natgillin/translations-raw huggingface dataset:
In the 11-18 year old population of the pivotal study, V59P13, the immunogenicity of a single dose of Menveo one month post vaccination is compared with the ACWY-D.
V populaciji, stari 11-18 let, so v osrednji študiji V59P13 primerjali imunogenost enojnega odmerka cepiva Menveo en mesec po cepljenju z ACWY-D.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients.
V 12 tednov trajajoči akutni fazi treh kliničnih preskušanj duloksetina pri bolnikih z bolečino diabetične nevropatije so pri bolnikih, zdravljenih z duloksetinom, opažali majhna, a statistično značilna povišanja koncentracij glukoze v krvi na tešče.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients.
V 12 tednov trajajoči akutni fazi treh kliničnih preskušanj duloksetina pri bolnikih z bolečino zaradi diabetične nevropatije so pri bolnikih, zdravljenih z duloksetinom, opažali majhna, a statistično značilna povišanja koncentracij glukoze v krvi na tešče.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients.
V 12 tednov trajajoči akutni fazi treh kliničnih preskušanj duloksetina pri bolnikih z bolečino, zaradi diabetične nevropatije so pri bolnikih, zdravljenih z duloksetinom, opažali majhna, a statistično značilna povišanja koncentracij glukoze v krvi na tešče.
In the 12 week controlled phase, the rate of all infections in the tocilizumab group was 344.7 per 100 patient years and 287.0 per 100 patient years in the placebo group.
V 12-tedenski, kontrolirani fazi je bil delež vseh okužb v skupini, ki je prejemala tocilizumab, 344,7 na 100 bolnik-let in 287,0 na 100 bolnik-let v skupini, ki je prejemala placebo.
In the 12 week controlled phase, the rate of serious infections in the tocilizumab group was 11.5 per 100 patient years.
V 12-tedenski, kontrolirani fazi je bil delež resnih okužb v skupini, ki je prejemala tocilizumab, 11,5 na 100 bolnik-let.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
V 12 tedenski študiji, ki je zajemala bolnike, ki so prejemali peritonealno dializo pa se je pokazala primerljivost zmajšanja iPTH- ja z bolniki, ki so prejemali kalcijev acetat.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
V 12 tedenski študiji, ki je zajemala bolnike, ki so prejemali peritonealno dializo, pa se je pokazala primerljivost zmajšanja iPTH- ja z bolniki, ki so prejemali kalcijev acetat.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Vendar pa so v 12-tedenski študiji, ki je zajemala bolnike na peritonealni dializi, opazili podobna znižanja iPTH v primerjavi z bolniki, ki so prejemali kalcijev acetat.
In the 12-14 months age group who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity.
V starostni skupini od 12 do 14 mesecev, ki je prejela 2 odmerka cepiva Nimenrix v presledku 2 mesecev, sta bila prvi in drugi odmerek povezana s podobnimi lokalnimi in sistemskimi reakcijami.
In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Incruse (1.0 units, p=0.05).
V 12-tedenski študiji z zdravilom Incruse v primerjavi s placebom niso ugotovili statistično značilnega izboljšanja fokalnega seštevka TDI po 12 tednih (1,0 enota, p = 0,05).
In the 12-week study, Incruse statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
V 12-tedenski študiji je zdravilo Incruse statistično značilno zmanjšalo uporabo rešilnega zdravila s salbutamolom v primerjavi s placebom (povprečno zmanjšanje 0,7 vdiha na dan v obdobju od 1. do 12. tedna, p = 0,025) in je doseglo večji odstotek dni brez potrebe po rešilnem zdravilu (povprečno 46,3 %) kot placebo (povprečno 35,2 %; formalne statistične analize tega opazovanega dogodka niso izvedli).
In the 120-week C208 trial where SIRTURO was administered for 24 weeks in combination with a background regimen, more deaths occurred in the SIRTURO treatment group than in the placebo group (see section 4.8).
V 120-tedenski študiji C208, v kateri so zdravilo SIRTURO odmerjali 24 tednov v kombinaciji z osnovno shemo, je v skupini z zdravilom SIRTURO prišlo do več smrtnih primerov kot v skupini s placebom (glejte poglavje 4.8).
In the 13 week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
V 13-tedenski študiji so pri visokih odmerkih z nizko incidenco poročali o spremembah kostnega mozga pri ženskih osebkih in o limfoidnih spremembah.
In the 13-week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
V 13. tednu študije so pri visokih odmerkih z nizko incidenco poročali o spremembah kostnega mozga pri ženskih osebkih in o limfoidnih spremembah.
In the 16 patients with MCD treated with 11 mg/kg every 3 weeks, overall tumour response rate by independent review was 43.8% with 6.3% complete response.
Pri 16 bolnikih z MCD, ki so prejemali odmerek 11 mg/kg vsake 3 tedne, je bila po oceni neodvisnih ocenjevalcev pogostnost celokupnega odziva 43,8%, popolnega odziva pa 6,3%.
In the 2 active controlled a DVT/PE treatment trials, RE-COVER and RE-COVER II, a total of 2,553 patients were included in the safety analysis for dabigatran etexilate.
V dveh z aktivnim zdravilom nadzorovanih preskušanjih o zdravljenju GVT/PE, RE-COVER in RE-COVER II, je bilo skupno število bolnikov, vključenih v analizo podatkov o varnosti dabigatran eteksilata2553.
In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz.
V obeh kliničnih študijah, ki sta vključili aktivno primerjalno zdravilo (UNCOVER-2 in UNCOVER- 3), je stopnja resnih neželenih dogodkov znašala 1,9 % tako za etanercept kot za zdravilo Taltz, stopnja prekinitve zdravljenja zaradi neželenih dogodkov pa je bila 1,2 % za etanercept in 2,0 % za zdravilo Taltz.
In the 2 studies in which patients were started and maintained on 150 mg every 2 weeks, the achieved mean reduction of LDL-C at week 12 was 62.6%.
V 2 študijah, v katerih so bolniki začeli in vzdrževali zdravljenje s 150 mg na 2 tedna, je bilo doseženo povprečno znižanje LDL-H 12. teden 62,6 %.
In the 2-year active- controlled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z zdravilno učinkovino, v kateri so bili bolniki zdravljeni z etanerceptom, metotreksatom ali kombinacijo enteracepta in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z zdravilno učinkovino, v kateri so bili bolniki zdravljeni z zdravilom Enbrel, metotreksatom ali kombinacijo zdravila Enbrel in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at
V 2-letni študiji karcinogenosti pri podganah je odmerjanje imanitiba 15, 30 in 60 mg/kg/dan povzročilo statistično značilno skrajšanje življenjske dobe samcev pri 60 mg/kg/dan in samic pri
In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases  3 times the upper limit of normal (ULN) were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients.
V 20 integriranih s placebom nadzorovanih študijah so opazili povišanja vrednosti jetrnih aminotransferaz za  3-kratno vrednost zgornje meje normalnih vrednosti (ZMN), in to pri 11,2 % bolnikov, ki so jemali bosentan, in 2,4 % bolnikov, ki so prejemali placebo.
In the 20 subjects who had none of these risk factors there was no inhibitor development.
Pri 20 preiskovancih brez navedenih dejavnikov tveganja se zaviralci niso pojavili.
In the 24-week clinical study, where Colobreathe was administered twice daily to adults and children aged 6-17, the adverse reactions identified in the paediatric population were similar to that for the overall population.
V 24-tedenski klinični študiji, kjer so zdravilo Colobreathe dajali dvakrat na dan odraslim in otrokom, starim 6 let do 17 let, so bili neželeni učinki, ugotovljeni v pediatrični populaciji, podobni kot pri splošni populaciji.
In the 3 controlled clinical ITP studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 8% and 8% of the eltrombopag and placebo groups, respectively (see section 4.4).
V 3 nadzorovanih ITP kliničnih študijah so o prehodnem zmanjšanju števila trombocitov na vrednosti, manjše od izhodiščnih vrednosti, poročali pri 8 % bolnikov v skupinah, ki so prejemale eltrombopag, in 8 % bolnikov v skupinah, ki so prejemale placebo (glejte poglavje 4.4).
In the 3 studies (one phase 2 and two phase 3 studies, Study 1 and Study 2), the cumulative frequency of PTLD was higher in belatacept treated patients at the recommended dosing regimen (LI) (1.3%; 6/472) than in the ciclosporin group (0.6%; 3/476), and was highest in the belatacept MI group (1.7%; 8/477).
V treh študijah (ena študija 2. faze in dve študiji 3. faze; Študija 1 in Študija 2) je bila kumulativna pogostnost PTLB večja pri bolnikih, ki so se zdravili s priporočenim režimom zdravljenja z belataceptom (MI) (1,3 %; 6/472), kot pri bolnikih, ki so prejemali ciklosporin (0,6 %; 3/476), najvišja pa je bila v skupini bolnikov, ki so belatacept prejemali po BI režimu (1,7 %; 8/477).
In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
V 3,5-letni PROactive študiji je 44/870 (5,1 %) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5 %) žensk, zdravljenih s primerjalnim zdravilom.
In the 301 clinical study, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values.
V klinični študiji 301 je bila verjetnost za zvišanje vrednosti testov jetrne funkcije večja pri bolnikih, katerih vrednosti ALT ali AST so bile zvišane že ob izhodišču, v primerjavi s tistimi bolniki, ki so imeli ob izhodišču normalne vrednosti.
In the 301 trial, patients with baseline ALT and AST ≥ 2.5 x ULN in the absence of liver metastases and > 5 x ULN in the presence of liver metastases were excluded.
V študijo 301 niso vključili bolnikov z izhodiščnimi koncentracijami ALT in AST na ≥ 2,5-kratniku zgornje meje normalnih vrednosti pri bolnikih brez jetrnih metastaz oziroma na > 5-kratnik zgornje meje normalnih vrednosti pri bolnikih s prisotnimi metastazami na jetrih.
In the 302 trial, patients with liver metastases were not eligible and patients with baseline ALT and AST ≥ 2.5 x ULN were excluded.
Za vključitev v študijo 302 niso bili primerni bolniki s prisotnimi metastazami na jetrih in izključili so bolnike z izhodiščnimi koncentracijami ALT in AST na ≥ 2,5-kratniku zgornje meje normalnih vrednosti.
In the 4 open-label studies, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
V 4 odprtih študijah so lahko klinično stabilni bolniki po vsaj 5 do 10 dneh zdravljenja z anidulafunginom prešli na peroralno zdravljenje z azoli.
In the 4 patients with indications of higher absorption, dose-normalised Cmax ranged from 788-900 ng/ml per gram of NexoBrid.
Pri 4 bolnikih z znaki večje absorpcije je bil Cmax, normaliziran na odmerek, v razponu 788–900 ng/ml na gram zdravila NexoBrid.
In the 4th year alone, Evista reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Samo v četrtem letu zdravljenja je prejemanje zdravila Evista znižalo tveganje za nov zlom vretenca za 39 % (RR 0,61 pri 95 % CI 0,43–0,88).
In the 4th year alone, Optruma reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Samo v četrtem letu zdravljenja je prejemanje zdravila Optruma znižalo tveganje za nov zlom vretenca za 39 % (RR 0,61 pri 95 % CI 0,43–0,88).
In the 4th year alone, raloxifene reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Samo v četrtem letu zdravljenja je prejemanje raloksifena znižalo tveganje za nov zlom vretenca za 39 % (RR 0,61 pri 95 % CI 0,43-0,88).
In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo.
V 5 s placebom kontroliranih študijah so se pljučni dogodki pojavili pri 0,6 % bolnikov v skupini z dronedaronom in pri 0,8 % bolnikov, ki so prejemali placebo.
In the 6-month controlled trials adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
V šestmesečnih kontroliranih kliničnih študijah je neželene učinke, povezane z infundiranjem (izbrane učinke, ki so se pojavili med infundiranjem ali v 24 urah po njem), navedlo 6,9 % bolnikov v skupini, ki je dobivala 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, in 5,1 % bolnikov v skupini, ki je dobivala placebo in imunomodulirajoča antirevmatična zdravila.
In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μl occurred in 1.7% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
V šestmesečnih kontroliranih kliničnih preskušanjih se je število trombocitov zmanjšalo pod 100 x 103/µl pri 1,7 % bolnikov, ki so dobivali 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili, in pri < 1 % tistih, ki so dobivali placebo v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Enurev Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Enurev Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
V 6-mesečni študiji je znašal odstotek bolnikov z zmernim oziroma s hudim poslabšanjem pri uporabi zdravila Enurev Breezhaler 17,5 %, pri uporabi placeba pa 24,2 %. (razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Enurev Breezhaler 32,8 %, pri uporabi placeba pa 40,2 % (razmerje ogroženosti: 0,66, p=0,001).
In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Seebri Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Seebri Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
V 6-mesečni študiji je znašal odstotek bolnikov z zmernim oziroma s hudim poslabšanjem pri uporabi zdravila Seebri Breezhaler 17,5 %, pri uporabi placeba pa 24,2 %. (razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Seebri Breezhaler 32,8 %, pri uporabi placeba pa 40,2 % (razmerje ogroženosti: 0,66, p=0,001).
In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Tovanor Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Tovanor Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
V 6-mesečni študiji je znašal odstotek bolnikov z zmernim oziroma s hudim poslabšanjem pri uporabi zdravila Tovanor Breezhaler 17,5 %, pri uporabi placeba pa 24,2 %. (razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Tovanor Breezhaler 32,8 %, pri uporabi placeba pa 40,2 % (razmerje ogroženosti: 0,66, p=0,001).
In the 64-week study patients were enrolled who had severe to very severe COPD.
V 64-tedensko študijo so bili vključeni bolniki s hudo do zelo hudo KOPB.
In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatment- emergent variants were seen in all 3 drug targets in 30 subjects.
Pri 67 preiskovancih, okuženih z genotipom 1a, so variante NS3 opažali pri 50 preiskovancih, variante NS5A pri 46 preiskovancih, variante NS5B pri 37 preiskovancih; med zdravljenjem nastale variante so ugotovili pri vseh 3 tarčnih genih zdravil pri 30 preiskovancih.
In the 99 MabThera patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Med 99 bolniki, ki so prejeli zdravilo MabThera, je bil celotni delež okužb na primarni končni točki po 6 mesecih približno 237 na 100 bolnik-let (95-% interval zaupanja, 197–285).
In the above circumstances, if the levels return to pre-treatment values, continuing or re-introducing STAYVEER may be considered.
Če se v zgoraj navedenih okoliščinah vrednosti vrnejo na vrednosti pred zdravljenjem, presodite o nadaljevanju ali ponovni uvedbi zdravljenja z zdravilom STAYVEER.
In the above circumstances, if the levels return to pre-treatment values, continuing or re-introducing Tracleer may be considered.
Če se v zgoraj navedenih okoliščinah vrednosti vrnejo na vrednosti pred zdravljenjem, presodite o nadaljevanju ali ponovni uvedbi zdravljenja z zdravilom Tracleer.
In the absence of a suitable formulation (6 mg/ml oral suspension), the pharmacy compounded preparation should preferentially be used.
V primeru, da primerna oblika (6 mg/ml peroralna suspenzija) ni na voljo, se mora preferenčno uporabiti v lekarni pripravljen izdelek.
In the absence of a teratogenic effect in animals, no malformative effect is expected in man.
V primeru odsotnosti teratogenega delovanja pri živalih tudi pri človeku ne pričakujemo malformacijskih učinkov.
In the absence of additional data, this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.
Zaradi pomanjkanja dodatnih podatkov zdravila ne smemo mešati z drugimi zdravili, ali ga sočasno infundirati po isti intravenski liniji.
In the absence of additional safety studies, do not repeat the treatment at intervals of less than 2 weeks, do not treat puppies less than 8 weeks of age, and dogs less than 2 kg bodyweight.
Ker ni dodatnih študij o varnosti, zdravljenja ne ponavljajte v intervalih, krajših od 2 tednov, in ne zdravite mladičev starih manj kot 8 tednov in psov lažjih od 2 kg.
In the absence of adequate data, Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 50 ml/minute).
Ker ni na voljo primernih podatkov, je treba pri bolnikih z zmerno ledvično okvaro (CLcr 30 do 50 ml/minuto) zdravilo Kineret uporabljati previdno.
In the absence of available data, the veterinary medicinal product should not be used on puppies less than 8 weeks old and /or dogs weighing less than 2 kg.
Ker ni ustreznih podatkov, se to zdravilo za uporabo v veterinarski medicini ne sme uporabljati za mladiče do 8 tednov starosti oziroma za pse, ki tehtajo manj kot 2 kg.
In the absence of available data, treatment of chicken less than 3 weeks of age should be based on a benefit/risk assessment by the responsible veterinarian.
Ker ni ustreznih podatkov, uporabite pri piščancih, ki so mlajši od 3 tednov, v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Ker ni razpoložljivih podatkov, mora zdravljenje mladičev, mlajših od 8 tednov in psov, lažjih od 2 kg, temeljiti na oceni razmerja korist ̶ tveganje odgovornega veterinarja.
In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Ker ni razpoložljivih podatkov, mora zdravljenje mladičev, mlajših od 8 tednov in/ali psov, lažjih od 2 kg temeljiti na oceni razmerja korist ̶ tveganje odgovornega veterinarja.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Ker ni razpoložljivih podatkov, mora zdravljenje mladičev, mlajših od 8 tednov in/ali psov, lažjih od 2 kg temeljiti na oceni razmerja korist ̶ tveganje odgovornega veterinarja.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Ker ni razpoložljivih podatkov, mora zdravljenje mladičev, mlajših od 8 tednov in/ali psov, lažjih od 2 kg temeljiti na oceni razmerja med koristjo in tveganjem odgovornega veterinarja.
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the gastrointestinal tract will be metabolised like the endogenous urea.
V odsotnosti bakterijske ureaze se bo vsa količina zaužite sečnine po absorpciji iz prebavil presnovila enako kot endogena sečnina.
In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Ker ni podatkov o varnosti za kost pri bolnikih s hudo ledvično okvaro, ki bi jemali stroncijev ranelat, zdravilo PROTELOS ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje 5.2).
In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
V odsotnosti kriterijev CHMP za imunogenost za otroke so bili za ocenitev seroloških podatkov po cepljenju otrok uporabljeni kriteriji CHMP za imunogenost za ocenitev sezonskih cepiv proti gripi za odrasle.
In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
V odsotnosti kriterijev CHMP za imunogenost za otroke so bili za oceno seroloških podatkov po cepljenju otrok uporabljeni kriteriji CHMP za imunogenost za oceno sezonskih cepiv proti gripi za odrasle.
In the absence of clinical efficacy and safety data, HEMANGIOL should not be used in children aged below 5 weeks.
Zaradi pomanjkanja podatkov o klinični učinkovitosti in varnosti zdravila HEMANGIOL ni dovoljeno uporabljati pri otrocih, mlajših od 5 tednov.