FrancophonIA/ELRC3.0 huggingface dataset:
English: EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex).
Croatian: EllaOne je hitna kontracepcija unutar 120 sati (pet dana) nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode (poput puknuća kondoma tijekom snošaja) za žene.
English: This study included women who took the medicine within two days of unprotected sex or contraceptive failure.
Croatian: Ovim su ispitivanjem obuhvaćene žene koje su uzele lijek unutar dva dana nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: What is ellaOne used for?
Croatian: Za što se ellaOne koristi?
English: What benefit has ellaOne shown during the studies?
Croatian: Koje su koristi lijeka ellaOne utvrđene u ispitivanjima?
English: How is ellaOne used?
Croatian: Kako se ellaOne koristi?
English: How does ellaOne work?
Croatian: Kako djeluje ellaOne?
English: How has ellaOne been studied?
Croatian: Kako je ellaOne ispitivan?
English: (% of recommended starting dose)
Croatian: (% preporučene početne doze)
English: The potential risk for humans is unknown.
Croatian: Mogući rizik za ljude je nepoznat.
English: You may feel tired and pale.
Croatian: Možda ćete se osjećati umorno i biti blijedi.
English: This “treatment cycle” will be repeated every 4 weeks.
Croatian: Taj će se „ciklus liječenja“ ponoviti svaka 4 tjedna.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: After reconstitution:
Croatian: Nakon rekonstitucije:
English: What is in this leaflet:
Croatian: Što se nalazi u ovoj uputi:
English: # at risk months months
Croatian: Broj pod rizikom mjeseci mjeseca
English: Time (months) from Randomization
Croatian: Vrijeme (mjeseci) od randomizacije
English: For single use only.
Croatian: Samo za jednokratnu uporabu.
English: There are also links to other websites about rare diseases and treatments.
Croatian: Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i njihovom liječenju.
English: The safety and efficacy of Vidaza in children aged 0-17 years have not yet been established.
Croatian: Sigurnost i djelotvornost Vidaze u djece u dobi od 0 do 17 godina nisu još ustanovljene.
English: • Vidaza is given every day for one week, followed by a rest period of 3 weeks.
Croatian: • Vidaza se primjenjuje svakoga dana tijekom jednog tjedna, nakon čega slijedi razdoblje stanke od 3 tjedna.
English: Investigations weight decreased * = rarely fatal cases have been reported
Croatian: Pretrage smanjenje težine *= rijetko su prijavljeni smrtni slučajevi
English: Date of latest renewal: 13 November 2013
Croatian: Datum posljednje obnove odobrenja: 13. studenog 2013.
English: From a microbiological point of view, the reconstituted product should be used immediately.
Croatian: S mikrobiološkog gledišta, rekonstituirani lijek treba odmah upotrijebiti.
English: Mannitol (E421)
Croatian: Manitol (E421)
English: They are also responsible for preparing and disposing of any unused Vidaza correctly.
Croatian: Također su odgovorni za pravilnu pripremu i zbrinjavanje neiskorištene Vidaze.
English: • Loss of appetite.
Croatian: • gubitak apetita
English: Total volume of reconstituted suspension required
Croatian: Ukupni volumen potrebne rekonstituirane suspenzije
English: You should not use Vidaza during pregnancy as it may be harmful to the baby.
Croatian: Ne smijete uzimati Vidazu tijekom trudnoće jer može biti štetna za dijete.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below (see “Reconstitution Procedure”).
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih ispod (vidjeti „Postupak rekonstitucije“).
English: Package leaflet: Information for the user
Croatian: Uputa o lijeku: Informacije za korisnika
English: Other medicines and Vidaza
Croatian: Drugi lijekovi i Vidaza
English: Following dose modifications, the cycle duration should return to 28 days.
Croatian: Nakon prilagodbi doza, trajanje ciklusa treba opet biti 28 dana.
English: Your doctor will check your progress and may change your dose if necessary.
Croatian: Vaš će liječnik provjeravati kako napreduje liječenje i ako bude potrebno, možda promijeniti dozu.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Tell your doctor straight away if you notice any of the following side effects:
Croatian: Odmah se obratite svojem liječniku ako primijetite bilo koju od sljedećih nuspojava:
English: The primary endpoint of the study was overall survival.
Croatian: Primarni ishod ispitivanja bilo je ukupno preživljenje.
English: Cardiopulmonary assessment before and during the treatment should be considered.
Croatian: Potrebno je razmotriti kardiopulmonalnu procjenu prije i tijekom liječenja.
English: • High or low blood pressure (hypertension or hypotension).
Croatian: • visok ili nizak krvni tlak (hipertenzija ili hipotenzija)
English: This is to check that you have enough blood cells and that your liver and kidneys are working properly.
Croatian: Time se provjerava imate li dovoljno krvnih stanica te funkcioniraju li Vaša jetra i bubrezi ispravno.
English: Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary.
Croatian: Na temelju rezultata ispitivanja na životinjama i mehanizma djelovanja, azacitidin se ne bi smio primjenjivati tijekom trudnoće, osobito tijekom prvog tromjesečja, osim ako je to prijeko potrebno.
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier 18.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: World Health Organisation (WHO) classification,
Croatian: Svjetske zdravstvene organizacije (SZO),
English: The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
Croatian: Prednosti liječenja treba usporediti s mogućim rizikom za fetus u svakom pojedinačnom slučaju.
English: • if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na azacitidin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: While there are limitations in the analysis, the available data suggest that patients do not experience meaningful deterioration in quality of life during treatment with Vidaza.
Croatian: Iako su u analizi postojala ograničenja, dostupni podaci pokazuju da bolesnici nemaju značajno pogoršanje kvalitete života tijekom liječenja Vidazom.
English: Patients with secondary MDS were excluded from the study.
Croatian: Bolesnici sa sekundarnim MDS-om bili su isključeni iz ispitivanja.
English: It must be taken into account that filters are present in some adaptors, spikes and closed systems; therefore such systems should not be used for administration of the medicinal product after reconstitution.
Croatian: Mora se uzeti u obzir da su filtri prisutni kod nekih nastavaka, šiljaka i zatvorenih sustava; stoga se takvi sustavi ne smiju upotrebljavati za primjenu lijeka nakon rekonstitucije.
English: Within the Intent to Treat population (ITT), the median age was 69 years (range 38 to 88 years).
Croatian: Intent to Treat, ITT) prosječna je dob bila 69 godina (raspon od 38 do 88 godina).
English: You will usually receive at least 6 treatment cycles.
Croatian: Uobičajeno je da primite najmanje 6 ciklusa liječenja.
English: It is therefore advised to exercise caution when prescribing azacitidine to these patients.
Croatian: Stoga se savjetuje oprez kad se azacitidin propisuje ovim bolesnicima.
English: Calculation of an individual dose The total dose, according to the body surface area (BSA) can be calculated as follows:
Croatian: Izračun pojedinačne doze Ukupna doza prema površini tijela (PT) računa se kako slijedi:
English: Treatment should be continued as long as the patient continues to benefit or until disease progression.
Croatian: Liječenje treba nastaviti sve dok bolesnik i dalje ima koristi ili do pojave znakova progresije bolesti.
English: Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred in 97 % of patients.
Croatian: Nuspojave za koje se smatra da su možda ili vjerojatno povezane s primjenom Vidaze pojavile su se kod 97 % bolesnika.
English: Doses greater than 4 mL should be injected into two separate sites.
Croatian: Doze veće od 4 mL treba ubrizgati na dva različita mjesta.
English: Non-proliferating cells are relatively insensitive to azacitidine.
Croatian: Neproliferativne stanice su relativno neosjetljive na azacitidin.
English: On analyses of age subgroups, an increase in median overall survival was observed for all groups (< 65 years, ≥ 65 years and ≥ 75 years).
Croatian: U analizi dobnih podskupina zabilježeno je povećanje medijana sveukupnog preživljenja kod svih skupina (< 65 godina, ≥ 65 godina i ≥ 75 godina).
English: • Tumour lysis syndrome - Metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
Croatian: • sindrom lize tumora - metaboličke komplikacije koje mogu nastati tijekom liječenja raka, a ponekad i bez liječenja.
English: Necrotising fasciitis
Croatian: Nekrotizirajući fasciitis
English: • if you have ever had a heart condition or heart attack or any history of lung disease.
Croatian: • ako ste u prošlosti imali srčanu bolest ili srčani udar ili bilo kakvu plućnu bolest.
English: Children and adolescents Vidaza is not recommended for use in children and adolescents below the age of 18.
Croatian: Ne preporučuje se primjena Vidaze u djece i adolescenata mlađih od 18 godina.
English: It is recommended that patients be treated for a minimum of 6 cycles.
Croatian: Preporučuje se bolesnike liječiti u najmanje 6 ciklusa.
English: The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m2.
Croatian: Sljedeća tablica služi samo kao primjer kako se računaju pojedinačne doze azacitidina prema prosječnoj vrijednosti PT-a od 1,8 m2.
English: Patients and physicians are also advised to be observant for signs and symptoms of bleeding.
Croatian: Bolesnicima i liječnicima također se savjetuje da obrate pozornost na znakove i simptome krvarenja.
English: The potential carcinogenicity of azacitidine was evaluated in mice and rats.
Croatian: Potencijalna kancerogenost azacitidina procijenjena je na miševima i štakorima.
English: The requirements for submission of periodic safety update reports for this medicinal are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Cumulatively, the safety database includes 51 cases with 56 events of pericarditis, myocarditis, and/or endocarditis reported with the use of Vidaza.
Croatian: Kumulativno, baza podataka o sigurnosti uključuje 51 slučaj s 56 događaja perikarditisa, miokarditisa i/ili endokarditisa prijavljenih uz primjenu lijeka Vidaza.
English: The product should be discarded if it contains large particles or agglomerates.
Croatian: Lijek treba baciti ako sadrži velike čestice ili nakupine.
English: These patients should be monitored closely and appropriate precautions taken.
Croatian: Te bolesnike treba pomno nadzirati i poduzimati odgovarajuće mjere opreza.
English: Urinary excretion is the primary route of elimination of azacitidine and/or its metabolites.
Croatian: Izlučivanje urinom glavni je put eliminacije azacitidina i/ili njegovih metabolita.
English: What Vidaza is and what it is used for What you need to know before you use Vidaza How to use Vidaza
Croatian: Što je Vidaza i za što se koristi Što morate znati prije nego počnete primjenjivati Vidazu Kako primjenjivati Vidazu
English: Your doctor, pharmacist or nurse are responsible for storing Vidaza.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra odgovorni su za čuvanje Vidaze.
English: No specific dose adjustments are recommended for the elderly.
Croatian: Ne preporučuju se posebne prilagodbe doza kod starijih osoba.
English: Myelosuppression may lead to neutropenia and an increased risk of infection.
Croatian: Mijelosupresija može dovesti do neutropenije i povećanog rizika od infekcije.
English: This may be due to an allergic (hypersensitivity) reaction.
Croatian: To može nastati zbog alergijske reakcije (preosjetljivost).
English: Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Croatian: Obratite se svom liječniku ako želite pohraniti sjeme prije početka liječenja.
English: Patients with severe hepatic organ impairment should be carefully monitored for adverse events.
Croatian: Bolesnike s teškim oštećenjem jetre treba pažljivo nadzirati zbog štetnih događaja.
English: Following intravenous administration, the mean volume of distribution was 76 ± 26 L, and systemic clearance was 147 ± 47 L/h.
Croatian: Nakon intravenske primjene srednji volumen distribucije bio je 76 ± 26 L, a sistemski klirens 147 ± 47 L/h.
English: White lyophilised powder.
Croatian: Bijeli liofilizirani prašak.
English: • Red or purple spots under your skin.
Croatian: • crvene ili ljubičaste mrlje ispod kože
English: Pharmacotherapeutic group: Antineoplastic agents, pyrimidine analogues; ATC code: L01BC07
Croatian: Farmakoterapijska skupina: antineoplastici, analozi pirimidina, ATK oznaka: L01BC07
English: Haematologic and cytogenetic responses were assessed by the investigator and by the IRC with similar results.
Croatian: Hematološke i citogenetske odgovore procijenili su ispitivač i IRC sa sličnim rezultatima.
English: • Weight loss.
Croatian: • gubitak na težini
English: For unopened vials of this medicine - there are no special storage conditions.
Croatian: Za neotvorene bočice ovog lijeka - nema posebnih uvjeta čuvanja.
English: • An infection of the blood caused by bacteria (sepsis).
Croatian: • infekcija krvi prouzročena bakterijama (sepsa).
English: Laboratory tests
Croatian: Laboratorijske pretrage
English: • The recommended dose is 75 mg per m2 body surface area.
Croatian: • Preporučena doza je 75 mg/m2 površine tijela.
English: • Having trouble sleeping (insomnia).
Croatian: • poteškoće sa spavanjem (nesanica)
English: • Skin infection (cellulitis).
Croatian: • infekcija kože (celulitis)
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: LIST OF EXCIPIENTS Also contains mannitol.
Croatian: POPIS POMOĆNIH TVARI Također sadrži manitol.
English: The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Croatian: Niže prikazani podaci odnose se na populaciju koju se namjeravalo liječiti u ispitivanju AZA-AML-001 (vidjeti dio 4.1 za odobrene indikacije).
English: The majority of adverse reactions occurred during the first 2 cycles and tended to decrease with subsequent cycles.
Croatian: Većina nuspojava pojavila se tijekom prva 2 ciklusa, s tendencijom smanjenja u sljedećim ciklusima.
English: This is because Vidaza may affect the way some other medicines work.
Croatian: To je potrebno zbog toga što Vidaza može utjecati na djelovanje drugih lijekova.
English: For doses requiring more than 1 vial, the dose should be equally divided e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe.
Croatian: Za doze koje zahtijevaju više od 1 bočice, dozu treba jednako podijeliti, npr. doza 150 mg = 6 mL, 2 štrcaljke s 3 mL u svakoj štrcaljki.
English: After reconstitution, the suspension should not be filtered.
Croatian: Nakon rekonstitucije suspenzija se nesmije filtrirati.
English: The effects of hepatic impairment (see section 4.2), gender, age, or race on the pharmacokinetics of azacitidine have not been formally studied.
Croatian: Učinci oštećenja jetre (vidjeti dio 4.2), spola, dobi ili rase na farmakokinetiku azacitidina nisu formalno ispitivani.
English: Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial.
Croatian: Zbog zadržavanja u bočici i igli, možda nije izvedivo izvlačenje cijele količine suspenzije iz bočice.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Patients should be monitored for haematologic response/toxicity and renal toxicities (see section 4.4); a delay in starting the next cycle or a dose reduction as described below may be necessary.
Croatian: Kod bolesnika treba pratiti hematološki odgovor/toksičnost i bubrežne toksičnosti (vidjeti dio 4.4); možda će biti nužna odgoda početka sljedećeg ciklusa ili smanjenje doze kao što je ispod opisano.
English: Vidaza treatment was also associated with a reduction in cytopenias, and their related symptoms.
Croatian: Liječenje Vidazom također je bilo povezano sa smanjenjem citopenija i s njima povezanih simptoma.
English: Vidaza is an anti-cancer agent which belongs to a group of medicines called ‘anti-metabolites'.
Croatian: Vidaza je lijek protiv raka i pripada skupini lijekova koji se zovu „antimetaboliti“.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mg
English: What you need to know before you use Vidaza
Croatian: Što morate znati prije nego počnete primjenjivati Vidazu
English: • A fall in blood pressure when standing (orthostatic hypotension) leading to dizziness when moving to a standing or sitting position.
Croatian: • pad krvnog tlaka tijekom stajanja (ortostatska hipotenzija) koji dovodi do omaglice kod ustajanja ili sjedanja
English: What Vidaza is and what it is used for
Croatian: Što je Vidaza i za što se koristi
English: Other side effects include:
Croatian: Ostale nuspojave uključuju:
English: Dose mg/m2
Croatian: Doza mg/m2
English: When IPSS cytogenetic subgroups were analysed, similar findings in terms of median overall survival were observed in all groups (good, intermediate, poor cytogenetics, including monosomy 7).
Croatian: Analizom citogenetičkih podskupina IPSS opaženi su slični rezultati medijana sveukupnog preživljenja u svim skupinama (dobra, srednja, loša citogenetika, uključujući monosomiju 7).
English: Also, some other medicines may affect the way Vidaza works.
Croatian: Isto tako, drugi lijekovi mogu utjecati na djelovanje Vidaze.
English: • Ulcers of your mouth or tongue.
Croatian: • ranice u ustima ili jeziku
English: Azacitidine is cleared rapidly from plasma with a mean elimination half-life (t½) after subcutaneous administration of 41 ± 8 minutes.
Croatian: Azacitidin se brzo uklanja iz plazme s prosječnim poluvremenom eliminacije (t½) nakon supkutane primjene od 41 ± 8 minuta.
English: Azacitidine has minor or moderate influence on the ability to drive and use machines.
Croatian: Azacitidin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Croatian: Budući da je u starijih bolesnika veća vjerojatnost smanjene bubrežne funkcije, korisno bi bilo nadzirati bubrežnu funkciju.
English: Vidaza should be reconstituted with water for injections.
Croatian: Vidazu treba rekonstituirati vodom za injekcije.
English: % Dose in the next cycle, if recovery* is not achieved within 14 days
Croatian: % doze u sljedećem ciklusu, ako oporavak* nije postignut unutar 14 dana
English: Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration studies (AZA PH GL 2003 CL 001 and AZA-AML-001) and therefore the safety and efficacy of azacitidine in these patients has not been established.
Croatian: Bolesnici s anamnezom teškoga kongestivnog zatajenja srca, klinički nestabilne bolesti srca ili bolesti pluća bili su isključeni iz pivotalnih registracijskih ispitivanja (AZA PH GL 2003 CL 001 i AZA-AML-001) pa stoga sigurnost i djelotvornost azacitidina u takvih bolesnika nije ustanovljena.
English: Do not filter the suspension after reconstitution since this could remove the active substance.
Croatian: Ne filtrirajte suspenziju nakon rekonstitucije jer to može ukloniti djelatnu tvar.
English: Such as blood in the stools due to bleeding in the stomach or gut, or such as bleeding inside your head.
Croatian: Kao što je krv u stolici zbog krvarenja u želucu ili crijevima ili krvarenje unutar glave.
English: However, exposure was within the same general range of exposures observed for subjects with normal renal function.
Croatian: Ipak, izloženost je bila unutar istog općeg raspona izloženosti kakav je opažen u ispitanika s normalnom funkcijom bubrega.
English: None of these adverse reactions led to discontinuation of azacitidine, or reduction of azacitidine dose in the pivotal studies.
Croatian: Nijedna od tih nuspojava nije dovela do prekida azacitidina, niti do smanjenja doza u pivotalnim ispitivanjima.
English: Once the suspension has been prepared it should be administered within 45 minutes.
Croatian: Kada je suspenzija pripremljena treba je primijeniti unutar 45 minuta.
English: Patients should be monitored for signs and symptoms of bleeding, particularly those with pre-existing or treatmentrelated thrombocytopenia.
Croatian: Bolesnike treba nadzirati zbog znakova i simptoma krvarenja, a osobito one s prethodno postojećom ili s liječenjem povezanom trombocitopenijom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/488/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/488/001
English: • Changes to your skin at the injection site.
Croatian: • promjene kože na mjestu primjene.
English: If reconstituted azacitidine comes into contact with the skin, immediately and thoroughly wash with soap and water.
Croatian: Ako rekonstituirani azacitidin dođe u dodir s kožom, treba je odmah dobro isprati sapunom i vodom.
English: New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Croatian: Nove injekcije treba primijeniti najmanje 2,5 cm od prethodnog mjesta i nikada na osjetljiva mjesta, mjesta s modricama, na crvena ili otvrdnuta područja.
English: KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval;
Croatian: KRATICE: AZA = azacitidin; CCR = režim konvencionalne skrbi; CI = interval pouzdanosti; HR = omjer hazarda
English: It is not known if this medicine passes into human milk.
Croatian: Nije poznato izlučuje li se ovaj lijek u majčino mlijeko u ljudi.
English: If large particles are present in the suspension it should be discarded.
Croatian: Ako su u suspenziji prisutne velike čestice, suspenziju treba baciti.