FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II.
Croatian: Benazeprilat je visoko potentan i selektivni inhibitor angiotenzin-konvertirajućeg enzima (ACE) i tako sprječava konverziju inaktivnog angiotenzina
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine koje se primjenjuju i način primjene
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Ceva Santé Animale 10, av. de la Ballastière 33500 Libourne France
Croatian: Ceva Santé Animale 10, av. de la Ballastiere 33500 Libourne Francuska
English: At steady state, mean Cmax of 324 μg/l and 66 μg/l are achieved for the primary metabolites, 7-α-thiomethyl-spironolactone and canrenone, 2 and 4 hours post-dosing, respectively.
Croatian: U ravnotežnom stanju, prosječne Cmax od 324 i 66 µg postižu se za primarne metabolite, 7-alfa-tiometil-spironolaktona i kanrenona, 2 odnosno 4 sata nakon doziranja.
English: As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and a combination of benazepril (hydrochloride) and spironolactone.
Croatian: S obzirom da je terapijski indeks digoksina vrlo uzak savjetuje se pomni nadzor pasa koji primaju digoksin i kombinaciju benazepril (hidroklorida) i spironolaktona.
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France
Croatian: Ceva Santé Animale 10 av. de La Ballastiere 33500 Libourne Francuska
English: 80 mg The tablets are brown coloured, palatable, oblong shaped with a score line and chewable.
Croatian: Tablete su smeđe boje, s umjetnim okusom, duguljastog oblika s razdjelnom linijom i namijenjene žvakanju.
English: After multiple oral doses of 2 mg spironolactone per kg (with 0.25 mg benazepril hydrochloride per kg) for 7 consecutive days, no accumulation is observed.
Croatian: Nakon višestrukih peroralnih doza od 2 mg spironolaktona po kg (s 0,25 mg benazepril hidroklorida po kg) tijekom 7 uzastopnih dana, nije uočena akumulacija.
English: CLINICAL PARTICULARS 4.1 Target species
Croatian: 4.1 Ciljne vrsta životinja
English: As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and a combination of benazepril hydrochloride and spironolactone.
Croatian: S obzirom da je terapijski indeks digoksina vrlo uzak savjetuje se da pomni nadzor pasa koji primaju digoksin i kombinaciju benazepril hidroklorida i spironolaktona.
English: Strength and number of tablets to be administered: Cardalis 2.5 mg/20 mg chewable tablets
Croatian: Jačina i broj tableta koje treba primijeniti: Cardalis 2,5 mg/20 mg tablete za žvakanje
English: The plasma clearances of canrenone and 7-αthiomethyl-spironolactone are 1.5 l/h/kg bw and 0.9 l/h/kg bw respectively.
Croatian: Plazmatski klirens kanrenona i 7-alfatiometil-spironolakton iznose 1,5 l/h/kg tjelesne težine odnosno 0,9 l/h/kg tjelesne težine.
English: Each chewable tablet contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta za žvakanje sadrži:
English: Cardalis chewable tablets should be administered to the dog once a day at a dosage of 0.25 mg/kg bodyweight benazepril hydrochloride (HCl) and 2 mg/kg bodyweight (bw) spironolactone, according to the following dosage table.
Croatian: Cardalis tablete za žvakanje treba davati psu jednom dnevno, u dozi od 0,25 mg/kg tjelesne težine benazepril hidroklorida (HCl) i 2 mg/kg tjelesne težine (bw) spironolaktona u skladu sa sljedećom tablicom doziranja.
English: A slight increase in aldosterone blood levels may be observed in animals on treatment.
Croatian: U životinja koje primaju ovaj lijek može se uočiti blagi porast razine aldosterona u krvi.
English: After multiple oral doses of 0.25 mg benazepril hydrochloride per kg (with 2 mg spironolactone per kg) for 7 consecutive days, a peak benazeprilat concentration (Cmax of 52.4 ng/ml) is achieved with a Tmax of 1.4 h.
Croatian: Nakon višestrukih peroralnih doza od 0,25 mg benazepril hidroklorida po kg (s 2 mg spironolaktona po kg) tijekom 7 uzastopnih dana vršne koncentracije benazeprilata (Cmax od 52,4 ng/ml) postižu se uz Tmax od 1,4 sata.
English: Pharmacodynamic properties
Croatian: Farmakodinamička svojstva
English: Benazepril, by preventing the formation of Angiotensin-II, inhibits the detrimental effects of vasoconstriction and stimulation of aldosterone release.
Croatian: Benazepril inhibira štetne učinke vazokonstrikcije i stimulacije otpuštanja aldosterona sprječavanjem nastanka angiotenzina II.
English: Kidney function and serum potassium levels should be evaluated before initiating the treatment with benazepril (hydrochloride) and spironolactone, especially in dogs which may suffer hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Croatian: Prije početka liječenja benazeprilom (hidrokloridom) i spironolaktonom treba procijeniti serumske razine kalija i funkciju bubrega, posebice u pasa koji mogu patiti od hipoadrenokorticizma, hiperkalijemije ili hiponatrijemije.
English: Kidney function and serum potassium levels should be evaluated before initiating the treatment with benazepril and spironolactone, especially in dogs which may suffer hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Croatian: Prije početka liječenja benazeprilom i spironolaktonom treba procijeniti serumske razine kalija, posebice u pasa koji mogu patiti od hipoadrenokorticizma, hiperkalijemije ili hiponatrijemije.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 30 tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Boca od 30 tableta
English: Do not administer in conjunction with Non Steroidal Anti-Inflammatory Drugs (NSAIDs) to dogs with renal insufficiency.
Croatian: Ne primjenjivati u kombinaciji s nesteroidnim protuupalnim lijekovima (NSAIDs) psima s oštećenom funkcijom bubrega.
English: There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.In a field study conducted in dogs with chronic degenerative valvular disease 85.9% of dogs showed good compliance with treatment (≥ 90% of prescribed tablets successfully administered) over a three month period.
Croatian: U terenskom ispitivanju provedenom na psima s kroničnom degenerativnom bolesti zalistaka 85,9% pasa pokazalo je dobru suradljivost (≥90% propisanih tableta uspješno je primijenjeno) tijekom razdoblja od tri mjeseca.
English: Name and address of the manufacturers responsible for batch release
Croatian: Ime i adresa proizvođača odgovornog za puštanje serije u promet
English: The concomitant administration of this veterinary medicinal product with other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may potentially lead to additive hypotensive effects.
Croatian: Istovremena primjena ovog veterinarsko-medicinskog proizvoda s drugim antihipertenzivima (primjerice s blokatorima kalcijevih kanala, alfa-blokatorima ili diureticima), anesteticima ili sedativima može uzrokovati dodatne hipotenzivne učinke.
English: After coadministration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-lives (t½) were 7 hours and 6 hours for canrenone and 7-α-thiomethylspironolactone respectively.
Croatian: Nakon istovremene primjene spironolaktona (2 mg/kg tjelesne težine) i benazepril hidroklorida (0,25 mg/kg tjelesne težine), terminalni poluživoti u plazmi (t½) iznosili su 7 odnosno 6 sati za kanrenon i 7-alfa-tiometilspironolakton.
English: Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril with laboratory animals (rats) at maternally non-toxic doses.
Croatian: Embriotoksični učinci (malformacije urinarnog trakta fetusa) uočene su u ispitivanjima benazeprila kod laboratorijskih životinja (štakora) pri netoksičnim dozama danim majci.
English: Benazeprilat is excreted via the biliary and the urinary route in dogs.
Croatian: Benazeprilat se u pasa izlučuje putem žuči i urina.
English: The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section "Special precautions for use in animals").
Croatian: Istovremena primjena ovog veterinarsko-medicinskog proizvoda s drugim terapijama koje štede kalij (poput ß-blokatora, blokatora kalcijevih kanala, blokatora angiotenzinskih receptora) može uzrokovati hiperkalijemiju (vidjeti dio „Posebne mjere predostrožnosti za primjenu na životinjama”).
English: Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril (as hydrochloride) with laboratory animals (rats) at maternally nontoxic doses.
Croatian: Embriotoksični učinci (malformacije urinarnog trakta fetusa) uočene su u ispitivanjima benazeprila (u obliku hidroklorida) kod laboratorijskih životinja (štakora) pri netoksičnim dozama danim majci.
English: benazepril HCl 2.5 mg, spironolactone 20 mg benazepril HCl 5 mg, spironolactone 40 mg benazepril HCl 10 mg, spironolactone 80 mg
Croatian: SASTAV DJELATNIH TVARI benazepril HCl 2,5 mg, spironolakton 20 mg benazepril HCl 5 mg, spironolakton 40 mg benazepril
English: The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section 4.5).
Croatian: Istovremena primjena ovog veterinarsko-medicinskog proizvoda s drugim terapijama koje štede kalij (poput alfa-blokatora, blokatora kalcijevih kanala, blokatora angiotenzinskih receptora) može uzrokovati hiperkalijemiju (vidjeti dio 4.5).
English: Special precautions for storage
Croatian: Posebne mjere pri čuvanju
English: Daily overdoses to healthy dogs, i.e. 6 times (1.5 mg/kg bw benazepril hydrochloride, 12 mg/kg bw spironolactone) and 10 times (2.5 mg/kg bw benazepril hydrochloride, 20 mg/kg bw spironolactone) the recommended dose, led to a slight dose related decrease in red cell mass.
Croatian: Dnevno predoziranje kod zdravih pasa, primjerice doza 6 puta (1,5 mg/kg tjelesne težine benazepril hidroklorida, 12 mg/kg tjelesne težine spironolaktona) i 10 puta (2,5 mg/kg tjelesne težine benazepril hidroklorida, 20 mg/kg tjelesne težine spironolaktona) veća od preporučene doze uzrokovala je blagi pad mase eritrocita povezan s dozom.
English: After co-administration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-life of benazeprilat (t½) was 18 hours.
Croatian: Nakon istovremene primjene spironolaktona (2 mg/kg tjelesne težine) i benazepril hidroklorida (0,25 mg/kg tjelesne težine) terminalni poluživot u plazmi benazeprilata (t½) iznosio je 18 sati.
English: After administration of up to 10 times the recommended dose (2.5 mg/kg bw benazepril hydrochloride, 20 mg/kg bw spironolactone) to healthy dogs, dose dependant adverse effects were noted (see section 4.6).
Croatian: Nakon primjene 10 puta veće doze od preporučene (2,5 mg/kg tjelesne težine benazepril hidroklorida, 20 mg/kg spironolaktona) zdravim psima, uočene su nuspojave ovisne o dozi, (vidjeti dio 4.6).
English: Cardalis 2.5 mg/20 mg tablets
Croatian: Cardalis 2,5 mg/20 mg tablete
English: Spironolactone
Croatian: Krospovidon
English: Brown palatable oblong shaped chewable tablets with a score line.
Croatian: Smeđe, duguljaste tablete za žvakanje umjetnim okusom s jednom razdjelnom crtom.
English: Chewable tablet
Croatian: OBLIK Tableta za žvakanje
English: Cardalis 5 mg/40 mg tablets
Croatian: Cardalis 5 mg/40 mg tablete
English: After administration of up to 10 times the recommended dose (2.5 mg/kg bw benazepril hydrochloride, 20 mg/kg spironolactone) to healthy dogs, dose dependent adverse effects were noted, see section "Adverse reactions".
Croatian: Nakon primjene 10 puta veće doze od preporučene (2,5 mg/kg tjelesne težine benazepril hidroklorida, 20 mg/kg spironolaktona) zdravim psima, uočene su nuspojave ovisne o dozi, (vidjeti dio „Nuspojave“).
English: Cardalis 10 mg/80 mg tablets
Croatian: Cardalis 10 mg/80 mg tablete
English: SPECIAL WARNING(S), IF NECESSARY
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs
Croatian: UPUTA O VMP Cardalis 2,5 mg/20 mg tablete za žvakanje za pse Cardalis 5 mg/40 mg tablete za žvakanje za pse Cardalis 10 mg/80 mg tablete za žvakanje za pse
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Benazepril hydrochloride 2.5 mg, spironolactone 20 mg Cardalis 5 mg/40 mg chewable tablets for dogs Benazepril hydrochloride 5 mg, spironolactone 40 mg Cardalis 10 mg/80 mg chewable tablets for dogs Benazepril hydrochloride 10 mg, spironolactone 80 mg
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Cardalis 2,5 mg/20 mg tablete za žvakanje za pse benazepril HCl 2,5 mg, spironolakton 20 mg Cardalis 5 mg/40 mg tablete za žvakanje za pse benazepril HCl 5 mg, spironolakton 40 mg Cardalis 10 mg/80 mg tablete za žvakanje za pse benazepril
English: Cardalis 10 mg/80 mg chewable tablets
Croatian: Cardalis 10 mg/80 mg tableta za žvakanje
English: Cardalis 5 mg/40 mg chewable tablets
Croatian: Cardalis 5 mg/40 mg tablete za žvakanje
English: C. STATEMENT OF THE MRLs
Croatian: C. IZVJEŠĆE O MRL Nije primjenjivo.
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs benazepril HCl/spironolactone
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Cardalis 2,5 mg/20 mg tablete za žvakanje za pse Cardalis 5 mg/40 mg tablete za žvakanje za pse Cardalis 10 mg/80 mg tablete za žvakanje za pse benazepril HCl/spironolakton
English: Veterinary medicinal product subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
English: Excipients:
Croatian: NUSPOJAVE
English: Stelara is a medicine used to treat the following diseases:
Croatian: Stelara je lijek koji se koristi za liječenje sljedećih bolesti:
English: The first injection is followed by a further injection four weeks later, and then an injection every 12 weeks.
Croatian: Nakon prve injekcije slijedi još jedna injekcija četiri tjedna kasnije, a nakon toga po jedna injekcija svakih 12 tjedana.
English: What is Stelara and what is it used for?
Croatian: Što je Stelara i za što se koristi?
English: The infusion lasts at least one hour and the dose depends on the patient's bodyweight.
Croatian: Infuzija traje najmanje jedan sat, a doza ovisi o bolesnikovoj tjelesnoj težini.
English: Most of these effects were considered mild and did not require treatment to be stopped.
Croatian: Većina tih nuspojava smatrala se blagima i nije bilo potrebno liječenje da bi se zaustavile.
English: However, patients in some studies had unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression which might be related to Stelara.
Croatian: No, bolesnici u nekim ispitivanjima pokazali su neočekivano povećanje tegoba sa srcem i krvnim žilama i psihijatrijskih problema poput depresije koji mogu biti povezani s lijekom Stelara.
English: The company that makes Stelara will also provide educational material for healthcare providers and patients.
Croatian: Tvrtka koja proizvodi lijek Stelara dostavit će edukacijske materijale za pružatelje zdravstvene skrbi i za bolesnike.
English: For adults the usual dose is 45 mg, whereas the dose in children depends on bodyweight.
Croatian: Za odrasle osobe uobičajena doza je 45 mg, dok u djece ona ovisi o tjelesnoj težini.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stelara on 16 January 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Stelara na snazi u Europskoj uniji od 16. siječnja 2009.
English: What measures are being taken to ensure the safe and effective use of Stelara?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Stelara?
English: This is a summary of the European public assessment report (EPAR) for Stelara.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Stelara.
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Croatian: Monoklonsko protutijelo je vrsta bjelančevine koja je osmišljena za prepoznavanje i vezivanje na specifičnu strukturu (zvanu antigen) u tijelu.
English: What are the risks associated with Stelara?
Croatian: Koji su rizici povezani s lijekom Stelara?
English: The longer-term results showed that with continuous treatment, the response to Stelara is maintained over 5 years.
Croatian: Dugoročni su rezultati pokazali da se kontinuiranom terapijom odgovor na lijek Stelara zadržava tijekom 5 godina.
English: Stelara must not be used in patients who have an active infection that the doctor considers important.
Croatian: Lijek Stelara ne smije se primjenjivati u bolesnika koji imaju aktivnu infekciju koju liječnik smatra ozbiljnom.
English: Eight weeks after the first infusion patients should receive 90 mg Stelara by injection under the skin.
Croatian: Osam tjedana nakon prve infuzije bolesnici trebaju primiti 90 mg lijeka Stelara injekcijom pod kožu.
English: These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Croatian: Oni će biti usmjereni na sigurnost lijeka Stelara, posebice na rizike od pojave tuberkuloze, ostalih infekcija i zloćudnih bolesti.
English: Stelara was more effective than placebo at improving the symptoms of plaque psoriasis.
Croatian: Lijek Stelara bio je djelotvorniji od placeba pri ublažavanju simptoma plak psorijaze.
English: Stelara is available as a solution for injection (45 and 90 mg) in vials or prefilled syringes and as a concentrate (130 mg) to make a solution for infusion (drip) into a vein.
Croatian: Stelara je dostupna kao otopina za injekciju (45 i 90 mg) u bočicama ili napunjenim štrcaljkama te kao koncentrat (130 mg) za otopinu za infuziju (drip) u venu.
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet light.
Croatian: PUVA je vrsta liječenja pri kojem bolesnik prima lijek koji sadrži spoj naziva „psoralen” prije izlaganja ultraljubičastom zračenju.
English: Why is Stelara approved?
Croatian: Zašto je lijek Stelara odobren?
English: EPAR summary for the public
Croatian: EPAR, sažetak za javnost ustekinumab
English: The most serious side effect reported with Stelara is serious hypersensitivity (allergic reaction).
Croatian: Najozbiljnija nuspojava prijavljena prilikom primjene lijeka Stelara jest ozbiljna preosjetljivost (alergijska reakcija).
English: Some of the patients from the two main studies went on to receive Stelara (injection under the skin) every 8 or 12 weeks, or placebo.
Croatian: Neki bolesnici iz dvaju glavnih ispitivanja nastavili su primati lijek Stelara (injekcijom pod kožu) svakih 8 ili 12 tjedana, a neki placebo.
English: By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Croatian: Inhibirajući njihovo djelovanje ustekinumab smanjuje djelovanje imunosnog sustava i ublažava simptome bolesti.
English: Stelara can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Stelara is used for.
Croatian: Stelara se izdaje samo na recept, a smije se primjenjivati samo pod nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju bolesti za koja se Stelara koristi.
English: It is used in adults and children above the age of 12 years whose condition has not responded to or who cannot use other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A).
Croatian: Koristi se u odraslih i djece starije od 12 godina koji nisu reagirali ili ne podnose druge sustavne terapije (za cijelo tijelo) za psorijazu, uključujući ciklosporin, metotreksate ili PUVA (psoralen i UVA zračenje).
English: Other information about Stelara
Croatian: Ostale informacije o lijeku Stelara
English: Patients weighing over 100 kg should be given Stelara in 90-mg doses for psoriasis, and this should also be considered for psoriatic arthritis.
Croatian: Bolesnici koji teže više od 100 kg trebaju primati lijek Stelara u dozama od 90 mg za psorijazu, a isto se preporuča i za psorijatični artritis.
English: In plaque psoriasis and psoriatic arthritis, Stelara is given as an injection under the skin.
Croatian: U slučaju plak psorijaze i psorijatičnog artritisa Stelara se daje kao injekcija pod kožu.
English: The comparative study showed that Stelara is more effective than etanercept after 12 weeks of treatment.
Croatian: Komparativno ispitivanje pokazalo je da je lijek Stelara djelotvorniji od etanercepta nakon 12 tjedana terapije.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su „odgovorili” na terapiju nakon 12 tjedana, što je značilo da su se rezultati simptoma poboljšali 75 % ili više.
English: The company subsequently provided the longer-term results of the studies (after 5 years of treatment), and the results of a study comparing Stelara with etanercept (another medicine for psoriasis).
Croatian: Proizvođač je naknadno dostavio određene dugoročnije rezultate ispitivanja (nakon 5-godišnje terapije), kao i rezultate ispitivanja u kojima je lijek Stelara uspoređen s etanerceptom (drugim lijekom za psorijazu).
English: Patients then continue with Stelara given under the skin every 8 or 12 weeks depending on response to treatment.
Croatian: Nakon toga bolesnicima se nastavlja davati lijek Stelara pod kožu svakih 8 ili 12 tjedana, ovisno o njihovu odgovoru na terapiju.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Stelara'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 Stelara nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The most common side effects with Stelara (seen in more than 5% of patients during clinical trials) are headache and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće nuspojave zabilježene pri primjeni lijeka Stelara (zabilježene u više od 5 % bolesnika tijekom kliničkih ispitivanja) jesu glavobolja i nazofaringitis (upala nosa i grla).
English: Stelara may be used alone or combined with methotrexate (a DMARD);
Croatian: Stelara se može koristiti kao monoterapija ili u kombinaciji s metotreksatom (DMARD).
English: In Crohn's disease, treatment is started with Stelara concentrate.
Croatian: Kod Crohnove bolesti terapija započinje koncentratom lijeka Stelara.
English: In the second study the figures were 56% for Stelara and 29% for placebo.
Croatian: U drugom ispitivanju te su vrijednosti iznosile 56 % za lijek Stelara i 29 % za placebo.