qanastek/EMEA-V3 huggingface dataset:
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. • 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.
Biex tgħin li tevita irritazzjoni tal- ġilda: • Waħħal impjastru fuq zona differenti tal- ġilda kuljum, per eżempju, fuq in- naħa tal- lemin ta ’ ġismek f’ ġurnata minnhom, imbagħad fuq in- naħa tax- xellug l- għada u fuq in- naħa ta ’ fuq ta ’ ġismek f’ ġurnata oħra, imbagħad l- għada fuq in- naħa t’ isfel ta ’ ġismek. • M’ għandekx twaħħal Neupro fuq l- istess zona tal- ġilda darbtejn fi żmien 14- il jum. • Twaħħalx l- impjastru fuq ġilda li tkun maqsuma jew jew fiha xi ferita jew fuq ġilda li hi ħamra jew irritata.
Each patch is packed in a separate sachet..
Kull impjastru hu ppakkjat f’ qartas separat.
How to remove a used patch
153 Kif tneħħi impjastru użat
148 Do not use alcohol or other dissolving liquids such as nail polish remover as these may irritate your skin.
Tużax alkoħol jew solventi oħrajn bħal nail polish remover għax dawn jistgħu jirritawlek il- ġilda.
If you stop using Neupro
Jekk tieqaf tuża Neupro
In order to avoid such symptoms, your daily dose of Neupro should be reduced gradually • by 1 mg every other day - if you use Neupro for Restless Legs Syndrome or • by 2 mg every other day - if you use Neupro for Parkinson’s disease
Sabiex tevita dawn is- sintomi, id- doża tiegħek ta ’ kuljum ta ’ Neupro għandha titnaqqas gradwalment • b’ 1 mg kull jumejn – jekk tuża Neupro għas- sindromu ta ’ Restless Legs, jew • b’ 2 mg kull jumejn – jekk tuża Neupro għall- marda ta ’ Parkinson.
149 • irritability • allergic reaction • sleepiness, falling asleep suddenly without warning, difficulty in sleeping, sleep problems, having unusual dreams • increased sex drive • itching • high blood pressure
Effetti sekondarji komuni ħafna (li jseħħu f’ iktar minn 1 minn kull 10 pazjent) • tħossok ħażin (dardir) • irritazzjonijiet tal- ġilda taħt il- garża, bħal ħmura u ħakk • debboleza (għajja) • uġigħ ta ’ ras 154 Effetti sekondarji komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 100) • rimettar, ħruq ta’ istonku • irritabilita ’ • reazzjoni allerġika • ngħas, li torqod għal għarrieda mingħajr l- ebda sinjal ta ’ twissija, problemi biex torqod, problem ta ’ l- irqad, ħolm mhux tas- soltu • xenqa ikbar għal attività sesswali • ħakk • pressjoni għolja tad- demm
Rare side effects (affects 1 to 10 users in 10,000) • unwanted and uncontrolled thoughts and behaviors
Effetti sekondarji rari (li jseħħu f’ 1 sa 10 pazjeni minn kull 10, 000) • ħsibijiet u aġir mhux kontrollati u mixtieqa
If you are using Neupro for Parkinson’s disease the following side effects may occur:
Jekk qed tuża Neupro għall- marda ta ’ Parkinson, dawn l- effetti mhux mixtieqa jistgħu jseħħu:
Very common side effects (affects more than 1 user in 10) • sleepiness, dizziness • feeling sick (nausea) • skin irritations under the patch such as redness and itching
Effetti sekondarji komuni ħafna (li jseħħu f’ iktar minn 1 minn kull 10 pazjent) • ngħas, sturdament • tħossok ħażin (dardir) • irritazzjonijiet tal- ġilda taħt il- garża, bħal ħmura u ħakk
Common side effects (affects 1 to 10 users in 100) • seeing or hearing things that are not real (hallucinations), confusion, having unusual dreams, difficulty in sleeping • involuntary movements related to Parkinson’s disease (dyskinesia), feeling dizzy when standing up because of a fall in blood pressure, headache • vomiting, diarrhoea, constipation, heartburn, dry mouth • increased or abnormal liver function test results • rash, redness, itching, increased sweating • swelling of legs and feet, feeling weak, weight loss • falling
Effetti sekondarji komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 100) • li tara jew tisma ’ affarijiet li mhumiex reali (alluċinazzjonijiet), konfużjoni, ikollok ħolm mhux tas- soltu, ma tkunx tista ’ torqod • movimenti involontarji marbuta mal- marda ta ’ Parkinson (diskinesija), tħossok stordut meta tqum bilwieqfa jew wara li toqgħod bilqiegħda minħabba tnaqqis fil- pressjoni tad- demm, uġigħ ta ’ ras • rimettar, dijareja, stitikezza, ħruq ta’ istonku, ħalq xott • riżultati tat- testijiet li juru żieda jew anormalità fil- funzjoni tal- fwied • raxx, ħmura, ħakk, żieda fl- għaraq • nefħa fir- riġlejn u fis- saqajn, tħossok dgħajjef, tnaqqis fil- piż • taqa ’
Uncommon side effects (affects 1 to 10 users in 1,000) • allergic reaction • loss of appetite, decreased appetite • falling asleep suddenly without warning, psychotic disorders including abnormal thinking about reality and behaviour (paranoid psychosis), unusual urge to perform an action that is harmful including excessive gambling and repetitive meaningless actions, increased sex drive, anxiety, sleep problems, nightmares, disorientation • fainting, fainting due to a fall in blood pressure, slow movement or extended spasm in group of muscles, increased sleepiness, feeling of tiredness or lack of energy (lethargy), reduced concentration, loss of memory, numbness or tingling sensation, food and drink tasting different, poor balance, tremors • visual disturbances such as seeing colours or lights, or blurred vision • a feeling of dizziness or "spinning" (vertigo) • abnormal heart rhythm, increased heart rate, feeling of heart beat (palpitation) • high blood pressure, low blood pressure • cough, hiccups, shortness of breath • stomach discomfort and pain • generalised itching, skin rash, skin irritation • swelling of the joints • being unable to achieve or maintain an erection • being unable to walk properly, feeling abnormal, weight increase
Effetti sekondarji mhux komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) • Reazzjonijiet allerġiċi • Telf t’ aptit, nuqqas t’ aptit • li torqod għal għarrieda mingħajr l- ebda sinjal ta ’ twissija, mard psikotiku li jinkludu ħsibijiet anormali dwar ir- realtà u l- imġiba (psikosi paranojde), xenqa mhux tas- soltu biex twettaq ċerti attivitajiet, li jinkludu logħob ta ’ l- azzard eċċessiv, azzjonijiet ripetuti bla sens u xenqa ikbar għal attività sesswali, ansjetà, problemi biex torqod, ħmar il- lejl, diżorjentament • ħass ħażin, ħass ħażin minħabba tnaqqis fil- pressjoni tad- demm, moviment bil- mod jew spażmu li jdum fi grupp ta ’ muskoli, żieda fin- ngħas, tħossok għajjien jew mingħajr enerġija (letarġija), nuqqas ta ’ konċentrazzjoni, telf ta ’ memorja, sensazzjoni ta ’ tmewwit jew tnemnim, ittiegħem l - ikel u x- xorb b’ mod differenti, nuqqas ta ’ bilanċ, rogħda • disturbi tal- vista bħal meta tara kuluri jew dwal jew vista mċajpra, • tħossok stordut jew kollox idur bik (vertigo) • rata irregolari ta ’ taħbit tal- qalb, rata mgħaġġla ta ’ taħbit tal- qalb, tħoss qalbek tħabbat bl- għaġla (palpitazzjonijiet) • żieda fil- pressjoni tad- demm, tnaqqis fil- pressjoni tad- demm • sogħla, sulluzzu, qtugħ ta ’ nifs
150 Rare side effects (affects 1 to 10 users in 10,000) • involuntary muscle spasms (fits) • loss of consciousness
Effetti sekondarji rari (li jseħħu f’ 1 sa 10 pazjenti minn kull 10, 000) • spażmi involontarji tal- muskoli (aċċessjonijiet) • tintilef minn sensik.
• Keep out of the reach and sight of children. • Do not use Neupro after the expiry date which is stated on the label and carton. • Store in a refrigerator (2°C – 8°C). • Store in the original package.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax Neupro wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna. • Aħżen fi friġġ. • Aħżen fil- pakkett oriġinali.
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).
Film tal- polyester film, silikoniżżat, aluminiżżat, miksi b’ kulur permezzz ta ’ saff ta ’ pigment (titanium dioxide (E171), pigment isfar 95, pigment aħmar 166) u stampat (pigment aħmar 144, pigment isfar 95, pigment iswed 7).
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 2 mg/ 24 h stampat fuqha.
Not all pack sizes may be marketed.
156 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
151 Shannon, Industrial Estate, Co.Clare, Ireland
Shannon, Industrial Estate, Co. Clare, L- Irlanda
Italia UCB Pharma S.p.A.
157 Suomi/ Finland Italia UCB Pharma Oy Finland UCB Pharma S. p. A.
153 PACKAGE LEAFLET:
158 FULJETT TA ’ TAGĦRIF:
an irresistible urge to move the legs..
b’ impuls irreżistibbli li ċċaqlaq riġlejk.
- If you have serious liver problems, your doctor may need to adjust the dose.
Jekk għandek problemi serji tal- fwied, lit- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża.
If during treatment
-
Driving and using machines
160 Sewqan u tħaddim ta ’ magni
155 Neupro may make you feel very drowsy, and you may fall asleep very suddenly.
Neupro jistgħu jġiegħlek tħossok bi ngħas ħafna, u tista ’ torqod għal għarrieda ħafna.
You should stick a new Neupro patch onto the skin once a day.
Għandek twaħħal impjastru fuq il- ġilda darba kuljum.
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. • 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.
Biex tgħin li tevita irritazzjoni tal- ġilda: • Waħħal Neupro fuq zona differenti tal- ġilda kuljum, per eżempju, fuq in- naħa tal- lemin ta ’ ġismek f’ ġurnata minnhom, imbagħad fuq in- naħa tax- xellug l- għada u fuq in- naħa ta ’ fuq ta ’ ġismek f’ ġurnata oħra, imbagħad l- għada fuq in- naħa t’ isfel ta ’ ġismek. • M’ għandekx twaħħal Neupro fuq l- istess zona tal- ġilda darbtejn fi żmien 14- il jum.
156 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.
Jekk xorta jkollok il- problemi fil- ġilda minħabba l- impjastru, jekk jogħġbok ara f ’ Sezzjoni 4 ‘ Effetti sekondarji li jista ’ jkollu ’, id- dettalji dwar x’ għandek tagħmel.
157 5.
162 5.
158 If you stop using Neupro
163 Jekk tieqaf tuża Neupro
159 • Do not use Neupro after the expiry date which is stated on the label and carton. • Store in a refrigerator (2°C – 8°C). • Store in the original package.
164 • Aħżen fi friġġ. • Aħżen fil- pakkett oriġinali.
Used patches still contain active substance, which may be harmful to others.
L- impjastri wżat xorta jkun għad fihom s- sustanza attiva, li jista ’ jkun ta ’ ħsara lil ħaddieħor.
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).
Film tal- polyester film, silikoniżżat, aluminiżżat, miksi b’ kulur permezz ta ’ saff ta ’ pigment (titanium dioxide (E171), pigment isfar 95, pigment aħmar 166) u stampat (pigment aħmar 144, pigment isfar 95, pigment iswed 7).
The outside is tan-coloured and is imprinted with Neupro 3 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 3 mg/ 24 h stampat fuqha.
Malta Pharmasud Ltd.
165 Malta Česká republika Pharmasud Ltd.
161 This leaflet was last approved in {MM/YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
162 PACKAGE LEAFLET:
166 FULJETT TA ’ TAGĦRIF:
- the signs and symptoms of Parkinson’s disease either alone or in combination with the drug
Neupro jintuża biex jikkura s- sinjali u s- sintomi tal- marda ta ’ Parkinson jew waħdu jew flimkien mal - mediċina msejħa levodopa.
Take special care with Neupro
Oqgħod attent ħafna b’ Neupro Din il- mediċina tista ’ taffettwalek il- pressjoni tad- demm, u għalhekk din ta ’ l- aħħar għandha
- This medicine may affect your blood pressure, so it should be measured regularly, especially at
-
also below in this section, under ‘Driving and using machines’).
167 tiegħek (ara wkoll, aktar l- isfel f’ din is- sezzjoni, taħt ‘ Sewqan u tħaddim ta ’ magni ’).
Driving and using machines
168 Sewqan u tħaddim ta ’ magni
164 Neupro may make you feel very drowsy, and you may fall asleep very suddenly.
Neupro jistgħu jġiegħlek tħossok bi ngħas ħafna, u tista ’ torqod għal għarrieda ħafna.
2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h.
2 mg/ 24 siegħa, 4 mg/ 24 siegħa, 6 mg/ 24 siegħa u 8 mg/ 24 siegħa.
Patients taking levodopa (advanced stage of Parkinson’s disease) You will start by using one Neupro 4 mg/24 h patch daily.
Pazjenti li jieħdu levodopa (istadju avvanzat tal- marda ta ’ Parkinson) Fil- bidu tal- kura ser tibda tuża impjastru ta ’ Neupro 4 mg/ 24 siegħa kuljum.
Where to stick the patch
Fejn twaħħal l- impjastru
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
169 Poġġi n- naħa li teħel tal- impjastru fuq ġilda li tkun nadifa, xotta, f’ saħħitha f’ dawn iż- żoni li ġejjin: • spalla • in- naħa ta ’ fuq tad- driegħ • żaqq • koxxa • ġenbejn • il- ġenb tal- ġisem (fuq ġenbejk, bejn il- kustilji u l- ġenbejn).
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. • 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.
Biex tgħin li tevita irritazzjoni tal- ġilda: • Waħħal l- impastru fuq zona differenti tal- ġilda kuljum, per eżempju, fuq in- naħa tal- lemin ta ’ ġismek f’ ġurnata minnhom, imbagħad fuq in- naħa tax- xellug l- għada u fuq in- naħa ta ’ fuq ta ’ ġismek f’ ġurnata oħra, imbagħad l- għada fuq in- naħa t’ isfel ta ’ ġismek. • M’ għandekx twaħħal Neupro fuq l- istess zona tal- ġilda darbtejn fi żmien 14- il jum. • Twaħħalx l- impjastru fuq ġilda li tkun maqsuma jew jew fiha xi ferita jew fuq ġilda li hi ħamra jew irritata.
Using higher doses of Neupro than your doctor has prescribed may cause side effects such as nausea (feeling sick), vomiting, low blood pressure, hallucinations (seeing or hearing things that are not real), confusion or extreme sleepiness.
171 Jekk tuża dożaġġi ogħla ta ’ Neupro minn dawk li kitiblek t- tabib tiegħek, dan jista ’ jikkawża dardir (tħossok ħażin), rimettar, pressjoni tad- demm baxxa, alluċinazzjonijiet (tara u tisma ’ affarijiet li mhumiex vera), konfużjoni jew ngħas estrem.
167 If you have forgotten to change the patch at the usual time
Jekk tinsa tibdel l- impjastru fil- ħin tas- soltu
In order to avoid such symptoms, your daily dose of Neupro should be reduced gradually • by 2 mg every other day - if you use Neupro for Parkinson’s disease
Sabiex tevita dawn is- sintomi, id- doża tiegħek ta ’ kuljum ta ’ Neupro għandha titnaqqas gradwalment • b’ 2 mg kull jumejn – jekk tuża Neupro għall- marda ta ’ Parkinson.
Common side effects (affects 1 to 10 users in 100) • seeing or hearing things that are not real (hallucinations), confusion, having unusual dreams, difficulty in sleeping • involuntary movements related to Parkinson’s disease (dyskinesia), feeling dizzy when standing up because of a fall in blood pressure, headache • vomiting, diarrhoea, constipation, heartburn, dry mouth • increased or abnormal liver function test results • rash, redness, itching, increased sweating • swelling of legs and feet, feeling weak, weight loss • falling
Effetti sekondarji komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 100)
Uncommon side effects (affects 1 to 10 users in 1,000) • allergic reaction • loss of appetite, decreased appetite • falling asleep suddenly without warning, psychotic disorders including abnormal thinking about reality and behaviour (paranoid psychosis), unusual urge to perform an action that is harmful
• li tara jew tisma ’ affarijiet li mhumiex reali (alluċinazzjonijiet), konfużjoni, ikollok ħolm mhux tas- soltu, ma tkunx tista ’ torqod • movimenti involontarji marbuta mal- marda ta ’ Parkinson (diskinesija), tħossok stordut meta tqum bilwieqfa jew wara li toqgħod bilqiegħda minħabba tnaqqis fil- pressjoni tad- demm, uġigħ ta ’ ras • rimettar, dijareja, stitikezza, ħruq ta’ istonku, ħalq xott • riżultati tat- testijiet li juru żieda jew anormalità fil- funzjoni tal- fwied • raxx, ħmura, ħakk, żieda fl- għaraq • nefħa fir- riġlejn u fis- saqajn, tħossok dgħajjef, tnaqqis fil- piż • taqa ’
168 including excessive gambling and repetitive meaningless actions, increased sex drive, anxiety, sleep problems, nightmares, disorientation • fainting, fainting due to a fall in blood pressure, slow movement or extended spasm in group of muscles, increased sleepiness, feeling of tiredness or lack of energy (lethargy), reduced concentration, loss of memory, numbness or tingling sensation, food and drink tasting different, poor balance, tremors • visual disturbances such as seeing colours or lights, or blurred vision • a feeling of dizziness or "spinning" (vertigo) • abnormal heart rhythm, increased heart rate, feeling of heart beat (palpitation) • high blood pressure, low blood pressure • cough, hiccups, shortness of breath • stomach discomfort and pain • generalised itching, skin rash, skin irritation • swelling of the joints • being unable to achieve or maintain an erection • being unable to walk properly, feeling abnormal, weight increase
172 Effetti sekondarji mhux komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) • Reazzjonijiet allerġiċi • Telf t’ aptit, nuqqas t’ aptit • li torqod għal għarrieda mingħajr l- ebda sinjal ta ’ twissija, mard psikotiku li jinkludu ħsibijiet anormali dwar ir- realtà u l- imġiba (psikosi paranojde), xenqa mhux tas- soltu biex twettaq ċerti attivitajiet, li jinkludu logħob ta ’ l- azzard eċċessiv, azzjonijiet ripetuti bla sens u xenqa ikbar għal attività sesswali, ansjetà, problemi biex torqod, ħmar il- lejl, diżorjentament • ħass ħażin, ħass ħażin minħabba tnaqqis fil- pressjoni tad- demm, moviment bil- mod jew spażmu li jdum fi grupp ta ’ muskoli, żieda fin- ngħas, tħossok għajjien jew mingħajr enerġija (letarġija), nuqqas ta ’ konċentrazzjoni, telf ta ’ memorja, sensazzjoni ta ’ tmewwit jew tnemnim, ittiegħem l - ikel u x- xorb b’ mod differenti, nuqqas ta ’ bilanċ, rogħda • disturbi tal- vista bħal meta tara kuluri jew dwal jew vista mċajpra, • tħossok stordut jew kollox idur bik (vertigo) • rata irregolari ta ’ taħbit tal- qalb, rata mgħaġġla ta ’ taħbit tal- qalb, tħoss qalbek tħabbat bl- għaġla (palpitazzjonijiet) • żieda fil- pressjoni tad- demm, tnaqqis fil- pressjoni tad- demm • sogħla, sulluzzu, qtugħ ta ’ nifs • skonfort u wġigħ fl- istonku • ħakk ġeneralizzat, raxx fil- ġilda, irritazzjoni tal- ġilda • nefħa fil- ġogi • ma jkunx jista ’ jkollok jew iżżomm erezzjoni • ma tkunx tista ’ timxi sewwa, ma tħossokx normali, żieda fil- piż
Rare side effects (affects 1 to 10 users in 10,000) • involuntary muscle spasms (fits) • loss of consciousness
Effetti sekondarji rari (li jseħħu f’ 1 sa 10 minn kull 10, 000) • spażmi involontarji tal- muskoli (aċċessjonijiet) • tintilef minn sensik.
• The other ingredients are poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
173 • Is- sustanzi l- oħra huma poly( dimethylsiloxane, trimethylsilyl silicate) - copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) u DL- α- tocopherol (E307).
Polyester film, siliconized, aluminized, olour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144,
Film tal- polyester film, silikoniżżat, aluminiżżat, miksi b’ kulur permezzz ta ’ saff ta ’ pigment (titanium dioxide (E171), pigment isfar 95, pigment aħmar 166) u stampat (pigment aħmar 144, pigment isfar 95, pigment iswed 7).
The outside is tan-coloured and is imprinted with Neupro 4 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 4 mg/ 24 h stampat fuqha.
España UCB Pharma, S.A.
174 Portugal España UCB Pharma (Produtos Farmacêuticos), Lda UCB Pharma, S. A.
171 PACKAGE LEAFLET:
175 FULJETT TA ’ TAGĦRIF:
What Neupro is and what it is used for 2.
X’ inhu Neupro u għalxiex jintuża '2.
- This medicine may affect your blood pressure, so it should be measured regularly, especially at
Din il- mediċina tista ’ taffettwalek il- pressjoni tad- demm, u għalhekk din ta ’ l- aħħar għandha
Rotigotine may pass into your breast milk and affect your baby and is also likely to reduce the amount of milk you produce.
177 sidrek u jaffettwa lit- tarbija tiegħek, u x’ aktarx inaqqas ukoll l- ammont ta ’ ħalib li tipproduċi.
173 Neupro may make you feel very drowsy, and you may fall asleep very suddenly.
Neupro jistgħu jġiegħlek tħossok bi ngħas ħafna, u tista ’ torqod għal għarrieda ħafna.
Treatment of Parkinson’s disease Patients not taking levodopa (early stage of Parkinson’s disease) You will start by using one Neupro 2 mg/24 h patch daily.
Trattament tal- Marda ta ’ Parkinson Pazjenti li m’ humiex jieħdu levodopa (istadju bikri tal- marda ta ’ Parkinson) Fil- bidu tal- kura ser tibda tuża impjastru wieħed ta ’ Neupro 2 mg/ 24 siegħa kuljum.
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
178 Poġġi n- naħa li teħel tal- impjastru fuq ġilda li tkun nadifa, xotta, f’ saħħitha f’ dawn iż- żoni li ġejjin: • spalla • in- naħa ta ’ fuq tad- driegħ • żaqq • koxxa • ġenbejn • il- ġenb tal- ġisem (fuq ġenbejk, bejn il- kustilji u l- ġenbejn).
3.
179 3.
Using higher doses of Neupro than your doctor has prescribed may cause side effects such as nausea (feeling sick), vomiting, low blood pressure, hallucinations (seeing or hearing things that are not real), confusion or extreme sleepiness.
180 Jekk tuża dożaġġi ogħla ta ’ Neupro minn dawk li kitiblek t- tabib tiegħek, dan jista ’ jikkawża dardir (tħossok ħażin), rimettar, pressjoni tad- demm baxxa, alluċinazzjonijiet (tara u tisma ’ affarijiet li mhumiex vera), konfużjoni jew ngħas estrem.
176 If you have forgotten to change the patch at the usual time
Jekk tinsa tibdel l- impjastru fil- ħin tas- soltu
177 including excessive gambling and repetitive meaningless actions, increased sex drive, anxiety, sleep problems, nightmares, disorientation • fainting, fainting due to a fall in blood pressure, slow movement or extended spasm in group of muscles, increased sleepiness, feeling of tiredness or lack of energy (lethargy), reduced concentration, loss of memory, numbness or tingling sensation, food and drink tasting different, poor balance, tremors • visual disturbances such as seeing colours or lights, or blurred vision • a feeling of dizziness or "spinning" (vertigo) • abnormal heart rhythm, increased heart rate, feeling of heart beat (palpitation) • high blood pressure, low blood pressure • cough, hiccups, shortness of breath • stomach discomfort and pain • generalised itching, skin rash, skin irritation • swelling of the joints • being unable to achieve or maintain an erection • being unable to walk properly, feeling abnormal, weight increase
181 Effetti sekondarji mhux komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) • Reazzjonijiet allerġiċi • Telf t’ aptit, nuqqas t’ aptit • li torqod għal għarrieda mingħajr l- ebda sinjal ta ’ twissija, mard psikotiku li jinkludu ħsibijiet anormali dwar ir- realtà u l- imġiba (psikosi paranojde), xenqa mhux tas- soltu biex twettaq ċerti attivitajiet, li jinkludu logħob ta ’ l- azzard eċċessiv, azzjonijiet ripetuti bla sens u xenqa ikbar għal attività sesswali, ansjetà, problemi biex torqod, ħmar il- lejl, diżorjentament • ħass ħażin, ħass ħażin minħabba tnaqqis fil- pressjoni tad- demm, moviment bil- mod jew spażmu li jdum fi grupp ta ’ muskoli, żieda fin- ngħas, tħossok għajjien jew mingħajr enerġija (letarġija), nuqqas ta ’ konċentrazzjoni, telf ta ’ memorja, sensazzjoni ta ’ tmewwit jew tnemnim, ittiegħem l - ikel u x- xorb b’ mod differenti, nuqqas ta ’ bilanċ, rogħda • disturbi tal- vista bħal meta tara kuluri jew dwal jew vista mċajpra, • tħossok stordut jew kollox idur bik (vertigo) • rata irregolari ta ’ taħbit tal- qalb, rata mgħaġġla ta ’ taħbit tal- qalb, tħoss qalbek tħabbat bl- għaġla (palpitazzjonijiet) • żieda fil- pressjoni tad- demm, tnaqqis fil- pressjoni tad- demm • sogħla, sulluzzu, qtugħ ta ’ nifs • skonfort u wġigħ fl- istonku • ħakk ġeneralizzat, raxx fil- ġilda, irritazzjoni tal- ġilda • nefħa fil- ġogi • ma jkunx jista ’ jkollok jew iżżomm erezzjoni • ma tkunx tista ’ timxi sewwa, ma tħossokx normali, żieda fil- piż
Rare side effects (affects 1 to 10 users in 10,000) • involuntary muscle spasms (fits) • loss of consciousness
Effetti sekondarji rari (li jseħħu f’ 1 sa 10 pazjenti minn kull 10, 000) • spażmi involontarji tal- muskoli (aċċessjonijiet) • tintilef minn sensik.
• The other ingredients are poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
182 • Is- sustanzi l- oħra huma poly( dimethylsiloxane, trimethylsilyl silicate) - copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) u DL- α- tocopherol (E307).
Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144,
Film tal- polyester film, silikoniżżat, aluminiżżat, miksi b’ kulur permezzz ta ’ saff ta ’ pigment (titanium dioxide (E171), pigment isfar 95, pigment aħmar 166) u stampat (pigment aħmar 144, pigment isfar 95, pigment iswed 7).
The outside is tan-coloured and is imprinted with Neupro 6 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 6 mg/ 24 h stampat fuqha.
Shannon, Industrial Estate, Co.Clare, Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
España UCB Pharma, S.A.
183 Portugal España UCB Pharma (Produtos Farmacêuticos), Lda UCB Pharma, S. A.
180 PACKAGE LEAFLET:
184 FULJETT TA ’ TAGĦRIF:
Driving and using machines
186 Sewqan u tħaddim ta ’ magni
182 Neupro may make you feel very drowsy, and you may fall asleep very suddenly.
Neupro jistgħu jġiegħlek tħossok bi ngħas ħafna, u tista ’ torqod għal għarrieda ħafna.
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
187 Poġġi n- naħa li teħel tal- impjastru fuq ġilda li tkun nadifa, xotta, f’ saħħitha f’ dawn iż- żoni li ġejjin: • spalla • in- naħa ta ’ fuq tad- driegħ • żaqq • koxxa • ġenbejn • il- ġenb tal- ġisem (fuq ġenbejk, bejn il- kustilji u l- ġenbejn).
Using higher doses of Neupro than your doctor has prescribed may cause side effects such as nausea (feeling sick), vomiting, low blood pressure, hallucinations (seeing or hearing things that are not real), confusion or extreme sleepiness.
189 Jekk tuża dożaġġi ogħla ta ’ Neupro minn dawk li kitiblek t- tabib tiegħek, dan jista ’ jikkawża dardir (tħossok ħażin), rimettar, pressjoni tad- demm baxxa, alluċinazzjonijiet (tara u tisma ’ affarijiet li mhumiex vera), konfużjoni jew ngħas estrem.
If you have forgotten to change the patch at the usual time 185 If you have forgotten to change the patch at your usual time, change it as soon as you remember: remove the old patch and use a new one.
Jekk tkun insejt tibdel l- impjastru fil- ħin tas- soltu tieghek, biddel l- impjastru hekk kif tiftakar: neħħi l - impjastru l- qadim u uża impjastru ġdid.
Uncommon side effects (affects 1 to 10 users in 1,000) • allergic reaction • loss of appetite, decreased appetite • falling asleep suddenly without warning, psychotic disorders including abnormal thinking about reality and behaviour (paranoid psychosis), unusual urge to perform an action that is harmful including excessive gambling and repetitive meaningless actions, increased sex drive, anxiety, sleep problems, nightmares, disorientation
• li tara jew tisma ’ affarijiet li mhumiex reali (alluċinazzjonijiet), konfużjoni, ikollok ħolm mhux tas- soltu, ma tkunx tista ’ torqod • movimenti involontarji marbuta mal- marda ta ’ Parkinson (diskinesija), tħossok stordut meta tqum bilwieqfa jew wara li toqgħod bilqiegħda minħabba tnaqqis fil- pressjoni tad- demm, uġigħ ta ’ ras • rimettar, dijareja, stitikezza, ħruq ta’ istonku, ħalq xott • riżultati tat- testijiet li juru żieda jew anormalità fil- funzjoni tal- fwied • raxx, ħmura, ħakk, żieda fl- għaraq • nefħa fir- riġlejn u fis- saqajn, tħossok dgħajjef, tnaqqis fil- piż • taqa ’
186 • fainting, fainting due to a fall in blood pressure, slow movement or extended spasm in group of muscles, increased sleepiness, feeling of tiredness or lack of energy (lethargy), reduced concentration, loss of memory, numbness or tingling sensation, food and drink tasting different, poor balance, tremors • visual disturbances such as seeing colours or lights, or blurred vision • a feeling of dizziness or "spinning" (vertigo) • abnormal heart rhythm, increased heart rate, feeling of heart beat (palpitation) • high blood pressure, low blood pressure • cough, hiccups, shortness of breath • stomach discomfort and pain • generalised itching, skin rash, skin irritation • swelling of the joints • being unable to achieve or maintain an erection • being unable to walk properly, feeling abnormal, weight increase
190 Effetti sekondarji mhux komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) • Reazzjonijiet allerġiċi • Telf t’ aptit, nuqqas t’ aptit • li torqod għal għarrieda mingħajr l- ebda sinjal ta ’ twissija, mard psikotiku li jinkludu ħsibijiet anormali dwar ir- realtà u l- imġiba (psikosi paranojde), xenqa mhux tas- soltu biex twettaq ċerti attivitajiet, li jinkludu logħob ta ’ l- azzard eċċessiv, azzjonijiet ripetuti bla sens u xenqa ikbar għal attività sesswali, ansjetà, problemi biex torqod, ħmar il- lejl, diżorjentament • ħass ħażin, ħass ħażin minħabba tnaqqis fil- pressjoni tad- demm, moviment bil- mod jew spażmu li jdum fi grupp ta ’ muskoli, żieda fin- ngħas, tħossok għajjien jew mingħajr enerġija (letarġija), nuqqas ta ’ konċentrazzjoni, telf ta ’ memorja, sensazzjoni ta ’ tmewwit jew tnemnim, ittiegħem l - ikel u x- xorb b’ mod differenti, nuqqas ta ’ bilanċ, rogħda • disturbi tal- vista bħal meta tara kuluri jew dwal jew vista mċajpra, • tħossok stordut jew kollox idur bik (vertigo) • rata irregolari ta ’ taħbit tal- qalb, rata mgħaġġla ta ’ taħbit tal- qalb, tħoss qalbek tħabbat bl- għaġla (palpitazzjonijiet) • żieda fil- pressjoni tad- demm, tnaqqis fil- pressjoni tad- demm • sogħla, sulluzzu, qtugħ ta ’ nifs • skonfort u wġigħ fl- istonku • ħakk ġeneralizzat, raxx fil- ġilda, irritazzjoni tal- ġilda • nefħa fil- ġogi • ma jkunx jista ’ jkollok jew iżżomm erezzjoni • ma tkunx tista ’ timxi sewwa, ma tħossokx normali, żieda fil- piż
• The other ingredients are poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
191 • Is- sustanzi l- oħra huma poly( dimethylsiloxane, trimethylsilyl silicate) - copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) u DL- α- tocopherol (E307).
What Neupro looks like and contents of pack 187 Neupro is a transdermal patch.
Neupro hu garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
The outside is tan-coloured and is imprinted with Neupro 8 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 8 mg/ 24 h stampat fuqha.
España UCB Pharma, S.A.
192 Portugal España UCB Pharma (Produtos Farmacêuticos), Lda UCB Pharma, S. A.
189 PACKAGE LEAFLET:
193 FULJETT TA ’ TAGĦRIF:
Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermal patch Rotigotine
Neupro 2 mg/ 24 siegħa Neupro 4 mg/ 24 siegħa Neupro 6 mg/ 24 siegħa Neupro 8 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine
1.
X’ inhu Neupro u għalxiex jintuża 1.
190
194
Rotigotine may pass into your breast milk and affect your baby and is also likely to reduce the amount of milk you produce.
195 sidrek u jaffettwa lit- tarbija tiegħek, u x’ aktarx inaqqas ukoll l- ammont ta ’ ħalib li tipproduċi.
191 Driving and using machines
Sewqan u tħaddim ta ’ magni
The Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches in each package.
Il- pakkett tal- bidu tal- kura ta ’ Neupro fih 4 pakketti differenti (wieħed għal kull qawwa) b’ 7 impjastri kull wieħed.
These packages are usually needed for the first four weeks of therapy, but depending on your response to Neupro, you may not need to use all of the dose packages included or you may need additional higher doses after week 4, which are not covered by this package.
Dawn il- pakketti normalment hemm bżonnhom għall- ewwel erba ’ ġimgħat tat- terapija, imma skond ir- rispons tiegħek għal Neupro, jista ’ ma ’ jkollokx bżonn l- pakketti tad- dożi kollha nklużi, jew jista ’ jkollok bżonn dożi ogħla addizzjonali wara ġimgħa 4, li mhumiex koperti minn dan il- pakkett.
On the first day of treatment, start with Neupro 2 mg (package marked “Week 1)“, and use one Neupro 2 mg transdermal patch daily.
Fl- ewwel jum tat- trattament, ibda b’ Neupro 2 mg (pakkett immarkat “ Ġimgħa 1 ”), uża impjastru wieħed ta ’ Neupro 2 mg kuljum.
You should take Neupro 2 mg for 7 days (e.g. if you start on a Sunday, switch to the next dose on the following Sunday.).
Jekk inti tibda il- Ħadd, aqleb għad- doża li jmiss il- Ħadd ta ’ wara.).
At the beginning of the second week, you should take Neupro 4 mg (package marked with “Week 2“).
Fil- bidu tat- tieni ġimgħa, inti għandek tieħu Neupro 4 mg (pakkett immarkat “ Ġimgħa 2 ”).
At the beginning of the third week, you should take Neupro 6 mg (package marked with “Week 3“).
Fil- bidu tat - tielet ġimgħa, inti għandek tieħu Neupro 6 mg (pakkett immarkat “ Ġimgħa 3).
At the beginning of the fourth week, you should take Neupro 8 mg (package marked with ”Week 4“).
888
The right dose for you will depend on your needs.
Id- doża addattata għalik tiddependi mill- bżonnijiet tiegħek.
4 mg of Neupro every day may be an effective dose for some patients.
4 mg ta ’ Neupro kuljum tista ’ tkun doża effettiva għal xi pazjenti.
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.
Fil- biċċa l- kbira tal- pazjenti bil - marda ta ’ Parkinson fl- istadju bikri, d- doża addattata tintlaħaq fi żmien 3 jew 4 ġimgħat, f’ dożi ta ’ 6 mg kuljum jew 8 mg kuljum rispettivament.
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.
Fil- biċċa l- kbira tal- pazjenti bil- marda ta ’ Parkinson fl- istadju avvanzat, d- doża addattata tintlaħaq fi żmien 3 sa 7 ġimgħat, f’ dożi ta ’ 8 mg kuljum sa doża massima ta ’ 16 mg kuljum.
192 Where to stick the patch
Fejn twaħħal l- impjastru
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).
196 Poġġi n- naħa li teħel tal- impjastru fuq ġilda li tkun nadifa, xotta, f’ saħħitha f’ dawn iż- żoni li ġejjin: • spalla • in- naħa ta ’ fuq tad- driegħ • żaqq • koxxa • ġenbejn • il- ġenb tal- ġisem (fuq ġenbejk, bejn il- kustilji u l- ġenbejn).
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.
Madankollu, iċċekkja li l- impjastru ma ikunx inqala ’ wara. • Għandek tevita sħana esterna (pereżempju dawl tax- xemx eċċessiv, sawnas, banjijiet b’ ilma jaħraq, heating pads jew fliexken mimlija misħun (hot- water bottles) fuq iz- zona tal- impjastru. • Jekk l- impjastru jkun irritalek il- ġilda, għandek iżżomm dik ir- roqgħa ta ’ ġilda protetta mix - xemx diretta, għax tista ’ tikkawża tibdil fil- kulur tal- ġilda.
3.
197 3.
194 Do not use alcohol or other dissolving liquids such as nail polish remover as these may irritate your skin.
Tużax alkoħol jew solventi oħrajn bħal nail polish remover għax dawn jistgħu jirritawlek il- ġilda.
Using higher doses of Neupro than your doctor has prescribed may cause side effects such as nausea (feeling sick), vomiting, low blood pressure, hallucinations (seeing or hearing things that are not real), confusion or extreme sleepiness.
198 Jekk tuża dożaġġi ogħla ta ’ Neupro minn dawk li kitiblek t- tabib tiegħek, dan jista ’ jikkawża dardir (tħossok ħażin), rimettar, pressjoni tad- demm baxxa, alluċinazzjonijiet (tara u tisma ’ affarijiet li mhumiex vera), konfużjoni jew ngħas estrem.
If you have used more p atches than your doctor told you to, remove the extra patches and contact your doctor or hospital for advice immediately.
Jekk tkun użajt iktar impjastri milli qallek it- tabib tiegħek, neħħi l - impjastri żejda, u kellem lit- tabib tiegħek jew l- isptar għal parir immedjatament.
If you have used a different patch (e.g.
Jekk użajt impjastru differenti (eż.
Neupro 4 mg/24 h instead of Neupro 2 mg/24 h) than your doctor told you to, remove the different patch and apply the accurate one.
Neupro 4 mg/ 24 siegħa minflok Neupro 2 mg/ 24 siegħa) minn dik li qallek it- tabib tiegħek, neħħi l- impajstru differenti u poġġi l- impjastru t- tajjeb.
If you have any unpleasant reactions, contact your doctor.
Jekk għandek xi reazzjonijiet ħżiena, kellem lit- tabib tiegħek.
Common side effects (affects 1 to 10 users in 100)
Effetti sekondarji komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 100)
195 • seeing or hearing things that are not real (hallucinations), confusion, having unusual dreams, difficulty in sleeping • involuntary movements related to Parkinson’s disease (dyskinesia), feeling dizzy when standing up because of a fall in blood pressure, headache • vomiting, diarrhoea, constipation, heartburn, dry mouth • increased or abnormal liver function test results • rash, redness, itching, increased sweating • swelling of legs and feet, feeling weak, weight loss • falling
• li tara jew tisma ’ affarijiet li mhumiex reali (alluċinazzjonijiet), konfużjoni, ikollok ħolm mhux tas- soltu, ma tkunx tista ’ torqod • movimenti involontarji marbuta mal- marda ta ’ Parkinson (diskinesija), tħossok stordut meta tqum bilwieqfa jew wara li toqgħod bilqiegħda minħabba tnaqqis fil- pressjoni tad- demm, uġigħ ta ’ ras • rimettar, dijareja, stitikezza, ħruq ta’ istonku, ħalq xott • riżultati tat- testijiet li juru żieda jew anormalità fil- funzjoni tal- fwied
Uncommon side effects (affects 1 to 10 users in 1,000) • allergic reaction • loss of appetite, decreased appetite • falling asleep suddenly without warning, psychotic disorders including abnormal thinking about reality and behaviour (paranoid psychosis), unusual urge to perform an action that is harmful including excessive gambling and repetitive meaningless actions, increased sex drive, anxiety, sleep problems, nightmares, disorientation • fainting, fainting due to a fall in blood pressure, slow movement or extended spasm in group of muscles, increased sleepiness, feeling of tiredness or lack of energy (lethargy), reduced concentration, loss of memory, numbness or tingling sensation, food and drink tasting different, poor balance, tremors • visual disturbances such as seeing colours or lights, or blurred vision • a feeling of dizziness or "spinning" (vertigo) • abnormal heart rhythm, increased heart rate, feeling of heart beat (palpitation) • high blood pressure, low blood pressure • cough, hiccups, shortness of breath • stomach discomfort and pain • generalised itching, skin rash, skin irritation • swelling of the joints • being unable to achieve or maintain an erection • being unable to walk properly, feeling abnormal, weight increase
Effetti sekondarji mhux komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) • Reazzjonijiet allerġiċi • Telf t’ aptit, nuqqas t’ aptit • li torqod għal għarrieda mingħajr l- ebda sinjal ta ’ twissija, mard psikotiku li jinkludu ħsibijiet anormali dwar ir- realtà u l- imġiba (psikosi paranojde), xenqa mhux tas- soltu biex twettaq ċerti attivitajiet, li jinkludu logħob ta ’ l- azzard eċċessiv, azzjonijiet ripetuti bla sens u xenqa ikbar għal attività sesswali, ansjetà, problemi biex torqod, ħmar il- lejl, diżorjentament • ħass ħażin, ħass ħażin minħabba tnaqqis fil- pressjoni tad- demm, moviment bil- mod jew spażmu li jdum fi grupp ta ’ muskoli, żieda fin- ngħas, tħossok għajjien jew mingħajr enerġija (letarġija), nuqqas ta ’ konċentrazzjoni, telf ta ’ memorja, sensazzjoni ta ’ tmewwit jew tnemnim, ittiegħem l - ikel u x- xorb b’ mod differenti, nuqqas ta ’ bilanċ, rogħda • disturbi tal- vista bħal meta tara kuluri jew dwal jew vista mċajpra, • tħossok stordut jew kollox idur bik (vertigo) • rata irregolari ta ’ taħbit tal- qalb, rata mgħaġġla ta ’ taħbit tal- qalb, tħoss qalbek tħabbat bl- għaġla (palpitazzjonijiet) • żieda fil- pressjoni tad- demm, tnaqqis fil- pressjoni tad- demm • sogħla, sulluzzu, qtugħ ta ’ nifs • skonfort u wġigħ fl- istonku • ħakk ġeneralizzat, raxx fil- ġilda, irritazzjoni tal- ġilda • nefħa fil- ġogi • ma jkunx jista ’ jkollok jew iżżomm erezzjoni • ma tkunx tista ’ timxi sewwa, ma tħossokx normali, żieda fil- piż
• The active substance is rotigotine.
200 • Is- sustanza attiva hi rotigotine.
Neupro 2 mg/24 h Each patch releases 2 mg of rotigotine per 24 hours.
Neupro 2 mg / 24 siegħa Kull impjastru jerħi 2 mg ta ’ rotigotine kull 24 siegħa.
Neupro 4 mg/24 h Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 4 mg / 24 siegħa Kull impjastru jerħi 4 mg ta ’ rotigotine kull 24 siegħa.
Neupro 6 mg/24 h Each patch releases 6 mg of rotigotine per 24 hours.
Neupro 6 mg / 24 siegħa Kull impjastru jerħi 6 mg ta ’ rotigotine kull 24 siegħa.
Neupro 8 mg/24 h Each patch releases 8 mg of rotigotine per 24 hours.
Neupro 8 mg / 24 siegħa Kull impjastru jerħi 8 mg ta ’ rotigotine kull 24 siegħa.
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 2 mg/ 24 h, 4 mg/ 24 h, 6 mg/ 24 h, 8 mg/ 24 h stampat fuqha.
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.
Pakkett tal- bidu tal- kura wieħed fih 28 ġarża li jipprovdi mediċina li tgħaddi taħt il- ġilda f ’ 4 kaxxi tal - kartun b ’ 2 mg, 4 mg, 6 mg, u 8 mg kull wieħed li huma ssiġillati individwalment fi qratas.
Malta Pharmasud Ltd.
201 Malta Česká republika Pharmasud Ltd.
NeuroBloc 5000 U/ ml solution for injection.
NeuroBloc 5000 U/ ml soluzzjoni għall- injezzjoni.
One ml contains 5000 U Botulinum Toxin Type B.
Millilitru fih 5000 U Botulinum Toxin Tip B.
NeuroBloc 5000U/ ml contains less than 1 mmol sodium per ml.
NeuroBloc 5000U/ ml fih inqas minn 1 mmol ta ’ sodju kull ml.
Clear and colourless to light yellow solution.
Soluzzjoni ċara u bla kulur għal isfar ċar.
NeuroBloc is indicated for the treatment of cervical dystonia (torticollis).
NeuroBloc huwa indikat għall- kura ta ’ distonja ċervikali (torticollis).
See Section 5.1 for data on efficacy in patients responsive / resistant to Botulinum Toxin Type A.
Ara Sezzjoni 5. 1 għall- informazzjoni dwar l- effikaċja f’ pazjenti li jirrispondu / jirreżistu għal Botulinum Toxin Tip A.
NeuroBloc should only be administered by intramuscular injection by a medical specialist with experience in the treatment of cervical dystonia and in the use of botulinum toxins.
NeuroBloc għandu jiġi mogħti biss permezz ta ’ injezzjoni minn ġol- muskoli minn speċjalista mediku b’ esperjenza fil- kura ta ’ distonja ċervikali u fl- użu ta ’ tossini ta ’ botulinum.
The dosage units are specific to NeuroBloc and are not interchangeable with those used to quantify the dose of other botulinum toxin products.
L- unitajiet ta ’ dożaġġ huma speċifiċi għal NeuroBloc u ma jistgħux jiġu mibdulin ma ’ dawk użati sabiex jikkwantifikaw id- doża ta ’ prodotti oħrajn tat- tossina ta ’ botulinum.
The dose and frequency of administration should be adjusted for each patient depending on the clinical response.
Id- doża u l- frekwenza ta ’ l- amministrazzjoni għandhom jiġu mibdula għal kull pazjent skond ir - respons kliniku.
The initial dose is 10,000 U and should be divided between the two to four most affected muscles.
Id- doża tal- bidu hija ta ’ 10, 000 U u din għandha tiġi maqsuma bejn iż- żewġ sa erba ’ muskoli l- aktar milqutin.
Data from clinical trials suggest that efficacy is dose dependent but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U.
Informazzjoni minn provi kliniċi tissuġġerixxi li l- effikaċja hija dipendenti fuq id- doża iżda dawn il- provi, minħabba li ma kienux iddisinjati għal tqabbil, ma jurux differenza sinifikanti bejn 5000 U u 10, 000 U.
Therefore an initial dose of 5000 U may also be considered but a dose of 10,000 U may increase the likelihood of clinical benefit.
Għalhekk tista ’ tiġi kkunsidrata doża tal- bidu ta ’ 5000 U iżda doża ta ’ 10, 000 U tista ’ żżid il- possibilità ta ’ benefiċċju kliniku.
Care should be taken to ensure that NeuroBloc is not injected into a blood vessel.
Għandha tingħata attenzjoni sabiex jiġi żgurat li NeuroBloc ma jiġix injettat ġo vina jew arterja.
NeuroBloc may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection.
NeuroBloc jista ’ jiġi dilwit b’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Injections should be repeated as required to maintain good function and minimise pain.
L- injezzjonijiet għandhom jiġu rrepetuti hekk kif meħtieġ sabiex tinżamm funzjoni tajba u jkun hemm tnaqqis fl- uġigħ.
In clinical studies the duration of effect was variable.
Fi studji kliniċi t- tul ta ’ l- effett kien varjabbli.
In the patients who responded to treatment (those who experienced an improvement in TWSTRS greater than 20% over baseline) the following duration of effect was observed: at least 4 weeks (40% of patients); at least 8 weeks (30%), at least 12 weeks (16%); 16 weeks or longer (14%).
F’ pazjenti li rrispondew għall- kura (dawk li kellhom titjib fit- TWSTRS ta ’ aktar minn 20% mill- linja bażi ta ’ referenza) ġie osservat it- tul ta ’ effett li ġej: mill- inqas 4 ġimgħat (40% tal- pazjenti); mill- inqas 8 ġimgħat (30%), mill- inqas 12- il ġimgħa (16%); 16- il ġimgħa jew aktar (14%).
Adults (including the elderly ≥ 65 years old) The dose recommended for cervical dystonia is applicable to adults of all ages, including the elderly.
Adulti (inklużi l- anzjani ≥ 65 sena) Id- doża rrakkommandata għal distonja ċervikali hija applikabbli għal adulti ta ’ l- etajiet kollha, inklużi l- anzjani.
2 For patients with reduced muscle mass the dose should be adjusted according to individual patient need.
2 Għal pazjenti b’ massa muskolari mnaqqsa, id- doża għandha tiġi mibdula skond il- ħtieġa tal- pazjent individwali.
Children and Adolescents The safety and efficacy of NeuroBloc have not been demonstrated in children.
Tfal u Adoloxxenti Is- sigurtà u l- effikaċja ta ’ NeuroBloc ma ġewx murija fit- tfal.
NeuroBloc is not recommended in children and adolescents until further data become available.
NeuroBloc mhux rakkomandat fit- tfal u adoloxxenti qabel ma jkun disponibbli aktar tagħrif.
Hepatic and renal impairment Studies have not been carried out in patients with hepatic or renal impairment.
Indeboliment epatiku u renali Ma sarux studji f’ pazjenti b’ indeboliment epatiku u renali.