FrancophonIA/ELRC3.0 huggingface dataset:
English: It cannot be excluded that other rare variants may also be associated with an increased risk of severe toxicity.
Croatian: Ne može se isključiti da i druge rijetke varijante mogu biti povezane s povećanim rizikom od teške toksičnosti.
English: Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Croatian: Vam je potrebna, kada je uzeti i koliko dugo je morate uzimati.
English: All measures should be initiated to prevent systemic infections and dehydration.
Croatian: Potrebno je poduzeti sve mjere kako bi se spriječile sistemske infekcije i dehidracija.
English: Date of latest renewal: 9 December 2016
Croatian: Datum posljednje obnove odobrenja: 9. prosinca 2016.
English: See section 5.1 for details of major studies, including study designs and major efficacy results.
Croatian: Vidjeti dio 5.1 radi detalja o najvažnijim ispitivanjima, uključujući njihov dizajn i glavne rezultate o djelotvornosti.
English: Body Surface Area (m
Croatian: Tjelesna površina (m
English: Ecansya may be used either alone or in combination with other medicines.
Croatian: Ecansya se može primijeniti samostalno ili u kombinaciji s drugim lijekovima.
English: This 21 day period is one treatment cycle.
Croatian: To razdoblje od 21 dana smatra se jednim ciklusom liječenja.
English: You must not take Ecansya if you are pregnant or think you might be.
Croatian: Ne smijete uzimati lijek Ecansya ako ste trudni ili mislite da biste mogli biti trudni.
English: Median Time to Event (Days)
Croatian: Medijan vremena do pojave događaja (dani)
English: About 3% of the administered dose is excreted in urine unchanged.
Croatian: Oko 3% primijenjene doze izlučuje se urinom u nepromijenjenom obliku.
English: These toxicities were reversible.
Croatian: Toksičnost je bila reverzibilna.
English: ADDITIONAL 6 MONTHS OF FOLLOW UP
Croatian: DODATNIH 6 MJESECI PRAĆENJA
English: Median overall survival ITT
Croatian: Medijan ukupnog preživljenja ITT
English: All treatment cycles were administered at intervals of 3 weeks.
Croatian: Svi ciklusi liječenja primjenjivali su se u intervalima od 3 tjedna.
English: Once the dose has been reduced, it should not be increased at a later time.
Croatian: Nakon smanjenja doze ona se ne smije ponovno povećavati.
English: No dose has been proven safe for patients with complete absence of DPD activity.
Croatian: Nijedna se doza nije pokazala sigurnom za bolesnike s potpunim izostankom aktivnosti DPD-a.
English: Ecansya tablets should not be crushed or cut.
Croatian: Ecansya tablete ne smiju se drobiti ni lomiti.
English: Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Prije početka liječenja obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The median time to progression was 93 and 98 days.
Croatian: Medijan vremena do progresije bolesti iznosio je 93 i 98 dana.
English: What Ecansya is and what it is used for
Croatian: Što je Ecansya i za što se koristi
English: This medicine does not require any special storage conditions.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: The AUC of 5-FU was 30%-35% higher on day 14.
Croatian: AUC 5-FU-a bila je 30%-35% veća 14. dan.
English: Instead, continue your regular dosing schedule and check with your doctor.
Croatian: Umjesto toga nastavite uzimati lijek prema propisanom rasporedu i posavjetujte se sa svojim liječnikom.
English: Ecansya tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Croatian: Ecansya tablete se obično uzimaju 14 dana, nakon čega slijedi 7 dana pauze (bez uzimanja tableta).
English: These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect.
Croatian: Ove nuspojave mogu postati teške, stoga je važno da se uvijek obratite svom liječniku odmah čim uočite nuspojave.
English: - Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water.
Croatian: - Tablete uzimajte najkasnije 30 minuta nakon što završite s jelom (doručkom i večerom) i progutajte ih cijele, s vodom.
English: This is calculated from your height and weight.
Croatian: Vaše visine i težine.
English: Food interaction
Croatian: Interakcije s hranom
English: See also section "Do not take Ecansya".
Croatian: Pogledajte i dio „Nemojte uzimati lijek Ecansya“.
English: This advice is applicable to all indications and to all special populations.
Croatian: Preporuka se odnosi na sve indikacije i sve skupine bolesnika.
English: Immediate admission to hospital is recommended.
Croatian: Preporučuje se bolesnike odmah hospitalizirati.
English: 9/L and/or thrombocyte counts of <100 x 10
Croatian: 9/l i/ili brojem trombocita <100 x 10
English: Injury, poisoning and procedural complications
Croatian: Ozljede, otrovanja i proceduralne komplikacije kontuzija
English: Hand and foot skin reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.
Croatian: Kožna reakcija na šakama i stopalima može dovesti do gubitka otisaka prstiju, što može utjecati na Vašu identifikaciju skeniranjem otisaka prstiju.
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Croatian: Nedostatak DPD-a je rijetko stanje prisutno od rođenja, koje obično nije povezano sa zdravstvenim problemima osim ako ne primate određene lijekove.
English: If you cannot swallow Ecansya tablets whole, tell your healthcare provider.
Croatian: Ako Ecansya tablete ne možete progutati cijele, obavijestite o tome svog zdravstvenog radnika.
English: Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced.
Croatian: Većina ovih nuspojava je reverzibilna i ne zahtijeva trajni prekid liječenja, iako može biti potrebno izostaviti ili smanjiti dozu.
English: Pharmacokinetics in special populations
Croatian: Farmakokinetika u posebnim populacijama
English: Modified XELIRI+ bevacizumab (ITT: N= 120)
Croatian: Modificiran XELIRI + bevacizumab (ITT: N= 120)
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Ecansya.
Croatian: Liječnik Vam može savjetovati da smanjite dozu i/ili privremeno prestanete uzimati lijek Ecansya.
English: The median follow up at the time of the analysis was 6.9 years.
Croatian: Medijan vremena praćenja u vrijeme analize iznosio je 6,9 godina.
English: Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.
Croatian: Treba razmotriti trajnu obustavu lijeka na temelju kliničke procjene nastupa, trajanja i težine opažene toksičnosti.
English: Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).
Croatian: Tek nakon što se apsorbira u organizmu, mijenja se u djelatni lijek protiv raka (više u tumorskom tkivu nego u zdravom tkivu).
English: Rare/Very Rare (Post-Marketing Experience)
Croatian: Rijetko/vrlo rijetko (iskustvo nakon stavljanja lijeka u promet)
English: This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal.
Croatian: Ta interakcija, koja dovodi do povećanja toksičnosti fluoropirimidina, može biti smrtonosna.
English: Do not take Ecansya - if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Ecansya - ako ste alergični na kapecitabin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Progression-free Survival after 6 months ITT
Croatian: Preživljenje bez progresije bolesti nakon 6 mjeseci ITT
English: Central or peripheral nervous system disease.
Croatian: Bolest središnjeg ili perifernog živčanog sustava
English: Your doctor may instruct you to restart treatment at a lower dose.
Croatian: Liječnik će Vam možda savjetovati da ponovno počnete liječenje manjom dozom.
English: Furthermore, Ecansya is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Croatian: Nadalje, Ecansya se koristi za sprječavanje pojave novog karcinoma kolona nakon što je tumor u potpunosti kirurški uklonjen.
English: 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Croatian: 5-fluorouracil: intravenska bolus injekcija odmah nakon leukovorina
English: Aluminium/aluminium blisters This medicinal product does not require any special storage conditions.
Croatian: Aluminij/aluminij blisteri Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Doses of capecitabine omitted for toxicity are not replaced.
Croatian: Doze kapecitabina koje su izostavljene zbog toksičnosti ne smiju se nadoknađivati.
English: Other medicines and Ecansya
Croatian: Drugi lijekovi i Ecansya
English: If you take more Ecansya than you should, contact your doctor as soon as possible before taking the next dose.
Croatian: Ako uzmete više Ecansya tableta nego što ste trebali, što prije se obratite svom liječniku prije uzimanja sljedeće doze.
English: Do not give Ecansya to children and adolescents.
Croatian: Nemojte davati lijek Ecansya djeci i adolescentima.
English: These findings are expected effects of fluoropyrimidine derivatives.
Croatian: Ovi nalazi su očekivani učinci derivata fluoropirimidina.
English: If you take more Ecansya than you should
Croatian: Ako uzmete više Ecansya tableta nego što ste trebali
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Croatian: Tablica 6 Protokoli liječenja u ispitivanju NO16966 (mCRC) Liječenje
English: For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Croatian: Za sindrom šaka-stopalo i hiperbilirubinemiju vidjeti dio 4.4.
English: Therefore, in the absence of serious toxicity the dose could be increased while carefully monitoring the patient.
Croatian: Stoga se, ako nema ozbiljne toksičnosti, doza može povećati, uz pomno praćenje bolesnika.
English: The requirements for submission of PSURs 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.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Each pack contains 30, 60 or 120 film-coated tablets.
Croatian: Svako pakiranje sadrži 30, 60 ili 120 filmom obloženih tableta.
English: Population
Croatian: Populacija
English: Capecitabine is activated via several enzymatic steps (see section 5.2).
Croatian: Kapecitabin se aktivira u nekoliko enzimskih koraka (vidjeti dio 5.2).
English: Do not crush or cut tablets.
Croatian: Nemojte drobiti ni lomiti tablete.
English: No studies have been conducted to assess the impact of capecitabine on milk production or its presence in human breast milk.
Croatian: Nisu provedena ispitivanja kako bi se ocijenio učinak kapecitabina na proizvodnju mlijeka i njegova prisutnost u majčinom mlijeku.
English: Previous therapy should have included an anthracycline.
Croatian: Prethodna terapija je morala uključivati antraciklin.
English: Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects).
Croatian: Odmah se obratite svom liječniku ako ste zabrinuti zbog bilo koje nuspojave ili ako primijetite dodatne nuspojave koje nisu navedene u uputi (vidjeti dio 4. Moguće nuspojave).
English: 820 patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
Croatian: 820 bolesnika randomizirano je u dvije skupine za primanje sekvencijske terapije (n = 410) ili kombinirane terapije (n = 410).
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5% of administered capecitabine dose is recovered in urine.
Croatian: Kapecitabin i njegovi metaboliti većinom se izlučuju urinom; 95,5% primijenjene doze kapecitabina ponovno se nađe u urinu.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC06.
Croatian: Farmakoterapijska skupina: antineoplastici, antimetaboliti, ATK oznaka: L01BC06
English: Careful monitoring during the first cycle of treatment is recommended for all patients.
Croatian: Preporučuje se pomno nadzirati sve bolesnike tijekom prvog ciklusa liječenja.
English: - It is important that you take all your medicine as prescribed by your doctor.
Croatian: - Važno je da lijek uzimate na način koji Vam je propisao liječnik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: See section 2 "Ecansya contains lactose".
Croatian: Vidjeti dio 2 "Ecansya sadrži laktozu".
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine downregulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Croatian: Budući da nije bilo utjecaja na metabolizam R-varfarina, ovi rezultati pokazuju da kapecitabin smanjuje djelovanje izoenzima 2C9, ali ne utječe na izoenzime 1A2 i 3A4.
English: These reactions occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within one month after stopping capecitabine.
Croatian: To se događa unutar nekoliko dana do nekoliko mjeseci nakon početka liječenja kapecitabinom, a u nekoliko slučajeva unutar mjesec dana nakon prestanka uzimanja kapecitabina.
English: The AUC of FBAL increased with age (20% increase in age results in a 15% increase in the AUC of FBAL).
Croatian: AUC FBAL porasla je s dobi (20% veća dob imala je 15%-tno povećanje AUC FBAL-a).
English: Severe and/or Lifethreatening (grade 34) or considered medically relevant
Croatian: Teške i/ili po život opasne (stupanj 3 do 4) ili one koje se smatraju medicinski značajnima
English: What Ecansya contains - The active substance is capecitabine.
Croatian: Što Ecansya sadrži - Djelatna tvar je kapecitabin.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Croatian: Liječnik će Vam propisati dozu i protokol liječenja koji je najučinkovitiji za Vas.
English: Genotyping for these alleles is recommended to identify patients at increased risk for severe toxicity.
Croatian: Preporučuje se genotipizacija tih alela kako bi se prepoznali bolesnici s povećanim rizikom od teške toksičnosti.
English: In animal studies effects on fertility were observed (see section 5.3).
Croatian: U ispitivanjima na životinjama opaženi su učinci na plodnost (vidjeti dio 5.3).
English: The following are the recommended dose modifications for toxicity.
Croatian: Sljedeća tablica pokazuje preporučene prilagodbe doze zbog toksičnosti:
English: Reduced dose
Croatian: Smanjena doza
English: The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Croatian: Ugradnja 5-FU dovodi do inhibicije sinteze RNK i proteina.
English: Ecansya is available in blisters (Aluminium-aluminium or PVC/PVdC-aluminium) containing 30, 60 or 120 film-coated tablets.
Croatian: Ecansya je dostupna u blisterima (aluminij-aluminij ili PVC/PVdC-aluminij) koji sadrže 30, 60 ili 120 filmom obloženih tableta.
English: Treatment of eye disorders should be initiated as clinically appropriate.
Croatian: Liječenje poremećaja oka treba započeti prema kliničkoj potrebi.
English: There are no pharmacokinetic data on patients with severe hepatic impairment.
Croatian: Nema farmakokinetičkih podataka za bolesnike s teškim oštećenjem jetre.
English: 25.5 months
Croatian: 25,5 mjeseci
English: Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Croatian: Liječenje predoziranja uključuje sve uobičajene terapijske i potporne medicinske intervencije koje su usmjerene prema uklanjanju postojećih kliničkih simptoma i prevenciji mogućih komplikacija.
English: ADDITIONAL 1 YEAR OF FOLLOW UP
Croatian: DODATNA GODINA PRAĆENJA
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment)
Croatian: Tablica 3 Raspored smanjivanja doze kapecitabina (ciklusi od 3 tjedna ili kontinuirano liječenje)
English: - metastatic colorectal cancer (see section 5.1).
Croatian: - metastatskog kolorektalnog karcinoma (vidjeti dio 5.1).
English: Table 9 Key efficacy results for the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
Croatian: Tablica 9 Ključni rezultati djelotvornosti iz analize neinferiornosti u ispitivanju NO 16967 PRIMARNA ANALIZA
English: By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled.
Croatian: Liječenje ne bi trebalo ponovno započeti dok se bolesnik ne rehidrira i dok uzroci dehidracije ne budu uklonjeni ili pod kontrolom.
English: 9/L should not be treated with capecitabine.
Croatian: 9/l ne bi trebalo liječiti kapecitabinom.
English: For terms marked with a “+”, the frequency count was based on grade 3-4 ADRs.
Croatian: Za pojmove označene s „+“ učestalost se temeljila na nuspojavama 3.-4. stupnja.
English: Data on the frequency of these DPYD variants in other populations than Caucasian is limited.
Croatian: Podaci o učestalosti ovih varijanti gena DPYD u drugim populacijama osim bijelaca su ograničeni.
English: Hazard ratio 95% CI P value
Croatian: Omjer hazarda 95% CI P-vrijednost
English: Although sensitivity analyses show that differences in regimen schedules and timing of tumor assessments impact the on-treatment PFS analysis, a full explanation for this result has not been found.
Croatian: Iako analize osjetljivosti pokazuju da razlike u rasporedu protokola i odabiru vremena za procjenu tumorskog učinka utječu na analizu preživljenja bez progresije bolesti tijekom liječenja, potpuno objašnjenje tog rezultata nije poznato.
English: Ecansya belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Croatian: Ecansya pripada skupini lijekova pod nazivom „citostatici“, koji zaustavljaju rast stanica karcinoma.
English: Persistent or severe hand-foot syndrome (Grade 2 and above) can eventually lead to loss of fingerprints which could impact patient identification.
Croatian: Perzistirajući ili težak sindrom šaka-stopalo (2. ili višeg stupnja) može naposljetku dovesti do gubitka otisaka prstiju, što može utjecati na identifikaciju bolesnika.
English: In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
Croatian: U to je ispitivanje slučajnim odabirom uključeno 1002 bolesnika u faktorijalnom dizajnu 2x2 u jednu od sljedeće 4 skupine:
English: The overall objective response rates (investigator assessment) were 20% (first trial) and 25% (second trial).
Croatian: Ukupni terapijski odgovor (procjena istraživača) iznosio je 20% (prvo ispitivanje), odnosno 25% (drugo ispitivanje).
English: Brivudine must not be administered concomitantly with capecitabine.
Croatian: Brivudin se ne smije primjenjivati istodobno s kapecitabinom.
English: There are no studies in pregnant women using capecitabine; however, it should be assumed that capecitabine may cause foetal harm if administered to pregnant women.
Croatian: Nisu provedena ispitivanja o djelovanju kapecitabina u trudnica; međutim, može se pretpostaviti da kapecitabin može štetiti plodu ako se daje trudnim ženama.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
English: Schedule
Croatian: Raspored
English: Not all pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sva pakiranja.
English: The major metabolite excreted in urine is FBAL, which represents 57% of the administered dose.
Croatian: Urinom se izlučuje glavni metabolit FBAL, koji čini 57% primijenjene doze.
English: This may also be relevant with folic acid supplementation for folate deficiency due to the similarity between folinic acid and folic acid.
Croatian: To može biti važno i kod primjene nadomjestaka folatne kiseline zbog deficijencije folata, s obzirom na sličnost između folinatne i folatne kiseline.
English: Do not take the missed dose at all.
Croatian: Nemojte uzeti propuštenu dozu.
English: For Aluminium-aluminium blisters
Croatian: Za aluminij-aluminij blistere
English: Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35% increase in AUC when creatinine clearance decreases by 50%) and to FBAL (114% increase in AUC when creatinine clearance decreases by 50%).
Croatian: Uočeno je da klirens kreatinina utječe na sistemsku izloženost 5'-DFUR (35%-tno povećanje AUC kada se klirens kreatinina smanji za 50%) i FBAL (114%-tno povećanje AUC kada se klirens kreatinina smanji za 50%).
English: Ecansya contains lactose
Croatian: Ecansya sadrži laktozu
English: Ecansya with food and drink You should take Ecansya no later than 30 minutes after meals.
Croatian: Ecansya s hranom i pićem Lijek Ecansya uzmite najkasnije 30 minuta nakon jela.
English: In a preplanned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
Croatian: Multivarijatna Cox analiza pokazala je superiornost kapecitabina u odnosu na bolus primjenu 5-FU/LV.
English: The dose of Ecansya is based on your body surface area.
Croatian: Doza lijeka Ecansya ovisi o Vašoj tjelesnoj površini, a izračunava se na temelju
English: Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during capecitabine treatment.
Croatian: Pozornost treba obratiti na bolesnike sa šećernom bolešću ili poremećajem elektrolita jer se mogu pogoršati tijekom liječenja kapecitabinom.
English: Film-coated tablet (tablet).
Croatian: Filmom obložena tableta (tableta).
English: 24.4 months
Croatian: 24,4 mjeseca
English: Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell.
Croatian: Budući da su DNK i RNK nužne za diobu i rast stanice, učinak 5-FU može stvoriti nedostatak timidina što izaziva poremećaj rasta i smrt stanice.
English: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and 4.4).
Croatian: Pomanjkanje DPD može uzrokovati povećanu toksičnost kapecitabina (vidjeti dijelove 4.3 i 4.4).
English: Careful monitoring of patients 60 years of age is advisable.
Croatian: Savjetuje se pažljivo praćenje bolesnika u dobi od ≥ 60 godina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2012
Croatian: Datum prvog odobrenja: 20. travnja 2012.
English: United Kingdom
Croatian: Ujedinjeno Kraljevstvo
English: - The other ingredients (excipients) are:
Croatian: - Drugi sastojci (pomoćne tvari) su:
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Croatian: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Ujedinjeno Kraljevstvo Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija