natgillin/translations-raw huggingface dataset:
• Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved. 
• Iako nema indikacija rizika za bolesnike, Inductos je suspendiran i neće više biti dostupan u EU-u sve dok se problemi s proizvodnom lokacijom za apsorbirajuću spužvu ne riješe.
• Problems have been identified with the way the absorbable sponge in Inductos is manufactured. 
• Identificirani su problemi u načinu proizvodnje apsorbirajuće spužve u lijeku Inductos.
Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process. 
Iako nema indikacija rizika za bolesnike povezane s nalazima inspekcije, Odbor za lijekove za humanu uporabu (CHMP) pri EMA-i zaključio je kako se kvaliteta lijeka Inductos ne može osigurati pomoću postojećeg proizvodnog procesa.
EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements. 
EMA je započela pregled lijeka Inductos nakon inspekcije koju su provele nizozemske i španjolske vlasti koje su utvrdile da proizvodna lokacija za apsorbirajuću spužvu ne udovoljava proizvodnim zahtjevima.
The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed. 
Stoga je CHMP zaključio da Inductos treba suspendirati sve dok se problemi proizvodnje ne riješe na zadovoljavajući način.
Inductos is available as a kit for implant containing a powder, solvent and absorbable collagen sponge (or matrix). 
Inductos je dostupan kao komplet za ugradnju koji sadrži prašak, otapalo i apsorbirajuću kolagensku spužvu (ili matriks).
Inductos to be suspended in the EU EMA/683814/2015 
EMA/683814/2015
The active substance is dibotermin alfa, a protein that acts on the bone structure and helps with the formation of new bone tissue. 
Djelatna tvar je dibotermin alfa, bjelančevina koja djeluje na koštane strukture i pomaže u formiranju novog koštanog tkiva.
The new bone tissue grows into the sponge, which is gradually degraded by the body. 
Novo koštano tkivo urasta u spužvu koju tijelo postupno razgrađuje.
Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved. 
Inductos ostaje suspendiran sve dok se problemi na proizvodnom mjestu za jednu od komponenti lijeka Inductos (apsorbirajuće spužve) ne uklone.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20/11/2015. 
Konačno mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je donijela konačnu pravno obvezujuću odluku primjenjivu u svim državama članicama EU-a dana
The volume of distribution of riluzole is about 245 ± 69 L (3.4 L/kg). 
Volumen distribucije riluzola iznosi oko 245 ± 69 L (3,4 L/kg).
This leaflet was last approved in {MM/YYYY}. 
Uputa je zadnji puta odobrena u {MM/GGGG}.
date of first authorisation: 10 June 1996 date of last renewal: 10 June 2006 
Datum posljednje obnove: 10. lipnja 2006.
Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections. 
Liječnik će možda hjeti uzeti uzorak krvi kako bi provjerio broj bijelih krvnih stanica koje su važne u borbi protiv infekcija.
What RILUTEK looks like and content of the pack 
Kako RILUTEK izgleda i sadržaj pakiranja
RILUTEK has not been shown to be effective in the late stages of ALS. 
RILUTEK se nije pokazao djelotvornim u kasnim fazama ALS-a.
Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
Nuspojave navedene u nastavku razvrstane su prema učestalosti pojavljivanja u sljedeće kategorije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/1000), nepoznato (ne može se procijeniti iz dostupnih podataka).
If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population. 
Ako ste mlađi od 18 godina, ne preporučuje se primjena lijeka RILUTEK jer nema podataka za tu populaciju.
The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours). 
Preporučena dnevna doza u odraslih ili starijih osoba iznosi 100 mg (50 mg svakih 12 sati).
If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK. 
Ako mislite da ste trudni ili namjeravate dojiti, obratite se svom liječniku za savjet prije nego uzmete RILUTEK.
Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population. 
Na temelju farmakokinetičkih podataka nema posebnih uputa za primjenu lijeka RILUTEK u ovoj populaciji.
What you need to know before you take RILUTEK 
Što morate znati prije nego počnete uzimati RILUTEK
ANNEX II A. MANUFACTURER(S) 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 
DODATAK II A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) 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 D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
Each package contains 56 tablets. 
Jedno pakiranje sadrži 56 tableta.
Tell your doctor immediately if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells. 
Odmah obavijestite svog liječnika ako dobijete vrućicu (povišenu temperaturu) jer RILUTEK može uzrokovati smanjenje broja bijelih krvnih stanica.
What RILUTEK is and what it is used for What you need to know before you take RILUTEK How to take RILUTEK 
Što je RILUTEK i za što se koristi Što morate znati prije nego počnete uzimati RILUTEK
OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE 
DRUGA POSEBNA UPOZORENJA (AKO JE POTREBNO)
Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease. 
Stoga se RILUTEK ne smije koristiti u bolesnika s nekim drugim oblikom bolesti motoričkih neurona.
IMPORTANT 
VAŽNO
If you take more RILUTEK than you should 
Ako uzmete više RILUTEK tableta nego što ste trebali
If you forget to take RILUTEK 
Ako ste zaboravili uzeti RILUTEK
Other medicines and RILUTEK Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove.
Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases. 
Liječenje lijekom RILUTEK smije započeti samo liječnik specijalist s iskustvom u liječenju bolesti motoričkih neurona.
RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged. 
RILUTEK blokira izlučivanje glutamata, što može pomoći u sprečavanju oštećenja živčanih stanica.
What RILUTEK is and what it is used for 
Što je RILUTEK i za što se koristi
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. 
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.
Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1). 
Klinička ispitivanja pokazala su da RILUTEK produljuje preživljenje u bolesnika s ALS-om (vidjeti dio 5.1).
There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. 
Nema dokaza da RILUTEK ima terapijski učinak na motoričku funkciju, funkciju pluća, fascikulacije, mišićnu snagu i motoričke simptome.
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. 
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.
The tablets are capsule-shaped, white and engraved with “RPR 202” on one side. 
Tablete su u obliku kapsula, bijele, s utisnutom oznakom "RPR 202" na jednoj strani.
The active substance in RILUTEK is riluzole which acts on the nervous system. 
Djelatna tvar u lijeku RILUTEK je riluzol koji djeluje na živčani sustav.
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. 
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.
Coating: hypromellose, macrogol 6000, titanium dioxide (E171). 
Ovojnica: hipromeloza, makrogol 6000, titanijev dioksid (E171).
Safety and efficacy of RILUTEK has only been studied in ALS. 
Sigurnost primjene i djelotvornost lijeka RILUTEK ispitana je samo u ALS-u.
What RILUTEK contains 
Što RILUTEK sadrži
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. 
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).
RILUTEK is available in a pack of 56 tablets to be taken orally. 
RILUTEK je dostupan u pakiranju od 56 tableta koje se uzimaju kroz usta.
RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3). 
RILUTEK je kontraindiciran u trudnoći (vidjeti dijelove 4.3 i 5.3).
Interstitial lung disease (see section 4.4) 
Intersticijska bolest pluća (vidjeti dio 4.4)
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 
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
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS). 
RILUTEK se koristi u bolesnika koji boluju od amiotrofične lateralne skleroze (ALS).
You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding. 
Trudnoća, dojenje i plodnost NE SMIJETE uzimati RILUTEK ako ste trudni, mislite da ste trudni ili dojite.
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 
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).
RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). 
RILUTEK je indiciran za produljenje života ili vremena do uvođenja mehaničke ventilacije u bolesnika s amiotrofičnom lateralnom sklerozom (ALS).
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). 
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.
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. 
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.
Diarrhoea, abdominal pain, vomiting 
Proljev, bol u abdomenu, povraćanje
Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation. 
Glavni sastojak u plazmi je nepromijenjeni riluzol, koji se opsežno metabolizira pomoću citokroma P450 i kasnijom glukuronidacijom.
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. 
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.
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. 
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
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). 
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).
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. 
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.
Headache, dizziness, oral paraesthesia, somnolence 
Glavobolja, omaglica, parestezija usta i somnolencija
Marketing Authorisation Holder Sanofi Mature IP 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sanofi Mature IP
RILUTEK is contraindicated in breast-feeding women (see sections 4.3 and 5.3). 
RILUTEK je kontraindiciran u dojilja (vidjeti dijelove 4.3 i 5.3).
How to take RILUTEK 
Kako uzimati RILUTEK
What RILUTEK is 
Što je RILUTEK
What RILUTEK is used for 
Za što se koristi RILUTEK
RILUTEK 50 mg film-coated tablets Riluzole 
RILUTEK 50 mg filmom obložene tablete riluzol
EU/1/96/010/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/010/001
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium; 
Jezgra: bezvodni kalcijev hidrogenfosfat, mikrokristalična celuloza, bezvodni koloidni silicijev dioksid, magnezijev stearat, umrežena karmelozanatrij;
How to store RILUTEK 
Kako čuvati RILUTEK
Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section 
Ispitivanja s primjenom ponovljenih doza nisu provedena u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 4.2).
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. 
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).
Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium 
Jezgra: kalcijev hidrogenfosfat, bezvodni celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni magnezijev stearat karmelozanatrij, umrežena
INFORMATION IN BRAILLE 
16. PODACI NA BRAILLEOVOM PISMU RILUTEK
NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets 
NAZIV LIJEKA RILUTEK 50 mg filmom obložene tablete
Titanium dioxide (E171) 
Ovojnica: hipromeloza makrogol 6000 titanijev dioksid (E171)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of riluzole For the full list of excipients, see section 6.1. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg riluzola.
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. 
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Mature IP 
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sanofi Mature IP
RILUTEK 
Tahikardija
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
Liver impairment 
Oštećenje jetre
Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are: 
Manje česte nuspojave lijeka RILUTEK (mogu se javiti u manje od 1 na 100 osoba) su: anemija alergijske reakcije upala gušterače (pankreatitis).
Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600 
Hrvatska sanofi-aventis Croatia d.o.o. Tel: +38516003400
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. 
TVARI Jedna filmom obložena tableta sadrži 50 mg riluzola.
Method of administration Oral use 
Način primjene Peroralna primjena
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration 
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
• over about 1 hour. 
• tijekom približno sat vremena.
• once each day 
• jedanput na dan
Date of first authorization: 11 February 2016 
Datum prvog odobrenja: 11 veljača 2016
Ask your doctor for more information. 
Pitajte svog liječnika za dodatne informacije.
The expiry date refers to the last day of that month. 
. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
Twentyfour patients had neutropaenia. 
24 bolesnika imalo je neutropeniju.
• if you have ever had any other medical problem. 
• ako ste ikada imali druge zdravstvene tegobe.
The following information is intended for medical or healthcare professionals only: 
Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim djelatnicima:
Your doctor will monitor how well the medicine works for you. 
Liječnik će pratiti koliko dobro lijek djeluje na Vas.
The safety information on treatment durations longer than 4 weeks is limited. 
Podaci o sigurnosti primjene u trajanju duljem od 4 tjedna su ograničeni.
A similar effect could be expected for other medicinal products that induce metabolic enzymes. 
Sličan učinak može se očekivati i od drugih lijekova koji induciraju metaboličke enzime.
Not Recommended 
Ne preporučuje se
• you are allergic to any other medicines 
• ako ste alergični na bilo koji drugi lijek
Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection. 
Vrućica i zimica koje ne reagiraju na antibiotike su najčešći znakovi ovog tipa infekcije.
The mechanism of resistance has not been established. 
Nije utvrđen mehanizam rezistencije.
It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby. 
Smije se primijeniti u trudnoći samo ako moguća korist opravdava mogući rizik za dijete.
Reconstituted concentrate: should be used immediately. 
Rekonstituirani koncentrat: mora se odmah primijeniti.
Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Denmark 
Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Danska
Children and adolescents The dose for children and adolescents may differ from the adult dose. 
Djeca i adolescenti Doza lijeka za djecu i adolescente može se razlikovati od doze za odrasle.
• -if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6). 
• ako ste alergični na kaspofungin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
This stops the infection from spreading and gives the body's natural defences a chance to completely get rid of the infection. 
Na taj način zaustavlja širenje infekcije i daje prirodnoj obrani tijela priliku da se riješi infekcije.
• rifampicin (an antibiotic). 
• rifampicin (antibiotik).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA DRUGO
This includes medicines obtained without a prescription, including herbal medicines. 
Ovo uključuje i lijekove koje ste nabavili bez recepta, uključujući i biljne lijekove.
The number of neutropenic patients enrolled in this study was also limited (8.0 %). 
Broj bolesnika s neutropenijom uključenih u ovo ispitivanje također je bio ograničen (8,0%).
Efficacy was a secondary endpoint in this study. 
Djelotvornost je bila sekundarni ishod ispitivanja.
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. 
Znači, eliminacija se odvija u odsustvu ravnotežne distribucije, a pravu procjenu volumena distribucije kaspofungina trenutno nije moguće odrediti.
Caspofungin should not be used during pregnancy unless clearly necessary. 
Kaspofungin se ne smije koristiti tijekom trudnoće, osim ako to nije uistinu neophodno.
• you have ever had liver problems - you might need a different dose of this medicine 
• ako ste ikada imali tegobe s jetrom - možda ćete trebati drugačiju dozu ovog lijeka
Caspofungin Accord is used to treat the following infections in children, adolescents and adults: 
Caspofungin Accord se koristi za liječenje sljedećih infekcija u djece, adolescenata i odraslih:
The mechanism of interaction could possibly be due to an initial inhibition and subsequent induction of transport proteins. 
Mehanizam interakcije mogao bi biti posljedica početne inhibicije i naknadne indukcije transportnih proteina.
Excretion is slow and the terminal half-life of radioactivity was 12 to 15 days. 
Izlučivanje je sporo, a poluvrijeme radioaktivnosti iznosi 12 do 15 dana.
These cases have been associated with poor clinical outcomes. 
Ovi slučajevi su povezani s lošim kliničkim ishodima.