FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have ever had an infusion reaction after previously using BLINCYTO.
Croatian: • ako ste ikada imali reakciju povezanu s infuzijom nakon prethodne primjene lijeka BLINCYTO.
English: o Ensure that the tubing is compatible with the infusion pump.
Croatian: o Provjerite da je cjevčica kompatibilna s infuzijskom pumpom.
English: Although there is a potential for the development of progressive multifocal leukoencephalopathy (PML), no confirmed case of PML has been reported in the clinical studies.
Croatian: Iako postoji mogućnost za razvoj progresivne multifokalne leukoencefalopatije (PML), u kliničkim ispitivanjima nije prijavljen ni jedan potvrđen slučaj PML-a.
English: What BLINCYTO looks like and contents of the pack
Croatian: Kako BLINCYTO izgleda i sadržaj pakiranja
English: Your doctor will discuss with you how long your treatment will last.
Croatian: Vaš liječnik će s Vama raspraviti trajanje Vašeg liječenja.
English: Medicines given before each cycle of BLINCYTO
Croatian: Lijekovi koji se primjenjuju prije svakog ciklusa lijeka BLINCYTO
English: Your next cycles
Croatian: Vaši sljedeći ciklusi
English: The effects of BLINCYTO in pregnant women are not known but based on its mechanism of action, BLINCYTO may harm your unborn baby.
Croatian: Nisu poznati učinci lijeka BLINCYTO u trudnica, ali s obzirom na njegov mehanizam djelovanja, BLINCYTO može naškoditi Vašem nerođenom djetetu.
English: Your treatment may also be interrupted depending on how you tolerate BLINCYTO.
Croatian: Također, Vaše liječenje može biti privremeno prekinuto ovisno o tome kako podnosite BLINCYTO.
English: Any changes to the pump settings may result in a dose that is too high or too low.
Croatian: Svaka promjena postavki pumpe može dovesti do primjene previsoke ili preniske doze.
English: • low levels of antibodies called “immunoglobulins” which help the immune system fight infection (decreased immunoglobulins)
Croatian: • niska razina antitijela zvanih „imunoglobulini“, koja pomažu imunološkom sustavu u borbi protiv infekcija (sniženi imunoglobulini)
English: Like other protein therapeutics, blinatumomab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Croatian: Kao i za druge proteinske lijekove, očekuje se da će se blinatumomab razgraditi u male peptide i aminokiseline kroz kataboličke puteve.
English: Cytokine storm
Croatian: Citokinska oluja
English: If you become pregnant during BLINCYTO treatment, please inform your doctor or nurse.
Croatian: Ako zatrudnite tijekom liječenja lijekom BLINCYTO, molimo obavijestite svog liječnika ili medicinsku sestru.
English: Primary refractory
Croatian: Primarno refraktorni
English: • fever (pyrexia)
Croatian: • vrućicu (pireksija)
English: The median time to onset of a CRS event was 2 days.
Croatian: Medijan vremena do pojave događaja CRS-a bio je 2 dana.
English: However the influence is negligible in adults and body surface area based dosing is recommended in the paediatric population.
Croatian: Međutim, utjecaj je zanemariv u odraslih, a u pedijatrijskoj populaciji preporučuje se doziranje temeljeno na površini tijela.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Consistency in OS results was shown in subgroups by stratification factors.
Croatian: Dosljednost u rezultatima OS-a potvrđena je u podskupinama prema faktorima stratifikacije.
English: • high blood pressure (hypertension)
Croatian: • visoki krvni tlak (hipertenzija)
English: Your infusion catheter will be attached to you at all times during each cycle of your treatment.
Croatian: Vaš kateter za infuziju bit će Vam pričvršćen cijelo vrijeme tijekom svakog ciklusa liječenja.
English: Contact your doctor or nurse if you have questions.
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako imate pitanja.
English: Neutropenia and febrile neutropenia
Croatian: Neutropenija i febrilna neutropenija
English: If the interruption of treatment after an adverse event is no longer than 7 days, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle.
Croatian: Ako privremeni prekid liječenja nakon štetnog događaja ne traje dulje od 7 dana, nastavite isti ciklus do sveukupnog trajanja infuzije od 28 dana, uključujući i dane prije i dane nakon privremenog prekida u tom ciklusu.
English: Your doctor may decide to then increase your dose for weeks 2, 3, and 4 of your treatment.
Croatian: Vaš liječnik nakon toga može odlučiti povisiti Vašu dozu u 2., 3. i 4. tjednu Vašeg liječenja.
English: • infections in the blood including bacteria, fungi, viruses, or other types of infection
Croatian: • infekcije u krvi uključujući bakterijske, gljivične, virusne i druge vrste infekcija
English: The median time to the first event was within the first two weeks of treatment.
Croatian: Medijan vremena do prvog događaja bio je unutar prva dva tjedna liječenja.
English: Cycle 1
Croatian: 1. ciklus
English: Diluted solution (prepared infusion bag): If your infusion bag is changed at home: - Infusion bags containing BLINCYTO solution for infusion will arrive in special packaging containing cooling packs.
Croatian: Razrijeđena otopina (pripremljena infuzijska vrećica): Ako se Vaša infuzijska vrećica mijenja kod kuće: - infuzijske vrećice koje sadrže BLINCYTO otopinu za infuziju biti će dostavljene u posebnom pakiranju koje sadrži pakete za hlađenje.
English: Recommended dose (for patients at least 45 kg in weight):
Croatian: Preporučena doza (za bolesnike čija je tjelesna težina najmanje 45 kg):
English: This was a two-part study, a dose-finding part to determine the appropriate dosing regimen, followed by a single-arm efficacy part using this regimen.
Croatian: Ovo je bilo ispitivanje u dva dijela, s dijelom za određivanje doze kako bi se utvrdio prikladan režim doziranja, nakon kojega je slijedio dio koji je bio ispitivanje s jednom skupinom a utvrđivao je djelotvornost uz primjenu ovog režima.
English: Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α and IFN-γ were measured and, IL-6, IL-10 and IFN-γ were most elevated.
Croatian: Izmjereni su citokini, uključujući IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α i IFN-γ, od čega su najviše povišeni bili IL-6, IL-10 i IFN-γ.
English: Acute lymphoblastic leukaemia is a cancer of the blood in which a particular kind of white blood cell called “B-lymphocyte” is growing out of control.
Croatian: Akutna limfoblastična leukemija je rak krvi u kojem posebna vrsta bijelih krvnih stanica nazvana „B limfociti“ nekontrolirano raste.
English: The majority of neurologic events (80.5 %) were clinically reversible and resolved following interruption of BLINCYTO.
Croatian: Većina neuroloških događaja (80,5%) bili su klinički reverzibilni i povukli su se nakon privremenog prekida primjene lijeka BLINCYTO.
English: Patients should be closely monitored for signs or symptoms of TLS, including renal function and fluid balance in the first 48 hours after the first infusion.
Croatian: Bolesnike treba pomno pratiti radi znakova i simptoma TLS-a, uključujući funkciju bubrega i ravnotežu tekućina u prvih 48 sati nakon prve infuzije.
English: The increase in mean Css values was approximately proportional to the dose in the range tested.
Croatian: Povećanje srednjih vrijednosti Css-a bilo je približno proporcionalno dozi u testiranom rasponu doza.
English: 5.9 months
Croatian: 5,9 mjeseci
English: Prior alloHSCT ECOG status - n (%)
Croatian: Prethodni aloHSCT ECOG status - n (%)
English: Overdoses resulted in adverse reactions which were consistent with the reactions observed at the recommended therapeutic dose and included fever, tremors, and headache.
Croatian: Predoziranja su rezultirala nuspojavama koje su bile u skladu s reakcijama opaženima prilikom primjene preporučenih terapijskih doza, a uključivale su vrućicu, tremor i glavobolju.
English: Patients should be observed closely for infusion reactions, especially during the initiation of the first and second treatment cycles and treated appropriately.
Croatian: Bolesnike treba pomno pratiti radi reakcija povezanih s infuzijom, posebno tijekom započinjanja prvog i drugog ciklusa liječenja, te ih je potrebno odgovarajuće liječiti.
English: Days 29-42
Croatian: Dani 29-42
English: - The package will be opened by your nurse and the infusion bags will be stored in a refrigerator until infusion.
Croatian: - Pakiranje će otvoriti Vaša medicinska sestra i infuzijska vrećica će se spremiti u hladnjak do infuzije.
English: Therefore once the CSF is cleared, treatment with BLINCYTO may be initiated.
Croatian: Prema tome, jednom kada se CST očisti, može se započeti liječenje lijekom BLINCYTO.
English: The potential benefits of treatment should be carefully weighed against the risk of neurologic events and heightened caution should be exercised when administering BLINCYTO to these patients.
Croatian: Potencijalna korist liječenja treba se pažljivo procijeniti u odnosu na rizik od neuroloških događaja te je potreban pojačan oprez prilikom primjene lijeka BLINCYTO u ovih bolesnika.
English: Action for patients less than 45 kg
Croatian: Postupak za bolesnike tjelesne težine manje od 45 kg
English: • decreased levels of certain white blood cells with or without fever ((febrile) neutropenia,
Croatian: • smanjene razine određenih bijelih krvnih stanica s ili bez vrućice (febrilna) neutropenija,
English: • headache, shaking (or tremor)
Croatian: • glavobolja, tresavica (ili tremor)
English: Each pack of BLINCYTO contains:
Croatian: Svako pakiranje lijeka BLINCYTO sadrži:
English: 6.8 months [2.2 to 12.0 months]
Croatian: 6,8 mjeseci [2,2 do 12,0 mjeseci]
English: Leukoencephalopathy has been reported.
Croatian: Prijavljena je leukoencefalopatija.
English: Do not drive, use heavy machines, or engage in hazardous activities while you are being given BLINCYTO.
Croatian: Nemojte upravljati vozilima ili teškim strojevima ili obavljati rizične aktivnosti tijekom liječenja lijekom BLINCYTO.
English: AlloHSCT = allogeneic haematopoietic stem cell transplantation SOC = standard of care
Croatian: aloHSCT = alogena transplantacija hematopoetskih matičnih stanica SOC = standardno liječenje
English: If an interruption due to an adverse event is longer than 7 days, start a new cycle.
Croatian: Ako privremeni prekid liječenja zbog štetnoga događaja traje dulje od 7 dana, započnite novi ciklus.
English: The CR/CRh* for patients less than 2 years of age was 40% (4/10), for patients 2 to 6 years was 30.0% (6/20); and for patients aged 7 to 17 years was 25% (10/40).
Croatian: CR/CRh* za bolesnike mlađe od 2 godine bila je 40% (4/10), za bolesnike u dobi od 2 do 6 godina bila 30,0% (6/20), a za bolesnike u dobi od 7 do 17 godina bila je 25% (10/40).
English: Transient elevation of cytokines was observed in the first two days following start of blinatumomab infusion.
Croatian: Prolazno povišenje citokina opaženo je u prva dva dana nakon početka infuzije blinatumomaba.
English: Diluted solution (prepared infusion bag)
Croatian: Razrijeđena otopina (pripremljena infuzijska vrećica)
English: *, 1 patient had progressive disease (OS 2.3 months) and 2 were non-responders (OS 1.1 months and 8.7 months, respectively).
Croatian: *, 1 bolesnik imao je progresivnu bolest (sveukupno preživljenje 2,3 mjeseca), a 2 nisu odgovorila na lijek (sveukupno preživljenje 1,1 i 8,7 mjeseci).
English: The MAH shall ensure that in each Member State where BLINCYTO is marketed, all healthcare professionals (HCP) and patients / caregivers who are expected to prescribe, dispense and use BLINCYTO are provided with the following educational packages:
Croatian: Nositelj odobrenja će osigurati da, u svim zemljama u kojima je BLINCYTO u prometu, svi zdravstveni radnici i bolesnici/njegovatelji za koje se očekuje da propisuju, isporučuju i primjenjuju BLINCYTO, dobiju sljedeće edukacijske pakete:
English: - Once at room temperature (up to 27°C) the solution will be infused within 96 hours.
Croatian: - Jednom kada postigne sobnu temperaturu (do 27°C), otopina će se primijeniti infuzijom unutar 96 sati.
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog organskog sustava, nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: Specific reconstitution and dilution instructions are provided for each dose and infusion time.
Croatian: Specifične upute za rekonstituciju i razrjeđivanje dane su za svaku dozu i trajanje infuzije.
English: [4.2 to 7.5 months]
Croatian: [4,2 do 7,5 mjeseci]
English: Sepsis Pneumonia
Croatian: Sepsa Pneumonija
English: Confusion and disorientation, coordination and balance disorders, risk of seizures and disturbances in consciousness can occur (see section 4.4).
Croatian: Može doći do konfuzije i dezorijentacije, poremećaja koordinacije i ravnoteže te rizika od napadaja i poremećaja svijesti (vidjeti dio 4.4).
English: The number of treatment cycles and the dose which you will be given will depend on how you tolerate and respond to BLINCYTO.
Croatian: Broj ciklusa liječnja i doza koja će se u Vas primijeniti ovisit će o tome koliko dobro podnosite i odgovarate na BLINCYTO.
English: Your doctor may decide to then increase your dose to 28 micrograms per day for weeks 2, 3, and 4 of your treatment.
Croatian: Vaš liječnik nakon toga može odlučiti povisiti Vašu dozu do 28 mikrograma na dan u 2., 3. i 4. tjednu Vašeg liječenja.
English: • Data from clinical trials, frequency and severity (grade 3 and 4 neurological toxicities were observed)
Croatian: • Podaci iz kliničkih ispitivanja, učestalost i ozbiljnost (opažene su neurološke toksičnosti 3. i 4. stupnja).
English: Six of those patients had anti-blinatumomab antibodies with in vitro neutralising activity.
Croatian: Šest od tih bolesnika je imalo anti-blinatumomab antitijela s in vitro neutralizirajućom aktivnosti.
English: BLINCYTO powder (powder for concentrate): White to off-white powder.
Croatian: BLINCYTO prašak (prašak za koncentrat): Bijeli do gotovo bijeli prašak.
English: Among these patients, the median time to the first neurologic event was within the first cycle of treatment.
Croatian: Među ovim bolesnicima, medijan vremena do prvog neurološkog događaja bio je unutar prvog ciklusa liječenja.
English: Patients with prior allogeneic HSCT had similar response rates to those without prior HSCT, older patients had similar response rates to younger patients, and no substantial difference was observed in remission rates based on the number of lines of prior salvage treatment.
Croatian: Bolesnici s prethodnim alogenim HSCT-om imali su slične stope odgovora onim bolesnicima bez prethodnog HSCT-a, stariji bolesnici su imali slične stope odgovora mlađim bolesnicima te nije opažena značajna razlika u stopi remisije s obzirom na broj linija prethodnog spasonosnog liječenja.
English: MRD response rates by age and MRD level at baseline subgroups were consistent with the results in the overall population.
Croatian: Stope MRB odgovora po dobi i razini MRB-a u početnim podskupinama bile su u skladu s rezultatima u ukupnoj populaciji.
English: Your doctor may need to take special care of you during your treatment with BLINCYTO.
Croatian: Vaš liječnik će možda morati voditi posebnu brigu o Vama tijekom Vašeg liječenja lijekom BLINCYTO.
English: Subsequent cycles Days 1-7 Days 8-28 Days 29-42 Days 1-28 Days 29-42
Croatian: Sljedeći ciklusi Dani 1 - 7 Dani 8 - 28 Dani 29 - 42 Dani 1 - 28 Dani 29 - 42
English: Reconstituted BLINCYTO (number of packages)
Croatian: Rekonstituirana otopina BLINCYTO (broj pakiranja)
English: • Description of the main signs and / or symptoms of neurologic events and the importance of notifying the treating physician or nurse immediately if symptoms occur
Croatian: • Opis glavnih znakova i/ili simptoma neuroloških događaja i važnost da se liječnik ili medicinska sestra odmah obavijeste ako se simptomi pojave.
English: Non-interventional post-authorisation safety study (PASS): The applicant should submit the final results of a follow-up observational study to further characterise the long-term safety of BLINCYTO including developmental aspects, HSCT and secondary malignancy in high-risk paediatric patients enrolled in Study 20120215*.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): podnositelj zahtjeva treba dostaviti konačne rezultate naknadnog opservacijskog ispitivanja za daljnje određivanje značajki dugoročne sigurnosti lijeka BLINCYTO uključujući razvojne aspekte, HSCT i sekundarne maligne bolesti u visoko-rizičnih pedijatrijskih bolesnika uključenih u ispitivanje 20120215*.
English: Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof.
Croatian: Ispiranje prilikom promjene vrećica ili po dovršetku infuzije može rezultirati prekomjernom dozom uslijed čega može doći do komplikacija.
English: In the first cycle, the initial dose was 9 mcg/day for week 1, then 28 mcg/day for the remaining 3 weeks.
Croatian: U prvom ciklusu, početna doza je bila 9 µg/dan za 1. tjedan, zatim 28 µg/dan za preostala 3 tjedna.
English: f. Only patients with HSCT in CR/CRh* remission (with no anti-leukemia agents used prior to HSCT) are included.
Croatian: f. Uključeni su samo bolesnici s HSCT u CR/CRh* remisiji (bez uporabe antileukemijskih lijekova prije HSCT).
English: A censored subject is indicated by a Vertical Bar l.
Croatian: Cenzurirani ispitanici označeni su vertikalnom osi I.
English: If formation of anti-blinatumomab antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Croatian: Ako se sumnja na stvaranje anti-blinatumomab antitijela s klinički značajnim učinkom, kontaktirajte Nositelja odobrenja za stavljanje lijeka u promet za razgovor o testiranju na antitijela.
English: A single cycle of treatment is 28 days (4 weeks) of continuous infusion.
Croatian: Jedan ciklus liječenja čini 28 dana (4 tjedna) kontinuirane infuzije.
English: Neurological toxicity
Croatian: Neurološka toksičnost
English: The terms contributing to the relevant adverse reaction are indicated below:
Croatian: Pojmovi koji doprinose određenoj nuspojavi navedeni su niže:
English: In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the initial 48 hours of the first treatment cycle.
Croatian: U sljedećim ciklusima liječenja, do povišenja citokina došlo je u manje bolesnika i uz manji intenzitet, u usporedbi s početnih 48 sati prvog ciklusa liječenja.
English: However some patients reported delayed onset of infusion reactions or in later cycles.
Croatian: Međutim, u nekih je bolesnika pojava reakcija povezanih s infuzijom bila odgođena ili se dogodila u kasnijim ciklusima.
English: T-cell counts initially declined within 1 to 2 days and then returned to baseline levels within 7 to 14 days in the majority of patients.
Croatian: Broj T limfocita početno se smanjio unutar 1 do 2 dana, nakon čega se vratio do razine početne vrijednosti unutar 7 do 14 dana u većine bolesnika.
English: [4.8 to 8.3 months]
Croatian: [4,8 do 8,3 mjeseci]
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents, ATC code: L01XC19.
Croatian: Farmakoterapijska skupina: Antineoplastični lijekovi - drugi antineoplastični lijekovi ATK oznaka: L01XC19.
English: • Remarks on the importance of reporting ADRs
Croatian: • Napomene o važnosti prijavljivanja nuspojava.
English: n = number of patients who achieved CR or CRh* in the first two cycles of treatment in the specified subgroup.
Croatian: n = broj bolesnika koji su postigli CR ili CRh* u prva dva ciklusa liječenja u specificiranoj podskupini.
English: Women who are able to become pregnant have to use effective contraception during treatment and for at least 48 hours after your last treatment.
Croatian: Žene koje mogu zatrudniti moraju koristiti učinkovitu kontracepciju tijekom liječenja i najmanje 48 sati nakon posljednjeg liječenja.
English: There are no data from the use of blinatumomab in pregnant women.
Croatian: Nema podataka o primjeni blinatumomaba u trudnica.
English: Non-interventional post-authorisation safety study (PASS): Study 20150136: an observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices*
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): ispitivanje 20150136: opservacijsko ispitivanje sigurnosti i djelotvornosti blinatumomaba te njegove primjene i terapijske prakse*
English: • Store the package at room temperature (up to 27°C).
Croatian: • Čuvajte pakiranje na sobnoj temperaturi (do najviše 27°C).
English: • excessive activation of white blood cells associated with inflammation (hemophagocytic histiocytosis)
Croatian: • prekomjerna aktivacija bijelih krvnih stanica povezana s upalom (hemofagocitna histiocitoza)
English: This belongs to a group of medicines called antineoplastic agents which target cancer cells.
Croatian: On pripada skupini antineoplastičnih lijekova koji su usmjereni na stanice raka.
English: Following continuous intravenous infusion, the steady state serum concentration (Css) was achieved within a day and remained stable over time.
Croatian: Nakon kontinuirane intravenske infuzije, koncentracija u serumu postigla je stanje dinamičke ravnoteže (Css, od eng. steady state concentration) unutar jednog dana i ostala stabilna tijekom vremena.
English: Initiation of BLINCYTO treatment causes transient release of cytokines during the first days of treatment that may suppress CYP450 enzymes.
Croatian: Započinjanje liječenja lijekom BLINCYTO uzrokuje prolazno otpuštanje citokina tijekom prvih dana liječenja, što može suzbiti aktivnost CYP450 enzima.
English: • the infusion bag empties before the scheduled bag change
Croatian: • se infuzijska vrećica isprazni prije predviđene promjene vrećice
English: Reinitiation of BLINCYTO at the correct therapeutic dose should be considered when all toxicities have resolved and no earlier than 12 hours after interruption of the infusion (see section 4.2).
Croatian: Ponovna primjena lijeka BLINCYTO u ispravnoj terapijskoj dozi treba se razmotriti kad se povuku sve toksičnosti i ne ranije od 12 sati nakon privremenog prekida infuzije (vidjeti dio 4.2).
English: Among patients that experienced a neurologic event, the median time to the first event was within the first two weeks of treatment and the majority of events resolved after treatment interruption and infrequently led to BLINCYTO treatment discontinuation.
Croatian: Među bolesnicima kod kojih se pojavio neurološki događaj, medijan vremena do prvog događaja bio je unutar prva dva tjedna liječenja, a većina događaja se povukla nakon privremenog prekida liječenja i rijetko je dovela do trajnog prekida primjene lijeka BLINCYTO.
English: • if you have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
Croatian: • ako imate tešku i trajnu bol u trbuhu, sa ili bez mučnine i povraćanja, jer to mogu biti simptomi ozbiljnog stanja s mogućim smrtnim ishodom poznatog kao pankreatitis (upala gušterače).
English: The median overall survival (OS) was 17.7 months (CI 3.1 - not estimable).
Croatian: Medijan sveukupnog preživljenja (OS, od eng. overall survival) bio je 17,7 mjeseci (CI 3,1 - nije procjenjivo).
English: • Do not reconstitute BLINCYTO powder for concentrate with the solution
Croatian: • Nemojte rekonstituirati BLINCYTO prašak za koncentrat s otopinom
English: Your doctor will talk to you about precautions in using vaccinations for your baby.
Croatian: Vaš liječnik će s Vama razgovarati o mjerama opreza prilikom primjene cjepiva u Vašeg djeteta.
English: Based on its pharmacological properties, a risk to the suckling child cannot be excluded.
Croatian: S obzirom na njegova farmakološka svojstva, ne može se isključiti rizik za dojenče.