natgillin/translations-raw huggingface dataset:
Based on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to drive and use machines.
Na osnovi poročanih neželenih učinkov ni pričakovati, da bi zdravilo Doribax vplivalo na sposobnost vožnje in upravljanja s stroji.
Based on reported data for another filgrastim product similar to Accofil, comparable findings plus increased fetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Na podlagi podatkov, o katerih so poročali pri drugem zdravilu s filgrastimom, podobnim zdravilu Accofil, so zabeležili primerljive izsledke ter več malformacij ploda pri odmerku 100 µg/kg/dan, tj. pri odmerku, toksičnem za samice, ki je ustrezal sistemski izpostavljenosti, ki je približno 50- do 90- krat večja izpostavljenosti, ki so jo zabeležili pri bolnikih, ki so prejemali klinični odmerek 5 µg/kg/dan.
Based on reported data for another filgrastim product similar to Accofil, comparable findings plus increased fetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Na podlagi podatkov, o katerih so poročali pri drugem zdravilu s filgrastimom, podobnim zdravilu Accofil, so zabeležili primerljive izsledke ter več malformacij ploda pri odmerku 100 µg/kg/dan, tj. pri odmerku, toksičnem za samice, ki je ustrezal sistemski izpostavljenosti, ki je približno 50- do 90- krat večja izpostavljenosti, ki so jo zabeležili pri bolnikih, ki so prejemali klinični odmerek µg/kg/dan.
Based on reported data for another filgrastim product, comparable findings plus increased fetal malformations were observed at 100 micrograms/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 micrograms/kg/day.
Na osnovi podatkov za drugo zdravilo, ki vsebuje filgrastim, so primerljive ugotovitve plus zvečano število malformacij ploda opazili pri 100 mikrogramih/kg/dan, pri odmerku, ki je bil toksičen za mater in ustreza približno 50-90-krat večji sistemski izpostavljenosti kot je izpostavljenost bolnikov, ki se zdravijo s kliničnimi odmerki 5 mikrogramov/kg/dan.
Based on reports from literature and post-marketing experience orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.4).
Na podlagi literaturnih podatkov in izkušenj iz časa trženja zdravila lahko orlistat potencialno zmanjša absorpcijo protiretrovirusnih zdravil za zdravljenje okužb z virusom HIV in lahko negativno vpliva na učinkovitost protiretrovirusnih zdravil za zdravljenje okužb z virusom HIV (glejte poglavje 4.4).
Based on results from clinical trials including 1725 patients approximately 8 % of patients treated with NeoRecormon are expected to experience adverse reactions.
Na podlagi izsledkov kliničnih preskušanj, ki so vključevale 1.725 bolnikov, se neželeni učinki pojavijo pri približno 8 % bolnikov, ki se zdravijo z zdravilom NeoRecormon.
Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Pogostnost, vrsta in izrazitost neželenih učinkov, opaženih pri starejših bolnikih in bolnikih z okvaro ledvic ali jeter, na podlagi kliničnih izkušenj ne kažejo razlik v primerjavi s širšimi izkušnjami v splošni populaciji.
Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in the elderly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Pogostnost, vrsta in izrazitost neželenih učinkov, opaženih pri starejših bolnikih in bolnikih z okvaro ledvic ali jeter na podlagi kliničnih izkušenj ne kažejo razlik v primerjavi s širšimi izkušnjami v splošni populaciji.
Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Aripiprazol se obsežno porazdeli po telesu in ima navidezni volumen porazdelitve 4,9 l/kg, kar kaže na izdatno zunajžilno porazdelitev.
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non- genotoxic.
Na podlagi celotnega spektra standardnih preskusov genotoksičnosti je bilo ocenjeno, da aripiprazol ni genotoksičen.
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non- genotoxic.
Na podlagi rezultatov celotnega spektra standardnih preizkusov genotoksičnosti je bilo ocenjeno, da aripiprazol ni genotoksičen.
Based on results of pre-clinical studies that investigated bleeding while on vorapaxar on the background of acetylsalicylic acid and clopidogrel, it may be possible to restore hemostasis by administering exogenous platelets. (See section 5.3.)
Na osnovi rezultatov predkliničnih študij, kjer so preučevali krvavitev med uporabo vorapaksarja skupaj z acetilsalicilno kislino in klopidogrelom, je hemostazo morda mogoče ponovno vzpostaviti z dajanjem eksogenih trombocitov. (Glejte poglavje 5.3.)
Based on safety and tolerability data, the dosage of pazopanib should be reduced to 200 mg once daily in subjects with moderate hepatic impairment (see section 4.2).
Na osnovi podatkov o varnosti in prenašanju je treba pri bolnikih z zmerno okvaro jeter odmerek pazopaniba zmanjšati na 200 mg enkrat na dan (glejte poglavje 4.2).
Based on simulations, dose adjustment is needed for patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regular haemodialysis (see sections 4.2 and 5.2).
Na podlagi simulacij je prilagoditev odmerjanja potrebna pri pacientih s kronično okvaro delovanja ledvic, katerih kreatininski očistek je manjši od 30 ml/min in ki redno ne prejemajo hemodialize (glejte poglavji 4.2 in 5.2).
Based on studies in animals, there is a potential risk that radiation from Xofigo could cause adverse effects on fertility (see section 5.3).
Na podlagi študij na živalih obstaja možno tveganje, da bi lahko sevanje zdravila Xofigo povzročilo neželene učinke na plodnost (glejte poglavje 5.3).
Based on studies in animals, Zydelig may be harmful to the unborn child.
Glede na študije na živalih lahko zdravilo Zydelig škoduje nerojenemu otroku.
Based on studies of GANFORT (multi-dose formulation), the IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily).
Študije večodmerne oblike zdravila GANFORT so pokazale, da učinek zdravila GANFORT za zniževanje IOT ni nič manjši od tistega, ki ga dosežemo s kombinirano terapijo z bimatoprostom (enkrat dnevno) in timololom (dvakrat dnevno).
Based on surveillance data following the introduction of Prevenar but before the introduction of Prevenar 13 in childhood vaccination programmes, the pneumococcal serotypes in Prevenar 13 may be responsible for at least 50 – 76% (depending on country) of IPD in adults.
Po podatkih opazovalnih študij po začetku uporabe cepiva Prevenar (vendar pred začetkom uporabe cepiva Prevenar 13) v programih cepljenja otrok, so pnevmokokni serotipi v cepivu Prevenar 13 odgovorni za najmanj 50-76 % (odvisno od države) IPD pri odraslih.
Based on the above patients are advised to contact their physician immediately to determine whether they should stop taking abacavir if: presence of skin rash; OR development of 1 or more symptom from at least 2 of the following groups:
Na podlagi zgoraj navedenega bolnikom svetujemo, da se takoj posvetujejo s svojim zdravnikom, ali naj prenehajo jemati abakavir v primeru pojava: izpuščaja na koži; ALI enega ali več simptomov iz vsaj DVEH od naslednjih skupin:
Based on the above, it is considered justified to document that cases of “encephalopathy” have been observed rarely in the Product Information of all levetiracetam-containing products.
Na podlagi zgoraj navedenega lahko za vsa zdravila, ki vsebujejo levetiracetam v informacije o zdravilu upravičeno dokumentiramo redko opažene primere 'encefalopatije'.
Based on the actual concentration of NovoThirteen, the dose volume (in millilitres) to be administered to patients weighing at least 24 kg can be calculated from the formula below:
Glede na dejansko koncentracijo zdravila NovoThirteen je mogoče velikost odmerka (v mililitrih) za bolnike, ki so težki najmanj 24 kg, izračunati po naslednji formuli:
Based on the analysis of cases of gastrointestinal haemorrhages reported in the post-marketing setting and in clinical trials, there is evidence to suggest a causal association with the use of apremilast.
Na podlagi analize primerov gastrointestinalnih krvavitev, o katerih so poročali v obdobju po prihodu zdravila na trg in v kliničnih preskušanjih, obstajajo dokazi, ki kažejo na vzročno povezavo z uporabo apremilasta.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,778 Parkinson’s disease patients on pramipexole and 1,297 patients on placebo, adverse drug reactions were frequently reported for both groups.
Skupna analiza s placebom nadzorovanih preskušanj pri 1.778 bolnikih s Parkinsonovo boleznijo, ki so jemali pramipeksol, in 1.297 bolnikih, ki so jemali placebo, je pokazala, da so bili neželeni učinki pogosti v obeh skupinah.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Skupna analiza s placebom nadzorovanih preskušanj pri 1923 bolnikih, ki so jemali pramipeksol, in 1354 bolnikih, ki so jemali placebo, je pokazala, da so bili neželeni učinki pogosti v obeh skupinah.
Based on the analysis of pre- and post-dose liver biopsies in males with Fabry Disease, the tissue half- life has been estimated to be in excess of 24 hours and hepatic uptake of the enzyme estimated to be 10% of administered dose.
Pri moških bolnikih s Fabryjevo boleznijo so na osnovi analize vzorcev jetrne biopsije pred in po odmerku ocenili, da razpolovni čas zdravila v tkivih presega 24 ur, privzem zdravila v jetra pa so ocenili na 10% prejetega odmerka.
Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Na podlagi ocene tega odbora je CHMP zaključil, da so koristi zdravila ChondroCelect večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Based on the available data and analysis presented in this PSUR, the PRAC considered that the summary of product characteristics and package leaflet of bimatoprost (all formulations) containing medicinal products should be amended to reflect the following adverse drug reactions: hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis, asthma, asthma exacerbation, COPD exacerbation and dyspnea, with a frequency not known.
Na podlagi podatkov in analiz, ki so na voljo v tem poročilu PSUR, je odbor PRAC predlagal spremembo povzetka glavnih značilnosti zdravila in navodil za uporabo zdravil, ki vsebujejo bimatoprost (vse formulacije), da bi iz njih bili razvidni naslednji neželeni učinki z neznano pogostnostjo: preobčutljivostna reakcija vključno z znaki in simptomi očesne alergije in alergijskega dermatitisa, astma, poslabšanje astme, poslabšanje KOPB in dispneja.
Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
Na podlagi razpoložljivih podatkov niso ugotovili dejavnikov tveganja (n.pr. velikost tumorja, lokacija tumorja, motnje strjevanja krvi), zaradi katerih bi bili ti bolniki izpostavljeni večjemu tveganju za eno od obeh oblik krvavitve.
Based on the available evidence, the CHMP decided that Multaq’s benefits are greater than its risks and recommended that Multaq be given marketing authorisation.
CHMP je na podlagi razpoložljivih dokazov zaključil, da so koristi zdravila Multaq večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Based on the calculated volume of olaratumab, aseptically remove the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection from the prefilled 250 mL intravenous container and transfer the olaratumab medicine into the container to bring the final volume in the container back to 250 mL.
Na podlagi izračunane prostornine olaratumaba iz predhodno napolnjenega 250-ml intravenskega vsebnika aseptično odstranite ustrezno prostornino 9 mg/ml (0,9-odstotne) raztopine natrijevega klorida za injiciranje in prenesite zdravilo z olaratumabom v intravenski vsebnik, tako da bo končna prostornina spet dosegla 250 ml.
Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the prefilled 250 ml intravenous container.
Glede na izračunano prostornino ramucirumaba odvzemite ustrezno prostornino 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje iz napolnjenega 250-mililitrskega vsebnika za intravensko infuzijo.
Based on the change in HbA1c values from baseline, the glycaemic control in patients treated with Insuman Implantable was similar to that of patients treated with semi-synthetic human insulin. (per protocol population:
Glede na spremembo vrednosti HbA1c od izhodišča je bila urejenost glikemije pri prejemnikih zdravila Insuman Implantable podobna kot pri prejemnikih polsinteznega humanega insulina (populacija po-protokolu: -0,25 v primerjavi z
Based on the clinical observations in this group of patients, there is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if co- administered with stiripentol.
Pri kliničnem opazovanju v tej skupini bolnikov niso našli dokazov za spremembo odmerka topamirata oz. načrta odmerjanja pri sočasnem dajanju s stiripentolom.
Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial onset seizures and primary generalized tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Na podlagi podatkovne zbirke kliničnih preskušanj s 196 mladostniki, ki so bili izpostavljeni perampanelu v dvojno slepih študijah zaradi napadov s parcialnim izvorom in primarnih generaliziranih tonično-kloničnih napadov, je bil celotni varnostni profil pri mladostnikih podoben kot pri odraslih, razen agresivnosti, ki so jo pogosteje ugotavljali pri mladostnikih kot pri odraslih.
Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.
Na osnovi kliničnih preskušanj so morfološke spremembe, ki jih povzroči zdravilo FABLYN, benigne in ne zahtevajo nadaljnjih preiskav, razen pri pojavu krvavitev iz nožnice.
Based on the concerns derived from pre-clinical studies (see section 5.3) and the proposed mechanism of action with the trophic effects on intestinal mucosa, there appears to be a risk for the promotion of small intestinal and/or colonic neoplasia.
Zaradi zadržkov, ki izhajajo iz predkliničnih študij (glejte poglavje 5.3), in zaradi predlaganega mehanizma delovanja s trofičnim učinkom na črevesno sluznico obstaja tveganje za pospeševanje novotvorb v tankem črevesu in/ali kolonu.
Based on the data submitted in this PSUR regarding overdose cases without a reported history of seizure and confounders, the PRAC concluded that reported cases of seizures should be added in the overdose section of the Product Information (Section 4.9).
Na podlagi v tem poročilu PSUR predloženih podatkov o primerih prevelikega odmerjanja brez predhodno poročanih epileptičnih napadov in dejavnikov tveganja, je odbor PRAC zaključil, da je treba poročane primere epileptičnih napadov vključiti v poglavje informacij o zdravilu o prevelikem odmerjanju (poglavje 4.9).
Based on the diminished exposure and limited hepatic reserve pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin > 3 X ULN regardless of any level of ALT) (see section 4.2).
Glede na manjšo izpostavljenost in majhno jetrno rezervo pri bolnikih s hudo okvaro jeter (opredeljeno kot celokupni bilirubin > 3-kratna ZMN ne glede na vrednost ALT) uporaba pazopaniba ni priporočljiva (glejte poglavje 4.2).
Based on the dose, the appropriate amount of sodium chloride 9 mg/ml (0.9%) solution for injection is extracted with a 50 ml syringe (Table 7).
Glede na odmerek izvlecite ustrezno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za injekciranje v 50 ml brizgo (Preglednica 7).
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G- CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti za mielosupresijo določen največji tolerantni odmerek 2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti za mielosupresijo določen največji tolerantni odmerek 2,0 mg/m2/dan pri uporabi G-CSF i 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka odvisne toksičnosti v obliki mielosupresije ugotovljen največji odmerek, ki ga bolniki še prenašajo (MTD), to je 2,0 mg/m2 na dan pri uporabi G-CSF in 1,4 mg/m2 na dan brez G-CSF (glejte poglavje 5.2).
Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE with other inhibitors of UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of ONIVYDE.
Na podlagi medsebojnega delovanja neliposomskega irinotekana in ketokonazola lahko tudi sočasno dajanje zdravila ONIVYDE in drugih zaviralcev encima UGT1A1 (npr. atazanavira, gemfibrozila, indinavira) poveča sistemsko izpostavljenost zdravilu ONIVYDE.
Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Thymanax (see also under “How to take Valdoxan” in section 3).
Glede na rezultate preiskav se bo zdravnik odločil, ali boste prejeli oz. nadaljevali z jemanjem zdravila Thymanax (glejte tudi poglavje 3 »Kako jemati zdravilo Thymanax«).
Based on the evidence from the studies, the CHMP concluded that Cinryze’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je na podlagi dokazov iz študij zaključil, da so koristi zdravila Cinryze večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Based on the evidence presented the PRAC considered that causal relationship between myocarditis and the trametinib/dabrafenib combination is likely in each of the two non-fatal cases based on temporal relationship, positive de-challenge and the absence of compelling alternative causes.
Na osnovi predstavljenih dejstev je odbor PRAC ocenil, da je vzročna povezanost miokarditisa s kombinacijo trametinib/dabrafenib verjetna v obeh primerih, ki nista bila smrtna, in sicer zaradi časovne povezanosti, pozitivnega učinka prenehanja jemanja zdravil in odsotnosti prepričljivih drugih možnih vzrokov.
Based on the existing data with the components, the use of Copalia HCT is not recommended during first trimester and contra- indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Glede na obstoječe podatke o posameznih sestavinah uporaba zdravila Copalia HCT ni priporočljiva v prvem trimesečju nosečnosti in je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
Based on the existing data with the components, the use of Dafiro HCT is not recommended during first trimester and contra- indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Glede na obstoječe podatke o posameznih sestavinah uporaba zdravila Dafiro HCT ni priporočljiva v prvem trimesečju nosečnosti in je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
Based on the existing data with the components, the use of Imprida HCT is not recommended during first trimester and contra- indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Glede na obstoječe podatke o posameznih sestavinah uporaba zdravila Imprida HCT ni priporočljiva v prvem trimesečju nosečnosti in je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
Based on the experience with glimepiride and with other sulphonylureas the following interactions have to be mentioned.
Na podlagi izkušenj z glimepiridom in drugimi sulfonilsečninami je treba omeniti naslednja medsebojna delovanja.
Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as:
V nadaljevanju so navedeni neželeni učinki, ki so bili ugotovljeni na podlagi izkušenj z repaglinidom in drugimi antidiabetiki.
Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Na podlagi izkušenj z repaglinidom in drugimi antidiabetiki so bili ugotovljeni naslednji neželeni učinki: opredelitev pogostnosti je: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Based on the experience with the use of other medicinal products that blunt the renin- angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Izkušnje z drugimi zdravili, ki zavirajo delovanje renin- angiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).
Based on the experience with the use of other medicinal products that blunt the renin- angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Izkušnje z drugimi zdravili, ki zavirajo delovanje renin-angiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).