natgillin/translations-raw huggingface dataset:
Point estimate of the difference (Victrelis-RGT minus VictrelisPR48) [95% CI] 
Točkovna procjena razlike (VictrelisRGT minus Victrelis-PR48) [95% CI]
Based on results of clinical studies, Victrelis must not be used alone due to the high probability of increased resistance without combination anti-HCV therapies (see section 5.1). 
Na temelju rezultata kliničkih ispitivanja, Victrelis se ne smije primjenjivati samostalno zbog velike vjerojatnosti povećane rezistencije bez kombinacije s drugim lijekovima protiv HCV-a (vidjeti dio 5.1).
Boceprevir is eliminated with a mean plasma half-life (t½) of approximately 3.4 hours. 
Boceprevir se eliminira uz srednji poluvijek u plazmi (t½) od oko 3,4 sata.
Following a single 800 mg oral 
Nakon jednokratne peroralne doze od 800 mg
The bioavailability of boceprevir is regardless of meal type (e.g., high-fat vs. low-fat) or whether taken 5 minutes prior to eating, during a meal, or immediately following completion of the meal. 
Na bioraspoloživost boceprevira ne utječe vrsta obroka (npr. punomasni ili nemasni) ili uzima li se 5 minuta prije jela, za vrijeme jela ili neposredno nakon obroka.
The percentage of patients with Grades 3-4 neutropenia (neutrophil counts < 0.75 x 10 
Postotak bolesnika s neutropenijom stupnja 3-4 (broj neutrofila < 0,75 x 10
Victrelis may be co-administered with AKR inhibitors. 
Victrelis se može primjenjivati zajedno s AKR inhibitorima.
o The duration of the tritherapy after the first 4 weeks of bitherapy should not be less than 32 weeks. 
o Trojna terapija nakon prva 4 tjedna dvojne terapije ne smije trajati kraće od 32 tjedna.
In 2-year carcinogenicity studies, no carcinogenicity was observed, but there was an increased incidence of hepatocellular adenomas in mice, which was not statistically significant, at systemic exposures 5.7-fold higher than those in humans at the recommended therapeutic dose. 
U dvogodišnjim istraživanjima karcinogenosti nije opažena kancerogenost, ali je zabilježena povećana incidencija hepatocelularnih adenoma u miševa, koja nije bila statistički značajna, pri sistemskoj izloženosti 5,7 puta većoj od izloženosti u ljudi pri preporučenim terapijskim dozama.
When boceprevir is administered with ritonavir alone, boceprevir concentrations are decreased. 
Kada se boceprevir primjenjuje samo s ritonavirom, koncentracije boceprevira se smanjuju.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Victrelis are provided with a healthcare professional educational pack containing the following at 
Nositelj odobrenja će osigurati da svi liječnici od kojih se očekuje da propisuju ili koriste Victrelis dobiju edukativni paket za zdravstvene radnike, koji će u trenutku stavljanja lijeka u promet sadržavati
For most of these subjects (n=54), the lowest dose of ribavirin received for at least 14 days was ≥ 600mg/day. 
U većine tih ispitanika (n=54) najniža doza ribavirina koju su primali tijekom najmanje 14 dana iznosila je ≥ 600 mg na dan.
Clinical studies of boceprevir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 
U klinička ispitivanja s boceprevirom nije bio uključen dovoljan broj ispitanika u dobi od 65 godina i starijih da bi se moglo odrediti reagiraju li oni na liječenje drugačije od mlađih ispitanika.
The clinical outcome of this observed reduction of Victrelis trough concentrations has not been directly assessed. 
Klinički ishodi tog opaženog sniženja najniže koncentracije lijeka Victrelis nisu izravno ispitivani.
• select statins - atorvastatin or pravastatin 
• određene statine - atorvastatin ili pravastatin
Clinical Study 
Kliničko ispitivanje
Boceprevir concentrations are not likely to be affected by maraviroc co-administration (based on elimination pathway of boceprevir). 
Nije vjerojatno da će istodobna primjena maraviroka utjecati na koncentracije boceprevira (na temelju puta eliminacije boceprevira).
If you have been told by your doctor that you cannot tolerate or digest some sugars (you have an intolerance to some sugars), such as Lapp lactase deficiency, or glucose-galactose malabsorption, talk to your doctor before taking this medicine. 
Ako Vam je liječnik rekao da ne podnosite ili ne možete probaviti neke šećere(imate intoleranciju na neke šećere), npr. da imate nedostatak Lapp laktaze ili malapsorpciju glukoze i galaktoze, savjetujte se s liječnikom prije uzimanja ovog lijeka.
Data obtained in juvenile rats suggest that the pharmacokinetic profile of boceprevir may be different than in adult rats, possibly due to immaturity of some metabolic pathways. 
Podaci dobiveni u mladih štakora ukazuju na to da bi se farmakokinetički profil boceprevira mogao razlikovati od onog u odraslih štakora, što može biti posljedica nezrelosti nekih metaboličkih puteva.
Clinical data (semen analyses and inhibin B levels - [a glycoprotein produced by Sertoli cells - used as a surrogate marker of testicular function]) showed no evidence of altered testicular function. 
Klinički podaci (analize sjemena i razine inhibina B - [glikoproteina kojeg stvaraju Sertolijeve stanice i koji se koristi kao surogatni biljeg funkcije testisa]) nisu pokazali promjene u funkciji testisa.
Patients should be informed that fatigue, dizziness, syncope, blood pressure fluctuations and blurred vision have been reported (see section 4.8). 
Bolesnicima treba reći da su prijavljeni umor, omaglica, sinkopa, fluktuacije krvnog tlaka i zamagljen vid (vidjeti dio 4.8).
Sarcoidosis*, porphyria non-acute 
sarkoidoza*, neakutna porfirija
The majority of the anaemia subjects received erythropoietin when haemoglobin levels were ≤ 10 g/dL (or 6.2 mmol/L). 
Većina ispitanika s anemijom dobila je eritropoetin kad im je koncentracija hemoglobina bila ≤ 10 g/dl (ili 6,2 mmol/l).
Steady state AUC, Cmax and Cmin increased in a less-than dose-proportional manner and individual exposures overlapped substantially at 800 mg and 1,200 mg, suggesting diminished absorption at higher doses. 
AUC, Cmax i Cmin u stanju dinamičke ravnoteže povećavaju se manje nego proporcionalno dozi, a individualna izloženost značajno se preklapa pri dozi od 800 mg i 1200 mg, što ukazuje na smanjenu apsorpciju pri višim dozama.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with Victrelis taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Mora se donijeti odluka treba li prekinuti dojenje ili privremeno/trajno prekinuti liječenje lijekom Victrelis, uzimajući u obzir korist dojenja za dijete i korist liječenja za majku.
In a study of patients with varying degrees of stable chronic liver impairment (mild, moderate and severe), no clinically significant differences in pharmacokinetic parameters were found, and no dose adjustment is recommended. 
U ispitivanju bolesnika s različitim stupnjevima stabilnog kroničnog oštećenja funkcije jetre (blagim, umjerenim i teškim) nisu ustanovljene klinički značajne razlike u farmakokinetičkim parametrima te se ne preporučuje prilagođavanje doze.
In healthy subjects who received 800 mg three times daily alone, boceprevir medicine exposure was characterized by AUC(т) of 6,147 ng 
U zdravih ispitanika koji su primili samo boceprevir u dozi od 800 mg triput na dan, pokazatelji izloženosti lijeku bili su: AUC(т) 6,147 ng
Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone. 
Pojedinim bolesnicima može biti potrebna dodatna titracija doze metadona kada se Victrelis uvodi ili prekida, kako bi se osigurao klinički učinak metadona.
Medicinal products by therapeutic areas 
Lijekovi po terapijskim područjima
The European Medicines Agency has deferred the obligation to submit the results of studies with Victrelis in one or more subsets of the paediatric population in chronic viral hepatitis C (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Victrelis u jednoj ili više podskupina pedijatrijske populacije u kroničnom hepatitisu C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
ASSESSMENT* (HCV-RNA Results 
PROCJENA* (razina HCV-RNK
%, (n/N) 69 (72/105) 75 (77/103) EOT % (n/N) 79 (83/105) 86 (89/103) 
%, (n/N) 69 (72/105) 75 (77/103) EOT %, (n/N) 79 (83/105) 86 (89/103) Relaps
• oral midazolam or oral triazolam - a sedative, given by mouth 
• oralni midazolam ili oralni triazolam - sedativ koji se uzima kroz usta
Use in patients with an organ transplant 
Primjena u bolesnika s transplantiranim organom
Talk to your doctor or pharmacist before taking your medicine if you: 
Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek:
Continue with all three medicines (PR + Victrelis) and finish through TW 36; and then 
Nastavite sa sva tri lijeka (PR + Victrelis) i završite tijekom TL 36; a zatim
Victrelis contains lactose (a type of sugar). 
Victrelis sadrži laktozu (vrstu šećera).
Boceprevir covalently, yet reversibly, binds to the NS3 protease active site serine (Ser139) through a (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells. 
Boceprevir se kovalentno, ali reverzibilno, veže na aktivno mjesto NS3 serinske proteaze (Ser139) pomoću (alfa)-ketoamidne funkcionalne skupine, kako bi spriječio replikaciju virusa u HCV-om zaraženim stanicama domaćina.
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency. 
Bolesnike koji uzimaju estrogene kao zamjensku hormonsku terapiju treba klinički nadzirati zbog moguće pojave znakova nedostatka estrogena.
Patients should be monitored for signs of opiate toxicity associated with buprenorphine. 
Bolesnike treba nadzirati zbog moguće pojave znakova opioidne toksičnosti povezane s buprenorfinom.
Venous thrombosis 
venska tromboza
Clear polychlorotrifluoroethylene /PVC/aluminium blisters containing 4 hard capsules per blister cavity. 
Prozirni poliklorotrifluoroetilen/PVC/aluminij blisteri sa 4 tvrde kapsule u blisterskoj jažici.
Subjects randomized to receive ribavirin dose reduction (N=249) 
Ispitanici randomizirani da primaju sniženu dozu ribavirina (N=249)
Do not take Victrelis in combination with peginterferon alfa and ribavirin if you: • are allergic to boceprevir or any of the other ingredients of this medicine (listed in section 6) 
Nemojte uzimati Victrelis u kombinaciji s peginterferonom alfa i ribavirinom: • ako ste alergični na boceprevir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Boceprevir has a mean apparent volume of distribution (Vd/F) of approximately 772 l at steady state. 
Boceprevir ima prividan volumen distribucije (Vd/F) od oko 772 l u stanju dinamičke ravnoteže.
Maraviroc 150 mg twice daily when co-administered with boceprevir. 
Maravirok 150 mg dvaput na dan kada se primjenjuje istodobno s boceprevirom.
• have hepatitis C other than genotype 1 
• ako imate hepatitis C koji nije genotipa 1
The percent change and arrows (↑ = increase, ↓ = decrease, ↔ = no change) are used to show the magnitude and direction of change in mean ratio estimate for each pharmacokinetic parameter. 
Postotak promjene i strelice (↑ = povećanje, ↓ = smanjenje, ↔ = nema promjene) pokazuju opseg i smjer promjene procijenjene srednje vrijednosti omjera za svaki farmakokinetički parametar.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
IL28B rs12979860 Genotype 
Genotip IL28B rs12979860
Food enhanced the exposure of boceprevir by up to 60% at the 800 mg three times daily dose when administered with a meal relative to the fasting state. 
Hrana je pojačala izloženost bocepreviru za do 60% pri dozi od 800 mg triput na dan kad se primjenjivao uz obrok u odnosu na primjenu natašte.
If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped. 
Ako Vaša partnerica nije trudna, ali je reproduktivne dobi, mora raditi test na trudnoću svaki mjesec tijekom liječenja i 7 mjeseci po njegovu završetku.
An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2). 
Treba očekivati povećanje plazmatskih koncentracija supstrata za efluksni transporter P-gp, poput digoksina ili dabigatrana (vidjeti Tablicu 2).
Prolonged exposure resulted in a 2-log decrease in RNA levels by Day 15. 
Produljena izloženost dovela je do smanjenja razine RNK od 2-log do 15. dana.
%, (n/N) 73 (80/110) 79 (90/114) EOT %, (n/N) 86 (95/110) 89 (101/114) Relapse 
%, (n/N) 73 (80/110) 79 (90/114) EOT %, (n/N) 86 (95/110) 89 (101/114)
• medicine used to treat symptoms of an enlarged prostate - doxazosin and tamsulosin 
• lijekove koji se koriste za liječenje simptoma povećane prostate - doksazozin i tamsulozin
The last available value in the period at and after FW 24. 
Posljednja dostupna vrijednost u ili nakon 24. tjedna praćenja.
• Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms 
Detaljne informacije o riziku od hematoloških poremećaja (osobito anemije) povezanih s lijekom Victrelis, koje se sastoje od činjeničnog opisa hematoloških poremećaja u smislu učestalosti i vremena do nastupa te s njima povezanih kliničkih simptoma.
Victrelis is a strong inhibitor of CYP3A4/5. 
Victrelis je snažan inhibitor CYP3A4/5.
Given the incremental risk of adverse events with Victrelis (anaemia notably); in case the patient cannot tolerate the treatment, consideration could be given to pursue with 12 weeks of bitherapy for the final 12 weeks of treatment instead of tritherapy (see sections 4.8 and 5.1). 
Obzirom na povećan rizik od nuspojava s lijekom Victrelis (osobito anemije), u slučaju da bolesnik ne podnosi liječenje, može se razmotriti da se u posljednjih 12 tjedana liječenja primjenjuje dvojna umjesto trojne terapije (vidjeti dijelove 4.8 i 5.1).
• antimicrobial medicine - pentamidine 
• antibiotik - pentamidin
Victrelis may be used in adults who are previously untreated for HCV infection or who have previously used medicines called ‘interferons' and ‘pegylated interferons'. 
Victrelis se može primjenjivati u odraslih osoba koje prethodno nisu liječile HCV infekciju kao i u onih koji su ranije koristili lijekove koji se nazivaju "interferonima" i "pegiliranim interferonima".
In an in vitro dog Purkinje fiber study, boceprevir prolonged the action potential duration with inverse frequency dependence; the clinical relevance remains uncertain. 
U jednom in vitro istraživanju Purkinjeovih vlakana u pasa, boceprevir je produljio trajanje akcijskog potencijala uz inverznu frekvencijsku ovisnost; važnost za kliničku primjenu nije poznata.
Pharmacokinetic results were similar between healthy subjects and HCV-infected subjects. 
Farmakokinetički rezultati zdravih ispitanika bili su slični rezultatima ispitanika zaraženih HCV-om.
Continue with all three medicines (peginterferon alfa and ribavirin [PR] + Victrelis) and finish through Treatment Week 28 (TW 28). 
Nastavite sa sva tri lijeka (peginterferon alfa i ribavirin [PR] + Victrelis) i završite tijekom 28. tjedna liječenja (TL 28).
At Treatment Week 8 
U 8. tjednu liječenja
The recommended dose of Victrelis is 800 mg administered orally three times daily (TID) with food (a meal or light snack). 
Preporučena doza lijeka Victrelis je 800 mg peroralno triput na dan, s hranom (uz obrok ili lagani međuobrok).
Do not use this medicine after the expiry date which is stated on the carton and blisterfoil after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake "EXP".
A genetic variant near the gene encoding interferon-lambda-3 (IL28B rs12979860, a C to T change) is a strong predictor of response to peginterferon alfa-2b/ribavirin. 
Genetska varijanta na mjestu gena koji kodira interferon-lambda-3 (IL28B rs12979860, promjena C u T) je snažan pretkazatelj odgovora na peginterferon alfa2-b/ribavirin.
• pimozide or lurasidone - used for mental health problems 
• pimozid ili lurasidon - za liječenje psihičkih problema
Subjects were treated with 4 weeks of PR followed by 44 weeks of Victrelis or placebo with PR. 
Ispitanici su primali PR tijekom 4 tjedna, a zatim tijekom 44 tjedna Victrelis ili placebo s PR-om.
The D168V single substitution did not reduce sensitivity to boceprevir. 
Pojedinačna supstitucija D168V nije smanjila osjetljivost na boceprevir.
Boceprevir is primarily metabolized by aldoketo reductase (AKR). 
Boceprevir se prvenstveno metabolizira pomoću aldoketoreduktaze (AKR).
A 3-year follow-up study of subjects who achieved SVR with a Victrelis-based regimen showed that > 99% (693/696) of patients maintained their SVR (no relapse) through the available follow-up period 
Trogodišnje ispitivanje praćenja ispitanika koji su postigli SVR uz terapiju temeljenu na lijeku Victrelis pokazalo je da je > 99% (693/696) bolesnika održalo SVR (bez relapsa) tijekom dostupnog razdoblja praćenja (medijan trajanja od 3,4 godine).
No effects on foetal development have been observed in rats and rabbits (see section 5.3). 
Nisu opaženi učinci na fetalni razvoj u štakora i kunića (vidjeti dio 5.3).
If a patient misses a dose and it is 2 or more hours before the next dose is due, the patient should take the missed dose with food and resume the normal dosing schedule. 
Ako bolesnik propusti dozu, a do sljedeće je doze ostalo 2 sata ili više, bolesnik treba uzeti propuštenu dozu s hranom i nastaviti s uobičajenim rasporedom doziranja.
Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control. 
Istodobna primjena atazanavira/ritonavira s boceprevirom izazvala je smanjenu izloženost atazanaviru, što može biti povezano sa slabijom djelotvornošću i gubitkom kontrole nad HIV-om.
Evaluation of varying combinations of boceprevir and interferon alfa-2b that produced 90% suppression of replicon RNA showed additivity of effect; no evidence of synergy or antagonism was 
Ispitivanja različitih kombinacija boceprevira i interferona alfa-2b koje su dovele do 90%-tne supresije RNK replikona pokazala su aditivnost učinka; nisu pronađeni dokazi sinergije niti antagonizma.
Patients without cirrhosis who are previously untreated or who have failed previous therapy The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1). 
Bolesnici bez ciroze koji prethodno nisu bili liječeni ili koji nisu odgovorili na prethodnu terapiju Sljedeće preporuke za doziranje se za neke podskupine razlikuju u odnosu na doze ispitivane u ispitivanjima faze III (vidjeti dio 5.1).
It is unknown what effect therapy with Victrelis will have on the activity of subsequently administered HCV protease inhibitors, including re-treatment with Victrelis. 
Nije poznato koji će učinak terapija lijekom Victrelis imati na djelovanje naknadno primijenjenih inhibitora HCV proteaze, uključujući i ponovno liječenje lijekom Victrelis.
ANTI-INFECTIVES Antifungals 
ANTIINFEKTIVI Antimikotici
Subjects were on an antiretroviral regimen with stable HIV disease (HIV-1 viral load < 50 copies/mL and CD4 count ≥ 200 cells/µL). 
Ispitanici su bili na antiretrovirusnoj terapiji i imali stabilnu HIV bolest (virusno opterećenje HIV-1 < 50 kopija/ml i broj CD4 stanica ≥ 200 stanica/µl).
Boceprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, human peripheral blood lymphocyte and mouse micronucleus assays. 
Boceprevir nije bio genotoksičan u nizu testova in vitro ili in vivo, uključujući testove mutagenosti bakterija, humanih limfocita u perifernoj krvi i mišjih mikronukleusa.
The concomitant use of Victrelis with rifampicin or anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) may significantly reduce the plasma exposure of boceprevir. 
Istodobna primjena lijeka Victrelis s rifampicinom ili antikonvulzivima (kao što su fenitoin, fenobarbital ili karbamazepin) može značajno smanjiti izloženost bocepreviru u plazmi.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
• quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder 
• kvetiapin - za liječenje shizofrenije, bipolarnog poremećaja te velikog depresivnog poremećaja
Table 2 provides dosing recommendations as a result of drug interactions with Victrelis. 
U Tablici 2 navedene su preporuke za doziranje s obzirom na interakcije s lijekom Victrelis.
The most common HIV PI taken was atazanavir followed by lopinavir and darunavir. 
Najčešće korišten inhibitor HIV proteaze bio je atazanavir, a zatim lopinavir i darunavir.
This regimen has only been tested in subjects who have failed previous therapy who were late responders (see section 5.1). 
Ovaj režim liječenja ispitivan je samo u bolesnika koji nisu odgovorili na prethodnu terapiju, a koji su imali kasni odgovor (vidjeti dio 5.1).
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 
Psihičke bolesti: promjene raspoloženja; osjećaj da Vam se život raspada; halucinacije (kada vidite, osjećate ili čujete stvari koje nisu stvarne); razmišljanje o samoubojstvu, pokušaj samoubojstva; osjećaj velike sreće (manija), a nakon toga osjećaj duboke tuge ili bezvrijednosti
The safety profile of Victrelis in HCV/HIV-1 co-infected patients (n=64) was overall similar to the safety profile in mono-infected HCV patients. 
Sigurnosni profil lijeka Victrelis u bolesnika s istodobnom HCV/HIV-1 infekcijom (n=64) sveukupno je bio sličan sigurnosnom profilu u bolesnika zaraženih samo HCV-om.
If you are not sure, talk to your doctor or pharmacist before taking Victrelis. 
Ako niste sigurni, porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete Victrelis.
Alternative contraceptives should be considered (see section 4.5). 
Treba razmotriti primjenu nekog drugog kontraceptiva (vidjeti dio 4.5).
Co-administration of Victrelis with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness. 
Nije vjerojatno da bi istodobna primjena lijeka Victrelis i oralnog kontraceptiva koji sadrži etinilestradiol i najmanje 1 mg noretindrona mogla izmijeniti djelotvornost kontraceptiva.
Multipack: 336 (4 packs of 84) hard capsules 
Višestruko pakiranje: 336 tvrdih kapsula (4 kutije sa 84 tvrde kapsule)
After this period, the medicinal product should be disposed. 
Nakon tog razdoblja lijek se treba zbrinuti.
Adverse reactions are listed by System Organ Class (see Table 3). 
Nuspojave su navedene prema klasifikaciji organskih sustava (vidjeti Tablicu 3).
• have ever had a blood problem such as anaemia (when you lack enough healthy red blood cells, which transport oxygen around your body) 
• ako ste nekad imali probleme s krvlju, kao što je anemija (premali broj zdravih crvenih krvnih stanica koje prenose kisik po organizmu)