natgillin/translations-raw huggingface dataset:
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 
Bolezni sečil občasni zvišana vrednost kreatinina v krvi, polakisurija, proteinurija neznana** okvara ledvic; pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kot so višja starost bolnika, sočasna uporaba nefrotoksičnih zdravil, diuretičnega zdravljenja ali dehidracija v času po infuziji, so poročali o redkih primerih odpovedi ledvic, pri kateri je potrebna dializa, in redkih primerih s smrtnim izidom (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
• A single dose of Zoledronic acid Teva Generics should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2). 
• Posamezen odmerek zoledronske kisline ne sme presegati 5 mg, infuzija pa mora trajati najmanj
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C. 
Če ni uporabljeno takoj, je za čas shranjevanja zdravila med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik sam. Čas shranjevanja naj praviloma ne presega 24 ur pri temperaturi od 2 do 8 °C.
Psychiatric disorders 
Psihiatrične motnje nespečnost
Women who were evaluated for the incidence of vertebral fractures did not receive concomitant osteoporosis therapy, which was allowed for women contributing to the hip and all clinical fracture evaluations. 
Ženske, ki so jih pregledovali glede zlomov vretenc, niso sočasno prejemale zdravil za zdravljenje osteoporoze,
Zoledronic acid Teva Generics is supplied in multipacks containing 5 or 10 bags. 
Zdravilo Zoledronska kislina Teva Generics je na voljo v skupnem pakiranju po 5 ali 10 vreč.
How to store Zoledronic acid Teva Generics 
Kako se daje zdravilo Zoledronska kislina Teva Generics
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C. 
Če ni uporabljeno takoj, je za čas shranjevanja zdravila med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik sam. Čas shranjevanja naj praviloma ne presega 24 ur pri temperaturi od 2 °C do 8 °C.
Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate). 
En ml raztopine vsebuje 0,05 mg zoledronske kisline (v obliki monohidrata).
Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 
Zdravljenje z odmerkom zoledronske kisline 5 mg na leto je statistično značilno znižalo vrednosti kostno specifične alkalne fosfataze po 12 mesecih za 30 % glede na izhodišče.
Relative risk reduction in fracture incidence % (CI) 
relativno znižanje tveganja za zlome % (IZ)
Absolute reduction in fracture incidence % (CI) 
absolutno znižanje deleža zlomov % (IZ)
Each bag contains 100 ml of solution. 
Ena vreča vsebuje 100 ml raztopine.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml; i.e. essentially “sodiumfree.” 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni “brez natrija.”
Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion. 
Zoledronsko kislino so prejemali enkrat na leto, dokler ni vsaj pri 211 bolnikih v študiji prišlo do dokazanega kliničnega zloma. Koncentracij vitamina D niso merili rutinsko, vendar je večina bolnikov 2 tedna pred infuzijo prejela večji začetni odmerek vitamina D (50.000 do 125.000
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (without blue box) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (brez »blue box« podatkov)
Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea 
utrujenost, astenija, bolečine, splošno slabo počutje, reakcija na mestu injiciranja periferni edemi, žeja, reakcija akutne faze vnetja, nekardiogena bolečina v prsnem košu neznana** dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (with blue box) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA SKUPNO PAKIRANJE (z »blue box« podatki)
Non-vertebral fracture (1) *p-value <0.001, **p-value <0.0001 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures 
(1) brez zlomov prstov rok in nog ter zlomov na področju obraza (2) vključno s kliničnimi zlomi prsnih in ledvenih vretenc
C-reactive protein increased Uncommon Blood calcium decreased 
Preiskave zvišana vrednost C-reaktivnega proteina znižana vrednost kalcija v krvi pri bolnikih, ki so sočasno jemali glukokortikoide.
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC. 
- Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodiumfree.” 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml vialo, kar v bistvu pomeni “brez natrija”.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, dispneja
Atrial fibrillation Uncommon Palpitations 
Srčne bolezni atrijska fibrilacija palpitacije
Relative reduction in fracture incidence % (CI) 
relativno znižanje odstotka zlomov % (IZ)
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC. 
- Po odprtju plastenke: kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
Mechanism of action 
Taki ukrepi
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients, listed in section 6.1. 
- Preobčutljivost na zdravilno učinkovino, katerega od difosfonatov ali katero koli pomožno snov,
Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction) 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija, artralgija, bolečine v kosteh, bolečine v hrbtu, bolečine v okončinah bolečina v vratu, mišičnoskeletna okorelost, otekanje sklepov, mišični spazmi, bolečine v rami, mišičnoskeletna bolečina v prsnem košu, mišičnoskeletna bolečina, okorelost sklepov, artritis, šibkost mišic atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice† (za difosfonate značilen neželeni učinek)
Other medicines and Zoledronic acid Teva Generics Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
- Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan
Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis# 
gastroezofagealna refluksna bolezen, obstipacija, suha usta, vnetje požiralnika, zobobol, gastritis#
The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03). 
Učinek na mineralno gostoto kosti (bone mineral density - BMD) Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zoledronsko kislino, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p <0,03).
It comes in a clear plastic bottle. 
Pakirana v prozornih plastenkah.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bags 
IME ZDRAVILA Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje v plastenkah
Uncommon Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia 
Bolezni živčevja glavobol, omotičnost letargija, parestezija, somnolenca, tremor, sinkopa, motnje okušanja
1 bag of 100 ml 
raztopina za infundiranje ena plastenka s 100 ml
Each bottle contains 100 ml of solution 
Ena vreča vsebuje 100 ml raztopine
Táncsics Mihály út 82., 
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82
Each bottle contains 100 ml of solution. 
Ena plastenka vsebuje 100 ml raztopine.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Generics for the treatment of postmenopausal osteoporosis. 
Pri bolnicah, ki so prejemale zdravilo Zoledronska kislina Teva Generics zaradi postmenopavzalne osteoporoze, so poročali o nepravilnem bitja srca (atrijski fibrilaciji).
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid. 
• Pred odmerjanjem zoledronske kisline morajo biti bolniki, zlasti starejši in tisti, ki jemljejo
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, anti-angiogenic medicinal products, corticosteroids, poor oral hygiene). 
Pri bolnikih s spremljajočimi dejavniki tveganja (na primer rak, kemoterapija, antiangiogena zdravila, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z difosfonati razmisliti o zobozdravniškem pregledu z ustreznimi preventivnimi zobozdravstvenimi ukrepi.
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Generics. 
Zdravnik mora pred vsakim odmerjanjem zdravila Zoledronska kislina Teva Generics s krvnimi preiskavami pregledati delovanje vaših ledvic.
Not known** Renal impairment. 
Bolezni imunskega sistema pogostnost neznana**
One bottle contains 5 mg zoledronic acid (as monohydrate). 
Ena plastenka s 100 ml raztopine vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Teva Gyógyszergyár Zrt 
Atipičen zlom stegnenice
• Zoledronic acid Teva Generics should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5). 
• Pri sočasni uporabi zoledronske kisline z drugimi zdravili, ki lahko vplivajo na delovanje ledvic,
Not known (frequency cannot be estimated from the available data) Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. 
Bolečine v ustih, zobeh in čeljusti, oteklina ali ranice v ustni votlini, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba - to so lahko znaki odmiranja kosti v čeljusti (osteonekroze).
- Do not use this medicine after the expiry date which is stated on the bag and carton after EXP. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vreči in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Zoledronic acid (N = 1,065) event rate (%) 
Izid zoledronska kislina (N=3.875) delež dogodkov placebo (N=3.861) delež dogodkov absolutno znižanje deleža zlomov % (IZ)
Effect on all clinical fractures 
Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
How to prepare and administer Zoledronic acid Teva Generics 
Druga zdravila in zdravilo Zoledronska kislina Teva Generics
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36% ; p<0.001). 
V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p < 0,001).
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001). 
V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p <0,001).
Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation. 
Neželene učinke zoledronske kisline na plodnost generacije staršev in prve generacije potomcev so ocenjevali na podganah.
(CI) 
V
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001). 
V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečalo mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p < 0,001).
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96%; p<0.001). 
V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p <0,001).
Effect on hip fractures 
Označevalci pregradnje kosti
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post-menopausal women in the HORIZON-PFT study. 
Po 24 mesecih so pri bolnikih, ki so prejemali zoledronsko kislino, opažali pomembno 3,6-odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom,
Zoledronic acid Teva Generics 5 mg solution for infusion in bags zoledronic acid 
Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje v vrečah zoledronska kislina
Zoledronic acid Teva Generics may also cause other side effects Very common: (may affect more than 1 in 10 people) Fever 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): Vročina.
You may eat normally on the day you are treated with Zoledronic acid Teva Generics. 
Na dan, ko dobite zdravilo Zoledronska kislina Teva Generics, lahko normalno jeste.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion zoledronic acid 
Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje zoledronic acid
Zoledronic acid Teva Generics 5 mg solution for infusion in bottles zoledronic acid 
Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje zoledronska kislina
Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures 
*vrednost p < 0,05, **vrednost p < 0,01
- Do not use Zoledronic acid Teva Generics after the expiry date which is stated on the bag. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhydrosis, pruritus, erythema Musculoskeletal and connective tissue disorders 
Bolezni živčevja pogosti glavobol, omotičnost občasni letargija, parestezija, somnolenca, tremor, sinkopa, motnje okušanja
Zoledronic acid Teva Generics may also cause other side effects Very common (may affect more than 1 in 10 people) Fever 
Nekateri neželeni učinki so lahko resni Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
This is called a ‘response'. 
To imenujemo ‘odziv'.
This may lead to very serious infection. 
To lahko vodi v zelo resno okužbo.
• then at least every month after that. 
• po tem najmanj enkrat mesečno.
• every week for the first 8 weeks of treatment 
• vsak teden v prvih 8 tednih zdravljenja,
However, the signs and symptoms can be greatly reduced or disappear for a period of time. 
Lahko pa se znaki in simptomi močno zmanjšajo ali za nekaj časa izginejo.
Date of first authorisation: 20th September 2018 
Datum prve odobritve: 20. september 2018
However, on some days you do not take any of the medicines. 
Na nekatere dni pa ne boste vzeli nobenega zdravila.
Do not use while pregnant or breastfeeding. 
Ne uporabljajte med nosečnostjo ali dojenjem.
Time to event 
Čas do dogodka
A national controlled distribution system has been implemented in collaboration with each National Competent Authority. 
Nacionalno nadzorovan sistem distribucije je bil uveljavljen v sodelovanju z vsemi pristojnimi nacionalnimi organi.
Take your next capsule at the usual time the next day. 
Naslednjo kapsulo vzemite naslednji dan ob običajnem času.
• An excess of iron in the body 
• prevelika količina železa v telesu;
Key elements to be included 
Ključni elementi, ki morajo biti vsebovani
• Depending on the day of the cycle, you will take one or more of the medicines. 
• Odvisno od dneva cikla boste vzeli eno ali več zdravil.
Special populations Elderly 
Posebne populacije Starejši
For all indications described below: 
Za vse indikacije, opisane v nadaljevanju:
Pregnancy, breast-feeding and contraception - information for women and men 
Nosečnost, dojenje in kontracepcija - informacije za ženske in moške
No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out. 
Splošnih razlik v varnosti in učinkovitosti med temi bolniki in mlajšimi bolniki niso opazili, vendar pa pri starejših bolnikih ni mogoče izključiti večje predispozicije.
Follow-up and end of treatment 
Sledenje in konec zdravljenja
This can damage the bones and kidneys. 
To lahko poškoduje kosti in ledvice.
Before you start treatment, your doctor will tell you: 
Preden boste začeli z zdravljenjem, vam bo zdravnik povedal:
• After completing each 28-day cycle, you should start a new ‘cycle' over the next 28 days. 
• Po dokončanju vsakega 28-dnevnega cikla boste začeli nov ‘cikel', ki bo trajal naslednjih 28 dni.
Overall response [n, %] Complete response [n, %] 
Celokupni odgovor [n, %] Popolni odgovor [n, %]
Therefore you must tell your doctor immediately if you experience: 
Zato morate zdravniku takoj povedati, če imate:
Enhanced clinical and laboratory monitoring is warranted notably during the first weeks of treatment. 
Natančnejše klinično in laboratorijsko spremljanje je upravičeno še posebej v prvih tednih zdravljenja.
Grade ≥ 3 infections occurred within the context of neutropenia in less than one-third of the patients. 
Okužbe stopnje ≥ 3 so se pojavile v povezavi z nevtropenijo pri manj kot eni tretjini bolnikov.
It is recommended that your partner seeks medical advice. 
Priporočljivo je, da vaša partnerica poišče zdravniško pomoč.
This medicine belongs to a group of medicines which affect how your immune system works. 
To zdravilo spada v skupino zdravil, ki vplivajo na delovanje vašega imunskega sistema.
• The patient has acknowledged the aforementioned conditions. 
• bolnica potrdi navedene pogoje.
• more than 12 hours have passed - do not take your capsule. 
• je minilo več kot 12 ur - ne vzemite kapsule.
• Infections of all types 
• okužbe vseh vrst;
An extended follow-up efficacy analysis was conducted with a median follow-up of 130.7 weeks. 
Opravili so podaljšano sledilno analizo učinkovitosti z mediano sledenja 130,7 tedna.
• some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working 
• nekatera zdravila, ki se uporabljajo za preprečevanje nosečnosti, kot so peroralni kontraceptivi, saj lahko prenehajo delovati
Currently available pharmacokinetic data are described in section 5.2. 
Farmakokinetični podatki, ki so trenutno na voljo, so opisani v poglavju 5.2.
Your doctor should check whether you have ever had hepatitis B infection 
Vaš zdravnik mora preveriti, ali ste kdaj imeli okužbo z virusom hepatitisa B;
If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have. 
Če so vam diagnozo postavili na novo, lahko zdravnik tudi oceni vaše zdravljenje na podlagi vaše starosti in drugih bolezni, ki jih mogoče že imate.
Children and adolescents Lenalidomide is not recommended for use in children and adolescents under 18 years. 
Otroci in mladostniki Zdravilo Lenalidomide ni priporočeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
• Changes to the colour of your skin, sensitivity to sunlight 
• spremembe barve vaše kože, občutljivost na sončno svetlobo;
The following information should also be provided in the appropriate brochure: 
V ustrezni brošuri je treba navesti tudi naslednje informacije:
• 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. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) 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.
• Each 28 - day cycle is called a ‘treatment cycle'. 
• Vsak 28-dnevni cikel se imenuje ‘cikel zdravljenja'.
• That the patient should not donate blood 
• opozorilo, da bolnik ne sme darovati krvi;
Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+). 
Lenalidomid ima asimetrični ogljikov atom, zato obstaja v dveh optično aktivnih oblikah, S(-) in R(+).
g Best assessment of adjudicated response during the treatment phase of the study (for definitions of each response category, Data cut-off date = 24 May 2013). 
g Najboljša ocena odziva po strokovni presoji med fazo zdravljenja tekom študije (za definicije vsake kategorije odzivov, Datum zaključka zbiranja podatkov 24. maja 2013).
In both studies, dose adjustments were allowed based on clinical and laboratory finding. 
V obeh študijah so bile dovoljene prilagoditve odmerka glede na klinične in laboratorijske ugotovitve.
Approximately 30% of the medicinal product in the body was removed during a single 4hour dialysis session. 
Približno 30 % zdravila v telesu je bilo odstranjenega v enem 4-urnem ciklu dialize.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Njihova pogostnost je določena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
You should continue the cycles of treatment until your doctor tells you to stop. 
S cikli zdravljenja morate nadaljevati, dokler vam zdravnik ne naroči, da prekinete.