FrancophonIA/ELRC3.0 huggingface dataset:
English: A severe inflammation at the back of the eye (usually due to viral infection), serious infection or inflammation inside the eye*, glaucoma (an eye disease in which increased pressure in the eye is associated with damage to the optic nerve), detachment of the light-sensitive layer from the back of the eye* (retinal detachment), tear of the light-sensitive layer at the back of the eye (retinal tear)*, a decrease in the eye pressure which is associated with leakage of the jelly (vitreous) from inside the eye*, inflammation inside the front part of the eye*, increased protein and cells in the front of the eye due to inflammation*,
Croatian: Jaka upala stražnjeg dijela oka (obično zbog virusne infekcije), ozbiljne infekcije ili upale u unutrašnjosti oka*, glaukom (bolest oka kod koje je povišen očni tlak povezan s oštećenjem očnog živca), odvajanje na svjetlo osjetljivog sloja u stražnjem dijelu oka (odvajanje mrežnice)*puknuće na svjetlo osjetljivog sloja u stražnjem dijelu oka (ruptura mrežnice)*, smanjenje očnog tlaka povezano s curenjem staklovine iz oka*, upala u prednjem dijelu oka*, porast količine bjelančevina i stanica u prednjem dijelu oka zbog upale*, neobičan osjećaj u oku*,
English: A total of 427 were randomised to OZURDEX, 414 to dexamethasone 350 µg and 426 patients to sham.
Croatian: Ukupno 427 bolesnika slučajnim je odabirom liječeno lijekom OZURDEX, 414 deksametazonom od 350 µg i 426 bolesnika placebo postupkom.
English: At baseline 3% of patients required IOP-lowering medication(s).
Croatian: Na početku ispitivanja 3% bolesnika zahtijevalo je lijek(ove) za snižavanje IOT-a.
English: • What are the steps following treatment with OZURDEX
Croatian: • Što slijedi nakon liječenja lijekom OZURDEX
English: Elevations of IOP either did not require treatment or were managed with the temporary use of topical IOP-lowering medicinal products.
Croatian: Povišeni očni tlak nije trebalo liječiti ili je liječen privremenom uporabom topikalnih lijekova koji snižavaju očni tlak.
English: Paediatric population There is no relevant use of OZURDEX in the paediatric population in
Croatian: Nema bitne indikacije za primjenu lijeka OZURDEX u pedijatrijskoj populaciji u slučaju
English: 59% of patients with a phakic study eye required cataract surgery by the 3 year final visit, with the majority performed in the 2nd and 3rd years.
Croatian: Na završnom pregledu nakon trogodišnjeg ispitivanja u 59% bolesnika utvrđena je potrebna operacija katarakte na fakičnom ispitivanom oku, a većina tih operacija obavljena je u 2. i 3. godini.
English: Week 12
Croatian: Tjedan 12
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see SmPC section 5.1)
Croatian: • makularnim edemom nakon okluzije grane mrežnične vene (Branch Retinal Vein Occlusion (BRVO) ili okluzije središnje mrežnične vene (Central Retinal Vein Occlusion (CRVO) (vidjeti dio 5.1 sažetka opisa svojstava lijeka)
English: ** in a 24-month real world observational study in the treatment of macular oedema following RVO and noninfectious uveitis affecting the posterior segment of the eye these adverse events were reported more frequently among patients who received >2 injections vs patients who received ≤2 injections; cataract formation (24.7% vs
Croatian: ** u 24-mjesečnom opservacijskom ispitivanju, u stvarnom životu, liječenja makularnog edema nakon RVO i neinfektivnog uveitisa stražnjeg segmenta oka ove su nuspojave prijavljivane češće u bolesnika koji su primili >2
English: Slowly press the actuator button until an audible click is noted.
Croatian: Polako pritišćite gumb za aktivaciju dok ne čujete jasan zvuk „klik“.
English: Of these, a total of 77 were randomised to receive OZURDEX, 76 to dexamethasone 350 µg and 76 to sham.
Croatian: Od ovih bolesnika, ukupno 77 bolesnika slučajnim je odabirom liječeno lijekom OZURDEX, 76 deksametazonom od 350 µg i 76 bolesnika placebo postupkom.
English: Necrotizing retinitis, endophthalmitis*, glaucoma, retinal detachment*, retinal tear*, hypotony of the eye*, anterior chamber inflammation*, anterior chamber cells/ flares*, abnormal sensation in eye*, eyelids pruritus, scleral hyperaemia*
Croatian: Nekrotizirajući retinitis, endoftalmitis*, glaukom, odvajanje mrežnice*, ruptura mrežnice*, hipotonija oka*, upala prednje komore*, stanice u prednjoj komori/ bljeskovi*, neuobičajen osjet u oku*, svrbež očnih kapaka, skleralna hiperemija*
English: How to store OZURDEX
Croatian: Kako primjenjivati OZURDEX
English: Proportion of patients with vitreous haze score of zero and ≥ 15 letters improvement from baseline best corrected visual acuity in the study eye (ITT population)
Croatian: Udio bolesnika s nultim stupnjem zamućenja staklastog tijela i s poboljšanjem od ≥ 15 slova u odnosu na početne vrijednosti najbolje korigirane oštrine vida (BCVA) u ispitivanom oku (populacija s namjerom liječenja)
English: This inflammation leads to a decrease of vision and/or the presence of floaters in the eye, (black dots or wispy lines that move across the field of vision).
Croatian: („mušica“) u oku (crne točkice ili snopovi crta koje se pomiču po vidnom polju).
English: • How to prepare for OZURDEX treatment
Croatian: • Upute za uporabu • Kako se pripremiti za liječenje lijekom OZURDEX
English: Hepatic impairment
Croatian: Bubrežne bolesti
English: In the 3 year DME clinical studies, at baseline, 87% of patients with a phakic study eye treated with OZURDEX had some degree of lens opacification/ early cataract.
Croatian: U trogodišnjem kliničkom ispitivanju DME, na početku ispitivanja, 87% bolesnika kod kojih je u ispitivano fakično oko apliciran OZURDEX imalo je neki stupanj zamućenja leće/ ranu kataraktu.
English: A total of 351 were randomised to OZURDEX, 347 to dexamethasone 350 µg and 350 patients to sham.
Croatian: Ukupno ih je 351 randomizirano u skupinu koja je primila OZURDEX, 347 deksametazon 350 µg i 350 placebo.
English: Sham N = 350
Croatian: Placebo N = 350
English: - The active substance is dexamethasone.
Croatian: - Djelatna tvar je deksametazon.
English: The primary and key secondary endpoints for studies 206207-010 and 011 are presented in Table 2.
Croatian: Rezultati praćenja primarnih i ključnih sekundarnih ishoda u ispitivanjima 206207-010 i 011 prikazani su u tablici 2. Poboljšanje vida u skupini DEX700 bilo je kompromitirano nastankom katarakte.
English: Sham N = 76
Croatian: Placebo postupak N = 76
English: In the 3 year DME clinical studies, 59% of patients with a phakic study eye treated with OZURDEX underwent cataract surgery in the study eye (see section 4.8).
Croatian: U trogodišnjem kliničkom ispitivanju DME 59% bolesnika kod kojih je ispitivano fakično oko liječeno lijekom OZURDEX podvrgnuto je operaciji katarakte istog oka (vidjeti dio 4.8).
English: The primary and key secondary endpoints for the pooled analysis for patients with any prior treatment are presented in Table 4.
Croatian: Rezultati praćenja primarnih i ključnih sekundarnih ishoda u objedinjenoj analizi bolesnika s bilo kojim prethodnim liječenjem prikazani su u tablici 4. Tablica 4. Učinkovitost u bolesnika s bilo kojim prethodnim liječenjem (objedinjena ispitivanja
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Croatian: Prilikom sistemske i topikalne primjene kortikosteroida mogu se zabilježiti smetnje vida.
English: Device dislocation* (migration of implant) with or without corneal oedema (see also section 4.4), complication of device insertion resulting in ocular tissue injury* (implant misplacement)
Croatian: Dislokacija uređaja* (migracija implantata) s edemom rožnice ili bez njega (vidjeti također dio
English: In the majority of patients who have not yet had an operation for cataract, a clouding of the eye's natural lens (a cataract) may occur after repeated treatment with OZURDEX.
Croatian: U većine bolesnika koji još nisu podvrgnuti operaciji mrene, zamućenje prirodne očne leće (mrena)
English: Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs (see SmPC section 4.4).
Croatian: Potrebno je pratiti bolesnike nakon ubrizgavanja kako bi bilo omogućeno rano liječenje ako dođe do infekcije ili povišenog očnog tlaka (vidjeti dio 4.4 sažetka opisa svojstava lijeka).
English: The OZURDEX applicator is for single use only.
Croatian: Aplikator za lijek OZURDEX namijenjen je samo za jednokratnu uporabu.
English: Based on the pooled analysis results, treatment with OZURDEX implants showed statistically significantly greater incidence of responders, defined as patients achieving a ≥ 15 letter improvement from baseline in Best Corrected Visual Acuity (BCVA) at 90 days following injection of a single implant, when compared with sham (p < 0.001).
Croatian: Na temelju rezultata analize objedinjenih podataka, liječenje implantatima OZURDEX pokazalo je statistički značajno veću incidenciju bolesnika koji su pokazali odgovor na liječenje, što je definirano na način da bolesnici ostvare poboljšanje od ≥ 15 slova u odnosu na početne vrijednosti u najbolje korigiranoj oštrini vida (BCVA, engl.
English: The clinical safety of OZURDEX in patients with macular oedema following central or branch retinal vein occlusion has been assessed in two Phase III randomised, double-masked, sham-controlled studies.
Croatian: Klinička sigurnost lijeka OZURDEX kod bolesnika s makularnim edemom nakon okluzije središnje mrežnične vene ili okluzije grane mrežnične vene procijenjena je u dvije randomizirane, dvostruko maskirane studije faze III kontrolirane placebo postupkom.
English: A total of 77 patients were randomised to receive OZURDEX and 76 to receive Sham.
Croatian: Ukupno 77 bolesnika odabranih slučajnim odabirom primalo je OZURDEX, a 76 primalo je placebo postupak.
English: OCT retinal thickness at center subfield mean average change over 3 years, AUC approach (µm) P-value
Croatian: Srednja vrijednost prosječne promjene OCT nalaza zadebljanja mrežnice u središnjem polju kroz 3 godine, AUC pristup (µm) P-vrijednost
English: Studies in animals have shown teratogenic effects following topical ophthalmic administration (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su teratogene učinke nakon topikalne oftalmološke primjene
English: One implant contains 700 micrograms of dexamethasone.
Croatian: Jedan implantat sadrži 700 mikrograma deksametazona.
English: Among patients who used anti-coagulant therapy, the frequency of haemorrhagic adverse events was similar in the OZURDEX and sham groups (29% vs 32%).
Croatian: Među bolesnicima koji su primali antikoagulantnu terapiju, učestalost neželjenog hemoragijskog događaja bila je slična učestalosti u skupini koja je primila OZURDEX u usporedbi s placebo skupinom (29% naspram 32%).
English: During the initial treatment period, 0.7 % (3/421) of the patients who received OZURDEX required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2 % (1/423) with sham.
Croatian: bolesnika koji su primili OZURDEX bio je potreban laserski ili operativni postupak za stavljanje povišenog očnog tlaka pod kontrolu u ispitivanom oku, u usporedbi s 0,2% (1/423) bolesnika koji su primili placebo postupak.
English: 2) Allow the applicator to meet the sclera at an oblique angle with the bevel of the needle facing up, away from the sclera.
Croatian: 2) Priđite aplikatorom bjeloočnici pod kosim kutom i s kôsim otvorom vrška igle okrenutim prema gore.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U
English: One implant contains 700 micrograms of dexamethasone
Croatian: Jedan implantat sadrži 700 mikrograma deksametazona
English: Efficacy in pseudophakic patients (pooled studies 206207-010 and 206207-011)
Croatian: Tablica 3. Učinkovitost u bolesnika s pseudofakijom (objedinjena ispitivanja 206207-010 i
English: The implant can move from the back to the front of the eye in patients with a tear in the back of the lens capsule and/or those who have an opening in the iris.
Croatian: Kod bolesnika koji imaju puknuće stražnje kapsule leće i/ili otvor u šarenici implantat se može pomaknuti iz stražnjeg u prednji dio oka.
English: OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone
Croatian: OZURDEX 700 mikrograma intravitrealni implantat u aplikatoru deksametazon
English: Sham N = 185
Croatian: Placebo N = 185
English: EXP Once pouch opened, use applicator immediately.
Croatian: Kada otvorite vrećicu, odmah upotrijebite aplikator.
English: The proportion of patients with vitreous haze score of 0 in the study eye at week 8 (primary endpoint) was 4-fold higher with OZURDEX (46.8%) compared to Sham (11.8%), p < 0.001.
Croatian: Udio bolesnika s nultim stupnjem zamućenja staklastog tijela u ispitivanom oku u 8. tjednu (primarna mjera ishoda) bila je 4 puta veća s lijekom OZURDEX (46,8%) u usporedbi s placebo postupkom
English: The most common haemorrhagic adverse event reported was conjunctival haemorrhage (up to 24%).
Croatian: Najučestaliji zabilježeni štetni hemoragijski događaj bilo je krvarenje konjunktive (do
English: The proportion of patients achieving the primary efficacy measure of ≥ 15 letter improvement from baseline in BCVA following injection of a single implant is shown in Table 5.
Croatian: Udio bolesnika koji su postigli primarnu mjeru djelotvornosti od ≥ 15 slova poboljšanja u odnosu na početne vrijednosti u najbolje korigiranoj oštrini vida (BCVA) nakon ubrizgavanja jednog implantata prikazan je u Tablici 5. Učinak liječenja primijećen je na prvom terminu promatranja na 30. dan.
English: The rank order of dexamethasone concentration was retina > iris > ciliary body > vitreous humour > aqueous humour > plasma.
Croatian: Redoslijed koncentracija deksametazona bio je mrežnica > šarenica
English: Sham N = 165
Croatian: Placebo N = 165
English: Ester terminated 50:50 poly D,L-lactide-co-glycolide.
Croatian: 50:50 poli(D,L-laktid-ko-glikolid) s terminalnom esterskom skupinom 50:50 poli(D,L-laktid-ko-glikolid) s terminalnom kiselinskom skupinom
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see section 5.1)
Croatian: Central Retinal Vein Occlusion, CRVO) (vidjeti dio 5.1)
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO)
Croatian: • makularnog edema nakon okluzije grane mrežnične vene (BRVO) ili okluzije središnje mrežnične vene (CRVO).
English: Pharmacotherapeutic group: Ophthalmologicals, antiinflammatory agents, ATC code: S01BA01
Croatian: Farmakoterapijska skupina: Oftalmici, protuupalni lijekovi, ATK oznaka: S01BA01 Za deksametazon, snažan kortikosteroid, dokazano je da smanjuje upalu na način da inhibira edem,
English: The clinical safety of OZURDEX in patients with diabetic macular oedema was assessed in two phase 3 randomized, double-masked, sham-controlled studies.
Croatian: Dijabetički makularni edem Klinička sigurnost lijeka OZURDEX u bolesnika s dijabetičkim makularnim edemom utvrđena je u dvama randomiziranima, dvostruko slijepima, placebom kontroliranim ispitivanjima faze 3.
English: - Each implant contains 700 micrograms of dexamethasone.
Croatian: - Jedan implantat sadrži 700 mikrograma deksametazona.
English: In a 6-month monkey study following a single intravitreal injection of OZURDEX the dexamethasone vitreous humour Cmax was 100 ng/mL at day 42 post-injection and 5.57 ng/mL at day 91.
Croatian: Cmax za deksametazon u staklastom tijelu bio je 100 ng/ml na 42. dan nakon ubrizgavanja te
English: Mean BCVA change from baseline at year 3/Final visit OCT retinal thickness at center subfield mean average change over 3 years, AUC approach (µm)
Croatian: Poboljšanje BCVA ≥ 15- slova u odnosu na početno stanje u 3. godini/završni pregled (%) Srednja vrijednost promjene BCVA u odnosu na početno stanje u 3. godini/završni pregled Srednja vrijednost prosječne promjene OCT nalaza zadebljanja mrežnice u središnjom polju kroz 3 godine, AUC pristup (µm)
English: There continued to be a numerically greater proportion of responders for a ≥ 15 letter improvement from baseline in BCVA in patients treated with OZURDEX compared with sham at day 180.
Croatian: I 180. dana i dalje je bio brojčano veći udio bolesnika koji su reagirali na liječenje s ≥ 15 slova poboljšanja u odnosu na početne vrijednosti u najbolje korigiranoj oštrini vida (BCVA) kod bolesnika koji su liječeni lijekom OZURDEX u usporedbi s onima koji su liječeni placebo postupkom.
English: Vitreous Haze Score of Zero BCVA improvement from baseline of ≥15 letters
Croatian: Poboljšanje od ≥15 slova u odnosu na početne vrijednosti BCVA
English: BCVA ≥ 15-letter improvement from baseline at Year 3/Final (%) P-value
Croatian: godini/završni pregled (%) P-vrijednost
English: Dexamethasone is excreted in breast milk No effects on the child are anticipated due to the route of administration and the resulting systemic levels.
Croatian: Ne očekuju se učinci u djetetu zbog načina primjene i sistemskih razina lijeka.
English: Tel.: +48 22 256 3700
Croatian: Allergan Sp. z o.o. Tel.: +48 22 256 3700
English: Patients who had a BCVA score of <84 OR retinal thickness > 250 microns by optical coherence tomography OCT and in the investigator's opinion treatment would not put the patient at risk; were eligible to receive an OZURDEX treatment in an open label extension.
Croatian: Optical Coherence Tomography) i za koje, prema mišljenju ispitivača, liječenje ne bi predstavljalo rizik, bili su prikladni za liječenje lijekom OZURDEX u otvorenom produžetku ispitivanja.
English: Before your OZURDEX injection tell your doctor if: - You have had cataract surgery, iris surgery (the coloured part of the eye that controls the amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from within the eye - You are taking any medicines to thin the blood - You are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to the eye - You have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has been there a long time, or sores on the eye)
Croatian: Prije ubrizgavanja lijeka OZURDEX obavijestite liječnika: - ako ste imali operaciju katarakte, operaciju šarenice (obojeni dio oka koji kontrolira količinu svjetlosti koja ulazi u oko) ili operaciju za uklanjanje gela (tzv. staklastog gela) iz oka
English: Ocular hypertension, cataract subcapsular, vitreous haemorrhage**, visual acuity reduced*, visual impairment/ disturbance, vitreous detachment*, vitreous floaters*, vitreous opacities*, blepharitis, eye pain*, photopsia*, conjunctival oedema* conjunctival hyperaemia*
Croatian: Okularna hipertenzija, subkapsularna katarakta, vitrealno krvarenje**, smanjena oštrina vida*, oštećenje/smetnje vida, odvajanje staklovine*,
English: High pressure in the eye, clouding at the back of the lens, bleeding into the inside of the eye*, worsening of vision*, difficulties in seeing clearly, detachment of the jelly inside the eye from the light-sensitive layer at the back of the eye (vitreous detachment)*, a feeling of spots in front of the eye (including ‘floaters')*, a feeling of looking through mist or fog*, inflammation of the eyelid, eye pain*, seeing flashes of light*, swelling of the layer over the white part of the eye*, redness of the eye*, headache
Croatian: osjećaj točkica ispred oka (uključujući lebdeće čestice („mušice“))*, osjećaj da se gleda kroz sumaglicu ili maglu*, upala očnog kapka, bol u oku*, bljeskanje pred očima*, oteklina sloja bjeloočnice*, crvenilo oka*, glavobolja Manje često (mogu se javiti kod do 1 na 100 osoba):
English: Proportion of patients with ≥ 15 letters improvement from baseline best corrected visual acuity in the study eye (pooled, ITT population)
Croatian: Tablica 5. Udio bolesnika s poboljšanjem od ≥ 15 slova u odnosu na početne vrijednosti najbolje korigirane oštrine vida (BCVA) u ispitivanom oku
English: Do not use OZURDEX after the expiry date which is stated on the carton and the pouch after EXP:.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza oznake
English: This will create a shelved scleral path.
Croatian: Time će put kroz bjeloočnicu promijeniti smjer.
English: Mean BCVA change from baseline at year 3/final visit (letters) P-value
Croatian: BCVA u odnosu na početno stanje u 3. godini/završni pregled (slova) P-vrijednost
English: Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting oedema, fibrin deposition, capillary leakage, and phagocytic migration of the inflammatory response.
Croatian: odlaganje fibrina, kapilarno propuštanje i migraciju fagocita kao dio reakcije na upalu.
English: Disposable injection device, containing a rod-shaped implant.
Croatian: Jednokratna brizgalica koja sadrži implantat u obliku štapića, koji se ne može vidjeti.
English: The recommended dose is one OZURDEX implant to be administered intra-vitreally to the affected eye. Administration to both eyes concurrently is not recommended (see section 4.4).
Croatian: Primjena u oba oka istovremeno nije preporučljiva (vidjeti dio 4.4).
English: OZURDEX works by reducing this swelling of the macular which helps to lessen or prevent more damage to the macula.
Croatian: (makule), što pomaže smanjivanju ili sprječavanju daljnjeg oštećenja žute pjege (makule).
English: Administering OZURDEX
Croatian: Primjena implantata OZURDEX
English: In both studies, a total of 347 patients were randomized and received OZURDEX and 350 patients received sham.
Croatian: U oba ispitivanja, ukupno 347 bolesnika raspoređeno je metodom slučajnog izbora u skupinu koja je primila
English: CARTON AND POUCH EXTENDED LABEL
Croatian: ŠIROKA NALJEPNICA ZA KUTIJU I VREĆICU
English: Contains
Croatian: Nuspojava
English: • Patient information leaflet
Croatian: KLINIČKI PODACI
English: Mean BCVA average change over 3 years, AUC approach (letters)
Croatian: godine, AUC pristup (slova)
English: feet and throat.
Croatian: stopala i grla.
English: In some cases you may need a blood transfusion.
Croatian: U nekim slučajevima možda ćete trebati transfuziju krvi.
English: - Hair loss.
Croatian: - ispadanje kose.
English: - Fever.
Croatian: - vrućica.
English: This condition can be fatal.
Croatian: Ovo stanje može imati smrtni ishod.
English: Each pack contains one vial.
Croatian: Svako pakiranje sadrži jednu bočicu.
English: Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako ste zabrinuti zbog količine lijeka koju primate.
English: Other medicines and Potactasol
Croatian: Drugi lijekovi i Potactasol
English: Study results Study GOG-0179
Croatian: Tablica 2. Rezultati ispitivanja GOG-0179
English: Vials 4 years.
Croatian: 4 godine.
English: The experience in children and adolescents is limited and treatment is therefore not recommended.
Croatian: Iskustvo u djece i adolescenata je ograničeno te se stoga ovaj lijek ne preporučuje za liječenje.
English: Symptoms may include yellow skin (jaundice).
Croatian: Simptomi mogu uključivati žutilo kože (žuticu).
English: Vials may or may not be sheathed in a protective sleeve.
Croatian: Bočice mogu i ne moraju biti omeđene zaštitnim omotom.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Croatian: Budući da Vam ovaj lijek daju liječnik ili medicinska sestra, malo je vjerojatno da ćete primiti previše lijeka.
English: Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015
Croatian: Datum posljednje obnove odobrenja: 5. listopada 2015.
English: Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
Croatian: Bolesnici koji su zabrinuti za svoju plodnost moraju se savjetovati sa svojim liječnikom o plodnosti i planiranju obitelji prije početka liječenja.