natgillin/translations-raw huggingface dataset:
No pattern of persistent decrease in platelet counts, as observed in non-human primates (see section 5.3), has been reported in humans (patients above 6 years of age), even though isolated cases of idiopathic thrombocytopenia, including severe cases, have been reported in the post-marketing setting.
Nije zabilježen obrazac trajnog sniženja broja trombocita u ljudi (bolesnici stariji od 6 godina) kao što je to opaženo u nečovjekolikih primata (vidjeti dio 5.3), iako su u post- marketinškim uvjetima zabilježeni izolirani slučajevi idiopatske trombocitopenije, uključujući teške slučajeve.
No pharmacodynamic interactions have been observed.
Nisu opažene farmakodinamičke interakcije.
No pharmacokinetc studies have been conducted with Teysuno in paediatric patients.
Nisu provedene farmakokinetičke studije sa lijekom Teysuno u pedijatrijskoj populaciji.
No pharmacokinetic data are available for paediatric patients following hepatic transplants.
Za djecu s presađenom jetrom nisu dostupni farmakokinetički podaci.
No pharmacokinetic data are available in children or adolescents.
Nema farmakokinetičkih podataka za djecu ili adolescente.
No pharmacokinetic data are available in paediatric patients.
Ne postoje farmakokinetički podaci za pedijatrijsku populaciju.
No pharmacokinetic data are available in paediatric patients.
Nema dostupnih farmakokinetičkih podataka u pedijatrijskih bolesnika.
No pharmacokinetic data are available in patients with haemophilia A younger than 12 years.
Nisu dostupni farmakokinetički podaci u bolesnika mlađih od 12 godina s hemofilijom A.
No pharmacokinetic data are available in the paediatric population.
Nisu dostupni farmakokinetički podaci u pedijatrijskoj populaciji.
No pharmacokinetic data are available in the paediatric population.
Nisu dostupni farmakokinetički podaci za pedijatrijsku populaciju.
No pharmacokinetic data are currently available in patients over 65 years of age.
Farmakokinetički podaci u bolesnika starijih od 65 godina trenutno nisu dostupni.
No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Nema dostupnih farmakokinetičkih podataka za zoledronatnu kiselinu u bolesnika s hiperkalcemijom ili bolesnika s teškom insuficijencijom jetre.
No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Nema dostupnih farmakokinetičkih podataka za zoledronatnu kiselinu u bolesnika s hiperkalcijemijom ili bolesnika sa insuficijencijom jetre.
No pharmacokinetic data in elderly patients are available.
Nema dostupnih podataka o farmakokinetici u starijih bolesnika.
No pharmacokinetic differences based on ethnic group were observed.
Nisu opažene razlike u farmakokinetici s obzirom na etničko podrijetlo.
No pharmacokinetic differences were observed between Japanese and Caucasian healthy volunteers.
Nisu opažene razlike u farmakokinetici između zdravih dobrovoljaca japanskog podrijetla i bijele rase.
No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study.
U kliničkom ispitivanju nisu utvrđene farmakokinetičke interakcije levofloksacina s teofilinom.
No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and Levemir when administering a single dose of Levemir 0.5 U/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Nisu opažene farmakokinetičke niti farmakodinamičke interakcije između liraglutida i lijeka Levemir nakon primjene jednokratne doze lijeka Levemir od 0,5 U/kg i 1,8 mg liraglutida u stanju dinamičke ravnoteže u bolesnika sa šećernom bolešću tipa 2.
No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or renal function on the pharmacokinetic profile of Coagadex.
Farmakokinetička ispitivanja nisu provedena, ali ne predviđa se učinak spola ili bubrežne funkcije na farmakokinetički profil lijeka Coagadex.
No pharmacokinetic studies in renally impaired patients have been conducted.
U bolesnika s oštećenjem funkcije bubrega nisu provedena farmakokinetička ispitivanja.
No pharmacokinetic studies were performed with IMBRUVICA in patients under 18 years of age.
U bolesnika mlađih od 18 godina nisu provedena farmakokinetička ispitivanja s lijekom IMBRUVICA.
No phase 2 conjugates of either compound have been identified in vivo.
edan od tih spojeva nisu in vivo identificirani konjugati faze 2.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Benlysta with other agents.
Nisu provedene studije o fizičkoj ili biokemijskoj kompatibilnosti u svrhu procjene istovremene primjene lijeka Benlysta s drugim lijekovima.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of ORENCIA with other agents.
Nisu provedena ispitivanja fizikalne ili biokemijske kompatibilnosti istodobne primjene lijeka ORENCIA s drugim lijekovima.
No polymorphic or non-polymorphic sequence variations outside of the A antigenic site on the RSV F protein were shown to render RSV resistant to neutralisation by palivizumab.
Varijacije na polimorfnim ili nepolimorfnim sekvencama izvan antigenskog mjesta A na proteinu RSV F nisu izazivale rezistenciju RSV-a na neutralizaciju palivizumabom.
No post-marketing surveillance data are available following Adjupanrix administration.
Nema podataka iz postmarketinškog praćenja nakon primjene cjepiva Adjupanrix.
No post-marketing surveillance data are available following AFLUNOV administration.
Nema dostupnih podataka o praćenju nakon stavljanja gotovog lijeka u promet nakon primjene cjepiva AFLUNOV.
No post-marketing surveillance data are available following Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics administration.
Nema dostupnih podataka o postmarketinškom praćenju Prepandemijskog cjepiva protiv influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano) Novartis Vaccines and Diagnostics.
No pre-clinical studies have been performed with Aerinaze.
Nisu provedena pretklinička ispitivanja s lijekom Aerinaze.
No preceding hormonal contraceptive use (in the past month)
Bez prethodne primjene hormonskih kontraceptiva (tijekom prethodnog mjeseca)
No preclinical safety testing with the vaccine has been conducted.
Nije provedeno pretkliničko ispitivanje sigurnosti ovog cjepiva.
No prenatal and postnatal reproductive studies have been conducted in animals.
Nisu provedena prenatalna i postnatalna ispitivanja reprodukcije na životinjama.
No primary endpoint
Bez primarnog ishoda
No primary IN mutation1
Bez primarne mutacije integraze1
No prior immunomodulatory exposure
Bez prethodnog izlaganja imunomodulatorima
No proarrhythmic effects were observed in 3,162 patients treated with Ranexa based on 7-day Holter monitoring in the MERLIN-TIMI 36 study.
Tijekom 7-dnevnog praćenja Holterom 3162 bolesnika liječenih Ranexom u istraživanju MERLIN- TIMI 36 nisu uočeni proaritmijski učinci.
No psychiatric comorbidities
Bez popratnih psihijatrijskih bolesti
No pulmonary embolism was reported for patients with pNET who received sunitinib in the phase 3 study.
U bolesnika s pNET-om koji su u ispitivanju faze III primali sunitinib nije zabilježena plućna embolija.
No rebound was observed.
Nije opisan niti jedan slučaj pogoršanja.
No recommendation on posology can be made for children under 12.
Ne mogu se dati preporuke za doziranje u djece mlađe od 12 godina.
No recommendation regarding
Ne može se dati preporuka za
No recommendations on posology can be made in this population.
Ne mogu se dati preporuke za doziranje u ovoj populaciji.
No relevant effect of gender was identified.
Značajan utjecaj spola nije ustanovljen.
No relevant effects were seen on the QTc interval, with doses of dolutegravir exceeding the clinical dose by approximately 3 fold.
Nisu primijećeni značajni učinci na QTc interval pri primjeni doza dolutegravira približno trostruko većih od kliničkih doza.
No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).
Nisu zamijećene bitne promjene farmakokinetičkih parametara kod bolesnika s teškim oštećenjem bubrega (n=8, pojedinačna doza od 25 mg), ali je oprez potreban kod bolesnika s teškim ili umjerenim oštećenjem bubrega s obzirom na to da su dostupni samo ograničeni klinički podaci za takve bolesnike (vidjeti dio 4.2).
No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Nisu provedene reproduktivne studije s koriogonadotropinom alfa na životinjama (vidjeti dio 5.3).
No reproductive and developmental toxicity studies have been performed with ONIVYDE.
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti s lijekom ONIVYDE.
No reproductive toxicity studies in animals were performed, and it is not known if Lymphoseek can cause foetal harm when administered to a pregnant woman.
Nisu provedena ispitivanja o reproduktivnoj toksičnosti na životinjama, te nije poznato može li Lymphoseek uzrokovati oštećenje fetusa prilikom primjene u trudnica.
No response
Bez odgovora
No response at No Negative treatment sustained predictive week response value
Bez odgovora u navedenom Bez Negativna tjednu trajnog prediktivna liječenja odgovora vrijednost
No safety concerns were raised in either treatment group.
Sigurnost primjene lijeka nije bila sporna ni u jednoj ispitivanoj skupini.
No safety data are available to demonstrate the impact of vaccination on lactation.
Ne postoje dostupni podaci o neškodljivosti koji bi pokazali utjecaj cijepljenja na laktaciju.
No safety or efficacy data are available from clinical trials regarding administration of RotaTeq to immunocompromised infants, infants infected with HIV or infants who have received a blood transfusion or immunoglobulins within 42 days of dosing.
Nema raspoloživih podataka iz kliničkih ispitivanja o sigurnosti i djelotvornosti primjene RotaTeq cjepiva u imunokompromitirane dojenčadi, dojenčadi zaražene HIV-om ili dojenčadi koja je primila krv ili imunoglobuline transfuzijom unutar 42 dana prije primjene cjepiva .
No safety signals have been identified in this group.
Sigurnosni signali nisu utvrđeni u ovoj skupini.
No second or higher degree AV Block was seen in these studies.
U tim ispitivanjima nije zabilježena pojava AV-bloka drugog ili višeg stupnja.
No second or higher degree AV Block was seen in. these studies.
U tim ispitivanjima nije zabilježena pojava AV-bloka drugog ili višeg stupnja.
No second or higher degree AV Block was seen in.these studies.
U tim ispitivanjima nije zabilježena pojava AV-bloka drugog ili višeg stupnja.
No serious adverse reactions related to Amyvid administration have been reported.
Nije prijavljena nijedna ozbiljna nuspojava povezana s primjenom lijeka Amyvid.
No serious adverse reactions related to DaTSCAN administration have been reported.
Nisu prijavljene ozbiljne nuspojave povezane s primjenom DaTSCAN-a.
No serious bacterial infections were reported during the efficacy period in subjects receiving Hizentra during clinical studies.
Nisu uočene ozbiljne bakterijske infekcije u pacijenata liječenih Hizentrom tijekom kliničkih ispitivanja.
No serious cardiovascular events were reported in patients who received Plegridy in the ADVANCE study.
Nije bilo prijavljenih ozbiljnih kardiovaskularnih događaja u bolesnika koji su primali Plegridy u ADVANCE studiji.
No serious ophthalmic or systemic adverse reactions related to OPATANOL were reported in clinical studies.
Tijekom kliničkih istraživanja nisu prijavljene ozbiljne oftalmičke ili sustavne nuspojave povezane s uzimanjem OPATANOLA.
No significant changes in rufinamide concentration are observed following co-administration with lamotrigine, topiramate or benzodiazepines.
Ne opažaju se značajne promjene koncentracije rufinamida nakon istovremene primjene lamotrigina, topiramata ili benzodiazepina.
No significant changes in the pharmacokinetics of sunitinib or the primary active metabolite are observed with repeated daily administration or with repeated cycles in the dosing schedules tested.
Nisu zabilježene značajne promjene u farmakokinetici sunitiniba i primarnog aktivnog metabolita tijekom opetovne svakodnevne primjene niti tijekom opetovanih ciklusa u okviru ispitivanih režima doziranja.
No significant difference in mean serum creatinine change (%) occurred between ADENURIC and allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 respectively; least square means difference: 4.0970 [95% confidence interval: -0.6467 ; 8.8406]; p=0.0903).
Nije bilo značajne razlike u promjeni srednje vrijednosti serumskog kreatinina (%) između ADENURICA i alopurinola (-0,83 ± 26,98 odnosno -4,92 ± 16,70); razlika srednjih vrijednosti procijenjena metodom najmanjih kvadrata: 4,0970 [95%-tni interval pouzdanosti: -0,6467
No significant difference in OS was observed between the two treatment arms at the final OS analysis performed after 76% (280/369) of the events had occurred (HR 0.87, 95% CI 0.67, 1.12 p=0.256).
Nije zabilježena značajna razlika u OS između dva kraka ispitivanja u završnoj analizi ukupnog preživljenja izvedenoj nakon što je zabilježeno 76% (280/389) događaja (HR 0,87; 95% CI 0,67;1,12 p=0,256).
No significant difference was observed in the pharmacokinetics of obinutuzumab among patients < 65 years (n=375), patients between 65-75 years (n=265) and patients
Nije primijećena značajna razlika u farmakokinetici obinutuzumaba između bolesnika < 65 godina (n = 375), bolesnika u dobi između 65 i 75 godina (n = 265) i bolesnika
No significant differences in safety and efficacy of Perjeta were observed between elderly patients aged 65 to 75 years and adult patients aged < 65 years.
Nisu primijećene značajne razlike u sigurnosti i djelotvornosti lijeka Perjeta između starijih bolesnika u dobi od 65 do 75 godina i odraslih bolesnika mlađih od 65 godina.
No significant differences in the incidence of adverse reactions were observed for oncology patients by disease, age, or gender.
U onkoloških bolesnika nisu zabilježene značajne razlike u incidenciji nuspojava s obzirom na bolest, dob ili spol.
No significant effect of a single intravenous dose of tigecycline 50 mg or 200 mg on QTc interval was detected in a randomized, placebo- and active-controlled four-arm crossover thorough QTc study of 46 healthy subjects.
U randomiziranom, placebom i aktivnim lijekom kontroliranom, temeljitom ispitivanju QTc-intervala, s četiri skupine ispitanika i križnom zamjenom skupina, provedenom u 46 zdravih ispitanika, jednokratna intravenska doza tigeciklina od 50 mg ili 200 mg nije imala značajni učinak na QTc- interval.
No significant effect on
Nije opažen značajan učinak na
No significant effect on
Nije primijećen značajan učinak
No significant effect on atazanavir
Nisu opaženi značajni učinci na
No significant effect on atazanavir concentrations was observed.
Nije opažen značajni učinak na koncentraciju atazanavira.
No significant effect on didanosine and etravirine PK parameters is seen.
Nije opažen značajni učinak
No significant effect on rifabutin and Viramune mean PK parameters is
Bez značajnog učinka na rifabutin i srednje vrijednosti PK parametara Viramunea.
No significant effects on the number of corpora lutea, implants, or live fetuses were observed.
Nije zabilježen značajan utjecaj na broj žutih tijela, broj implantacija ili živih fetusa.
No significant effects on the number of corpora lutea, implants, or live fetuses were observed.
Nije zabilježen značajan utjecaj na broj žutih tijela, broj implantacija niti broj živih fetusa.
No significant effects on the number of corpora lutea, implants, or live fetuses were observed.
Nisu uočeni značajni učinci na broj žutih tijela, implantacija ili živih fetusa.
No significant impact of age (range: 28 years - 87 years) on the pharmacokinetics of afatinib could be observed.
Nije bio primijećen značajan utjecaj dobi (raspon: 28 - 87 godina) na farmakokinetiku afatiniba.
No significant interactions were shown when oral sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Nisu opažene značajne interakcije kada je sildenafil (50 mg) primijenjen peroralno istovremeno s tolbutamidom (250 mg) ili varfarinom (40 mg), koji se oba metaboliziraju pomoću CYP2C9.
No significant nausea
Bez značajne mučnine
No significant nausea (maximum VAS < 25 mm on a scale of 0-100 mm)
Izostanak značajne mučnine (<25 mm na vizualnoj analognoj ljestvici 0-100 mm)
No significant pharmacokinetic alteration has been observed in these patients (see section 5.2).
Nisu opažene nikakve značajne farmakokinetičke promjene u ovih pacijenata (vidjeti dio 5.2).
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended dose.
U mladih svinja nisu opaženi znakovi nepodnošenja pri dozama do 10 puta većim od preporučene.
No signs of intolerance have been observed in pigs at up to 100 mg tylvalosin per kg bodyweight per day for 5 days.
Nisu opaženi znakovi nepodnošenja u pilića uz dozu tilvalozina do 100 mg po kilogramu tjelesne mase na dan tijekom 5 dana.
No signs of medicinal product-related local irritation or incompatibility were noted in dogs after intravenous, intra-arterial and paravenous injection when cetrorelix was administered in doses clearly above the intended clinical use in man.
U pasa nisu primijećeni znakovi lokalne iritacije ili inkompatibilnosti povezane s lijekom, nakon intravenske, intraarterijske i paravenske injekcije kada je cetroreliks primjenjivan u dozama koje su bile jasno veće od onih što su namijenjene primjeni u ljudi.
No soaps, oils, lotions, or any other agents that might irritate the skin or alter its absorption characteristics, should be used to clean the application site.
Za čišćenje mjesta primjene ne smiju se koristiti sapuni, ulja, losioni ili druga sredstva koja bi mogla nadražiti kožu ili promijeniti svojstva apsorpcije.
No special considerations are needed.
Nisu potrebne posebne mjere opreza.
No special dose adjustment is required in patients aged > 65 years old.
Nije potrebno posebno prilagođavati dozu bolesnicima starijima od 65 godina.
No special dose adjustment of NUEDEXTA is required in older patients.
U starijih bolesnika nije potrebna posebna prilagodba doze lijeka NUEDEXTA.
No special precautions for storage.
Nema posebnih mjera za čuvanje.
No special storage conditions.
Nema posebnih uvjeta čuvanja.
No special studies in patients with renal impairment have been conducted with Eylea.
Nisu provedena posebna ispitivanja lijeka Eylea u bolesnika s oštećenjem funkcije bubrega.
No specific advice can be given on whether to use or not in breastfeeding mothers.
Ne može se dati poseban savjet o primjeni ovog lijeka u dojilja.
No specific advice can be given on whether to use or not in breastfeeding mothers.
Nije moguće dati poseban savjet o primjeni lijeka u dojilja.
No specific antidote is available for overdose with Kalydeco.
Nije dostupan specifični antidot za predoziranje lijekom Kalydeco.
No specific antidote is available for overdose with Orkambi.
Nije dostupan specifični antidot za predoziranje lijekom Orkambi.
No specific antidote is known.
Nije poznat specifični protuotrov.
No specific antidotes for pradofloxacin (or other fluoroquinolones) are known, therefore, in case of overdose, symptomatic treatment should be given.
Specifični antidot za pradofloksacin (ili druge fluorokinolone) nije poznat, stoga je u slučaju predoziranja, potrebno primijeniti simptomatsko liječenje.
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole.
Nisu provedena specifična klinička ispitivanja za procjenu lijek-lijek interakcije između intravenskog busulfana i itrakonazola.
No specific data are available on the safety and efficacy of this veterinary medicinal product when used in the target species with any other veterinary medicinal product.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog veterinarsko-medicinskog proizvoda kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom u ciljnih životinjskih vrsta.
No specific data is available on the safety and efficacy of this veterinary medicinal product when used in the target species with any other veterinary medicinal product.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog veterinarsko-medicinskog proizvoda kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom u ciljnih životinjskih vrsta.
No specific dose
Ne može se dati posebna
No specific dose adjustment is necessary in this population.
U ove populacije nije potrebno posebno prilagođivati dozu.
No specific dose adjustment is necessary.
Nije potrebno posebno prilagođavati dozu.
No specific dose adjustment is needed in patients with mild or moderate renal impairment.
Nije potrebno prilagođavanje doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2).
Nije potrebna posebna prilagodba doze za starije pacijente (u dobi od ≥ 65 godina) (vidjeti dio 5.2).
No specific dose adjustment is required for elderly patients (aged ≥ 65 years).
Nije potrebna specifična prilagodba doze za starije bolesnike (dobi ≥ 65 godina).
No specific dose adjustment is required for the treatment of LHON in elderly patients.
Nije potrebno posebno prilagođavanje doze za liječenje LHON-a u starijih osoba.
No specific dose adjustments are recommended for the elderly ≤75 years of age.
Nisu preporučene posebne prilagodbe doze kod starijih osoba u dobi ≤75 godina.
No specific dose recommendation is necessary in older people.
Za starije ljudenije potrebna posebna preporuka doziranja.
No specific dose recommendation is necessary in the older people.
Za starije osobe nije potrebna posebna preporuka doziranja.
No specific drug-drug interaction study has been performed.
Nisu provedena specifična interakcijska
No specific fertility studies in animals have been performed to evaluate the effect of pertuzumab.
Nisu provedena posebna ispitivanja na životinjama kojima bi se procijenio učinak pertuzumaba na plodnost.
No specific information is available on the treatment of overdosage with Bonviva.
Nisu dostupne specifične informacije o liječenju u slučajevima predoziranja lijekom Bonviva.
No specific information is available on the treatment of overdosage with Bonviva.
Nisu dostupni specifični podaci o liječenju u slučajevima predoziranja lijekom Bonviva.
No specific information is available on the treatment of overdosage with Ibandronic acid Accord.
Nisu dostupni specifični podaci o liječenju u slučajevima predoziranja lijekom Ibandronic acid Accord.
No specific information is available on the treatment of overdosage with Ibandronic Acid Teva.
Nisu dostupne specifične informacije o liječenju u slučaju predoziranja Ibandronatnom kiselinom Teva.
No specific information is available on the treatment of overdose with
Nema dostupnih specifičnih podataka o liječenju predoziranja Sabervelom.
No specific information is available on the treatment of overdose with Akynzeo.
Nisu dostupne specifične informacije o liječenju predoziranja Akynzeom.
No specific information is available on the treatment of overdose with Ibandronic Acid Teva.
Nisu dostupne specifične informacije o liječenju u slučajevima predoziranja Ibandronatnom kiselinom Teva.
No specific information is available on the treatment of overdose with ISENTRESS.
Nema specifičnih podataka o liječenju predoziranja lijekom ISENTRESS.
No specific interaction studies have been performed with the bimatoprost / timolol fixed combination.
Nisu provedena ispitivanja interakcija s fiksnom kombinacijom bimatoprost/timolol.