natgillin/translations-raw huggingface dataset:
116 patients were switched from previous oral therapy to receive up to 8 mg/24 h of rotigotine, among these were 47 who had been treated with ropinirole up to 9 mg/day, 47 who had been treated with pramipexole up to 2 mg/day and 22 who had been treated with cabergoline up to 3 mg/day.
116 bolnikom so peroralno zdravljenje zamenjali z zdravljenjem do 8 mg/24 ur rotigotina; med njimi je bilo 47 bolnikov zdravljenih z do 9 mg ropinirola na dan, 47 bolnikov je prejemalo do 2 mg pramipeksola na dan in 22 bolnikov se je zdravilo z do 3 mg kabergolina na dan.
In both arms treatment was titrated to optimal or maximum dose of 8 mg/24 h or 9 mg/day, respectively.
V obeh skupinah so prilagodili odmerek na optimalnega 8 mg/dan ali maksimalnega 9 mg/dan.
• abnormal heart rhythm
• nenormalen ritem srca
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Neželeni učinki, o katerih so poročali pri več kot 10 % bolnikov, zdravljenih s transdermalnim obližem zdravila Leganto, so navzea, bruhanje, reakcije na mestu aplikacije, somnolenca, omotica in glavobol.
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Legantoand 607 placebo-treated patients, 72.5% of the patients on Leganto and 58.0% of patients on placebo reported at least one adverse reaction.
Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 1.307 bolnikov, zdravljenih z zdravilom Leganto, in 607 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 72,5 % bolnikov, ki so prejemali zdravilo Leganto, in pri 58,0 % bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
• Release liner: Transparent fluoropolymer coated polyester film.
• Zaščitna plast: poliestrski film, prekrit s prozornim fluoropolimerom
In the double-blind study SP515, 201 patients received rotigotine, 200 received pramipexole and 100 patients received placebo.
V dvojno slepi študiji SP515 je 201 bolnikov prejemalo rotigotin, 200 jih je prejemalo pramipeksol, 100 bolnikov pa je prejemalo placebo.
• Hold the patch in both hands with the release liner facing you.
• Obliž primite v roke, tako da je zaščitna plast obrnjena proti vam.
Side effects more likely at the start of treatment You may feel sick (nausea) and vomit at the start of treatment.
Neželeni učinki, ki so bolj pogosti na začetku zdravljenja Na začetku zdravljenja se lahko pojavita občutek slabosti (navzea) in bruhanje.
• 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.
• 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.
In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo.
V dvojno slepi študiji SP512 del I je 177 bolnikov prejemalo rotigotin, 96 bolnikov pa placebo.
Transparent fluoropolymer coated polyester film.
Poliestrski film, prekrit s prozornim fluoropolimerom.
How to use the patch
Kako uporabljati obliž
For example, a daily dose of 14 mg may 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.
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.
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.
Za odmerke večje od 8 mg/24 h (odmerke, ki jih je predpisal zdravnik in so večji od razpoložljivih jakosti) je treba uporabiti več obližev za doseg končnega odmerka.
• redness, increased sweating, itching
• rdečica, povečano znojenje, srbenje
There is no known antidote for overdose of dopamine agonists.
Za preveliko odmerjanje agonistov dopamina ni znanega antidota.
hallucination, hallucination visual, hallucination auditory, illusion), nightmare e,
(vključno s halucinacijami, vizualnimi halucinacijami, zvočnimi halucinacijami, iluzijami), nočna mora e,
If you are not sure about this, talk to your doctor or pharmacist first.
Če niste prepričani o tem, se najprej posvetujte s svojim zdravnikom ali farmacevtom.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto are nausea, application site reactions, asthenic conditions and headache.
Neželeni učinki, o katerih so poročali pri več kot 10 % bolnikov, zdravljenih s transdermalnim obližem zdravila Leganto, so navzea, reakcije na mestu aplikacije, astenična stanja in glavobol.
• For most patients, the right dose is between 6 mg and 8 mg each day.
• Za večino bolnikov je ustrezen odmerek med 6 mg in 8 mg na dan.
On the first day of treatment the patient starts with Leganto 2 mg/24 h. During the second week, the patient takes Leganto 4 mg/24 h. During the third week, he or she takes Leganto 6 mg/24 h and during the fourth week Leganto 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”.
Prvi dan zdravljenja bolnik začne z obližem zdravila Leganto 2 mg/24 h. V drugem tednu uporablja zdravilo Leganto 4 mg/24 h. Tretji teden uporablja zdravilo Leganto 6 mg/24 h, četrti teden pa zdravilo Leganto 8 mg/24 h. Pakiranja so označena z nalepko “1.
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 ropinirolegroup after 4 weeks of maintenance.
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.
Observed in studies performed in patients with Parkinson's disease Parkinson's disease
Opaženo pri študijah z bolniki s Parkinsonovo boleznijo Parkinsonova bolezen
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Legantoand 214 placebo-treated patients, 65.5% of the patients on Leganto and 33.2% of patients on placebo reported at least one adverse reaction.
Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 748 bolnikov, zdravljenih z zdravilom Leganto, in 214 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 65,5 % bolnikov, ki so prejemali zdravilo Leganto, in pri 33,2 % bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment.
Prilagajanje odmerka pri bolnikih z blago do zmerno jetrno okvaro ni potrebno .
In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin adhesion of the improved room temperature patch formulation was compared to the cold storage formulation, using the 8 mg/24 h rotigotine patch.
V multicentrični, dvojno slepi, randomizirani, dvosmerni, navzkrižni študiji so pri 52 bolnikih primerjali oprijem na koži formulacije obliža, ki se ga shranjuje na sobni temperaturi, z obližem, ki se ga shranjuje na hladnem.
The majority of the adverse reactions of increased CPK observed in all double-blind and open-label studies resolved and were considered mild in severity.
Večino neželenih učinkov povečane CPK, ki so jih smatrali za blage.
• For most patients, the right dose is between 8 mg and 16 mg each day.
• Za večino bolnikov je ustrezen odmerek med 8 mg in 16 mg na dan.
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.
Sočasna uporaba domperidona in rotigotina ne vpliva na farmakokinetiko rotigotina.
Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)
Pomožne snovi: poli(dimetilsiloksan, trimetilsililsilikat)-kopolimerizat, povidon K90, E171, E223, E304, E307, fluoropolimer, poliester, silikon, aluminij, barvila (rumeno barvilo 95, rdeče barvilo 166, rdeče barvilo 144, črno barvilo 7).
Take the patch out of the sachet.
Obliž vzemite iz zaščitne vrečke.
• Stick the new patch on a different area of the skin each day.
• Obliž vsak dan prilepite na drugo mesto na koži.
For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively.
Pri večini bolnikov se učinkovit odmerek doseže v 3 ali 4 tednih pri odmerkih 6 mg/24 h ali 8 mg/24 h.
• Do not use alcohol or other dissolving liquids - such as nail polish remover.
• Ne uporabite alkohola ali drugih topil - kot je odstranjevalec laka za nohte, ker vam lahko razdražijo kožo.
If you are not sure about this, talk to your doctor, pharmacist or nurse first.
Če niste prepričani o tem, se najprej posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo.
V kliničnih preskušanjih z rotigotinom so opazili sinkopo, katere pogostnost je bila podobna kot pri bolnikih, ki so prejemali placebo.
For most patients with advanced-stage Parkinson's disease the right dose is reached within 3 to 7 weeks, at doses of 8 mg per day up to a maximum dose of 16 mg per day.
Večina bolnikov v napredovali fazi Parkinsonove bolezni doseže ustrezni odmerek v 3 do 7 tednih, pri odmerkih od 8 mg na dan do največjega odmerka 16 mg na dan.
Hepatic and renal impairment
Jetrna in ledvična okvara
• binge eating (eating large amount of food in a short period of time), compulsive eating (eating more food than normal and more than needed to satisfy hunger)
• prenajedanje (uživanje velike količine hrane v kratkem času), kompulzivno prehranjevanje (uživanje več hrane kot običajno in več kot je potrebno za potešitev lakote)
hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disorders a,d
(vključno s hiperseksualnostjo, povečanim libidom), nespečnost, motnje spanja, nenavadne sanje, motnje pri kontroli dražljajev a,d
• Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
• poli(dimetilsiloksan, trimetilsililsilikat)-kopolimerizat, povidon K90, natrijev metabisulfit (E223), askorbilpalmitat (E304) in DL-α-tokoferol (E307)
Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine.
Za preprečevanje nosečnosti med zdravljenjem z rotigotinom morajo ženske v rodni dobi uporabljati ustrezno kontracepcijo.
• dropped head syndrome
• driska sindrom padajoče glave
The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of illness) were primary efficacy parameters.
Primarna parametra učinkovitosti sta sprememba izhodiščne vrednosti na mednarodni lestvici sindroma nemirnih nog (IRLS - International Restless Legs Syndrome Rating Scale) in sprememba stopnje 1 splošne ocene kliničnega stanja - resnost bolezni (Clinical Global Impressions Item 1CGI-Item 1).
The mean improvement in the UPDRS score (Parts II + III) was 6.83 points (baseline 33.2 points) in the rotigotine arm, 10.78 points in the ropinirole arm (baseline 32.2 points) and 2.33 points in the placebo arm (baseline 31.3 points).
+ III. del) je bila pri bolnikih, ki so prejemali rotigotin, 6,83 točke (izhodiščna vrednost 33,2 točke), pri bolnikih, ki so prejemali ropinirol, 10,78 točke (izhodiščna vrednost 32,2 točke), pri bolnikih, ki so prejemali placebo, pa 2,33 točke (izhodiščna vrednost 31,3 točke).
Component of a multipack, can't be sold separately
28 transdermalnih obližev Del večkratnega pakiranja; ni za posamično prodajo.
One treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 4 mg, 6 mg, and 8 mg each, which are individually sealed in sachets.
Eno pakiranje za začetno zdravljenje vsebuje 28 transdermalnih obližev v 4 škatlah s 7 obliži po 2 mg, 4 mg, 6 mg, in 8 mg v vsaki, posamezno pakiranih v zaščitne vrečke.
For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.
Pri odmerkih nad 8 mg/24 h lahko za doseganje končnega odmerka uporabimo več obližev, npr. odmerek 10 mg/24 h lahko dosežemo s kombinacijo obližev z odmerkom 6 mg/24 h in 4 mg/24 h.
Vision blurred, visual impairment, photopsia
Očesne bolezni zamegljen vid, okvara vida, fotopsija
The treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 4 mg, 6 mg, and 8 mg each, individually sealed in sachets.
Pakiranje za začetno zdravljenje vsebuje 28 transdermalnih obližev v 4 škatlah s 7 obliži po 2 mg, 4 mg, 6 mg, in 8 mg v vsaki, posamezno pakiranih v zaščitne vrečke.
You must take your Leganto patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium.
Da se izognete opeklinam na koži, morate obliž zdravila Leganto odstraniti tik pred magnetnoresonančnim slikanjem ali kardioverzijo, saj obliž vsebuje aluminij.
• The maximum dose is 16 mg each day.
• Največji dnevni odmerek je 16 mg.
How to use Leganto
Kako uporabljati zdravilo Leganto
For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h.
Pri večini bolnikov se učinkovit odmerek doseže v 3 do 7 tednih pri odmerkih od 8 mg/24 h do največjega odmerka 16 mg/24 h.
In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
V dvojno slepi študiji SP513 del I je 213 bolnikov prejemalo rotigotin, 227 bolnikov je prejemalo ropinirol, 117 bolnikov pa placebo.
Palpitations e,
Srčne bolezni palpitacije e,
• weight loss, weight increase
• zmanjšanje telesne mase, povečanje telesne mase
• movements you cannot control related to Parkinson's disease (dyskinesia)
• nekontrolirani gibi povezani s Parkinsonovo boleznijo (diskinezija)
• unable to resist the impulse to perform an action that is harmful involving excessive gambling,
• nezmožnost upreti se impulzu po opravljanju določenih škodljivih dejavnosti, vključno s pretiranim hazardiranjem, ponavljanjem nesmiselnih dejanj, nekontroliranim nakupovanjem in zapravljanjem
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi,če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
In a subsequent open-label study (SP824), a multicenter, multinational study, the tolerability of overnight switching from ropinirole, pramipexole or cabergoline to rotigotine transdermal patch and its effect on symptoms in subjects with idiopathic Parkinson's disease have been studied.
V sledeči odprti študiji (SP824), multicentrični, mednarodni študiji so spremljali prenašanje in učinke na simptome pri bolnikih z idiopatsko Parkinsonovo boleznijo ob nenadni zamenjavi ropinirola, pramipeksola ali kabergolina z rotigotinskim transdermalnim obližem.
• agitation
• vznemirjenost
Which strength patches to use The dose of Lengato will depend on your illness - see below.
Katero jakost obližev uporabiti Odmerek zdravila Leganto, ki ga boste uporabljali je odvisen od vaše bolezni - glejte spodaj.
• feeling irritable
• občutek razdražljivosti
Treatment of Parkinson's disease
Zdravljenje Parkinsonove bolezni
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).
+ III. del) -3,98 točke (izhodiščna vrednost 29,9 točke), medtem ko so pri bolnikih, ki so prejemali placebo, opazili poslabšanje za 1,31 točke (izhodiščna vrednost 30,0 točke).
The box contains 7, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.
Škatla vsebuje 7, 28, 30 ali 84 (večkratno pakiranje vsebuje 3 pakiranja po 28) transdermalnih obližev, posamezno pakiranih v zaščitne vrečke.
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.
Mesto namestitve obliža ne sme biti izpostavljeno zunanji toploti (pretirani sončni svetlobi, ogrevalnim blazinam in drugim virom toplote, kot sta savna ali vroča kopel).
The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Leganto in 7.2% of subjects.
Večina reakcij na mestu aplikacije je bila blagih ali zmernih, omejenih na mesto aplikacije, zdravljenje z zdravilom Leganto pa so zaradi njih prekinili le pri 7,2 % vseh bolnikov, ki so prejemali zdravilo Leganto.
The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/24 h starting at 4 mg/24 h to a maximum dose of 16 mg/24 h. In the pramipexole group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/day.
Bolnikom so odmerek postopno povečevali do optimalnega odmerka rotigotina v tedenskih korakih po 2 mg/24 h, od 4 mg/24 h do največ 16 mg/24 h. V skupini, ki je prejemala pramipeksol, so bolniki prvi teden prejemali 0,375 mg, drugi teden 0,75 mg, nato pa so odmerek postopno povečevali v tedenskih korakih po 0,75 mg do optimalnega odmerka največ 4,5 mg/24 h. Bolniki v vseh skupinah so svoj optimalni odmerek prejemali 4 mesece.
• feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems,
• občutek zaspanosti, nenaden spanec brez opozorila, nespečnost, motnje spanja, nenavadne sanje
Orthostatic hypotension, hypertension
Žilne bolezni ortostatska hipotenzija, hipertenzija hipotenzija
Boxes containing 7, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.
Škatle, ki vsebujejo 7, 28, 30 ali 84 (večkratno pakiranje vsebuje 3 pakiranja po 28) transdermalnih obližev, posamezno pakiranih v zaščitne vrečke.
Patients taking levodopa - advanced stage of Parkinson's disease
Bolniki, ki jemljejo levodopo - napredovala faza Parkinsonove bolezni
If you notice any problems with your eyesight between checks, talk to your doctor straight away.
Če opazite kakršnekoli težave z vidom, morate o tem takoj obvestiti zdravnika.
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.
Jakosti 2 mg/24 h, 4 mg/24 h, 6 mg/24 h in 8 mg/24 h so za zdravljenje Parkinsonove bolezni.
INTERMEDIATE BOX (WITHOUT BLUE BOX) BOX OF 28 PATCHES
PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “BLUE BOXA”) ŠKATLA Z 28 OBLIŽI
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 Leganto (see section 4.4).
Dnevni odmerek zmanjšujemo v korakih po 1 mg/24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Leganto (glejte poglavje 4.4).
Skin adhesion
Oprijem na koži
Leganto 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.
Zdravilo Leganto lahko povzroči nenavadne težnje ali želje, ki se jim ne morete upreti in bi lahko škodovale vam ali drugim.
Treatment of Restless Legs Syndrome
Zdravljenje sindroma nemirnih nog
Transdermal patch rotigotine
Transdermalni obliž rotigotin
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.
Večina bolnikov v zgodnji fazi Parkinsonove bolezni doseže ustrezni odmerek 3. ali 4. teden zdravljenja, pri odmerkih 6 mg dnevno ali 8 mg dnevno.
The patch should be applied at approximately the same time every day.
Zdravilo Leganto namestimo enkrat na dan. Obliž je treba namestiti vsak dan ob približno istem času.
• Do not use alcohol or other dissolving liquids such as nail polish remover.
• Ne uporabite alkohola ali drugih topil, kot je odstranjevalec laka za nohte, ker vam lahko razdražijo kožo.
You can also use a little baby oil to remove any stickiness that will not wash off.
Lepilo, ki ga ne morete odstraniti z umivanjem, lahko odstranite z manjšo količino olja za dojenčke.
At the beginning of the fourth week, you should take Leganto 8 mg (package marked with “Week 4”).
Na začetku četrtega tedna zdravljenja uporabite zdravilo Leganto 8 mg (pakiranje označeno z nalepko “4.
delusion d, delirium d
delirij d
Neuroleptics
Nevroleptiki
In case of suspected overdose, removal of the patch(es) should be considered because after removal of the patch(es) the active substance input is stopped and the plasma concentration of rotigotine decreases rapidly.
Po odstranitvi obliža (obližev) se vnos učinkovine ustavi in plazemska koncentracija rotigotina se hitro zmanjša.
Skin problems caused by the patch
Kožne reakcije povzročene z obližem
• Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
• Oporna plast: silikoniziran aluminiziran poliestrski film, obarvan s plastjo barvila (titanov dioksid (E171), rumeno barvilo 95, rdeče barvilo 166) z natisom (rdeče barvilo 144, rumeno barvilo 95, črno barvilo 7)
Warnings and precautions Talk to your doctor or pharmacist before using Leganto.
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Leganto se posvetujte z zdravnikom ali farmacevtom, saj:
In isolated cases people have fallen asleep while driving and this has caused accidents.
V posameznih primerih je nastopil "nenaden spanec" med vožnjo, zaradi katerega so se zgodile prometne nesreče.
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 Leganto, experienced application site reactions.
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 Leganto.
Sleep attacks/sudden onset of sleep, sexual desire disorders a
Psihiatrične motnje napadi spanca/nenaden spanec, motnje spolnega poželenja a
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 Leganto (see section 4.4).
Dnevni odmerek zmanjšujemo po 2 mg/24 h, po možnosti vsak drugi dan, do popolne odtegnitve zdravila Leganto (glejte poglavje 4.4).
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 Leganto transdermal patch, experienced application site reactions.
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 Leganto.
• feeling agitated
• občutek vznemirjenosti
What Leganto is used for Leganto is used in adults to treat the signs and symptoms of:
Zakaj se uporablja zdravilo Leganto Zdravilo Leganto se uporablja pri odraslih za zdravljenje znakov in simptomov:
syncope, syncope vasovagal, loss of consciousness), dyskinesia e,
(vključno s sinkopo, vazovagalno sinkopo, izgubo zavesti) diskinezija a,
Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
Silikoniziran aluminiziran poliestrski film, obarvan s plastjo barvila (titanov dioksid (E171), rumeno barvilo 95, rdeče barvilo 166) z natisom (rdeče barvilo 144, rumeno barvilo 95, črno barvilo 7).