natgillin/translations-raw huggingface dataset:
Rebetol has also been studied in 177 children and adolescents aged between three and 17 years who had not been treated before. 
Osim toga, Rebetol je ispitan na 177 djece i adolescenata u dobi od 3 do 17 godina koji nisu prethodno bili liječeni.
Rebetol on its own has no effect on eliminating the hepatitis C virus from the body. 
Rebetol sam po sebi nema učinka na uklanjanje virusa hepatitisa C iz organizma.
Other information about Rebetol 
Ostale informacije o lijeku Rebetol
Children above 3 years of age and adolescents who weigh less than 47 kg or who cannot swallow capsules should take the oral solution at a dose of 15 mg per kilogram body weight a day. 
Djeca u dobi od 3 ili više godina i adolescenti tjelesne težine manje od 47 kg ili koji ne mogu progutati kapsule trebaju uzimati oralnu otopinu u dozi od 15 mg po kilogramu tjelesne težine dnevno.
Rebetol has been studied in a total of over 6,000 adults who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV. 
Rebetol je ispitan na više od ukupno 6000 odraslih koji prethodno nisu bili liječeni, uključujući 328 bolesnika s cirozom i 507 bolesnika koji su također zaraženi HIV-om.
Haemolytic anaemia (anaemia caused by abnormal breakdown of red blood cells) is a common side effect (seen in between 1 and 10 patients in 100), usually during the first few weeks of treatment. 
Hemolitička anemija (anemija uzrokovana abnormalnim raspadanjem crvenih krvnih stanica) uobičajena je nuspojava (uočena u između 1 i 10 na 100 bolesnika) koja se javlja tijekom prvih tjedana liječenja.
It has also been studied in 1,699 adults whose disease had come back after previous treatment or whose previous treatment had failed. 
Nadalje, ispitan je na 1699 bolesnika kojima se bolest vratila nakon prethodnog liječenja ili čije je prethodno liječenje bilo neuspješno.
The main measure of effectiveness in these studies was the number of patients who had no detectable hepatitis C virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured. 
Glavna mjera učinkovitosti u ovim ispitivanjima bio je broj bolesnika koji nisu imali mjerljivu koncentraciju virusa hepatitisa C u krvi 24 tjedna nakon završetka terapije, zbog čega su se mogli smatrati izliječenima.
This is a summary of the European public assessment report (EPAR) for Rebetol. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rebetol.
Rebetol is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply. 
Smatra se da Rebetol interferira s proizvodnjom ili djelovanjem DNK i RNK virusa, koji su nužni kako bi virusi preživjeli i umnožavali se.
Triple therapy led to a 30% increase in the number of previously untreated early responders who were cured after six months. 
Trostruka terapija dovela je do 30 %-tnog povećanja broja prethodno neliječenih ispitanika koji su rano odgovorili na liječenje, a koji su izliječeni nakon šest mjeseci.
A risk management plan has been developed to ensure that Rebetol is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rebetol.
What is the risk associated with Rebetol? 
Koji su rizici povezani s lijekom Rebetol?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rebetol. 
Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Rebetol.
For more information about treatment with Rebetol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Rebetol pročitajte u uputi lijeka (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
In most of the studies, the main measure of effectiveness was the amount of virus in the blood before and after six months or a year of treatment, and at ‘follow-up', six months later. 
U većini je ispitivanja glavna mjera djelotvornosti bila količina virusa u krvi prije i nakon šest mjeseci ili jedne godine liječenja te tijekom praćenja nakon liječenja, šest mjeseci kasnije.
In children weighing between 47 and 65 kg the dose ranges from 3 to 4 capsules. 
U djece tjelesne težine između 47 i 65 kg doza se kreće od 3 do 4 kapsule.
The haemolytic anaemia may affect a patient's heart function and lead to abnormal test values for substances such as uric acid and bilirubin in the blood. 
Hemolitička anemija može utjecati na bolesnikovu funkciju srca te uzrokovati abnormalne rezultate ispitivanja vrijednosti tvari kao što su urična kiselina i bilirubin u krvi.
There are several other side effects of Rebetol, some of which are very common (occurring in more than 1 in 10 patients). 
Rebetol, od kojih su neke vrlo česte (pojavljuju se kod više od 1 u 10 bolesnika).
The duration of treatment depends on the patient's condition and response to treatment, and ranges from six months to a year. 
Trajanje liječenja ovisi o stanju i reakciji bolesnika na terapiju i traje od šest mjeseci do jedne godine.
What is Rebetol? 
Što je Rebetol?
Why has Rebetol been approved? 
Zašto je Rebetol odobren?
The dose of Rebetol is based on the patient's body weight, and ranges from five to six capsules a day in adults. 
Doza lijeka Rebetol ovisi o tjelesnoj težini bolesnika i kreće se od pet do šest kapsula dnevno u odraslih.
Combination treatment including Rebetol was effective in around a quarter of the adults whose disease had come back after previous treatment or whose previous treatment did not work, and over half of the children and adolescents treated. 
Kombinirana terapija koja je uključivala Rebetol bila je učinkovita u otprilike četvrtine odraslih čija se bolest vratila nakon prethodnog liječenja ili čije prethodno liječenje nije postiglo rezultate te u više od pola djece i adolescenata koji su primali terapiju.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rebetol, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Rebetol uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Rebetol is a medicine that contains the active substance ribavirin. 
Rebetol je lijek koji sadrži djelatnu tvar ribavirin.
The CHMP decided that Rebetol's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor (CHMP) je odlučio da koristi lijeka Rebetol nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Treatment with Rebetol should be started and monitored by a doctor who has experience in the management of long-term hepatitis C. 
Liječenje lijekom Rebetol mora započeti i nadzirati liječnik iskusan u liječenju kroničnog hepatitisa C.
It can also be used in previously untreated patients aged three years and over whose livers are working properly. 
Također se može koristiti u djece u dobi od tri ili više godina čija jetra ne funkcionira ispravno.
Rebetol must not be used in patients with severe heart disease and blood disorders such as thalassaemia and sickle cell anaemia or in pregnant or breast-feeding women. 
Rebetol ne smiju uzimati bolesnici s ozbiljnim srčanim tegobama i poremećajem krvne slike, kao što su talasemija i anemija srpastih stanica, te žene koje su trudne ili koje doje.
The active substance in Rebetol, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'. 
Ribavirin, djelatna tvar lijeka Rebetol, je antivirotik koji pripada skupini analoga nukleozida.
Additional data from the published literature show the positive effects of ribavirin-containing medicines when taken in different combinations, including combinations with peginterferon alfa-2a and a class of medicines known as direct acting antivirals (or DAAs). 
Dodatni podaci iz objavljene literature ukazuju na pozitivne učinke lijekova koji sadrže ribavirin kada se uzimaju u različitim kombinacijama, uključujući kombinacije s peginterferonom alfa-2a i razredom lijekova poznatih kao antivirotici koji djeluju direktno.
In adults who had not been treated before, Rebetol in combination with interferon alfa 2b was more effective than interferon alfa 2b on its own, with 41% of the patients responding to the combination treatment and 16% to the interferon alone. 
Kod bolesnika koji nisu prethodno liječeni Rebetol u kombinaciji s interferonom alfa 2b bio je učinkovitiji nego sam interferon alfa 2b; 41 % pacijenata reagiralo je na kombiniranu terapiju, a 16 % reagiralo je na sam interferon.
Response rates were higher when Rebetol was used with peginterferon alfa 2b. 
Stope odgovora bile su više kada se Rebetol primjenjivao s peginterferonom alfa 2b.
What benefit has Rebetol shown during the studies? 
Koje su koristi lijeka Rebetol utvrđene u ispitivanjima?
Rebetol is used in combination with other medicines to treat adults with long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus). 
Rebetol je u kombinaciji s drugim lijekovima indiciran za liječenje kroničnog hepatitisa C (bolesti jetre nastale uslijed infekcije virusom hepatitisa C) u odraslih osoba.
In all of the studies, Rebetol was given in combination with interferon alfa-2b or peginterferon alfa-2b. 
Rebetol je u svim ispitivanjima davan u kombinaciji s interferonom alfa-2b ili peginterferonom alfa-2b.
Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ribavirin in a triple therapy combination with peginterferon alfa-2b and boceprevir. 
U dvama glavnim ispitivanjima, koja su obuhvaćala 1503 odrasla bolesnika s hepatitisom C tipa 1 i kompenziranom bolesti jetre, ispitivao se učinak ribavirina u trostrukoj kombiniranoj terapiji s peginterferonom alfa-2b i boceprevirom.
Rebetol in combination with peginterferon alfa 2b was also effective in adults with cirrhosis or HIV. 
Kombinirana terapija lijeka Rebetol i peginterferona alfa 2b također je bila učinkovita kod odraslih bolesnika s cirozom ili virusom HIV-a.
The Committee noted that Rebetol in combination with other medicines, including peginterferon alfa and DAAs is effective against long-term hepatitis C virus infection in adults and children. 
Odbor je uočio da je Rebetol u kombinaciji s drugim lijekovima, uključujući peginterferon alfa i antivirotike koji djeluju direktno, učinkovit protiv kronične infekcije virusom hepatitisa C u odraslih i u djece.
In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ribavirin in combination with peginterferon alfa 2b and boceprevir was shown to be more effective than the dual combination with peginterferon alfa 2b alone. 
U ispitivanjima trostruke terapije u bolesnika s hepatitisom C tipa 1 i kompenziranom bolesti jetre pokazalo se da je ribavirin u kombinaciji s peginterferonom alfa 2b i boceprevirom učinkovitiji nego dvostruka kombinacija samo s peginterferonom alfa 2b.
What is Rebetol used for? 
Za što se Rebetol koristi?
A 40% increase was seen among patients who had been treated before. 
U bolesnika koji su prethodno bili liječeni uočeno je 40 %-tno povećanje.
How is Rebetol used? 
Kako se Rebetol koristi?
For a full list of restrictions, see the package leaflet. 
Potpuni popis ograničenja potražite u uputi o lijeku.
How does Rebetol work? 
Kako djeluje Rebetol?
For the full list of side effects reported with Rebetol, see the package leaflet. 
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Rebetol potražite u uputi lijeka.
How has Rebetol been studied? 
Kako je Rebetol ispitivan?
Wash hands after use. 
Nakon upotrebe oprati ruke.
These signs are temporary and should resolve when the journey ends. 
Ovi znakovi su privremeni te bi trebali proći kada putovanje završi.
EXP {month/year} Once broached, use by:……….. 
ROK VALJANOSTI EXP {mjesec/godina} Jednom odčepljen, upotrijebiti do:….
The inter-individual variation in kinetics may be large, up to 70 CV% for AUC. 
Inter-individualne razlike u kinetici mogu biti velike, čak do 70 CV% za AUC.
Date of first authorisation: 29/09/2006. 
Datum prvog odobrenja: 29/09/2006
Date of last renewal: 29/09/2011. 
Datum posljednjeg produljenja: 29/09/2011
* Correct dose for dogs of less than 3 kg cannot be accurately achieved. 
*Točna doza za pse lakše od 3 kg ne može se točno postići
Vall de Bianya 17813 (Girona) SPAIN 
Vall de Bianya 17813 (Girona) ŠPANJOLSKA
• Holding one side of the cut firmly, pull the other side towards the centre of the blister until the tablet is visible. 
• Držeći čvrsto jednu stranu zareza povucite drugu stranu prema sredini blistera dok se ne vidi tableta.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. 
Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 3 godine.
No data have been presented on overdoses in adult cats. 
Nema podataka o predoziranju u odraslih mačaka.
EXP {month/year} Once broached, use within 28 days. 
Jednom otvoren, upotrijebiti unutar 28 dana.
Vomiting is a complex process coordinated centrally by the emetic centre. 
Povraćanje je složen proces koji je centralno koordiniran od strane centra za povraćanje.
The elimination t1/2 following intravenous dosing was approximately 5.8 h. 
Eliminacija t1/2 nakon intravenoznog doziranja je oko 5,8 h.
Shelf life of half tablets: 2 days. 
Rok valjanosti prepolovljene tablete: 2 dana.
For the major metabolite 10.4% of the maropitant dose was recovered in urine and 9.3% in faeces. 
Za glavni metabolit 10,4% doze maropitanta je utvrđeno u urinu i 9,3% u fecesu.
Sulphobutyl ether β-cyclodextrin (SBECD) Metacresol 
Sulfobutil eter β-ciklodekstrin (SBECD) Metakrezol
4 tablets 
4 tablete
Although Cerenia has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively. 
Iako je Cerenia pokazala učinkovitost i kod liječenja i sprječavanja povraćanja uzrokovanog kemoterapijom, smatra se da je učinkovitije ako se daje preventivno.
Each cardboard box contains 1 vial. 
Svaka kartonska kutija sadrži 1 bočicu.
This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid. 
Centar se sastoji od nekoliko jezgri moždanog stabla (area postrema, nucleus tractus solitarius, dorzalna motorička jezgra vagusa) koje primaju i integriraju osjetne podražaje iz centralnih i perifernih izvora i kemijske podražaje iz cirkulacije i cerebro-spinalne tekućine.
Cerenia must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested. 
Cerenia se ne smije miješati u istoj brizgalici s drugim veterinarsko medicinskim proizvodima zato što kompatibilnost s drugim proizvodima nije testirana.
Cardboard box containing one aluminium-aluminium blister pack, each containing four tablets per pack. 
Kartonska kutija u kojoj je jedan aluminijsko-aluminijski blister, svaki blister sadrži četiri tablete.
Tablets should be administered at least one hour before starting the journey. 
Tablete treba dati barem jedan sat prije početka putovanja.
• For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine. 
• Za sprječavanje perioperativne mučnine, povraćanja i poboljšanje oporavka od opće anestezije nakon primjene agonista µ-opijata receptora, morfija.
Note: No attempt should be made to remove the tablet by pushing it through the blister backing as this will damage both the tablet and blister. 
Napomena: ne pokušavajte izvaditi tabletu gurajući ju kroz blister jer će to oštetiti i tabletu i blister.
Overdose (symptoms, emergency procedures, antidotes): 
Predoziranje (simptomi, postupci u slučaju nužde, antidota):
With the extended use of Cerenia tablets in dogs from 5 to 14 consecutive days, the periodic safety update report (PSUR) cycle for Cerenia has been reset and the data lock point for the next PSUR is 30 June 2014 for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals. 
S produženom uporabom Cerenia tableta u pasa od 5 - 14 uzastopnih dana, ciklus periodičkog izvješća o neškodljivosti (PSUR) je ponovo pokrenut, a zaključavanje baze podataka za sljedeće PSUR-ove je 30. lipanj 2014., za podnošenje 6 mjesečnih izvješća (koja uključuju sva odobrena pakovanja proizvoda) u sljedeće 2 godine, koje potom slijede godišnja izvješća u sljedeće dvije godine, a nakon toga u trogodišnjem intervalu.
The elimination halflife at 8 mg/kg was 5.47 hours. 
Vrijeme polueliminacije pri dozi od 8 mg/kg iznosi 5,47 sati.
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose. 
S obzirom da je farmakokinetička varijacija velika i da se maropitant nakuplja u organizmu nakon ponovljene dnevne doze, doza niža od preporučene može biti dovoljna kod nekih jedinki u slučaju da je potrebno ponoviti dozu.
Treatment may be repeated for up to five consecutive days. 
Liječenje se može ponoviti do pet uzastopnih dana.
Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver. 
Maropitant prolazi kroz metabolizam citokroma P450 (CYP) u jetri.
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sunset Yellow (E110) as a colorant 
Karmelozanatrij Laktoza monohidrat Magnezijev stearat Mikrokristalinična celuloza Sunset žuto (E110) kao bojilo
Maropitant (as maropitant citrate monohydrate) 
Maropitant (u obliku maropitant citrat monohidrata)
The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from viral enteritis). 
Neškodljivost maropitanta tijekom liječenja više od 5 dana nije bila istražena u ciljnoj populaciji (tj. u mladih pasa koji boluju od virusnog enteritisa).
Pale orange tablet 
Blijedo narančasta tableta
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP ili mislite da lijek ne djeluje, molimo obavijestite svog veterinara.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe. 
U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko-medicinski proizvod ne smije se miješati s drugim veterinarsko-medicinskim proizvodima.
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention. 
U slučaju nehotičnog kontakta s očima, isprati s puno vode i potražiti liječničku pomoć.
Administering Cerenia on a completely empty stomach may cause your dog to vomit. 
Davanje Cerenie na prazan želudac može uzrokovati povraćanje kod Vašeg psa.
Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg. 
Procjene peroralne bioraspoloživosti maropitanta su bile 23,7% za dozu od 2 mg/kg i 37% za 8 mg/kg.
Plasma protein binding of maropitant in dogs is more than 99%. 
Vezanje proteina plazme za maropitant kod pasa je veće od 99%.
Intravenous administration of Cerenia should be given as a single bolus without mixing the product with any other fluids. 
Intravenoznu primjenu Cerenie treba primijeniti kao jednostruki bolus, bez miješanja proizvoda s drugim tekućinama.
Substance P is found in significant concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter involved in vomiting. 
P tvar se u značajnim koncentracijama nalazi u jezgrama koje obuhvaćaju centar povraćanja i smatra se ključnim neurotransmiterom uključenim u akt povraćanja.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / Tablets 
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA BLISTER / Tableta
Half-tablets should be stored for a maximum of two days after removal from the blister. 
Polovinu tablete treba iskoristiti nakon najviše dva dana od otvaranja blistera.
At a dose of 8 mg/kg, Cmax of 776 ng/ml was reached at 1.7 hours post-dosing. 
Pri dozi od 8 mg/kg, postignuta je Cmax od 776 ng/ml, 1,7 sati nakon aplikacije.
EU/2/06/062/001 (16 mg tablets) EU/2/06/062/002 (24 mg tablets) EU/2/06/062/003 (60 mg tablets) EU/2/06/062/004 (160 mg tablets) 
EU/2/06/062/001 (tablete 16 mg) EU/2/06/062/002 (tablete 24 mg) EU/2/06/062/003 (tablete 60 mg) EU/2/06/062/004 (tablete 160 mg)
Interaction with other medicinal products and other forms of interaction: Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels. 
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Cerenia se ne smije davati istodobno s antagonistima kalcijevih kanala jer maropitant ima sklonost prema njima.
DATE ON WHICH PACKAGE LEAFLET WAS LAST APPROVED 
14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
• Firstly, fold or cut along the perforation between each tablet as shown by the scissor symbol  
• Prvo presavinite ili prerežite blister po perforaciji između dvije tablete kako je prikazano simbolom škara .
A clear, colourless to light yellow solution. 
Bistra, bezbojna do blijedo žuta otopina.
Injecting the product at refrigerated temperature may reduce pain at injection. 
Injiciranje rashlađenog pripravka može smanjiti bol prilikom aplikacije.
The elimination t1/2 following intravenous dosing was approximately 4.9 h. There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults. 
Eliminacija t1/2 nakon intravenoznog doziranja je oko 4,9 h.Pretpostavlja se da postoji farmakokinetički efekt maropitanta vezan za starost životinje jer mačići imaju veće izlučivanje od odraslih mačaka
For subcutaneous or intravenous use in dogs and cats. 
Za subkutanu ili intravenoznu primjenu kod pasa i mačaka.
Cerenia solution for injection may be administered for up to five days and Cerenia tablets for up to fourteen days. 
Cerenia otopina za injekciju može se primjenjivati do 5 dana, a Cerenia tablete do četrnaest dana.
Therefore, it is recommended to administer the antiemetic prior to administration of the chemotherapeutic agent. 
S toga se preporučuje davanje antiemetika prije davanja kemoterapeutika.
It also contains metacresol (as preservative). 
Sadrži metakrezol (kao konzervans).
In some individual dogs and when repeating the treatment, lower doses than recommended might be sufficient. 
Kod nekih pasa pri ponovljenom davanju tablete niže doze od propisanih mogu biti dovoljne.
Use only according to the benefit-risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species. 
Primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara, pošto zaključna ispitivanja reproduktivne toksičnosti nisu provedena ni kod jedne od ciljnih vrsta.
Dogs should be carefully observed following administration to ensure that each tablet is swallowed. 
Pse treba motriti nakon davanja lijeka kako bi bili sigurni da je tableta progutana.