FrancophonIA/ELRC3.0 huggingface dataset:
English: Hetlioz is intended for long-term use.
Croatian: Hetlioz je namijenjen za dugoročnu primjenu.
English: This is a summary of the European public assessment report (EPAR) for Hetlioz.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Hetlioz.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hetlioz on 3 July 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Hetlioz vrijedi na prostoru Europske unije od 3. srpnja 2015.
English: In the second study, 57 patients first received Hetlioz for around 11 weeks.
Croatian: U drugom ispitivanju, 57 bolesnika najprije je primalo lijek Hetlioz tijekom otprilike 11 tjedana.
English: The recommended dose is one capsule per day, taken one hour before bedtime, at the same time every night.
Croatian: Preporučena dnevna doza lijeka Hetlioz je 1 kapsula koja se uzima jedan sat prije spavanja i svake noći u isto vrijeme.
English: What measures are being taken to ensure the safe and effective use of Hetlioz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Hetlioz?
English: In people with normal perception of light and dark, melatonin is produced in hours of darkness and promotes sleep by acting on melatonin receptors in specific areas of the brain.
Croatian: U osoba s normalnom percepcijom svjetla i noći, melatonin se proizvodi u sati tame i potiče spavanje tako što djeluje na receptore melatonina u određenim područjima u mozgu.
English: A hormone called melatonin plays a key role in co-ordinating the body's sleep-wake cycle.
Croatian: Hormon naziva melatonin ima ključnu ulogu u koordinaciji ciklusa spavanja tijela.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Hetlioz nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, somnolence, nausea (feeling sick) and dizziness.
Croatian: Najčešće nuspojave lijeka Hetlioz (koje se mogu javiti u više od 3 na 100 osoba) su glavobolja, somnolencija, mučnina (osjećaj slabosti) i vrtoglavica.
English: Hetlioz is available as 20 mg capsules and can only be obtained with a prescription.
Croatian: Hetlioz je dostupan u kapsulama od 20 mg i izdaje se samo na liječnički recept.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Hetlioz dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Hetlioz approved?
Croatian: Zašto je Hetlioz odobren?
English: The main measure of effectiveness was the percentage of patients who were able to adjust to the 24-hour clock, which was calculated by looking at how the amount of melatonin breakdown products changed in the patient's urine over time.
Croatian: Glavna mjera djelotvornosti bio je postotak bolesnika koji su se mogli prilagoditi na 24-satni ciklus koji je izračunat promatranjem kako količina melatonina razgrađuje tvari izmijenjen u urinu bolesnika tijekom vremena.
English: What are the risks associated with Hetlioz?
Croatian: Koji su rizici povezani s lijekom Hetlioz?
English: Other information about Hetlioz
Croatian: Ostale informacije o lijeku Hetlioz
English: What is Hetlioz and what is it used for?
Croatian: Što je Hetlioz i za što se koristi?
English: The CHMP noted that only around 20% of patients would be able to benefit from treatment with Hetlioz, but in view of the lack of approved treatments for non-24-hour sleep-wake disorder, which is a debilitating condition, this modest response was still considered important.
Croatian: CHMP je zaključio da bi otprilike 20% bolesnika moglo imati koristi od terapije lijekom Hetlioz, no u svjetlu nedostatka odobrenih terapija za poremećajem cirkadijalnog ritma, koje je iscrpljujuće stanje, ovaj ograničeni odgovor može se i dalje smatrati važnim.
English: It is not intended to provide practical advice on how to use Hetlioz.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Hetlioz.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hetlioz, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Hetlioz nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The active substance in Hetlioz, tasimelteon, acts on the same receptors as melatonin to promote sleep and regulate sleep patterns.
Croatian: Djelatna tvar lijeka Hetlioz, tasimelteon, djeluje na iste receptore kao melatonin kako bi potaknuo spavanje i regulirao uzorke spavanja.
English: By taking it at a suitable time each day it can help to reset the sleep-wake cycle to more standard timing.
Croatian: Uzimajući ovaj lijek kao svakodnevnu zamjenu može pomoći pri vraćanju ciklusa spavanja i budnosti na uobičajenija vremena.
English: The full EPAR and risk management plan summary for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Hetlioz kao i sažetak plana upravljanja rizikom za lijek Hetlioz nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Hetlioz is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Hetlioz.
English: Non-24hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients have sleep patterns that are not synchronised with day and night and often follow a cycle that is longer than the standard 24-hour clock.
Croatian: Poremećaja cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata je stanje koje nastupa gotovo isključivo u osoba koje su potpuno slijepe, pri čemu bolesnici imaju uzorak spavanja koji nije sinkroniziran s danom i noći, te često slijedi ciklus koji je dulji od standardnog 24-satnog ciklusa.
English: For more information about treatment with Hetlioz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Hetlioz pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Regarding safety, Hetlioz was shown to be well tolerated, causing only few mild side effects.
Croatian: Vezano uz sigurnu primjenu, utvrđeno je kako je Hetlioz dobro podnošen te da uzrokuje samo nekoliko blagih nuspojava.
English: Of the 10 patients who remained on Hetlioz, 9 people remained adjusted to 24-hour clock at the end of the study, compared with 2 of the 10 patients who were switched to placebo.
Croatian: Od 10 bolesnika koji su ostali na lijeku Hetlioz, 9 osoba zadržalo je prilagođeni 24-satni ciklus po završetku ispitivanja, u usporedbi s 2 od 10 bolesnika koji su prebačeni na placebo.
English: Those patients who were able to adjust to the 24-hour clock (20 patients in total) were then given Hetlioz or placebo for a further 8 weeks to study how well the effect of Hetlioz was maintained.
Croatian: Bolesnici koji su mogli prilagoditi 24-satnom ciklusu (ukupno 20 bolesnika) primili su zatim Hetlioz ili placebo tijekom daljnjih 8 tjedana kako bi se istražilo koliko se dobro održava djelovanje lijeka Hetlioz.
English: 20% of patients who received Hetlioz (8 out of 40) were able to adjust to the 24-hour clock after 1 months of treatment, compared with around 3% of patients on placebo (1 out of 38).
Croatian: 20% bolesnika koji su primili lijek Hetlioz (8 od 40) bilo je u stanju prilagoditi 24satni ciklus tijekom 1 mjeseca terapije u usporedbi s otprilike 30% bolesnika koji su uzimali placebo (1 od 38).
English: For practical information about using Hetlioz, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Hetlioz bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Hetlioz contains the active substance tasimelteon.
Croatian: Hetlioz sadrži djelatnu tvar tasimelteon.
English: Because the number of patients with non-24-hour sleep-wake disorder is low, the disease is considered ‘rare', and Hetlioz was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2011.
Croatian: Budući da je broj bolesnika s poremećajem cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata nizak, ta se bolest smatra „rijetkom” te je lijek Hetlioz 23. veljače 2011. uvršten u skupinu lijekova za rijetke bolesti.
English: The first study, which involved a total of 84 totally blind patients with non-24-hour sleep-wake disorder, compared Hetlioz with placebo (a dummy treatment).
Croatian: Prvo ispitivanje, koje je obuhvatilo ukupno 84 slijepih osoba s poremećajem cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata, usporedilo je Hetlioz s palcebom (prividnim liječenjem).
English: What benefits of Hetlioz have been shown in studies?
Croatian: Koje su koristi lijeka Hetlioz utvrđene u ispitivanjima?
English: How is Hetlioz used?
Croatian: Kako se Hetlioz koristi?
English: Hetlioz is a medicine used to treat totally blind adults with non-24-hour sleep-wake disorder.
Croatian: Hetlioz je lijek koji se koristi za liječenje potpuno slijepih odraslih osoba s poremećajem (dnevnog) cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata.
English: For the full list of all side effects and restrictions with Hetlioz, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Hetlioz potražite u uputi o lijeku.
English: How does Hetlioz work?
Croatian: Kako djeluje Hetlioz?
English: Hetlioz has been shown to be effective at helping patients adjust to the standard 24-hour clock in 2 main studies.
Croatian: U dva glavna ispitivanja utvrđena je učinkovitost lijeka Hetlioz pri pomaganju bolesnicima da se prilagode 24-satnom ciklusu.
English: ATCvet code: QJ01DD91.
Croatian: ATCvet kod: QJ01DD91.
English: (2003 survey)
Croatian: (ispitivanje 2003.)
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Croatian: Nositelj ovog odobrenja za stavljanje u promet mora obavijestiti Europsku komisiju o planovima za stavljanje u promet medicinskog proizvoda odobrenog ovom odlukom.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
English: Allergic reactions to these substances may occasionally be serious.
Croatian: Alergijske reakcije na te tvari ponekad mogu biti ozbiljne.
English: Treated animals should not be used for breeding for 12 weeks after the last administration.
Croatian: Liječene životinje ne bi trebalo upotrebljavati za rasplod 12 tjedana nakon posljednje primjene.
English: In the event of contact, wash skin with soap and water.
Croatian: Ako dođe do kontakta, operite kožu sapunom i vodom.
English: Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Croatian: Oticanje lica, usnica ili očiju ili teškoće pri disanju ozbiljniji su simptomi i zahtijevaju hitnu medicinsku pomoć.
English: Elimination half-life is long - approximately 6.9 days.
Croatian: Poluživot eliminacije je dugačak - približno 6,9 dana.
English: Elimination half-life is long - approximately 5.5 days.
Croatian: Poluživot eliminacije je dugačak - približno 5,5 dana.
English: Store in the original package in order to protect from light (before and after reconstitution).
Croatian: Čuvati u originalnom pakovanju radi zaštite od svjetla (prije i nakon rekonstitucije).
English: The antimicrobial activity of Convenia following a single injection lasts for up to 14 days.
Croatian: Antimikrobna aktivnost Convenije nakon jedne injekcije traje do 14 dana.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko-medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
English: To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Croatian: Da bi se osigurala pravilna doza, tjelesnu težinu treba utvrditi što preciznije kako bi se izbjeglo poddoziranje.
English: 1348 Louvain-la-Neuve BELGIUM
Croatian: 1348 Louvain-la-Neuve
English: Store in the original package in order to protect from light.
Croatian: Čuvati u originalnom pakovanju radi zaštite od svjetla.
English: Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
Croatian: Ne rukujte ovim proizvodom ako znate da ste preosjetljivi ili ako vam je savjetovano da ne radite s takvim pripravcima.
English: Do not use in dogs and cats less than 8 weeks old.
Croatian: Ne primjenjivati na psima i mačkama mlađim od 8 tjedana.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 3 godine.
English: Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Croatian: Primjenu proizvoda treba temeljiti na testiranju osjetljivosti, a u obzir treba uzeti i službenu te lokalnu antimikrobnu politiku.
English: EXP: {mm/yyyy}
Croatian: EXP: {mm/gggg}
English: Dogs and cats.
Croatian: Psi i mačke.
English: However, if stored as recommended, potency is not affected.
Croatian: Međutim, ako se čuva prema uputi, potentnost neće biti narušena.
English: ADVICE ON CORRECT ADMINISTRATION
Croatian: SAVJETI ZA ISPRAVNU PRIMJENU
English: Shake the vial until the powder is seen to have fully dissolved.
Croatian: Tresite bočicu dok se prašak potpuno ne otopi.
English: Veterinarians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Croatian: Veterinari bi trebali biti svjesni da se simptomi alergije mogu javiti ponovo nakon prekida simptomatske terapije.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Cefovecin is primarily eliminated unchanged via the kidneys.
Croatian: Cefovecin se primarno eliminira nepromijenjen putem bubrega.
English: 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.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: Periodontal isolates were collected during a European (France and Belgium) clinical efficacy and safety field study (2008).
Croatian: Periodontalni izolati prikupljeni su tijekom terenske studije kliničke djelotvornosti i neškodljivosti provedene u Europi (u Francuskoj i Belgiji 2008.).
English: As with other cephalosporins, the colour of the reconstituted solution may darken during this period.
Croatian: Kao i kod ostalih cefalosporina, tijekom tog razdoblja boja rekonstituirane otopine može potamniti.
English: The safety of Convenia in dogs and cats has not been established during pregnancy and lactation.
Croatian: Neškodljivost Convenije u pasa i mačaka nije utvrđena tijekom graviditeta i laktacije.
English: For use only for the following infections requiring prolonged treatment.
Croatian: Za primjenu samo za sljedeće infekcije koje zahtijevaju produljeno liječenje.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: It is, therefore, advisable to determine the underlying cause and to treat the animal accordingly.
Croatian: Stoga je preporučljivo utvrditi primarne uzročnike i liječiti životinju shodno tome.
English: If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning.
Croatian: Ako nakon izlaganja razvijete simptome, na primjer osip na koži, potražite savjet liječnika i pokažite mu ovo upozorenje.
English: The fundamental requirement of the treatment of periodontal disease is mechanical and/or surgical intervention by the veterinarian.
Croatian: Temeljni uvjet pri liječenju periodontalnih bolesti je mehanička i/ili kirurška intervencija veterinara.
English: If required, an additional dose may be administered 14 days after the first injection.
Croatian: Ako je to potrebno, jedna dodatna doza može se primijeniti 14 dana nakon prve injekcije.
English: If you know you are allergic to penicillins or cephalosporins, avoid contact with contaminated litter.
Croatian: Ako znate da ste alergični na peniciline ili cefalosporine, izbjegavajte kontakt sa kontaminiranim otpadom.
English: If required, treatment may be repeated at 14 day intervals up to a further three times.
Croatian: Ako je to potrebno, terapija se može ponoviti još tri puta u intervalima od 14 dana.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Croatian: Čuvati u hladnjaku.
English: Resistance may be chromosomal or plasmid-encoded and may be transferred if associated with transposons or plasmids.
Croatian: Otpornost može biti kodirana u kromosomima ili plazmidima i može se prenositi ako je povezana s transposonima ili plazmidima.
English: INDICATION(S) For certain skin, soft tissue, urinary tract and severe periodontal infections.
Croatian: INDIKACIJA(E) Za određene infekcije kože, mekog tkiva, urinarnog trakta i teške periodontalne infekcije.
English: A single subcutaneous injection.
Croatian: Pojedinačna subkutana injekcija.
English: A single administration of 22.5 times the recommended dose caused transient oedema and discomfort at the injection site.
Croatian: Pojedinačna primjena 22,5 puta veće doze od preporučene uzrokovala je prolazni edem i nelagodu na mjestu ubrizgavanja.
English: In accordance with good veterinary practice, treatment of pyoderma should be extended beyond complete resolution of clinical signs.
Croatian: U skladu s dobrom veterinarskom praksom, liječenje pioderme trebalo bi potrajati i nakon potpunog povlačenja kliničkih znakova.
English: Slight and transient injection site swellings were observed after the first and second administration.
Croatian: Lagano i prolazno oticanje na mjestu ubrizgavanja uočeno je nakon prve i druge primjene.
English: Before reconstitution:
Croatian: Prije rekonstitucije:
English: 1 Lowest concentration, which completely inhibits visible growth of at least 50 % of isolates 2 Lowest concentration, which completely inhibits visible growth of at least 90 % of isolates 3 Some of these pathogens (e.g. S. aureus) exhibited natural in vitro resistance to cefovecin 4 The clinical significance of these in vitro data has not been demonstrated.
Croatian: 1 Najniža koncentracija, koja potpuno inhibira vidljiv rast najmanje 50% izolata 2 Najniža koncentracija, koja potpuno inhibira vidljiv rast najmanje 90% izolata 3 Neki od tih patogena (npr. S. aureus) pokazali su prirodnu in vitro otpornost na cefovecin 4 Klinički značaj tih in vitro podataka nije demonstriran.
English: Plasma protein binding is high (more than 99 %) and the volume of distribution is low (0.09 l/kg).
Croatian: Vezanje proteina u plazmi je visoko (više od 99%), a volumen distribucije je nizak (0,09 l/kg).
English: 4.4 Special warnings for each target species
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja
English: were 2.3 %, 2.7 %, 3.1 % and 1.4 %,
Croatian: i Proteus spp. bio je 2,3%, 2,7%, 3,1%, odnosno 1,4%.
English: Dogs:
Croatian: Psi:
English: STATEMENT OF THE MRLs
Croatian: IZVJEŠĆE O MRL
English: Plasma protein binding is high (96.0 % to 98.7 %) and the volume of distribution is low (0.1 l/kg).
Croatian: Vezanje proteina u plazmi je visoko (96,0% do 98,7%), a volumen distribucije je nizak (0,1 l/kg).
English: Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa.
Croatian: Preosjetljivost na peniciline može dovesti do križne osjetljivosti na cefalosporine i obrnuto.
English: 4.1 Target species
Croatian: 4.1 Ciljne vrste životinja
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injection
Croatian: Natrijev hidroksid (za prilagođavanje pH) Klorovodična kiselina (za prilagođavanje pH)
English: Porphyromonas gingivalis and Prevotella intermedia collected from canine periodontal disease were also shown to be susceptible.
Croatian: Porphyromonas gingivalis i Prevotella intermedia prikupljene s psećih periodontalnih oboljenja također su se pokazali osjetljivima.
English: Cefovecin is a third generation cephalosporin with a broad-spectrum of activity against Gram-positive and Gram-negative bacteria.
Croatian: Cefovecin je cefalosporin treće generacije sa širokim spektrom djelovanja na gram-pozitivne i gramnegativne bakterije.
English: Handle this product with care to avoid exposure, taking all recommended precautions.
Croatian: Da biste izbjegli izlaganje, oprezno rukujte ovim proizvodom, poduzimajući sve preporučene mjere opreza.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobivenih primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: No. of Isolates cefovecin MIC (µg/ml)
Croatian: Cefovecin MIC (µg/ml)
English: Max MIC50
Croatian: MIC50
English: Following repeated administrations at the recommended dose, elevated concentrations of cefovecin were observed in plasma.
Croatian: Nakon ponovljenih primjena u preporučenoj dozi u plazmi su uočene povišene koncentracije cefovecina.
English: The powder is off-white to yellow and the diluent (solvent) is a clear, colourless liquid.
Croatian: Prašak je prljavo bijele do žute boje, a razrjeđivač (otapalo) je bistra, bezbojna tekućina.
English: It differs from other cephalosporins in that it is highly protein bound and has a long duration of activity.
Croatian: Razlikuje se od drugih cefalosporina po tome što je visoko vezan na bjelančevine i ima dugotrajno djelovanje.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE ILI PRIMJENE
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2006
Croatian: Datum prvog odobrenja : 19/06/2006 Datum posljednjeg produljenja odobrenja : 15/06/2011
English: CLINICAL PARTICULARS
Croatian: KLINIČKE POJEDINOSTI