: To je uspoređeno s dva napadaja mjesečno za bolesnike koji su uzimali placebo (prividno liječenje).
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu3151551
English: The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Croatian: Preporučena početna doza lijeka Takhzyro iznosi 300 mg svaka dva tjedna.
English: Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Croatian: Više informacija o lijeku Takhzyro nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Takhzyro.
English: Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks.
Croatian: Bolesnici su imali u prosjeku 0,3 napadaja mjesečno kada su dobivali injekcije lijeka Takhzyro svaka dva tjedna i 0,5 napadaja kada su dobivali injekcije svaka četiri tjedna.
English: If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
Croatian: Ako bolesnik nema napadaje pri dozi koja se uzima jednom svaka dva tjedna, liječnik može smanjiti učestalost uzimanja lijeka na jednom svaka četiri tjedna.
English: Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 October 2015.
Croatian: Nasljedni angioedem rijetka je bolest, a Takhzyro je dobio status „lijeka za rijetku bolest” 9. listopada 2015.
English: Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs.
Croatian: U bolesnika s angioedemom dolazi do brzog oticanja tkiva ispod kože, u područjima kao što su lice, grlo, ruke i noge.
English: What measures are being taken to ensure the safe and effective use of Takhzyro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Takhzyro?
English: Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Takhzyro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Takhzyro have 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 Takhzyro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency therefore decided that Takhzyro'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 Takhzyro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Other information about Takhzyro
Croatian: Ostale informacije o lijeku Takhzyro
English: Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.
Croatian: Napadaji nasljednog angioedema mogu biti opasni po život ako oteklina oko grla pritišće dišne puteve.
English: The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.
Croatian: Najčešće nuspojave lijeka Takhzyro (koje se mogu pojaviti u više od 1 na 10 bolesnika) su reakcije na mjestu injiciranja, uključujući eritem (crvenilo), modrice i bol.
English: By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.
Croatian: Inhibiranjem djelovanja kalikreina, lanadelumab pomaže u sprječavanju oticanja i povezanih simptoma angioedema.
English: As for all medicines, data on the use of Takhzyro are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Takhzyro kontinuirano se prate.
English: What is Takhzyro and what is it used for?
Croatian: Što je Takhzyro i za što se primjenjuje?
English: An overview of Takhzyro and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Takhzyro i zašto je odobren u EU-u
English: For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Takhzyro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.
Croatian: Bolesnici s nasljednim angioedemom imaju visoke razine tvari koja se naziva bradikinin i koja uzrokuje proširenje krvnih žila i propuštanje tekućine u okolna tkiva, što uzrokuje napadaje oticanja, koje nalazimo pri pojavi angioedema.
English: Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.
Croatian: Lijek Takhzyro izdaje se samo na liječnički recept, a liječenje se mora započeti pod nadzorom liječnika s iskustvom u liječenju nasljednog angioedema.
English: Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 12 years and over.
Croatian: Takhzyro je lijek za sprječavanje napadaja nasljednog angioedema u bolesnika u dobi od 12 godina i starijih.
English: What are the risks associated with Takhzyro?
Croatian: Koji su rizici povezani s lijekom Takhzyro?
English: Why is Takhzyro authorised in the EU?
Croatian: Zašto je lijek Takhzyro odobren u EU-u?
English: Overall, the safety profile was considered acceptable.
Croatian: Sigurnosni profil lijeka Takhzyro smatra se prihvatljivim.
English: The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin.
Croatian: Djelatna tvar u lijeku Takhzyro, lanadelumab, djeluje tako da se vezuje na enzim u krvi kalikrein i inhibira ga, što ima nekoliko funkcija, uključujući povećanje razine bradikinina.
English: EMA/734573/2018
Croatian: Takhzyro (lanadelumab) EMA/734573/2018
English: How is Takhzyro used?
Croatian: Kako se Takhzyro koristi?
English: How does Takhzyro work?
Croatian: Kako djeluje Takhzyro?
English: Takhzyro is given as an injection under the skin, preferably in the abdomen (belly), thighs or upper arms.
Croatian: Takhzyro se primjenjuje kao potkožna injekcija, po mogućnosti u trbuh, bedro ili nadlakticu.
English: What benefits of Takhzyro have been shown in studies?
Croatian: Koje su koristi od lijeka Takhzyro utvrđene u ispitivanjima?
English: Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments.
Croatian: Činjenica da ga je potrebno uzimati samo jednom svaka dva ili četiri tjedna smatrala se prednošću u odnosu na postojeće oblike liječenja.
English: For the full list of side effects and restrictions with Takhzyro, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Takhzyro potražite u uputi o lijeku.
English: Takhzyro contains the active substance lanadelumab.
Croatian: Takhzyro (lanadelumab)
English: Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.
Croatian: U glavnom ispitivanju kojim je obuhvaćeno 126 odraslih osoba i djece starije od 12 godina oboljelih od angioedema utvrđeno je da je lijek Takhzyro učinkovit u smanjivanju broja napadaja angioedema.
English: Date of first authorisation: 13 July 2017
Croatian: Datum prvog odobrenja: 13. srpnja 2017.
English: Your doctor will decide if you should receive other treatment at the same time.
Croatian: Vaš će liječnik odlučiti trebate li istovremeno primati drugo liječenje.
English: Also please tell your doctor if you have had a lot of infections in the past or
Croatian: Također, recite liječniku ako ste u prošlosti imali puno infekcija ili
English: Key results from all four studies are summarised in table 4.
Croatian: Najvažniji rezultati svih četiriju ispitivanja sažeti su u Tablici 4.
English: Rituzena may also cause changes in laboratory tests carried out by your doctor.
Croatian: Rituzena može uzrokovati i promjene u nalazima laboratorijskih pretraga koje provodi Vaš liječnik.
English: Read this leaflet carefully before you start taking this medicine because it contains important
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: p-value (Wald test, not
Croatian: p-vrijednost (Waldov test, bez prilagođavanja)
English: Of 356 patients evaluated for HACA, 1.1 % (4 patients) were positive.
Croatian: Od 356 bolesnika ispitivanih na HACA-u, pozitivno je bilo njih 1,1 % (četiri bolesnika).
English: There was no cumulative toxicity in terms of infections reported over a 2 year treatment period.
Croatian: Nije zabilježena kumulativna toksičnost u smislu infekcija prijavljenih tijekom dvogodišnje terapije.
English: If you have heart disease or angina, these infusion reactions might get worse.
Croatian: Ako imate srčanu bolest ili anginu pektoris, ove se infuzijske reakcije mogu pogoršati.
English: Contents of the pack and other information What Rituzena contains
Croatian: Sadržaj pakiranja i druge informacije Što Rituzena sadrži
English: The safety and efficacy of Rituzena in children below 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Rituzena u djece mlađe od 18 godina nisu ustanovljene.
English: The risk of disease progression was reduced by 46 % and the risk of relapse by
Croatian: Rizik od progresije bolesti smanjen je za 46 %, a rizik od relapsa za 51 %.
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Croatian: Kartica sadrži važne informacije o sigurnosti za bolesnike, vezane uz potencijalno povećani rizik od infekcija, uključujući PML.
English: Rituzena is indicated in adults for the following indications:
Croatian: Rituzena je indicirana u odraslih u sljedećim indikacijama:
English: Do not have Rituzena if any of the above apply to you.
Croatian: Nemojte primiti lijek Rituzena ako se nešto od navedenoga odnosi na Vas.
English: What Rituzena looks like and contents of the pack
Croatian: Kako Rituzena izgleda i sadržaj pakiranja
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Rituzena.
Croatian: Ako ste u dobi kada možete zatrudnjeti, Vi i Vaš partner morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom Rituzena.
English: During or within the first 2 hours of the first infusion you may develop fever, chills and shivering.
Croatian: Tijekom ili unutar prva 2 sata nakon prve infuzije može doći do vrućice, zimice i drhtavice.
English: For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Croatian: Zbog tih se razloga rituksimab ne smije primjenjivati u trudnica, osim ako moguća korist od liječenja nadilazi potencijalni rizik.
English: Stamullen, Co. Meath K32 YD60, Ireland
Croatian: Meath K32 YD60, Irska
English: • if you think you may need any vaccinations in the near future, including vaccinations for travel to other countries.
Croatian: • ako mislite da ćete u bliskoj budućnosti morati primiti neko cjepivo, uključujući ono koje je obavezno prije putovanja u druge zemlje.
English: The two treatment groups were well balanced in baseline disease characteristics and disease status.
Croatian: Dvije liječene skupine bile su dobro uravnotežene u pogledu početnih karakteristika i stanja bolesti.
English: The spread of these abnormal B-lymphocytes is the cause of symptoms you may have.
Croatian: Pretjerano stvaranje tih abnormalnih B-limfocita uzrokuje simptome koje možda imate.
English: It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome.
Croatian: Ostaje nepoznato mogu li rano otkrivanje PML-a i prekid liječenja lijekom rituksimab dovesti do slične stabilizacije ili poboljšanog ishoda.
English: • asthma, too little oxygen reaching the body organs
Croatian: astma, dotok premale količine kisika u tjelesne organe
English: Rituzena is a biosimilar medicinal product.
Croatian: Rituzena je biosličan lijek.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska antitijela; ATK oznaka: L01XC02
English: Rituzena will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Croatian: Lijek Rituzena će Vam dati liječnik ili medicinska sestra s iskustvom u primjeni te vrste lijekova.
English: Rituzena can be given alone or with other medicines called “chemotherapy”.
Croatian: Rituzena se može primjenjivati samostalno ili s drugim lijekovima koji se nazivaju „kemoterapijom“.
English: This card tells you:
Croatian: Što se nalazi u ovoj uputi:
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Croatian: Ovisno o težini infuzijske reakcije i potrebnim intervencijama valja privremeno ili trajno prekinuti primjenu lijeka rituksimab.
English: What Rituzena is and what it is used for
Croatian: Što je Rituzena i za što se koristi
English: The prepared infusion solution of rituximab is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Croatian: Pripremljena infuzijska otopina rituksimaba fizikalno je i kemijski stabilna 24 sata na temperaturi od 2 °C do 8 °C, a nakon toga još 12 sati na sobnoj temperaturi (ne višoj od 30 °C).
English: Rituzena may be used for the treatment of several different conditions in adults.
Croatian: Rituzena se može primjenjivati za liječenje nekoliko različitih bolesti u odraslih bolesnika.
English: Patients with active hepatitis B disease should not be treated with rituximab.
Croatian: Bolesnici s aktivnim hepatitisom B ne smiju se liječiti lijekom rituksimab.
English: Do not have Rituzena if you have an active infection or a serious problem with your
Croatian: Ne smijete primiti lijek Rituzena ako imate aktivnu infekciju ili ozbiljne poteškoće s imunološkim sustavom.
English: Therefore patients with a history of cardiac disease should be monitored closely (see Infusion related reactions, above).
Croatian: Stoga se bolesnici s anamnezom bolesti srca moraju pažljivo nadzirati (vidjeti Reakcije povezane s infuzijom u gornjem tekstu).
English: Currently, there are limited data on possible medicinal product interactions with rituximab.
Croatian: Trenutno su dostupni ograničeni podaci o mogućim interakcijama drugih lijekova s lijekom rituksimab.
English: Rarely Rituzena can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Croatian: Rituzena rijetko može uzrokovati ozbiljnu infekciju mozga koja se naziva 'progresivna multifokalna leukoencefalopatija' ili PML.
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first
Croatian: Prosječni Cmax za obje je doze bio 16 % do 19 % veći nakon druge infuzije u usporedbi s prvom infuzijom.
English: This is because Rituzena can affect the way some other medicines work.
Croatian: To je važno jer Rituzena može utjecati na način djelovanja nekih lijekova.
English: Summary of the safety profile (rheumatoid arthritis)
Croatian: Sažetak sigurnosnog profila (reumatoidni artritis)
English: The cells that are affected by Rituzena help to fight infection and you should wait until the infection has passed before you are given Rituzena.
Croatian: Rituzena utječe na stanice koje pomažu u borbi protiv infekcija pa stoga morate pričekati dok infekcija ne prođe prije nego što primite lijek Rituzena.
English: The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (<65 years), with previously untreated or relapsed/refractory CLL.
Croatian: Incidencija hematoloških i limfatičkih nuspojava stupnja 3/4 bila je veća u starijih bolesnika u usporedbi s mlađim bolesnicima (< 65 godina) s prethodno neliječenim ili relapsirajućim/refraktornim KLL-om.
English: You should also tell them about your Rituzena treatment.
Croatian: Recite im i da se liječite lijekom Rituzena.
English: Rituzena will be given to you once a week for 4 weeks.
Croatian: Lijek Rituzena primat ćete jedanput na tjedan tijekom 4 tjedna.
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis or microscopic polyangiitis.
Croatian: • ako imate teško zatajenje srca ili tešku nekontroliranu srčanu bolest i imate granulomatozu s poliangiitisom ili mikroskopski poliangiitis.
English: It is designed to stick to a type of white blood cell called “B-Lymphocyte”.
Croatian: Napravljen je da se veže na površinu jedne vrste bijelih krvnih stanica koje se zovu „B-limfociti“.
English: Rituzena is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Croatian: Rituzena je bistra, bezbojna otopina, dostupna u obliku koncentrata za otopinu za infuziju u staklenoj bočici.
English: • recurrence of a previous Hepatitis B infection
Croatian: povratak ranije hepatitis B infekcije
English: A total of 23/99 (23%) rituximab-treated patients in the trial tested positive for HACA by 18 months.
Croatian: Ukupno je 23/99 (23 %) bolesnika liječenih rituksimabom u ovom ispitivanju do 18. mjeseca bilo pozitivno na HACA-u.
English: The transient IgM increase usually returned to at least
Croatian: Prolazno povećanje razine IgM-a obično se vratilo barem na početnu razinu u roku od 4 mjeseca.
English: No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would have no or negligible influence on the ability to drive and use machines.
Croatian: Nisu provedena ispitivanja o utjecaju lijeka rituksimab na sposobnost upravljanja vozilima i rada sa strojevima, iako farmakološka aktivnost i dosad prijavljene nuspojave ukazuju na to da rituksimab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Table 7 Percentage of patients who achieved complete remission at 6 months Cyclophosphamide (n = 98)
Croatian: Postotak bolesnika koji su postigli potpunu remisiju nakon 6 mjeseci (populacija Ciklofosfamid (n = 98)
English: Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Croatian: S obzirom na mehanizam djelovanja lijeka rituksimab i činjenicu da B stanice igraju važnu ulogu u održavanju normalnog imunološkog odgovora, nakon terapije lijekom rituksimab bolesnici su izloženi povećanom riziku od infekcija (vidjeti dio 5.1).
English: This is in case you get any
Croatian: Naime, u nekim slučajevima
English: Rituzena in combination with chemotherapy destroys these cells.
Croatian: Rituzena u kombinaciji s kemoterapijom uništava te stanice.
English: • The need to carry the card at all times and to show the card to all treating health
Croatian: • Karticu uvijek treba nositi sa sobom i pokazati je svim zdravstvenim radnicima koji bolesnika
English: Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution.
Croatian: Bolesnike s velikom zahvaćenošću tumorom ili visokim brojem (≥ 25 x 109/l) cirkulirajućih zloćudnih stanica, kao što su bolesnici s KLL-om, u kojih može postojati povećan rizik od osobito teškog sindroma otpuštanja citokina, smije se liječiti samo uz izniman oprez.
English: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2 %) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Croatian: Tijekom razdoblja liječenja (razdoblje uvodnog liječenja koje se sastojalo od primjene R-CHOP tijekom najviše osam ciklusa) četvero bolesnika (2 %) iz R-CHOP skupine, svi s kardiovaskularnim faktorima rizika, doživjelo je cerebrovaskularnu tromboemboliju tijekom prvog ciklusa liječenja.
English: This is because in a few cases, Rituzena could cause hepatitis B to become active again, which can be fatal in very rare cases.
Croatian: Naime, u nekim slučajevima Rituzena može ponovno aktivirati hepatitis B, što u vrlo rijetkim slučajevima može biti smrtonosno.
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following rituximab (see section 4.5).
Croatian: Premalo je podataka iz kliničkih ispitivanja da bi se u potpunosti mogla procijeniti sigurnost sekvencijske primjene drugih DMARD-a (uključujući TNF-inhibitore i ostale biološke lijekove) nakon lijeka rituksimab (vidjeti dio 4.5).
English: No dose reductions of Rituzena are recommended.
Croatian: Ne preporučuje se smanjenje doze lijeka Rituzena.
English: Treatment with Rituzena uses four separate infusions given at weekly intervals.
Croatian: Liječenje lijekom Rituzena obuhvaća četiri zasebne infuzije koje se daju u razmacima od tjedan dana.
English: Cases of interstitial lung disease, some with fatal outcome, have been reported.
Croatian: Prijavljeni su slučajevi intersticijske bolesti pluća, neki sa smrtnim ishodom.