natgillin/translations-raw huggingface dataset:
The capsules should not be chewed.
Kapsule se ne smiju žvakati.
Aspartame (E951) Sorbitol
Aspartam (E951) Sorbitol
Dose increases should be gradual, taking place over a few weeks while the dose(s) of the other antiepileptic medicine(s) is (are) reduced at the same time.
Povećanje doze treba biti postupno, tijekom nekoliko tjedana, dok se doza(e) drugog(ih) antiepileptika smanjuje(u) u isto vrijeme.
Risk related to stiripentol
Rizik povezan sa stiripentolom
Other medicines and Diacomit
Drugi lijekovi i Diacomit
excitement, restlessness and hallucinations).
uzbuđenost, nemir i halucinacije).
Caution should be exercised when prescribing to pregnant women and use of efficient methods of contraception is advisable.
Treba biti oprezan u propisivanju lijeka trudnicama, a savjetuje se uporaba djelotvornih metoda kontracepcije.
To eliminate these side effects, your child's doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child.
Da bi se ove nuspojave uklonile, liječnik Vašeg djeteta će možda morati promijeniti dozu Diacomita ili jednog od drugih lijekova propisanih za Vaše dijete.
During pregnancy, effective antiepileptic treatment must NOT be stopped.
Tijekom trudnoće, učinkovito liječenje epilepsije se NE smije prekinuti.
Talk to your child's doctor or pharmacist before taking Diacomit
Obratite se liječniku Vašeg djeteta ili ljekarniku prije nego ono počne uzimati Diacomit
Your child should always take these capsules exactly as your child's doctor has told you.
Vaše dijete mora uvijek uzimati ove kapsule točno onako kako Vam je to rekao djetetov liječnik.
However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.
Situacija je, međutim, drukčija ako povraćanje nastupi više od jednog sata nakon uzimanja lijeka, jer se stiripentol brzo apsorbira.
Your child's doctor has prescribed this medicine to help treat your child's epilepsy.
Liječnik Vašeg djeteta prepisao je ovaj lijek za pomoć u liječenju epilepsije u Vašeg djeteta.
In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.
U slučaju povraćanja u prvih nekoliko minuta nakon uzimanja, smatra se da se lijek nije apsorbirao, pa treba dati novu dozu.
The main metabolic processes are demethylenation and glucuronidation, although precise identification of the enzymes involved has not yet been achieved.
Glavni metabolički procesi su demetilacija i glukuronidacija, iako nije postignuta precizna identifikacija svih uključenih enzima.
In the absence of available clinical data, caution should be taken with the following clinically relevant interactions with stiripentol:
U odsustvu dostupnih kliničkih podataka, potreban je oprez u sljedećim klinički relevantnim interakcijama sa stiripentolom:
For the interaction of stiripentol with food, please see section 4.5.
Za interakciju stiripentola s hranom, molimo pogledajte dio 4.5.
• hyperkinesis (exaggerated movements);
• hiperkineza (pretjerani pokreti);
Hyperkinesias
Hiperkineze
midazolam or triazolam (medicines used to reduce anxiety and sleeplessness - in combination with Diacomit they may make your child very sleepy);
midazolam ili triazolam (lijekovi koji se koriste za smanjenje tjeskobe i protiv nesanice - u kombinaciji s Diacomitom, Vaše dijete može biti veoma pospano);
Carcinogenicity studies gave negative results in the rat.
Ispitivanje karcinogenosti u štakora su dala negativne rezultate.
Data on clinical overdose are not available.
Podaci o kliničkom predoziranju nisu dostupni.
Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Niti neklinički niti klinički podaci nisu dostupni za procjenu upotrebe aspartama u dojenčadi mlađe od 12 tjedana.
• decrease of platelet level in the blood;
• smanjenje razine krvnih pločica (trombocita) u krvi;
This could occur by inhibition of synaptosomal uptake of GABA and/or inhibition of GABA transaminase.
Ovo može nastati inhibicijom sinaptosomalnog unosa GABA i/ili inhibicijom GABA transaminaze.
Substances interfering with CYP enzymes
Tvari koje interferiraju sa CYP enzimima
Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.
Stiripentol, djelatni sastojak Diacomita, pripada skupini lijekova koji se nazivaju antiepileptici.
Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Ispitivanja genotoksičnosti nisu otkrila nikakvu mutagenu ili klastogenu aktivnost.
Caution is advised when combining stiripentol with other substances that inhibit or induce one or more of these enzymes.
Savjetuje se oprez kad se stiripentol kombinira s drugim tvarima koje inhibiraju ili induciraju jedan ili više ovih enzima.
Although other factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large extent, is caused by the treatment.
Iako drugi čimbenici, kao što je epilepsija, mogu doprinijeti, dostupni dokazi ukazuju da je ovaj porast uvelike uzrokovan lijekovima.
Many of the above adverse reactions are often due to an increase in plasma levels of other anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these medicinal products is reduced.
Mnoge od gore navedenih nuspojava često nastaju zbog porasta razine drugog antikonvulzivnog lijeka u plazmi (vidjeti dijelove 4.4 i 4.5) i mogu se povući kad se doze ovih lijekova smanje.
These interactions may result in increased systemic levels of these active substances that may lead to enhanced pharmacological effects and to an increase in adverse reactions.
Ove interakcije mogu dati povećane sistemske razine ovih djelatnih tvari, što može voditi do povećanja farmakološkog učinka i povećanja nuspojava.
A French compassionate use program included children from 6 months of age because the diagnosis of Dravet's syndrome may be made with confidence at that age in some patients.
U francuskom programu milosrdne primjene, bila su uključena djeca dobi od 6 mjeseci, zato što se pouzdana dijagnoza Dravetovog sindroma može postaviti u toj dobi kod nekih bolesnika.
If your child forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next dose.
Ako Vaše dijete zaboravi uzeti dozu lijeka, on ili ona ga mora uzeti čim se sjetite, osim ako nije vrijeme za sljedeću dozu.
The pivotal clinical studies did not include children below 3 years old.
Ključna klinička ispitivanja nisu uključila djecu mlađu od 3 godine.
In the treated population, an increase in malformations has been noted with polytherapy.
Kod populacije koja se liječi, porast u malformacijama je zabilježen u primjeni politerapije.
Levetiracetam does not undergo hepatic metabolism to a major extent.
Levetiracetam ne podliježe hepatičkom metabolizmu u velikoj mjeri.
• if your child has ever experienced attacks of delirium (a mental state with confusion,
• ako je Vaše dijete ikada imalo napade delirija (mentalno stanje koje karakteriziraju zbunjenost,
Your child should not take a double dose to make up for a forgotten individual dose.
Vaše dijete ne treba uzimati dvostruku dozu da bi nadoknadilo dozu koju je zaboravilo uzeti.
No data on exposed pregnancies are available.
Nisu dostupni podaci o izloženim trudnoćama.
Stiripentol is extensively metabolized, 13 different metabolites having been found in urine.
Stiripentol se metabolizira u velikoj mjeri i 13 različitih metabolita je nađeno u urinu.
In the mouse there was only a small increase in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day for 78 weeks but not in those given 60 mg/kg/day.
U miševa je bio smo jedan mali porast u incidenciji hepatičkih adenoma i karcinoma u životinja kojima su davane doze od 200 ili 600 mg/kg/dan tijekom 78 tjedana, ali ne i u onih kojima je davano 60 mg/kg/dan.
Your child should not use any tools, machines, ride or drive if affected in this way.
Vaše dijete ne bi smjelo koristiti nikakve alate, strojeve, upravljati motornim ili drugim vozilima kada je pod djelovanjem ovog lijeka.
Your child should always take the contents of each sachet exactly as your child's doctor has told you.
Vaše dijete mora uvijek uzimati sadržaj svake vrećice točno onako kako Vam je to rekao djetetov liječnik.
Raised γ-GT
Povišen γ-GT
• aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
• agresivnost, razdražljivost, uznemirenost, pretjerana uzbuđenost (neuobičajeno stanje uzbuđenosti);
This finding is considered to be an adaptive response to a high metabolic burden on the liver.
Smatra se da su ovi nalazi adaptivni odgovor na visoko metaboličko opterećenje jetre.
The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the only dose of Diacomit evaluated in the pivotal studies (see section 5.1).
Preporučena doza od 50 mg/kg/dan zasniva se na dostupnim nalazima kliničkih studija i bila je jedina doza Diacomita ocijenjena u ključnim ispitivanjima (vidjeti dio 5.1).
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} [product code]
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj} [oznaka lijeka]
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor.
Ako u Vašeg djeteta nastanu neki problemi prilikom prelaska s kapsula na prašak za oralnu suspenziju ili obrnuto, obavijestite liječnika o tome.
The absolute bioavailability of stiripentol is not known since an intravenous formulation is not available for testing.
Apsolutna bioraspoloživost stiripentola nije poznata jer intravenski farmaceutski oblik nije dostupan za testiranje.
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i strojevima.
If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.
Ako je vaša kćer trudna ili doji, misli da je trudna ili planira imati dijete, pitajte njezinog liječnika za savjet prije uzimanja ovog lijeka.
Sachets are made with a composite paper/aluminium/polyethylene film.
Vrećice su napravljene od filma sastava papir/aluminij/polietilen.
The dose will be adjusted by the doctor according to your child's condition.
Liječnik će prilagoditi dozu prema stanju Vašeg djeteta.
There are slight differences between the Diacomit capsules and powder for oral suspension.
Postoje neznatne razlike između Diacomita u kapsulama i praška za oralnu suspenziju.
Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Općeniti rizik vezan uz epilepsiju i antiepileptičke lijekove Već je pokazano da je u potomstvu žena koje imaju epilepsiju prevalencija malformacija dva do tri puta veća nego stopa od približno 3% u općoj populaciji.
The dose is adjusted by the doctor according to your child's age, weight and condition, generally 50 mg per kg bodyweight and per day.
Dozu određuje liječnik prema djetetovoj dobi, težini i stanju, uglavnom iznosi 50 mg po kg tjelesne težine dnevno.
The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard deviation of random effect = 122%).
Procjena konstante brzine apsorpcije Ka u populacijije bila 2,08 h-1 (standardna devijacija randomnog učinka = 122%).
As the flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose intolerance should not take this medicine.
Kako komponenta koja daje okus sadrži nešto malo sorbitola, bolesnici s nasljednim problemima netolerancije na fruktozu ne bi smjeli uzimati ovaj lijek.
Anorexia, loss of appetite, weight loss
Anoreksija, gubitak teka, gubitak na težini
The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.
Tvrde kapsule su pakirane u plastične bočice koje sadrže 30, 60 ili 90 kapsula, u kartonskim kutijama.
Distribution Stiripentol binds extensively to circulating plasma proteins (about 99%).
Stiripentol se opsežno veže za cirkulirajuće proteine plazme (oko 99%).
It should always be taken in combination with clobazam and valproate under the direction of a doctor.
On se uvijek mora uzimati u kombinaciji s klobazamom i valproatom pod liječničkim nadzorom.
Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to excessive sedation.
Povećanje razine benzodiazepina u plazmi može nastati zbog smanjenja hepatičkog metabolizma, što vodi u prekomjernu sedaciju.
The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses.
Medijan dobi je bio 7,3 godine (raspon: 1 do 17,6 godina), a medijan dnevne doze stiripentola je bio 45,4 mg/kg/dan (raspon: 27,1 do 89,3 mg/kg/dan) primijenjen u dvije ili tri podijeljene doze.
Stiripentol powder for oral suspension in sachet contains aspartame, a source of phenylalanine.
Stiripentol prašak za oralnu suspenziju u vrećici sadrži aspartam, izvor fenilananina.
Please consult your child's doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
Obratite se liječniku Vašeg djeteta u slučaju bilo kakvih nuspojava, jer liječnik mora prilagoditi dozu ovog lijeka i drugog antiepileptičkog lijeka (drugih antiepileptičkih lijekova).
chlorpromazine (used for mental illness such as psychosis).
klorpromazin (koristi se u liječenju mentalnih bolesti poput psihoze).
The capsule should be swallowed whole with a glass of water.
Kapsule treba progutati cijele s čašom vode.
As a consequence, it is recommended that children between 6 months and 3 years of age are carefully monitored whilst on stiripentol therapy.
Kao posljedica toga, preporuka je da se djeca dobi od 6 mjeseci do 3 godine pomno nadziru dok su na terapiji stiripentolom.
Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 30mg/kg/day for 1 week.
Povećanje doze stiripentola treba biti postupno, počevši s 20mg/kg/dan tijekom prvog tjedna, a potom 30mg/kg/dan tijekom drugog tjedna.
- Valproate
- Valproat
PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
OBLIK I SADRŽAJ 30 tvrdih kapsula
The potential for metabolic interaction between stiripentol and valproate is considered modest and thus, no modification of valproate dosage should be needed when stiripentol is added, except for clinical safety reasons.
Mogućnost metaboličke interakcije između stiripentola i valproata se smatra skromnom, te stoga nije potrebno mijenjati doziranje valproata uz dodatnu terapiju stiripentolom, osim iz razloga kliničke sigurnosti.
By reporting side affects you can help provide more information on the safety of this medicine.
Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
• double vision when used in combination with the antiepileptic medicine carbamazepine;
• dvostruka slika kada se uzima u kombinaciji s antiepileptičkim lijekom karbamazepinom;
As a result, pharmacokinetic interactions of metabolic origin with other medicines may be expected.
Posljedično, mogu se očekivati farmakokinetičke interakcije metaboličkog podrijetla s drugim lijekovima.
Tell your doctor if your child is taking any of the following medicines:
Obavijestite liječnika ako Vaše dijete uzima neki od sledećih lijekova:
If you have the impression that the effect of this medicine is too strong or too weak, talk to your child's doctor or pharmacist.
Ako imate dojam da je djelovanje ovog lijeka prejako ili preslabo, obratite se liječniku Vašeg djeteta ili ljekarniku.
• loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
• gubitak teka, gubitak težine (posebno u kombinaciji s antiepileptičkim lijekom natrijevim valproatom);
Patients with rare glucosegalactose malabsorption should not take this medicine, as the formulation contains glucose.
Bolesnici s rijetkom malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek, jer farmaceutski oblik sadrži glukozu.
Your child's doctor will tell you the new dose of the other antiepileptic medicine(s).
Liječnik vašeg djeteta će Vas uputiti o novoj dozi drugog(ih) antiepileptika.
Patients then received stiripentol in an open fashion.
Poslije toga je stiripentol davan bolesnicima otvoreno.
• ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia
• ataksija (nesposobnost koordinacije mišićnih pokreta), hipotonija (gubitak snage mišića),
PHARMACEUTICAL FORM Powder for oral suspension Pale pink crystalline powder
OBLIK Prašak za oralnu suspenziju Blijedo ružičasti kristalni prašak
A dose-adjustment may be necessary for substances metabolised by CYP2D6 and that are individually dose titrated.
Može biti neophodna prilagodba doze za tvari koje metabolizira CYP2D6 i čija se doza individualno titrira.
No impact on fertility was detected in animal studies (see section 5.3).
Nije otkriven utjecaj na plodnost u ispitivanjima na životinjama (vidjeti dio 5.3).
A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and clobazam.
Populacijsko farmakokinetičko ispitivanje je provedeno u 35 djece s Dravetovim sindromom, liječene stiripentolom i s druge dvije tvari za koje se ne zna da utječu na farmakokinetiku stiripentolavalproatom i klobazamom.
These capsules should be swallowed whole with water.
Ove kapsule treba progutati cijele s vodom.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at non-maternotoxic doses (see section 5.3).
Ispitivanja na životinjama ne pokazuju izravne niti neizravne štetne učinke po trudnoću, fetalni razvoj, porođaj ili postnatalni razvoj na razini netoksičnih doza po majku (vidjeti dio 5.3).
Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours.
Stiripentol se brzo apsorbira, i za otprilike 1,5 sat dostiže najvišu razinu koncentracije u plazmi.
Size 0, white capsule
Bijela kapsula veličine 0
• The active substance is stiripentol.
• Djelatna tvar je stiripentol.
- If your child takes medicines containing: caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma).
- Ako Vaše dijete uzima lijekove koji sadrže: kofein (ova tvar pomaže vraćanju mentalne budnosti) ili teofilin (ova tvar se koristi u slučaju astme).
In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
U životinjskim modelima, stiripentol djeluje protiv napadaja izazvanih elektrošokom, pentetrazolom i bikukulinom.
Your child should take this medicine two or three times a day at regular intervals as directed by your child's doctor, for example morning - noon - bed-time to cover the night-and-day period.
Vaše dijete mora uzimati ovaj lijek dva ili tri puta dnevno u redovnim razmacima, kako je odredio njegov liječnik, na primjer jutro - podne - pred spavanje, kako bi se pokrio noćni i dnevni period.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
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.
As a result, no pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated.
Shodno tomu, ne očekuje se farmakokinetička metabolička interakcija stiripentola i levetiracetama.
The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with clobazam and valproate.
Započinjanje dodatne terapije sa stiripentolom treba provesti postupnim povećavanjem doze do preporučene doze od 50 mg/kg/dan, primijenjene zajedno s klobazamom i valproatom.
• sleep disorders (abnormal sleeping);
• poremećaji sna (promjene spavanja);
This warning is not only restricted to medicinal products but also to a considerable number of foods and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (see section 4.2).
Ovo upozorenje nije ograničeno samo na lijekove, nego i na znatan broj namirnica i prehrambenih pripravaka namijenjenih djeci: Bolesnici ne bi smjeli piti kola napitke koji sadrže znatne količine kofeina, ili jesti čokoladu, koja sadrži teofilin u tragovima (vidjeti dio 4.2).
Further dosage escalation is age dependent: - children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus achieving the recommended dose of 50 mg/kg/day in three weeks; - children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus achieving the recommended dose of 50 mg/kg/day in four weeks; - children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week until the optimum dose is reached based on clinical judgment.
Daljnje povećanje doze ovisi o dobi: - djeca mlađa od 6 godina bi trebala primiti dodatnih 20 mg/kg/dan tijekom trećeg tjedna, dostižući tako preporučenu dozu od 50 mg/kg/dan za tri tjedna; - djeca od 6 do manje od 12 godina trebala bi primiti dodatnih 10 mg/kg/dan svaki tjedan, dostižući tako preporučenu dozu od 50 mg/kg/dan za četiri tjedna; - djeca i adolescenti u dobi od 12 godina i stariji trebali bi primiti dodatnih 5 mg/kg/dan svaki tjedan sve dok se ne dostigne optimalna doza na temelju kliničke procjene.
In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid (GABA) - the major inhibitory neurotransmitter in mammalian brain.
Čini se da u štakora, stiripentol povećava razine gama-aminomaslačne kiseline (GABA) u mozgu - glavnog inhibitornog neurotransmitera u mozgu sisavaca.
In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam and valproate in 41% of 230 cases.
U jednom francuskom programu milosrdne primjene stiripentola, topiramat je dodan stiripentolu, klobazamu i valproatu u 41% of 230 slučajeva.
In the pivotal studies in the event of gastrointestinal adverse reactions such as loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week.
U ključnim ispitivanjima u slučajevima gastrointestinalnih nuspojava, kao što su gubitak teka, gubitak težine, dnevna doza valproata se svakog tjedna smanjivala za oko 30%.
Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines.
Obavijestite liječnika svog djeteta ili ljekarnika ako vaše dijete uzima, nedavno je uzimalo ili bi moglo uzimati bilo koji drugi lijek.
The two formulations were bioequivalent in terms of AUC but not in terms of Cmax.
Ova dva farmaceutska oblika su bila bioekvivalentna obzirom na AUC, ali ne i obzirom na Cmax.