FrancophonIA/ELRC3.0 huggingface dataset:
English: If symptoms are persistent and worsening, administration should be delayed or discontinued.
Croatian: Ako simptomi ustraju ili se pogoršavaju, primjenu treba odgoditi ili prekinuti.
English: It may be difficult to distinguish allergic reactions from exaggerated inflammatory responses, but patients should be monitored for signs of allergic reactions.
Croatian: Razlikovanje alergijske reakcije od pretjeranog upalnog odgovora može biti teško, no kod bolesnika treba pratiti znakove alergijske reakcije.
English: You should not stop treatment with MEPACT before finishing the course of treatment without discussing with your doctor first.
Croatian: Ne smijete prekinuti liječenje lijekom MEPACT prije predviđenog završetka terapije bez da se prethodno posavjetujete sa svojim liječnikom.
English: If you stop using MEPACT
Croatian: Ako prestanete uzimati MEPACT
English: Many of the very commonly reported adverse reactions as shown in the following summary table are thought to be related to the mechanism of action of mifamurtide (see table 1).
Croatian: Za većinu vrlo često prijavljenih nuspojava, kao što je prikazano u zbirnoj tablici koja slijedi, smatra se da su povezane s mehanizmom djelovanja mifamurtida (vidjeti tablicu 1).
English: Post-procedural pain
Croatian: Postproceduralna bol
English: Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis (see section 5.1).
Croatian: Sigurnost i djelotvornost su ocijenjene u ispitivanjima na bolesnicima koji su bili u dobi od 2 do 30 godina pri postavljanju dijagnoze (vidjeti dio 5.1).
English: White to off-white homogeneous cake or powder.
Croatian: Bijeli do bjelkasti homogeni kolačić ili prašak.
English: The mean area under the curve (AUC) was 17.0 ± 4.86 h x nM and Cmax (maximum concentration) was 15.7 ± 3.72 nM.
Croatian: Srednja vrijednost područja ispod krivulje AUC bila je 17,0 ± 4,86 h x nM, a Cmax (maksimalna koncentracija) bila je 15,7 ± 3,72 nM.
English: • 1 single use 60 or 100 mL sterile syringe with luer lock
Croatian: • 1 jednokratna sterilna štrcaljka od 60 ili 100 ml sa luer lock spojnicom
English: See section 2 “MEPACT contains sodium”
Croatian: Pogledajte dio 2 „MEPACT sadrži natrij“.
English: What MEPACT is and what it is used for What you need to know before you use MEPACT How to use MEPACT
Croatian: Što je MEPACT i za što se koristi Što morate znati prije nego počnete primjenjivati MEPACT Kako primjenjivati MEPACT
English: In 2 of 4 patients with lung metastases, radioactivity was associated with lung metastases.
Croatian: U 2 od 4 bolesnika s plućnim metastazama radioaktivnost je bila povezana s plućnim metastazama.
English: Detailed information on warnings and precautions relating to side effects that could occur while you are taking the medicine is presented in section 4.
Croatian: Detaljnije informacije o upozorenjima i predostrožnostima povezanim s nuspojavama koje bi se mogle javiti tijekom primjene lijeka prikazane su u dijelu 4.
English: Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux France
Croatian: Takeda France SAS Immeuble Pacific 11-13 cours Valmy 92800 - Puteaux Francuska
English: The majority of patients experience chills, fever and fatigue especially during the first administration of MEPACT.
Croatian: Većina bolesnika ima zimicu, vrućicu i umor, posebno tijekom prve primjene lijeka MEPACT.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of mifamurtide therapy to the woman.
Croatian: Odluku o nastavku/prekidu dojenja ili nastavku/prekidu liječenja treba donijeti uzimajući u obzir korist od dojenja za dijete i korist od liječenja mifamurtidom za ženu.
English: MTP-PE is a potent activator of monocytes and macrophages.
Croatian: MTP-PE je potentni aktivator monocita i makrofaga.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mifamurtide, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za mifamurtid, znanstveni zaključci CHMP-a su sljedeći:
English: It is not necessary to interrupt your schedule of MEPACT if your chemotherapy is delayed; you should complete 36 weeks (9 months) of treatment with MEPACT without an interruption.
Croatian: Nema potrebe prekidati raspored primjene lijeka MEPACT ukoliko se odgodi primjena kemoterapije; 36 tjedana (9 mjeseci) liječenja lijekom MEPACT treba završiti bez prekida.
English: In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m dose level.
Croatian: U ispitivanju faze I, bila je jedna prijava ozbiljne alergijske reakcije koja se pojavila nakon prve infuzije mifamurtida, primijenjenog u dozi od 6 mg/m2.
English: In sensitive species (rabbit and dog) the highest daily dose of liposomal mifamurtide that did not cause adverse effects was 0.1 mg/kg, corresponding to 1.2 and 2 mg/m2, respectively.
Croatian: U osjetljivih vrsta (kunić i pas) najveća dnevna doza liposomalnog mifamurtida koja nije izazvala nuspojave iznosila je 0,1 mg/kg, što odgovara 1,2 i 2 mg/m2.
English: Mifamurtide was not mutagenic and did not cause teratogenic effects in rats and rabbits.
Croatian: Mifamurtid nije bio mutagen i nije pokazao teratogeno djelovanje kod štakora i kunića.
English: Oedema, chest discomfort, local infusion or catheter site reactions and ‘feeling cold' were less frequently reported in these patients, mostly with late stage malignant disease.
Croatian: Edem, nelagoda u prsištu, lokalne reakcije na mjestu infuzije ili katetera i „osjećaj hladnoće“ su manje često prijavljeni kod tih bolesnika, uglavnom u kasnijoj fazi maligne bolesti.
English: MEPACT has a moderate influence on the ability to drive and use machines.
Croatian: MEPACT ima umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: A healthy adult volunteer accidentally received a single dose of 6.96 mg mifamurtide and experienced a reversible treatment-related event of orthostatic hypotension.
Croatian: Zdravi odrasli dobrovoljac je slučajno primio jednokratnu dozu od 6,96 mg mifamurtida i imao prolaznu ortostatsku hipotenziju povezanu s liječenjem.
English: - ciclosporin, tacrolimus, used after a transplant to prevent rejection of transplanted organs, or other immunosuppressants used e.g. to treat psoriasis (a skin disease).
Croatian: - ciklosporin, takrolimus, koji se koriste nakon transplantacije za sprečavanje odbacivanja transplantiranih organa, ili druge imunosupresive koji se koriste npr. za liječenje psorijaze (bolesti kože).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su navedene slijedom smanjenja ozbiljnosti.
English: • 2 medium (18) gauge sterile injection needles
Croatian: • 2 srednje (18G) sterilne injekcijske igle
English: The schedule of your MEPACT treatments can be adjusted to fit with your chemotherapy schedule.
Croatian: Raspored primjene lijeka MEPACT može se prilagoditi kako bi se uklopio u raspored Vaših kemoterapija.
English: Mifamurtide treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of osteosarcoma.
Croatian: Liječenje mifamurtidom treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju osteosarkoma.
English: MTP-PE is a specific ligand of NOD2, a receptor found primarily on monocytes, dendritic cells and macrophages.
Croatian: MTP-PE je specifični ligand NOD2, receptora koji se prvenstveno nalazi na monocitima, dendritičkim stanicama i makrofazima.
English: The excretion of mifamurtide in milk has not been studied in animals.
Croatian: Izlučivanje mifamurtida u mlijeko nije ispitivano kod životinja.
English: Association of mifamurtide with signs of pronounced inflammatory response, including pericarditis and pleuritis, was uncommon.
Croatian: Povezanost mifamurtida sa znakovima naglašenog upalnog odgovora, uključujući perikarditis i pleuritis, nije česta.
English: The safety of liposomal mifamurtide has been assessed in more than 700 patients with various kinds and stages of cancer and in 21 healthy adult subjects (see section 4.8).
Croatian: Sigurnost liposomalnog mifamurtida ispitana je u više od 700 bolesnika s različitim vrstama i stupnjevima raka te u 21 zdravog odraslog ispitanika (vidjeti dio 4.8).
English: Based on the liposomal nature of the product, use of an infusion set with an in-line filter during administration is not recommended.
Croatian: Na temelju liposomalne prirode lijeka, ne preporučuje se korištenje infuzije postavljene s in-line filtrom tijekom primjene.
English: Mifamurtide (muramyl tripeptide phosphatidyl ethanolamine, MTP-PE) is a fully synthetic derivative of muramyl dipeptide (MDP), the smallest naturally-occurring immune stimulatory component of cell walls from Mycobacterium sp.
Croatian: Mifamurtid (muramil tripeptid fosfatidil etanolamin, MTP-PE) je potpuno sintetski derivat muramil dipeptida (MDP), najmanje imunostimulacijske komponente stanične stijenke Mycobacterium sp. koja se javlja u prirodi.
English: MEPACT is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection.
Croatian: MEPACT je indiciran kod djece, adolescenata i mladih odraslih za liječenje resektabilnog nemetastatskog osteosarkoma visokog stupnja malignosti nakon makroskopski potpune kirurške resekcije.
English: In a separate study in 14 patients, mean serum concentration-time curves of total and free mifamurtide that were assessed after the first infusion of mifamurtide and after a last infusion 11 or 12 weeks later, were almost superimposable and the mean AUC values of the free mifamurtide after the first and last infusion were similar.
Croatian: U zasebnom ispitivanju u 14 bolesnika, srednje vrijednosti krivulje serumske koncentracije u vremenu ukupnog i slobodnog mifamurtida koje su procijenjivane nakon prve infuzije mifamutida i nakon posljednje infuzije 11 ili 12 tjedana kasnije bile su gotovo podudarne, a srednje vrijednosti AUC slobodnog mifamurtida nakon prve i posljednje infuzije bile su slične.
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 6 hours at room temperature.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja odgovornost su korisnika i ne smiju prijeći 6 sati na sobnoj temperaturi.
English: Mifamurtide may be given during periods of neutropenia, but subsequent fever attributed to the treatment should be monitored closely.
Croatian: Mifamurtid se može davati u razdobljima neutropenije, ali posljedičnu vrućicu koja se pripisuje liječenju treba pomno nadzirati.
English: If a severe respiratory reaction occurs, administration of mifamurtide should be discontinued and appropriate treatment initiated.
Croatian: Ako se pojavi jaka respiratorna reakcija, potrebno je prekinuti primjenu mifamurtida i započeti primjereno liječenje.
English: Materials provided in each package:
Croatian: Oprema priložena u jednom pakiranju:
English: Dehydration, Hypokalaemia, Decreased appetite
Croatian: Dehidracija, hipokalemija, smanjeni apetit
English: Embryotoxic effects were observed only at maternal toxic levels.
Croatian: Embriotoksičnost je zapažena samo kod doza toksičnih za majku.
English: Limited studies of the interaction of mifamurtide with chemotherapy have been conducted.
Croatian: Provedena su ograničena ispitivanja interakcija mifamurtida s kemoterapijom.
English: abdomen, arm or leg - cough, trouble breathing or rapid breathing - low body temperature - low number of red blood cells
Croatian: rukama ili nogama - kašalj, teško disanje ili ubrzano disanje - snižena tjelesna temperatura - smanjeni broj crvenih krvnih stanica
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna za konačni zaključak o reproduktivnoj toksičnosti (vidjeti dio 5.3).
English: - Non-steroidal-anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, or diclofenac, used for treatment of headaches, fever or pain.
Croatian: - nesteroidne protuupalne lijekove (NSAIL), poput acetilsalicilne kiseline, ibuprofena ili diklofenaka, koji se koriste za liječenje glavobolje, vrućice ili boli.
English: Continued monitoring of the kidney and liver function is recommended if mifamurtide is used beyond completion of chemotherapy until all therapy is completed.
Croatian: Preporučuje se nastaviti pratiti funkciju bubrega i jetre ako se mifamurtid koristi nakon završetka kemoterapije, sve do završetka terapije.
English: MEPACT is a liposomal formulation specifically designed for in vivo targeting to macrophages by intravenous infusion.
Croatian: MEPACT je liposomalna formulacija koja je posebno dizajnirana za in vivo ciljanje makrofaga putem intravenske infuzije.
English: Examples include paracetamol for fever, chills and headache and anti-emetics (other than steroids) for nausea and vomiting.
Croatian: Primjeri uključuju paracetamol za vrućicu, zimicu i glavobolju te antiemetike (osim steroida) za mučninu i povraćanje.
English: The exact mechanism by which mifamurtide activation of monocytes and macrophages leads to anti-tumour activity in animals and humans is not yet known.
Croatian: Točni mehanizam kojim aktivacija monocita i makrofaga mifamurtidom dovodi do antitumorske aktivnosti kod životinja i ljudi nije još poznat.
English: Although these studies are not conclusive, there is no evidence of interference of mifamurtide with the anti-tumour effects of chemotherapy and vice versa.
Croatian: Iako ta ispitivanja nisu konačna, nema dokaza da mifamurtid ometa antitumorsko djelovanje kemoterapije ili obrnuto.
English: Cyanosis, Palpitations
Croatian: Cijanoza, palpitacije
English: Store in a refrigerator (2 C-8 °C).
Croatian: Čuvati u hladnjaku (2°C-8°C).
English: What you need to know before you use MEPACT
Croatian: Što morate znati prije nego počnete primjenjivati MEPACT
English: Fever or chills persisting for more than 8 hours after administration of mifamurtide should be evaluated for possible sepsis.
Croatian: Ako vrućica ili zimica traju dulje od 8 sati nakon primjene mifamurtida, potrebno je uzeti u obzir moguću sepsu.
English: The spike should then be inserted into the vial septum firmly until seated.
Croatian: Šiljak zatim treba čvrsto umetnuti u septum bočice dok ne sjedne.
English: The bag should be gently swirled to mix the solution.
Croatian: 12. Vrećicu treba nježno okretati kako bi se otopina izmiješala.
English: There are no data from the use of mifamurtide in pregnant women.
Croatian: Nema podataka o primjeni mifamurtida kod trudnica.
English: MEPACT contains the active substance mifamurtide, similar to a component of the cell wall of certain bacteria.
Croatian: MEPACT sadrži djelatnu tvar mifamurtid, sličnu sastojku stanične stijenke određenih bakterija.
English: In a randomised phase III study of 678 patients (age range from 1.4 to 30.6 years) with newly-diagnosed resectable high-grade osteosarcoma, the addition of adjuvant mifamurtide to chemotherapy (either doxorubicin cisplatin and methotrexate with or without ifosfamide), significantly increased the 6-year overall survival and resulted in a relative reduction in the risk of death by 28% (p = 0.0313, hazard ratio (HR) = 0.72 [95% confidence interval (CI): 0.53, 0.
Croatian: U randomiziranom ispitivanju faze III na 678 bolesnika (raspon godina od 1,4 do 30,6) s novodijagnosticiranim resektabilnim osteosarkomom visokog stupnja malignosti, dodatak adjuvantne terapije mifamurtida kemoterapiji (s doksorubicinom, cisplatinom i metotreksatom s ili bez ifosfamida) značajno je povećao ukupno 6-godišnje preživljenje i rezultiralo je relativnim smanjenjem rizika od smrti od 28% (p=0,0313, omjer hazarda (HR) = 0,72 [95% interval pouzdanosti (CI): 0,53,
English: For further instructions on reconstitution, filtering using the filter provided and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za dodatne upute o rekonstituciji, filtriranju s priloženim filtrom i razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Activation of human macrophages by mifamurtide is associated with production of cytokines, including tumour necrosis factor (TNF-), interleukin-1 (IL-1), IL-6, IL-8, and IL-12 and adhesion molecules, including lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1).
Croatian: Aktivacija ljudskih makrofaga mifamurtidom povezana je sa stvaranjem citokina, uključujući tumor nekrotizirajući faktor (TNF-α), interleukin-1 (IL-1β), IL-6, IL-8 i IL-12 te adhezijskih molekula, uključujući limfocitni funkcionalni antigen-1 (LFA-1) i međustaničnu adhezijsku molekulu-1 (ICAM-1).
English: Instructions for preparation of MEPACT for intravenous infusion
Croatian: Upute za pripremu MEPACT intravenske infuzije
English: These changes were not considered to be clinically meaningful as the maximum tolerated dose (4-6 mg/m2) of mifamurtide is
Croatian: Smatra se da te promjene nisu klinički značajne jer je maksimalna podnošljiva doza mifamurtida (4-6 mg/m2) 2-3 puta veća od preporučene doze
English: Mifamurtide is not recommended for use during pregnancy and in women of childbearing potential not using effective contraception.
Croatian: Mifamurtid se ne preporučuje koristiti tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici i na kutiji iza oznake „EXP“.
English: The vial should be allowed to stand undisturbed for 1 minute to ensure thorough hydration of the dry substance.
Croatian: Bočicu treba ostaviti da miruje 1 minutu kako bi se osigurala temeljita hidracija suhe tvari.
English: Regular use of corticosteroids should be avoided when using MEPACT as this may affect the way the medicine works.
Croatian: Redovito uzimanje kortkosteroida treba izbjegavati kada se koristi MEPACT jer mogu utjecati na njegovo djelovanje.
English: Nausea, vomiting and loss of appetite are very common adverse reactions to mifamurtide (see section 4.8).
Croatian: Mučnina, povraćanje i gubitak apetita su vrlo česte nuspojave mifamurtida (vidjeti dio 4.8).
English: Metabolism of liposomal MTP-PE has not been studied in humans.
Croatian: Metabolizam liposomalnog MTP-PE nije ispitivan u ljudi.
English: OUTER PACKAGING
Croatian: VANJSKO PAKIRANJE
English: Gastrointestinal toxicity may be exacerbated when mifamurtide is used in combination with high dose, multi-agent chemotherapy and was associated with an increased use of parenteral nutrition.
Croatian: Gastrointestinalna toksičnost može biti pojačana kad se mifamurtid koristi u kombinaciji s visokim dozama polikemoterapije i povezana je s češćom primjenom parenteralne prehrane.
English: It is used after you have had surgery to remove the tumour and together with chemotherapy to kill remaining cancer cells to reduce the risk of cancer coming back.
Croatian: Koristi se nakon operacije kojom je uklonjen tumor i zajedno s kemoterapijom kako bi se uništile preostale tumorske stanice i smanjio rizik ponovnog javljanja bolesti.
English: There was no effect of mild hepatic impairment on the systemic exposure (AUCinf) of total MTP-PE.
Croatian: Blago oštećenje jetre nije imalo utjecaja na sistemsku izloženost (AUCinf) ukupnom MTP-PE.
English: On the basis of the scientific conclusions for mifamurtide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mifamurtide is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za mifamurtid, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) mifamurtid nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If you have any further questions on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih drugih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
English: During mifamurtide administration, patients should be monitored for unusual signs or symptoms, such as arthritis or synovitis, suggestive of uncontrolled inflammatory reactions.
Croatian: Tijekom primjene mifamurtida kod bolesnika treba obratiti pažnju na neuobičajene znakove ili simptome, poput artritisa ili sinovitisa, koji ukazuju na nekontroliranu upalnu reakciju.
English: The maximum tolerated dose in phase I studies was 4-6 mg/m with a high variability of adverse reactions.
Croatian: Maksimalna podnošljiva doza u ispitivanjima faze I bila je 4-6 mg/m s velikom varijabilnosti nuspojava.
English: Liposomal and non-liposomal mifamurtide do not induce the metabolic activity or the transcription of cytochrome P450 in primary cultures of freshly isolated human hepatocytes.
Croatian: Liposomalni i neliposomalni mifamurtid ne potiču metaboličku aktivnost ili transkripciju citokroma P450 u primarnim kulturama svježe izoliranih ljudskih hepatocita.
English: Pharmacokinetic variability was higher in the moderate hepatic impairment group (co-efficient of variation in systemic exposure [AUCinf] was 50% versus < 30% in the other hepatic function groups).
Croatian: Famakokinetička varijabilnost bila je veća u skupini s umjerenim oštećenjem jetre (koeficijent varijacije sistemske izloženosti [AUCinf] bio je 50% u odnosu na < 30% u drugim skupinama).
English: • Filter for MEPACT
Croatian: • Filtar za MEPACT
English: In 21 healthy adult subjects mifamurtide was cleared rapidly from serum (minutes) with a half-life of 2.05 ± 0.40 hours, resulting in a very low serum concentration of total (liposomal and free) mifamurtide.
Croatian: U 21 zdravog odraslog ispitanika mifamurtid se brzo uklonio iz seruma (u minutama) s poluvijekom od 2,05 ± 0,40 sati, rezultirajući vrlo niskom serumskom koncentracijom ukupnog (liposomalnog i slobodnog) mifamurtida.
English: The recommended dose of mifamurtide for all patients is 2 mg/m body surface area.
Croatian: Preporučena doza mifamurtida za sve bolesnike je 2 mg/m tjelesne površine.
English: After injection of radiolabelled liposomes containing mifamurtide, mean half-life of radiolabelled material was biphasic with an α-phase of about 15 minutes and a terminal half-life of approximately 18 hours.
Croatian: Nakon injiciranja radioaktivno označenih liposoma koji sadrže mifamurtid, srednja vrijednost poluvijeka radioaktivno označenog materijala bila je dvofazna sa α fazom od oko 15 minuta i terminalnim poluvijekom od približno 18 sati.
English: Data from a six-month dog study of daily intravenous injections of up to 0.5 mg/kg (10 mg/m mifamurtide provide an 8- to 19-fold cumulative exposure safety margin for overt toxicity for the intended clinical dose in humans.
Croatian: Podaci iz šestomjesečnog ispitivanja na psima svakodnevnih intravenskih injekcija do 0,5 mg/kg (10 mg/m2) mifamurtida pokazuju 8-erostruku do 19-erostruku sigurnosnu marginu kumulativne izloženosti za očitu toksičnost kliničke doze namijenjene ljudima.
English: Consistent with other generalised symptoms, the very common nervous system disorders were headache (50%) and dizziness (17%).
Croatian: Sukladno drugim općim simptomima, vrlo česti poremećaji živčanog sustava bili su glavobolja (50%) i omaglica (17%).
English: It is used in combination with post-operative multi-agent chemotherapy.
Croatian: Koristi se u kombinaciji s postoperacijskom polikemoterapijom.
English: There was also one report of a grade 4 allergic reaction (hypertension) requiring hospitalization in the phase III study (see section 4.4).
Croatian: U ispitivanju faze III bila je, također, i jedna prijava alergijske reakcije stupnja 4 (hipertenzija) koja je zahtjevala hospitalizaciju bolesnika (vidjeti dio 4.4).