natgillin/translations-raw huggingface dataset:
The majority of patients (97.4%) had metastatic disease at baseline, 23.6% of patients had bone-only disease, and 49.2% of patients had visceral disease.
Većina bolesnica (97,4%) je imala metastatsku bolest pri početnim vrijednostima, 23,6% bolesnica je imalo samo metastaze na kostima, a 49,2% bolesnica je imalo visceralne metastaze.
The mean Cmax of palbociclib is generally observed between 6 to 12 hours following oral administration.
Prosječni Cmax palbocikliba općenito je opažen između 6 i 12 sati nakon peroralne primjene.
24.8 (22.1, NE)
24,8 (22,1; NP)
Pre/perimenopausal women received the LHRH agonist goserelin.
Pre/perimenopauzalne žene primale su LHRH agonist goserelin.
• Nefazodone used to treat depression.
• nefazodon, koji se koristi za liječenje depresije.
The primary target organ findings of potential relevance to humans included haematolymphopoietic and male reproductive organ effects in rats and dogs in studies up to 39 weeks duration.
Nalazi primarnog ciljnog organa potencijalne važnosti za ljude uključivali su učinke na hematolimfopoetičke i muške reproduktivne organe u štakora i pasa u ispitivanjima koja su trajala do 39 tjedana.
a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Preffered Terms) navedeni su u skladu s MedDRA 17.1. b. Infekcije uključuju sve preporučene pojmove koji su dio Infekcija i infestacija u sklopu klasifikacije organskih sustava.
CBR=clinical benefit response; CI=confidence interval; N=number of patients; OR=objective response.
CBR=odgovor kliničke koristi; CI=interval pouzdanosti; N=broj bolesnika; OR=objektivni odgovor.
The median time to first episode of any grade neutropenia was 15 days (12-700 days) and the median duration of Grade ≥3 neutropenia was 7 days across 3 randomised clinical studies.
Medijan vremena do prve epizode bilo kojeg stupnja neutropenije iznosio je 15 dana (12 - 700 dana) i medijan trajanja stupnja ≥ 3 neutropenije iznosio je 7 dana u 3 randomizirana klinička ispitivanja.
Similarly, no relation was observed when studying the response to palbociclib in in vivo models with patient-derived xenografts (PDX models).
Slično tome, nije primijećena nikakva veza pri proučavanju odgovora na palbociklib u in vivo modelima s ksenograftovima dobivenim od bolesnica (engl. patient-derived xenografts, PDX modeli).
If Grade 3 on Day 15, continue IBRANCE at the current dose to complete cycle and repeat complete blood count on Day 22.
Ako se 15. dana ustanovi stupanj 3, nastaviti liječenje lijekom IBRANCE pri trenutnoj dozi kako biste dovršili ciklus i ponoviti kompletnu krvnu sliku 22. dana.
IBRANCE contains lactose
IBRANCE sadrži laktozu
Febrile neutropenia has been reported in about 2% of patients exposed to IBRANCE across the overall clinical programme.
Febrilna neutropenija je prijavljena u otprilike 2% bolesnica izloženih lijeku IBRANCE u sklopu ukupnog kliničkog programa.
The exposure of animals at the no observed effect level for aneugenicity was approximately 7 times human clinical exposure based on AUC.
Izloženost životinja pri razini pri kojoj nije uočen učinak za aneugeničnost bila je približno 7 puta veća od izloženosti ljudi u kliničkim uvjetima na temelju AUC.
Table 6 shows the efficacy results based on the primary and the updated analyses from the PALOMA-2 study, as assessed by the investigator and by the independent review.
Tablica 6 prikazuje rezultate djelotvornosti temeljene na primarnoj i ažuriranoj analizi iz ispitivanja PALOMA-2 te procjeni ispitivača i neovisnoj procjeni podataka.
In faeces, the sulfamic acid conjugate of palbociclib was the major drug-related component, accounting for 25.8% of the administered dose.
U fecesu, konjugat sulfamične kiseline palbocikliba bila je glavna komponenta povezana s lijekom i čini 25,8% primijenjene doze.
Interstitial lung disease/pneumonitis
Intersticijska bolest pluća/pneumonitis
Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 9.
Dodatne mjere djelotvornosti (OR i TTR) primijećene u podskupinama bolesnica sa ili bez visceralne bolesti prikazane su u Tablici 9.
The recommended dose is 125 mg of IBRANCE taken once a day for 3 weeks followed by 1 week without taking IBRANCE.
Preporučena doza lijeka IBRANCE je 125 mg koja se uzima jednom dnevno tijekom 3 tjedna, nakon čega slijedi tjedan dana bez uzimanja lijeka IBRANCE.
• Sulfasalazine used to treat rheumatoid arthritis.
• sulfasalazin, koji se koristi za liječenje reumatoidnog artritisa.
In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient.
U bolesnika s novim ili pogoršanim respiratornim simptomima, u kojih se sumnja na pojavu IBP-a/pneumonitisa, odmah prekinite primjenu lijeka IBRANCE i procijenite bolesnika.
Women of childbearing potential or their male partners must use a highly effective method of contraception while taking IBRANCE (see section 4.6).
Žene u reproduktivnoj dobi ili partneri žena u reproduktivnoj dobi moraju koristiti visoko učinkovitu metodu kontracepcije dok uzimaju IBRANCE (vidjeti dio 4.6).
Pregnancy and breast-feeding and fertility
Trudnoća, dojenje i plodnost
PALOMA-2 (intent-to-treat population) - Efficacy results based on primary and updated cutoff dates
Tablica 6. PALOMA-2 (populacija predviđena za liječenje) - rezultati djelotvornosti temeljeni na primarnim i ažuriranim zaključnim datumima prikupljanja podataka
Palbociclib may decrease fertility in men.
Palbociklib može smanjiti plodnost u muškaraca.
The European Medicines Agency has waived the obligation to submit the results of studies with IBRANCE in all subsets of the paediatric population in the treatment of breast carcinoma (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka IBRANCE u svim podskupinama pedijatrijske populacije liječene zbog raka dojka (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Updated analysis (23 October 2015 cutoff) IBRANCE plus fulvestrant (N=347)
Ažurirana analiza (Presjek podataka 23. listopada 2015.) IBRANCE i fulvestrant (N=347)
Concomitant treatment with inhibitors or inducers of CYP3A4
Istodobno liječenje inhibitorima ili induktorima CYP3A4
With repeated once daily administration, palbociclib accumulates with a median accumulation ratio of 2.4 (range 1.5-4.2).
S ponovljenom primjenom jednom dnevno, palbociklib se nakuplja s medijanom omjera akumulacije od 2,4 (raspon 1,5-4,2).
Women of childbearing potential/Contraception
Žene u reproduktivnoj dobi/kontracepcija
In vitro, the uptake of palbociclib into human hepatocytes occurred mainly via passive diffusion.
In vitro, unos palbocikliba u ljudske hepatocite događa se većinom putem pasivne difuzije.
• dry cough
• suhi kašalj
Based on male reproductive organ findings (seminiferous tubule degeneration in testis, epididymal hypospermia, lower sperm motility and density, and decreased prostate secretion) in nonclinical safety studies, male fertility may be compromised by treatment with palbociclib (see section 5.3).
Na temelju nalaza muških reproduktivnih organa (degeneracija seminifernih tubula u testisima, epididimalna hipospermija, manja pokretljivost spermija i gustoća te smanjeno izlučivanje prostate) u nekliničkim sigurnosnim ispitivanjima, muška plodnost može biti ugrožena liječenjem palbociklibom (vidjeti dio 5.3).
The relevance of the male rat neoplastic finding to humans is unknown.
Nije poznata važnost neoplastičnog nalaza mužjaka štakora za ljude.
The pharmacokinetics of palbociclib were characterised in patients with solid tumours including advanced breast cancer and in healthy volunteers.
Farmakokinetika palbocikliba bila je procijenjena u bolesnika sa solidnim tumorima uključujući uznapredovali rak dojke u zdravih dobrovoljaca.
If coadministration with a strong CYP3A inhibitor is unavoidable, reduce the IBRANCE dose to 75 mg once daily.
Ako je istodobna primjena sa snažnim inhibitorima CYP3A neizbježna, smanjite dozu lijeka IBRANCE na 75 mg jednom dnevno.
Patients should be monitored for signs and symptoms of infection and treated as medically appropriate (see section 4.2).
Bolesnice treba pratiti zbog moguće pojave znakova i simptoma infekcije i liječiti na medicinski prikladan način (vidjeti dio 4.2).
Through inhibition of CDK4/6, palbociclib reduced cellular proliferation by blocking progression of the cell from G1 into S phase of the cell cycle.
Putem inhibicije CDK4/6 palbociklib je smanjio staničnu proliferaciju blokadom progresije stanice iz G1 u S fazu staničnog ciklusa.
• Quinidine generally used to treat heart rhythm problems.
• kinidin, koji se općenito koristi za liječenje problema sa srčanim ritmom.
IBRANCE hard capsules come in different strengths.
IBRANCE tvrde kapsule su dostupne u različitim jačinama.
Palbociclib was the major circulating drug-derived entity in plasma.
Palbociklib je bio glavni entitet dobiven iz cirkulirajućeg lijeka u plazmi.
Available clinical data are reported in the clinical efficacy and safety section (see section
Dostupni klinički podaci se nalaze u dijelu o kliničkoj djelotvornosti i sigurnosti (vidjeti dio 5.1).
The results from the investigator-assessed PFS and final OS data from PALOMA-3 study are presented in Table 8.
Rezultati PFS-a prema procjeni ispitivača i konačni podaci OS-a dobiveni iz ispitivanja PALOMA-3 prikazani su u Tablici 8.
Insufficient data are available in patients requiring haemodialysis to provide any dose adjustment recommendation in this patient population (see sections 4.4 and 5.2).
Nema dovoljno podataka u bolesnica kojima je potrebna hemodijaliza kako bi se osigurale bilo kakve preporuke za prilagodbu doze u ovoj populaciji bolesnika (vidjeti dijelove 4.4 i 5.2).
CTCAE=Common Terminology Criteria for Adverse Events.
CTCAE=Zajednička terminologija za nuspojave.
• Dihydroergotamine and ergotamine used to treat migraine.
• dihidroergotamin i ergotamin, koji se koriste za liječenje migrena.
IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative) which have spread beyond the original tumour and/or to other organs.
IBRANCE se koristi za liječenje bolesnika s određenim tipovima raka dojke (na hormonski receptor pozitivan, negativan na receptor humanog epidermalnog faktora rasta 2) koji su se proširili izvan prvotnog tumora i/ili na druge organe.
Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3, and no Grade 4 or fatal cases were reported.
U kliničkim je ispitivanjima (PALOMA-1, PALOMA-2, PALOMA-3) 1,4% bolesnika liječenih lijekom IBRANCE imalo IBP/pneumonitis bilo kojeg stupnja; 0,1% bolesnika imali su bolest stupnja 3, a slučajevi stupnja 4 kao ni slučajevi smrtnog ishoda nisu prijavljeni.
Withhold IBRANCE until recovery to Grade ≤2.
Prekinuti liječenje lijekom IBRANCE sve do oporavka na stupanj ≤ 2.
Patients receiving palbociclib should not breast feed.
Bolesnice koje primaju palbociklib ne smiju dojiti.
A total of 405 PFS events were observed; 245 events (55.2%) in the palbociclib plus letrozole arm and 160 (72.1%) in the comparator arm respectively.
Opaženo je ukupno 405 PFS događaja; 245 događaja (55,2%) u skupini koja je primala palbociklib i letrozol, odnosno 160 događaja (72,1%) u skupini koja je primala usporedni lijek.
Given the reduced effect on gastric pH of H2-receptor antagonists and local antacids compared to PPIs, no clinically relevant effect of H2-receptor antagonists or local antacids on palbociclib exposure is expected when palbociclib is taken with food.
S obzirom na smanjeni učinak na želučani pH antagonista H2-receptora i lokalnih antacida u usporedbi s inhibitorima protonske pumpe, ne očekuje se klinički značajan učinak antagonista H2-receptora ili lokalnih antacida na izloženost palbociklibu kada se palbociklib uzima s hranom.
Excretion of unchanged palbociclib in faeces and urine was 2% and 7% of the administered dose, respectively.
Izlučivanje nepromijenjenog palbocikliba u fecesu i urinu iznosilo je 2%, odnosno 7% primijenjene doze.
• Pimozide used to treat schizophrenia and chronic psychosis.
• pimozid, koji se koristi za liječenje shizofrenije i kronične psihoze.
If you forget to take IBRANCE
Ako ste zaboravili uzeti IBRANCE
Women of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception such as condom and diaphragm).
Žene u reproduktivnoj dobi koje primaju ovaj lijek ili njihovi muški partneri moraju koristiti odgovarajuće metode kontracepcije (primjerice primjena dvostruke mehaničke kontracepcije, kao na primjer prezervativ i dijafragma).
Palbociclib should not be taken with grapefruit or grapefruit juice (see section 4.5).
Palbociklib se ne smije uzimati s grejpom niti sokom od grejpa (vidjeti dio 4.5).
An increased incidence of a skeletal variation (increased incidence of a rib present at the seventh cervical vertebra) at ≥100 mg/kg/day was observed in rats.
Povećana incidencija promjena u kosturu (povećana incidencija prisutnosti rebra u sedmom cervikalnom kralješku) pri ≥ 100 mg/kg/dan uočena je kod štakora.
Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).
Na temelju in vitro podataka, palbociklib može inhibirati unos organskog kationskog transportera OCT1 i potom može povećati izloženost lijekovima supstratima ovog transportera (primjerice metformina).
Randomised Phase 3 Study PALOMA-3: IBRANCE in combination with fulvestrant
Randomizirano ispitivanje faze 3 PALOMA-3: IBRANCE u kombinaciji s fulvestrantom
These methods should be used during therapy and for at least 3 weeks after completing therapy for females and for at least 14 weeks for males.
Ovu zaštitu je potrebno koristiti tijekom liječenja i još najkraće tri tjedna nakon završetka liječenja za žene i najkraće 14 tjedana nakon dovršetka liječenja za muškarce.
Management of some adverse reactions may require temporary dose interruptions/delays, and/or dose reductions, or permanent discontinuation as per dose reduction schedules provided in Tables 1, 2, and 3 (see sections 4.4 and 4.8).
Liječenje nekih nuspojava može zahtijevati privremene prekide/odgode doze i/ili smanjenja doze ili trajni prekid prema rasporedima smanjenja doze koji je dan u Tablicama 1, 2 i 3 (vidjeti dijelove 4.4 i
The relevant Kaplan-Meier plots are shown in Figures 2 and 3, respectively.
Relevantne Kaplan-Meierove krivulje prikazane su na slici 2, odnosno slici 3.
FUL=fulvestrant; PAL=palbociclib; PCB=placebo.
FUL=fulvestrant; PAL=palbociklib; PCB=placebo.
In the dosing range of 25 mg to 225 mg, the area under the curve (AUC) and Cmax increase proportionally with dose in general.
U rasponu doziranja od 25 mg do 225 mg, u području ispod krivulje AUC i Cmax rastu proporcionalno s dozom općenito.
When coadministered with palbociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter.
Kad se primjenjuje istodobno s palbociklibom, preporučena doza fulvestranta je 500 mg primijenjenog intramuskularno 1., 15., 29. dana i nakon toga jednom mjesečno.
What IBRANCE contains - The active substance is palbociclib.
Što IBRANCE sadrži - Djelatna tvar je palbociklib.
The recommended dose is 125 mg of palbociclib once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.
Preporučena doza je 125 mg palbocikliba jednom dnevno tijekom 21 uzastopnog dana nakon čega slijedi 7 dana bez terapije (raspored 3/1) kako bi se dovršio potpuni ciklus od 28 dana.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Bolesnice s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjele uzimati ovaj lijek.
Despite these male reproductive organ findings, there were no effects on mating or fertility in male rats at projected exposure levels 13 times human clinical exposure based on AUC.
Usprkos nalazima na tim muškim reproduktivnim organima, nije bilo učinaka na parenje ili plodnost kod muških štakora pri projiciranom izlaganju 13 puta većem od kliničkog izlaganja ljudi na temelju AUC.
Withhold IBRANCE, until recovery to Grade ≤2, and repeat complete blood count monitoring within 1 week.
Prekinuti liječenje lijekom IBRANCE sve do oporavka na stupanj ≤ 2 i ponoviti kompletnu krvnu sliku unutar tjedan dana.
Testing of palbociclib in a panel of molecularly profiled breast cancer cell lines revealed high activity against luminal breast cancers, particularly ER-positive breast cancers.
Testiranje palbocikliba u panelu molekularno profiliranih linija stanica raka dojke otkrilo je visoku djelotvornost protiv luminalnog raka dojke, posebice kod ER-pozitivnog raka dojke.
Febrile neutropenia has been reported in 0.9% of patients receiving IBRANCE in combination with fulvestrant and in 1.7% of patients receiving palbociclib in combination with letrozole.
Febrilna neutropenija prijavljena je u 0,9% bolesnica koje su primale IBRANCE u kombinaciji s fulvestrantom te u 1,7% bolesnica koje su primale palbociklib u kombinaciji s letrozolom.
Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy.
Teška, po život opasna ili smrtonosna intersticijska bolest pluća (IBP) i/ili pneumonitis mogu se pojaviti u bolesnika liječenih lijekom IBRANCE kad se primjenjuje u kombinaciji s endokrinom terapijom.
Thus, men may consider sperm preservation prior to beginning therapy with IBRANCE.
Stoga, muškarci moraju uzeti u obzir pohranjivanje sperme prije početka terapije lijekom IBRANCE.
Effects of palbociclib on the pharmacokinetics of other medicinal products
Učinci palbocikliba na farmakokinetiku ostalih lijekova
N=number of patients; CI=confidence interval; OR=objective response based on confirmed and unconfirmed responses according to RECIST 1.1; TTR=time to first tumour response.
N=broj bolesnika; CI=interval pouzdanosti; OR=objektivni odgovor temeljen na potvrđenim i nepotvrđenim odgovorima u skladu s kriterijima RECIST 1.1; TTR=vrijeme do prvog tumorskog odgovora.
Effect of CYP3A inducers
Učinak induktora CYP3A
c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
c. Neutropenija uključuje sljedeće preporučene pojmove: Neutropenija, smanjen broj neutrofila.
Effects on glucose metabolism were associated with findings in the pancreas and secondary effects on eye, teeth, kidney, and adipose tissue in studies ≥15 weeks duration in rats only and bone changes were observed in rats only following 27 weeks of dosing.
Učinci na metabolizam glukoze bili su povezani s nalazima na gušterači te sekundarnim učincima na oko, zube, bubrege te masno tkivo u ispitivanjima u trajanju od ≥ 15 tjedana samo u štakora, a promjene na kostima su uočene samo u štakora nakon 27 tjedana doziranja.
IBRANCE is for oral use.
IBRANCE je namijenjen za peroralnu primjenu.
Palbociclib was not mutagenic in a bacterial reverse mutation (Ames) assay and did not induce structural chromosomal aberrations in the in vitro human lymphocyte chromosome aberration assay.
Palbociklib nije bio mutagen u testu bakterijski reverzne mutacije (Ames) i nije inducirao strukturalne kromosomske aberacije u in vitro testu aberacije kromosoma ljudskih limfocita.
There are no or limited amount of data from the use of palbociclib in pregnant women.
Nema podataka ili su podaci o primjeni palbocikliba u trudnica ograničeni.
No dose adjustments are needed for mild and moderate CYP3A inhibitors.
Nisu potrebne prilagodbe doze za blage i umjerene inhibitore CYP3A.
IBRANCE is an anticancer medicine containing the active substance palbociclib.
IBRANCE je lijek protiv raka koji sadrži djelatnu tvar palbociklib.
For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, complete blood counts for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.
U bolesnika koji u prvih 6 ciklusa razviju neutropeniju najviše 1. ili 2. stupnja, treba pratiti kompletnu krvnu sliku za sljedeće cikluse svaka 3 mjeseca, prije početka ciklusa te prema kliničkoj potrebi.
In vitro evaluations indicate that palbociclib has low potential to inhibit the activities of organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2, organic anion transporting polypeptide (OATP)1B1, OATP1B3, and bile salt export pump (BSEP) at clinically relevant concentrations.
In vitro procjene ukazuju da palbociklib ima niski potencijal inhibicije aktivnosti transportera organskog aniona (OAT)1, OAT3, transportera organskog kationa (OCT)2, polipeptida koji prenosi organski anion (OATP)1B1, OATP1B3 i pumpe za izbacivanje žučnih soli (BSEP) pri klinički značajnim koncentracijama.
IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs of 21 or 63 hard capsules and in plastic bottles of 21 hard capsules.
IBRANCE 75 mg, 100 mg and 125 mg su dostupni u blister pakiranjima od 21 ili 63 tvrde kapsule te u plastičnim bočicama od 21 tvrde kapsule.
Time-to-Deterioration was prespecified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
Vrijeme do pogoršanja bilo je prethodno specificirano kao vrijeme između početne vrijednosti i prve pojave porasta od ≥ 10 točaka od početne vrijednosti u ljestvicama simptoma boli.
No dose adjustment of IBRANCE is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min).
Nije potrebna prilagodba doze lijeka IBRANCE u bolesnica s blagim, umjerenim ili teškim oštećenjem bubrega (klirens kreatinina [CrCl] ≥ 15 ml/min).
In vitro studies with human hepatocytes, liver cytosolic and S9 fractions, and recombinant sulphotransferase (SULT) enzymes indicated that CYP3A and SULT2A1 are mainly involved in the metabolism of palbociclib.
In vitro ispitivanja s ljudskim hepatocitima, frakcijama S9 i jetrenog citosola te rekombinantnim enzimima sulfotransferaze (SULT) pokazala su da su CYP3A i SULT2A1 uglavnom uključeni u metabolizam palbocikliba.
In 6 healthy male subjects given a single oral dose of [14C]palbociclib, a median of 92% of the total administered radioactive dose was recovered in 15 days; faeces (74% of dose) was the major route of excretion, with 17% of the dose recovered in urine.
U 6 zdravih muških ispitanika koji su primili pojedinačnu peroralnu dozu C]palbocikliba, medijan od 92% ukupne primijenjene radioaktivne doze povraćeno je u 15 dana; feces (74% doze) je bio glavni put izlučivanja sa 17% doze povraćene u urinu.
The reversibility of the effects on glucose homeostasis, pancreas, eye, kidney, and bone was not established following a 12-week nondosing period, whereas partial to full reversal of effects on the haematolymphopoietic and male reproductive systems, teeth, and adipose tissue was observed.
Reverzibilnost učinaka na homeostazu glukoze, gušteraču, oko, bubrege i kost nije utvrđen nakon razdoblja od 12 tjedana nedoziranja; dok je bio uočen djelomični do puni povratak učinaka na hematolimfopoetske i muške reproduktivne sustave, zube i masno tkivo.
Females of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 3 weeks or 14 weeks after completing therapy for females and males, respectively (see section 4.5).
Žene u reproduktivnoj dobi koje primaju ovaj lijek ili njihovi muški partneri, moraju koristiti odgovarajuće metode kontracepcije (primjerice, dvostruka mehanička kontracepcija) tijekom liječenja i najkraće tijekom 3 tjedna nakon dovršetka terapije za žene, odnosno 14 tjedana za muškarce (vidjeti dio 4.5).