FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take RILUTEK if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases), if you are pregnant or breast-feeding.
Croatian: Nemojte uzimati RILUTEK ako ste alergični na riluzol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), ako imate neku bolest jetre ili povišene razine nekih jetrenih enzima (transaminaza) u krvi, ako ste trudni ili dojite.
English: Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1).
Croatian: Klinička ispitivanja pokazala su da RILUTEK produljuje preživljenje u bolesnika s ALS-om (vidjeti dio 5.1).
English: There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Croatian: Nema dokaza da RILUTEK ima terapijski učinak na motoričku funkciju, funkciju pluća, fascikulacije, mišićnu snagu i motoričke simptome.
English: RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Croatian: Ne preporučuje se primjena lijeka RILUTEK u pedijatrijskoj populaciji jer nema podataka o sigurnosti primjene i djelotvornosti riluzola niti za jednu neurodegenerativnu bolest koja se javlja u djece i adolescenata.
English: Sanofi Mature IP 54 rue La Boétie 75008 Paris France
Croatian: Sanofi Mature IP 54 rue La Boétie 75008 Paris
English: The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Croatian: Tablete su u obliku kapsula, bijele, s utisnutom oznakom "RPR 202" na jednoj strani.
English: The active substance in RILUTEK is riluzole which acts on the nervous system.
Croatian: Djelatna tvar u lijeku RILUTEK je riluzol koji djeluje na živčani sustav.
English: A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
Croatian: N-hidroksiriluzola nakon oralne primjene ponovljenih doza dva puta na dan tijekom 8 dana u 16 zdravih odraslih Japanaca i 16 zdravih odraslih muškaraca bijelaca pokazalo je manju izloženost riluzolu u skupini s japanskim ispitanicima (Cmax 0,85 [90% CI 0,68-1,08] i AUCinf. 0,88 [90% CI 0,69-1,13]) te sličnu izloženost metabolitu.
English: Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
Croatian: Ovojnica: hipromeloza, makrogol 6000, titanijev dioksid (E171).
English: Safety and efficacy of RILUTEK has only been studied in ALS.
Croatian: Sigurnost primjene i djelotvornost lijeka RILUTEK ispitana je samo u ALS-u.
English: What RILUTEK contains
Croatian: Što RILUTEK sadrži
English: Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Croatian: Riluzol treba propisivati uz oprez bolesnicima s anamnezom poremećaja funkcije jetre kao i bolesnicima s blago povišenim vrijednostima serumskih transaminaza (ALT/SGPT ili AST/SGOT do 3 puta iznad gornje granice normalnih vrijednosti (GGN)), razina bilirubina i/ili gamaglutamiltransferaza (GGT).
English: RILUTEK is available in a pack of 56 tablets to be taken orally.
Croatian: RILUTEK je dostupan u pakiranju od 56 tableta koje se uzimaju kroz usta.
English: RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3).
Croatian: RILUTEK je kontraindiciran u trudnoći (vidjeti dijelove 4.3 i 5.3).
English: Interstitial lung disease (see section 4.4)
Croatian: Intersticijska bolest pluća (vidjeti dio 4.4)
English: Common side effects (may affect up to 1 in 10 people) of RILUTEK are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Croatian: Česte nuspojave lijeka RILUTEK (mogu se javiti u manje od 1 na 10 osoba) su: omaglica utrnulost ili trnci u ustima povraćanje pospanost ubrzano kucanje srca proljev glavobolja bol u trbuhu bol
English: RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
Croatian: RILUTEK se koristi u bolesnika koji boluju od amiotrofične lateralne skleroze (ALS).
English: You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding.
Croatian: Trudnoća, dojenje i plodnost NE SMIJETE uzimati RILUTEK ako ste trudni, mislite da ste trudni ili dojite.
English: In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Croatian: U bolesnika (n=20) u kliničkim ispitivanjima kojima je ALT porastao više od 5 puta iznad GGN liječenje je prekinuto, a razine enzima su se u većini slučajeva vratile na manje od 2 puta iznad GGN u roku od 2 do 4 mjeseca (vidjeti dio 4.4).
English: Core:
Croatian: NN:
English: RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Croatian: RILUTEK je indiciran za produljenje života ili vremena do uvođenja mehaničke ventilacije u bolesnika s amiotrofičnom lateralnom sklerozom (ALS).
English: Very common side effects (may affect more than 1 in 10 people) of RILUTEK are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Croatian: Vrlo česte nuspojave lijeka RILUTEK (mogu se javiti u više od 1 na 10 osoba) su: umor mučnina povišene razine nekih jetrenih enzima (transaminaza) u krvi.
English: In a single toxicity study, the absence of corpora lutea was noted at a higher incidence in the ovary of treated compared to control female rats.
Croatian: Samo u jednom ispitivanju toksičnosti primjećena je veća incidencija odsutnosti žutih tijela u jajnicima ženki štakora kojima je primijenjen lijek u usporedbi s kontrolnom skupinom.
English: Diarrhoea, abdominal pain, vomiting
Croatian: Proljev, bol u abdomenu, povraćanje
English: Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
Croatian: Glavni sastojak u plazmi je nepromijenjeni riluzol, koji se opsežno metabolizira pomoću citokroma P450 i kasnijom glukuronidacijom.
English: In a trial, 155 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 12 to 21 months.
Croatian: U jednom ispitivanju 155 bolesnika randomizirano je u skupinu koja je primala riluzol u dozi od 100 mg na dan (50 mg dva puta dnevno) ili placebo te su praćeni tijekom 12 do 21 mjeseca.
English: Warnings and precautions Talk to your doctor before taking RILUTEK: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Croatian: Obratite se svom liječniku prije nego uzmete RILUTEK: ako imate probleme s jetrom: žutilo kože ili bjeloočnica (žutica), svrbež po cijelom tijelu, mučnina, povraćanje ako Vam bubrezi ne rade dobro ako dobijete vrućicu: ona može biti posljedica smanjenog broja bijelih krvnih stanica, što može povećati rizik od infekcije
English: RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Croatian: Ne preporučuje se primjena lijeka RILUTEK u bolesnika s oštećenjem funkcije bubrega jer u ovoj populaciji nisu provedena ispitivanja s primjenom ponovljenih doza (vidjeti dio 4.4).
English: In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months.
Croatian: U ispitivanju za određivanje raspona doza, 959 bolesnika s ALS-om randomizirano je u jednu od četiri terapijske skupine: riluzol u dozi od 50, 100 ili 200 mg na dan ili placebo te su praćeni tijekom 18 mjeseci.
English: Headache, dizziness, oral paraesthesia, somnolence
Croatian: Glavobolja, omaglica, parestezija usta i somnolencija
English: Marketing Authorisation Holder Sanofi Mature IP
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sanofi Mature IP
English: RILUTEK is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Croatian: RILUTEK je kontraindiciran u dojilja (vidjeti dijelove 4.3 i 5.3).
English: How to take RILUTEK
Croatian: Kako uzimati RILUTEK
English: What RILUTEK is
Croatian: Što je RILUTEK
English: What RILUTEK is used for
Croatian: Za što se koristi RILUTEK
English: RILUTEK 50 mg film-coated tablets Riluzole
Croatian: RILUTEK 50 mg filmom obložene tablete riluzol
English: EU/1/96/010/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/010/001
English: Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Croatian: Jezgra: bezvodni kalcijev hidrogenfosfat, mikrokristalična celuloza, bezvodni koloidni silicijev dioksid, magnezijev stearat, umrežena karmelozanatrij;
English: How to store RILUTEK
Croatian: Kako čuvati RILUTEK
English: Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Croatian: Ispitivanja s primjenom ponovljenih doza nisu provedena u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 4.2).
English: if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
Croatian: ako nastupi neki od sljedećih simptoma: žutilo kože ili bjeloočnica (žutica), svrbež po cijelom tijelu, mučnina ili povraćanje, jer to mogu biti znakovi bolesti jetre (hepatitisa).
English: Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Croatian: Jezgra: kalcijev hidrogenfosfat, bezvodni celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni magnezijev stearat karmelozanatrij, umrežena
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU RILUTEK
English: NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets
Croatian: NAZIV LIJEKA RILUTEK 50 mg filmom obložene tablete
English: Titanium dioxide (E171)
Croatian: Ovojnica: hipromeloza makrogol 6000 titanijev dioksid (E171)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of riluzole For the full list of excipients, see section 6.1.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg riluzola.
English: Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Mature IP
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sanofi Mature IP
English: RILUTEK
Croatian: Tahikardija
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
English: Liver impairment
Croatian: Oštećenje jetre
English: Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are:
Croatian: Manje česte nuspojave lijeka RILUTEK (mogu se javiti u manje od 1 na 100 osoba) su: anemija alergijske reakcije upala gušterače (pankreatitis).
English: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Croatian: Hrvatska sanofi-aventis Croatia d.o.o. Tel: +38516003400
English: Sanofi S.p.A. Tel: 800 536389
Croatian: Tel: 800 536389
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets riluzole STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of riluzole.
Croatian: TVARI Jedna filmom obložena tableta sadrži 50 mg riluzola.
English: Method of administration Oral use
Croatian: Način primjene Peroralna primjena
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: • over about 1 hour.
Croatian: • tijekom približno sat vremena.
English: • once each day
Croatian: • jedanput na dan
English: Date of first authorization: 11 February 2016
Croatian: Datum prvog odobrenja: 11 veljača 2016
English: Ask your doctor for more information.
Croatian: Pitajte svog liječnika za dodatne informacije.
English: The expiry date refers to the last day of that month.
Croatian: . Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: Twentyfour patients had neutropaenia.
Croatian: 24 bolesnika imalo je neutropeniju.
English: • if you have ever had any other medical problem.
Croatian: • ako ste ikada imali druge zdravstvene tegobe.
English: The following information is intended for medical or healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim djelatnicima:
English: Your doctor will monitor how well the medicine works for you.
Croatian: Liječnik će pratiti koliko dobro lijek djeluje na Vas.
English: The safety information on treatment durations longer than 4 weeks is limited.
Croatian: Podaci o sigurnosti primjene u trajanju duljem od 4 tjedna su ograničeni.
English: A similar effect could be expected for other medicinal products that induce metabolic enzymes.
Croatian: Sličan učinak može se očekivati i od drugih lijekova koji induciraju metaboličke enzime.
English: Not Recommended
Croatian: Ne preporučuje se
English: • you are allergic to any other medicines
Croatian: • ako ste alergični na bilo koji drugi lijek
English: Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection.
Croatian: Vrućica i zimica koje ne reagiraju na antibiotike su najčešći znakovi ovog tipa infekcije.
English: The mechanism of resistance has not been established.
Croatian: Nije utvrđen mehanizam rezistencije.
English: It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.
Croatian: Smije se primijeniti u trudnoći samo ako moguća korist opravdava mogući rizik za dijete.
English: Reconstituted concentrate: should be used immediately.
Croatian: Rekonstituirani koncentrat: mora se odmah primijeniti.
English: Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Denmark
Croatian: Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Danska
English: Children and adolescents The dose for children and adolescents may differ from the adult dose.
Croatian: Djeca i adolescenti Doza lijeka za djecu i adolescente može se razlikovati od doze za odrasle.
English: • -if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na kaspofungin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: This stops the infection from spreading and gives the body's natural defences a chance to completely get rid of the infection.
Croatian: Na taj način zaustavlja širenje infekcije i daje prirodnoj obrani tijela priliku da se riješi infekcije.
English: • rifampicin (an antibiotic).
Croatian: • rifampicin (antibiotik).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA DRUGO
English: This includes medicines obtained without a prescription, including herbal medicines.
Croatian: Ovo uključuje i lijekove koje ste nabavili bez recepta, uključujući i biljne lijekove.
English: The number of neutropenic patients enrolled in this study was also limited (8.0 %).
Croatian: Broj bolesnika s neutropenijom uključenih u ovo ispitivanje također je bio ograničen (8,0%).
English: Efficacy was a secondary endpoint in this study.
Croatian: Djelotvornost je bila sekundarni ishod ispitivanja.
English: Therefore, elimination occurs in the absence of a distribution equilibrium, and a true estimate of the volume of distribution of caspofungin is currently impossible to obtain.
Croatian: Znači, eliminacija se odvija u odsustvu ravnotežne distribucije, a pravu procjenu volumena distribucije kaspofungina trenutno nije moguće odrediti.
English: Caspofungin should not be used during pregnancy unless clearly necessary.
Croatian: Kaspofungin se ne smije koristiti tijekom trudnoće, osim ako to nije uistinu neophodno.
English: • you have ever had liver problems - you might need a different dose of this medicine
Croatian: • ako ste ikada imali tegobe s jetrom - možda ćete trebati drugačiju dozu ovog lijeka
English: Caspofungin Accord is used to treat the following infections in children, adolescents and adults:
Croatian: Caspofungin Accord se koristi za liječenje sljedećih infekcija u djece, adolescenata i odraslih:
English: The mechanism of interaction could possibly be due to an initial inhibition and subsequent induction of transport proteins.
Croatian: Mehanizam interakcije mogao bi biti posljedica početne inhibicije i naknadne indukcije transportnih proteina.
English: Excretion is slow and the terminal half-life of radioactivity was 12 to 15 days.
Croatian: Izlučivanje je sporo, a poluvrijeme radioaktivnosti iznosi 12 do 15 dana.
English: These cases have been associated with poor clinical outcomes.
Croatian: Ovi slučajevi su povezani s lošim kliničkim ishodima.
English: In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Croatian: Općenito se liječenje antimikoticima mora nastaviti najmanje 14 dana nakon posljednje pozitivne kulture.
English: Paediatric patients (12 months to 17 years)
Croatian: Pedijatrijski bolesnici (od 12 mjeseci do 17 godina)
English: If you are pregnant or breast-feeding ,think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: However, no systematic dosage adjustment is required.
Croatian: Međutim, nije potrebno sustavno prilagođavati dozu.
English: Other side effects in adults include
Croatian: Ostale nuspojave zabilježene u odraslih osoba uključuju
English: Generally the increase was modest and not large enough to warrant dosage adjustment.
Croatian: Povećanje izloženosti je općenito bilo umjereno i nedovoljno veliko da bi zahtijevalo prilagodbu doze.
English: [Justification for not including Braille accepted]
Croatian: [Prihvaćeno obrazloženje za nenavođeje Brailleovog pisma]
English: Volume of reconstituted
Croatian: Volumen rekonstituiranog lijeka
English: Caution is advised when treating this age group.
Croatian: Savjetuje se oprez pri primjeni u ovoj dobnoj skupini.
English: Gender: Caspofungin plasma concentrations were on average 17-38 % higher in women than in men.
Croatian: Spol: koncentracije kaspofungina u plazmi bile su u prosjeku 17-38% veće u žena nego u muškaraca.
English: 50 mg at reduced volume
Croatian: 50 mg pri smanjenom volumenu
English: A small amount of caspofungin is excreted unchanged in urine (approximately 1.4 % of dose).
Croatian: Mala količina kaspofungina izlučuje se neizmijenjena u mokraći (otprilike 1,4% doze).
English: A short alpha-phase occurs immediately post-infusion, followed by a beta-phase with a halflife of 9 to 11 hours.
Croatian: Kratka alfa faza nastupa neposredno nakon infuzije nakon čega slijedi beta faza s poluvremenom od 9 do 11 sati.
English: However, paediatric patients probably have a different adverse event profile compared to adult patients.
Croatian: Međutim, pedijatrijski bolesnici vjerojatno imaju drugačiji profil štetnih događaja u odnosu na odrasle bolesnike.
English: For reconstitution directions see section 6.6.
Croatian: Za upute o pripremi vidjeti dio 6.6.
English: 70 mg (from two 50 mg vials)**
Croatian: 70 mg (iz dvije bočice od 50 mg)**
English: Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
Croatian: U cjelini, dostupni podaci o farmakokinetici, djelotvornosti i sigurnosti primjene ograničeni su za bolesnike u dobi od 3 do 10 mjeseci.
English: If you are worried that you may have been given too much Caspofungin Accord, tell your doctor or nurse straight away.
Croatian: Ako ste zabrinuti da ste možda primili previše lijeka Caspofungin Accord , odmah obavijestite svog liječnika ili medicinsku sestru.
English: After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered.
Croatian: Nakon što se znakovi i simptomi invazivne kandidijaze poboljšaju, a kulture postanu negativne, može se razmotriti prelazak na liječenje oralnim antimikoticima.
English: The study design, diagnostic criteria, and criteria for efficacy assessment were similar to the corresponding studies in adult patients (see section 5.1).
Croatian: Ustroj ispitivanja, dijagnostički kriteriji i kriteriji ocjene djelotvornosti bili su slični odgovarajućim ispitivanjima u odraslih bolesnika (vidjeti dio 5.1).
English: Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Caspofungin Accord”).
Croatian: Samo osposobljeni zdravstveni radnik,, koji je pročitao cijele upute, smije pripremiti lijek (vidjeti niže “Upute za rekonstituciju i razrjeđivanje lijeka Caspofungin Accord ”).
English: Each pack contains one vial of powder.
Croatian: Jedno pakiranje sadrži jednu bočicu s praškom.
English: Animal studies have shown developmental toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su razvojnu toksičnost (vidjeti dio 5.3).
English: An increase in the incidence of cervical ribs was also noted.
Croatian: Bila je zabilježena i povećana incidencija vratnih rebara.
English: Caspofungin resistance in Candida has been observed but the incidence may differ by species or region.
Croatian: Zapažena je rezistencija roda Candida na kaspofungin, ali incidencija se može razlikovati ovisno o vrsti ili regiji.
English: The following adverse reactions were reportedduring clinical studies and/or post-marketing use:
Croatian: Sljedeće nuspojave prijavljene su tijekom kliničkih ispitivanja i/ili nakon stavljanja lijeka u promet:
English: However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).
Croatian: Međutim, dostupni podaci pokazuju da se kaspofungin nastavlja dobro podnositi pri duljem trajanju liječenja (do 162 dana u odraslih bolesnika i do 87 dana u pedijatrijskih bolesnika).
English: • by slow injection into a vein (intravenous infusion)
Croatian: • sporom injekcijom u venu (intravenska infuzija)
English: Pharmacotherapeutic group: antimycotics for systemic use, ATC code: J02AX04
Croatian: Farmakoterapijska skupina: antimikotici za sistemsku primjenu, ATK oznaka: J02AX04
English: In this study, the caspofungin dose was administered over 2 hours (instead of the routine 1-hour administration).
Croatian: U tom se ispitivanju doza kaspofungina primjenjivala tijekom 2 sata (umjesto rutinske infuzije u trajanju od 1 sata).