qanastek/EMEA-V3 huggingface dataset:
EU/1/05/331/018 [84 transdermal patches] EU/1/05/331/003 [100 transdermal patches]
EU/ 1/ 05/ 331/ 003 [84 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 018 [100 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
93 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS KARTUNA TAN- NOFS (MINGĦAJR IL- BLUE BOX) KAXXA TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
94 Aħżen fi friġġ.
Neupro 2 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 2 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine Użu transdermali.
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
96 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA (BIL- BLUE BOX) (ESKLUŻI L- PAKKETTI MULTIPLI) KAXXA TA ’ 7 [20] [28] [30] [56] [60] [90] IMPJASTRU
Neupro 3 mg/24 h transdermal patch Rotigotine
Neupro 3 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine
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 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 049 [28 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 048 [20 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 050 [30 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 051 [56 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 052 [60 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 054 [90 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
Neupro 3 mg/24 h
Neupro 3 mg/ 24 siegħa
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
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS TIKKETTA TA ’ BARRA (BIL- BLUE BOX) KAXXA TA ’ 84 [100] IMPJASTRU LI FIH 2 KAXXI TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
99 Aħżen fi friġġ.
EU/1/05/331/053 [84 transdermal patches] EU/1/05/331/055 [100 transdermal patches]
EU/ 1/ 05/ 331/ 053 [84 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 055 [100 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
100 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS KARTUNA TAN- NOFS (MINGĦAJR IL- BLUE BOX) KAXXA TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
101 Aħżen fi friġġ.
96 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
102 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Neupro 3 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 3 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine Użu transdermali.
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
103 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA (BIL- BLUE BOX) (ESKLUŻI L- PAKKETTI MULTIPLI) KAXXA TA ’ 7 [20] [28] [30] [56] [60] [90] IMPJASTRU
Neupro 4 mg/24 h transdermal patch Rotigotine
Neupro 4 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine
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 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 005 [28 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 020 [20 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 021 [30 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 022 [56 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 023 [60 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 025 [90 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
Neupro 4 mg/24 h
Neupro 4 mg/ 24 siegħa
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
105 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS TIKKETTA TA ’ BARRA (BIL- BLUE BOX) KAXXA TA ’ 84 [100] GARZA LI FIHA 2 KAXXI TA ’ 42 [50] IMPJASTRU
84 transdermal patches; multipack, containing 2 boxes with 42 patches each 100 transdermal patches, multipack, containing 2 boxes with 50 patches each
84 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda, pakkett multiplu, li fih 2 kaxxi bi 42 impjastru f’ kull wieħed 100 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda, pakkett multiplu, li fih 2 kaxxi b’ 50 impjastru f’ kull wieħed
Store in a refrigerator.
106 Aħżen fi friġġ.
EU/1/05/331/024 [84 transdermal patches] EU/1/05/331/006 [100 transdermal patches]
EU/ 1/ 05/ 331/ 024 [84 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 006 [100 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS KARTUNA TAN- NOFS (MINGĦAJR IL- BLUE BOX) KAXXA TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
108 Aħżen fi friġġ.
103 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Neupro 4 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 4 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine Użu transdermali.
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
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA (BIL- BLUE BOX) (ESKLUŻI L- PAKKETTI MULTIPLI) KAXXA TA ’ 7 [20] [28] [30] [56] [60] [90] IMPJASTRU
Neupro 6 mg/24 h transdermal patch Rotigotine
Neupro 6 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine
Each patch of 30 cm2 contains 1 3.5 mg of rotigotine.
Kull impjastru ta ’ 30 cm2 fih 13. 5 mg ta ’ rotigotine.
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 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 008 [28 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 026 [20 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 027 [30 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 028 [56 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 029 [60 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 031 [90 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
Neupro 6 mg/24 h
Neupro 6 mg/ 24 siegħa
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
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS TIKKETTA TA ’ BARRA (BIL- BLUE BOX) KAXXA TA ’ 84 [100] IMPJASTRU LI FIHA 2 KAXXI TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
113 Aħżen fi friġġ.
EU/1/05/331/030 [84 transdermal patches] EU/1/05/331/009 [100 transdermal patches]
EU/ 1/ 05/ 331/ 030 [84 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 009 [100 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
114 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS KARTUNA TAN- NOFS (MINGĦAJR IL- BLUE BOX) KAXXA TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
115 Aħżen fi friġġC.
110 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
116 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Neupro 6 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 6 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine Użu transdermali.
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
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA (BIL- BLUE BOX) (ESKLUŻI L- PAKKETTI MULTIPLI) KAXXA TA ’ 7 [20] [28] [30] [56] [60] [90] IMPJASTRU
Neupro 8 mg/24 h transdermal patch Rotigotine
Neupro 8 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine
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 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 011 [28 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 032 [20 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 033 [30 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 034 [56 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 035 [60 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 037 [90 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
Neupro 8 mg/24 h
Neupro 8 mg/ 24 siegħa
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
119 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS TIKKETTA TA ’ BARRA (BIL- BLUE BOX) KAXXA TA ’ 84 [100] GARZA LI FIHA 2 KAXXI TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
120 Aħżen fi friġġ.
EU/1/05/331/036 [84 transdermal patches] EU/1/05/331/012 [100 transdermal patches]
EU/ 1/ 05/ 331/ 036 [84 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda] EU/ 1/ 05/ 331/ 012 [100 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda]
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS KARTUNA TAN- NOFS (MINGĦAJR IL- BLUE BOX) KAXXA TA ’ 42 [50] IMPJASTRU
Store in a refrigerator.
122 Aħżen fi friġġ.
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
123 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Neupro 8 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 8 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine Użu transdermali.
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
124 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 28 PATCHES –TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
KAXXA TA ’ 28 IMPJASTRI – PAKKETT TAL- BIDU TAL- KURA – SKEDA TAL- KURA TA ’ 4 ĠIMGĦAT
Neupro 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Neupro 2 mg/ 24 siegħa 4 mg/ 24 siegħa 6 mg/ 24 siegħa 8 mg/ 24 siegħa
Transdermal patch Rotigotine
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda 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.
Treatment initiation pack with 28 transdermal patches for a 4 week treatment schedule contains:
Pakkett tal- bidu tal- kura bi 28 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda għal skeda ta ’ kura ta ’ 4 ġiimgħat fih:
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 garżi Neupro 2 mg/ 24 siegħa li jipprovdu mediċina li tgħaddi minn ġol- ġilda 7 garżi Neupro 4 mg/ 24 siegħa li jipprovdu mediċina li tgħaddi minn ġol- ġilda 7 garżi Neupro 6 mg/ 24 siegħa li jipprovdu mediċina li tgħaddi minn ġol- ġilda 7 garżi Neupro 8 mg/ 24 siegħa li jipprovdu mediċina li tgħaddi minn ġol- ġilda
119 Transdermal use.
Użu transdermali.
15.
126 15.
Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Neupro 2 mg/ 24 siegħa, 4 mg/ 24 siegħa, 6 mg/ 24 siegħa, 8 mg/ 24 siegħa.
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
127 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 7 PATCHES – WEEK 1
KAXXA TA ’ 7 IMPJASTRI – ĠIMGĦA 1
Week 1.
7 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Ġimgħa 1
122 10.
128 10.
123 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
129 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET LABEL – WEEK 1
TIKKETTA TAL- QARTAS - ĠIMGĦA 1
Neupro 2 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 2 mg / 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Rotigotine Użu transdermali.
Week 1
Ġimgħa 1
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
130 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 7 PATCHES – WEEK 2
KAXXA TA ’ 7 IMPJASTRI – ĠIMGĦA 2
Week 2.
7 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Ġimgħa 2
125 10.
131 10.
126 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
132 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET LABEL – WEEK 2
TIKKETTA TAL- QARTAS - ĠIMGĦA 2
Week 2
Ġimgħa 2
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
133 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 7 PATCHES – WEEK 3
KAXXA TA ’ 7 IMPJASTRI – ĠIMGĦA 3
Week 3.
7 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Ġimgħa 3
129 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
135 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET LABEL - WEEK 3
TIKKETTA TAL- QARTAS - ĠIMGĦA 3
Week 3
Ġimgħa 3
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
136 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 7 PATCHES – WEEK 4
KAXXA TA ’ 7 IMPJASTRI – ĠIMGĦA 4
Week 4
7 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Ġimgħa 4
132 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
138 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET LABEL – WEEK 4
TIKKETTA TAL- QARTAS - ĠIMGĦA 4
Week 4
Ġimgħa 4
133 B.
139 B.
134 PACKAGE LEAFLET:
140 FULJETT TA ’ TAGĦRIF:
if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bhal tiegħek.
What Neupro is and what it is used for 2.
X’ inhu Neupro u għalxiex jintuża 2.
Before you use Neupro 3.
Qabel ma tuża Neupro 3.
How to use Neupro 4.
Kif għandek tuża Neupro 4.
How to store Neupro 6.
Kif taħżen Neupro 6.
WHAT NEUPRO IS AND WHAT IT IS USED FOR
X’ INHU NEUPRO U GĦALXIEX JINTUŻA
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.
Neupro jappartjeni għal grupp ta ’ mediċini msejħa agonisti ta ’ dopamine li jistimulaw ċerti tipi ta ’ ċelloli li jintrabtu ma ’ riċetturi ta ’ dopamine fil- moħħ.
Neupro is used to treat:
Neupro jintuża biex jikkura:
- the signs and symptoms of Restless Legs Syndrome (RLS), a condition that is characterized by
- s- sinjali u s- sintomi tas- sindromu ta ’ Restless Legs (RLS), kundizzjoni li hija kkaratterizzata
an irresistible urge to move the legs.
b’ impuls irreżistibbli li ċċaqlaq riġlejk.
BEFORE YOU USE NEUPRO
QABEL MA TUŻA NEUPRO
Do NOT use Neupro
TUŻAX Neupro
- if you are allergic (hypersensitive) to rotigotine or any of the other ingredients of Neupro (see
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal rotigotine jew sustanzi l- oħra ta ’
Section 6, ‘Further information’).
Neupro (ara Sezzjoni 6, Aktar tagħrif).
- if you need to have magnetic resonance imaging (method to visualise internal organs and
- jekk ikollok bżonn li ssirlek immaġni bir- rizonanza manjetika (li hu metodu biex tara l- organi u
tissues of the body) or cardioversion (treatment of abnormal heart rhythm).
tessuti interni tal- ġisem) jew kardjoverżjoni (trattament ta ’ rittmu anormali tal- qalb).
You must take your Neupro patch off before such procedures.
Għandek tneħħi l- impjastru Neupro qabel dawn it- tip ta ’ proċeduri.
You can put a new patch on after the procedure.
Tista ’ twaħħal impjastru ġdid wara l - proċedura.
Take special care with Neupro
Oqgħod attent ħafna b’ Neupro
- 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
the beginning of your treatment.
titkejjel regolarment, speċjalment fil- bidu tal- kura tiegħek.
However, if you
- Eżamijiet tal- vista f ’ intervalli regolari huma rakkomandati waqt l- użu ta ’ Neupro.
notice any problems with your sight in -between examinations, you should contact your doctor immediately.
Madanakollu, għandek tikkuntattja lit- tabib tiegħek immedjatament jekk tinnota xi problemi bil - vista tiegħek bejn l- eżamijiet tal- vista.
If during treatment
- Jekk għandek problemi serji tal- fwied, lit- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża.
your liver problems get worse, you should contact your doctor as soon as possible.
Għandek tikkuntattja lit- tabib tiegħek, jekk waqt it- trattament il- problemi tal- fwied imorru għall- agħar.
- If you feel very drowsy or find that you fall asleep suddenly, please contact your doctor (see
- Jekk tħossok bi ngħas ħafna jew tiskopri li torqod f’ daqqa, jekk jogħġbok ikkuntattja lit- tabib
also below in this section, under ‘Driving and using machines’).
tiegħek (ara wkoll, aktar l- isfel f’ din is- sezzjoni, taħt ‘ Sewqan u tħaddim ta ’ magni ’).
- As with other medicines in this class, Neupro may cause excessive gambling and increased sex
- Bħal mediċini oħra ta ’ din il- klassi, Neupro jista ’ jikkawża logħob ta ’ l- azzard eċċessiv u żieda
drive.
fix- xenqa għall- attività sesswali.
If you notice such effects, please contact your doctor.
Jekk jogħġbok ikkuntattja lit- tabib tiegħek, jekk tinnota effetti bħal dawn.
- Neupro may cause hallucinations (seeing or hearing things that are not real).
- Neupro jista ’ jikkawża alluċinazzjonijiet (tara u tisma ’ affarijiet li mhumiex vera).
If you notice such
Jekk tinnota
effects, please contact your doctor.
effetti bħal dawn, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
- As with every patch or bandage, Neupro can cause skin reactions, such as reddening and
- Bħal ma jiġri b’ kull impjastru jew faxxa, Neupro jista ’ jikkawża reazzjonijiet tal- ġilda, bħal per
itching.
eżempju ħmura u ħakk.
They are usually mild or moderate, and only affect the area of skin the patch has been on.
Normalment, dawn ikunu ħfief għal moderati u jaffettwaw biss iz- zona tal- ġilda li l- impjastru jkun tpoġġa fuqha.
The reactions normally disappear after a few hours when you remove the patch.
Ir- reazzjonijiet normalment imorru wara ftit sigħat li tneħħi l- impjastru.
If you have a skin reaction which lasts for more than a few days, is severe, or spreads outside the area of skin that was covered by the patch, please contact your doctor.
Jekk ikollok reazzjoni tal- ġilda li ddum iktar minn ftit jiem, jekk reazzjoni tal- ġilda tiggrava, jew jekk ir- reazzjoni tal- ġilda tinfirex ’ il barra miz- zona mgħottija mill - impjastru, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by Neupro.
Evita d- dawl tax- xemx u espożizzjoni f’ xi solarium fuq żoni tal- ġilda li jkollhom kwalunkwe tip ta ’ reazzjoni tal- ġilda kkawżata minn Neupro.
To help avoid the skin reactions, you should put the patch on a different area of skin every day, and only use the same area again after 14 days.
Biex tevita li jkollok reazzjonijiet tal- ġilda, għandek tpoġġi l- impjastru f’ post differenti kuljum u tuża biss l- istess zona tal- ġilda wara 14- il jum.
- Neupro should not be used by children.
- Neupro m’ għandux jintuża mit- tfal.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
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).
M’ għandekx tieħu dawn il- mediċini meta tkun qed tuża Neupro, jistgħu jnaqqsu l- effett tiegħu: anti - psikotiċi (mediċini li jintużaw biex jikkuraw ċerti mard mentali) jew metoclopramide (użat għall- kura tad- dardir u rimettar).
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.
Jekk inti qiegħed fuq trattament ta ’ Neupro u levodopa flimkien, xi effetti mhux mixtieqa jistgħu jiggravaw, bħal per eżempju tara u tisma ’ affarijiet li mhumiex vera (alluċinazzjonijiet), movimenti involontarji li jixbħu dawk tal- marda ta ’ Parkinson (dyskinesia), u nefħa fir- riġlejn u s- saqajn.
Please ask your doctor whether it is safe for you to:
Jekk jogħġbok staqsi lit- tabib tiegħek jekk huwiex sigur għalik li:
- drink alcohol or
- tixrob l- alkoħol jew
- take sedating medicines (for example benzodiazepines, medicines used to treat mental
- tieħu mediċini sedattivi (pereżempju, benzodiazepine, mediċini biex tikkura mard mentali u
conditions or depression) while you are using Neupro.
mediċini biex tikkura d- dipressjoni) meta tkun qed tieħu Neupro.
Using Neupro with food and drink
Meta tuża Neupro ma ’ l- ikel u max- xorb
Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine works.
Minħabba li rotigotine jidħol fiċ- ċirkolazzjoni tad- demm minn ġol- ġilda, l- ikel u x- xorb ma jaffettwax il- mod kif taħdem il- mediċina.
You should discuss with your doctor if it is safe for you to drink alcohol while using Neupro.
Jekk jogħġbok staqsi lit- tabib tiegħek jekk huwiex sikur għalik li tixrob alkoħol waqt li qed tieħu Neupro.
You should not use Neupro if you are pregnant, as the effects of rotigotine on pregnancy and the unborn baby are not known.
M’ għandekx tuża Neupro jekk inti tqila, għax l- effetti ta ’ rotigotine fuq it- tqala u fuq it- tarbija mhux imwielda mhumiex magħrufa.
Tell your doctor if you are pregnant or planning to become pregnant.
Għid lit- tabib tiegħek jekk inti tqila jew jekk qed tippjana li toħroġ tqila.
Breast-feeding is not recommended during treatment with Neupro.
It- treddiegħ mhux rakkomandat jekk tkun qed tuża Neupro.
Rotigotine may pass into your breast milk and affect your baby and is also likely to reduce the amount of milk you produce.
Rotigotine jista ’ jgħaddi ġol- ħalib ta ’ sidrek u jaffettwa lit- tarbija tiegħek, u x’ aktarx inaqqas ukoll l- ammont ta ’ ħalib li tipproduċi.
136 Driving and using machines
142 Sewqan u tħaddim ta ’ magni
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.
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.
Jekk dan jaffettwak, m’ għandekx issuq jew tieħu sehem f’ attivitajiet fejn jekk ma tkunx attent tista ’ tpoġġi lilek innifsek jew lill- oħrajn f’ riskju ta ’ korriment serju, pereżempju, meta tuża l- magni.
In isolated cases people have fallen asleep while driving and this has caused accidents.
F’ każijiet iżolati, xi nies raqdu waqt li kienu qed isuqu, u dan ikkawża inċidenti.
HOW TO USE NEUPRO
KIF GĦANDEK TUŻA NEUPRO
Always use Neupro exactly as your doctor has told you.
Dejjem għandek tuża Neupro skond il- parir tat- tabib.
Neupro is generally used as a long term treatment.
Neupro huwa ġeneralment użat f’ trattament fit- tul.
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.
Normalment, ser tibda t- trattament b’ doża baxxa u, jekk ikun neċessarju, iżżidha ġimgħa wara ġimgħa, kif jgħidlek it- tabib tiegħek, sakemm tilħaq id - doża korretta għalik.
You will then continue treatment with this dose, also called the maintenance dose.
Imbagħad għandek tkompli t- trattament b’ din id- doża, li jgħidulha doża ta ’ manteniment.
You should change your Neupro patch once a day.
Għandek tibdel l- impjastru Neupro darba kuljum.
For reaching the needed doses, different patches of Neupro are available, each releasing a different amount of the active substance per day:
Biex jintlaħqu d- dożi li jkun hemm bżonn, impjastri ta ’ Neupro differenti huma disponibbli, kollha jerħu ammont differenti ta ’ sustanza attiva kuljum:
1 mg/24 h, 2 mg/24 h and 3 mg/24 h.
1 mg/ 24 siegħa, 2 mg/ 24 siegħa u 3 mg/ 24 siegħa.
Treatment of Restless Legs Syndrome You will start by using one Neupro 1 mg/24 h patch daily.
Trattament tas- sindromu ta ’ Restless Legs Tibda billi tuża impjastru wieħed Neupro 1 mg / 24 siegħa kuljum.
If necessary, this daily dose may be increased by 1 mg, on a weekly basis, until reaching the right (maintenance) dose for you.
Jekk ikun neċessarju, din id- doża ta ’ kuljum tista ’ tiżdied b ’ 1 mg, kull ġimgħa, sakemm jintlaħaq id- doża addattata (ta ’ manteniment) għalik.
The maximum dose is 3 mg per day.
Id- doża massima hi ta ’ 3 mg kuljum.
If you have to stop taking this medicine, see Section 3, ‘If you stop using Neupro‘.
Jekk ikollok tieqaf tuża din il- mediċina, ara Sezzjoni 3, ‘ Jekk tieqaf tuża Neupro ‘.
FOLLOW THESE INSTRUCTIONS WHEN USING NEUPRO:
SEGWI DAWN L- ISTRUZZJONIJIET META TUŻA NEUPRO:
You should stick a new Neupro patch onto the skin once a day.
Għandek twaħħal impjastru Neupro fuq il- ġilda darba kuljum.
Leave the patch on your skin for 24 hours, then remove it and apply a new one.
Ħalli l- impjastru fuq il- ġilda għal 24 siegħa u mbagħad neħħieħ u għamel wieħed ġdid.
Make sure that you take the old patch off before applying a new one; place the new patch on a different area of skin.
Aċċerta ruħek li neħħejt l- impjastru l- qadim qabel ma twaħħal l- impjastru l- ġdid; poġġi l- impjastru l- ġdid f’ post differenti kuljum.
You should change your patch at around the same time every day.
Għandek tibdel l- impjastru bejn wieħed u ieħor fl- istess ħin kuljum.
Do not cut the Neupro patches into pieces.
Taqtax l- impjastri Neupro f’ biċċiet.
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).
Fejn twaħħal l- impjastru 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.
Biex tgħin li tevita irritazzjoni tal- ġilda: • Waħħal l- 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.
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.
143 • Twaħħalx l- impjastru fuq ġilda li tkun maqsuma jew jew fiha xi ferita jew fuq ġilda li hi ħamra jew irritata.
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.
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.
Biex tipprevjeni li l- impjastru ma jibqax imwaħħal sew jew li jaqa ’ • Għandek tpoġġi l- impjastru fejn ma jkunx jista ’ jħokk ma ’ ilbies issikkat li jista ’ jaqilgħuh. • Tużax kremi, żjut, lotions, terra jew xi prodotti oħra tal- ġilda fuq iz- zona ta ’ ġilda fejn tkun ser twaħħal l- impjastru jew qrib impjastru li diġà jkun imwaħħal.
If the patch falls off, a new patch should be applied for the rest of the day, then replace the patch at the same time as usual.
Jekk l- impjastru jaqa ’, għandu jitwaħħal impjastru ġdid għal kumplament tal- ġurnata, u imbagħad tibdel l- impjastru fl- istess ħin tas- soltu.
NOTE • Bathing, showering and exercising should not affect how Neupro works.
NOTA • Jekk tieħu banju, xawer u l- eżerċizzju fiżiku, dan m’ għandux jaffettwa l- mod li bih jaħdem 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.
Madankollu, iċċekkja li l- impjastru ma jkunx 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.
How to use the patch
Kif tuża l- impjastru
Each patch is packed in a separate sachet.
Kull impjastru hu ppakkjat f’ qartas separat.
You should stick Neupro onto your skin as soon as you have opened the sachet and removed the protective liner.
Għandek twaħħal Neupro fuq il- ġilda tiegħek hekk kif tkun ftaħt il- qartas u neħħejt l- inforra protettiva.
To open the sachet, hold the two sides of the sachet.
Biex tiftaħ il- qartas, żomm iż- żewġ naħat tal- qartas.
Peel apart the foil and open the sachet.
Qaxxar il- fojl u iftaħ il - qartas.
Take the patch out of the sachet.
Oħroġ l- impjastru mill - qartas.
The sticky side of the patch is covered by a transparent protective liner.
In- naħa li teħel tal- impjastru hi miksija b’ inforra protettiva trasparenti.
Hold the patch in both hands with the protective liner facing you.
Żomm l- impjastru f’ idejk it- tnejn bl- inforra protettiva tħares lejk.
Bend the patch in half so that the S-shaped break in the liner opens.
Ilwi l- impjastru min- nofs sabiex il- qasma f’ forma ta ’ S fl- inforra tinfetaħ.
138 5.
144 5.
Peel off one side of the protective liner.
Qaxxar naħa waħda ta ’ l - inforra protettiva.
Don’t touch the sticky side of the patch with your fingers.
Tmissx in - naħa li teħel tal- impjastru b’ subgħajk.
Hold the other half of the rigid protective liner and put the sticky surface of the patch onto your skin.
Żomm in- nofs l- ieħor ta ’ l - inforra protettiva riġida u poġġi l- wiċċ li jeħel tal - impjastru fuq il- ġilda.
Press the sticky side of the patch firmly into place.
Agħfas b’ mod sod in- naħa li teħel tal- impjastru fil- post.
Fold back the other half of the patch and remove the other side of the protective liner.
Itwi lura n- nofs l- ieħor tal - impjastru u neħħi n- naħa l - oħra ta ’ l- inforra protettiva.
Press the patch down firmly with the palm of your hand for about 20 to 30 seconds to make sure the patch is touching the skin and the edges stick well.
Agħfas l- impjastru b’ mod sod bil- keffa ta ’ idejk għal madwar 20 sa 30 sekonda biex taċċerta ruħek li l - impjastru jkun qed imiss mal- ġilda u li t- truf ikunu mwaħħlin tajjeb.
Wash your hands with soap and water immediately after handling the patch.
Aħsel idejk bis- sapun u bl- ilma minnufih malli tkun lestejt.
How to remove a used patch
Kif tneħħi impjastru użat
Slowly and carefully peel off the used patch.
Qaxxar l- impjastru l- qadim bil- mod u bl- attenzjoni.
Gently washing the area with warm water and mild soap should remove any adhesive that stays on your skin after you remove the patch.
Il- ħasil bil- mod taż- żona tal- ġilda b’ ilma sħun u sapuna ħafifa, għandu jneħħi kwalunkwe sustanza li twaħħal li tibqa ’ fuq il- ġilda wara li tneħħi l- impjastru.
You can also use a small amount of baby oil to remove any adhesive that won’t wash off.
Tista ’ wkoll tuża ammont żgħir ta ’ żejt tat- trabi biex tneħħi kwalunkwe sustanza li twaħħal li ma tkunx tista ’ tinqala ’.
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.
Choose a new area of skin where you will apply a new patch, then follow the instructions above.
Għażel post ġdid tal- ġilda fejn ser tpoġġi l- impjastru ġdid, u imbagħad segwi l- istruzzjonijiet t’ hawn fuq.
If you use more Neupro than you should
Jekk tieħu aktar Neupro milli suppost
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.
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 patches 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 forgotten to change the patch at the usual time
Jekk tinsa tibdel l- impjastru fil- ħin tas- soltu
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.
If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.
Jekk tkun insejt twaħħal impjastru ġdid wara li tneħħi l- qadim, uża impjastru ġdid malli tiftakar.
In both cases, on the following day you should use a new patch at the usual time.
Fiż- żewġt każi, fil- jum ta ’ wara, għandek tuża impjastru ġdid fil- ħin tas- soltu.
Do not use a double dose to make up for a forgotten dose.
M’ għandekx tuża doża doppja biex tpatti għal doża li tkun insejt.
139 If you stop using Neupro
145 Jekk tieqaf tuża Neupro
Do not stop using Neupro suddenly without talking to your doctor, as you may have symptoms like fever, rigid joints, fast heart beats or reduced consciousness.
Tieqafx tieħu Neupro għal għarrieda mingħajr ma tkellem lit- tabib tiegħek, għaliex jista ’ jkollok sintomi bħal deni, ġogi iebsin, żieda fit- taħbit tal- qalb jew disturbi fil- koxjenza.
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
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.
Like all medicines, Neupro can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Neupro jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You may experience nausea (feeling sick) and vomiting at the beginning of treatment.
Jista ’ jkollok dardir (tħossok ħażin) u rimettar fil- bidu tat- terapija.
These effects are usually mild or moderate and only last for a short time.
Dawn normalment ikunu ħfief jew moderati u jgħaddu malajr.
You should contact your doctor if they last for a long time or if you worry about them.
Għandek tkellem lit- tabib tiegħek, jekk idumu u jekk tkun inkwitat.
Skin problems caused by the patch You may get skin reactions from the patch such as redness, itching.
Problemi fil- ġilda ikkawżati mill- impjastri Jista ’ jkollok reazzjonijiet tal- ġilda bħal ħmura u ħakk.
They are usually mild or moderate and only affect the area of skin the patch has been on.
Normalment dawn ikunu ħfief jew moderati u jaffettwaw biss iz- zona tal- ġilda fejn tkun tpoġġiet l- impjastru.
The reactions normally disappear after a few hours when you remove the patch.
Ir- reazzjonijiet is- soltu jgħibu wara ftit sigħat wara li tneħħi l- impjastru.
If you have a skin reaction that lasts longer than a few days, is severe, or spreads outside the area of skin that was covered by the patch, you should contact your doctor.
Jekk ikollok reazzjoni tal- ġilda li ddum iktar minn ftit jiem, reazzjoni severa, jew reazzjoni tal- ġilda li tinfirex ’ il barra miz- zona mgħottija mill- impjastru, għandek tkellem lit- tabib tiegħek.
If you are using Neupro for Restless Legs Syndrome the following side effects may occur:
Jekk qed tuża Neupro għas- sindromu ta ’ Restless Legs, dawn l- effetti mhux mixtieqa jistgħu jseħħu:
Very common side effects (affects more than 1 user in 10) • feeling sick (nausea) • skin irritations under the patch such as redness and itching • weakness (fatigue) • headache
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
Common side effects (affects 1 to 10 users in 100) • vomiting, heartburn • 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 (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
Uncommon side effects (affects 1 to 10 users in 1,000) • inability to resist the impulse to perform an action that is harmful involving excessive gambling and repetitive meaningless actions • feeling dizzy when standing up because of a fall in blood pressure
Effetti sekondarji mhux komuni (li jseħħu f’ 1 sa 10 pazjenti minn kull 1, 000) • xenqa mhux tas- soltu biex twettaq ċerti attivitajiet, li jinkludu logħob ta ’ l- azzard eċċessiv u azzjonijiet ripetuti bla sens • tħossok stordut minħabba tnaqqis fil- pressjoni tad- demm meta tqum bilwiefqa
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 pazjenti minn kull 10, 000) • ħsibijiet u aġir mhux kontrollati u mixtieqa
HOW TO STORE NEUPRO
KIF TAĦŻEN NEUPRO
• Keep out of the reach and sight of children.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax Neupro wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
140 • 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.
146 • Aħżen fi friġġ. • Aħżen fil- pakkett oriġinali.
What to do with the used and unused patches
X’ għandek tagħmel bl- impjastri użati u mhux użati
Used patches still contain active substance, which may be harmful to others.
L- impjastri wżati xorta jkun għad fihom s- sustanza attiva, li jista ’ jkun ta ’ ħsara lil ħaddieħor.
Fold the used patch with the sticky side inwards.
Itwi l - impjastru użat min- nofs, bin- naħa tas- sustanza li twaħħal tħares ’ il ġewwa.
Put the patch in the original sachet and then throw it away safely, out of the reach of children.
Poġġi l- impastru fil- qartas oriġinali u mbagħad armih fejn ma jintlaħaqx mit- tfal.
You should follow local guidelines for domestic waste when throwing away used or unused patches or return them to the pharmacy.
L- impjastri użati jew mhux użati għandhom jintremew skond ir- rekwiżiti lokali jew jittieħdu lura lill - ispiżerija.
Do not flush them down the toilet, nor place them in liquid waste disposal systems.
Tifflaxxjahomx, u tpoġġihomx f’ sistemi tar- rimi ta ’ l- iskart likwidu.
What Neupro contains
X’ fih Neupro
• The active substance is rotigotine.
• Is- sustanza attiva hi rotigotine.
• The other ingredients are poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
• 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, 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).
What Neupro looks like and contents of pack
Id- dehra ta ’ Neupro u l- kontenuti tal- pakkett
Neupro is a transdermal patch.
Neupro hu garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
It is thin and has three layers.
Hi rqiqa u fiha tliet saffi.
It is square-shaped with rounded edges.
Għandha forma kwadra bi truf jagħtu fit- tond.
The outside is tan-coloured and is imprinted with Neupro 1 mg/24 h.
In- naħa ta ’ barra hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 1 mg/ 24 h stampat fuqha.
Neupro is available in the following pack-sizes:
Neupro hu disponibbli fid- daqsijiet tal- pakketti li ġejjin:
Cartons containing 7, 20, 28, 30, 56, 60, 84, 90 or 100 patches, which are individually sealed in sachets.
Kaxxi tal- kartun li fihom 7, 20, 28, 30, 56, 60, 84, 90 jew 100 impjastru, li huma ssiġillati individwalment fi qratas.
Marketing Authorisation Holder and Manufacturer SCHWARZ PHARMA Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur SCHWARZ PHARMA Ltd.
Malta Pharmasud Ltd.
147 Malta Česká republika Pharmasud Ltd.
143 PACKAGE LEAFLET:
148 FULJETT TA ’ TAGĦRIF:
Before you use Neupro 3.
Qabel ma tuża Neupro Kif għandek tuża Neupro 3.
- the signs and symptoms of Parkinson’s disease either alone or in combination with the drug
- s- sinjali u s- sintomi tal- marda ta ’ Parkinson jew waħdu jew flimkien mal- mediċina msejħa
notice any problems with your sight in-between examinations, you should contact your doctor immediately.
Madanakollu, għandek tikkuntattja lit- tabib tiegħek immedjatament jekk tinnota xi problemi bil - vista tiegħek bejn l- eżamijiet tal- vista.
Rotigotine may pass into your breast milk and affect your baby and is also likely to reduce the amount of milk you produce.
150 sidrek u jaffettwa lit- tarbija tiegħek, u x’ aktarx inaqqas ukoll l- ammont ta ’ ħalib li tipproduċi.
145 Driving and using machines
Sewqan u tħaddim ta ’ magni
1 mg/24 h, 2 mg/24 h, 3 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h.
1 mg/ 24 siegħa, 2 mg/ 24 siegħa, 3 mg/ 24 siegħa, 4 mg/ 24 siegħa, 6 mg/ 24 siegħa u 8 mg/ 24 siegħa.
For higher doses, multiple patches must be applied.
Għal dożi ogħla, impjastri multipli jridu jiġu applikati.
For example a daily dose of 10 mg may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Per eżempju, doża ta ’ 10 mg tista ’ tintlaħaq billi tapplika impjastru ta ’ 6 mg/ 24 siegħa u impjastru ta ’ 4 mg/ 24 siegħa.
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 ta ’ Neupro 2 mg/ 24 siegħa kuljum.
From the second week, the daily dose will be increased by 2 mg, on a weekly basis, until reaching the right (maintenance) dose for you.
Mitt- tieni ġimgħa, id - doża ta ’ kuljum ser tibda tiżdied kull ġimgħa b’ inkrementi ta ’ 2 mg, sakemm id- doża li tkun tajba għall- ħtiġijiet tiegħek (id- doża tal- manteniment) tintlaħaq.
For most patients, the right dose is between 6 mg and 8 mg per day (reached within 3 to 4 weeks).
Għall- biċċa l- kbira tal- pazjenti, id- doża korretta hija ta ’ bejn 6 mg u 8 mg kuljum (tintlaħaq fi żmien 3 sa 4 ġimgħat).
The maximum dose is 8 mg per day.
Id- doża massima hi ta ’ 8 mg kuljum.
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 wieħed ta ’ Neupro 4 mg/ 24 siegħa kuljum.
From the second week, the daily dose will be increased by 2 mg, on a weekly basis, until reaching the right (maintenance) dose for you.
Mitt- tieni ġimgħa, id- doża ta ’ kuljum ser tibda tiżdied kull ġimgħa b’ inkrementi ta ’ 2 mg, sakemm id- doża li tkun tajba għall- ħtiġijiet tiegħek (id- doża tal- manteniment) tintlaħaq.
For most patients, the right dose is between 8 mg and 16 mg per day (reached within 3 to 7 weeks).
Għall- biċċa l- kbira tal- pazjenti, id- doża korretta hija ta ’ bejn 8 mg u 16 mg kuljum (tintlaħaq fi żmien 3 sa 7 ġimgħat).
The maximum dose is 16 mg per day.
Id- doża massima hi ta ’ 16 mg kuljum.
Make sure that you take the old patch off before applying a new one; place the new patch on a different area of skin.
151 qabel ma twaħħal l- impjastru l- ġdid; poġġi l- impjastru l- ġdid f’ post differenti kuljum.
146 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).
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).