natgillin/translations-raw huggingface dataset:
64 Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,083 Neupro- and 508 placebo-treated patients, 73.0% of the patients on Neupro and 56.3% of patients on placebo reported at least one adverse reaction.
Põhinedes kogutud platseebokontrollitud kliiniliste uuringute analüüsil, kus osales kokku 1083 Neuproga ravitavat ja 508 platseeboga ravitavat patsienti, kirjeldati vähemalt ühte kõrvaltoimet 73, 0% - l Neuprot kasutavatest patsientidest ja 56, 3% - l platseebot kasutavatest patsientidest.
dyskinesia, dizziness postural, headachea
düskineesiaa, posturaalne peapööritus, peavalua
syncope, vasovagal convulsion, loss of syncope, dystonia, consciousness hypersomnia, lethargia, disturbance in attention, memory impaired, paraesthesia, dysgeusia, balance disorder, tremor
minestus, vasovagaalne minestus, düstoonia, hüpersomnia, letargia, tähelepanuhäired,
visual disturbance, photopsia, blurred vision
krambid, teadvusekaotus
65 Ear and labyrinth disorders
65
vertigo (incl. positional)
Organsüsteemid vastavalt MedDRA - le
Cardiac disorders
Väga sage > 1/ 10
atrial fibrillation, heart rate increased, palpitations a
Sage > 1/ 100, ≤ 1/ 10
supraventricular tachycardia
Aeg- ajalt > 1/ 1000, ≤ 1/ 100 mälu halvenemine, paresteesia, maitsehäired, tasakaaluhäired, treemor
Vascular disorders
Harv ≤1/ 1000
orthostatic hypotension (see section 4.4)
Silma kahjustused (vt lõik 4. 4)
hypertension, hypotension a
nägemishäired, fotopsia, ebaselge nägemine
Respiratory, thoracic and mediastinal disorders
Kõrva ja labürindi kahjustused
cough, hiccup, dyspnoea
peapööritus (k. a asendist tulenev)
Gastrointestinal disorders
Südame häired
nauseaa
kodade virvendus, kiirenenud pulss, südamepekslemine
vomiting, a diarrhoea,
supraventrikulaarne tahhükardia
abdominal pain (incl. upper
Vaskulaarsed häired
constipationa, a
ortostaatiline hüpot ensioon (vt lõik 4. 4)
abdominal pain),
hüpertensioona, hüpotensioon
dyspepsia, dry a mouth
Respiratoorsed, rindkere ja mediastiinumi häired
stomach discomfort
köha, luksuminea, düspnoe
Hepato-biliary disorder
Seedetrakti häired Maksa ja sapiteede häired
hepatic enzyme increased (including GGT, ALAT, ASAT)
oksendaminea, kõhukinnisusa, düspepsiaa, suukuivusa maksaensüümide aktiivsuse tõus (k. a GGT, ALAT, ASAT)
Skin and subcutaneous tissue disorders
kõhuvalu (k. a ülakõhuvalu), ebamugavustunne maos
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, a hyperhydrosis,
lööve (k. a allergiline, makulaarne eksanteem) (vt lõik 4. 4), erüteema, pruuritus, hüperhidroosa
application site b
reaktsioonid kasutamiskohalb (k. a erüteema, pruuritusa, ärritusa, põletustunnea, dermatiita, põletik, paapulad, vesiikulid, villid, valu, ülitundlikkus) (vt lõik 4. 4)
oedema peripheral,
perifeersed ödeemida, asteenilised seisundidb (k. a väsimusa, asteenia, haiglane olek), kaalulangus
gait disturbance,
kaaluhäireda, ebaterve tunne, suurenenud kaala
and administration site conditions
Vigastus, mürgistus ja protseduuri
reactions (including a erythema, a
Organsüsteemid
a
Väga sage
asthenic b conditions (incl. a fatigue, asthenia,
Sage
feeling abnormal, a weight increased,
Aeg- ajalt
pruritus
Harv
, irritation, a
vastavalt MedDRA - > 1/ 10 le tüsistused a
malaise), weight
> 1/ 100, ≤ 1/ 10
burning, dermatitis,
> 1/ 1000, ≤ 1/ 100
decreased
≤1/ 1000
66 Patients treated with dopamine agonists including Neupro, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Dopamiini agonistidega, sealhulgas Neuproga ravitavatel patsientidel olid kirjeldatud nähud nagu hasartmängude mängimine, suurenenud libiido ja hüperseksuaalsus tavaliselt pöörduvad, kui annust vähendati või ravi lõpetati.
At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i. e.
Säilitusravi lõpus oli 91% - l rotigotiini saanud patsientidest rotigotiini optimaalne annus maksimaalne lubatud annus ehk 6 mg/ 24 h.
An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29% CI95% 18%; 39%, p < 0.0001).
67 19% - l platseebot saanud patsientidel (erinevus 29% CI95% 18%; 39%, p < 0, 0001).
67 At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i. e.
Säilitusravi lõpus oli 92% - l rotigotiini saavatel patsientidel optimaalne annus maksimaalne lubatud annus ehk 8 mg/ 24 h.
Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
68 Umbes 45% plaastri toimeainest vabaneb nahasse 24 tunni jooksul.
68 The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Jaotumine Rotigotiini in vitro seonduvus plasmavalkudega on umbes 92%.
Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse Lymphoma Assay with metabolic activation and weaker effects without metabolic activation.
69 Rotigotiin ei põhjustanud geenimutatsioone Ames’ i testis, kuid avaldas in vitro hiirelümfoomi katses toimet metaboolse aktiveerimise korral ning nõrgemat toimet ilma metaboolse aktiveerimiseta.
Schwarz Pharma Ltd.
SCHWARZ PHARMA Ltd.
Shannon Industrial Estate Shannon, Co. Clare Ireland
Shannon Industrial Estate, Shannon, Co. Clare, Iirimaa
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 5 (13 March 2008) presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Ravimiohutuse järelvalvesüsteem Müügiloa hoidja peab tagama ravimiohutuse järelevalvesüsteemi vastavalt müügiloa taotluse mooduli 1. 8. 1 versioonile 5 (13. märts 2008) valmisoleku ja funktsioneerimise enne ravimi turuletoomist ja turustamise ajal.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 6 (18 April 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Riskijuhtimise plaan Müügiloa hoidja kohustub teostama ravimiohutuse järelevalve plaanis kirjeldatud uuringuid ja lisanduvaid ravimiohutuse järelvalvetoiminguid vastavalt müügiloa taotluse moodul 1. 8. 2 riskijuhtimise plaani versioonile 6 (18. aprill 2008) ja järgnevatele uuendustele riskijuhtimise plaanis kokkuleppeliselt CHMP- ga.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kaasajastatud riskijuhtimise plaan tuleb esitada samaaegselt perioodilise ohutusaruandega (PSUR) vastavalt CHMP juhistele inimestel kasutatavate ravimite kohta käiva riskijuhtimise plaanile.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Lisaks tuleb esitada kaasajastatud riskijuhtimise plaan • kui saadakse uut teavet, mis mõjutab hetkel kehtivaid ohutusandmeid, ravimiohutuse järelvalve plaani või riski minimiseerimiseks tehtavaid tegevusi • 60 päeva jooksul enne olulise tähtaja saabumist (puudutab ravimiohutuse järelevalvet või riskide minimeerimist) • EMEA nõudel
In order to address the quality defect in relation to the crystal formation in the patches, the MAH commits to:
Kvaliteedivea (kristalliseerumine plaastrites) käsitlemiseks kohustub müügiloa hoidja:
Storing, shipping, and distributing all Neupro patches via an integral cold chain (2 to 8°C).
kõiki Neupro plaastreid säilitama, transportima ja tarnima muutumatus külmaahelas (2 kuni 8°C);
73 • Replacing the currently marketed product within a timeframe of 3 months.
• •
• Submitting changes to the Marketing Authorisation in relation to the product specifications, shelf-life and storage conditions.
asendama praegu turul oleva toote 3 kuu jooksul; esitama toote spetsifikatsioonide, kõlblikkusaja ja säilitustingimuste muudatused müügiloa dokumentatsioonis; 73
• Pursuing further optimization of the manufacturing process and to submitting the results and necessary variations for assessment to CHMP
• otsima võimalusi tootmisprotsessi edasiseks optimiseerimiseks ning esitama tulemused ja vajalikud muudatused hindamiseks CHMP- le.
74 ANNEX III
74 LISA III
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) BOX OF 7 [20] [28] [30] [56] [60] [90] PATCHES
76 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (“ BLUE BOX ”) (V. A RÜHMAPAKENDID) KARBID 7 [20] [28] [30] [56] [60] [90] PLAASTRIGA
Neupro 1 mg/24 h transdermal patch Rotigotine
Neupro 1 mg/ 24 h transdermaalne plaaster Rotigotiin
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)
Abiained: polü( dimetüülsiloksaan, trimetüülsilüül silikaat) - kopolümerisaat, povidoonK90, E171, E223, E304, E307, fluoropolümeer, polüester, silikoon, alumiinium, pigmentvärvid (kollane95, punane166, punane144, must7).
7 transdermal patches 20 transdermal patches 28 transdermal patches 30 transdermal patches 56 transdermal patches 60 transdermal patches 90 transdermal patches
7 transdermaalset plaastrit 20 transdermaalset plaastrit 28 transdermaalset plaastrit 30 transdermaalset plaastrit 56 transdermaalset plaastrit 60 transdermaalset plaastrit 90 transdermaalset plaastrit
Shannon, Industrial Estate, Co.Clare, Ireland
Shannon, Industrial Estate, Co. Clare, Iirimaa
EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/039 [20 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/042 [56 transdermal patches] EU/1/05/331/043 [60 transdermal patches] EU/1/05/331/045 [90 transdermal patches]
EU/ 1/ 05/ 331/ 038 [7 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 040 [28 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 039 [20 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 041 [30 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 042 [56 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 043 [60 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 045 [90 transdermaalset plaastrit]
Neupro 1 mg/24 h
Neupro 1 mg/ 24 h
78 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
78 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID VÄLIMINE SILT (“ BLUE BOX ”) KARBID 84 [100] PLAASTRIGA, SISALDAVAD KAHTE (2) KARPI 42 [50] PLAASTRIGA
84 transdermal patches, multipack, containing 2 boxes with 42 patches each 100 transdermal patches, multipack, containing 2 boxes with 50 patches each
100 transdermaalset plaastrit.
EU/1/05/331/044 [84 transdermal patches] EU/1/05/331/046 [100 transdermal patches]
EU/ 1/ 05/ 331/ 044 [84 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 046 [100 transdermaalset plaastrit]
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
80 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID SISEMINE KESKMINE PAPPKARP (ILMA “ BLUE BOX ”) KARP 42 [50] PLAASTRIGA
42 transdermal patches, component of a multipack comprising 2 boxes, each containing 42 patches 50 transdermal patches, component of a multipack comprising 2 boxes, each containing 50 patches
Multipakendi osa, koosneb 2 pakendist, üks pakend sisaldab 50 transdermaalset plaastrit.
82 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
Neupro 1 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 1 mg/ 24 h transdermaalne plaaster Rotigotiin Transdermaalne.
1 transdermal patch.
1 transdermaalne plaaster.
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) BOX OF 7 [20] [28] [30] [56] [60] [90] PATCHES
83 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (“ BLUE BOX ”) (V. A RÜHMAPAKENDID) KARBID 7 [20] [28] [30] [56] [60] [90] PLAASTRIGA
Neupro 2 mg/24 h transdermal patch Rotigotine
Neupro 2 mg/ 24 h transdermaalne plaaster Rotigotiin
EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/014 [20 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/016 [56 transdermal patches] EU/1/05/331/017 [60 transdermal patches] EU/1/05/331/019 [90 transdermal patches]
EU/ 1/ 05/ 331/ 001 [7 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 002 [28 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 014 [20 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 015 [30 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 016 [56 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 017 [60 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 019 [90 transdermaalset plaastrit]
Neupro 2 mg/24 h
Neupro 2 mg/ 24 h
85 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
85 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID VÄLIMINE SILT (“ BLUE BOX ”) KARBID 84 [100] PLAASTRIGA, SISALDAVAD KAHTE (2) KARPI 42 [50] PLAASTRIGA
EU/1/05/331/018 [84 transdermal patches] EU/1/05/331/003 [100 transdermal patches]
EU/ 1/ 05/ 331/ 018 [84 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 003 [100 transdermaalset plaastrit]
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
87 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID SISEMINE KESKMINE PAPPKARP (ILMA “ BLUE BOX ”) KARP 42 [50] PLAASTRIGA
89 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
89 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
Neupro 2 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 2 mg/ 24 h transdermaalne plaaster Rotigotiin Transdermaalne.
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
90 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (“ BLUE BOX ”) (V. A RÜHMAPAKENDID) KARBID 7 [20] [28] [30] [56] [60] [90] PLAASTRIGA
Neupro 3 mg/24 h transdermal patch Rotigotine
Neupro 3 mg/ 24 h transdermaalne plaaster Rotigotiin
91 9.
91 9.
EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/048 [20 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/051 [56 transdermal patches] EU/1/05/331/052 [60 transdermal patches] EU/1/05/331/054 [90 transdermal patches]
EU/ 1/ 05/ 331/ 047 [7 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 049 [28 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 048 [20 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 050 [30 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 051 [56 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 052 [60 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 054 [90 transdermaalset plaastrit]
Neupro 3 mg/24 h
Neupro 3 mg/ 24 h
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
92 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID VÄLIMINE SILT (“ BLUE BOX ”) KARBID 84 [100] PLAASTRIGA, SISALDAVAD KAHTE (2) KARPI 42 [50] PLAASTRIGA
EU/1/05/331/053 [84 transdermal patches] EU/1/05/331/055 [100 transdermal patches]
EU/ 1/ 05/ 331/ 053 [84 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 055 [100 transdermaalset plaastrit]
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
94 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID SISEMINE KESKMINE PAPPKARP (ILMA “ BLUE BOX ”) KARP 42 [50] PLAASTRIGA
Neupro 3 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 3 mg/ 24 h transdermaalne plaaster Rotigotiin Transdermaalne.
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
97 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (“ BLUE BOX ”) (V. A RÜHMAPAKENDID) KARBID 7 [20] [28] [30] [56] [60] [90] PLAASTRIGA
Neupro 4 mg/24 h transdermal patch Rotigotine
Neupro 4 mg/ 24 h transdermaalne plaaster Rotigotiin
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 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 005 [28 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 020 [20 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 021 [30 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 022 [56 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 023 [60 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 025 [90 transdermaalset plaastrit]
Neupro 4 mg/24 h
Neupro 4 mg/ 24 h
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
99 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID VÄLIMINE SILT (“ BLUE BOX ”) KARBID 84 [100] PLAASTRIGA, SISALDAVAD KAHTE (2) KARPI 42 [50] PLAASTRIGA
84 transdermal patches; multipack, containing 2 boxes with 42 patches each 100 transdermal patches, multipack, containing 2 boxes with 50 patches each
100 transdermaalset plaastrit.
EU/1/05/331/024 [84 transdermal patches] EU/1/05/331/006 [100 transdermal patches]
EU/ 1/ 05/ 331/ 024 [84 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 006 [100 transdermaalset plaastrit]
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
101 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID SISEMINE KESKMINE PAPPKARP (ILMA “ BLUE BOX ”) KARP 42 [50] PLAASTRIGA
103 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
103 MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
Neupro 4 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 4 mg/ 24 h transdermaalne plaaster Rotigotiin Transdermaalne.
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
104 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (“ BLUE BOX ”) (V. A RÜHMAPAKENDID) KARBID 7 [20] [28] [30] [56] [60] [90] PLAASTRIGA
Neupro 6 mg/24 h transdermal patch Rotigotine
Neupro 6 mg/ 24 h transdermaalne plaaster Rotigotiin
Each patch of 30 cm2 contains 1 3.5 mg of rotigotine.
Iga 30 cm2 suurune plaaster sisaldab 13, 5 mg rotigotiini.
105 9.
105 9.
EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/026 [20 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/028 [56 transdermal patches] EU/1/05/331/029 [60 transdermal patches] EU/1/05/331/031 [90 transdermal patches]
EU/ 1/ 05/ 331/ 007 [7 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 008 [28 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 026 [20 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 027 [30 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 028 [56 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 029 [60 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 031 [90 transdermaalset plaastrit]
Neupro 6 mg/24 h
Neupro 6 mg/ 24 h
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
106 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID VÄLIMINE SILT (“ BLUE BOX ”) KARBID 84 [100] PLAASTRIGA, SISALDAVAD KAHTE (2) KARPI 42 [50] PLAASTRIGA
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
VAJADUSEL
107 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
EU/1/05/331/030 [84 transdermal patches] EU/1/05/331/009 [100 transdermal patches]
EU/ 1/ 05/ 331/ 030 [84 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 009 [100 transdermaalset plaastrit]
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
108 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID SISEMINE KESKMINE PAPPKARP (ILMA “ BLUE BOX ”) KARP 42 [50] PLAASTRIGA
109 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE
Neupro 6 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 6 mg/ 24 h transdermaalne plaaster Rotigotiin Transdermaalne.
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
111 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND (“ BLUE BOX ”) (V. A RÜHMAPAKENDID) KARBID 7 [20] [28] [30] [56] [60] [90] PLAASTRIGA
Neupro 8 mg/24 h transdermal patch Rotigotine
Neupro 8 mg/ 24 h transdermaalne plaaster Rotigotiin
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 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 011 [28 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 032 [20 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 033 [30 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 034 [56 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 035 [60 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 037 [90 transdermaalset plaastrit]
Neupro 8 mg/24 h
Neupro 8 mg/ 24 h
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
113 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID VÄLIMINE SILT (“ BLUE BOX ”) KARBID 84 [100] PLAASTRIGA, SISALDAVAD KAHTE (2) KARPI 42 [50] PLAASTRIGA
EU/1/05/331/036 [84 transdermal patches] EU/1/05/331/012 [100 transdermal patches]
EU/ 1/ 05/ 331/ 036 [84 transdermaalset plaastrit] EU/ 1/ 05/ 331/ 012 [100 transdermaalset plaastrit]
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
115 VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED AINULT RÜHMAPAKENDID SISEMINE KESKMINE PAPPKARP (ILMA “ BLUE BOX ”) KARP 42 [50] PLAASTRIGA
116 10.
10.
Neupro 8 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 8 mg/ 24 h transdermaalne plaaster Rotigotiin Transdermaalne.
BOX OF 28 PATCHES –TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
28 PLAASTRIGA KARP – RAVI ALUSTAMISE PAKEND – 4- NÄDALASE RAVI GRAAFIK
Neupro 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Neupro 2 mg/ 24 h 4 mg/ 24 h 6 mg/ 24 h 8 mg/ 24 h
Transdermal patch Rotigotine
Transdermaalne plaaster Rotigotiin
Neupro 2 mg/24 h Each patch releases 2 mg of rotigotine per 24 hours.
Neupro 2 mg/ 24 h Iga plaaster vabastab 24 tunni vältel 2 mg rotigotiini.
Neupro 4 mg/24 h Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 4 mg/ 24 h Iga plaaster vabastab 24 tunni vältel 4 mg rotigotiini.
Neupro 6 mg/24 h Each patch releases 6 mg of rotigotine per 24 hours.
Neupro 6 mg/ 24 h Iga plaaster vabastab 24 tunni vältel 6 mg rotigotiini.
Neupro 8 mg/24 h Each patch releases 8 mg of rotigotine per 24 hours.
Neupro 8 mg/ 24 h Iga plaaster vabastab 24 tunni vältel 8 mg rotigotiini.
Treatment initiation pack with 28 transdermal patches for a 4 week treatment schedule contains:
28 transdermaalse plaastriga ravi alustamise pakend 4- nädalase ravigraafiku jaoks sisaldab: