natgillin/translations-raw huggingface dataset:
The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated.
Varnost uporabe zdravila pri živalih v času razploda, med brejostjo in pri kobilah v laktaciji ni bila preučena.
The safety of the product has not been established in dogs less than 2 months of age and weighing less than 1.4 kg, during pregnancy, lactation, or in breeding dogs.
Varnost zdravila ni bila dokazana pri psih, mlajših od dveh mesecev ali lažjih od 1,4 kg, v obdobju brejosti in laktacije ter pri vzrejnih psih.
The safety of the recommended dose has been demonstrated in puppies treated every two weeks, on up to five occasions.
Varnost priporočenega odmerka je bila dokazana pri mladičih, zdravljenih do pet krat vsaka dva tedna.
The safety of the vaccine was studied in several laboratory studies in cattle and sheep at the minimum age of two and a half months and during pregnancy in ewes and cows.
Varnost zdravila je bila raziskana v več laboratorijskih študijah pri govedu in ovcah, starih najmanj 2,5 meseca, ter med brejostjo ovc in krav.
The safety of the veterinary medicinal product during pregnancy has not been established in horses during pregnancy and the product should not be used during pregnancy.
Varnost zdravila v obdobju brejosti pri konjih ni bila ugotovljena.
The safety of the veterinary medicinal product during pregnancy has not been established in horses.
Varnost zdravila v obdobju brejosti pri konjih ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during lactation.
Varnost zdravila med laktacijo ni dokazana.
The safety of the veterinary medicinal product has not been established during lay in turkeys.
Varnost zdravila za uporabo v veterinarski medicini v obdobju nesnosti pri puranih ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during lay.
Varnost zdravila za uporabo v veterinarski medicini ni bila ugotovljena med obdobjem nesnosti.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Varnost veterinarskega zdravila v obdobju brejosti in laktacije ni bila ugotovljena (glejte poglavje 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Varnost zdravila med brejostjo in laktacijo ni raziskana (glejte 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Varnost zdravila v obdobju brejostji in laktacije ni bila ugotovljena (glejte poglavje 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in adult female cats.
Varnost zdravila v obdobju brejosti in laktacije pri odraslih mačkah ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in pigs.
Varnost zdravila Aivlosin v obdobju brejosti in laktacije pri prašičih ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in pigs.
Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti in laktacije pri prašičih ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding.
Varnost zdravila v obdobju brejosti in laktacije ter pri psih, namenjenih za razplod, ni bila ugotovljena, zato uporabo pri živalih v obdobju brejosti in laktacije ter pri psih, namenjenih za razplod, odsvetujemo.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation, thus the use is not recommended during pregnancy and lactation.
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena, zato uporaba izdelka ni priporočljiva v obdobju brejosti in laktacije.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Ni dokazana varnost zdravila v obdobju brejosti in laktacije
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost uporabe tulatromicina pri govedu in prašičih med brejostjo in laktacijo ni bila preizkušena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila med brejostjo in laktacijo ni bila dokazana.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila v obdobju brejosti in laktacije ni dokazana.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila v obdobju brejosti laktacije nesnosti ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila v obdobju brejostj in laktacij ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila v obdobju brejostji in laktacije ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti ali laktacije ni bila ugotovljena.
The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Varnost zdravila za uporabo v veterinarski medicini ni bila dokazana za mačke, mlajše od 4 mesecev, in pse, mlajše od 2 mesecev, oziroma za mačke ali pse, lažje od 2,5 kg telesne mase.
The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Varnost zdravila za uporabo v veterinarski medicini ni bila dokazana za mačke, lažje od 2,5 kg telesne mase oziroma mlajše od 4 mesecev.
The safety of the veterinary medicinal product has not been established in dogs younger than 7 weeks or weighing less than 1.5 kg.
Varnost zdravila za uporabo v veterinarski medicini še ni bila ugotovljena pri psih mlajših od 7 tednov ali lažjih od 1,5 kg.
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Ni dokazana varnost zdravila v obdobju brejosti in laktacije.
The safety of the veterinary medicinal product has not been established in horses during pregnancy, and the product should not be used during pregnancy.
Varnost zdravila v obdobju brejosti pri konjih ni bila ugotovljena, zato se zdravilo v obdobju brejosti ne sme uporabljati.
The safety of the veterinary medicinal product has not been established in pregnant and lactating bitches; therefore, the product should not be used during pregnancy and lactation.
Varnost zdravila pri brejih psicah in psicah v obdobju laktacije ni bila ugotovljena, zato se zdravilo v obdobju brejosti in laktacije ne sme uporabljati.
The safety of the veterinary medicinal product has not been investigated in pregnant dogs and lactating dogs.
Varnost zdravila v obdobju brejosti in laktacije psic ni bila raziskana.
The safety of the veterinary medicinal product has not been tested in dogs weighing less than 5 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Varnosti zdravila za uporabo v veterinarski medicini niso testirali pri psih s telesno maso manj kot 5 kg ali pri psih z zdravstvenimi težavami, kot so ledvična, jetrna, srčna, prebavna ali drugačna bolezen.
The safety of the veterinary medicinal product has not been tested in dogs weighing less than 5 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Varnosti zdravila za uporabo v veterinarski medicini niso testirali pri psih s telesno maso manj kot 5 kg ali pri psih, kjer obstajajo zdravstvene težave, kot so ledvična, jetrna, srčna, prebavna ali drugačna bolezen.
The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has been demonstrated.
Varnost zdravila za uporabo v veterinarski medicini pri psih za vzrejo, v dobi brejosti in laktacije je bila dokazana.
The safety of this product in male dogs and cats used for breeding has not been determined.
Varnost zdravila pri pasjih in mačjih samcih, namenjenih za vzrejo, ni bila ugotovljena.
The safety of this veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti in laktacije pri mački ni bila ugotovljena.
The safety of this veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Varnost tega zdravila za uporabo v veterinarski medicini ni bila dokazana za mačke, mlajše od 4 mesecev, in pse, mlajše od 2 mesecev, oziroma za mačke ali pse, lažje od 2,5 kg telesne mase.
The safety of this veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Varnost tega zdravila za uporabo v veterinarski medicini ni bila dokazana za mačke, lažje od 2,5 kg telesne mase oziroma mlajše od 4 mesecev.
The safety of this veterinary medicinal product has not been established in young dogs, so careful monitoring by your veterinary surgeon is recommended if the dog is less than 6 months of age.
Varnost zdravila pri mladih živalih ni bila ustrezno raziskana, zato se priporoča skrbno spremljanje zdravljenja mladih psov mlajših od 6 mesecev.
The safety of this veterinary medicine has not been established in cat younger than 7 weeks of age or weighing less than 0.6 kg.
Varnost zdravila za uporabo v veterinarski medicini še ni bila ugotovljena pri mačkah mlajših od 7 tednov ali lažjih od 0,6 kg.
The safety of this veterinary medicine has not been established in dogs younger than 7 weeks or weighing less than 1.5 kg.
Varnost zdravila za uporabo v veterinarski medicini še ni bila ugotovljena pri psih mlajših od 7 tednov ali lažjih od 1,5 kg.
The safety of this veterinary medicine in bitches has not been established during pregnancy and lactation.
Varnost zdravila v obdobju brejosti in laktacije pri psicah ni bila ugotovljena.
The safety of tocilizumab has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Varnost tocilizumaba so preučevali v štirih s placebom kontroliranih študijah (študije II, III, IV in V), eni z metotreksatom kontrolirani študiji (študija I) ter v njihovih odprtih, podaljšanih fazah (glejte poglavje 5.1).
The safety of tocilizumab in pJIA has been studied in 188 patients from 2 to 17 years of age.
Varnost tocilizumaba pri bolnikih s pJIA so proučevali pri 188 bolnikih, starih od 2 do 17 let.
The safety of tocilizumab in sJIA has been studied in 112 patients from 2 to 17 years of age.
Varnost tocilizumaba pri bolnikih s sJIA so preučevali pri 112 bolnikih, starih od 2 do 17 let.
The safety of toclizumab in the pediatric population in the sections on pJIA and sJIA below.
Varnost tocilizumaba pri pediatrični populaciji je predstavljena v spodnjih poglavjih za pJIA in sJIA.
The safety of trametinib monotherapy has been evaluated in the integrated safety population of 329 patients with metastatic melanoma treated with trametinib 2 mg once daily.
Varnost trametiniba v monoterapiji so ocenili v skupni varnostni populaciji 329 bolnikov z metastatskim melanomom, zdravljenih z 2 mg trametiniba enkrat na dan.
The safety of trastuzumab emtansine has been evaluated in1871 breast cancer patients in clinical studies.
Varnost trastuzumaba emtanzina so ocenili v kliničnih študijah pri 1871 bolnikih z rakom dojk.
The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs.
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
The safety of Tybost in 73 HIV-1 infected treatment-experienced patients with mild to moderate renal impairment (eGFR by Cockcroft-Gault method 50-89 ml/min) who switched pharmacokinetic enhancer from ritonavir to cobicistat was evaluated in an open-label clinical study (GS-US-236-0118) of cobicistat-boosted atazanavir or darunavir plus two NRTIs.
Varnost zdravila Tybost pri 73 predhodno zdravljenih bolnikih, okuženih z virusom HIV-1 z blago do zmerno ledvično okvaro (eGFR po Cockcroft-Gaultovi metodi 50–89 ml/min), ki so prešli s farmakokinetičnega ojačevalca ritonavirja na kobicistat, je bila ocenjena v odprti klinični študiji (GS-US-236-0118) z atazanavirjem ali darunavirjem, okrepljenim s kobicistatom, sočasno z dvema NRTI.
The safety of using Protopic for a long time is not known.
Varnost dolgotrajne uporabe zdravila Protopic ni znana.
The safety of using Senshio concomitantly with oestrogens or other SERMS, such as tamoxifen, toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not recommended.
Varnosti zdravila Senshio pri sočasni uporabi z estrogeni ali drugimi SERM, kot so tamoksifen, toremifen, bazedoksifen in raloksifen, niso preučili, zato se sočasna uporaba ne priporoča.
The safety of ustekinumab has been studied in a phase 3 study of 110 patients from 12 to 17 years of age for up to 60 weeks.
Varnost ustekinumaba so preučevali v študiji faze 3 pri 110 bolnikih, starih od 12 do 17 let, do največ 60 tednov.
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: severe hepatic impairment (Child-Pugh C),
Varnost vardenafila ni raziskana v podskupinah bolnikov, ki imajo hude motnje pri delovanju jeter (Child-Pugh C),
The safety of Veraflox has not been established during pregnancy and lactation in cats and dogs.
Varnost zdravila v obdobju brejosti in laktacije pri psih in mačkah ni bila ugotovljena.
The safety of Veraflox has not been established during pregnancy and lactation in dogs.
Varnost zdravila v obdobju brejosti in laktacije pri mačkah ni bila ugotovljena.
The safety of Veraflox has not been established in queens during pregnancy and lactation.
Varnost zdravila v obdobju brejosti in laktacije pri psih in mačkah ni bila ugotovljena.
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183 ) and therapeutic use (105 ) in clinical trials.
Varnost vorikonazola so raziskali pri 228 pediatričnih bolnikih, starih od 2 do < 12 let (169) in od 12 do < 18 let (119), ki so vorikonazol v kliničnih preskušanjih dobivali za profilakso (183) in terapijo (105).
The safety of XGEVA was evaluated in:
Varnost zdravila XGEVA so ocenili pri:
The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Parametri varnosti mešanih cepiv se ne razlikujejo od parametrov, ki so opisani za cepiva, ki se dajejo ločeno.
The safety population of Gilenya is derived from two Phase III placebo-controlled clinical studies and one Phase III active-controlled clinical study in patients with relapsing remitting multiple sclerosis.
Populacija za oceno varnosti zdravila Gilenya izhaja iz dveh s placebom kontroliranih kliničnih študij faze III in ene aktivno kontrolirane klinične študije faze III pri bolnikih z recidivno-remitentno multiplo sklerozo.
The safety profile for axial spondyloarthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Varnostni profil pri bolnikih z aksialnim spondiloartritisom, ki so bili zdravljeni z zdravilom Cimzia, je bil skladen z varnostnim profilom pri revmatoidnem artritisu in s prejšnjimi izkušnjami z zdravilom Cimzia.
The safety profile for patients with HS treated with Humira weekly was consistent with the known safety profile of Humira.
Varnostni profil bolnikov s HS, ki so bili tedensko zdravljeni z zdravilom Humira, je v skladu z znanim varnostnim profilom zdravila Humira.
The safety profile in 50 adolescent patients who received treatment with Genvoya was similar to that in adults (see section 5.1).
Varnostni profil pri 50 mladostnikih, ki so prejemali zdravljenje z zdravilom Genvoya, je bil podoben kot pri odraslih (glejte poglavje 5.1).
The safety profile in a 26-week open-label extension trial was similar to that observed in the short- term, placebo-controlled trial.
V 26-tedenskem, odprtem, podaljšanem preskušanju je bil profil varnosti podoben profilu varnosti v kratkotrajnem, s placebom nadzorovanem preskušanju.
The safety profile in approximately 500 patients who received Doribax 1 g every 8 hours as a 4-hour infusion in phase I, II and III clinical trials, was consistent with the safety profile for patients receiving 500 mg every 8 hours.
Varnostni profil pri približno 500 bolnikih, ki so prejemali zdravilo Doribax v odmerku 1 g na 8 ur v obliki 4-urnega infundiranja v kliničnih študijah faze I, II in III je bil konsistenten z varnostnim profilom bolnikov, ki so prejemali odmerek 500 mg na 8 ur.
The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people subjects.
Varnostni profil pri preiskovancih, ki so imunsko kompromitirani in pri bolnikih s kroničnimi bolezenskimi stanji, je podoben kot pri zdravih odraslih in starejših preiskovancih.
The safety profile in paediatric patients was similar to that seen in adult populations and no clinically relevant new adverse reactions were seen.
Varnostni profil pediatričnih bolnikov je bil podoben kot pri odrasli populaciji klinično pomembnih novih neželenih učinkov niso opazili .
The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3–15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Varnostni profil v prvi nenadzorovani pediatrični študiji s filmsko obloženimi tabletami (BREATHE- 3: n = 19, mediana starosti 10 let [razpon 3-15 let], odprta študija z bosentanom 2 mg/kg dvakrat na dan; trajanje zdravljenja 12 tednov) je bil podoben kot v ključnih študijah pri odraslih bolnikih s PAH.
The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3–15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Varnostni profil v prvi nenadzorovani pediatrični študiji s filmsko obloženimi tabletami (BREATHE-3: n = 19, mediana starosti 10 let [razpon 3-15 let], odprta študija z bosentanom 2 mg/kg dvakrat na dan; trajanje zdravljenja 12 tednov) je bil podoben kot v ključnih študijah pri odraslih bolnikih s PAH.
The safety profile in these paediatric patients is consistent with that in adult patients.
Varnostni profil pri teh pediatričnih bolnikih se je ujemal z varnostnim profilom pri odraslih bolnikih.
The safety profile in this study is consistent with adverse reactions observed with patients on FIRDAPSE.
Varnost v tej študiji je v skladu z neželenimi učinki, ki so jih opazili pri bolnikih, ki so uporabljali zdravilo FIRDAPSE.
The safety profile is based on pooled data from 2,672 patients treated with Afinitor in ten clinical studies, consisting of five randomised, double-blind, placebo controlled phase III studies and five open-label phase I and phase II studies, related to the approved indications.
Varnostne lastnosti zdravila izhajajo iz združenih podatkov 2.672 bolnikov, ki so prejemali zdravilo Afinitor v desetih kliničnih študijah, med katerimi je bilo pet randomiziranih, dvojno slepih, s placebom kontroliranih študij faze III in pet z odobrenimi indikacijami povezanih odprtih študij faze I in faze II.
The safety profile is based on pooled data from 981 patients treated with IMBRUVICA in three phase 2 clinical studies and four randomised phase 3 studies and from post-marketing experience.
Podatki o varnosti zdravila temeljijo na združenih podatkih 981 bolnikov, ki so jih zdravili z zdravilom IMBRUVICA v treh kliničnih študijah faze 2, štirih randomiziranih študijah faze 3 in podatkih po začetku trženja zdravila.
The safety profile is based on pooled data from Phase IIb and Phase III clinical studies in 1222 previously untreated patients, 357 previously treated patients unexposed to integrase inhibitors and 264 patients with prior treatment failure that included an integrase inhibitor (including integrase class resistance).
Varnostni profil temelji na združenih podatkih kliničnih študij faze IIb in faze III pri 1222 predhodno še nezdravljenih osebah, pri 357, ki so že bile predhodno zdravljene, vendar ne z zaviralci integraze, in pri 264 predhodno neuspešno zdravljenih osebah, ki so že dobivale zdravilo iz skupine zaviralcev integraze (vključno z odpornostjo na zdravila iz skupine zaviralcev integraze).
The safety profile is generally consistent among children and adolescents and is also consistent with adult patients.
Varnostni profil se na splošno ujema med otroki in mladostniki in tudi z odraslimi bolniki.
The safety profile observed in patients with ankylosing spondylitis treated with Cosentyx is consistent with the safety profile in psoriasis.
Varnostni profil zdravila Cosentyx, ki so ga opažali pri bolnikih z ankilozirajočim spondilitisom, se je ujemal z varnostnim profilom pri bolnikih s psoriazo.
The safety profile observed in patients with psoriatic arthritis treated with Cosentyx is consistent with the safety profile in psoriasis.
Varnostni profil zdravila Cosentyx, ki so ga opažali pri bolnikih s psoriatičnim artritisom, se je ujemal z varnostnim profilom pri bolnikih s psoriazo.
The safety profile of ANORO is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Varnostne značilnosti zdravila ANORO temeljijo na izkušnjah z varnostjo kombinacije umeklidinij/vilanterol in s posameznima sestavinama iz programa kliničnega razvoja, ki je zajel 6.855 bolnikov s KOPB, in iz spontanega poročanja.
The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Varnostne značilnosti aprepitanta so ocenili pri približno 6.500 odraslih.
The safety profile of aprepitant was evaluated in approximately 6,500 individuals.
Varnostni profil aprepitanta je bil ovrednoten pri približno 6.500 osebah.
The safety profile of Bondenza is derived from controlled clinical trials and post-marketing experience
Varnostni profil zdravila Bondenza izhaja iz kontroliranih kliničnih preskušanj in izkušenj po prihodu zdravila na trg.
The safety profile of Bondenza is derived from controlled clinical trials and post-marketing experience.
Varnostni profil zdravila Bondenza izhaja iz kontroliranih kliničnih preskušanj in izkušenj po prihodu zdravila na trg.
The safety profile of busulfan combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Varnostne značilnosti busulfana v kombinaciji s fludarabinom (FB) so raziskali s pregledom neželenih učinkov, opisanih v objavljenih podatkih kliničnih preskušanj, v katerih so uporabljali pripravljalno shemo zmanjšane intenzivnosti (RIC).
The safety profile of co-administered alogliptin and metformin was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for metformin.
Varnostni profil sočasno uporabljenih alogliptina in metformina je bil konsistenten s tistim pri posameznih učinkovinah, kot je bil dokazan v kliničnih preskušanjih z alogliptinom in na osnovi izčrpnih podatkov, ki so na voljo za metformin.