FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended BESPONSA dose was determined to be 1.8 mg/m2/cycle administered at a dose of 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi.
Croatian: 1,8 mg/m 2/ciklusu primijenjena u dozi od 0,8 mg/m 2 1. dana, te 0,5 mg/m 2 8. dana i 15. dana 28
English: Median OS; months [95% CI]
Croatian: ; mjeseci [95% CI]
English: (NCI CTCAE) version 3.0.
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE), verzija
English: c CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.
Croatian: CR je definiran kao < 5% blasta u koštanoj srži i odsutnost leukemijskih blasta u perifernoj krvi, puni oporavak broja krvnih stanica u perifernoj krvi (trombociti ≥ 100 x 10
English: a CR, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.
Croatian: Prema EAC-u se CR definira kao < 5% blasta u koštanoj srži i odsutnost leukemičnih blasta u perifernoj krvi, potpuno obnavljanje broja krvnih stanica u perifernoj krvi (trombociti ≥ 100 × 10
English: b CRi, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, partial recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
Croatian: Prema EAC-u se CRi definira kao < 5% blasta u koštanoj srži i odsutnost leukemičnih blasta u perifernoj krvi, djelomično obnavljanje broja krvnih stanica u perifernoj krvi (trombociti < 100 × 10
English: Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
Croatian: +), koje su prethodno neuspješno liječene barem jednim inhibitorom tirozin-kinaze (engl. tyrosine kinase inhibitor, TKI).
English: For patients with a high tumour burden, pre-medication to reduce uric acid levels and hydration is recommended prior to dosing (see section 4.4).
Croatian: Premedikacija u svrhu smanjenja razine mokraćne kiseline i hidratacija preporučuju se prije doziranja u bolesnika s velikim tumorskim opterećenjem (vidjeti dio 4.4).
English: Platelet count was ≥ 50 × 109/La
Croatian: 9/l i broj trombocita se vrati na ≥ 50 × 10
English: The active ingredient in BESPONSA is inotuzumab ozogamicin.
Croatian: Djelatna tvar lijeka BESPONSA je inotuzumab ozogamicin.
English: PC:
Croatian: c
English: SN:
Croatian: A.
English: May be harmful to the teeth.
Croatian: Može biti štetno za zube.
English: These will require specific and sometimes preventive treatment.
Croatian: To zahtjeva specifično i ponekad preventivno liječenje.
English: From birth* to 13 days old
Croatian: Od rođenja* do 13 dana starosti
English: These events have often been transitory.
Croatian: Navedeni događaji su često bili prolazni.
English: The follow-up time was up to 24 weeks of age.
Croatian: Razdoblje praćenja bilo je do 24 tjedna starosti.
English: It also increases CD4 cell counts.
Croatian: Također povećava broj CD4 stanica.
English: Do not change the dose on your own.
Croatian: Ne mijenjajte sami dozu.
English: Your doctor will therefore be monitoring the effectiveness of your treatment.
Croatian: Vaš će liječnik nadzirati učinkovitost Vašeg liječenja.
English: The absolute bioavailability is 86±18%.
Croatian: Apsolutna bioraspoloživost je 86±18%.
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih
English: Other medicines and Zerit
Croatian: Drugi lijekovi i Zerit
English: This rare, but very serious side effect occurs more often in women, particularly if very overweight.
Croatian: Ova rijetka, ali vrlo ozbiljna nuspojava javlja se češće u žena, naročito s prekomjernom težinom.
English: Zerit with food and drink
Croatian: Zerit s hranom i pićem
English: For this reason, it is important that you inform your doctor of any change in your health.
Croatian: Zbog toga je važno da obavijestite Vašeg liječnika o svim promjenama Vašeg zdravstvenog stanja.
English: a Number of patients evaluable.
Croatian: a broj evaluiranih bolesnika.
English: ≤ 25 ml/min (including dialysis dependence*)
Croatian: ≤ 25 ml/min (uključujući ovisnost o dijalizi *)
English: Do not worry if the solution remains slightly hazy after mixing with water; this is normal.
Croatian: Nemojte se brinuti ako otopina nakon miješanja s vodom ostane lagano magličasta; to je normalno.
English: Please follow these recommendations closely as they will give you the best chance to delay development of a resistance to the medicinal product.
Croatian: Molimo Vas da slijedite strogo ove preporuke jer one Vam omogućuju najveću šansu da odgodite razvoj rezistencije na ovaj lijek.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: Bolesnike bi trebalo uputiti da ako osjete ove simptome izbjegavaju potencijalno opasne zadatke kao što je vožnja ili upravljanje strojevima.
English: Date of last renewal: 20 April 2011
Croatian: Datum posljednje obnove odobrenja: 20 travnja 2011
English: If you are affected, do not drive and do not use any tools or machines.
Croatian: Ukoliko to primijetite, nemojte voziti niti rukovati alatom ili strojevima.
English: Similar effects have been observed with other nucleoside analogues.
Croatian: Slični učinci opaženi su i kod drugih analoga nukleozida.
English: Contact your doctor if you notice such changes.
Croatian: Obratite se svom liječniku ako primijetite takve promjene.
English: Instructions for preparation, see section 6.6.
Croatian: Za uputu o pripremi, vidjeti dio 6.6.
English: Continue to take this medicine until your doctor tells you otherwise.
Croatian: Nastavite uzimati lijek sve dok Vam Vaš liječnik ne kaže drugačije.
English: The mechanism and clinical significance of this difference are unknown.
Croatian: Mehanizam i klinička značajnost ove razlike nije poznat.
English: Stable for 30 days after reconstitution, when stored in a refrigerator.
Croatian: Stabilno 30 dana nakon pripreme za primjenu, kada se čuva u hladnjaku.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Tipično se takve reakcije pojavljuju tijekom prvih nekoliko tjedana ili mjeseci liječenja CART-om.
English: The AUC(inf) for stavudine was 61% of the AUC(inf) of the total circulating radioactivity.
Croatian: AUC(inf) stavudina iznosila je 61% AUC(inf) ukupne cirkulirajuće radioaktivnosti.
English: This should be taken into account in patients with diabetes mellitus.
Croatian: Ovo treba uzeti u obzir kod bolesnika sa šećernom bolesti.
English: Check with your doctor if you are not sure.
Croatian: Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.
English: Dosing recommendations are not available for neonates with a gestational age < 37 weeks.
Croatian: Preporuke za doziranje nisu dostupne za novorođenčad s gestacijskom dobi < 37 tjedana.
English: What Zerit looks like and content of the pack
Croatian: Kako Zerit izgleda i sadržaj pakiranja
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Vjeruje se da su ti simptomi posljedica poboljšanja tjelesnog imunološkog odgovora, koje omogućava tijelu da se bori protiv infekcija koje mogu biti prisutne bez jasnih simptoma.
English: These CD4 cells play an important role in maintaining a healthy immune system to help fight infection.
Croatian: Ove CD4 stanice imaju važnu ulogu u održanju zdravog imunološkog sustava kojim se organizam brani od infekcije.
English: Zidovudine is therefore not recommended to be used in combination with stavudine.
Croatian: Stoga se ne preporuča upotreba zidovudina u kombinaciji sa stavudinom.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Shake well before use.
Croatian: DRUGA POSEBNA UPOZORENJA AKO JE POTREBNO Dobro protresite prije uporabe.
English: If you accidentally miss a dose, then simply take your normal dose when the next one is due.
Croatian: Ako ste slučajno propustili dozu, onda jednostavno uzmite normalnu dozu kada je njeno vrijeme.
English: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL United Kingdom
Croatian: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL Ujedinjeno Kraljevstvo
English: Table 1: Efficacy Outcomes at Week 48 (Studies AI455-099 and AI455-096)
Croatian: Tablica 1: Rezultati djelotvornosti u 48. tjednu (ispitivanja AI455-099 i AI455-096)
English: It is not known whether stavudine is removed by peritoneal dialysis.
Croatian: Nije poznato da li se stavudin uklanja peritonealnom dijalizom.
English: Dublin 15, D15 T867
Croatian: D15 T867
English: Zerit should not be used during pregnancy unless clearly necessary.
Croatian: Zerit se ne treba davati tijekom trudnoće, osim ukoliko to nije nužno potrebno.
English: The patient should be instructed to shake the bottle well prior to measuring each dose.
Croatian: Bolesnika je potrebno uputiti da dobro protrese bocu prije odmjeravanja svake doze.
English: The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C).
Croatian: Pripremljena oralna otopina je stabilna 30 dana u hladnjaku (2°C -8°C).
English: Clinical experience in pregnant women is limited, but congenital anomalies and abortions have been reported.
Croatian: Kliničko iskustvo u trudnica je ograničeno, ali opisane su kongenitalne anomalije i pobačaji.
English: Patient weight 26-50 ml/min
Croatian: 26-50 ml/min
English: The bottle should be shaken well, until the powder dissolves completely.
Croatian: Boca se mora dobro protresti, sve dok se prašak u potpunosti ne otopi.
English: What Zerit contains
Croatian: Što Zerit sadrži
English: The requirements for submission of periodic safety update reports for this medicinal product 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 107c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
English: Lactose intolerance: the hard capsule contains lactose.
Croatian: Intolerancija na laktozu: tvrda kapsula sadrži laktozu.
English: These capsules contain lactose.
Croatian: Ove kapsule sadrže laktozu.
English: The mother-infant pairs were randomised to receive either stavudine (N= 91), didanosine (N= 94), stavudine + didanosine (N= 88) or zidovudine (N= 89).
Croatian: Parovi majka-dojenče randomizirani su prema primanju stavudina (n= 91), didanozina (n= 94), stavudina + didanozina (n= 88) ili zidovudina (n= 89).
English: Peripheral neuropathy: up to 20% of patients treated with Zerit will develop peripheral neuropathy, often starting after some months of treatment.
Croatian: Periferna neuropatija: do 20% bolesnika liječenih lijekom Zerit razvit će perifernu neuropatiju, koja često počinje nakon nekoliko mjeseci liječenja.
English: Therefore, mothers should be instructed to discontinue breast-feeding prior to receiving Zerit.
Croatian: Stoga, majke treba uputiti da prekinu dojenje prije nego počnu primati Zerit.
English: Stavudine may cause dizziness and/or somnolence.
Croatian: Stavudin može uzrokovati omaglicu i/ili somnolenciju.
English: The number of reports in older infants was too small to identify a pattern.
Croatian: Broj opisanih slučajeva u starije dojenčadi bio je premalen za identifikaciju sličnog uzorka.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGA POSEBNA UPOZORENJA AKO JE POTREBNO
English: Because stavudine is not protein-bound, it is not expected to affect the pharmacokinetics of protein-bound medicines.
Croatian: Budući da se stavudin ne veže na proteine, ne očekuje se njegov učinak na farmakokinetiku lijekova koji se vežu na proteine.
English: Patient weight
Croatian: Težina bolesnika
English: This condition usually does not occur until a few months after onset of treatment.
Croatian: Ovo stanje se obično ne pojavljuje sve dok ne prođe nekoliko mjeseci nakon početka liječenja.
English: Lactic acidosis generally occurred after a few or several months of treatment.
Croatian: Laktična acidoza se općenito javljala nakon nekoliko mjeseci liječenja.
English: The clinical relevance of these findings suggest that stavudine should be generally avoided in the presence of TAMs, especially M41L and T215Y.
Croatian: Klinička važnost ovog nalaza ukazuje na to da bi se stavudin općenito morao izbjegavati kad su prisutne TAM, osobito M41L i T215Y.
English: If you take more Zerit than you should
Croatian: Ako uzmete više lijeka Zerit nego što ste trebali
English: Experience in adults treated with up to 12 times the recommended daily dosage revealed no acute toxicity.
Croatian: Na temelju iskustva s odraslima, doze do 12 puta veće od preporuče dnevne doze nisu izazvale nikakvu akutnu toksičnost.
English: Patients treated with Zerit have reported the following side effects:
Croatian: Bolesnici liječeni lijekom Zerit prijavili su sljedeće nuspojave:
English: What Zerit is and what it is used for 2.
Croatian: Što je Zerit i za što se koristi 2.
English: At least 14 days old and < 30 kg ≥ 30 kg
Croatian: Najmanje 14 dana starosti i < 30 kg ≥ 30 kg
English: The possible benefits of a dose reduction should be balanced in each case against the risks - which may result from this measure (lower intracellular concentrations).
Croatian: Kod svakog slučaja zasebno treba uravnotežiti moguće dobrobiti smanjenja doze s mogućim rizicima - koji mogu proizaći iz ove mjere (niže intracelularne koncentracije).
English: If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger.
Croatian: Ako ste uzeli previše kapsula ili ako je netko slučajno progutao nekoliko, nema neposredne opasnosti.
English: If you stop taking Zerit The decision to stop using Zerit should be discussed with your doctor.
Croatian: Ako prestanete uzimati Zerit Odluka o prestanku uzimanja lijeka Zerit treba biti raspravljena s Vašim liječnikom.
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Croatian: Navedeni nalazi ne utječu na trenutno važeće nacionalne preporuke o upotrebi antiretrovirusne terapije u trudnica u smislu prevencije vertikalnog prenošenja HIV-a.
English: Although there are insufficient data to recommend a specific dosage adjustment of Zerit in this patient population, a reduction in the dose and/or an increase in the interval between doses proportional to the reduction for adults should be considered.
Croatian: Iako ne postoji dovoljno podataka za preporuku specifične doze lijeka Zerit u ovoj populaciji bolesnika, treba razmotriti smanjenje doze i/ili produženje razmaka među dozama razmjerno smanjenju u odraslih.
English: Infants under the age of 3 months: safety data are available from clinical trials up to 6 weeks of treatment in 179 newborns and infants < 3 months of age (see section 4.8).
Croatian: Dojenčad mlađa od 3 mjeseca: podaci o sigurnosti dostupni su iz kliničkih ispitivanja s trajanjem liječenja do 6 tjedana u 179 novorođenčadi i dojenčadi < 3 mjeseca (vidjeti dio 4.8).
English: Zerit may also be administered by carefully opening the hard capsule and mixing the contents with food.
Croatian: Zerit se također može uzimati tako da se tvrdu kapsulu pažljivo otvori i sadržaj kapsule pomiješa s hranom.
English: In addition, K65R has been reported in patients receiving stavudine/didanosine or stavudine/lamivudine, but not in patients receiving stavudine monotherapy.
Croatian: Osim toga, K65R je bila zabilježena u bolesnika koji su primali stavudin/didanozin ili stavudin/lamivudin, ali ne i u bolesnika koji su primali monoterapiju stavudinom.
English: The clinical significance of this is unknown.
Croatian: Klinički značaj navedenog nije poznat.
English: If you have taken Zerit during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste uzeli Zerit za vrijeme trudnoće, Vaš liječnik može zatražiti redovite pretrage krvi i druge dijagnostičke pretrage, kako bi pratio razvoj Vašeg djeteta.
English: The safety and efficacy of stavudine has not been established in patients with significant underlying liver disorders.
Croatian: Sigurnost i djelotvornost stavudina nije potvrđena u bolesnika s postojećim značajnim poremećajima jetre.
English: In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study.
Croatian: Ispitivanje AI455-094, koje je provedeno u Južnoafričkoj Republici, uključilo je 362 para majkadojenče u ispitivanje prevencije prijenosa s majke na dijete.
English: In study AI455-094 (see also section 4.6), the safety follow-up period was restricted to only six months, which may be insufficient to capture long-term data on neurological adverse events and mitochondrial toxicity.
Croatian: U ispitivanju AI455-094 (vidjeti dio 4.6) razdoblje sigurnosnog praćenja bilo je ograničeno na samo šest mjeseci, što može biti nedovoljno za uočavanje dugoročnih podataka o neurološkim nuspojavama i mitohondrijalnoj toksičnosti.
English: The frequency of adverse reactions listed below is defined using the following convention: 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).
Croatian: Učestalost nuspojava definira se prema slijedećem prikazu učestalosti nuspojava: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10000 i < 1/1000); vrlo rijetko (< 1/10000).
English: Hepatic impairment: no initial dosage adjustment is necessary.
Croatian: Oštećenje jetre: početnu dozu nije potrebno prilagođavati.
English: The combination of stavudine with didanosine is contraindicated given that both drugs exhibits high risk of mitochondrial toxicity (see sections 4.3 and 4.4).
Croatian: Kombinacija stavudina s didanozinom je kontraindicirana s obzirom da oba lijeka pokazuju visok rizik mitohondrijske toksičnosti (vidjeti dijelove 4.3 i 4.4.)
English: Until additional data become available, Zerit should be given during pregnancy only after special consideration; there is insufficient information to recommend Zerit for prevention of mother-to-child transmission of HIV.
Croatian: Sve dok nisu dostupni dodatni podaci, Zerit se u trudnoći smije davati samo u posebnim uvjetima; ne postoji dovoljno podataka koji bi dopuštali preporuku za Zerit u prevenciji prijenosa HIV-a s majke na dijete.
English: There have been no formal interaction studies with other medicinal products.
Croatian: Formalna ispitivanja interakcije s drugim lijekovima nisu provedena.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju istovremene primjene antivirusne terapije za hepatitis B ili C, moraju se uzeti u obzir odgovarajuće informacije o navedenim lijekovima.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Croatian: Ako primjetite bilo koji simptom infekcije, molimo Vas da odmah obavijestite Vašeg liječnika.
English: Store below 25°C (aclar/alu blisters).
Croatian: Čuvati na temperaturi ispod 25°C (aclar/Alu blisteri)
English: For infants who require a dose less than 10 ml, ask your pharmacist for a syringe to use to accurately measure the oral dose.
Croatian: Za djecu koja trebau dozu manju od 10 ml, upitajte ljekarnika za štrcaljku kako bi točno odmjerili oralnu dozu.
English: Then screw the cap on tightly and shake the bottle well until the powder dissolves completely, and take or dispense the solution with the measuring cup provided.
Croatian: . Zatim čvrsto zavrnite zatvarač i dobro promućkajte bocu dok se prašak ne otopi u potpunosti i uzmite ili podijelite otopinu s odmjernom čašicom.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: Dužina kombinirane antiretrovirusne terapije, upotreba kortikosteroida, konzumiranje alkohola, teška imunosupresija, povišeni indeks tjelesne mase, između ostalih, mogu biti neki od brojnih rizičnih čimbenika za razvoj te bolesti.
English: Patients with a high risk of pancreatitis or those receiving products known to be associated with pancreatitis should be closely followed for symptoms of this condition.
Croatian: Bolesnici s visokim rizikom razvoja pankreatitisa ili oni koji uzimaju lijekove za koje se zna da su povezani s razvojem pankreatitisa moraju se pažljivo pratiti radi otkrivanja simptoma ovog stanja.
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji mogu se pojaviti i više mjeseci nakon početka liječenja.
English: It occurs in ~1% of patients receiving stavudine.
Croatian: To se događa u ~1% bolesnika koji primaju stavudin.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Croatian: Osim oportunističkih infekcija, autoimuni poremećaji (stanja kada imunološki sustav napada zdrava tjelesna tkiva) se mogu i pojaviti i nakon početka uzimanja lijekova za Vašu HIV infekciju.
English: Zerit should be reconstituted with water to a 200 ml deliverable volume solution (stavudine concentration of 1 mg/ml).
Croatian: Zerit se treba rekonstituirati s vodom do volumena otopine koji se primjenjuje od 200 ml (koncentracija stavudina je 1 mg/ml).
English: This medicinal product, in combination with other antiretrovirals, reduces the HIV viral load and keeps it at a low level.
Croatian: Ovaj lijek u kombinaciji s drugim antiretroviroticima, smanjuje broj virusnih čestica HIV-a i održava ga na niskoj razini.
English: Blanchardstown Corporate Park 2
Croatian: Blanchardstown Corporate Park 2 Dublin 15
English: * Patients on haemodialysis should take Zerit after the completion of haemodialysis, and at the same time on non-dialysis days.
Croatian: * Bolesnici na hemodijalizi trebaju uzeti Zerit nakon završetka hemodijalize, u isto vrijeme kao i u dane kada se ne dijaliziraju.
English: The activity of stavudine is also affected by multi-drug resistance associated mutations such as Q151M.
Croatian: Na aktivnost stavudina također utječu mutacije povezane s rezistencijom na više lijekova, kao što je Q151M.
English: If you forget to take Zerit
Croatian: Ako ste zaboravili uzeti Zerit
English: Unchanged stavudine was the major drug-related component in total plasma radioactivity circulating after an oral 80 mg dose of 14C-stavudine in healthy subjects.
Croatian: Neizmijenjeni stavudin činio je glavnu komponentu ukupne plazmatske radioaktivnosti prisutne u krvotoku nakon oralne primjene 80 mg 14C-stavudina u zdravih ispitanika.
English: Most of these cases occurred in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome (see section 4.4).
Croatian: Većina ovih slučajeva pojavila se u okviru simptomatske hiperlaktatemije ili sindroma laktične acidoze (vidjeti dio 4.4).
English: However, you should contact your doctor or the nearest hospital for advice.
Croatian: Ipak, trebate potražiti savjet Vašeg liječnika ili se javite u najbližu bolnicu.