natgillin/translations-raw huggingface dataset:
Therefore, in view of available data regarding nephrotic syndrome adverse reactions and skin lesions reported in children, the PRAC considered that changes to the product information were warranted.”
Stoga, s obzirom na dostupne podatke o nuspojavi nefrotskog sindroma i lezijama kože u djece, Povjerenstvo za ocjenu rizika na području farmakovigilancije smatra da su izmjene informacija o proizvodu opravdane.“
Therefore, in view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
Stoga, s obzirom na dostupne podatke o orlistatu, PRAC smatra da su izmjene informacija o lijeku opravdane.
Therefore, in view of available data regarding overdose the PRAC considered that changes to the product information were warranted.
Stoga, s obzirom na raspoložive podatke u vezi s predoziranjem, PRAC je zaključio da je potrebno izmijeniti informacije o lijeku.
Therefore, in view of available data regarding pallor and over-whitening, the PRAC considered that changes to the product information are warranted.
Stoga, u pogledu dostupnih podataka vezanih za bljedilo i prekomjerno blijeđenje, PRAC smatra da su izmjene informacija o lijeku, opravdane.
Therefore, in view of available data regarding rash and cases of incorrect route of administration, the PRAC considered that changes to the product information were warranted.
Stoga, u pogledu dostupnih podataka u vezi osipa i slučajeva nepravilnog puta primjene, PRAC je smatrao da su izmjene informacija o lijeku opravdane.
Therefore, in view of available data regarding regadenoson, the PRAC considered that changes to the product information were warranted.
Prema tome, s obzirom na raspoložive podatke vezane uz regadenoson, PRAC smatra da su izmjene informacija o lijeku bile opravdane.
Therefore, in view of available data regarding temozolomide, the PRAC considered that changes to the product information were warranted.
Stoga, na temelju dostupnih podataka za temozolomid, PRAC smatra promjene u informacijama o lijeku opravdanima.
Therefore, in view of available data regarding teriflunomide, the PRAC considered that changes to the product information were warranted.
Stoga je, s obzirom na dostupne podatke o teriflunomidu, PRAC smatrao da su izmjene informacija o lijeku opravdane.
Therefore, in view of available data regarding vildagliptin and vildagliptin/metformin, the PRAC considered that changes to the product information were warranted.
Stoga, na temelju dostupnih podataka vezanih za vildagliptin i vildagliptin/metformin, PRAC smatra da su izmjene u informacijama o lijeku opravdane.
Therefore, in view of available data regarding, the PRAC considered that changes to the product information were warranted.
Stoga, sukladno dostupnim podacima, PRAC drži da su promjene o informacijama o lijeku opravdane.
Therefore, in view of available data the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Stoga uzimajući u obzir dostupne podatke, PRAC smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.
Stoga, s obzirom na dostupne podatke o vrućici u djece, PRAC smatra da su izmjene informacija o lijeku opravdane.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal product(s) containing sofosbuvir were warranted.
Stoga, u pogledu podataka prikazanih u pregledanim PSUR-evima, PRAC smatra da su izmjene informacija o lijeku za lijek(ove) koji sadrži(e) sofosbuvir bile opravdane.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing bimatoprost were warranted.
Stoga je, s obzirom na podatke prikazane u ocijenjenim PSUR-evima, PRAC smatrao da su izmjene informacija o lijekovima koji sadrže bimatoprost neophodne.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing irbesartan are warranted.
Stoga je, s obzirom na podatke prikazane u pregledanim PSUR(-evima), PRAC smatrao da su izmjene informacija o lijeku za lijekove koji sadrže irbesartan opravdane.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing paclitaxel albumin were warranted.
Stoga, u pogledu podataka prikazanih u pregledanim PSUR-eevima, PRAC smatra da su izmjene informacija o lijek u za lijekove koji sadrže paklitaksel albumin opravdane.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing zoledronic acid (indicated for cancer and fractures) were warranted.
Stoga, s obzirom na podatke prikazane u pregledanim PSUR-evima, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže zoledronatnu kiselinu (indiciranu za rak i prijelome) opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the PI of medicinal products containing ibandronic acid were warranted.
Stoga je, s obzirom na podatke prikazane u ocijenjenom PSUR-u, PRAC smatrao da su izmjene informacija o lijekovima koje sadrže ibandronatnu kiselinu opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information and conditions of the marketing authorisation of medicinal products containing vismodegib were warranted.
Stoga, s obzirom na podatke navedene u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku i uvjeta odobrenja za stavljanje lijeka u promet za lijekove koji sadrže vizmodegib bile opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal product containing eribulin were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže eribulin opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže aklidinijev bromid, opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide/formoterol fumarate dihydrate were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene u informacijama o lijeku za lijekove koji sadrže aklidinijev bromid/formoterolfumarat dihidrat, opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide/formoterol fumarate dihydrate were warranted.
Stoga, u pogledu podatka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene u informacijama o lijeku za lijekove koji sadrže aklidinijev bromid/formoterolfumarat dihidrat, opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aflibercept were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže aflibercept opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing alemtuzumab were warranted.
Stoga je, s obzirom na podatke predstavljene u pregledanom PSUR-u, PRAC smatrao da su izmjene informacija o lijekovima koji sadrže alemtuzumab opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing bimatoprost/timolol were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže bimatoprost/timolol opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing clofarabine were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže klofarabin opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing deferasirox were warranted.
Stoga, u pogledu podatka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže deferasiroks opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing florbetaben were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene u informacijama o lijeku za lijekove koji sadrže florbetaben opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing influenza vaccine (surface antigen, inactivated, prepared in cell cultures) were warranted.
Stoga, na temelju podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su promjene u informacijama o lijeku za lijekove koji sadrže cjepivo protiv influence (površinski antigen, inaktivirano, pripremljeno iz staničnih kultura) opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing ingenol mebutate were warranted.
Stoga, uzimajući u obzir podatke navedene u pregledanom PSUR-u, PRAC smatra da su promjene informacija o lijeku za lijekove koji sadrže ingenol mebutat (ingenoli mebutas) opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing liraglutide were warranted
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene u informacijama o lijeku za lijekove koji sadrže liraglutid opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing lomitapide were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže lomitapid opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing mirabegron were warranted.
Stoga, obzirom na podatke prikazane u dostavljenom PSUR-u, PRAC smatra da su promjene informacija o lijekovima koji sadrže mirabegron, opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing omalizumab were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže omalizumab opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing para-aminosalicylic acid were warranted.
Stoga, u pogledu podatka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže paraaminosalicilatnu kiselinu opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing tegafur, gimeracil and oteracil (as monopotassium) were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže tegafur, gimeracil i oteracil (u obliku kalijeve soli) opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing thalidomide were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže talidomid opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing trametinib were warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže trametinib opravdane.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considers that changes to the product information of medicinal products containing umeclidinium bromide /vilanterol are warranted.
Stoga, u pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene u informacijama o lijeku za lijekove koji sadrže umeklidinijev bromid/ vilanterol opravdane.
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing aripiprazole were warranted.
Stoga je, s obzirom na prikazane podatke u pregledanim PSUR-ovima, PRAC smatrao da su promjene informacijama o lijeku za lijekove koji sadrže aripiprazol opravdane.
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing pregabalin were warranted.
Stoga, u pogledu prikazanih podataka u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže pregabalin opravdane.
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing sevelamer hydrochloride and carbonate were warranted.
Stoga, u pogledu podataka prikazanih u pregledanim PSUR(-evima), PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže sevelamerklorid i sevelamerkarbonat opravdane.
Therefore, INCIVO must not be co-administered with rifampicin.
Stoga se INCIVO ne smije primjenjivati istodobno s rifampicinom.
Therefore, information on pulmonary hypertension is included in sections 4.4 and 4.8 of the thalidomide product information.
Stoga su informacije o plućnoj hipertenziji uključene u dijelove 4.4 i 4.8 informacija o lijeku za talidomid.
Therefore, information regarding drug- drug interactions with other antiretroviral products (including protease inhibitors and non-nucleoside reverse transcriptase inhibitors) is not provided (see section 4.4).
Stoga, nisu navedene informacije o interakcijama lijekova s drugim antiretrovirusnim lijekovima (kao ni s inhibitorima proteaze i nukleozidnim inhibitorima reverzne transkriptaze) (vidjeti dio 4.4).
Therefore, information regarding drug-drug interactions with other antiretroviral products (including PIs and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) is not provided (see section 4.4).
Stoga nisu navedene informacije o interakcijama lijeka s drugim antiretrovirusnim lijekovima (uključujući IP i nenukleozidne inhibitore reverzne transkriptaze [NNRTI]) (vidjeti dio 4.4).
Therefore, inhibitors of these isoenzymes reduce vardenafil clearance.
Stoga inhibitori ovih izoenzima mogu smanjiti klirens vardenafila.
Therefore, interactions between melatonin and other active substances as a consequence of melatonin’s effect on CYP1A enzymes are not likely to be significant.
Stoga vjerojatno neće biti značajnih interakcija između melatonina i drugih djelatnih tvari zbog učinka melatonina na enzime CYP1A.
Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicinal products are unlikely.
Zato interakcije koje uključuju metabolizam putem CYP istodobno primijenjenih lijekova nisu vjerojatne.
Therefore, interactions resulting from displacement of highly protein- bound drugs are unlikely.
Zbog toga, interakcije nastale istiskivanjem lijekova koji su u velikoj mjeri vezani na proteine nisu vjerojatne.
Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely.
Zbog toga, interakcije nastale istiskivanjem lijekova, koji su u velikoj mjeri vezani na proteine, nisu vjerojatne.
Therefore, ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Stoga ISENTRESS treba primjenjivati uz oprez u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 5.2).
Therefore, ISENTRESS should be used with caution in this population.
Stoga ISENTRESS u ovoj populaciji treba primjenjivati uz oprez.
Therefore, it is considered appropriate to give a lower total dose of follitropin alfa than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation (see section 5.1).
Stoga se smatra prikladnim davati manje ukupne doze folitropina alfa od doza općenito primjenjivanih za urinarni FSH, ne samo radi optimiziranja razvoja folikula, nego također radi umanjivanja rizika od neželjene hiperstimulacije jajnika (vidjeti dio 5.1).
Therefore, it is important that you follow the advice given in section 3.
Stoga je važno da se pridržavate uputa navedenih u dijelu 3.
Therefore, it is important that your child continues taking Aptivus correctly, as described above.
Stoga je važno nastaviti s ispravnom primjenom Aptivusa, kako je prethodno opisano.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of oritavancin (see section 4.8).
Stoga je ovu dijagnozu nužno uzeti u obzir u bolesnika koji se javljaju zbog proljeva neposredno nakon primjene oritavancina (vidjeti dio 4.8.).
Therefore, it is not expected to potentiate bradykinin- mediated adverse effects.
Stoga se ne očekuje potenciranje nuspojava posredovanih bradikininom.
Therefore, it is recommended that children and adolescent patients receiving PegIntron/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
Zato se preporučuje obustaviti liječenje u djece i adolescenata koji primaju kombinaciju PegIntron/ribavirin ako im HCV-RNK u 12. tjednu padne za < 2 log10 u odnosu na vrijednost prije liječenja ili ako imaju mjerljivu HCV-RNK u 24. tjednu liječenja.
Therefore, it is recommended that if nitisinone treatment with Orfadin hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Stoga se preporučuje da se, ako se liječenje nitizinonom (Orfadin tvrdim kapsulama) započne s hranom, takav režim liječenja održava rutinski, vidjeti dio 4.2.
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Stoga se prije početka liječenja ribavirinom preporučuje ocijeniti funkciju bubrega u svih bolesnika.
Therefore, it is recommended that the MA is subjected to an additional renewal.
Stoga se preporuča da odobrenje za stavljanje u promet bude podvrgnuto još jednom dodatnom produženju.
Therefore, it is recommended that the platelet count be determined at least once a week in these patients.
U ovih se bolesnika stoga preporučuje kontrola broja trombocita najmanje jednom tjedno.
Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment.
Stoga se preporučuje izmjeriti broj trombocita prije započinjanja liječenja enoksaparin-natrijem i potom redovito kontrolirati tijekom liječenja.
Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment.
Stoga se preporučuje izmjeriti broj trombocita prije započinjanja liječenja enoksaparinnatrijem i potom redovito kontrolirati tijekom liječenja.
Therefore, it is recommended that the tablets should be taken after an overnight fast (at least 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Stoga se uzimanje tableta preporučuje natašte, nakon noćnog gladovanja (barem 6 sati), a hrana se ne smije uzimati najmanje još sljedećih 30 minuta nakon uzimanja doze (vidjeti dio 4.2).
Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Stoga se uzimanje tableta preporučuje natašte, nakon noćnog gladovanja (barem 6 sati), a hrana se ne smije uzimati još barem 30 minuta nakon uzimanja doze (vidjeti dio 4.2).
Therefore, it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.
Stoga se savjetuje da, dok uzimate Zebinix, koristite druge oblike sigurne i učinkovite kontracepcije sve do kraja tekućeg menstrualnog ciklusa nakon prekida liječenja.
Therefore, it is recommended to assess the actual water intake during a 4-hour time period the day before vaccination.
Stoga, preporuča se da ocijenite stvarni unos vode tijekom razdoblja od 4 sata na dan prije cijepljenja.
Therefore, it is recommended to clean and disinfect bird houses where the vaccine was applied after completion of the finishing or rearing period.
Iz tog razloga, preporuča se čišćenje i dezinfekcija peradnjaka u kojima je primijenjena vakcina nakon završetka uzgojnog ili proizvodnog ciklusa (pilići) ili 7 dana (pure).
Therefore, it is recommended to clean and disinfect bird houses where the vaccine was applied after completion of the finishing or rearing period.
Iz tog razloga, preporuča se čišćenje i dezinfekcija peradnjaka, u kojima je primijenjena vakcina, nakon završetka uzgojnog ili proizvodnog ciklusa.
Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Stoga se preporučuje pažljivo nadzirati sve bolesnike zbog moguće pojave inhibitora nakon prelaska na drugi lijek.
Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Stoga se preporučuje pažljivo nadzirati sve bolesnike zbog moguće pojave inhibitora nakon prelaska s jednoga lijeka na drugi.
Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Stoga se preporučuje pomno pratiti sve bolesnike na pojavu inhibitora nakon bilo koje promjene lijeka.
Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Stoga se preporučuje pozorno pratiti sve bolesnike na pojavu inhibitora nakon svakog prijelaza s jednog lijeka na drugi.
Therefore, it is recommended to monitor patients carefully for inhibitor occurrence following any product switch.
Stoga se preporučuju kontrole bolesnika radi uočavanja pojave inhibitora nakon zamjene lijeka.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings.
Stoga, ponekad je potrebno kombinirati primjenu Advocate Spot-on s tretiranjem okoliša usmjerenim na prekidanje razvojnog ciklusa buha u okolišu.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings.
Stoga, ponekad je potrebno kombinirati primjenu Advocate-a s tretiranjem okoliša usmjerenim na prekidanje razvojnog ciklusa buha u okolišu.