natgillin/translations-raw huggingface dataset:
Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML). 
Takve infekcije uključuju reaktivaciju latentnih virusa, poput reaktivacije hepatitisa B ili hepatitisa C i infekcije uzrokovane polioma virusima (nefropatija povezana s BK virusom, progresivna multifokalna leukoencefalopatija (PML) povezana s JC virusom).
Renal transplant n = 991 
Bubrežni presadak n = 991
CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with CellCept and CsA compared with patients receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4). 
A smanjuje izloženost MPA-u za 30-50% u usporedbi s bolesnicima koji primaju sirolimus ili belatacept i slične doze lijeka CellCept (vidjeti i dio 4.4).
The initial dose of CellCept 500 mg powder for concentrate for solution for infusion should be given within 24 hours following transplantation. 
Inicijalna doza CellCept 500 mg praška za koncentrat za otopinu za infuziju mora se primijeniti u roku od 24 sata nakon presađivanja.
There are no data on CellCept with phosphate binders other than sevelamer. 
Ne postoje podaci o primjeni lijeka CellCept s lijekovima koji vežu fosfate, osim sevelamera.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28 - 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment. 
U ispitivanju primjene jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrežne funkcije (brzina glomerularne filtracije < 25 ml/min/1,73 m2) bile su 28 - 75% više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima oštećenja bubrežne funkcije.
CellCept 1 g/5 ml powder for oral suspension sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous 
CellCept 1 g/5 ml prašak za oralnu suspenziju sorbitol silikon, koloidni bezvodni natrijev citrat sojin lecitin okus miješanog voća ksantanska guma aspartam* (E951) metilparahidroksibenzoat (E218) citratna kiselina bezvodna
• They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets. 
• Nalaze se u pakiranju od 50 tableta (u blister pakiranjima od po 10 tableta) ili višestrukom pakiranju od 150 tableta (3 pakiranja od po 50 tableta)
When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between CellCept patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen. 
Kada su se uspoređivale stope odbacivanja transplantata, stope gubitka presatka ili profili nuspojava između bolesnika liječenih lijekom CellCept koji su istodobno primali telmisartan i onih koji nisu primali telmisartan, nisu primijećene kliničke posljedice farmakokinetičke interakcije između tih dvaju lijekova.
If you forget to take CellCept 
Ako ste zaboravili uzeti CellCept
Sodium less than 1 mmol (23 mg) per dose 
Natrij: manje od 1 mmol (23 mg) po dozi.
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure. 
Lijekovi koji utječu na glukuronidaciju (npr. izavukonazol, telmisartan) Istodobna primjena lijekova koji utječu na glukuronidaciju MPA može promijeniti izloženost MPA-u.
Take the dispenser and push the plunger completely down toward the tip of the dispenser. 
Uzmite dozator i potisnite cijeli klip prema vrhu dozatora.
• phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood 
• lijekove koji vežu fosfate - primjenjuju se kod bolesnika s kroničnim zatajenjem bubrega kako bi se smanjila apsorpcija fosfata u krv
Thus, other substances known to undergo renal tubular secretion may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion. 
Na taj se način druge tvari koje se izlučuju putem bubrežnih tubula mogu natjecati s MPAG-om i tako povećavati plazmatske koncentracije MPAG-a ili drugih tvari koje se izlučuju tubularnom sekrecijom.
If you stop taking CellCept 
Ako prestanete uzimati CellCept
Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution. 
Lagano protresite bočicu da se lijek otopi i stvori žućkasta otopina.
CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body. 
CellCept kapsule: duguljasta, plavosmeđa kapsula s crnim natpisom "CellCept 250" na kapici kapsule i imenom „Roche“ na tijelu kapsule.
Cardiac disorders Tachycardia 
Srčani poremećaji Tahikardija
They have “CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule body. 
"CellCept 250" na kapici kapsule i crni natpis „Roche“ na tijelu kapsule.
Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in faeces. 
Peroralna primjena radioizotopom označenog mofetilmikofenolata rezultira potpunom ponovnom detekcijom primijenjene doze, od čega se 93% primijenjene doze ponovno detektira u urinu, a 6% u fecesu.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "ROCHE" name on the other. 
CellCept tablete: ovalna tableta boje lavande s utisnutim "CellCept 500" s jedne strane i imenom
When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking PPIs vs. CellCept patients not taking PPIs, no significant differences were seen. 
Uspoređujući stope odbacivanja transplantata ili stope gubitka presatka između bolesnika koji su uzimali CellCept i IPP naspram bolesnika koji s lijekom CellCept nisu uzimali IPP, nisu primijećene značajne razlike.
• Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil). 
• Prema izvješćima iz literature, malformacije su se pojavile u 23 - 27% živorođene djece čije su majke bile izložene mofetilmikofenolatu tijekom trudnoće (u usporedbi sa stopom od 2 - 3% kod živorođene djece u cjelokupnoj populaciji te približno 4 - 5% kod živorođene djece bolesnica s presatkom solidnog organa liječenih drugim imunosupresivima osim mofetilmikofenolata).
There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants. 
Objavljeni su izvještaji o bronhiektazijama u odraslih i djece koji su primili CellCept u kombinaciji s drugim imunosupresivima.
Hernia 
Hernija
Urinary problems such as: blood in the urine. 
Poteškoće s mokrenjem kao što su: krv u mokraći
Then, tightly close the bottle with child safety bottle cap. 
Čvrsto zatvorite bocu sigurnosnim zatvaračem za djecu.
Contents of the pack and other information Making-up the medicine 
Sadržaj pakiranja i druge informacije Priprema lijeka
CellCept 500 mg powder for concentrate for solution for infusion solution should not be mixed or administered concurrently via the same catheter with other intravenous medicinal products or infusion admixtures. 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju ne smije se miješati ni zajednički primjenjivati putem istog katetera s drugim intravenskim lijekovima ili infuzijskim smjesama.
OTHER SPECIAL WARNING(S), IF NECESSARY CellCept capsules should be handled with care 
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO CellCept kapsulama rukujte oprezno
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with CellCept in combination with other immunosuppressants, some of which have been fatal. 
Zabilježeni su izolirani slučajevi intersticijske plućne bolesti i plućne fibroze kod bolesnika liječenih lijekom CellCept u kombinaciji s drugim imunosupresivima, od kojih su neki bili sa smrtnim ishodom.
If you are not sure, talk to your doctor or nurse before having CellCept. 
Ako niste sigurni, razgovarajte sa svojim liječnikom ili medicinskom sestrom prije primanja lijeka CellCept.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. 
Kod bolesnika s presađenim bubregom i teškim kroničnim oštećenjem bubrežne funkcije (brzina glomerularne filtracije < 25 ml/min/1,73 m2) izvan neposrednog postoperativnog razdoblja, moraju se izbjegavati doze veće od 1 g primijenjene dvaput dnevno.
Heart and blood vessel problems such as: change in blood pressure, accelerated heartbeat, widening of blood vessels. 
Poteškoće sa srcem i krvnim žilama kao što su: • promjena krvnog tlaka, ubrzani otkucaji srca i proširenje krvnih žila
CellCept 500 mg powder for concentrate for solution for infusion polysorbate 80 citric acid hydrochloric acid sodium chloride 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju polisorbat 80 citratna kiselina kloridna kiselina natrijev klorid
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing mothers (see section 4.3). 
Zbog mogućih ozbiljnih nuspojava mofetilmikofenolata kod dojenčadi CellCept je kontraindiciran u dojilja (vidjeti dio 4.3).
Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA. 
Nakon intravenske primjene, mofetilmikofenolat brzo se i potpuno metabolizira do aktivnog metabolita, MPA.
This leaflet was last revised on {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu 
Ova uputa je zadnji puta revidirana u {MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product. 
Ako infuzijska otopina nije priređena neposredno prije primjene, primjenu infuzijske otopine treba započeti najkasnije 3 sata od otapanja i razrjeđivanja lijeka.
Talk to your doctor if you develop a persistent cough or breathlessness. 
Razgovarajte sa svojim liječnikom u slučaju pojave trajnog kašlja ili nedostatka zraka.
This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 mL) must be further diluted into 140 mL glucose intravenous infusion 5% solution. 
To znači da je za pripremu doze od 1 g mofetilmikofenolata otopljeni sadržaj dvije bočice (otprilike 2 x 15 ml) potrebno dalje razrijediti sa 140 ml otopine 5% glukoze za infuziju u venu.
The final concentration of the solution is 6 mg/mL mycophenolate mofetil. 
Krajnja je koncentracija otopine 6 mg/ml mofetilmikofenolata.
• Take 4 capsules in the morning and then 4 capsules in the evening. 
• Uzmite 4 kapsule ujutro te 4 kapsule navečer.
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with CellCept. 
Zapaženi su izolirani slučajevi patološke morfologije neutrofila, uključujući i stečenu Pelger-Huet anomaliju kod bolesnika liječenih lijekom CellCept.
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2). 
Nakon primjene jedne doze od 1,5 g mofetilmikofenolata u normalnih zdravih ispitanika koji su prethodno liječeni dozom od 4 g kolestiramina triput dnevno tijekom četiri dana, došlo je do smanjenja AUC-a (površina ispod krivulje) MPA za 40% (vidjeti dijelove 4.4 i 5.2).
• They are available as a carton of 100 or 300 capsules (both in blister packs of 10). 
• Nalaze se u pakiranju od 100 ili 300 kapsula ( u blister pakiranjima od po 10 kapsula)
Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of MPA concentrations. 
Istodobna primjena telmisartana i lijeka CellCept snizila je koncentracije MPA za približno 30%.
Blood and lymphatic system disorders Anemia 
Poremećaji krvi i limfnog sustava Anemija
Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment. 
Muškarci ne smiju donirati spermu tijekom liječenja lijekom CellCept i najmanje 90 dana nakon prestanka liječenja.
By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9). 
Interferencijom s enterohepatičnom recirkulacijom lijeka, lijekovi za snižavanje razine žučnih kiselina, poput kolestiramina, snizuju AUC MPA (vidjeti dio 4.9).
CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection. 
CellCept je kontraindiciran tijekom trudnoće, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka.
1 bottle adapter and 2 oral dispensers are provided 
Priloženi su 1 plastični nastavak za bocu i 2 oralna dozatora
If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with CellCept. 
Ako se bilo što od gore navedenog odnosi na Vas (ili niste sigurni), odmah razgovarajte sa svojim liječnikom prije nego što započnete liječenje lijekom CellCept.
Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study. 
Među njima je 991 bolesnik bio uključen u tri ispitivanja primjene nakon presađivanja bubrega, 277 bolesnika sudjelovalo je u jednom ispitivanju primjene nakon presađivanja jetre, a 289 bolesnika bilo je uključeno u jedno ispitivanje primjene nakon presađivanja srca.
If you need to have a vaccine (a live vaccine) while taking CellCept, talk to your doctor or pharmacist first. 
Ako se tijekom uzimanja lijeka CellCept trebate cijepiti (živim cjepivom), prvo razgovarajte sa svojim liječnikom ili ljekarnikom.
What CellCept is and what it is used for What you need to know before you take CellCept How to take CellCept 
Što je CellCept i za što se koristi Što morate znati prije nego počnete uzimati CellCept
The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride. 
• Drugi sastojci su: polisorbat 80, citratna kiselina, kloridna kiselina, natrijev klorid.
The full name of your medicine is CellCept 250 mg capsules. 
Puno ime Vašeg lijeka je CellCept 250 mg kapsule
Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion, and further increases in concentrations of both substances may occur. 
Budući da se kod oštećenja funkcije bubrega koncentracije MPAG-a u plazmi povećavaju kao i koncentracije aciklovira, moguće je da se mofetilmikofenolat i aciklovir, ili njegovi predlijekovi, npr. valaciklovir, natječu za tubularno izlučivanje pa može doći do dodatnih povećanja koncentracija oba lijeka.
CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions. 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju ne sadrži antibakterijske konzervanse te se stoga lijek mora rekonstituirati i razrijediti u aseptičnim uvjetima.
CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6). 
CellCept 500 mg prašak za koncentrat za otopinu za infuziju mora se pripremiti i prije primjene u bolesnika dodatno razrijediti otopinom 5%-tne glukoze za intravensku infuziju (vidjeti dio 6.6).
Therefore, CellCept is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection. 
Stoga je CellCept kontraindiciran tijekom trudnoće, osim ako ne postoje prikladni alternativni načini liječenja kojima bi se spriječilo odbacivanje presatka.
Further dilute the content of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of glucose intravenous infusion 5%. 
Dodatno razrijedite otopljeni sadržaj dviju bočica (otprilike 2 x 15 ml) sa 140 ml 5%-tne glukoze za intravensku infuziju.
PVC/aluminium foil blister strips 
Blister trake od PVC/aluminijske folije.
Caution should be used with medicinal products that interfere with enterohepatic recirculation because of their potential to reduce the efficacy of CellCept. 
Za lijekove koji interferiraju s enterohepatičnom recirkulacijom potreban je povećani oprez zbog mogućnosti smanjenja djelotvornosti lijeka CellCept.
Caution should be used during concomitant administration because of the potential to reduce efficacy of CellCept. 
Tijekom istodobne primjene potreban je povećan oprez zbog moguće smanjene djelotvornosti lijeka CellCept.
What CellCept is and what it is used for What you need to know before you have CellCept How you have CellCept 
Što je CellCept i za što se koristi Što morate znati prije nego počnete primati CellCept
Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA. 
Nakon peroralne primjene, mofetilmikofenolat se brzo i ekstenzivno apsorbira i prolazi cjelokupni metabolizam sve do aktivnog metabolita, MPA.
Hepatic transplant n = 277 
Jetreni presadak n = 277
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous infusion only Reconstitute and dilute before use Read the package leaflet before use 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za infuziju u venu Prije uporabe pripremiti i razrijediti Prije uporabe pročitajte uputu o lijeku
Congenital malformations have been observed post-marketing in children of patients exposed to CellCept in combination with other immunosuppressants, see section 4.6. 
Nakon stavljanja lijeka u promet primijećene su kongenitalne malformacije u djece bolesnica izloženih lijeku CellCept u kombinaciji s drugim imunosupresivima (vidjeti dio 4.6).
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone. 
Veće koncentracije aciklovira u plazmi primijećene su prilikom primjene mofetilmikofenolata s aciklovirom, u odnosu na primjenu aciklovira zasebno.
Take 6 capsules in the morning and then 6 capsules in the evening. 
• Uzmite 6 kapsula ujutro te 6 kapsula navečer.
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2). 
Farmakokinetika i farmakodinamika oralnih kontraceptiva nije se izmijenila njihovom istodobnom primjenom s lijekom CellCept (vidjeti i dio 5.2).
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules. 
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, CellCept kapsule ne smiju se otvarati ni drobiti, kako bi se izbjeglo udisanje ili izravan kontakt kože ili sluznica s praškom sadržanim u CellCept kapsulama.
No data are available for treatment of first or refractory rejection in paediatric transplant patients. 
Nema dostupnih podataka o liječenju prvog ili ponovnog odbacivanja presatka u pedijatrijskih bolesnika.
Of these, 991 were included in the three renal studies and 277 were included in one hepatic study. 
Među njima je 991 bolesnik bio uključen u tri ispitivanja primjene nakon presađivanja bubrega, a 277 bolesnika sudjelovalo je u jednom ispitivanju primjene nakon presađivanja jetre.
The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex. 
Najčešće oportunističke infekcije koje se pojavljuju kod bolesnika koji primaju CellCept (2 g ili 3 g dnevno) uz druge imunosupresive u kontroliranim kliničkim ispitivanjima u bolesnika s presađenim bubregom, srcem i jetrom, tijekom praćenja od barem godinu dana, bile su mukokutana kandidijaza, citomegalovirusna (CMV) viremija/sindrom i herpes simpleks.
During your entire treatment with CellCept 
• čitavo razdoblje liječenja lijekom CellCept
Viral infections 
Virusne infekcije
A bottle adapter and 2 oral dispensers are also provided. 
Također su priloženi plastični nastavak za bocu i 2 oralna dozatora.
Then shake the closed bottle well for about 1 minute. 
• Snažno tresite zatvorenu bocu približno 1 minutu.
Oral CellCept 1 g/5 ml powder for oral suspension should be initiated within 72 hours following transplantation. 
Prašak za oralnu suspenziju CellCept 1 g/5 ml mora se uzeti unutar 72 sata nakon presađivanja.
The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex. 
Najčešće oportunističke infekcije koje se pojavljuju kod bolesnika koji primaju CellCept (2 g ili 3 g dnevno) uz druge imunosupresive u kontroliranim kliničkim ispitivanjima u bolesnika s presađenim bubregom i jetrom, tijekom praćenja od barem godinu dana, bile su mukokutana kandidijaza, citomegalovirusna (CMV) viremija/sindrom i herpes simpleks.
• The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous. 
• Drugi sastojci su: sorbitol; silikon, koloidni bezvodni; natrijev citrat; sojin lecitin; okus miješanog voća; ksantanska guma; aspartam* (E951); metilparahidroksibenzoat (E218); citratna kiselina bezvodna *sadrži fenilalanin u vrijednosti 2,78 mg/5 ml suspenzije.
• Abnormalities of the ear (e.g. abnormally formed or absent externalear), external auditory canal atresia (middle ear); 
• abnormalnosti uha (npr. abnormalan oblik ili izostanak vanjskog uha), atrezija vanjskog zvukovoda (srednje uho);
• CellCept treatment should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 
• Liječenje lijekom CellCept ne smije se započeti kod žena reproduktivne dobi bez predočenja nalaza testa na trudnoću kako bi se isključila mogućnost nehotične primjene u trudnoći (vidjeti dio 4.6)
The systemic exposure at these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day (see section 4.6). 
Sistemska izloženost na tim razinama otprilike je ekvivalentna ili manja od 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan (vidjeti dio 4.6).