natgillin/translations-raw huggingface dataset:
Not known** Renal impairment. 
Nije poznato** Oštećenje funkcije bubrega.
Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men. 
Osteoporoza je bolest koja uključuje stanjivanje i slabljenje kostiju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (without blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (bez plavog okvira)
In patients with Paget's disease symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported. 
kao što su grčevi mišića, utrnulost ili trnci, osobito u području oko usta.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/912/001
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (s plavim okvirom)
One bottle contains 5 mg zoledronic acid (as monohydrate). 
Jedna bočica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Mechanism of action 
stopa događaja
Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis# 
Manje često Dispepsija, bol u gornjem dijelu trbuha, bol u trbuhu, gastroezofagealna refluksna bolest, konstipacija, suhoća usta,
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2). 
Zoledronatna kiselina se sistemski ne metabolizira i ne utječe na humane enzime citokroma
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 
Vertebralni prijelom (2) Nevertebralni prijelom (1) *p-vrijednost <0,05, **p- vrijednost <0,01
Relative reduction in fracture incidence % (CI) 
Relativno smanjenje incidencije prijeloma % (CI)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/004 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/912/004
Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5. zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures. 
zbroj vrata bedrene kosti ispod -2,5 a 45% bolesnika je imalo BMD T-zbroj vrata bedrene kosti iznad -2,5.
The educational programme contains the following: 
Program izobrazbe sadrži sljedeće: • Edukativne materijale za liječnika
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bags 
NAZIV LIJEKA Zoledronatna kiselina Teva Generics 5 mg otopina za infuziju u vrećicama
Zoledronic acid Teva Generics 5 mg solution for infusion in bottles zoledronic acid 
Zoledronatna kiselina Teva Generics 5 mg otopina za infuziju u bočicama zoledronatna kiselina
Relative risk reduction in fracture incidence % (CI) 
Relativno smanjenje rizika od incidencije prijeloma % (CI)
- Do not use this medicine after the expiry date which is stated on the bag and carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vrećici i kutiji iza „Rok valjanosti“.
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 
Nevertebralni prijelom (1) *p-vrijednost <0,001, **p-vrijednost <0,0001
Gastrointestinal disorders 
Analiza mikrokompjuteriziranom tomografijom
- Do not use Zoledronic acid Teva Generics after the expiry date which is stated on the bag. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vrećici.
(CI) 
U
- Zoledronic acid Teva Generics 5 mg solution for infusion is ready for use. 
Kako pripremiti i primijeniti Zoledronatnu kiselinu Teva Generics - Zoledronatna kiselina Teva Generics 5 mg otopina za infuziju je spremna za uporabu.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following zoledronic acid administration (see section 4.2). 
Osim toga, u bolesnika s Pagetovom bolešću posebno se savjetuje osigurati uzimanje kalcija u obliku odgovarajućeg dodatka prehrani koji odgovara količini od najmanje 500 mg elementarnog kalcija,
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bottles 
NAZIV LIJEKA Zoledronatna kiselina Teva Generics 5 mg otopina za infuziju u bočicama
Bone turnover markers 
Markeri koštane pregradnje
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). 
U subpopulaciji bolesnika koji su primali glukokortikoide 3 mjeseca ili kraće prije randomizacije zoledronatna kiselina povećala je BMD lumbalne kralježnice za 2,60% u odnosu na 0,64% pri primjeni risedronata
Osteonecrosis of the jaw has been reported in patients treated with zoledronic acid. 
U bolesnika koji su liječeni zoledronatnom kiselinom prijavljena je osteonekroza čeljusti.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Generics. 
Pretraga za praćenje Prije svake doze Zoledronatne kiseline Teva Generics liječnik Vam mora napraviti krvnu pretragu kako bi provjerio Vašu bubrežnu funkciju (razine kreatinina).
You may eat normally on the day you are treated with Zoledronic acid Teva Generics. 
Na dan kad ćete primiti Zoledronatnu kiselinu Teva Generics možete normalno jesti.
- Zoledronic acid Teva Generics 5 mg solution for infusion in bags is ready for use. 
Kako pripremiti i primijeniti Zoledronatnu kiselinu Teva Generics u vrećicama - Zoledronatna kiselina Teva Generics 5 mg otopina za infuziju u vrećicama je spremna za uporabu.
One bag contains 5 mg zoledronic acid (as monohydrate). 
Jedna vrećica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following zoledronic acid administration (see section 4.4). 
U bolesnika s Pagetovom bolešću, snažno se preporučuje osigurati uzimanje odgovarajućeg nadomjestka kalcija, koji odgovara količini od najmanje 500 mg elementarnog kalcija,
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava Manje često Anemija Poremećaji imunološkog sustava
Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4). 
Oprez je indiciran kad se zoledronatna kiselina primjenjuje zajedno s lijekovima koji mogu značajno utjecati na bubrežnu funkciju (npr.
Only clear solution free from particles and discoloration should be used. 
Upotrebljavati se smije samo bistra otopina u kojoj nema čestica i koja nije promijenila boju.
- Patients with hypocalcaemia (see section 4.4). 
aminoglikozidi ili diuretici koji mogu uzrokovati dehidraciju) (vidjeti dio 4.4).
- 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. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza „Rok valjanosti“.
Teva Pharma Belgium N.V. 
Teva Nederland B.V.
Zoledronic acid Teva Generics 5 mg solution for infusion in bags zoledronic acid 
Zoledronatna kiselina Teva Generics 5 mg otopina za infuziju zoledronatna kiselina
- if you have a kidney problem, or used to have one. 
- ako imate ili ste imali problema s bubrezima.
Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, anti-angiogenic medicinal products, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anaemia, coagulopathies, infection, pre-existing dental disease). 
U bolesnika s osteonekrozom čeljusti dobro su dokumentirani višestruki rizični faktori koji uključuju dijagnozu raka, istovremene terapije (npr.
Zoledronic acid Teva Generics contains the active substance zoledronic acid. 
Zoledronatnu kiselinu Teva Generics zbog postmenopauzalne osteoporoze.
STATEMENT OF ACTIVE SUBSTANCE(S) Each bottle contains 5 mg zoledronic acid (as monohydrate). 
TVARI Svaka bočica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Kidney disorders (e.g. decreased urine output) may occur. 
Mogu se javiti poremećaji bubrega (npr. smanjena proizvodnja mokraće).
STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 5 mg zoledronic acid (as monohydrate). 
TVARI Jedna bočica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
Batch 
Swen
If you missed a dose of Zoledronic acid Teva Generics Contact your doctor or hospital as soon as possible to re-schedule your appointment. 
Obratite se svom liječniku ili javite u bolnicu što je prije moguće kako biste ugovorili novi termin.
STATEMENT OF ACTIVE SUBSTANCE(S) One bag contains 5 mg zoledronic acid (as monohydrate). 
TVARI Jedna vrećica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
In case you recently broke your hip, it is recommended that Zoledronic acid Teva Generics is administered two or more weeks after your hip repair surgery. 
Teva Generics dva ili više tjedana nakon kirurškog zahvata na kuku.
• then at least every month after that. 
• zatim najmanje svaki mjesec nakon toga.
This is called a ‘response'. 
To se naziva 'odgovor'.
It works in a number of different ways: 
Djeluje na brojne različite načine:
• every week for the first 8 weeks of treatment 
• svaki tjedan tijekom prvih 8 tjedana liječenja
Ask your pharmacist how to throw away medicines you no longer use. 
Pitajte ljekarnika kako da bacite lijekove koje više ne koristite.
However, on some days you do not take any of the medicines. 
Međutim, na neke dane nećete uzeti nijedan lijek.
Take your next capsule at the usual time the next day. 
Uzmite sljedeću kapsulu u uobičajeno vrijeme sljedećega dana.
• An excess of iron in the body 
• prekomjerna količina željeza u tijelu
Time to event 
Vrijeme do događaja
Date of first authorisation: 20th September 2018 
Datum prvog odobrenja: 20. rujna 2018
ATC code: L04AX04. 
ATK oznaka: L04AX04.
It is recommended that your partner seeks medical advice. 
Preporučuje se da Vaša partnerica potraži medicinski savjet.
Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established. 
Može biti opravdano dodatno praćenje i procjena ako nije moguće uspostaviti alternativnu dijagnozu.
Your doctor will ask you to have a blood test: 
Liječnik će od Vas zatražiti da pretrage krvi obavite:
However, the signs and symptoms can be greatly reduced or disappear for a period of time. 
Međutim, znakovi i simptomi bolesti mogu se uvelike smanjiti ili povući na neko vrijeme.
• That the patient should not donate blood 
• da bolesnik ne bi smio darivati krv
Otherwise, decrease by one dose level at start of next cycle. 
U protivnom, snizite dozu za jednu razinu na početku sljedećeg ciklusa.
• Ringing in the ears (tinnitus) 
• zvonjava u ušima (tinitus)
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. 
Nije primijećena sveukupna razlika u sigurnosti ili djelotvornosti između ovih bolesnika i mlađih bolesnika, ali ne može se isključiti veća predispozicija među starijim osobama.
For all indications described below: 
Za sve indikacije opisane u nastavku:
If you are able to become pregnant 
Ako možete zatrudnjeti
Your doctor will advise you on appropriate methods of contraception. 
Liječnik će Vas savjetovati o odgovarajućim metodama kontracepcije.
• The patient has acknowledged the aforementioned conditions. 
• da je bolesnica razumjela prethodno navedene uvjete.
Your doctor should check whether you have ever had hepatitis B infection 
Liječnik bi trebao provjeriti jeste li ikada imali infekciju hepatitisa B.
• After completing each 28-day cycle, you should start a new ‘cycle' over the next 28 days. 
• Nakon završetka svakog ciklusa od 28 dana, započet ćete novi 'ciklus' od sljedećih 28 dana.
Injury, Poisoning and Procedural Complications 
Ozljede, trovanja i proceduralne komplikacije
Pregnancy, breast-feeding and contraception - information for women and men 
Trudnoća, dojenje i kontracepcija - informacije za žene i muškarce
An extended follow-up efficacy analysis was conducted with a median follow-up of 130.7 weeks. 
Produljeno praćenje analize djelotvornosti provedeno je s medijanom praćenja od 130,7 tjedana.
Safety advice for men 
Sigurnosne savjete za muškarce
Lenalidomide is taken on certain days over 4 weeks (28 days). 
Lenalidomid se uzima na određene dane tijekom 4 tjedna (28 dana).
The following information should also be provided in the appropriate brochure: 
Sljedeće informacije također treba navesti u odgovarajućoj knjižici:
Before you start treatment, your doctor will tell you: 
Prije nego što započnete liječenje, liječnik će Vam reći:
Gastrointestinal perforations may lead to septic complications and may be associated with fatal outcome. 
Gastrointestinalne perforacije mogu dovesti do septičkih komplikacija i mogu biti povezane sa smrtnim ishodom.
• Verification that appropriate counselling has taken place 
• potvrdu da je provedeno odgovarajuće savjetovanje
Overall response [n, %] Complete response [n, %] 
Ukupni odgovor [n, %] Potpuni odgovor [n, %]
Therefore you must tell your doctor immediately if you experience: 
Stoga morate odmah obavijestiti svog liječnika ako osjetite:
You should continue the cycles of treatment until your doctor tells you to stop. 
Trebate nastaviti cikluse liječenja sve dok Vam liječnik ne kaže da prestanete.
• Depending on the day of the cycle, you will take one or more of the medicines. 
• Ovisno o danu ciklusa uzet ćete jedan ili više lijekova.
• Mood change, difficulty sleeping 
• promjene raspoloženja, teškoće sa spavanjem
Developmental toxicity studies were previously conducted in rabbits. 
Ispitivanja razvojne toksičnosti prethodno su provedena na kunićima.
In particular, tell your doctor or nurse if you are taking any of the following medicines: 
Posebice recite svom liječniku ili medicinskoj sestri ako uzimate bilo koji od sljedećih lijekova:
• some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working 
• neke lijekove za sprječavanje trudnoće poput oralnih kontraceptiva jer mogu prestati djelovati
e Exploratory endpoint (PFS2). 
e Eksploratorni ishod (PFS2).
In IFM 2005-02, the adverse reactions were from the maintenance treatment period only. 
U IFM 2005-02 nuspojave su bile samo iz razdoblja održavanja liječenja.
In both studies, dose adjustments were allowed based on clinical and laboratory finding. 
U oba ispitivanja bile su dopuštene prilagodbe doze na temelju kliničkog i laboratorijskog nalaza.
If you think you may be allergic, ask your doctor for advice. 
Ako mislite da biste mogli biti alergični, obratite se liječniku za savjet.
• more than 12 hours have passed - do not take your capsule. 
• prošlo je više od 12 sati - nemojte uzeti kapsulu.
• The need to avoid foetal exposure 
• potreba za izbjegavanjem fetalne izloženosti
This medicine belongs to a group of medicines which affect how your immune system works. 
Ovaj lijek pripada skupini lijekova koji utječu na način rada Vašeg imunološkog sustava.
Tell your doctor or nurse if you are taking ,have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation. 
Ako ste u stanju zatrudnjeti, Vaš liječnik će zabilježiti uz svaki recept da su poduzete potrebne mjere te će Vam dati tu potvrdu.
Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+). 
Lenalidomid ima asimetrični ugljikov atom i stoga može postojati u optički aktivnim oblicima S(-) i R(+).
Common C-reactive protein increased 
Često povišen C-reaktivni protein
Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. 
Liječnik može provjeriti imate li veliku ukupnu količinu tumora u tijelu, uključujući koštanu srž.
Grade ≥ 3 infections occurred within the context of neutropenia in less than one-third of the patients. 
Infekcije ≥ 3. stupnja događale su se u prisutnosti neutropenije u manje od jedne trećine bolesnika.
This can damage the bones and kidneys. 
To može oštetiti kosti i bubrege.
A second analysis identified events that occurred after the start of maintenance treatment. 
Druga analiza identificirala je događaje koji su nastali nakon početka terapije održavanja.
Children and adolescents Lenalidomide is not recommended for use in children and adolescents under 18 years. 
Djeca i adolescenti Lenalidomid se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
e Exploratory endpoint (PFS2) f The median is the univariate statistic without adjusting for censoring. 
e Eksploratorni ishod (PFS2) f Medijan je univarijantna statistička mjera bez prilagodbe za cenzuru.
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of. 
Bolesnike također treba savjetovati da obavijeste partnera ili njegovatelja o svom liječenju, jer oni mogu primijetiti simptome kojih bolesnik nije svjestan.
Multiple myeloma generally cannot be cured. 
Multipli mijelom se najčešće ne može izliječiti.
If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have. 
Ako Vam je dijagnoza postavljena nedavno, liječnik će možda također procijeniti liječenje na temelju Vaše dobi i drugih zdravstvenih stanja koja već imate.
Tests and checks 
Testovi i pretrage
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6). 
Moraju se poduzeti učinkovite mjere kako bi se izbjegla trudnoća (vidjeti dijelove 4.4 i 4.6).
• less than 12 hours have passed - take your capsule immediately. 
• prošlo je manje od 12 sati - odmah uzmite kapsulu
Approximately 30% of the medicinal product in the body was removed during a single 4hour dialysis session. 
Približno 30 % lijeka u tijelu uklonjeno je tijekom jednog postupka dijalize u trajanju od 4 sata.
OTHER SPECIAL WARNING(S), IF NECESSARY WARNING: Risk of severe birth defects. 
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO UPOZORENJE: Rizik od teških urođenih mana.
If dose increased (15 mg) a 
U slučaju povećanja doze (15 mg)a
Therefore, caution is recommended when driving or operating machines. 
Stoga se preporučuje oprez prilikom upravljanja vozilima ili strojevima.
You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own. 
Ove druge lijekove primit ćete na početku liječenja, a zatim ćete nastaviti uzimati samo lenalidomid.
08039 Barcelona, Spain 
08039 Barcelona,
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses 
• spolni odnos samo s partnerom koji je podvrgnut vazektomiji; vazektomija se mora potvrditi dvjema negativnim analizama sperme
If any of these apply to you, do not take lenalidomide . 
Ako se bilo što od ovoga odnosi na Vas, nemojte uzeti lenalidomid.
Patients should be advised to promptly report febrile episodes. 
Bolesnicima treba savjetovati da što prije prijave febrilne epizode.
• if you have or have ever had previous viral infection, particularly hepatitis B infection, varicella zona, HIV. 
• ako imate ili ste ikada prije imali virusnu infekciju, posebice infekciju hepatitisa B, varičelu, HIV.
• That the patient should not give Lenalidomide Accord to any other person 
• da bolesnik ne smije davati Lenalidomid Accord bilo kojoj drugoj osobi
Some of the cases of viral reactivation had a fatal outcome. 
Neki od tih slučajeva reaktivacije virusa imali su smrtni ishod.
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). 
Učestalost se definira kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment for safe disposal. 
Bolesnike treba upozoriti da nikada ne daju svoj lijek drugoj osobi te da sve neiskorištene kapsule vrate svom ljekarniku po završetku liječenja radi sigurnog zbrinjavanja.
• on what days of your treatment cycle to take each medicine. 
• na koje dane ciklusa liječenja morate uzeti svaki od tih lijekova.
To remove the capsule from the blister: 
Vađenje kapsule iz blistera:
It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment. 
Ne može se isključiti da će djelotvornost oralnih kontraceptiva možda biti smanjena tijekom liječenja.
The ECOG performance status was comparable between both groups, as was the number and type of prior therapies. 
Status funkcionalnog stanja prema ljestvici ECOG bio je usporediv između obje skupine kao i broj i vrsta prethodnih linija liječenja.
If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day. 
Ako je prošlo više od 12 sati od uobičajenog vremena propuštene doze, bolesnik ne smije uzeti dozu nego treba uzeti sljedeću dozu u uobičajeno vrijeme idućega dana.
The results for the study, using a cut-off of 1 February 2016, are presented in Table 4 
Rezultati studije, sa zaključnim datumom podataka 1. veljače 2016., su prikazani u tablici 4.
Not Known Solid organ transplant rejection 
Nepoznato odbacivanje transplantiranog solidnog organa
A negative JCV PCR does not exclude PML. 
PCR negativna na JCV ne isključuje postojanje PML-a.
Though this risk is not yet fully characterized, it should be kept in mind when considering and using lenalidomide in this setting. 
Iako taj rizik nije još potpuno definiran, potrebno ga je uzeti u obzir prilikom razmatranja primjene i same primjene lenalidomida u takvim okolnostima.
• She understands the expected teratogenic risk to the unborn child 
• Žena razumije očekivani teratogeni rizik za nerođeno dijete.
These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). 
To mogu biti simptomi ozbiljnog i potencijalno smrtonosnog moždanog poremećaja koji se naziva progresivna multifokalna leukoencefalopatija (PML).
• Each 28 - day cycle is called a ‘treatment cycle'. 
• Svaki ciklus od 28 dana naziva se ‘ciklus liječenja'.
Safety advice relevant to all patients 
Sigurnosne savjete koji vrijede za sve bolesnike
a The median is based on the Kaplan-Meier estimate. 
Medijan se temelji na Kaplan-Meierovoj procjeni.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. 
• Ako ste alergični na lenalidomid ili neki drugi sastojak ovog lijeka naveden u dijelu 6.
• how much of the other medicines you should take in combination with lenalidomide , if any 
• koliko drugih lijekova morate uzeti u kombinaciji s lenalidomidom, ako ih uopće morate uzeti