FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Na koncu vzdrževalnega zdravljenja je bil optimalni odmerek pri 91 % bolnikov, ki so prejemali rotigotin, največji dovoljeni odmerek, tj. 6 mg/24 h. 20-odstotno izboljšanje so opazili pri 48 % bolnikov, ki so prejemali rotigotin, in pri 19 % bolnikov, ki so prejemali placebo (razlika 29 %, CI95% 18 % - 39 %, p<0,0001).
English: How to use the Leganto patches
Slovenian: Kako uporabljati Leganto obliže
English: Using higher doses of Leganto 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 Leganto, kot bi smeli Uporaba večjih odmerkov zdravila Leganto, kot vam je predpisal zdravnik, lahko povzroči neželene učinke kot so občutek slabost (navzea) ali bruhanje, nizek krvni tlak, videnje ali slišanje stvari, ki niso resnične (halucinacije), občutek zmedenosti, hude zaspanosti, nehoteni gibi in konvulzije.
English: • The maximum dose is 3 mg per day.
Slovenian: • Največji dnevni odmerek je 3 mg.
English: Reproductive system and breast disorder
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija
English: • feeling sick (nausea), vomiting
Slovenian: • občutek slabosti (navzea), bruhanje
English: Leganto was not investigated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo jetrno okvaro zdravila Leganto niso raziskovali.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih padci a
English: Leganto 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: pathological gambling, stereotypy/ punding, binge eating/eating disorder b, compulsive shopping c)
Slovenian: (vključno s patološkim hazardiranjem, ponavljanjem nesmiselnih dejanj, prenajedanjem/ motnjami prehranjevanja b kompulzivnim nakupovanjem c)
English: Use and handling
Slovenian: Priprava in ravnanje z zdravilom
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: On the first day of treatment, start with Leganto 2 mg (package marked “Week 1”), and use one Leganto 2 mg transdermal patch daily.
Slovenian: Prvi dan zdravljenja začnite z zdravilom Leganto 2 mg (pakiranje označeno z nalepko “1.
English: Do not take the following medicines while using Leganto - because they may decrease its effect:
Slovenian: Naslednjih zdravil ne jemljite med uporabo zdravila Leganto, saj lahko zmanjšajo njegov učineko:
English: At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects receiving placebo (Difference rotigotine versus placebo 25%, CI95% 13%; 36%, difference pramipexole versus placebo 32%, CI95% 21%; 43%, difference pramipexole versus rotigotine 7%, CI95% -2%; 17%).
Slovenian: Na koncu vzdrževalnega zdravljenja so opazili vsaj 30-odstotno izboljšanje pri 60 % bolnikov, ki so prejemali rotigotin, pri 67 % bolnikov, ki so prejemali pramipeksol, in pri 35 % bolnikov, ki so prejemali placebo (razlika med rotigotinom in placebom je bila 25 %; CI95% 13 % - 36 %, razlika med pramipeksolom in placebom je bila 32 %; CI95% 21 % - 43 %, razlika med pramipeksolom in rotigotinom je bila 7 %; CI95% -2 % - 17 %).
English: At the beginning of the third week, you should take Leganto 6 mg (package marked with “Week 3”).
Slovenian: Na začetku tretjega tedna zdravljenja uporabite zdravilo Leganto 6 mg (pakiranje označeno z nalepko“3.
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 Leganto 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: 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 fosfokinaze (CPK).
English: • constipation, dry mouth, heartburn
Slovenian: • zaprtje, suha usta, zgaga
English: paranoia e, confusional state e, psychotic disorder e, delusion e, delirium e
Slovenian: psihotične motnje e, blodnje e, delirij e
English: At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%, CI95% 7.6%; 25.7%).
Slovenian: Na koncu vzdrževalnega zdravljenja je bil optimalni odmerek pri 92 % bolnikov, ki so prejemali rotigotin, največji dovoljeni odmerek, tj. 8 mg/24 h. 20-odstotno izboljšanje so opazili pri 52 % bolnikov, ki so prejemali rotigotin, 68 % bolnikov, ki so prejemali ropinirol, in pri 30 % bolnikov, ki so prejemali placebo (razlika med rotigotinom in placebom je bila 21,7 %; CI95% 11,1 % - 32,4 %; razlika med ropinirolom in placebom je bila 38,4 %, CI95% 28,1 %- 48,6 %; razlika med ropinirolom in rotigotinom je bila 16,6 %, CI95% 7,6 % - 25,7 %).
English: AST, ALT, GGT), weight increased, heart rate increased, CPK increased d
Slovenian: (vključno z AST, ALT, γ GT), povečanje telesne mase e, pospešeno bitje srca e, zvišan CPK
English: • Thigh or hip.
Slovenian: • stegno ali kolk.
English: Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal function.
Slovenian: Ravni konjugatov rotigotina in njegovih presnovkov po dealkilaciji v plazmi se pri okvarjenem delovanju ledvic povečajo, vendar ni vpliva teh presnovkov na klinične učinke
English: A dose reduction might be needed in case of worsening of the hepatic impairment.
Slovenian: Če se jetrna okvara poslabša, bo mogoče potrebno zmanjšanje odmerka.
English: • vertigo (sensation of whirling motion)
Slovenian: • vrtoglavica (občutek vrtenja)
English: Constipation e,
Slovenian: zmedenost e,
English: • if you have serious liver problems, your doctor may need to change the dose.
Slovenian: • vam bo moral zdravnik prilagoditi odmerek, če imate resne težave z jetri.
English: Leganto 2 mg/24 h Leganto 4 mg/24 h Leganto 6 mg/24 h Leganto 8 mg/24 h Transdermal patch
Slovenian: Leganto 2 mg/24 h Leganto 4 mg/24 h Leganto 6 mg/24 h Leganto 8 mg/24 h Transdermalni obliž rotigotin
English: Each patch of 30 cm contains 13.5 mg of rotigotine.
Slovenian: Vsak obliž s površino 30 cm vsebuje 13,5 mg rotigotina.
English: CGI-I responder rates (much improved, very much improved) were 43.0% and 67.5% for placebo and rotigotine respectively (difference 24.5% CI 95%: 14.2%; 34.8%, p<0.0001).
Slovenian: Stopnje odziva po CGI-1 (precej izboljšan, zelo izboljšan) so bile 43,0 % za placebo in 67,5% za rotigotin (razlika 24,5% CI95%: 14,2 % - 34,8 %, p<0,0001) V 7-tedenskem, s placebom nadzorovanem preskušanju so bili raziskani polisomnografski parametri.
English: • abnormal heart beat
Slovenian: • nenormalen srčni ritem
English: If your doctor says you should stop Leganto, the daily dose should be lowered gradually:
Slovenian: Če se zdravnik odloči za prenehanje zdravljenja z zdravilom Leganto, je treba dnevni odmerek zdravila Leganto morate zmanjševati postopoma:
English: What Leganto is Leganto contains the active substance rotigotine.
Slovenian: Kaj je zdravilo Leganto Zdravilo Leganto vsebuje učinkovino rotigotin.
English: • skin irritations under the patch such as redness and itching
Slovenian: • draženje kože pod obližem, kot sta rdečica in srbenje
English: Side effects when using Leganto for Restless Legs Syndrome Tell your doctor or pharmacist if you notice any of the following side effects:
Slovenian: Neželeni učinki pri uporabi zdravila Leganto za zdravljenje sindroma nemirnih nog Če se pojavijo naslednji neželeni učinki se posvetujte z zdravnikom ali farmacevtom:
English: Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
Slovenian: Pri nekaterih bolnikih, ki so zdravljeni z dopaminergičnimi snovmi, pridelanimi iz ergota, so poročali o primerih retroperitonealne fibroze, pljučnih infiltratov, plevralnega izliva, plevralne odebelitve, perikarditisa in srčne valvulopatije.
English: At the end of the maintenance treatment an improvement of at least 30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/24 h and 12 mg/24 h, respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively, CI95% 10%; 35% and 8%; 33%, respectively, p<0.001 for both rotigotine groups).
Slovenian: Na koncu vzdrževalnega zdravljenja so opazili vsaj 30-odstotno izboljšanje pri 57 % bolnikov, ki so prejemali 8 mg rotigotina/24 h, pri 55 % bolnikov, ki so prejemali 12 mg rotigotina/24 h, in pri 34 % bolnikov, ki so prejemali placebo (pri skupini, ki je prejemala 8 mg rotigotina/24 h, je bila razlika 22 %; CI95% 10 % - 35 %, pri skupini, ki je prejemala 12 mg rotigotina/24 h, pa 21 %; CI95% 8 % - 33 %, p<0,001 pri obeh skupinah, ki sta prejemali rotigotin).
English: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and
Slovenian: Samolepilna matriksna plast poli(dimetilsiloksan, trimetilsililsilikat)-kopolimerizat, povidon K90, natrijev metabisulfit (E223), askorbilpalmitat (E304) in
English: If you still get problems with your skin because of the patch, please see ‘Skin problems caused by the patch' in section 4 for more information.
Slovenian: Če imate zaradi obliža še vedno težave s kožo, si za dodatne informacije poglejte ‘Kožne reakcije, povzročene z obližem' v poglavju 4.
English: The mean reduction in the “off” time was 2.5 hours in the rotigotine arm, 2.8 hours in the pramipexole arm and 0.9 hours in the placebo arm. All differences between the active treatments and placebo were statistically significant.
Slovenian: Srednja vrednost zmanjšanja časa »izklop« je bila pri skupini, ki je prejemala rotigotin, 2,5 ure, pri skupini, ki je prejemala pramipeksol, 2,8 ure, pri skupini, ki je prejemala placebo, pa 0,9 ure.
English: Observed in studies performed in patients with Parkinson's disease Description of selected adverse reactions
Slovenian: Opaženo pri študijah z bolniki s Parkinsonovo boleznijo Opis izbranih neželenih učinkov Nenaden spanec in somnolenca
English: Augmentation may occur.
Slovenian: Pojavi se lahko avgmentacija.
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: At the beginning of the second week, you should take Leganto 4 mg (package marked with “Week 2”).
Slovenian: Na začetku drugega tedna zdravljenja uporabite zdravilo Leganto 4 mg (pakiranje označeno z nalepko “2.
English: • Press the patch down firmly with the palm of your hand.
Slovenian: • Obliž z dlanjo močno pritisnite.
English: Erythema e, hyperhidrosis e,
Slovenian: Bolezni kože in podkožja pruritus eritem e, hiperhidroza e,
English: Then, the patch is fold back and the second part of the release liner is removed.
Slovenian: Nato obliž prepognemo nazaj in odstranimo še drugo polovico zaščitne plasti.
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see section 4.4).
Slovenian: Pri bolnikih, zdravljenih z agonisti dopamina, vključno z rotigotinom, se lahko pojavi patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prehranjevanje (glejte poglavje 4.4).
English: Leganto may make you feel very sleepy and you may fall asleep very suddenly.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Leganto ste lahko zelo zaspani in lahko povsem nenadno zaspite.
English: • The maximum dose is 8 mg each day.
Slovenian: • Največji dnevni odmerek je 8 mg.
English: The outside is tan-coloured and is imprinted with Leganto 1 mg/24 h or 3 mg/24 h.
Slovenian: Zunanja stran je rumenorjave barve, z natisnjenim napisom Leganto 1 mg/24 h ali 3 mg/24 h.
English: • Make sure that you take the old patch off before putting on a new one.
Slovenian: • Preden nalepite nov obliž, se prepričajte, da ste odstranili stari obliž.
English: BOX OF 7 PATCHES - WEEK 1
Slovenian: ŠKATLA S 7 OBLIŽI - 1.
English: Leganto may decrease blood pressure when you stand up
Slovenian: Zdravilo Leganto lahko zniža krvni tlak, ko vstanete - ta učinek se lahko poslabša ob jemanju zdravila za zniževanje krvnega tlaka.
English: Ophthalmologic monitoring
Slovenian: Okulistični nadzor
English: • Keep it pressed for about
Slovenian: • Pritiskajte približno 30
English: Each patch of 15 cm contains 6.75 mg of rotigotine.
Slovenian: Vsak obliž s površino 15 cm vsebuje 6,75 mg rotigotina.
English: hallucination, hallucination visual, hallucination auditory, illusion), insomnia, sleep disorder, nightmare, abnormal dreams, impulsecontrol disorders a,d
Slovenian: (halucinacije, vizualne halucinacije, zvočne halucinacije, iluzije), nespečnost, motnje spanja, nočne more, nenavadne sanje, motnje pri kontroli dražljajev a,d napadi spanca/nenaden spanec, paranoja, motnje spolnega poželenja a
English: Aggressive behaviour/ aggression b, disorientation d
Slovenian: obsesivno kompulzivna motnja, agitiranost d nasilno vedenje/ agresivnost b, dezorientiranost d dopaminski disregulacijski sindrom c,
English: Each patch of 40 cm contains 18.0 mg of rotigotine.
Slovenian: Vsak obliž s površino 40 cm vsebuje 18,0 mg rotigotina.
English: Peel apart the foil.
Slovenian: Odstranite folijo.
English: • Peel off one side of the release liner.
Slovenian: • Odstranite eno stran zaščitne plasti.
English: fatigue, asthenia, malaise)
Slovenian: (vključno z utrujenostjo, astenijo, splošnim slabim počutjem)
English: dermatitis contact e, rash generalised e
Slovenian: kontaktni dermatitis e,
English: • 8 mg/24 h: Each patch releases 8 mg of rotigotine per 24 hours.
Slovenian: • 8 mg/24 h: Vsak obliž sprosti 8 mg rotigotina v 24 urah.
English: BOX OF 7 PATCHES - WEEK 4
Slovenian: ŠKATLA S 7 OBLIŽI - 4.
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi Oporna plast
English: Each patch of 5 cm contains 2.25 mg of rotigotine.
Slovenian: En obliž s površino 5 cm2 vsebuje 2,25 mg rotigotina.
English: dizziness postural e, lethargy e, convulsion e
Slovenian: posturalna omotica e, letargija e,
English: The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS).
Slovenian: Ocena primarne končne točke raziskave je bila rezultat komponente dnevnih aktivnosti (ADL) (II.
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditions a
Slovenian: (vključno z eritemom, pruritusom, draženjem, izpuščajem, dermatitisom, mehurji, bolečino, ekcemom, vnetjem, oteklino, razbarvanjem, papulami, lupljenjem, koprivnico, preobčutljivostjo), astenična stanja a
English: The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 16 mg/24 h over 8 weeks, followed by a maintenance period of 4 weeks.
Slovenian: 8 tednov so bolnikom odmerek postopno povečevali do optimalnega odmerka rotigotina ali placeba v tedenskih korakih po 2 mg/24 h, od 2 mg/24 h do največjega odmerka 16 mg/24 h, nato so 4 tedne prejemali vzdrževalni odmerek.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)
Slovenian: (vključno z eritemom, pruritusom, draženjem, izpuščajem, dermatitisom, mehurji, bolečino, ekcemom, vnetjem, oteklino, razbarvanjem, papulami, lupljenjem, koprivnico, preobčutljivostjo)
English: The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 6 mg/24 h. Patients in each treatment group were maintained at their optimal dose for 6 months.
Slovenian: Bolnikom so odmerek postopno povečevali do optimalnega odmerka rotigotina ali placeba v tedenskih korakih po 2 mg/24 h, od 2 mg/24 h do največjega odmerka 6 mg/24 h. Bolniki v vseh skupinah so svoj optimalni odmerek prejemali 6 mesecev.
English: • loss of consciousness, involuntary movements (dyskinesia)
Slovenian: • izguba zavesti, nehoteni gibi (diskinezija)
English: Hypertension Orthostatic hypotension
Slovenian: Žilne bolezni hipertenzija ortostatska hipotenzija hipotenzija e
English: The patients were titrated to their optimal doses of rotigotine or placebo in weekly increments of 2 mg/24 h starting at 4 mg/24 h. Patients in each treatment group were maintained at their optimal dose for 6 months.
Slovenian: Bolnikom so odmerek postopno povečevali do optimalnega odmerka rotigotina ali placeba v tedenskih korakih po 2 mg/24 h, z začetnim odmerkom 4 mg/24 h. Bolniki v vseh skupinah so svoj optimalni odmerek prejemali 6 mesecev.
English: BOX OF 7 PATCHES - WEEK 3
Slovenian: ŠKATLA S 7 OBLIŽI - 3.
English: The outside is tan-coloured and is imprinted with Leganto 4 mg/24 h Leganto 6 mg/24 h or Leganto 8 mg/24 h.
Slovenian: Zunanja stran je rumenorjave barve, z natisnjenim napisom Leganto 4 mg/24 h, Leganto 6 mg/24 h ali Leganto 8 mg/24 h.
English: Leganto 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 8 mg/24 h'.
Slovenian: Leganto 8 mg/24 h transdermalni obliž Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Leganto 8 mg/24 h'.
English: Each patch of 20 cm contains 9.0 mg of rotigotine.
Slovenian: Vsak obliž s površino 20 cm vsebuje 9,0 mg rotigotina.
English: Skin adhesion was measured on 2 consecutive days of 24 hours patch application.
Slovenian: Uporabljeni so bili obliži z rotigotinom 8 mg/24 h. Oprijem na koži so merili 2 zaporedna dneva z uporabo vsakega obliža 24 ur.
English: Dopaminergic adverse reactions
Slovenian: Dopaminergični neželeni učinki
English: 7 transdermal patches of Leganto 6 mg/24 h
Slovenian: 7 transdermalnih obližev Leganto 6 mg/24 h
English: 7 transdermal patches of Leganto 8 mg/24 h
Slovenian: 7 transdermalnih obližev Leganto 8 mg/24 h
English: BOX OF 7 PATCHES - WEEK 2
Slovenian: ŠKATLA S 7 OBLIŽI - 2.
English: The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided.
Slovenian: Obliž namestimo na čisto, suho, nepoškodovano zdravo kožo na trebuhu, stegnih, kolkih, bokih, ramah ali nadlahteh.
English: Put the patch in the original sachet and then throw it away safely, out of the reach of children.
Slovenian: Po odstranitvi je treba obliž prepogniti na pol, z lepljivo plastjo navznoter, ga dati v originalno zaščitno vrečko in nato odstraniti tako, da je zunaj dosega otrok.
English: Transdermal use.
Slovenian: transdermalni obliž
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Slovenian: Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h ali 8 mg/24 h'.
English: 7 transdermal patches of Leganto 4 mg/24 h
Slovenian: 7 transdermalnih obližev Leganto 4 mg/24 h
English: Nausea, vomiting Constipation, dry mouth, dyspepsia
Slovenian: Bolezni prebavil navzea, bruhanje zaprtje, suha usta, dispepsija bolečine v trebuhu driska c
English: • swelling of legs and feet
Slovenian: • otekanje nog in stopal
English: How to store Leganto
Slovenian: Shranjevanje zdravila Leganto
English: • feeling dizzy
Slovenian: • bruhanje, zgaga
English: Leganto 8 mg/24 h transdermal patch EU/1/11/695/046
Slovenian: Leganto 8 mg/24 h transdermalni obliž EU/1/11/695/046
English: 1 transdermal patch
Slovenian: 1 transdermalni obliž
English: • 3 mg/24 h: Each patch releases 3 mg of rotigotine per 24 hours.
Slovenian: • 3 mg/24 h: Vsak obliž sprosti 3 mg rotigotina v 24 urah.
English: • falling
Slovenian: • padci
English: • Each patch releases 2 mg of rotigotine per 24 hours.
Slovenian: • Vsak obliž sprosti 2 mg rotigotina v 24 urah.
English: • 6 mg/24 h: Each patch releases 6 mg of rotigotine per 24 hours.
Slovenian: • 6 mg/24 h: Vsak obliž sprosti 6 mg rotigotina v 24 urah.
English: In both cases, use a new patch at the usual time on the following day.
Slovenian: V obeh primerih zamenjajte obliž z novim ob običajnem času naslednji dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Each patch of 10 cm contains 4.5 mg of rotigotine.
Slovenian: En obliž s površino 10 cm2 vsebuje 4,5 mg rotigotina.
English: Leganto 8 mg/24 h transdermal patch Each patch releases 8 mg of rotigotine per 24 hours.
Slovenian: Leganto 8 mg/24 h transdermalni obliž En obliž sprosti 8 mg rotigotina v 24 urah.
English: The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 2 mg/24 h'.
Slovenian: Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Leganto 2 mg/24 h'.
English: Leganto 1 mg/24 h transdermal patch EU/1/11/695/001
Slovenian: Leganto 1 mg/24 h transdermalni obliž EU/1/11/695/001
English: • diarrhoea
Slovenian: • blodnje
English: Leganto 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 6 mg/24 h'.
Slovenian: Leganto 6 mg/24 h transdermalni obliž Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Leganto 6 mg/24 h'.
English: • feeling weak (fatigue)
Slovenian: • občutek šibkosti (izčrpanost)
English: Each patch releases 1 mg of rotigotine per 24 hours.
Slovenian: Vsak obliž sprosti 1 mg rotigotina v 24 urah.
English: System/organ classes acc. to MedDRA
Slovenian: Organski sistem po MedDRA
English: • Talk to your doctor if you have a skin reaction that lasts longer than a few days or is severe.
Slovenian: • Če imate kožno reakcijo, ki traja dlje kot nekaj dni ali je huda ali se razširi zunaj mesta, ki ga je pokrival obliž, se posvetujte z zdravnikom.
English: dry mouth e, abdominal pain e, diarrhoea c
Slovenian: Bolezni dihal, prsnega koša in mediastinalne ga prostora kolcanje e