FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus letrozole compared to patients receiving placebo plus letrozole in the full analysis set (hazard ratio of 0.556, 95% CI: 0.429, 0.720, one sided stratified log-rank test p-value 0.00000329) with clinically meaningful treatment effect.
Croatian: Rezultati djelotvornosti pokazali su statistički značajno poboljšanje PFS-a u bolesnica koje su primale Kisqali plus letrozol u usporedbi s bolesnicama koje su primale placebo plus letrozol u potpunom skupu podataka za analizu (omjer hazarda od 0,556, 95% CI: 0,429; 0,720, p-vrijednost jednostranog stratificiranog log-rang testa 0,00000329) s klinički važnim terapijskim učinkom.
English: After initiating treatment LFTs should be performed every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated.
Croatian: Nakon početka liječenja testove jetrene funkcije treba provoditi svaka 2 tjedna tijekom prva 2 ciklusa, zatim na početku svakog od naredna 4 ciklusa, a nakon toga prema kliničkoj indikaciji.
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Baseline = prior to treatment initiation
Croatian: Common Terminology Criteria for Adverse Events - Zajednički terminološki kriteriji za nuspojave) ** Početna vrijednost = prije početka liječenja GGN = gornja granica normale
English: Figure 6 MONALEESA-3 - Kaplan-Meier plot of PFS based on investigator assessment
Croatian: Slika 6 MONALEESA-3 - Kaplan-Meierov dijagram PFS-a na temelju ispitivačeve procjene
English: General disorders and administration site conditions Fatigue, peripheral oedema, asthenia, pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene Umor, periferni edem, astenija, pireksija vrlo često
English: Data from a clinical study in patients with breast cancer indicated no clinically relevant drug interaction between ribociclib and anastrozole following co-administration of these medicinal products.
Croatian: Podaci iz kliničkog ispitivanja u bolesnica s rakom dojke ukazali su da nema klinički relevantnih interakcija između ribocikliba i anastrozola nakon istodobne primjene tih lijekova.
English: • Medicines used for the treatment of gastrointestinal disorders such as cisapride.
Croatian: • Lijekove koji se koriste za liječenje poremećaja probavnog sustava kao što je cisaprid.
English: Median PFS was 20.5 months (95% CI: 18.5, 23.5) for Kisqali plus fulvestrant treated patients and 12.8 months (95% CI: 10.9, 16.3) for patients receiving placebo plus fulvestrant.
Croatian: Medijan PFS-a iznosio je 20,5 mjeseci (95% CI: 18,5; 23,5) za bolesnice liječene Kisqalijem plus fulvestrantom te 12,8 mjeseci (95% CI: 10,9; 16,3) za bolesnice koje su primale placebo plus fulvestrant.
English: OS data remain immature.
Croatian: Podaci o OS-u i dalje nisu zreli.
English: Placebo + letrozole (%, 95% CI)
Croatian: Placebo + letrozol (%, 95% CI)
English: How to take Kisqali
Croatian: Kako uzimati Kisqali
English: Cardiac disorders Syncope
Croatian: Srčani poremećaji Sinkopa često
English: Kisqali + letrozole (%, 95% CI)
Croatian: Kisqali + letrozol (%, 95% CI)
English: Median PFS was 25.3 months (95% CI: 23.0, 30.3) for ribociclib plus letrozole treated patients and 16.0 months (95% CI: 13.4, 18.2) for patients receiving placebo plus letrozole.
Croatian: Medijan PFS-a bio je 25,3 mjeseca (95% CI; 23,0; 30,3) za bolesnice liječene ribociklibom plus letrozolom te 16,0 mjeseci (95% CI: 13,4; 18,2) za bolesnice koje su primale placebo plus letrozol.
English: The primary efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus fulvestrant compared to patients receiving placebo plus fulvestrant in the full analysis set (hazard ratio of 0.593, 95% CI: 0.480, 0.732, one-sided stratified log-rank test p-value 4.1x10
Croatian: Rezultati primarne djelotvornosti pokazali su statistički značajno poboljšanje PFS-a u bolesnica koje su primale Kisqali plus fulvestrant u usporedbi s bolesnicama koje su primale placebo plus fulvestrant u potpunom skupu podataka za analizu (omjer hazarda 0,593, 95% CI: 0,480; 0,732, p-vrijednost jednostranog stratificiranog log-rang testa 4,1x10
English: Study CLEE011E2301 (MONALEESA-7)
Croatian: Ispitivanje CLEEO11E2301(MONALEESA-7)
English: Table 8 MONALEESA-2 - Efficacy results (ORR, CBR) based on investigator assessment(02 January 2017 cut-off)
Croatian: - Rezultati djelotvornosti (ORR, CBR) na temelju ispitivačeve procjene (isključni datum 2. siječnja 2017.)
English: Dose modification for use of Kisqali with strong CYP3A4 inhibitors Concomitant use of strong CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with less potential to inhibit CYP3A4 inhibition should be considered.
Croatian: Potrebno je izbjegavati istodobnu primjenu snažnih CYP3A4 inhibitora te razmotriti zamjenski istodobno primijenjen lijek s manje potencijala za inhibiranje CYP3A4.
English: What Kisqali is
Croatian: Što je Kisqali
English: Figure 2 MONALEESA-7 - Kaplan-Meier plot of PFS in overall population based on investigator assessment
Croatian: Slika 2 MONALEESA-7 - Kaplan-Meierov dijagram PFS-a na temelju ispitivačeve procjene u cjelokupnoj populaciji
English: Drug-drug interaction between ribociclib and tamoxifen
Croatian: Interakcije između ribocikliba i tamoksifena
English: • with electrolyte abnormalities.
Croatian: • s poremećenim vrijednostima elektrolita.
English: ** Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events)
Croatian: ** Određivanje stupnja prema CTCAE-u verzija 4.03 (CTCAE= engl.
English: No tablet should be ingested if it is broken, cracked or otherwise not intact.
Croatian: Ne smiju se uzimati tablete koje su razlomljene, napuknute ili na neki drugi način oštećene.
English: Censoring times Ribociclib (N=334) Placebo (N=334)
Croatian: Vrijeme cenzuriranja Ribociklib (N=334) Placebo (N=334)
English: Within this subgroup, the hazard ratio for the second line patients who had received prior endocrine therapy in the advanced breast cancer setting was 0.539 (95% CI: 0.333, 0.873), with a median PFS of 18.8 months (95% CI: 12.5, NE) and 11.4 months (95% CI: 3.7, 16.3) in the Kisqali and placebo arms, respectively.
Croatian: Unutar te podskupine, omjer hazarda za bolesnice u drugoj liniji liječenja koje su primale prethodnu endokrinu terapiju za uznapredovali rak dojke bio je 0,539 (95% CI: 0,333, 0,873), s medijanom PFS-a od 18,8 mjeseci (95% CI: 12,5; NP) za skupinu koja je primala Kisqali, odnosno 11,4 mjeseci (95% CI: 3,7; 16,3) za skupinu koja je primala placebo.
English: In the subgroup of patients who had received up to one line of treatment for metastatic/advanced disease, the hazard ratio was of 0.565 (95% CI: 0.428, 0.744), with a median PFS of 14.6 months (95% CI: 12.5, 18.5) and 9.1 months (95% CI: 6.1, 11.1) in the Kisqali and placebo arms, respectively.
Croatian: U podskupini bolesnica koje su primale najviše jednu liniju liječenja za metastatsku/uznapredovalu bolest, omjer hazarda iznosio je 0,565 (95% CI: 0,428; 0,744), pri čemu je medijan PFS-a za skupinu koja je primala Kisqali iznosio 14,6 mjeseci (95% CI: 12,5; 18,5), a za skupinu koja je primala placebo 9,1 mjeseci (95% CI: 6,1; 11,1).
English: Kisqali was evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease in combination with letrozole versus letrozole alone.
Croatian: Kisqali je bio ocijenjen u randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom kliničkom ispitivanju faze III u kojem se ispitivalo liječenje postmenopauzalnih žena s uznapredovalim HER2-negativnim rakom dojke pozitivnim na hormonski receptor, koje prethodno nisu primale terapiju za uznapredovalu bolest, u kombinaciji s letrozolom, u odnosu na liječenje samim letrozolom.
English: Censoring times Ribociclib (N=248) Placebo (N=247)
Croatian: Vrijeme cenzuriranja Ribociklib (N=248) Placebo (N=247)
English: • Some medicines used to treat fungal infections, such as ketoconazole, itraconazole,
Croatian: • Neke lijekove koji se koriste za liječenje gljivičnih infekcija, kao što su ketokonazol,
English: Kisqali was evaluated in a randomised double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of men and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who had received no or only one line of prior endocrine treatment, in combination with fulvestrant versus fulvestrant alone.
Croatian: Kisqali je bio ocijenjen u randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom kliničkom ispitivanju faze III u kojem se ispitivalo liječenje muškaraca i postmenopauzalnih žena s uznapredovalim HER2-negativnim rakom dojke pozitivnim na hormonski receptor, koji prethodno nisu primali endokrino liječenje ili su primili samo jednu liniju prethodnog endokrinog liječenja, u kombinaciji s fulvestrantom u odnosu na samo fulvestrant.
English: Censoring Times Ribociclib (N=335) Placebo (N=337)
Croatian: Vrijeme cenzuriranja Ribociklib (N=335) Placebo (N=337)
English: In the subgroup of patients who were treatment-naive in the metastatic/advanced disease setting, the hazard ratio was of 0.577 (95% CI: 0.415, 0.802), with a median PFS not reached in the Kisqali arm and 18.3 months (95% CI: 14.8, 23.1) in the placebo arm.
Croatian: U podskupini bolesnica koje nisu prethodno bile liječene za metastatsku/uznapredovalu bolest, omjer hazarda iznosio je 0,577 (95% CI: 0,415; 0,802), pri čemu medijan PFS-a nije dosegnut u skupini koja je primala Kisqali, a u skupini koja je primala placebo iznosio je 18,3 mjeseci (95% CI: 14,8; 23,1).
English: Based on the severity of the transaminase elevations, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 3 (see sections 4.2 and 4.8).
Croatian: Ovisno o tome koliko su porasle vrijednosti transaminaza, liječenje Kisqalijem možda će biti potrebno privremeno prekinuti, smanjiti dozu ili trajno prekinuti kako je opisano u Tablici 3 (vidjeti dijelove 4.2 i 4.8).
English: Drug-drug interaction between ribociclib and letrozole
Croatian: Interakcija između ribocikliba i letrozola
English: • Medicines used to prevent the rejection of an organ transplant such as tacrolimus, sirolimus and ciclosporin (also used to treat inflammation in rheumatoid arthritis and psoriasis).
Croatian: sirolimus i ciklosporin (također se koriste za liječenje upale kod reumatoidnog artritisa i psorijaze).
English: Based on the severity of the neutropenia, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 2 (see sections 4.2 and 4.8).
Croatian: Ovisno o težini neutropenije, liječenje Kisqalijem možda će trebati privremeno prekinuti, smanjiti dozu ili trajno prekinuti kako je opisano u Tablici 2 (vidjeti dijelove 4.2 i 4.8).
English: • Weakness (asthenia)
Croatian: • Slabost (astenija)
English: Very common (may affect more than 1 in 10 people).
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba).
English: At the time of the primary PFS analysis overall survival data were not mature with 89 (13%) of deaths (HR 0.
Croatian: U vrijeme primarne analize PFS-a podaci o ukupnom preživljenju nisu bili zreli uz 89 (13%) smrtnih slučajeva (HR 0,916 [95% CI: 0,601; 1,396]).
English: How to store Kisqali
Croatian: Kako čuvati Kisqali
English: Monitoring during your treatment with Kisqali
Croatian: Praćenje tijekom liječenja Kisqalijem
English: 189 (3 x 63) film-coated tablets (in PCTFE/PVC blisters)
Croatian: 189 (3 x 63) filmom obloženih tableta (u PCTFE/PVC blisterima)
English: Kaplan-Meier median Ribociclib: NE Placebo: 40.9 months
Croatian: Kaplan-Meierov medijan Ribociklib: NP Placebo: 40,9 mjeseci
English: Kaplan-Meier median Ribociclib: NE Placebo: 40.7 months
Croatian: Kaplan-Meierov medijan Ribociklib: NP Placebo: 40,7 mjeseci
English: Figure 3 MONALEESA-7 - Kaplan-Meier plot of PFS based on investigator assessment in patients who received NSAI
Croatian: Slika 3 MONALEESA-7 - Kaplan-Meierov dijagram PFS-a u bolesnica koje su primale NSAI na temelju ispitivačeve procjene
English: Table 7 MONALEESA-2 - Efficacy results (PFS) based on investigator radiological assessment (02 January 2017 cut-off)
Croatian: - Rezultati djelotvornosti (PFS) na temelju ispitivačeve radiološke procjene (isključni datum 2. siječnja 2017.)
English: Complete blood counts (CBC) should be performed before initiating treatment with Kisqali.
Croatian: Prije početka liječenja Kisqalijem mora se napraviti kompletna krvna slika (KKS).
English: Efficacy results for overall response rate (ORR) and clinical benefit rate (CBR) per investigator assessment based on RECIST v1.1 are provided in Table 13.
Croatian: Rezultati djelotvornosti za stopu ukupnog odgovora (ORR) i stopu kliničke koristi (CBR) prema ispitivačevoj procjeni na temelju kriterija RECIST v1.1 prikazani su u Tablici 13. Tablica 13 MONALEESA-3 - Rezultati djelotvornosti (ORR, CBR) na temelju ispitivačeve procjene
English: 126 (3 x 42) film-coated tablets (in PCTFE/PVC blisters)
Croatian: 126 (3 x 42) filmom obloženih tableta (u PCTFE/PVC blisterima)
English: • Abdominal (belly) pain
Croatian: • Bol u trbuhu (abdomenu)
English: Hepatic impairment
Croatian: Vrtoglavica često
English: If grade 2 recurs, resume Kisqali at next lower dose level.
Croatian: Ako se vrati stupanj 2, nastaviti s Kisqalijem u sljedećoj nižoj dozi.
English: If grade 3 recurs, resume Kisqali at the next lower dose level.
Croatian: Ako se vrati stupanj 3, nastaviti s Kisqalijem u sljedećoj nižoj dozi.
English: • Spinning sensation (vertigo)
Croatian: • Osjećaj vrtnje (vrtoglavica)
English: If grade 3 recurs, discontinue Kisqali.
Croatian: Ako se vrati stupanj 3, trajno prekinuti primjenu Kisqalija.
English: Treatment with Kisqali should be initiated only in patients with QTcF values less than 450 msec. ECG should be repeated at approximately day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated (see sections 4.2 and
Croatian: EKG je potrebno ponoviti otprilike 14. dana prvog ciklusa i na početku drugog ciklusa, a zatim prema kliničkoj indikaciji (vidjeti dijelove 4.2 i 4.8).
English: Table 2 Dose modification and management - Neutropenia
Croatian: Tablica 2 Prilagodba doze i zbrinjavanje
English: 21 film-coated tablets (in PCTFE/PVC blisters)
Croatian: 21 filmom obložena tableta (u PCTFE/PVC blisterima)
English: 63 (3 x 21) film-coated tablets (in PCTFE/PVC blisters)
Croatian: 63 (3 x 21) filmom obložene tablete (u PCTFE/PVC blisterima)
English: If co-administration of Kisqali with a strong CYP3A4 inhibitor cannot be avoided, the dose of Kisqali should be reduced as described in section 4.2.
Croatian: Ako se istodobna primjena Kisqalija sa snažnim CYP3A4 inhibitorom ne može izbjeći, dozu Kisqalija treba smanjiti kako je opisano u dijelu 4.2. Međutim, nema kliničkih podataka za ove prilagodbe doze.
English: 42 film-coated tablets (in PCTFE/PVC blisters)
Croatian: 42 filmom obložene tablete (u PCTFE/PVC blisterima)
English: 189 (3 x 63) film-coated tablets (in PA/alu/PVC blisters)
Croatian: 189 (3 x 63) filmom obloženih tableta (u PA/Al/PVC blisterima)
English: 63 film-coated tablets (in PCTFE/PVC blisters)
Croatian: 63 filmom obložene tablete (u PCTFE/PVC blisterima)
English: 126 (3 x 42) film-coated tablets (in PA/alu/PVC blisters)
Croatian: 126 (3 x 42) filmom obloženih tableta (u PA/Al/PVC blisterima)
English: • Some medicines used to treat heart rhythm problems or high blood pressure such as amiodarone, disopyramide, procainamide, quinidine, sotalol and verapamil.
Croatian: kao što su amiodaron, dizopiramid, prokainamid, kinidin, sotalol i verapamil.
English: Common (may affect up to 1 in 10 people).
Croatian: Često (mogu se javiti u do 1 na 10 osoba).
English: How much Kisqali to take
Croatian: Koliko Kisqalija uzimati
English: 21 film-coated tablets (in PA/alu/PVC blisters)
Croatian: 21 filmom obložena tableta (u PA/Al/PVC blisterima)
English: 63 (3 x 21) film-coated tablets (in PA/alu/PVC blisters)
Croatian: 63 (3 x 21) filmom obložene tablete (u PA/Al/PVC blisterima)
English: 42 film-coated tablets (in PA/alu/PVC blisters)
Croatian: 42 filmom obložene tablete (u PA/Al/PVC blisterima)
English: 63 film-coated tablets (in PA/alu/PVC blisters)
Croatian: 63 filmom obložene tablete (u PA/Al/PVC blisterima)
English: The primary endpoint for the study was met at the planned interim analysis conducted after observing 80% of targeted progression-free survival (PFS) events using Response Evaluation Criteria in Solid Tumours (RECIST v1.1), based on the investigator assessment in the full population (all randomised patients), and confirmed by a blinded independent central radiological assessment.
Croatian: Mjera primarnog ishoda za ispitivanje ostvarena je u planiranoj interim analizi provedenoj nakon opažanja 80% ciljanih događaja preživljenja bez progresije (engl. progression-free survival, PFS) koristeći Kriterije za ocjenjivanje tumora kod solidnih tumora (engl.
English: If QTcF ≥481 msec recurs, interrupt dose until QTcF resolves to
Croatian: 3. Ako se vrati QTcF ≥481 msek, prekinuti doziranje dok se QTcF ne oporavi na <481 msek i zatim nastaviti s Kisqalijem u sljedećoj nižoj dozi.
English: Liver function tests should be performed before initiating treatment with Kisqali.
Croatian: Prije početka liječenja Kisqalijem potrebno je obaviti testove jetrene funkcije.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea, cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Dispneja, kašalj vrlo često
English: Dose interruption until recovery to ≤ baseline grade, then resume Kisqali at same dose level.
Croatian: Početni stupanj <2: prekid doziranja do oporavka na ≤ početni stupanj, zatim nastaviti s Kisqalijem u istoj dozi.
English: • Dry mouth
Croatian: Primjena kroz usta
English: Uncommon (may affect up to 1 in 100 people).
Croatian: Manje često (mogu se javiti u više od 1 na 100 osoba).
English: If you have any questions about how Kisqali works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Croatian: Ako imate bilo kakvih pitanja o tome kako Kisqali djeluje ili zašto
English: • Sore throat (oropharyngeal pain)
Croatian: • Grlobolja (bol u usnoj šupljini i ždrijelu)
English: Hepatobiliary disorders Hepatotoxicity
Croatian: Poremećaji jetre i žuči Hepatotoksičnost često
English: 2/ End of 2016
Croatian: 2) Kraj 2016. godine
English: Within 1 week from CMDh adopted position
Croatian: Unutar 1 tjedna nakon usvajanja mišljenja CMDha
English: Within 24 months after protocol agreement
Croatian: Unutar 24 mjeseca nakon usuglašavanja protokola
English: The primary composite endpoint is 90-day mortality and 90-days renal failure.
Croatian: Primarna složena krajnja točka je 90-dnevni mortalitet i 90-dnevno oštećenje bubrega.
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela država članica ili referentnih država članica, ako se primjenjuje, osiguravaju da nositelji odobrenja ispune sljedeće uvjete:
English: The MAH(s) should submit the core elements (including protocol of DUS, protocol of the RCTs) of a risk management plan in EU format.
Croatian: Nositelji odobrenja trebaju dostaviti ključne elemente (uključujući protokol DUS-a, protokol RCT-ova) plana upravljanja rizicima u EU formatu.
English: The MAH(s) should perform two phase IV randomised clinical trials (RCTs) with an appropriate control and clinically meaningful endpoints to demonstrate the efficacy and safety in the perioperative setting and trauma.
Croatian: Nositelji odobrenja trebaju provesti dva randomizirana klinička ispitivanja faze IV (RCT-ove) uz primjenu odgovarajuće kontrole i klinički smislenih krajnjih točaka kako bi se prikazala djelotvornost i sigurnost u perioperativnom okruženju i traumi.
English: Study protocol by:
Croatian: Protokol ispitivanja sastavio:
English: The MAH(s) should conduct a drug utilisation study in several Member States to evaluate the effectiveness of the risk minimisation measures taken.
Croatian: Nositelja odobrenja trebaju provesti ispitivanje o primjeni lijeka u nekoliko država članica kako bi ocijenili djelotvornost poduzetih mjera smanjivanja rizika.
English: - Haemodynamic stabilisation in relation to dose (e.g. Heart rate, mean arterial pressure, central venous pressure, central venous oxygen saturation, serum lactate level, base excess and urine output) - length of stay, morbidity, coagulation, inflammation, hospital mortality - measurement of creatinine (GFR) 1/ The protocol of the studies should be submitted to the NCAs 2/ Final study reports by:
Croatian: Sekundarne krajnje točke su: - značajne perioperativne komplikacije (primjerice infekcije, krvarenja, insuficijencija anastomoze, stopa ponavljanja kirurškog zahvata, dijagnoza pulmonalnog endema), - hemodinamička stabilizacija u odnosu na dozu (primjerice frekvencija srca, srednji arterijski tlak, središnji venski tlak, središnje vensko zasićenje kisikom, razina laktata u serumu, bazni eksces i izlučena količina mokraće), - duljina ostanka, morbiditet, koagulacija, upala, bolnički mortalitet, - mjerenje kreatinina (GFR).
English: DHPC Communication circulation according to the PRAC agreed communication plan and conditions.
Croatian: Pisma liječnicima u skladu s komunikacijskim planom i uvjetima usuglašenim s PRAC-om.
English: They are available in Austria, Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Croatian: Dostupni su u Austriji, Belgiji, Bugarskoj, Češkoj, Njemačkoj, Grčkoj, Italiji, Latviji, Litvi, Luksemburgu, Mađarskoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji i na Malti.
English: The review of bacterial lysate medicines was initiated on 28 June 2018 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled lijekova bakterijskog lizata pokrenut je 28. lipnja 2018. na zahtjev Italije, u skladu s člankom 31. Direktive 2001/83/EZ.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 09 September 2019.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je 9. rujna 2019. donijela konačnu, pravno obvezujuću odluku primjenjivu u svim državama članicama EU-a.
English: They are sold under several brand names including Broncho Munal, Broncho Vaxom, Buccalin, Immubron, Immucytal, Ismigen, Lantigen B, Luivac, Ommunal, Paspat, Pir-05, Polyvaccinum, Provax, Respivax and Ribomunyl.
Croatian: Prodaju se pod nekoliko trgovačkih naziva kao što su Broncho Munal, Broncho Vaxom, Buccalin, Immubron, Immucytal, Ismigen, Lantigen B, Luivac, Ommunal, Paspat, Pir-05, Polyvaccinum, Provax, Respivax i Ribomunyl.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Croatian: Pregled je proveo Odbor za lijekove za humanu uporabu (CHMP), nadležan za pitanja o lijekovima za humanu uporabu, koji je usvojio mišljenje Agencije.
English: These medicines are taken by mouth (as capsules, tablets, granules/powder for making up an oral mixture or drops), dissolved under the tongue (as tablets), inhaled through the nose (as a liquid) or given by injection into a muscle or under the skin.
Croatian: Ti se lijekovi uzimaju na usta (kao kapsule, tablete, granule/prašak za oralnu mješavinu ili kapi), otapaju se pod jezikom (kao tablete), udišu se kroz nos (kao tekućina) ili se injiciraju u mišić ili pod kožu.