FrancophonIA/ELRC3.0 huggingface dataset:
English: This is because rotigotine may pass into your breast milk and affect your baby.
Croatian: Neupro jer se rotigotin izlučuje u majčino mlijeko i može utjecati na dijete, a vjerojatno će i smanjiti količinu majčinog mlijeka koje se izlučuje.
English: What Neupro is Neupro contains the active substance rotigotine.
Croatian: Što je Neupro Neupro sadrži djelatnu tvar rotigotin.
English: What Neupro is used for
Croatian: Za što se Neupro koristi
English: hallucination, hallucination visual, hallucination auditory, illusion), nightmaree, paranoia e, confusional state e, psychotic disorder e, delusion e, delirium e
Croatian: (uključujući halucinacije, vizualne halucinacije, slušne halucinacije, iluzije), noćne moree, paranojae, konfuzno stanjee, psihotični poremećaje, deluzijae, delirije
English: • fainting, feeling dizzy when standing up because of fall in blood pressure
Croatian: • uznemirenost • osjećaj omaglice pri ustajanju zbog pada krvnog tlaka
English: The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Neupro in 7.2% of subjects.
Croatian: Većina reakcija na mjestu primjene bila je blagog ili umjerenog intenziteta, ograničena na područja primjene, a 7,2% ispitanika zbog njih prekinulo primjenu Neupra.
English: At the beginning of the third week, you should take Neupro 6 mg (package marked with “Week 3”).
Croatian: Na početku trećeg tjedna primijenite Neupro 6 mg/24 h (pakiranje označeno “Tjedan 3”).
English: At the beginning of the fourth week, you should take Neupro 8 mg (package marked with “Week 4”).
Croatian: Na početku četvrtkog tjedna primijenite Neupro 8 mg/24 h (pakiranje označeno “Tjedan 4”).
English: Currently available data are described in section 5.2 but no recommendation on a posology in children with RLS can be made.
Croatian: Sigurnost i djelotvornost rotigotina u djece i adolescenata još uvijek nisu ustanovljene.Trenutno dostupni podaci opisani su u dijelu 5.2, no nije moguće dati preporuku o doziranju u djece sa sindromom nemirnih nogu.
English: Vision blurred, visual impairment, photopsia
Croatian: Poremećaji oka zamagljen vid, oštećenje vida, fotopsija
English: The strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson's disease.
Croatian: Jačine su: 2 mg/24 h, 4 mg/24 h, 6 mg/24 h i 8 mg/24 h za liječenje Parkinsonove bolesti.
English: The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with Neupro in only 4.3% of all subjects receiving Neupro.
Croatian: Većina reakcija na mjestu primjene bila je blagog ili umjerenog intenziteta, ograničena na područja primjene, a samo je 4,3% ispitanika koji su primali Neupro zbog njih prekinulo liječenje Neuprom.
English: Neupro is for transdermal use.
Croatian: Neupro je za transdermalnu primjenu.
English: At the beginning of the second week, you should take Neupro 4 mg (package marked with “Week 2”).
Croatian: Na početku drugog tjedna primijenite Neupro 4 mg/24 h (pakiranje označeno “Tjedan 2”).
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine.
Croatian: Bolesnici i njegovatelji moraju biti svjesni da se u bolesnika liječenih agonistima dopamina uključujući rotigotin, mogu pojaviti bihevioralni simptomi poremećaja kontrole nagona uključujući patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno uzimanje hrane.
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.5% of the patients on Neupro and 33.2% of patients on placebo reported at least one adverse reaction.
Croatian: Analizom objedinjenih podataka iz placebom kontroliranih kliničkih ispitivanja u kojima je sudjelovalo ukupno 748 bolesnika koji su liječeni Neuprom te 214 bolesnika koji su primali placebo, najmanje jedna nuspojava zabilježena je u 65,5% bolesnika liječenih Neuprom i u 33,2% bolesnika na placebu.
English: Each patch of 15 cm2 contains 6.75 mg of rotigotine.
Croatian: Jedan flaster površine 15 cm2 sadrži 6,75 mg rotigotina.
English: h may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Croatian: mg moguće je postići primjenom jednog flastera od 6 mg/24 h i jednog flastera od 4 mg/24 h.
English: Week 4.
Croatian: Tjedan 4.
English: With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points).
Croatian: Sa rotigotinom prosječno poboljšanje ocjene prema UPDRS ljestvici (dio II + III) bilo je -3,98 bodova (početno 29,9 bodova), a u-skupini koja je primala placebo zabilježeno je pogoršanje za 1,31 bod (početno 30,0 bodova).
English: For example the daily dose of 10 mg may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Croatian: Primjerice, dnevnu dozu od 10/24 h mg moguće je postići primjenom jednog flastera od 6 mg/24 h i jednog flastera od 4 mg/24 h.
English: Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, baseline 19.3) and 1.9 points (placebo, baseline 20.5).
Croatian: Poboljšanje u ukupnoj prosječnoj ocjeni prema PDSS-2 ljestvici bila je 5,9 (rotigotin, početno 19,3) i 1,9 bodova(placebo, početno 20,5).
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Croatian: Nuspojave zabilježene u više od 10% bolesnika koji su primjenjivali Neupro transdermalni flaster jesu mučnina, povraćanje, reakcije na mjestu primjene, somnolencija, omaglica i glavobolja.
English: In trials where the application sites were rotated as reflected in the instructions provided in the SmPC and package leaflet, 34.2% of 748 patients using Neupro, experienced application site reactions.
Croatian: U ispitivanjima u kojima je mjesto primjene mijenjano u skladu s preporukama koje se nalaze u sažetku opisa svojstava lijeka i uputi o lijeku, u 34,2% od 748 bolesnika koji su primjenjivali
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Neuproand 607 placebo-treated patients, 72.5% of the patients on Neupro and 58.0% of patients on placebo reported at least one adverse reaction.
Croatian: Analizom objedinjenih podataka placebom kontroliranih kliničkih ispitivanja u kojima je sudjelovalo ukupno 1307 bolesnika koji su liječeni Neuprom te 607 bolesnika koji su primjenjivali placebo, najmanje jedna nuspojava zabilježena je u 72,5% bolesnika liječenih Neuprom i u 58,0% bolesnika na placebu.
English: Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Croatian: Poremećaji kože i potkožnog tkiva eritem, hiperhidroza, svrbež generalizirani svrbež, iritacija kože, kontaktni dermatitis generalizirani osip
English: Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Croatian: Jedan flaster površine 30 cm2 sadrži 13,5 mg rotigotina.
English: Palpitationse, atrial fibrillatione, supraventricular tachycardiae
Croatian: Srčani poremećaji palpitacijee, fibrilacija atrijae, supraventrikul arna tahikardijae
English: Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Croatian: Jedan flaster površine 40 cm2 sadrži 18,0 mg rotigotina.
English: Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermal patch
Croatian: Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermalni flaster rotigotin
English: Neupro may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate pre-existing dyskinesia, as described with other dopamine agonists.
Croatian: Kao i drugi agonisti dopamina, tako i Neupro može pojačati nuspojave dopaminergičkog tipa koje uzrokuje primjena levodope i može uzrokovati pojavu diskinezije i/ili pogoršati postojeću diskineziju.
English: At the end of maintenance, the mean UPDRS part III score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the placebogroup (baseline 32.0).
Croatian: Na kraju terapije održavanja, prosječna ocjena prema UPDRS (dio III) ljestvici popravila se za 7 bodova u bolesnika koji su liječeni rotigotinom (početno 29,6) te za 3,9 bodova u placebo-skupini (početno 32,0).
English: AST, ALT, GGT), weight increased e, heart rate increased e, CPK increased d,e
Croatian: (uključujući AST, ALT, GGT), povećanje tjelesne težinee, ubrzanje srčane frekvencijee, povišena kreatin fosfokinaza (CPK)d,e
English: Erythema e, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Croatian: Poremećaji kože i potkožnog tkiva svrbež eriteme, hiperhidrozae, generalizirani svrbeže, iritacija kožee, kontaktni dermatitise, generalizirani osipe
English: Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Croatian: Jedan flaster površine 5 cm2 sadrži 2,25 mg rotigotina.
English: Warnings and precautions Talk to your doctor or pharmacist before using Neupro.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Neupro.
English: The outside is tan-coloured and is imprinted with Neupro 1 mg/24 h or 3 mg/24 h.
Croatian: Vanjska strana je boje kože s otisnutim natpisom Neupro 1 mg/24 h ili 3 mg/24 h.
English: Dopamine dysregulation syndromec, perception disturbancese
Croatian: Psihijatrijski poremećaji poremećaji percepcijea
English: Neupro 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 8 mg/24 h'.
Croatian: Neupro 8 mg/24 h transdermalni flaster Vanjski potporni sloj jest boje kože s otisnutim „Neupro 8 mg/24 h“.
English: syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsion e
Croatian: (uključujući sinkopu, vazovagalnu sinkopu, gubitak svijesti), diskinezijae, posturalna omaglicae, letargijae, konvulzijae
English: 7 transdermal patches of Neupro 8 mg/24 h
Croatian: 7 transdermalnih flastera Neupra 8 mg/24 h
English: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Croatian: Vanjski potporni sloj jest boje kože s otisnutim „Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h ili 8 mg/24 h“.
English: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h'.
Croatian: Vanjski potporni sloj jest boje kože s otisnutim „Neupro 2 mg/24 h“.
English: In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the Neupro transdermal patch, experienced application site reactions.
Croatian: U ispitivanjima u kojima je mjesto primjene mijenjano u skladu s preporukama koje se nalaze u sažetku opisa svojstava lijeka i uputi o lijeku, u 35,7% od 830 bolesnika koji su primjenjivali
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, asthenic conditions and headache.
Croatian: Nuspojave zabilježene u više od 10% bolesnika liječenih Neuprom jesu mučnina, reakcija na mjestu primjene, astenična stanja i glavobolja.
English: pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc)
Croatian: (uključujući patološko kockanje, stereotipne/pona vljajuće besmislene radnje, prejedanje/pore mećaj prehraneb, kompulzivno kupovanjec)
English: Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch
Croatian: Neupro 1 mg/24 h transdermalni flaster Neupro 3 mg/24 h transdermalni flaster
English: The outside is tan-coloured and is imprinted with Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/ 24 h.
Croatian: Vanjska strana je boje kože s otisnutim natpisom Neupro 4 mg/24 h, Neupro 6 mg/24 h ili Neupro 8 mg/24 h.
English: Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch
Croatian: Neupro 4 mg/24 h transdermalni flaster Neupro 6 mg/24 h transdermalni flaster Neupro 8 mg/24 h transdermalni flaster rotigotin
English: 7 transdermal patches of Neupro 6 mg/24 h
Croatian: 7 transdermalnih flastera Neupra 6 mg/24 h
English: Each patch of 20 cm2 contains 9.0 mg of rotigotine.
Croatian: Jedan flaster površine 20 cm2 sadrži 9,0 mg rotigotina.
English: Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd
Croatian: opsesivnokompulzivni poremećaj, agitacijad agresivno ponašanje/ agresijab, dezorijenta cijad sindrom dopaminergičke disregulacijec, poremećaji percepcijee
English: Fall e a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson's disease
Croatian: Ozljede, trovanja i proceduralne komplikacije pad aPojam visoke razine bOpaženo u otvorenim studijama cOpaženo tijekom postmarketinškog razdoblja dOpaženo u objedinjenim podacima dvostruko slijepih placebom kontroliranih ispitivanja iz 2011.g.
English: 7 transdermal patches of Neupro 4 mg/24 h
Croatian: 7 transdermalnih flastera Neupra 4 mg/24 h
English: Neupro may cause other behaviours and abnormal thinking.
Croatian: Neupro može uzrokovati i druge promjene u ponašanju i razmišljanju, koje mogu uključivati:
English: Neupro 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h'.
Croatian: Neupro 6 mg/24 h transdermalni flaster Vanjski potporni sloj jest boje kože s otisnutim „Neupro 6 mg/24 h“.
English: Weight decreasede, hepatic enzyme increasede (incl.
Croatian: Pretrage smanjenje tjelesn težinee, povećanje vrijednosti jetrenih enzimae
English: Patients in each treatment group were maintained for 4 months.
Croatian: Bolesnici u svim terapijskim skupinama zatim su 4 mjeseca primjenjivali odgovarajuću terapijsku dozu.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja štucanje
English: Pregnancy and breast-feeding
Croatian: Trudnoća i dojenje Nemojte uzimati
English: Neupro 1 mg/24 h transdermal patch EU/1/05/331/038
Croatian: Neupro 1 mg/24 h transdermalni flaster EU/1/05/331/038
English: Nausea, vomiting Constipation, dry mouth, dyspepsia
Croatian: Poremećaji probavnog sustava mučnina, povraćanje konstipacija, suha usta, dispepsija bol u abdomenu proljevc
English: Neupro 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h'.
Croatian: Neupro 4 mg/24 h transdermalni flaster Vanjski potporni sloj jest boje kože s otisnutim „Neupro 4 mg/24 h“.
English: Vision blurrede, visual impairmente, photopsiae
Croatian: Poremećaji oka zamagljen vide, oštećenje vidae, fotopsijae
English: Neupro 8 mg/24 h transdermal patch EU/1/05/331/010
Croatian: Neupro 8 mg/24 h transdermalni flaster EU/1/05/331/010
English: The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
Croatian: Vanjska strana je boje kože s otisnutim natpisom Neupro 2 mg/24 h.
English: The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Croatian: Vanjska strana je boje kože s otisnutim natpisom Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h ili 8 mg/24 h.
English: Do not breast-feed during treatment with Neupro.
Croatian: Nemojte dojiti dok uzimate
English: Weight decreased e, hepatic enzyme increasede (incl.
Croatian: Pretrage smanjenje tjelesne težinee, povećanje vrijednosti jetrenih enzimae
English: Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
Croatian: Neupro 6 mg/24 h transdermalni flaster EU/1/05/331/007
English: At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001).
Croatian: Poboljšanje od 20% zabilježeno je u 48% ispitanika liječenih rotigotinom i u 19% ispitanika koji su primali placebo (razlika 29%, CI95%: 18%; 39%, p <0,0001).
English: Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Croatian: Neupro 4 mg/24 h transdermalni flaster EU/1/05/331/004
English: Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Croatian: Neupro 3 mg/24 h transdermalni flaster EU/1/05/331/047
English: EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
Croatian: EU/1/05/331/047 [7 transdermalnih flastera] EU/1/05/331/049 [28 transdermalnih flastera] EU/1/05/331/050 [30 transdermalnih flastera] EU/1/05/331/058 [14 transdermalnih flastera]
English: EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
Croatian: EU/1/05/331/038 [7 transdermalnih flastera] EU/1/05/331/040 [28 transdermalnih flastera] EU/1/05/331/041 [30 transdermalnih flastera] EU/1/05/331/056 [14 transdermalnih flastera]
English: You may have to use more than one patch to reach your dose, as prescribed by your doctor.
Croatian: Za primjenu odgovarajuće doze koju je propisao Vaš liječnik, možda ćete trebati primijeniti više od jednog flastera.
English: EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
Croatian: EU/1/05/331/010 [7 transdermalnih flastera] EU/1/05/331/011 [28 transdermalnih flastera] EU/1/05/331/033 [30 transdermalnih flastera] EU/1/05/331/061 [14 transdermalnih flastera]
English: neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Croatian: 16. PODACI NA BRAILLEOVOM PISMU neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
English: Neupro 8 mg/24 h transdermal patch rotigotine
Croatian: Neupro 8 mg/24 h transdermalni flaster rotigotin
English: LABELLING AND PACKAGE LEAFLET
Croatian: Kako Neupro izgleda i sadržaj pakiranja
English: Neupro 8 mg/24 h transdermal patch
Croatian: Neupro 8 mg/24 h transdermalni flaster
English: hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disordersa,d (incl.
Croatian: Psihijatrijski poremećaji napadi spavanja/iznenadne epizode spavanja, poremećaji spolne željea (uključujući hiperseksualnost, povećanje libida), nesanica, poremećaj spavanja, abnormalni snovi, poremećaji kontrole nagonaa, d
English: EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
Croatian: EU/1/05/331/004 [7 transdermalnih flastera] EU/1/05/331/005 [28 transdermalnih flastera] EU/1/05/331/021 [30 transdermalnih flastera] EU/1/05/331/059 [14 transdermalnih flastera]
English: Neupro 6 mg/24 h transdermal patch
Croatian: Neupro 6 mg/24 h transdermalni flaster
English: Neupro 1 mg/24 h transdermal patch rotigotine
Croatian: Neupro 1 mg/24 h transdermalni flaster rotigotin
English: EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
Croatian: EU/1/05/331/007 [7 transdermalnih flastera] EU/1/05/331/008 [28 transdermalnih flastera] EU/1/05/331/027 [30 transdermalnih flastera] EU/1/05/331/060 [14 transdermalnih flastera]
English: EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
Croatian: EU/1/05/331/001 [7 transdermalnih flastera] EU/1/05/331/002 [28 transdermalnih flastera] EU/1/05/331/015 [30 transdermalnih flastera] EU/1/05/331/057 [14 transdermalnih flastera]
English: 4 mg/24 h may be an effective dose in some patients.
Croatian: Za neke bolesnike učinkovita doza može biti 4 mg/24 h.
English: Neupro 6 mg/24 h transdermal patch rotigotine
Croatian: Neupro 6 mg/24 h transdermalni flaster rotigotin
English: Neupro 4 mg/24 h transdermal patch
Croatian: Neupro 4 mg/24 h transdermalni flaster
English: Neupro 3 mg/24 h transdermal patch
Croatian: Neupro 3 mg/24 h transdermalni flaster
English: The signs include: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma).
Croatian: Pretrage smanjenje tjelesne težine povećanje vrijednosti jetrenih enzima (uključujući AST, ALT, GGT), povećanje tjelesne težine, ubrzanje srčane frekvencije, povišena kreatin fosfokinaza (CPK)d (vidjeti
English: EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/018 [84 transdermalna flastera (3 pakiranja od 28)]
English: Neupro 3 mg/24 h transdermal patch rotigotine
Croatian: Neupro 3 mg/24 h transdermalni flaster rotigotin
English: EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/053 [84 transdermalna flastera (3 pakiranja od 28)]
English: On the first day of treatment the patient starts with Neupro 2 mg/24 h. During the second week, the patient takes Neupro 4 mg/24 h. During the third week, he or she takes Neupro 6 mg/24 h and during the fourth week Neupro 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”.
Croatian: Tijekom trećeg tjedna, on ili ona primjenjuje Neupro 6 mg/24 h, a tijekom četvrtog tjedna Neupro 8 mg/24 h.
English: Neupro 2 mg/24 h transdermal patch rotigotine
Croatian: Neupro 2 mg/24 h transdermalni flaster rotigotin
English: Neupro 4 mg/24 h transdermal patch rotigotine
Croatian: Neupro 4 mg/24 h transdermalni flaster rotigotin
English: EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/036 [84 transdermalna flastera (3 pakiranja od 28)]
English: EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/044 [84 transdermalna flastera (3 pakiranja od 28)]
English: EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/024 [84 transdermalna flastera (3 pakiranja od 28)]
English: EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/030 [84 transdermalna flastera (3 pakiranja od 28)]
English: Erectile dysfunction e
Croatian: Poremećaji reproduktivno g sustava i dojki erektilna disfunkcija
English: Neutropenia lasted on average 1.6 days with both medicines.
Croatian: Neutropenija je u prosjeku trajala 1,6 dana s oba lijeka.
English: Further information on Pelgraz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Pelgraz nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effect with Pelgraz (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Pelgraz (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: This means that Pelgraz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Pelgraz je visoko sličan drugom biološkom lijeku („referentni lijek“) koji je već odobren u EU-u.
English: What measures are being taken to ensure the safe and effective use of Pelgraz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pelgraz?