natgillin/translations-raw huggingface dataset:
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
90 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “ BLUE BOXA ”) ŠKATLA Z 42 [50] OBLIŽI
89 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
92 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Neupro 2 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 2 mg/ 24 h transdermalni obliž Rotigotin Transdermalna uporaba.
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) BOX OF 7 [20] [28] [30] [56] [60] [90] PATCHES
93 PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z “ BLUE BOXOM ”) (RAZEN PAKIRANJ Z VEČ OBLIŽI) ŠKATLA S 7 [20] [28] [30] [56] [60] [90] OBLIŽI
Neupro 3 mg/24 h transdermal patch Rotigotine
Neupro 3 mg/ 24 h transdermalni obliž Rotigotin
91 9.
94 9.
EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/048 [20 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/051 [56 transdermal patches] EU/1/05/331/052 [60 transdermal patches] EU/1/05/331/054 [90 transdermal patches]
EU/ 1/ 05/ 331/ 047 [7 transdermalnih obližev] EU/ 1/ 05/ 331/ 049 [28 transdermalnih obližev] EU/ 1/ 05/ 331/ 048 [20 transdermalnih obližev] EU/ 1/ 05/ 331/ 050 [30 transdermalnih obližev] EU/ 1/ 05/ 331/ 051 [56 transdermalnih obližev] EU/ 1/ 05/ 331/ 052 [60 transdermalnih obližev] EU/ 1/ 05/ 331/ 054 [90 transdermalnih obližev]
92 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY OUTER LABEL (WITH BLUE BOX) BOX OF 84 [100] PATCHES CONTAINING 2 BOXES OF 42 [50] PATCHES
95 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “ BLUE BOXOM ”) ŠKATLA S 84 [100] OBLIŽI, KI VSEBUJE 2 ŠKATLI S PO 42 [50] OBLIŽI
EU/1/05/331/053 [84 transdermal patches] EU/1/05/331/055 [100 transdermal patches]
EU/ 1/ 05/ 331/ 053 [84 transdermalnih obližev] EU/ 1/ 05/ 331/ 055 [100 transdermalnih obližev]
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
97 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “ BLUE BOXA ”) ŠKATLA Z 42 [50] OBLIŽI
96 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
99 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Neupro 3 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 3 mg/ 24 h transdermalni obliž Rotigotin Transdermalna uporaba.
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) BOX OF 7 [20] [28] [30] [56] [60] [90] PATCHES
100 PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z “ BLUE BOXOM ”) (RAZEN PAKIRANJ Z VEČ OBLIŽI) ŠKATLA S 7 [20] [28] [30] [56] [60] [90] OBLIŽI
Neupro 4 mg/24 h transdermal patch Rotigotine
Neupro 4 mg/ 24 h transdermalni obliž Rotigotin
98 9.
101 9.
EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/020 [20 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/022 [56 transdermal patches] EU/1/05/331/023 [60 transdermal patches] EU/1/05/331/025 [90 transdermal patches]
EU/ 1/ 05/ 331/ 004 [7 transdermalnih obližev] EU/ 1/ 05/ 331/ 005 [28 transdermalnih obližev] EU/ 1/ 05/ 331/ 020 [20 transdermalnih obližev] EU/ 1/ 05/ 331/ 021 [30 transdermalnih obližev] EU/ 1/ 05/ 331/ 022 [56 transdermalnih obližev] EU/ 1/ 05/ 331/ 023 [60 transdermalnih obližev] EU/ 1/ 05/ 331/ 025 [90 transdermalnih obližev]
99 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY OUTER LABEL (WITH BLUE BOX) BOX OF 84 [100] PATCHES CONTAINING 2 BOXES OF 42 [50] PATCHES
102 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “ BLUE BOXOM ”) ŠKATLA S 84 [100] OBLIŽI, KI VSEBUJE 2 ŠKATLI S PO 42 [50] OBLIŽI
84 transdermal patches; multipack, containing 2 boxes with 42 patches each 100 transdermal patches, multipack, containing 2 boxes with 50 patches each
100 transdermalnih obližev.
EU/1/05/331/024 [84 transdermal patches] EU/1/05/331/006 [100 transdermal patches]
EU/ 1/ 05/ 331/ 024 [84 transdermalnih obližev] EU/ 1/ 05/ 331/ 006 [100 transdermalnih obližev]
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
104 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “ BLUE BOXA ”) ŠKATLA Z 42 [50] OBLIŽI
103 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
106 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Neupro 4 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 4 mg/ 24 h transdermalni obliž Rotigotin Transdermalna uporaba.
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) BOX OF 7 [20] [28] [30] [56] [60] [90] PATCHES
107 PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z “ BLUE BOXOM ”) (RAZEN PAKIRANJ Z VEČ OBLIŽI) ŠKATLA S 7 [20] [28] [30] [56] [60] [90] OBLIŽI
Neupro 6 mg/24 h transdermal patch Rotigotine
Neupro 6 mg/ 24 h transdermalni obliž Rotigotin
Each patch of 30 cm2 contains 1 3.5 mg of rotigotine.
En obliž s površino 30 cm2 vsebuje 13, 5 mg rotigotina.
105 9.
108 9.
EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/026 [20 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/028 [56 transdermal patches] EU/1/05/331/029 [60 transdermal patches] EU/1/05/331/031 [90 transdermal patches]
EU/ 1/ 05/ 331/ 007 [7 transdermalnih obližev] EU/ 1/ 05/ 331/ 008 [28 transdermalnih obližev] EU/ 1/ 05/ 331/ 026 [20 transdermalnih obližev] EU/ 1/ 05/ 331/ 027 [30 transdermalnih obližev] EU/ 1/ 05/ 331/ 028 [56 transdermalnih obližev] EU/ 1/ 05/ 331/ 029 [60 transdermalnih obližev] EU/ 1/ 05/ 331/ 031 [90 transdermalnih obližev]
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY OUTER LABEL (WITH BLUE BOX) BOX OF 84 [100] PATCHES CONTAINING 2 BOXES OF 42 [50] PATCHES
109 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “ BLUE BOXOM ”) ŠKATLA S 84 [100] OBLIŽI, KI VSEBUJE 2 ŠKATLI S PO 42 [50] OBLIŽI
EU/1/05/331/030 [84 transdermal patches] EU/1/05/331/009 [100 transdermal patches]
EU/ 1/ 05/ 331/ 030 [84 transdermalnih obližev] EU/ 1/ 05/ 331/ 009 [100 transdermalnih obližev]
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
111 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “ BLUE BOXA ”) ŠKATLA Z 42 [50] OBLIŽI
110 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
113 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Neupro 6 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 6 mg/ 24 h transdermalni obliž Rotigotin Transdermalna uporaba.
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) BOX OF 7 [20] [28] [30] [56] [60] [90] PATCHES
114 PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z “ BLUE BOXOM ”) (RAZEN PAKIRANJ Z VEČ OBLIŽI) ŠKATLA S 7 [20] [28] [30] [56] [60] [90] OBLIŽI
Neupro 8 mg/24 h transdermal patch Rotigotine
Neupro 8 mg/ 24 h transdermalni obliž Rotigotin
112 9.
115 9.
EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/032 [20 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/034 [56 transdermal patches] EU/1/05/331/035 [60 transdermal patches] EU/1/05/331/037 [90 transdermal patches]
EU/ 1/ 05/ 331/ 010 [7 transdermalnih obližev] EU/ 1/ 05/ 331/ 011 [28 transdermalnih obližev] EU/ 1/ 05/ 331/ 032 [20 transdermalnih obližev] EU/ 1/ 05/ 331/ 033 [30 transdermalnih obližev] EU/ 1/ 05/ 331/ 034 [56 transdermalnih obližev] EU/ 1/ 05/ 331/ 035 [60 transdermalnih obližev] EU/ 1/ 05/ 331/ 037 [90 transdermalnih obližev]
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY OUTER LABEL (WITH BLUE BOX) BOX OF 84 [100] PATCHES CONTAINING 2 BOXES OF 42 [50] PATCHES
116 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “ BLUE BOXOM ”) ŠKATLA S 84 [100] OBLIŽI, KI VSEBUJE 2 ŠKATLI S PO 42 [50] OBLIŽI.
EU/1/05/331/036 [84 transdermal patches] EU/1/05/331/012 [100 transdermal patches]
EU/ 1/ 05/ 331/ 036 [84 transdermalnih obližev] EU/ 1/ 05/ 331/ 012 [100 transdermalnih obližev]
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
118 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “ BLUE BOXA ”) ŠKATLA Z 42 [50] OBLIŽI
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
120 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Neupro 8 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 8 mg/ 24 h transdermalni obliž Rotigotin Transdermalna uporaba.
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
121 PODATKI NA ZUNANJI OVOJNINI
BOX OF 28 PATCHES –TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
ŠKATLA Z 28 OBLIŽI – PAKIRANJE ZA ZAČETNO ZDRAVLJENJE – 4- TEDENSKI RAZPORED ZDRAVLJENJA
Transdermal patch Rotigotine
Transdermalni obliž Rotigotin
Neupro 2 mg/24 h Each patch releases 2 mg of rotigotine per 24 hours.
Neupro 2 mg/ 24 h En obliž sprosti 2 mg rotigotina v 24 urah.
Neupro 4 mg/24 h Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 4 mg/ 24 h En obliž sprosti 4 mg rotigotina v 24 urah.
Neupro 6 mg/24 h Each patch releases 6 mg of rotigotine per 24 hours.
Neupro 6 mg/ 24 h En obliž sprosti 6 mg rotigotina v 24 urah.
Neupro 8 mg/24 h Each patch releases 8 mg of rotigotine per 24 hours.
Neupro 8 mg/ 24 h En obliž sprosti 8 mg rotigotina v 24 urah.
Treatment initiation pack with 28 transdermal patches for a 4 week treatment schedule contains:
Pakiranje za začetno zdravljenje z 28 transdermalnimi obliži za 4- tedenski razpored zdravljenja vsebuje:
7 transdermal patches of Neupro 2 mg/24 h 7 transdermal patches of Neupro 4 mg/24 h 7 transdermal patches of Neupro 6 mg/24 h 7 transdermal patches of Neupro 8 mg/24 h
7 transdermalnih obližev Neupro 2 mg/ 24 h 7 transdermalnih obližev Neupro 4 mg/ 24 h 7 transdermalnih obližev Neupro 6 mg/ 24 h 7 transdermalnih obližev Neupro 8 mg/ 24 h
119 Transdermal use.
Transdermalna uporaba.
120 16.
123 16.
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
124 PODATKI NA ZUNANJI OVOJNINI
BOX OF 7 PATCHES – WEEK 1
TEDEN
Week 1.
7 transdermalnih obližev 1. teden
Store in the original package.
125 Shranjujte v originalni ovojnini.
123 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
126 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SACHET LABEL – WEEK 1
TEDEN
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
127 PODATKI NA ZUNANJI OVOJNINI
BOX OF 7 PATCHES – WEEK 2
TEDEN
Week 2.
7 transdermalnih obližev 2. teden
Store in the original package.
128 Shranjujte v originalni ovojnini.
126 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
129 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SACHET LABEL – WEEK 2
TEDEN
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
130 PODATKI NA ZUNANJI OVOJNINI
BOX OF 7 PATCHES – WEEK 3
TEDEN
Week 3.
7 transdermalnih obližev 3. teden
Store in the original package.
131 Shranjujte v originalni ovojnini.
129 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
132 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SACHET LABEL - WEEK 3
TEDEN
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
133 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
BOX OF 7 PATCHES – WEEK 4
TEDEN
Week 4
7 transdermalnih obližev 4. teden
Store in the original package.
134 Shranjujte v originalni ovojnini.
132 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
135 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SACHET LABEL – WEEK 4
TEDEN
133 B.
136 B.
INFORMATION FOR THE USER
137 NAVODILO ZA UPORABO
What Neupro is and what it is used for 2.
Kaj je zdravilo Neupro in za kaj ga uporabljamo 2.
Before you use Neupro 3.
Kaj morate vedeti, preden boste uporabili zdravilo Neupro 3.
How to use Neupro 4.
Kako uporabljati zdravilo Neupro 4.
How to store Neupro 6.
Shranjevanje zdravila Neupro 6.
WHAT NEUPRO IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NEUPRO IN ZA KAJ GA UPORABLJAMO
Neupro belongs to a group of medicines called dopamine agon ists which stimulate a certain type of cells that bind with dopamine receptors in the brain.
Zdravilo Neupro spada v skupino zdravil, imenovanih dopaminski agonisti, ki spodbujajo določeno vrsto celic, da se vežejo z dopaminskimi receptorji v možganih.
- the signs and symptoms of Restless Legs Syndrome (RLS), a condition that is characterized by
Zdravilo Neupro se uporablja za zdravljenje: − znakov in simptomov sindroma nemirnih nog (Restless Legs Syndrome - RLS), stanja, ki je opisano kot nepremagljiva nuja po premikanju nog.
BEFORE YOU USE NEUPRO
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO NEUPRO
Do NOT use Neupro
NE uporabljajte zdravila Neupro
- if you are allergic (hypersensitive) to rotigotine or any of the other ingredients of Neupro (see
- če ste alergični na (preobčutljivi za) rotigotin ali katerokoli sestavino zdravila Neupro (glejte
Section 6, ‘Further information’).
poglavje 6, ‘ Dodatne informacije ’).
- if you need to have magnetic resonance imaging (method to visualise internal organs and
- če vam bodo opravili magnetnoresonančno slikanje (metoda za prikaz notranjih organov in
tissues of the body) or cardioversion (treatment of abnormal heart rhythm).
tkiv) ali kardioverzijo (zdravljenje nenormalnega srčnega ritma).
You must take your Neupro patch off before such procedures.
Pred takimi postopki morate obliž zdravila Neupro odstraniti.
You can put a new patch on after the procedure.
Po postopku lahko namestite nov obliž.
Take special care with Neupro
Bodite posebno pozorni pri uporabi zdravila Neupro
- This medicine may affect your blood pressure, so it should be measured regularly, especially at
- To zdravilo lahko vpliva na vaš krvni tlak, zato ga morate redno meriti, zlasti na začetku
the beginning of your treatment.
zdravljenja.
- Eye examinations are recommended at regular intervals while using Neurpo.
- Pri uporabi zdravila Neupro so priporočljivi redni okulistični pregledi.
However, if you
Če med pregledi
notice any problems with your sight in -between examinations, you should contact your doctor immediately.
nastopijo težave z vidom, morate o tem takoj obvestiti svojega zdravnika.
- If you have serious liver problems, your doctor may need to adjust the dose.
- Če imate resne težave z jetri, bo mogoče moral vaš zdravnik prilagoditi odmerek.
If during treatment
Če se med
your liver problems get worse, you should contact your doctor as soon as possible.
zdravljenjem težave z jetri poslabšajo, se morate čimprej posvetovati s svojim zdravnikom.
135
138
- If you feel very drowsy or find that you fall asleep suddenly, please contact your doctor (see
- Če ste zelo dremavi ali če nenadno zaspite, se posvetujte s svojim zdravnikom (glejte tudi
also below in this section, under ‘Driving and using machines’).
poglavje 2, 'Vpliv na sposobnost upravljanja vozil in strojev').
- As with other medicines in this class, Neupro may cause excessive gambling and increased sex
- Kot pri ostalih zdravilih iz tega razreda lahko zdravilo Neupro povzroči pretirano hazardiranje
drive.
in povečan spolni nagon.
- Neupro may cause hallucinations (seeing or hearing things that are not real).
- Zdravilo Neupro lahko povzroči halucinacije (videnje in slišanje stvari, ki niso resnične).
If you notice such
Če
effects, please contact your doctor.
opazite takšne znake, se posvetujte s svojim zdravnikom.
- As with every patch or bandage, Neupro can cause skin reactions, such as reddening and
- Kot vsi obliži in preveze lahko zdravilo Neupro povzroči kožne reakcije, kot sta rdečica in
itching.
srbenje.
Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by Neupro.
Izogibajte se izpostavljanju predela kože, na katerih so kakršnekoli kožne reakcije, ki jih je povzročilo zdravilo Neupro, sončni svetlobi in svetlobi v solariju.
- Neupro should not be used by children.
- Zdravila Neupro ne smete uporabiti pri otrocih.
You should not take the following medicines while using Neupro, because they may decrease its effect: anti-psychotics (used to treat certain mental conditions) or metoclopramide (used to treat nausea and vomiting).
Naslednjih zdravil ne smete jemati med uporabo zdravila Neupro, saj lahko zmanjšajo njegovo učinkovitost: antipsihotiki (zdravila, za zdravljenje določenih duševnih stanj) ali metoklopramid (uporablja se za zdravljenje slabosti in bruhanja).
If you are treated with Neupro and levodopa at the same time, some side effects may get more serious, such as seeing or hearing things that are not real (hallucinations), involuntary movements related to Parkinson’s disease (dyskinesia), and swelling of legs and feet.
Če se sočasno zdravite z zdravilom Neupro in L- dopo, lahko nekateri neželeni učinki postanejo resnejši, kot na primer videnje in slišanje stvari, ki niso resnične (halucinacije), neželeni gibi povezani s Parkinsonovo boleznijo (diskinezija) in otekanje nog ter stopal.
conditions or depression) while you are using Neupro.
Vprašajte zdravnika, ali je med uporabo zdravila Neupro varno: − piti alkohol ali − jemati sedative, na primer benzodiazepin (zdravila za zdravljenje duševnih motenj in depresije).
Using Neupro with food and drink
Uporaba zdravila Neupro skupaj s hrano in pijačo
Tell your doctor if you are pregnant or planning to become pregnant.
Povejte zdravniku, če ste noseči ali če načrtujete nosečnost.
Rotigotine may pass into your breast milk and affect your baby and is also likely to reduce the amount of milk you produce.
Prav tako lahko zmanjša količino mleka.
136 Driving and using machines
139 Vpliv na sposobnost upravljanja vozil in strojev
If this affects you, you should not drive or take part in activities where not being alert may put you or others at risk of serious injury, for example, using machines.
Če zdravilo tako učinkuje na vas, ne smete voziti ali opravljati dejavnosti, na primer uporabljati strojev, pri katerih lahko zmanjšana pozornost vas ali druge izpostavi tveganju za resne poškodbe.
HOW TO USE NEUPRO
KAKO UPORABLJATI ZDRAVILO NEUPRO
Always use Neupro exactly as your doctor has told you.
Pri uporabi zdravila Neupro natančno upoštevajte zdravnikova navodila.
Neupro is generally used as a long term treatment.
Zdravilo Neupro se običajno uporablja za dolgotrajno zdravljenje.
Normally, you will start your treatment with a low dose and, if necessary, increase it week by week, as told by your doctor, until reaching the right dose for you.
Zdravljenje boste začeli z nizkimi odmerki in jih, če bo treba, tedensko zviševali po navodilu zdravnika, dokler ne boste dosegli ustreznega odmerka za vas.
You will then continue treatment with this dose, also called the maintenance dose.
Zdravljenje boste nato nadaljevali s tem odmerkom (ti. vzdrževalnim odmerkom).
You should change your Neupro patch once a day.
Obliž zdravila Neupro morate zamenjati enkrat dnevno.
For reaching the needed doses, different patches of Neupro are available, each releasing a different amount of the active substance per day:
Za doseganje potrebnih odmerkov so na voljo različni obliži zdravila Neupro, vsak sprosti različno količino aktivne učinkovine na dan:
1 mg/24 h, 2 mg/24 h and 3 mg/24 h.
1 mg/ 24 h, 2 mg/ 24 h in 3 mg/ 24 h.
Treatment of Restless Legs Syndrome You will start by using one Neupro 1 mg/24 h patch daily.
Zdravljenje sindroma nemirnih nog Začeli boste z uporabo enega obliža zdravila Neupro 1 mg/ 24 h dnevno.
If necessary, this daily dose may be increased by 1 mg, on a weekly basis, until reaching the right (maintenance) dose for you.
Če bo treba, boste odmerek po zdravnikovih navodilih tedensko zviševali po 1 mg, dokler ne boste dosegli ustreznega (vzdrževalnega) odmerka za vas.
The maximum dose is 3 mg per day.
Maksimalni dnevni odmerek je 3 mg.
FOLLOW THESE INSTRUCTIONS WHEN USING NEUPRO:
PRI UPORABI ZDRAVILA NEUPRO UPOŠTEVAJTE NASLEDNJA NAVODILA:
Put the sticky side of the patch onto clean, dry, healthy skin on the following areas, as indicated by the grey areas in the picture: • shoulder • upper arm • belly • thigh • hip • flank (your side, between your ribs and your hip).
Lepljivo stran obliža namestite na čisto, suho, zdravo kožo na mestih, kot je prikazano s sivimi predeli na sliki:
To help avoid skin irritation: • Stick the patch onto a different area of skin each day, for example on the right side of your body one day, then on the left side the next day; on your upper body one day, then on your lower body.
rama, nadlaket, trebuh, stegno, kolk, bok (med rebri in kolkom).
137 • Do not stick Neupro on the same area of skin twice within 14 days. • Do not stick the patch on broken or damaged skin or on skin that is red or irritated.
140 • Obliž zdravila Neupro vsak dan nalepite na drugo mesto na koži (na primer na desno stran telesa en dan, nato na levo stran naslednji dan ter na zgornji del telesa en dan, nato na spodnji del telesa). • Obliža zdravila Neupro ne nalepite ponovno na isto mesto prej kot v 14 dneh. • Obliža zdravila Neupro ne uporabite na razpokani ali poškodovani koži ali na koži, ki je pordela ali razdražena.
If you still get problems with your skin because of the patch, please see in Section 4 ‘Possible side effects’ the details about what you should do.
Če imate zaradi obliža še vedno probleme s kožo, si podrobnosti o tem, kaj morate storiti poglejte v poglavju 4 ‘ Možni neželeni učinki ’.
To prevent the patch becoming loose or falling off • Do not put the patch in an area where it can be rubbed by tight clothing. • Do not use creams, oils, lotions, powders or other skin products on the area of skin you will be sticking the patch on or near a patch you are already wearing. • If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days before sticking the patch there.
Da bi preprečili zrahljanje obliža in njegovo odlepitev • Obliža ne namestite na mesto, kjer se bodo ob njega drgnila tesna oblačila. • Ne uporabljajte krem, olj, losjonov, pudrov ali drugih izdelkov za kožo na mestu, kjer boste nalepili obliž, ali v bližini obliža, ki ga že nosite. • Če morate obliž nalepiti na poraščeno mesto na koži, morate to mesto obriti vsaj tri dni pred namestitvijo obliža.
NOTE • Bathing, showering and exercising should not affect how Neupro works.
OPOMBA • Kopanje, prhanje in telovadba ne bi smeli vplivati na delovanje zdravila Neupro.
Nevertheless, check that the patch has not fallen off afterwards. • You should avoid external heat (for example excessive sunlight, saunas, hot baths heating pads or hot-water bottles) on the area of the patch. • If the patch has irritated your skin, you should keep that area protected from direct sunlight, as it may cause changes in the colour of the skin.
Vendar pozneje preverite, ali se je obliž odlepil. • Izogibajte se zunanji toploti (na primer pretiranemu sončenju, savnam, vročim kopelim, uporabi ogrevalnih blazin ali termoforjev) na mestu, kjer je obliž. • Če obliž razdraži kožo, to mesto na koži zaščitite pred direktno sončno svetlobo, ker lahko povzroči spremembo obarvanosti kože.
You should stick Neupro onto your skin as soon as you have opened the sachet and removed the protective liner.
Obliž zdravila Neupro morate nalepiti na kožo takoj, ko odprete zaščitno vrečko in odstranite zaščitno plast.
The sticky side of the patch is covered by a transparent protective liner.
Lepljiva stran obliža je pokrita s prozorno zaščitno plastjo.
Hold the patch in both hands with the protective liner facing you.
Obliž primite v roke, tako da je zaščitna plast obrnjena proti vam.
4.
141 4.
Peel off one side of the protective liner.
Odstranite eno stran zaščitne plasti.
Hold the other half of the rigid protective liner and put the sticky surface of the patch onto your skin.
Primite drugo polovico trdne zaščitne plasti in namestite lepljivo površino obliža na kožo.