natgillin/translations-raw huggingface dataset:
No adverse reactions were observed after an overdose administration of the veterinary medicinal product other than those mentioned in section 6, except local reactions that can last longer (from 5 to 6 weeks at the most).
Po aplikaciji prevelikega odmerka zdravila za uporabo v veterinarski medicini ni bilo opaziti neželenih učinkov, razen tistih, ki so omenjeni v poglavju 6, z izjemo lokalnih reakcij, ki lahko trajajo dlje časa (od 5 do 6 tednov največ).
No adverse reactions were observed following oral administration to puppies aged 8–9 weeks and weighing 2.0–3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg bodyweight) on three occasions at shorter intervals than recommended (8-week intervals).
Ko so psičkom, starim 8-9 tednov in težkim 2,0-3,6 kg, dajali do 5krat večje odmerke od največjega priporočenega (56 mg, 168 mg in 280 mg fluralanerja/ kg telesne teže ) trikrat v krajših razmikih, kot je priporočeno (8-tedenski razmiki), niso opazili nobenih neželenih učinkov.
No adverse reactions were observed following topical administration to puppies aged 8–9 weeks and weighing 2.0–3.7 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg bodyweight) on three occasions at shorter intervals than recommended (8-week intervals).
Ko so psičkom, starim 8-9 tednov in težkim 2,0-3,6 kg, dajali lokalno do 5krat večje odmerke od največjega priporočenega (56 mg, 168 mg in 280 mg fluralanerja/kg telesne teže ) trikrat v krajših razmikih, kot je priporočeno (8-tedenski razmiki), niso opazili nobenih neželenih učinkov.
No adverse reactions were observed in dogs aged 8 weeks and older, treated 8 times at 4 week intervals or 6 times at 2 week intervals, with 5 times the recommended dose.
Nobenih neželenih učinkov niso opazili pri psih, starih 8 tednov ali več, ki so jim dali 5-kratni priporočeni odmerek 8-krat v 4-tedenskih razmakih ali 5-kratni priporočeni odmerek 6-krat v 2- tedenskih razmakih.
No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.
Pri zdravih pasjih mladičih starih 8 tednov in več niso opazili nobenih neželenih učinkov med 6-kratnim zdravljenjem s 5-kratnikom največjega odmerka.
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of 2-4 weeks.
Pri zdravih mladičih pasme beagle, starih 8 tednov in več niso opazili nobenih neželenih učinkov med 6-kratnim zdravljenjem s 5-kratnikom največjega odmerka v dvotedenskih do štiritedenskih intervalih.
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
Pri zdravih mladičih pasme beagle, starih 8 tednov in več niso opazili nobenih neželenih učinkov med 6-kratnim zdravljenjem s 5-kratnikom največjega odmerka v dvotedenskih do štiritedenskih intervalih.
No adverse reactions, except those mentioned in the section “Adverse Reactions” were observed after the administration of a double dose of vaccine.
Po odmerjanju dvojnega odmerka cepiva ni bil opažen noben neželen učinek razen tistih, ki so omenjeni v poglavju “Neželeni učinki (pogostost in resnost)”.
No adverse reactionts on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD).
Pri samcih in samicah podgan niso opazili neželenih učinkov na plodnost ali na sposobnost razmnoževanja pri odmerkih, ki povzročijo plazemsko izpostavljenost (AUC) do približno 2-krat plazemske AUC pri ljudeh pri največjem priporočenem odmerku za človeka.
No AEs were reported following this event of trametinib overdose.
Po tem primeru prevelikega odmerjanja niso zabeležili neželenih učinkov.
No age-related dose modification is required in patients less than 75 years old (see section 5.2).
S starostjo povezano prilagajanje odmerka pri bolnikih, mlajših od 75 let, ni potrebno (glejte točko 5.2).
No age-specific differences in adverse reactions were observed between paediatric and adults subjects.
Starostno specifičnih razlik v neželenih učinkih med pediatričnimi in odraslimi osebami niso opazili.
no AK lesion present, neither visible nor palpable
ni lezij aktinične keratoze, niso vidne niti otipljive
No ALT elevations ≥ 3 X ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis.
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z zdravilom Humira pri pediatričnih bolnikih s psoriazo v plakih.
No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis.
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z zdravilom Humira pri pediatričnih bolnikih s psoriazo v plakih.
No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis.
Do zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z zdravilom Humira pri pediatričnih bolnikih s psoriazo v plakih.
No alteration of fertility was detected.
Spremembe plodnosti niso zasledili.
No altered dose recommendations with the exception of grade 1 neurologic toxicity and grade 1 generalised toxic dermatitis.
Z izjemo 1. stopnje nevrološke toksičnosti in 1. stopnje generaliziranega toksičnega dermatitisa se prilagajanja odmerkov ne priporoča.
No amino acid substitutions associated with resistance to tenofovir disoproxil fumarate were identified in these isolates.
V teh izolatih niso identificirali nobenih substitucij aminokislin, ki bi bile povezane z rezistenco na dizoproksiltenofovirijev fumarat.
No amino acid substitutions associated with tenofovir disoproxil fumarate resistance were detected in any subject.
Pri nobenem bolniku niso ugotovili nobenih substitucij aminokislin, povezanih z rezistenco na dizoproksiltenofovirijev fumarat.
No animal fertility studies have been conducted with Kovaltry and its effect on human fertility has not been established in controlled clinical trials.
Študij na živalih o vplivu zdravila Kovaltry na plodnost niso izvedli in njegovih učinkov na plodnost pri ljudeh niso ugotavljali v nadzorovanih kliničnih preskušanjih.
No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab or its effect on fertility.
Študije na živalih, na podlagi katerih bi bilo mogoče oceniti genotoksični in karcinogeni potencial ekulizumaba ali njegov učinek na plodnost, niso bile opravljene.
No animal studies have been conducted to investigate the reproductive effects in florbetaben (18F) (see section 5.3).
Študij na živalih, s katerimi bi preučili učinke [18F]florbetabena na razmnoževanje, niso izvedli (glejte poglavje 5.3).
No animal studies have been conducted to investigate the reproductive effects of florbetapir (18F) (see section 5.3).
Študij na živalih, s katerimi bi preučili učinke florbetapirja (18F) na razmnoževanje niso izvedli (glejte poglavje 5.3).
No animal studies have been performed to determine potential effects on fertility in males or females.
Na živalih niso izvajali študij za oceno morebitnega vpliva zdravila na plodnost samcev ali samic.
No antagonism of antiviral activity was observed.
Antagonizma protivirusnemu delovanju niso opazili.
No antagonism was observed with emtricitabine or tenofovir alafenamide when combined with other antiretroviral agents.
Antagonizma z emtricitabinom ali alafenamidtenofovirjem v kombinaciji z drugimi protiretrovirusnimi zdravili niso opazili.
No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals (tested agents: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc, adefovir and raltegravir).
Pri testiranju dolutegravirja in drugih protivirusnih zdravil (preskušana zdravila: stavudin, abakavir, efavirenz, nevirapin, lopinavir, amprenavir, enfuvirtid, maravirok, adefovir in raltegravir) niso opazili nobenih antagonističnih učinkov in vitro.
No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals tested: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc and raltegravir.
Pri testiranju dolutegravirja in drugih protivirusnih zdravil, kot so stavudin, abakavir, efavirenz, nevirapin, lopinavir, amprenavir, enfuvirtid, maravirok in raltegravir, niso opazili nobenih antagonističnih učinkov in vitro.
No antagonistic effects in vitro were seen with zidovudine and other antiretrovirals (tested agents: abacavir, didanosine and interferon-alpha).
Antagonističnih učinkov z zidovudinom in drugimi protiretrovirusnimi učinkovinami (preskušane učinkovine: abakavir, didanozin in interferon-α) niso zaznali In vitro.
No antibodies to NSP were detected using the PrioCHECK FMDV NS test kit:
Z uporabo PrioCHECK® FMDV NS testa niso bila zaznana protitelesa proti NSP:
No antiemetic treatment
brez antiemetičnega zdravljenja
No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was observed.
Očitne povezave med nastankom protiteles in pojavom reakcije na mestu injiciranja niso opazili.
No apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12 week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine).
V 12-tedenski farmakokinetični podštudiji, kjer so raziskovali učinek ribavirina na intracelularno fosforilacijo nekaterih nukleozidnih zaviralcev reverzne transkriptaze (lamivudin in zidovudin ali stavudin) pri 47 bolnikih, sočasno okuženih s HIV in HCV, ki so zaključili podštudijo, jasnih dokazov o interakcijah med zdravili niso opazili.
no appetite for food
pomanjkanje apetita
No appreciable accumulation of ceftaroline is observed following multiple intravenous infusions of 600 mg administered over 60 minutes every 12 hours for up to 14 days in healthy adults with normal renal function.
Pri zdravih odraslih z normalnim delovanjem ledvic niso zabeležili opaznega kopičenja ceftarolina po večkratnih intravenskih infuzijah 600 mg v obdobju 60 minut na 12 ur do 14 dni.
No appreciable accumulation of ceftolozane/tazobactam is observed following multiple 1-hour IV infusions of 1 g / 0.5 g ceftolozane/tazobactam administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Pri zdravih odraslih z normalnim delovanjem ledvic niso opazili pomembnega kopičenja ceftolozana/tazobaktama po večkratnih 1-urnih intravenskih infuzijah 1 g/0,5 g ceftolozana/tazobaktama, uporabljenih na 8 ur do 10 dni.
No arrhythmic events were reported in AURAex or AURA2 (see section 4.8).
V študijah AURAex in AURA2 niso poročali o motnjah srčnega ritma (glejte poglavje 4.8).
No arrhythmic events were reported in AURAex or AURA2 (see sections 4.4 and 5.1).
V študijah AURAex in AURA2 niso zabeležili motenj srčnega ritma (glejte poglavji 4.4 in 5.1).
No assessment
Ocena ni bila izvedena
No back up contraception is needed.
Dodatna kontracepcija ni potrebna.
No back-up contraception is needed.
Dodatna kontracepcija ni potrebna.
No benefit was observed for MACE or all cause mortality .
Ugotovili niso nobene koristi ne glede MACE ne glede umrljivosti zaradi vseh vzrokov.
No benefit was observed for MACE or all cause mortality.
Ugotovili niso nobene koristi ne glede MACE ne glede umrljivosti zaradi vseh vzrokov.
No benefit, attributable to Extavia, in quality of life (as measured by FAMS – Functional Assessment of MS: Treatment Outcomes Index) was seen.
Po merilih ocene sposobnosti pri multipli sklerozi (FAMS - Functional Assessment of MS) niso opažali izboljšanja kakovosti življenja, ki bi ga lahko pripisali zdravilu Extavia.
No bleeding episodes were experienced in 45.3% of subjects while on individualised prophylaxis and in 17.4% of subjects while on weekly prophylaxis.
Epizode krvavitve se niso pojavile pri 45,3 % oseb na individualizirani profilaksi in pri 17,4 % oseb na tedenski profilaksi.
No bleeding episodes were experienced in 46.4% of paediatric subjects.
Pri 46,4 % pediatričnih oseb ni bilo epizod krvavitev.
No Blue Box included
Brez podatkov za »modro okence« (Blue Box)
no Blue Box included
Ne vključuje modrega okenca
No breakpoint for Brachyspira hyodysenteriae has been established.
MIK vrednosti za bakterijo Brachyspira hyodysenteriae niso določili.
No breakpoint for Brachyspira hyodysenteriae has been established.
Za Brachyspira hyodysenteriae ni bilo utrjene nobene točke spremembe.
No cabozantinib-treated subjects in this study had a confirmed QTcF >500 ms, nor did any cabozantinib-treated subjects in the RCC study (at a dose of 60 mg).
Nobena oseba, ki ni bila zdravljena s kabozantinibom v tej študiji, ni imela potrjenega QTcF > 500 ms, niti ga ni imela nobena oseba, zdravljena s kabozantinibom v študiji KLC (pri odmerku 60 mg).
No carcinogenic potential was detected.
Pri podganah je pri odmerku
No carcinogenic studies have been conducted with cysteamine bitartrarte gastro-resistant hard capsules.
Študij kancerogenosti z gastrorezistentnimi trdimi kapsulami cisteaminijevega bitartrata niso izvedli.
No carcinogenicity studies have been performed with ONIVYDE.
Študij kancerogenosti zdravila ONIVYDE niso izvedli.
No carcinogenicity, mutagenicity or impairment of fertility studies have been conducted with DepoCyte.
Z zdravilom DepoCyte niso opravili nikakršnih raziskav karcinogenosti, mutagenosti ali oslabitve plodnosti.
no cardiac
obolenja
No case of an overdose in the paediatric population has been observed.
Primerov prekomernega odmerjanja v pediatrični populaciji ni bilo.
No case of overdose has been reported within the approved indication.
Pri uporabi v skladu z odobreno indikacijo niso poročali o primerih prevelikega odmerjanja.
No case of overdose has been reported.
Ni poročil o primerov prevelikega odmerjanja.
No case of overdose have been reported.
Ni poročil o primerih prevelikega odmerjanja.
No case of overdose in adults or paediatrics has been reported.
Poročali niso o nobenem primeru prevelikega odmerjanja pri odraslih ali otrocih.
No case of overdose of Aldurazyme has been reported.
Ni poročil o primerih prevelikega odmerjanja.
No case of RPLS was reported in this study, but RPLS has been reported in other clinical studies.
V teh študiji niso poročali o nobenem primeru RPLS, vendar so o RPLS poročali v drugih kliničnih študijah.
No cases of cancer caused by Xofigo have been reported in clinical trials with a follow-up of up to three years.
Iz kliničnih preskušanj z do triletnim spremljanjem ni poročil o raku, ki bi ga povzročilo zdravilo Xofigo.
No cases of ILD-like events have been reported with ONIVYDE therapy in clinical studies.
Pri zdravljenju z zdravilom ONIVYDE v kliničnih študijah ni bilo primerov učinkov, podobnih IPB.
No cases of interstitial lung diseases (ILD) have been reported with teriflunomide in the clinical trials.
V kliničnih preskušanjih teriflunomida niso ugotovili primerov intersticijskih pljučnih bolezni (ILD- interstitial lung diseases).
No cases of overdose after cutaneous use of Mirvaso were reported during the clinical development program.
O primerih prevelikega odmerjanja po dermalni uporabi zdravila Mervaso med programom kliničnega razvoja niso poročali.
No cases of overdose associated with adverse reactions were reported in clinical studies with Abilify Maintena.
V kliničnih študijah z zdravilom Abilify Maintena niso poročali o primerih prevelikega odmerjanja, povezanimi z neželenimi učinki.
No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann’s thrombasthenia.
Med bolniki s pridobljeno hemofilijo ali Glanzmannovo trombastenijo ni opisanih primerov prevelikega odmerjanja.
No cases of overdose with recombinant coagulation factor VIII have been reported.
Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
No cases of PML were reported in clinical studies of vedolizumab however, healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms as outlined in physician education materials, and consider neurological referral if they occur.
V kliničnih študijah pri uporabi vedolizumaba o primerih progresivne multifokalne levkoencefalopatije (PML) sicer niso poročali, vendar pa morajo zdravstveni delavci kljub temu bolnike nadzirati glede pojava kakršnih koli novih ali poslabšanja že prisotnih nevroloških znakov in simptomov, kot je opisano v izobraževalnem gradivu za zdravnike, in bolnike po potrebi napotiti na specialistični nevrološki pregled.
No cases of severe hypoglycaemia were observed
Primerov hude hipoglikemije pri zdravilu Trulicity ali pri placebu niso opazili.
No cases of severe hypoglycaemia were observed.
Primerov hude hipoglikemije pri uporabi dulaglutida niso opazili.
No cases of severe hypoglycaemia with dulaglutide were observed.
Primerov hude hipoglikemije niso opazili.
No cases of Torsades de Pointes or temporally related events suggestive of proarrhythmias occurred.
Primerov Torsades de Pointes ali časovno povezanih dogodkov, ki bi nakazovali proaritmije, niso opazili.
No cases of Xofigo-induced cancer have been reported in clinical trials in follow-up of up to three years.
V kliničnih preskušanjih z do triletnim spremljanjem bolnikov niso poročali o rakavih boleznih, povzročenih z zdravilom Xofigo.
No cases were reported in patients in FAC arm .
Med bolnicami v kraku FAC niso zabeležili nobenega primera.
No cases were reported in patients in FAC arm.
Med bolnicami v kraku FAC niso zabeležili nobenega primera.
No cases were reported in patients in FAC.
Med bolnicami v kraku FAC niso zabeležili nobenega primera.
No cases with fatal outcome were reported in GIST, MRCC and pNET registrational studies.
V registracijskih študijah GIST, MRCC in pNET ni bilo opisanih smrtnih izidov.
No change
Brez sprememb
No change in dose is required for elderly patients.
Pri starejših bolnikih odmerka zdravila ni treba spreminjati.
No change in dose is required for elderly patients.
Za starejše bolnike ni potrebno spreminjanje odmerka.
No change in dose is required for patients with renal impairment.
Spreminjanje odmerka zdravila pri bolnikih z okvaro ledvic ni potrebno.
No change in dose is required for renal impairment.
Pri ledvičnih okvarah ni potrebno spreminjati odmerka.
No change in dose or schedule.
Ni sprememb v odmerku ali v razporedu odmerjanja.
No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted.
Spremembe v izpostavljenosti karbamazepinu ali njegovemu presnovku karbamazepin- epoksidu pa niso zaznali.
No change in plasma concentration were shown with paclitaxel concentrate.
Pri koncentratu paklitaksela niso opazili nobene spremembe v plazmi.
No changes in blood biochemical parameters such as ALT or ALP were determined in postmenopausal women treated with Ospemifene in clinical studies.
Pri ženskah po menopavzi, ki so se v kliničnih študijah zdravile z ospemifenom, niso opazili sprememb biokemičnih parametrov v krvi, kot sta vrednost ALT ali ALP.
No changes in methadone
Glede na klinično stanje
No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of
Ni sprememb navideznega očistka lamivudina in volumna porazdelitve, kar kaže, da nevirapin nima indukcijskega učinka na očistek lamivudina.
No children of less than 5 years of age were treated.
Otrok, mlajših od 5 let, niso zdravili.
No cirrhosis
Brez ciroze
no cirrhosis
brez ciroze s cirozo
No cirrhosis With cirrhosis
Brez ciroze S cirozo
No cirrhosis**
Brez ciroze
No cirrhosisa
Brez cirozea
No cirrhosisc
Brez cirozec
No clear cutoff for PD-L1 expression can reliably be established when considering the relevant endpoints of tumour response and PFS.
Jasne mejne vrednosti ekspresije PD-L1 ni bilo mogoče ugotoviti, če upoštevamo relevantne opazovane dogodke odziva tumorja in PFS.
No clear treatment-related effects or adverse effects were observed in reproductive toxicology studies in mice with a surrogate terminal complement inhibitory antibody.
V okviru reproduktivnih toksikoloških študij na miših z nadomestnim protitelesom z zaviralnim učinkom na terminalni komplement niso opazili nikakršnih učinkov, nedvoumno povezanih z zdravljenjem, ali neželenih učinkov.
No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.
Jasne težnje po povečanju sistemske izpostavljenosti AsIII, AsV, MMAV ali DMAV ni bilo opaziti z zmanjšanjem ravni delovanja jeter pri oceni AUC z normaliziranim odmerkom (na mg odmerka).
No clinical data are available on the interaction between IT chemotherapy and IT ziconotide.
Podatkov o interakcijah med IT zikonotidom in IT kemoterapevtiki ni.
No clinical data are available, potential risk for human is unknown.
Kliničnih podatkov ni na voljo, morebitno tveganje za ljudi je neznano.
No clinical data available for the
atazanavirja ni kliničnih podatkov.
No clinical data for safinamide on exposed pregnancies is available.
Za safinamid niso na voljo podatki o nosečnostih, v katerih bi bile nosečnice izpostavljene zdravilu.
No clinical data on exposed pregnancies are available.
Za rivastigmin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
No clinical data on protective efficacy of Dukoral against cholera after administration of booster doses are available.
Ni na voljo podatkov o učinkovitosti zaščite Dukorala proti koleri po dajanju poživitvenega odmerka.
No clinical data on the effects of Holoclar on fertility are available.
Kliničnih podatkov o učinkih zdravila Holoclar na plodnost ni.
No clinical data on the need to adjust the dosage in patients with impaired hepatic or renal function are available (see section 4.4).
Kliničnih podatkov, da bi bilo treba pri bolnikih z jetrno ali ledvično okvaro odmerek prilagoditi, ni (glejte poglavje 4.4)
No clinical DDI studies have been conducted to assess this finding, and clinically relevant inhibition of intestinal BCRP cannot be ruled out.
Kliničnih študij medsebojnega delovanja zdravil za oceno tega izsledka niso izvedli in klinično pomembnega zavrtja BCRP na ravni črevesja ni mogoče izključiti.
No clinical efficacy and safety studies have been conducted using Neofordex in the treatment of multiple myeloma.
Študij o klinični učinkovitosti in varnosti zdravila Neofordex pri zdravljenju multiplega mieloma niso opravili.
No clinical or animal data with insulin human on male or female fertility are available.
Kliničnih podatkov ali podatkov iz študij na živalih o vplivu humanega insulina na moško ali žensko plodnost ni na voljo.
No clinical or animal data with insulin human on male or female fertility are available.
Kliničnih podatkov ali podatkov pri živalih o vplivu humanega insulina na plodnost moških ali žensk ni .
No clinical or non-clinical fertility studies have been conducted with TRISENOX.
Zdravila Trisenox niso preskušali v kliničnih ali predkliničnih študijah plodnosti.
No clinical relevance has been established.
Klinični pomen teh sprememb ni znan.
No clinical studies have been conducted in patients with hepatic insufficiency.
Klinične študije pri bolnikih z jetrno insuficienco niso bilo izvedene.
No clinical studies have been performed in children 0-7 years old and therefore no dose can be recommended for this age group.
Pri otrocih, starih od 0 do 7 let, ni bilo opravljenih kliničnih študij, zato za to starostno skupino ni možno priporočiti odmerka.
No clinical studies have been performed to evaluate the effects of talimogene laherparepvec on fertility see section 5.3).
Kliničnih študij za oceno vplivov talimogena laherparepveka na plodnost niso izvedli (glejte poglavje 5.3).
No clinical studies with NovoMix 50 have been carried out in children and adolescents under the age of 18 years.
Pri otrocih in mladostnikih do 18. leta starosti klinične študije z zdravilom NovoMix 50 niso bile izvedene.