natgillin/translations-raw huggingface dataset:
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW 12; then discontinue 
TZ vrednost HCV-RNA večjo ali enako 100 i.e./ml: ukinite zdravljenje s tremi
Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with direct-acting antivirals not given in combination with peginterferon alfa and ribavirin. 
Med zdravljenjem ali po zdravljenju z neposredno delujočimi protivirusnimi zdravili, ki jih niso uporabljali v kombinaciji s peginterferonom alfa in ribavirinom, so poročali o primerih reaktivacije HBV, nekaterih s smrtnim izidom.
It is not known whether boceprevir is excreted in human breast milk. 
Ni znano, ali se boceprevir
The subjects were then continued on different treatment regimens based on TW 8 response-guide therapy (Victrelis-RGT). 
Preiskovanci so nato nadaljevali zdravljenje po različnih shemah, upoštevaje zdravljenje glede na odziv v 8.
The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in patients co-infected with hepatitis B virus 
Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje kroničnega hepatitisa C genotipa 1 pri bolnikih, ki imajo sočasno okužbo z virusom hepatitisa B (HBV) in HCV, nista bili raziskani.
Not studied 
Medsebojno delovanje ni raziskano.
Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing EOF data. 
Delež recidiva je bilo razmerje števila preiskovancev z nezaznavno HCV-RNA na koncu zdravljenja (KZ) in zaznavno HCV-RNA na koncu spremljanja (KS) med preiskovanci, ki so imeli nezaznavno HCV-RNA ob KZ in niso imeli manjkajočih podatkov na KS.
No dose adjustment of omeprazole or Victrelis is recommended. 
Prilagoditev odmerka omeprazola ali zdravila Victrelis ni potrebna.
3 mg daily + ethinyl estradiol 0.02 mg daily + Victrelis 800 mg three times daily) 
Noretindron†/etinilestradiol: (noretindron 1 mg na dan + etinilestradiol 0,035 mg na dan + zdravilo Victrelis 800 mg trikrat na dan)
Refer to Summary of Product Characteristics for ribavirin and peginterferon alfa for additional information. 
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila za ribavirin in peginterferon alfa.
No dose adjustment required for Victrelis or tenofovir. 
Odmerka zdravila Victrelis ali tenofovirja ni treba prilagoditi.
Victrelis in combination with peginterferon alfa and ribavirin is not recommended in patients who 
Uporaba zdravila Victrelis v kombinaciji s peginterferonom alfa in ribavirinom ni priporočljiva pri bolnikih, ki imajo v izhodišču število trombocitov < 100.000/mm
Medicines metabolized primarily by CYP3A4/5 may have increased exposure when administered with Victrelis, which could increase or prolong their therapeutic and adverse reactions (see Table 2). 
Izpostavljenost zdravilom, ki se presnavljajo primarno s CYP3A4/5, se lahko med uporabo z zdravilom Victrelis poveča.
This is not observed in mice 
Pri miših ali opicah tega niso opazili.
o Subjects with a detectable HCV-RNA at TW 8 but subsequently undetectable at TW 12 (late responders) were changed in a blinded fashion to placebo at the TW 36 visit and continued treatment with peginterferon alfa-2b + ribavirin for an additional 12 weeks, for a total treatment duration of 48 weeks. 
TZ na "slep" način prešli na placebo ter nadaljevali zdravljenje s peginterferonom alfa-2b in ribavirinom dodatnih 12 tednov, tako da je
No dose adjustment of buprenorphine/naloxone or Victrelis is recommended. 
Prilagoditev odmerkov buprenorfina/naloksona ali zdravila Victrelis ni potrebna.
Talk to your doctor or pharmacist before taking your medicine if you: 
Pred začetkom jemanja zdravila se posvetujte z zdravnikom ali farmacevtom:
No dose adjustment of Victrelis is required for patients with mild, moderate or severe hepatic impairment. 
Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerka zdravila Victrelis ni treba prilagoditi.
A study with peginterferon alfa-2a in treatment experienced patients gave consistent results as compared to the study P05101 (see section 4.4). 
Rezultati iz študije s peginterferonom alfa-2b pri že zdravljenih bolnikih so bili skladni z rezultati iz
Merck Sharp & Dohme d.o.o. 
Česká republika Merck Sharp & Dohme s.r.o.
Skin and hair: cold sores, tingling or numbness of the skin; reduced feeling or sense of touch; skin rash, patchy skin rash, red skin; red raised skin rash sometimes with pus-filled blisters; hot, tender and red skin, sometimes with fever and chills; increased sweating; skin disease with thick patches of red skin - often with silvery scales Joints and muscles: muscle spasm; feeling tired, muscle weakness, feeling cold; back pain, 
Oči in ušesa: suhost oči, zvonjenje v ušesih, spremembe vida Usta, nos in žrelo: bolečina v ustih, zobobol, bolečina pri požiranju, krvavitev iz nosu, zamašen nos, spremembe voha, boleče in privzdignjene lehe v ustih, občutek velike žeje ter suha usta ali suha koža, oteklost ščitnice, vratu ali glasilk, zmanjšano delovanje ščitnice, bolečnost ali oteklost v ustih, pekoč občutek na jeziku, občutek napetosti in polnosti v nosu, licih in za očmi - včasih z utripajočo bolečino, zvišano telesno temperaturo ali zamašenim nosom (sinuzitis) Koža, lasje in dlake: herpes, mravljinčenje ali omrtvičenost kože, zmanjšan občutek ali zaznava dotika, kožni izpuščaj, lisast kožni izpuščaj, rdeča koža, rdeč privzdignjen kožni izpuščaj, včasih z gnojnimi mehurji, vroča, občutljiva in rdeča koža, včasih z zvišano telesno temperaturo in mrzlico, močnejše znojenje, kožna bolezen z debelimi rdečimi lisami - pogosto s
Boceprevir also undergoes, to a lesser extent, oxidative metabolism 
V manjši meri se boceprevir presnovi tudi oksidativno s CYP3A4/5.
Reminder: Please also read the “Possible side effects” in the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis. 
Opozorilo: Preden začnete jemati zdravilo Victrelis, prosimo, preberite tudi poglavje "Možni neželeni učinki" v navodilih za uporabo za peginterferon alfa in ribavirin.
It is not recommended to co-administer lopinavir/ritonavir and Victrelis. 
Sočasne uporabe lopinavirja/ritonavirja in zdravila Victrelis ne priporočamo.
SVR § % (n/N) EOT % (n/N) Relapse 
SVR (n/N) KZ % (n/N) Recidiv (n/N)
No dose adjustment of Victrelis is required in patients with any degree of renal impairment (see 
Pri bolnikih z okvaro ledvic (ne glede na stopnjo) odmerka zdravila Victrelis ni treba prilagoditi
The SVR rates in subjects randomized to receive ribavirin dose reduction and randomized to receive 
Delež SVR pri preiskovancih, randomiziranih v skupino, ki je prejemala zmanjšan odmerka ribavirina, in preiskovancih, randomiziranih v skupino, ki je prejemala eritropoetina, je bil primerljiv.
PROTON PUMP INHIBITOR Omeprazole*: (omeprazole 40 mg daily + Victrelis 800 mg three times daily) 
Escitalopram* (escitalopram 10 mg enkratni odmerek + zdravilo Victrelis 800 mg trikrat na dan)
It is not recommended to co-administer darunavir/ritonavir and Victrelis. 
Sočasne uporabe darunavirja/ritonavirja in zdravila Victrelis ne priporočamo.
• The Patient Information Leaflet 
Shranjevanje pri bolniku
EXP 
aspermija
Relapsers 
Izdelovalec
HCV Relapse Rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable 
Delež HCV recidiva je bilo razmerje števila preiskovancev z nezaznavno HCV-RNA na koncu zdravljenja (KZ) in zaznavno HCV-RNA na koncu spremljanja (KS) pri preiskovancih, ki so imeli nezaznavno HCV-RNA ob KZ in niso imeli manjkajočih podatkov na KS.
Cases of pancytopenia have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin. 
Pri bolnikih, ki so prejemali zdravilo Victrelis v kombinaciji s peginterferonom alfa in ribavirinom, so poročali o primerih pancitopenije.
Please refer to the Summary of Product Characteristics for peginterferon alfa for the contraindication in patients with decompensated liver disease. 
Glede kontraindikacij pri bolnikih z dekompenzirano boleznijo jeter, prosimo, glejte povzetek glavnih značilnosti zdravila za peginterferon alfa.
HCV protease monotherapy 
1 HCV-RNA v plazmi
Pregnancy must be avoided due to the use of Victrelis with ribavirin. 
Zaradi uporabe zdravila Victrelis z ribavirinom ženska ne sme zanositi.
Maximum daily dose of Victrelis is 2,400 mg. Administration without food could be associated with a net loss of efficacy due to sub-optimal exposure. 
Pri uporabi brez hrane bi se zaradi suboptimalne izpostavljenosti lahko zmanjšala učinkovitost zdravila.
No clinically significant differences in pharmacokinetic parameters were observed between patients with end-stage renal disease (ESRD) and healthy subjects. 
Med bolniki s končno odpovedjo ledvic in zdravimi preiskovanci niso ugotovili klinično pomembnih razlik v farmakokinetičnih parametrih.
These are called peginterferon alfa and ribavirin. 
Med preiskovanci, ki so prejemali samo peginterferon alfa-2b in ribavirin, je
Mental illness: changes in mood; feeling like your life is falling apart; seeing, feeling or hearing things that are not real (hallucinations); thoughts of killing yourself (suicide), trying to kill yourself; feeling of great happiness (mania) and then a feeling of deep sadness or not being 
Duševne bolezni: spremembe razpoloženja, občutek, da vam življenje razpada, videnje, občutenje ali slišanje stvari, ki niso resnične (halucinacije), misli na samomor, poskus samomora, občutek velike sreče (manija) in potem občutek globoke žalosti ali ničvrednosti Prsni koš: kratka sapa v leže, resna okužba pljuč, npr. pljučnica, ostre bolečine v prsnem košu, ki se poslabšajo pri dihanju, bolečina za prsnico, ki se lahko širi v vrat in rame Srce in obtočila: srčni infarkt, prenehanje dihanja, krvni strdek v nogi ali roki, zmanjšan pretok krvi v delih možganov (npr. omotica, dvojni vid ali šibkost obeh strani telesa)
Plasma trough concentrations of Victrelis were decreased when administered with efavirenz. 
V primeru uporabe skupaj z efavirenzem se je najmanjša koncentracija zdravila Victrelis v plazmi zmanjšala.
FW 24. 
v plazmi 24. teden spremljanja.
Administer peginterferon alfa and ribavirin for 4 weeks, and then 
Trajanje zdravljenja = 28 tednov 1. 4 tedne uporabljajte peginterferon alfa in ribavirin, nato
22 July 2010 
22 julija 2010
The proposal was rejected by the majority of CVMP members. 
Predlog je večina članov CVMO zavrnila.
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain and Sweden. 
Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bilo Združeno kraljestvo referenčna država članica, Avstrija, Belgija, Ciper, Češka republika, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Italija, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Slovaška, Španija in Švedska pa zadevne države članice.
The Mutual Recognition Procedure UK/V/0321/001/MR started on 1 May 2008. 
Postopek medsebojnega priznavanja UK/V/0321/001/MR se je začel 1. maja 2008.
The opinion was converted into a Decision by the European Commission on 22 July 2010. 
Mnenje je bilo spremenjeno v odločbo Evropske komisije dne 22 julija 2010.
Article 33(4) of Directive 2001/82/EC, as amended. 
Clen 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.
The referral procedure started on 12 November 2008. 
Napotitveni postopek se je začel 12. novembra 2008.
Given that no absolute majority was attained, the opinion of 15 July 2009 stands. 
Glede na to, da ni bila dosežena absolutna večina, mnenje z dne 15 julija 2009 še vedno velja.
The Rapporteur and Co-Rapporteur appointed were: Prof. Christian Friis and Dr Valda Sejane, respectively. 
Za poročevalca in soporočevalca sta bila imenovana: prof. Christian Friis oziroma dr. Valda Sejane.
On 4 November 2008, the United Kingdom, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Belgium and Sweden, that the efficacy of the product has not been sufficiently demonstrated. 
Združeno kraljestvo je 4. novembra 2008 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na agencijo zaradi zadržkov, ki sta jih izpostavili Belgija in Švedska, in sicer, da učinkovitost zdravila ni bila zadostno dokazana.
Oral explanations were given on 16 June 2009. 
Ustna pojasnila je podal 16. junija 2009.
During its 15-17 September 2009 meeting, the CVMP appointed Dr David Murphy as rapporteur and Dr Jiří Bureš as co-rapporteur for the re-examination of the above mentioned opinion. 
Na zasedanju CVMP od 15. do 17. septembra 2009 je bil dr. David Murphy imenovan za poročevalca in dr. MJiří Bureš za soporočevalca v postopku ponovne proučitve zgoraj omenjenega mnenja.
The detailed grounds for the re-examination were submitted by CEVA Animal Health Ltd on 21 September 2009 and the re-examination procedure started on 22 September 2009. 
Podrobne razloge za ponovno proučitev je družba CEVA Animal Health Ltd predložila 21. septembra 2009, postopek ponovne presoje pa se je začel 22. septembra 2009.
On 5 August 2009, CEVA Animal Health Ltd notified the Agency of its intention to request a reexamination of the CVMP opinion of 15 July 2009. 
Dne 5. avgusta 2009 je družba CEVA Animal Health Ltd obvestila agencijo, da namerava zaprositi za ponovno ovrednotenje mnenja CVMP z dne 15. julija 2009.
Written explanations were provided by the Applicant on 16 February 2009. 
Predlagatelj je pisna pojasnila predložil 16. februarja 2009.
Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy. 
Na podlagi ocene poročevalčevega vrednotenja trenutno razpoložljivih podatkov je Odbor za zdravila za uporabo v veterinarski medici (CVMP) menil, da vloga glede učinkovitosti ne ustreza merilom za odobritev.
Therefore, the Committee adopted an opinion on 15 July 2009 recommending the suspension of the existing marketing authorisation and the refusal of the granting of the marketing authorisations for Tildren 500 mg, lyophilisate for solution for infusion. 
Zato je 15. julija 2009 sprejel mnenje, v katerem je priporočil umik obstoječega dovoljenja za promet in zavrnitev odobritve dovoljenja za promet z zdravilom Tildern 500 mg liofilizat za raztopino za infundiranje.
Tiludronic acid as the disodium salt, is a synthetic derivative of pyrophosphate belonging to the class of biphosphonates. 
Tiludronska kislina v obliki dinatrijeve soli je sintetični derivat pirofosfata, ki spada v razred bifosfonatov.
Based on the evaluation of the rapporteurs' assessment of the detailed grounds for the re-examination, on 11 November 2009, the CVMP considered the rapporteurs' proposal for amending the opinion adopted on 15 July 2009. 
Na podlagi ocene poročevalčevega vrednotenja podrobnih razlogov za ponovno proučitev je CVMP 11 novembra 2009 sprejel poročevalčev predlog za spremembo mnenja z dne 15 julija 2009.
TILDREN 500 mg, lyophilisate for solution for infusion is a veterinary medicinal product indicated as an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime in horses over 3 years of age. 
Zdravilo TILDREN 500 mg liofilizat za raztopino za infundiranje je zdravilo za uporabo v veterinarski medicini, indicirano kot pomoč pri zdravljenju kliničnih znakov šepavosti, povezanih z bramorjem kosti v kombinaciji z nadzorovanim režimom vadbe pri konjih, starejših od 3 let.
The marketing authorisation holder, CEVA Animal Health Ltd, submitted an application for a mutual recognition procedure for TILDREN 500 mg, lyophilisate for solution for infusion, on the basis of the marketing authorisation granted by the United Kingdom. 
Imetnik dovoljenja za promet z zdravilom, družba CEVA Animal Health Ltd, je predložila vlogo za postopek medsebojnega priznavanja za zdravilo TILDREN 500 mg liofilizat za raztopino za infundiranje na podlagi dovoljenja za promet z zdravilom, ki ji ga je dodelilo Združeno kraljestvo.
Opinion following an Article 33(4) referral for TILDREN 500 mg, lyophilisate for solution for infusion 
Mnenje v zvezi z napotitvijo v skladu s členom 33(4) za zdravilo TILDREN 500 mg liofilizat za raztopino za infundiranje
referral for TILDREN 500 mg, lyophilisate for solution for infusion 
za zdravilo TILDREN 500 mg liofilizat za raztopino za infundiranje
Evaluate as appropriate. 
Ovrednotite, kot je primerno.
Use of gloves and other protective equipment is recommended. 
Priporočena je uporaba rokavic in druge zaščitne opreme.
The infusion may last up to 30 minutes. 
Infuzija lahko traja do 30 minut.
You may also be given other medicines. 
Morda boste dobivali še druga zdravila.
Cycle 2 and all subsequent cycles 
2. ciklus in vsi nadaljnji ciklusi
Your doctor will examine you and review your full medical history. 
Zdravnik vas bo pregledal in se seznanil z vašo celotno zdravstveno zgodovino.
Each pack contains 1 vial. 
Vsako pakiranje vsebuje 1 vialo.
Remove vial from refrigerator just prior to use. 
Vialo vzemite iz hladilnika tik pred uporabo.
Proper aseptic technique must be observed. 
Upoštevati morate pravilno aseptično tehniko.
18.7 (15.6, NE) 
18,7 (15,6, NO)
The median follow-up was approximately 37 months. 
Mediani čas spremljanja je bil približno 37 mesecev.
Elderly patients (≥ 75 years) 
Starejši bolniki (≥ 75 let)
Each 28-day period is one treatment cycle. 
Vsako 28-dnevno obdobje predstavlja en ciklus zdravljenja.
Some of these events have been fatal. 
Nekateri od teh dogodkov so bili smrtni.
• Any other major disease for which you were hospitalised or received any medicine. 
• Kakršno koli drugo pomembno bolezen, zaradi katere ste se zdravili v bolnišnici ali ste zaradi nje dobivali kakršna koli zdravila.
Most patients will receive treatment for as long as their disease improves or remains stable. 
Večina bolnikov bo prejemala zdravljenje tako dolgo, dokler se njihova bolezen ne izboljša ali postane stabilna.
a. Study PX-171-009 
a. Študija PX-171-009
Tell your doctor straight away if you get notice any of the following symptoms: 
Zdravniku morate takoj povedati, če opazite katerega od naslednjih simptomov:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015 
Datum prve odobritve: 19. november 2015
The proteasome is a system within the cells that breaks down proteins when they are damaged or no longer needed. 
Proteasom je sistem znotraj celic, ki razgrajuje beljakovine, kadar so le-te poškodovane ali niso več potrebne.
Some of these events have been fatal (see section 4.8). 
Nekateri od teh dogodkov so bili smrtni (glejte poglavje 4.8).
The elapsed time from reconstitution to administration should not exceed 24 hours. 
Čas od rekonstitucije do uporabe ne sme preseči 24 ur.
Oral and/or intravenous hydration should be continued, as needed, in subsequent cycles. 
S peroralno in/ali intravensko hidracijo je potrebno v nadaljnjih ciklusih nadaljevati, kot je potrebno.
Recommended action 
Priporočeno ukrepanje
In addition and according to the agreed case definition by Mentzer et al., two cases of level 1, one case of level 2 and one case of level 3 were identified. 
Poleg tega in v skladu z dogovorjeno opredelitvijo primerov po Mentzerju in drugih, sta bila ugotovljena dva primera 1. stopnje in en primer 2. stopnje ter en primer 3. stopnje.
Dose level reductions are presented in table 4. 
Ravni zmanjšanja odmerka so predstavljena v tabeli 4.
Subsequently patients should be treated with caution and remain under close follow-up. 
V nadaljevanju je treba bolnike zdraviti previdno in jih natančno spremljati.
This study did not evaluate the benefit/risk ratio in the broader refractory population. 
Ta študija ni raziskala razmerja koristi in tveganja v širši populaciji odpornih bolnikov.
There is currently insufficient information to draw conclusions about the safety of doses higher than those evaluated in clinical studies. 
Trenutno ni dovolj podatkov za sklepanje o varnosti odmerkov, večjih od tistih, ocenjenih v kliničnih študijah.
• Reduced blood flow to the heart 
• zmanjšan dotok krvi v srce,
If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C. 
Če ni uporabljeno takoj, so čas in pogoji shranjevanja med uporabo odgovornost uporabnika in čas običajno ne sme presegati 24 ur na temperaturi 2 °C - 8 °C.
• Difficulty sleeping (insomnia) 
• težave s spanjem (nespečnost),
Special attention should be paid to patients with moderate and severe hepatic impairment in view of the very limited efficacy and safety data on this population. 
Bolnikom z zmerno in hudo okvaro jeter je treba nameniti posebno pozornost glede na zelo maloštevilne podatke o učinkovitosti in varnosti v tej populaciji.
This can indicate you have low numbers of platelets (cells that help the blood to clot) 
To lahko pomeni, da imate nizko število krvnih ploščic (celic, ki pomagajo, da se kri strdi).
The dose will be calculated based on your height and weight (body surface area). 
Odmerek vam bodo izračunali na podlagi vaše telesne višine in teže (tj. na podlagi telesne površine).
* Frequency is calculated based on data from clinical trials in which most patients used prophylaxis 
* Pogostost je izračunana na podlagi podatkov iz kliničnih študij, v katerih je večina bolnikov prejela profilakso
• Ringing in the ears (tinnitus) 
• zvenenje v ušesih (tinitus),
The results of study 2011-003 are summarised in table 7. 
Rezultati študije 2011-003 so povzeti v tabeli 7.
As this medicine is being given by a doctor or nurse, it is unlikely that you will be given too much. 
Zdravilo vam bo dal zdravnik ali medicinska sestra, zato ni zelo verjetno, da bi ga dobili preveč.
Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia). 
Ukrepati je treba, da bi čim bolj zmanjšali vse dejavnike tveganja, na katere je mogoče vplivati (npr. kajenje, hipertenzija in hiperlipidemija).
Your doctor or nurse will check if you are getting enough fluids. 
Zdravnik ali medicinska sestra bosta preverila, da boste dobivali dovolj tekočine.
Based on its pharmacological properties, a risk to the suckling child cannot be excluded. 
Na podlagi njegovih farmakoloških značilnosti, tveganja za dojenega otroka ne moremo izključiti.
Read the complete preparation instructions prior to reconstitution. 
Pred rekonstituiranjem preberite celotna navodila za pripravo.
If you had these symptoms prior to treatment with carfilzomib, tell your doctor about any change in these symptoms. 
Če ste navedene simptome imeli že pred zdravljenjem s karfilzomibom, povejte zdravniku o vsaki morebitni spremembi teh simptomov.
You will be monitored closely during treatment. 
Med zdravljenjem vas bo skrbno nadzoroval.
This assessment should optimise the patient's status, with particular attention to blood pressure control and fluid management. 
Ocena mora optimizirati bolnikovo stanje, posebno pozornost pa je treba nameniti ureditvi krvnega tlaka in uravnavanju tekočin.
Do not take Kyprolis if you are pregnant, think you may be pregnant or are planning to have a baby. 
Ne jemljite zdravila Kyprolis, če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
• Serum creatinine equal to or greater than 2 × baseline; or 
• Kreatinin v serumu enak ali večji 2-kratni izhodiščni vrednosti; ali
This is to check that you have enough blood cells and your liver and kidneys are working properly. 
Tako bodo preverili, da imate dovolj krvnih celic ter da vam jetra in ledvice ustrezno delujejo.