FrancophonIA/ELRC3.0 huggingface dataset:
English: Hexacima helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexacima is given to children from six weeks of age.
Slovenian: Cepivo Hexacima ščiti vašega otroka pred davico, tetanusom, oslovskim kašljem, hepatitisom B, otroško paralizo in hudimi boleznimi, ki jih povzroča Haemophilus influenzae tipa b. Cepivo
English: 25 micrograms
Slovenian: 25/25 µg
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Slovenian: Mešano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu influence tipa b (konjugirano), adsorbirano.
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Slovenian: 2 Kot spodnja meja zaupanja (p = 0,95).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Francija
English: EXPIRY DATE EXP: MM/YYYY
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do: MM/LLLL
English: • Uncommon side effects (may affect up to 1 in 100 people) are: - allergic reaction - lump (nodule) at the injection site - high fever (temperature 39.6°C or higher)
Slovenian: • Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 cepljenih) so: - alergijska reakcija
English: With hepatitis B
Slovenian: s cepljenjem proti hepatitisu
English: Without hepatitis B vaccination at birth
Slovenian: s cepljenjem proti hepatitisu B ob rojstvu brez cepljenja proti hepatitisu B ob rojstvu
English: • has had any of the following events after receiving a pertussis vaccine, as the decision to give further doses of pertussis containing vaccine will need to be carefully considered: - fever of 40°C or above within 48 hours not due to another identifiable cause.
Slovenian: • imel po prejemu cepiva proti oslovskemu kašlju katerega koli izmed naslednjih neželenih učinkov, je treba temeljito pretehtati odločitev o dajanju nadaljnjih odmerkov cepiva:
English: Marketing Authorisation Holder: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon , France
Slovenian: Imetnik dovoljenja za promet z zdravilom: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Francija
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), without needle.
Slovenian: Cepivo Hexacima v napolnjenih injekcijskih brizgah 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz halobutila) in zaščiteni z zaporko (iz halobutila), brez igle.
English: Additional injections (booster)
Slovenian: Dodatno cepljenje (obnovitveno cepljenje)
English: Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth ( Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
Slovenian: ‡‡ Serokonverzija: najmanj 4-kratno povišanje v primerjavi s stopnjo pred cepljenjem (pred odmerkom 1) § Odziv na cepljenje: Če je koncentracija protiteles pred cepljenjem < 8 EU/ml je koncentracija protiteles po cepljenju lahko ≥ 8 EU/ml.
English: MARKETING AUTHORISATION HOLDER Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Francija
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hexacima suspension for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Hexacima suspenzija za injiciranje DTaP-IPV-HB-Hib i. m.
English: Disodium hydrogen phosphate
Slovenian: 25 mikrogramov filamentozni hemaglutinin
English: Hexacima will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
Slovenian: A, hepatitis C in hepatitis E, ali drugi jetrni patogeni.
English: Some of these effects may be serious.
Slovenian: Nekateri od teh učinkov so lahko resni.
English: Day -- -
Slovenian: dan -- -
English: This will be done by a healthcare professional.
Slovenian: To bo naredil zdravstveni delavec.
English: Unopened vial 18 months.
Slovenian: Neodprta viala 18 mesecev.
English: Do not give by other routes.
Slovenian: Ne dajajte ga po drugi poti.
English: Therefore no dose recommendations can be made in this population.
Slovenian: Zato priporočil za odmerjanje pri tej populaciji ni mogoče dati.
English: Best response
Slovenian: Najboljši odziv
English: Dissolution of the lyophilised powder is completed in less than 2 minutes.
Slovenian: Raztapljanje liofiliziranega praška je končano v manj kot 2 minutah.
English: • Risk Management Plan (RMP)
Slovenian: - Načrt za obvladovanje tveganj (RMP)
English: 02-954 Warszawa Polska
Slovenian: 02-954 Warszawa
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno dostopni podatki so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni možno dati.
English: This is not considered clinically relevant.
Slovenian: Rezultat nima kliničnega pomena.
English: These patients should be monitored closely and appropriate precautions taken.
Slovenian: Te bolnike je treba skrbno spremljati in upoštevati ustrezne previdnostne ukrepe.
English: Information on autonomic neuropathy and its contribution to these undesirable effects is limited.
Slovenian: Podatki o avtonomni nevropatiji in tem, koliko ta prispeva k tem neželenim učinkom, so omejeni.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Slovenian: To zdravilo bo injiciral vaš zdravnik ali medicinska sestra, zato ni verjetno, da bi ga lahko prejeli preveč.
English: Hyde Park, Hayes 3
Slovenian: Hyde Park, Hayes 3 5th Floor
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 22 July 2016
Slovenian: Datum prve odobritve: 22. julij 2016 Datum zadnjega podaljšanja:
English: If, despite these measures, pregnancy occurs, tell your doctor immediately.
Slovenian: Če kljub tem ukrepom zanosite, takoj obvestite zdravnika.
English: Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
Slovenian: Raziskave plodnosti niso opravili, opravili pa so ovrednotenje reproduktivnih tkiv v raziskavah splošne toksičnosti.
English: Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Slovenian: Zdravljenje je trajalo največ 9 krogov (približno 54 tednov) in je bilo v primeru napredovanja bolezni ali nesprejemljive toksičnosti prekinjeno prej.
English: Ranbaxy (Poland) Sp. Z o. o. ul.
Slovenian: Polska Ranbaxy (Poland) Sp. Z o. o.
English: This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Slovenian: Ta stopnja preživetja je bila večja od 6 do 9-mesečne mediane preživetja, ki jo pričakujejo konziliarni klinični raziskovalci za podobno skupino bolnikov.
English: - swelling of body, to include around eyes and other parts of the body.
Slovenian: - otekanje telesa, vključno z otekanjem okoli oči in drugih delov telesa.
English: albumin, and region.
Slovenian: mikroglobulin, albumin in regija.
English: Decreased appetite
Slovenian: - izguba apetita
English: Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Slovenian: Večina primerov PML je bila diagnosticirana v 12 mesecih po prvem odmerku bortezomiba.
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: One hundred and twenty seven matched pairs of patients were identified.
Slovenian: Definiranih je bilo stosedemindvajset izenačenih parov bolnikov.
English: For dose adjustments, see Table 5 below.
Slovenian: Za prilagajanje odmerkov glejte spodnjo preglednico 5.
English: Proteasomes play an important role in controlling cell function and growth.
Slovenian: Proteasomi imajo pomembno vlogo pri nadzoru delovanja in rasti celic.
English: Reduction in serum Mprotein populationg n=667
Slovenian: Zmanjšanje serumskega Mproteina populacijag n=667
English: Time to first response in CR + PR
Slovenian: Čas do prvega odziva pri CR + PR
English: Day 8, 11
Slovenian: dan 8, 11
English: 2132JH HOOFDDORP NETHERLANDS
Slovenian: 2132 JH HOOFDDORP NIZOZEMSKA
English: Consider reduction of the melphalan dose by 25% in the next cycle.
Slovenian: V naslednjem krogu zdravljenja razmislite o zmanjšanju odmerka melfalana za 25 %.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Slovenian: AST = aspartat-aminotransferaza; ULN (upper limit of the normal range) = zgornja meja razpona normalnih vrednosti.
English: Peri- and postnatal development studies were not conducted.
Slovenian: Raziskav peri- in postnatalnega obdobja niso opravili.
English: Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
Slovenian: Zaradi te zgodnje zamenjave zdravila je mediana trajanja spremljanja preživelih bolnikov 8,3 meseca.
English: Patients with risk factors for or existing heart disease should be closely monitored.
Slovenian: Bolnike z dejavniki tveganja za srčno bolezen ali z obstoječo srčno boleznijo je treba skrbno spremljati.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Slovenian: S protokolom določena vmesna analiza (na podlagi 249 TTP-dogodkov) je vodila do predčasne prekinitve študije, kar zadeva ugotavljanje učinkovitosti.
English: From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Slovenian: Z mikrobiološkega vidika je treba rekonstituirano raztopino porabiti takoj po pripravi.
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Slovenian: Preglednica 14: Povzetek izidov bolezni v preskušanjih faze III (APEX) in II
English: a Based on Independent Review Committee (IRC) assessment (radiological data only).
Slovenian: a Na podlagi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
English: The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
Slovenian: Skupen čas shranjevanja rekonstituiranega zdravila pred injiciranjem ne sme biti daljši od 8 ur.
English: If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.
Slovenian: Če ste preboleli hepatitis B, vas bo zdravnik skrbno spremljal glede znakov aktivnega hepatitisa B.
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzmbDx group.
Slovenian: Mediani čas trajanja zdravljenja je bil 13 tednov v skupini VDDx in 11 tednov v skupini BzmbDx.
English: The educational material shall consist of the following:
Slovenian: Izobraževalno gradivo bo vsebovalo:
English: The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
Slovenian: Mehanizem nastanka tega pojava ni znan, čeprav je deloma lahko posledica avtonomne nevropatije.
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Slovenian: Za preprečevanje stika s kožo morate uporabljati rokavice in druga zaščitna oblačila.
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Slovenian: Stopnja 1 (asimptomatična; izguba refleksa globoke tetive ali parestezija) brez bolečine ali izguba funkcije ni potrebna
English: Both men and women receiving Bortezomib SUN must use effective contraception during and for up to 3 months after treatment.
Slovenian: Moški in ženske, ki prejemajo zdravilo Bortezomib SUN, morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 3 mesece po njem.
English: After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Slovenian: Po prilagoditvi glede na BSA, drugi demografski dejavniki kot so starost, telesna masa in spol, niso imeli klinično pomembnega vpliva na očistek bortezomiba.
English: • Additional risk minimisation measures In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se bo v vsaki državi članici s pristojnim nacionalnim organom države dogovoril za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce.
English: The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Slovenian: Cmax je bila po subkutanem dajanju (20,4 ng/ml) nižja kot pri intravenskem (223 ng/ml).
English: Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Slovenian: Skrbno pretehtajte potencialne koristi zdravljenja glede na tveganja, še posebej v primeru zmerne do resne trombocitopenije in ob obstoječih dejavnikih tveganja za krvavitev.
English: Tel. +40 (264) 501 500
Slovenian: România Tel. +40 (264) 501 500
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Slovenian: Stopnja geometrične sredine AUClast je bila 0,99 in 90 % intervali zaupanja 80,18-122,80 %.
English: The safety and efficacy of bortezomib in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Slovenian: Pediatrična populacija Varnost in učinkovitost bortezomiba pri otrocih, mlajših od 18 let, nista bili dokazani (glejte poglavji 5.1 in 5.2).
English: Prior to initiating a new cycle of therapy:
Slovenian: Pred začetkom novega kroga zdravljenja:
English: Complete response (CR) was evaluated at the end of Block 1.
Slovenian: Popolni odgovor (CR-Complete Response) so ocenili na koncu 1. sklopa zdravljenja.
English: In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Slovenian: V primeru pojava novih ali poslabšanja obstoječih pljučnih simptomov (npr.: kašelj, dispneja) je potrebna takojšnja diagnostična ocena in uvedba ustreznega zdravljenja bolnika.
English: Overall, the literature results are suggestive of a possible causal association between bortezomib (and other proteasome inhibitors) and TMA.
Slovenian: Na splošno rezultati iz literature kažejo na možno povezavo med bortezomibom (in drugimi zaviralci proteaze) in TMA.
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Slovenian: Mediana preživetja vseh bolnikov, vključenih v raziskavo, je bila 17 mesecev (razpon < 1 do 36 mesecev).
English: The resulting solution is then either injected into a vein or under the skin.
Slovenian: Nastala raztopina se potem injicira v veno ali pod kožo.
English: e Median duration of follow up is 11.8 months
Slovenian: e Mediano trajanje nadaljevanja zdravljenja je 11,8 meseca.
English: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
Slovenian: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company
English: The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Slovenian: Končna analiza OS po medianem spremljanju bolnikov 8,6 leta ni pokazala pomembne razlike v OS
English: Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Slovenian: Pri psih so zaznali tudi majhno podaljšanje korigiranega QT-intervala.
English: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Median duration Days (months) Time to response CR+PR(days)
Slovenian: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Mediana trajanja odziva dnevi (meseci)
English: MARKETING AUTHORISATION NUMBER EU/1/16/1102/001
Slovenian: EU/1/16/1102/001
English: Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznakeEXP.
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Slovenian: Za predklinična farmakološka preskušanja kardiovaskularne varnosti zdravila glejte poglavje 5.3.
English: TTP, months
Slovenian: TTP, dnevi
English: Similar proportions of patients had creatinine clearance ≤30 ml/min (3% in each arm).
Slovenian: Podobno razmerje bolnikov je imelo očistek kreatinina ≤ 30 ml/min (3 % v vsakem kraku študije).
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Slovenian: Priporočamo, da bolniki z najmanj delnim odzivom prejmejo 2 dodatna kroga zdravljenja.
English: No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Slovenian: Podatkov o možnih posledicah ali ozdravitvah periferne nevropatije v tej študiji ni na voljo.
English: Phase III
Slovenian: Faza III
English: The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Slovenian: Primarna ocena učinkovitosti je bil najboljši potrjeni odziv na ponovno zdravljenje, skladno z EBMTkriteriji.
English: Table 8 has been generated using Version 16 of the MedDRA.
Slovenian: Preglednica 8 je pripravljena po klasifikaciji MedDRA, različica 16.
English: The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Slovenian: Rekonstituirana raztopina je bistra in brezbarvna, njen končni pH pa je od 4 do 7.
English: The duration of a treatment cycle is 21 days (3 weeks).
Slovenian: Trajanje enega kroga zdravljenja je 21 dni (3 tedne).
English: Since patients with neutropenia are at increased risk of infections, they should be monitored for signs and symptoms of infection and treated promptly.
Slovenian: Bolniki z nevtropenijo so izpostavljeni zvečanemu tveganju za okužbe, zato jih je treba spremljati glede pojava znakov in simptomov okužbe ter takoj zdraviti.
English: In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Slovenian: Sekundarna stopnja odziva in čas do z dogodkom povezane učinkovitosti sta pokazali dosledne rezultate za subkutano in intravensko uporabo (preglednica 15).
English: Table 11: Efficacy results following the final survival update to VISTA study
Slovenian: Preglednica 11: Rezultati učinkovitosti zdravila po posodobljenih podatkih o končnem preživetju iz študije VISTA
English: Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Slovenian: Poskusi so potrdili, da je bortezomib citotoksičen za številne različne vrste rakavih celic in da so rakave celice bolj občutljive za proapoptotične učinke zavore proteasoma od normalnih.
English: In addition, following a search of the worldwide medical and scientific literature carried out for the period covered by this PSUSA and a number of papers reporting safety information, 35 cases of Thrombotic Microangiopathy (TMA) were retrieved.
Slovenian: Po pregledu svetovne medicinske in znanstvene literature v obdobju zadevnega PSUR in številnih poročil o varnosti, je bilo dodatno odkrito 35 primerov trombotične mikroangiopatije (TMA).
English: Bortezomib should not be used during pregnancy unless the clinical condition of the woman requires treatment with bortezomib.
Slovenian: Bortezomiba ne smete uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z bortezomibom.
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Slovenian: Preglednica 7 je pripravljena po klasifikaciji MedDRA, različica 14.1.
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Slovenian: 1.3 Rekonstituirana raztopina ne vsebuje konzervansov in jo je treba porabiti takoj po pripravi.
English: Intrathecal administration has resulted in death.
Slovenian: Intratekalna uporaba se je končala s smrtjo.
English: In the unlikely event of an overdose, your doctor will monitor you for side effects.
Slovenian: V malo verjetnem primeru prevelikega odmerjanja vas bo vaš zdravnik spremljal glede pojava neželenih učinkov.
English: Bortezomib is highly selective for the proteasome.
Slovenian: Bortezomib je močno selektiven za proteasom.
English: Cycle 1
Slovenian: krog 1
English: In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Slovenian: Psi z zmanjšano kontraktilnostjo srca so se odzvali na učinkovine s pozitivnim inotropnim ali presorskim delovanjem.
English: In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant Group.
Slovenian: Odziv na zdravljenje v populaciji bolnikov faze II preskušanja, ki so bili odporni na zdravljenje, je ugotavljala neodvisna komisija, ki je uporabila kriterije za odziv Evropske skupine za transplantacijo kostnega mozga (European Bone Marrow Transplant Group).
English: Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Slovenian: Zastajanje tekočin v telesu je lahko dejavnik tveganja za pojav znakov in simptomov srčnega popuščanja.
English: Bortezomib may have a moderate influence on the ability to drive and use machines.
Slovenian: Bortezomib ima lahko zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: - The other ingredient is mannitol (E421).
Slovenian: - Drugi sestavini zdravila je manitol (E421).
English: The 26S proteasome is a large protein complex that degrades ubiquitinated proteins.
Slovenian: 26S-proteasom je velik beljakovinski kompleks, ki razgradi ubikvitinske beljakovine.
English: In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal.
Slovenian: Pri redkih bolnikih, ki so imeli hepatitis B, lahko bolezen ponovno izbruhne, z možnim smrtnim izidom.
English: Posology modification or delay
Slovenian: Prilagoditev ali zakasnitev odmerka
English: Day 29 Rest period
Slovenian: dan 29 premor