FrancophonIA/ELRC3.0 huggingface dataset:
English: Neupro contains sodium metabisulphite (E223) Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
Slovenian: Zdravilo Neupro vsebuje natrijev metabisulfit (E223) Natrijev metabisulfit (E223) lahko redko povzroči resne preobčutljivostne (alergijske) reakcije in bronhospazem (težave z dihanjem zaradi zožanja dihalnih poti).
English: If you have to stop taking this medicine, see ‘If you stop using Neupro' in section 3.
Slovenian: Če morate prekiniti uporabo zdravila, glejte, 'Če ste prenehali uporabljati zdravilo Neupro' v poglavju 3.
English: Each pack of 28 transdermal patches for a 4 week treatment schedule contains: 7 transdermal patches of Neupro 2 mg/24 h
Slovenian: Vsako pakiranje z 28 transdermalnimi obliži za 4-tedenski razpored zdravljenja vsebuje: 7 transdermalnih obližev Neupro 2 mg/24 h
English: Dopamine dysregulation syndromec
Slovenian: dopaminski disregulacijski sindrom c
English: Do not stop using Neupro without talking to your doctor.
Slovenian: Z uporabo zdravila Neupro ne smete prenehati brez posveta s svojim zdravnikom.
English: Which strength patches to use The dose of Neupro will depend on your illness - see below.
Slovenian: Katero jakost obližev uporabiti Odmerek zdravila Neupro bo odvisen od vaše bolezni - glejte spodaj.
English: What Neupro is and what it is used for What you need to know before you use Neupro How to use Neupro
Slovenian: Kaj je zdravilo Neupro in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Neupro Kako uporabljati zdravilo Neupro Možni neželeni učinki
English: If your liver problems get worse during treatment, talk to your doctor straight away.
Slovenian: Če se med zdravljenjem težave z jetri poslabšajo, se morate čimprej posvetovati z zdravnikom.
English: Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-treated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients.
Slovenian: Spanje (PDSS) je bilo izboljšano za 4,1 ± 13,8 točk pri bolnikih zdravljenih z rotigotinom in 2,5 ± 13,5 točk pri bolnikih zdravljenih z ropinirolom.
English: How to use the Neupro patches:
Slovenian: Kako uporabljati Neupro obliže:
English: Neupro is used in adults to treat the signs and symptoms of:
Slovenian: Zdravilo Neupro se uporablja pri odraslih za zdravljenje znakov in simptomov:
English: Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months.
Slovenian: Dve pivotni preskušanji (SP512 del I in SP513 del I), pri katerih so preučevali učinkovitost rotigotina pri zdravljenju znakov in simptomov idiopatične Parkinsonove bolezni, so opravili na bolnikih, ki niso prejemali sočasnega zdravljenja z agonistom dopamina in ki bodisi niso nikoli prejemali L-dope ali katerih predhodno zdravljenje z L-dopo je trajalo ≤ 6 mesecev.
English: In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at equivalent doses were shown to have comparable efficacy.
Slovenian: V študijah SP824 in SP825 , ki so potekale od začetnega primerjalnega preskušanja, je bila dokazana primerljiva učinkovitost rotigotina in ropinirola pri enakih odmerkih.
English: If you experience these symptoms after beginning treatment with Neupro, contact your doctor.
Slovenian: Če imate te simptome po začetku zdravljenja z zdravilom Neupro, obvestite svojega zdravnika.
English: Neupro can cause loss of consciousness.
Slovenian: Zdravilo Neupro lahko povzroči izgubo zavesti.
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.
Slovenian: Večina reakcij na mestu aplikacije je bila blagih ali zmernih, omejenih na mesto aplikacije, zdravljenje z zdravilom Neupro pa so zaradi njih prekinili le pri 4,3 % vseh bolnikov, ki so prejemali zdravilo Neupro.
English: The Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches in each package.
Slovenian: Pakiranje za začetno zdravljenje z zdravilom Neupro vsebuje 4 različna pakiranja (po eno za vsako jakost) s 7 obliži v vsakem pakiranju.
English: • your eyes need checking regularly while using Neupro.
Slovenian: • potrebujete redne okulistične preglede med uporabo zdravila Neupro.
English: To open the sachet, hold the sachet in both hands.
Slovenian: Zaščitno vrečko odprite tako, da jo primete na z obema rokama.
English: 7 transdermal patches 14 transdermal patches 28 transdermal patches 30 transdermal patches
Slovenian: 7 transdermalnih obližev 14 transdermalnih obližev 28 transdermalnih obližev 30 transdermalnih obližev
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Neupro.
Slovenian: To imenujemo ‘dopaminski disregulacijski sindrom', ki lahko vodi do pretirane uporabe zdravila Neupro.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije UCB Pharma S.A.
English: If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
Slovenian: Če se pojavijo splošne kožne reakcije (npr. alergijski izpuščaj, vključno z eritematoznim, makuloznim ali papuloznim izpuščajem, ali pruritus), povezane z uporabo obliža zdravila Neupro, je treba zdravljenje z zdravilom Neupro prekiniti.
English: • Stick the Neupro patch onto your skin as soon as you have opened the sachet and removed the release liner.
Slovenian: • Obliž zdravila Neupro nalepite na kožo takoj, ko odprete zaščitno vrečko in odstranite zaščitno plast.
English: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
Slovenian: Zdravilo Neupro je indicirano za simptomatično zdravljenje zmerne do hude oblike idiopatičnega sindroma nemirnih nog (RLS - Restless Legs Syndrome) pri odraslih.
English: Sleep attacks/sudden onset of sleep, paranoia, sexual desire disordersa
Slovenian: napadi spanca/nenaden spanec, paranoja, motnje spolnega poželenja a
English: Tell your doctor if you notice any changes in behaviour, thinking or both that are listed above.
Slovenian: Povejte zdravniku, če se pri vas pojavijo kakršne koli spremembe v vedenju, mišljenju ali obeh, kot je navedno zgoraj.
English: Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment.
Slovenian: Prilagajanje odmerka pri bolnikih z blago do zmerno jetrno okvaro ni potrebno.
English: For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths), multiple patches must be applied to achieve the final dose.
Slovenian: • Za odmerke večje od 8 mg/24 h (odmerke, ki jih je predpisal zdravnik in so večji od razpoložljivih jakosti) morate uporabiti več obližev za doseg končnega odmerka.
English: Convulsion Dropped head syndromec,e
Slovenian: konvulzija sindrom padajoče glave c,e
English: • Do not stick Neupro on the same area of skin twice within 14 days.
Slovenian: • Ne lepite obliža zdravila Neupro ponovno na isto mesto prej kot v 14 dneh.
English: Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine is absorbed by the body.
Slovenian: Zdravilo Neupro skupaj s hrano, pijačo in alkoholom Rotigotin vstopa v krvni obtok skozi kožo, zato hrana in pijača na absorpcijo zdravila v telo ne vplivata.
English: Neupro is available in different strength patches which release the medicine over 24 hours.
Slovenian: Zdravilo Neupro je na voljo v različnih jakostih obližev, vsak sprosti različno količino učinkovine v 24 urah.
English: Neupro can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others - the symptoms are mainly seen in patients with Parkinson's disease.
Slovenian: Zdravilo Neupro lahko povzroči nenavadne težnje ali želje, ki se jim ne morete upreti in bi lahko škodovale vam ali drugim - ti simptomi so večinoma opazni pri bolnikih s Parkinsonovo boleznijo.
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Neupro
Slovenian: To imenujemo ‘dopaminski disregulacijski sindrom', ki lahko vodi do pretirane uporabe zdravila Neupro
English: Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches each, for the first four weeks of therapy.
Slovenian: Komplet za začetno zdravljenje zdravila Neupro vsebuje 4 različna pakiranja (po eno za vsako jakost) za prve štiri tedne zdravljenja, v vsakem od njih je 7 obližev.
English: Side effects when using Neupro for Parkinson's disease Tell your doctor, pharmacist or nurse if you get any of the following side effects:
Slovenian: Neželeni učinki pri uporabi zdravila Neupro za zdravljenje Parkinsonove bolezni Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, če opazite katerega koli od naslednjih neželenih učinkov:
English: This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
Slovenian: Ne jemljite zdravila Neupro, če ste noseči, saj učinki rotigotina na nosečnost in nerojenega otroka niso znani.
English: In a randomized, open-label study (SP825) in patients with early stage Parkinson's disease, 25 patients were randomized to rotigotine treatment and 26 to ropinirole.
Slovenian: V randomizirani, odprti študiji (SP825) z bolniki v zgodnji fazi Parkinsonove bolezni je 25 bolnikov prejemalo rotigotin in 26 ropinirol.
English: If your doctor says you should stop Neupro, the daily dose should be lowered gradually:
Slovenian: Če se zdravnik odloči za prenehanje zdravljenja z zdravilom Neupro, je treba dnevni odmerek zdravila Neupro zmanjševati postopoma:
English: For example, a daily dose of 14 mg can be reached by applying one patch of 6 mg/24 h and one patch of 8 mg/24 h and likewise, a daily dose of 16 mg can be reached by applying two patches of 8 mg/24 h.
Slovenian: Na primer, dnevni odmerek 14 mg se lahko doseže z uporabo enega obliža 6 mg/24 h in enega obliža 8 mg/24 h in podobno se lahko 16 mg doseže z uporabo dveh obližev 8 mg/24 h.
English: Motor symptoms (UPDRS Part III) improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirole-group after 4 weeks of maintenance.
Slovenian: Po štirih tednih so bili motorični simptomi (UPDRS del III) izboljšani za 6,3 ± 1,3 točk v skupini bolnikov zdravljenih z rotigotinom in 5,9 ± 1,3 točk v skupini z ropinirolom.
English: If your doctor says you should stop Neupro, the daily dose of Neupro should be lowered gradually:
Slovenian: Če se zdravnik odloči za prenehanje zdravljenja z zdravilom Neupro, je treba dnevni odmerek zdravila Neupro morate zmanjševati postopoma:
English: Using higher doses of Neupro than your doctor has prescribed may cause side effects such as feeling sick (nausea) or vomiting, low blood pressure, seeing or hearing things that are not real (hallucinations), feeling confused, very sleepy, having involuntary movements and convulsions.
Slovenian: Če ste uporabili večji odmerek zdravila Neupro, kot bi smeli Uporaba večjih odmerkov zdravila Neupro, kot vam je predpisal zdravnik, lahko povzroči neželene učinke kot so občutek slabosti (navzea) ali bruhanje, nizek krvni tlak, videnje ali slišanje stvari, ki niso resnične (halucinacije), občutek zmedenosti, hude zaspanosti, nehoteni gibi in konvulzije.
English: OUTER LABEL (WITH BLUE BOX) BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES
Slovenian: PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “BLUE BOXOM”) ŠKATLA S 84 OBLIŽI, KI VSEBUJE 3 ŠKATLE S PO 28 OBLIŽ
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve padci
English: The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Slovenian: Jakosti 1 mg/24 h, 2 mg/24 h in 3 mg/24 h so za zdravljenje sindroma nemirnih nog.
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.
Slovenian: Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 748 bolnikov, zdravljenih z zdravilom Neupro, in 214 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 65,5 % bolnikov, ki so prejemali zdravilo Neupro, in pri 33,2 % bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
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.
Slovenian: Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 1.307 bolnikov, zdravljenih z zdravilom Neupro, in 607 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 72,5 % bolnikov, ki so prejemali zdravilo Neupro, in pri 58,0 % bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
English: • dropped head syndrome
Slovenian: • sindrom padajoče glave
English: For most patients with early stage Parkinson's disease, the right dose is reached within 3 or 4 weeks, at doses of 6 mg per day or 8 mg per day, respectively.
Slovenian: Večina bolnikov v zgodnji fazi Parkinsonove bolezni doseže ustrezni odmerek 3. ali 4. teden zdravljenja, pri odmerkih 6 mg dnevno ali 8 mg dnevno.
English: • binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Slovenian: • prenajedanje (uživanje velike količine hrane v kratkem času), kompulzivno prehranjevanje (uživanje več hrane kot običajno in več kot je potrebno za potešitev lakote).
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.
Slovenian: Neželeni učinki, o katerih so poročali pri več kot 10 % bolnikov, zdravljenih s transdermalnim obližem zdravila Neupro, so navzea, bruhanje, reakcije na mestu aplikacije, somnolenca, omotica in glavobol.
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)”.
Slovenian: Prvi dan zdravljenja bolnik začne z obližem zdravila Neupro 2 mg/24 h. V drugem tednu uporablja zdravilo Neupro 4 mg/24 h. Tretji teden uporablja zdravilo Neupro 6 mg/24 h, četrti teden pa zdravilo Neupro 8 mg/24 h. Pakiranja so označena z nalepko “1.
English: Where to stick the patch Put the sticky side of the patch onto clean, dry, healthy skin on the following areas as shown in grey on the pictures opposite:
Slovenian: Kam namestiti obliž Lepljivo stran obliža namestite na čisto, suho, zdravo kožo na spodaj navedena mesta, kot je prikazano s sivimi predeli na sliki nasproti:
English: Boxes containing 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.
Slovenian: Škatle, ki vsebujejo 7, 14, 28, 30 ali 84 (večkratno pakiranje vsebuje 3 pakiranja po 28) transdermalnih obližev, posamezno pakiranih v zaščitne vrečke.
English: Palpitationse, atrial fibrillatione, supraventricular tachycardiae
Slovenian: Srčne bolezni palpitacije atrijska fibrilacija supraventrikularna tahikardija
English: Neupro is for transdermal use.
Slovenian: Zdravilo Neupro je za transdermalno uporabo.
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, asthenic conditions and headache.
Slovenian: Neželeni učinki, o katerih so poročali pri več kot 10 % bolnikov, zdravljenih s transdermalnim obližem zdravila Neupro, so navzea, reakcije na mestu aplikacije, astenična stanja in glavobol.
English: The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.
Slovenian: Škatla vsebuje 7, 14, 28, 30 ali 84 (večkratno pakiranje vsebuje 3 pakiranja po 28) transdermalnih obližev, posamezno pakiranih v zaščitne vrečke.
English: hypersexuality, libido increased), confusional state, disorientationd, agitationd
Slovenian: hiperseksualnostjo, povečanim libidom), zmedenost, dezorientiranost d,
English: Chemin du Foriest B-1420 Braine l'Alleud Belgium
Slovenian: B-1420 Braine l'Alleud
English: Palpitationse, atrial fibrillatione, supraventricular tachycardia e
Slovenian: atrijska fibrilacija e, supraventrikularna tahikardija e
English: What Neupro contains
Slovenian: Kaj vsebuje zdravilo Neupro
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.
Slovenian: Večina reakcij na mestu aplikacije je bila blagih ali zmernih, omejenih na mesto aplikacije, zdravljenje z zdravilom Neupro pa so zaradi njih prekinili le pri 7,2 % vseh bolnikov, ki so prejemali zdravilo Neupro.
English: How to use Neupro
Slovenian: Kako uporabljati zdravilo Neupro
English: • For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths),
Slovenian: • Za odmerke, večje kot 8 mg/24 h (odmerki, ki jih je predpisal zdravnik, in so večji od razpoložljivih jakosti) je treba uporabiti več obližev za doseg končnega odmerka.
English: The patch should be applied at approximately the same time every day.
Slovenian: Zdravilo Neupro namestimo enkrat na dan. Obliž je treba namestiti vsak dan ob približno istem času.
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.
Slovenian: Pri preskušanjih, v katerih so mesto aplikacije spreminjali po navodilih iz povzetka glavnih značilnosti zdravila in navodila za uporabo, so se reakcije na mestu aplikacije pojavile pri 35,7 % od 830 bolnikov, ki so uporabljali transdermalni obliž zdravila Neupro.
English: At the beginning of the fourth week, you should take Neupro 8 mg (package marked with “Week 4”).
Slovenian: Na začetku četrtega tedna zdravljenja uporabite zdravilo Neupro 8 mg (pakiranje označeno z nalepko “4.
English: Neupro should be discontinued gradually.
Slovenian: Zdravljenje z obližem zdravila Neupro je treba prekiniti postopno.
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).
Slovenian: Na koncu vzdrževalnega zdravljenja se je pri bolnikih, zdravljenih z rotigotinom, srednja vrednost rezultatov UPDRS III. del izboljšala za 7,0 točk (izhodiščna vrednost 29.6), pri bolnikih, ki so prejemali placebo, pa za 3,9 točke (izhodiščna vrednost 32,0).
English: • movements you cannot control related to Parkinson's disease (dyskinesia)
Slovenian: • nekontolirani gibi, povezani s Parkinsonovo boleznijo (diskinezija)
English: Self adhesive matrix layer
Slovenian: Samolepilna matriksna plast:
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.
Slovenian: Pri preskušanjih, v katerih so mesto aplikacije spreminjali po navodilih iz povzetka glavnih značilnosti zdravila in navodila za uporabo, so se reakcije na mestu aplikacije pojavile pri 34,2 % od 748 bolnikov, ki so uporabljali transdermalni obliž zdravila Neupro.
English: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off' fluctuations).
Slovenian: Uporablja se kot monoterapija (brez L-dope) ali v kombinaciji z L-dopo, v poteku bolezni, do poznih faz, ko učinek L-dope popušča ali postane neustrezen ter ko se pojavijo nihanja terapevtskega učinka (ob koncu odmerjanja ali nihanja »vklop-izklop«).
English: At the beginning of the third week, you should take Neupro 6 mg (package marked with “Week 3”).
Slovenian: Na začetku tretjega tedna zdravljenja uporabite zdravilo Neupro 6 mg (pakiranje označeno z nalepko“3.
English: The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Slovenian: Dnevni odmerek zmanjšujemo v korakih po 1 mg/24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Neupro (glejte poglavje 4.4).
English: Neupro can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others.
Slovenian: Zdravilo Neupro lahko povzroči nenavadne težnje ali želje, ki se jim ne morete upreti in bi lahko škodovale vam ali drugim.
English: paranoia e, confusional state e, psychotic disorder e, delusione, deliriume
Slovenian: psihotične motnje e, blodnje e, delirij e
English: On the first day of treatment, start with Neupro 2 mg (package marked “Week 1”), and use one Neupro 2 mg transdermal patch daily.
Slovenian: Prvi dan zdravljenja začnite z zdravilom Neupro 2 mg (pakiranje označeno z nalepko “1.
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.
Slovenian: Na primer, dnevni odmerek 10 mg lahko dosežete tako, da uporabite en obliž z odmerkom 6 mg/24 h in enega z odmerkom 4 mg/24 h.
English: How to use the Neupro patches
Slovenian: Kako uporabljati Neupro obliže
English: Neupro is a patch that is put on the skin.
Slovenian: Zdravilo Neupro je obliž, ki ga prilepite na kožo.
English: The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Slovenian: Dnevni odmerek zmanjšujemo po 2 mg/24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Neupro (glejte poglavje 4.4).
English: Adverse reactions of increased creatine phosphokinase (CPK) were observed with rotigotine in clinical studies conducted in Japan.
Slovenian: Pri kliničnih študijah, izvedenih na Japonskem, so opazili neželene učinke zvišane kreatin fsofokinaze (CPK).
English: You must take your Neupro patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium.
Slovenian: Da se izognete opeklinam na koži, morate obliž zdravila Neupro morate odstraniti tik pred magnetnoresonančnim slikanjem ali kardioverzijo, saj obliž vsebuje aluminij.
English: Tell your doctor if you notice any changes in behaviour, thinking or both, that are listed below.
Slovenian: Spremembe v vedenju in nenormalno mišljenje Povejte zdravniku, če opazite kakršnekoli spremembe v vedenju, mišljenju ali obeh, kot je navedeno spodaj.
English: Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Slovenian: Bolezni kože in podkožja eritem, hiperhidroza, pruritus razširjen pruritus, draženje kože, kontaktni dermatitis razširjen izpuščaj
English: AST, ALT, GGT), weight increased e, heart rate increased e, CPK increased d,e
Slovenian: (vključno z AST, ALT, γ GT), povečanje telesne mase e, pospešeno bitje srca e, zvišan CPK