FrancophonIA/ELRC3.0 huggingface dataset:
English: In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in study M2-128.
Croatian: U dva šestomjesečna ispitivanja predbronhodilatacijski FEV1 značajno je povećan za 49 ml (primarni ishod, p<0,0001) povrh bronhodilatacijskog učinka istodobnog liječenja salmeterolom u ispitivanju M2-127, te za 80 ml (primarni ishod, p<0,0001) dodatno na istodobno liječenje tiotropijem u ispitivanju M2-128.
English: The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95%CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Croatian: Stopa (po bolesniku po godini) umjerenih egzacerbacija (koje zahtijevaju uvođenje sistemskih glukokortikoida) ili teških egzacerbacija (koje dovode do hospitalizacije i/ili smrti) bila je nakon godine dana 1,142 uz roflumilast i 1,374 uz placebo, što odgovara relativnom smanjenju rizika od 16,9% (95% CI: 8,2% do 24,8%) (primarni ishod p=0,0003).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following: - a medicine containing theophylline (a medicine to treat respiratory diseases), or - a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove, a naročito sljedeće: - lijekove koji sadrže teofilin (lijek za liječenje dišnih bolesti), ili - lijekove koji se koriste za liječenje imunoloških bolesti, poput metotreksata, azatioprina, infliksimaba, etanercepta ili oralnih kortikosteroida u dugotrajnoj terapiji, ili - lijekove koji sadrže fluvoksamin (lijek za liječenje tjeskobe i depresije), enoksacin (lijek za liječenje bakterijskih infekcija) ili cimetidin (lijek za liječenje ulkusa želuca i žgaravice).
English: How to store Libertek
Croatian: Kako čuvati Libertek
English: In study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
Croatian: U ispitivanju RO-2455-404-RD, inhibicijska aktivnost PDE4 određena na temelju ex vivo nevezane frakcije bila je, u usporedbi s cjelokupnom populacijom, 15% viša u bolesnika u dobi od ≥75 godina, te 11% viša u bolesnika s početnom tjelesnom težinom < 60 kg (vidjeti dio 4.4).
English: In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
Croatian: U kliničkim ispitivanjima kod bolesnika s KOPB-om, približno 16% bolesnika liječenih Libertekom imalo je nuspojave (u usporedbi s 5% na placebu).
English: Posology The recommended dose is 500 micrograms (one tablet) roflumilast once daily.
Croatian: Doziranje Preporučena doza je 500 mikrograma (jedna tableta) roflumilasta jedanput na dan.
English: 3 How to take Libertek
Croatian: Kako uzimati Libertek
English: Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Croatian: Primjena Liberteka kod bolesnika s kongestivnim zatajenjem srca (NYHA stupnjevi 3 i 4) nije ispitana te se liječenje takvih bolesnika ne preporučuje.
English: More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95%CI: 1.19 to 1.65).
Croatian: Od uzimanja ispitivanog lijeka je iz bilo kojeg razloga odustao veći udio bolesnika na roflumilastu (27,6%) nego na placebu (19,8%) (omjer rizika: 1,40; 95% CI: 1,19 do 1,65).
English: Caution is necessary in Child-Pugh A patients (see section 4.2).
Croatian: Kod bolesnika s Child-Pugh A potreban je oprez (vidjeti dio 4.2).
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Libertek (see section 4.3).
Croatian: Bolesnici s umjerenim i teškim oštećenjem jetre klasificiranim kao Child-Pugh B ili C ne smiju uzimati Libertek (vidjeti dio 4.3).
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g..multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertekshould not be initiated or should be stopped in these patients.
Croatian: Nedostatak iskustva kod bolesnika s HIV-infekcijom ili aktivnim hepatitisom, s teškim imunološkim bolestima (npr. multipla skleroza, eritemski lupus, multifokalna leukoencefalopatija) ili koji se liječe imunosupresivnom terapijom (osim kratkotrajne terapije sistemskim kortikosteroidima).Kod takvih bolesnika Libertekne treba uvoditi ili terapiju treba prekinuti.
English: Rescue medicinal products Libertek is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Croatian: Lijekovi za hitno ublažavanje simptoma Libertek nije indiciran kao lijek za hitno ublažavanje akutnog bronhospazma.
English: • Summary of Product Characteristics and Patient Information Leaflet for Libertek
Croatian: • Sažetak opisa svojstava lijeka i uputu o lijeku za Libertek
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95%CI: 7.5% to 33.1%).
Croatian: U podskupini bolesnika s anamnezom učestalih egzacerbacija (barem 2 egzacerbacije u posljednjih godinu dana) stopa egzacerbacija bila je 1,526 s roflumilastom i 1,941 s placebom, što odgovara relativnom smanjenju rizika od 21,3% (95% CI: 7,5% do 33,1%).
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Croatian: Zbog nedostatnog iskustva roflumilast ne treba uvesti, ili postojeću terapiju roflumilastom treba prekinuti, kod bolesnika s teškim imunološkim oboljenjima (npr. HIV-infekcijom, multiplom sklerozom, eritemskim lupusom, progresivnom multifokalnom encefalopatijom), teškim akutnim zaraznim bolestima, karcinomom (osim bazocelularnog karcinoma) ili bolesnika koji se liječe imunosupresivnim lijekovima (npr. metotreksatom, azatioprinom, infliksimabom, etanerceptom, ili dugotrajno uzimaju oralne kortikosteroide; ograničenje se ne odnosi na kratkotrajnu sustavnu primjenu kortikosteroida).
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Libertek.
Croatian: Ako dođe do pojave novih ili pogoršanja postojećih psihijatrijskih simptoma ili ako se prepoznaju suicidalne misli ili ponašanje, preporučuje se prekinuti liječenje Libertekom.
English: - The other ingredients are: - Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Croatian: - Ovojnica: hipromeloza, makrogol 4000, titanijev dioksid (E171), željezov oksid žuti (E172).
English: What Libertek looks like and contents of the pack Libertek 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Croatian: Libertek 500 mikrograma filmom obložene tablete su žute filmom obložene tablete u obliku slova D, s utisnutim “D” s jedne strane.
English: Paediatric population
Croatian: Pedijatrijski bolesnici
English: That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:
Croatian: Da se bolesniciili osobe koje o njima brinu morajuobratiti liječniku ako sekod bolesnikapojave simptomi koji ukazuju na:
English: Libertek is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Croatian: Libertek se ne preporučuje bolesnicima s prethodnom depresijom povezanom sa suicidalnim mislima ili ponašanjem.
English: Libertek is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Croatian: Libertek se ne preporučuje bolesnicima koji u povijesti bolesti imaju depresiju povezanu sa suicidalnim mislima ili ponašanjem.
English: Back pain
Croatian: Poissonova regresija
English: Vomiting Gastro-esophageal reflux disease Dyspepsia
Croatian: Poremećaji probavnog sustava gastritis povraćanje gastroezofagealna refluksna bolest dispepsija hematohezija konstipacija
English: Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in study M2-127 or tiotropium in study M2-128.
Croatian: odnosno salmeterolu u ispitivanju M2-127 ili tiotropiju u ispitivanju M2-128.
English: Libertek 500 micrograms tablets roflumilast
Croatian: Libertek 500 mikrograma tablete roflumilast
English: A total of 2,690 patients were included and randomized in two supportive 1-year studies (M2-111 and M2-112).
Croatian: U dva suportivna jednogodišnja ispitivanja (M2-111 i M2-112) uključeno je i randomizirano ukupno 2690 bolesnika.
English: AstraZeneca d.o.o.
Croatian: Ελλάδα AstraZeneca A.E.
English: (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Croatian: Uglavnom se radilo o gastrointestinalnoj nepodnošljivosti (npr. povraćanje, pojačano lučenje želučane kiseline, želučane erozije, upale crijeva) i srčanim nalazima (npr. fokalna krvarenja, odlaganje hemosiderina i infiltracije limfohistiocitnih stanica u desnom atriju pasa te smanjenje krvnog tlaka i porast frekvencije srca kod štakora, zamoraca i pasa).
English: Urticaria
Croatian: Umjerena
English: Angioedema
Croatian: Roflumilast
English: Libertek 500 micrograms film-coated tablets
Croatian: Libertek 500 mikrograma filmom obložene tablete
English: Libertek 500 micrograms film-coated tablets Roflumilast
Croatian: Libertek 500 mikrograma filmom obložene tablete roflumilast
English: Gastrointestinal disorders Diarrhoea
Croatian: Endokrini poremećaji ginekomastija
English: (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Croatian: Libertek se ne preporučuje ako imate jednu ili više sljedećih bolesti: - tešku imunološku bolest poput HIV-infekcije, multiple skleroze (MS), eritemskog lupusa (LE) ili progresivne multifokalne leukoencefalopatije (PML) - tešku akutnu infektivnu bolest poput tuberkuloze ili akutnog hepatitisa, - karcinom (osim bazocelularnog karcinoma, vrste sporo napredujućeg karcinoma kože) - ili teško oštećenje funkcije srca Ne postoje primjereni podaci o primjeni Liberteka u takvim okolnostima.
English: Batch
Croatian: Placebo
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost angioedem
English: AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
Croatian: AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
English: It is available as capsules (20 mg).
Croatian: Dostupan je u obliku kapsula (20 mg).
English: The recommended dose is one capsule once a day.
Croatian: Preporučena doza je jedna kapsula na dan.
English: The main measure of effectiveness was based on an assessment of the patients' nerve damage and quality of life after 18 months of treatment.
Croatian: Glavna mjera djelotvornosti temeljena je na procjeni oštećenja živaca bolesnika i kvalitete života nakon 18 mjeseci liječenja.
English: This summary was last updated in 06-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u lipnju 2016.
English: Vyndaqel has been authorised under ‘exceptional circumstances'.
Croatian: Vyndaqel je odobren u „iznimnim okolnostima”.
English: Treatment should be started and supervised by a doctor knowledgeable in the management of patients with this disease.
Croatian: Liječenje mora započeti i nadzirati liječnik koji je upoznat s liječenjem bolesnika s ovom bolešću.
English: The medicine presented no major safety concerns and the risks were considered to be manageable.
Croatian: Nisu ustanovljeni razlozi za ozbiljnu zabrinutost u pogledu sigurnosti lijeka i smatralo se da se rizicima može upravljati.
English: The material will include a leaflet containing information on the risks of the medicine including the risks to the unborn baby and on how to contribute to a post-marketing study and a surveillance programme for pregnant women.
Croatian: U materijalima će se nalaziti uputa s informacijama o rizicima povezanima s lijekom, uključujući rizike za nerođeno dijete, o tome kako pridonijeti ispitivanju nakon izdavanja odobrenja za stavljanje lijeka u promet i o programu nadzora za trudnice.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vyndaqel on 16 November 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vyndaqel na snazi u Europskoj uniji od 16. studenog 2011.
English: The results did not include patients with more severe disease who left the study early because they needed to undergo a liver transplant.
Croatian: Rezultati nisu obuhvaćali bolesnike u kojih je bolest bila ozbiljnija, odnosno koji su ranije napustili ispitivanje jer su morali biti podvrgnuti transplantaciji jetre.
English: This means that because transthyretin amyloidosis is rare, for scientific reasons, it has not been possible to obtain complete information about Vyndaqel.
Croatian: To znači da zbog rijetke učestalosti transtiretinske amiloidoze, a iz znanstvenih razloga, nije bilo moguće dobiti potpune informacije o lijeku Vyndaqel.
English: The full EPAR for Vyndaqel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Vyndaqel nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Vyndaqel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vyndaqel pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: Vyndaqel is used in adult patients with the early stage of nerve disease (stage 1).
Croatian: Lijek Vyndaqel upotrebljava se u odraslih bolesnika u ranoj fazi bolesti živaca (1. stadij).
English: What measures are being taken to ensure the safe and effective use of Vyndaqel?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vyndaqel?
English: This is a summary of the European public assessment report (EPAR) for Vyndaqel.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vyndaqel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vyndaqel have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici i bolesnici trebaju poštovati radi sigurne i učinkovite uporabe lijeka Vyndaqel također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vyndaqel.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Vyndaqel.
English: The most common side effects with Vyndaqel (seen in more than 1 patient in 10) are urinary tract infection (infection of the structures that carry urine), vaginal infection, upper abdominal pain (stomach ache) and diarrhoea.
Croatian: Najčešće nuspojave lijeka Vyndaqel (mogu se javiti u više od 1 na 10 bolesnika) jesu infekcija mokraćnog sustava (infekcija struktura koje prenose urin), vaginalna infekcija, bol u gornjem dijelu abdomena (bol u trbuhu) i proljev.
English: The company will also provide long-term post-marketing safety data.
Croatian: Proizvođač lijeka također će osigurati dugoročne podatke o sigurnosti primjene nakon izdavanja odobrenja za stavljanje lijeka u promet.
English: The company that makes Vyndaqel will carry out a study on the effects of the medicine in a subgroup of patients with certain genetic mutations.
Croatian: Tvrtka koja proizvodi lijek Vyndaqel provest će ispitivanje o učincima lijeka u podskupini bolesnika s određenim genskim mutacijama.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vyndaqel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Vyndaqel dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The company that markets Vyndaqel will provide educational material to all doctors expected to prescribe Vyndaqel.
Croatian: Tvrtka koja lijek Vyndaqel stavlja u promet osigurat će edukativne materijale za liječnike od kojih se očekuje da će prepisivati lijek Vyndaqel.
English: Vyndaqel is a medicine that contains the active substance tafamidis.
Croatian: Vyndaqel je lijek koji sadrži djelatnu tvar tafamidis.
English: In patients with transthyretin amyloidosis, a blood protein called transthyretin is defective and breaks easily.
Croatian: U bolesnika s transtiretinskom amiloidozom bjelančevina u krvi koja se zove transtiretin oštećena je i lako se raspada.
English: In 45% of patients taking Vyndaqel, nerve function either improved or stabilised, compared with 30% of patients taking placebo.
Croatian: Funkcija živaca poboljšala se ili stabilizirala u 45 % bolesnika koji su uzimali lijek Vyndaqel, u usporedbi s 30 % bolesnika koji su uzimali placebo.
English: Other information about Vyndaqel
Croatian: Ostale informacije o lijeku Vyndaqel
English: Why has Vyndaqel been approved?
Croatian: Zašto je Vyndaqel odobren?
English: The broken protein forms a fibrous substance called amyloid that is deposited in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Croatian: Raspadnuta bjelančevina stvara vlaknastu tvar naziva amiloid koja se taloži u tkivu i organima u tijelu, uključujući i oko živaca, i ometa njihove normalne funkcije.
English: The CHMP therefore concluded that the benefits of Vyndaqel are greater than its risks and recommended that it be granted marketing authorisation.
Croatian: CHMP je stoga odlučio da koristi od lijeka Vyndaqel nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Vyndaqel?
Croatian: Koji su rizici povezani s lijekom Vyndaqel?
English: It attaches to transthyretin, which prevents the protein from breaking up, thereby stopping the formation of amyloid and slowing down the progression of the nerve disease.
Croatian: Tafamidis se veže na transtiretin, što sprečava raspadanje bjelančevine i time zaustavlja stvaranje amiloida i usporava napredovanje bolesti živaca.
English: Vyndaqel is used to delay nerve damage caused by transthyretin amyloidosis, a hereditary disease in which fibres called amyloid build up in tissues around the body including around the nerves.
Croatian: Lijek Vyndaqel upotrebljava se za odgađanje oštećenja živaca koja su uzrokovana transtiretinskom amiloidozom, nasljednom bolešću pri kojoj se niti koje se zovu amiloid nakupljaju u tkivu u tijelu, uključujući i oko živaca.
English: Vyndaqel was more effective than placebo at treating patients with transthyretin amyloidosis.
Croatian: Lijek Vyndaqel pokazao se djelotvorniji od placeba u liječenju bolesnika s transtiretinskom amiloidozom.
English: The active substance in Vyndaqel, tafamidis, is a transthyretin stabilizer.
Croatian: Djelatna tvar lijeka Vyndaqel, tafamidis, stabilizator je transtiretina.
English: What information is still awaited for Vyndaqel?
Croatian: Koje se još informacije očekuju o lijeku Vyndaqel?
English: The CHMP noted that, apart from in patients who left the study because they needed a liver transplant, Vyndaqel was more effective than placebo in delaying nerve damage in patients with transthyretin amyloidosis.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) ocijenio je da je lijek Vyndaqel, uz iznimku bolesnika koji su napustili ispitivanje jer su morali biti podvrgnuti transplantaciji jetre, bio djelotvorniji od placeba u odgađanju oštećenja živaca u bolesnika s transtiretinskom amiloidozom.
English: Because the number of patients with transthyretin amyloidosis is low, the disease is considered ‘rare', and Vyndaqel was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 August
Croatian: Budući da je broj bolesnika s transtiretinskom amiloidozom nizak, bolest se smatra „rijetkom” te se od 28. kolovoza 2006.
English: What is Vyndaqel?
Croatian: Što je Vyndaqel?
English: Vyndaqel was compared with placebo (a dummy treatment) in 128 patients with transthyretin amyloidosis.
Croatian: Lijek Vyndaqel uspoređen je u 128 bolesnika s transtiretinskom amiloidozom s placebom (slijepo liječenje).
English: What is Vyndaqel used for?
Croatian: Za što se Vyndaqel koristi?
English: For the full list of all side effects and restrictions with Vyndaqel, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Vyndaqel potražite u uputi o lijeku.
English: What benefit has Vyndaqel shown during the studies?
Croatian: Koje su koristi lijeka Vyndaqel utvrđene u ispitivanjima?
English: How has Vyndaqel been studied?
Croatian: Kako je Vyndaqel ispitivan?
English: How does Vyndaqel work?
Croatian: Kako djeluje Vyndaqel?
English: How is Vyndaqel used?
Croatian: Kako se Vyndaqel koristi?
English: EU/1/09/537/001 Mozobil
Croatian: EU/1/09/537/001
English: 24 mg / 1.2 ml
Croatian: Bočica (staklo) 24 mg/1,2 ml
English: 20 mg/ml Solution for injection
Croatian: 20 mg/ml
English: 2 As lower confidence limit (p = 0.95)
Croatian: 2 kao donja granica pouzdanosti (p = 0,95)
English: 1 Infectious Units
Croatian: 1 infektivnih jedinica
English: _*_One 2-ml dose contains: rotavirus serotype* G1
Croatian: _*_Jedna doza (2 ml) sadrži: rotavirus serotipa* G1
English: not less than 2.3 x 106 IU1, 2 * human-bovine rotavirus reassortants (live), produced in Vero cells.
Croatian: ne manje od 2,0 x 106 IU1, 2 rotavirus serotipa* P1A[8] ne manje od 2,3 x 106 IU1, 2 * reasortanti humano-bovinih rotavirusa (živi), proizvedeni na Vero stanicama.
English: Packaging
Croatian: Farmaceutski oblik
English: Oral use sachet (LDPE/Alu/LDPE/paper)
Croatian: Peroralna primjena vrećica (LDPE/alu/LDPE/papir)
English: Immediate Packaging Content
Croatian: Put primjene Unutarnje pakiranje Sadržaj