natgillin/translations-raw huggingface dataset:
49 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Neupro 8 mg/ 24 h transdermal patch
Neupro 8 mg/ 24 h transdermalni obliž
Each patch of 40 cm2 contains 18.0 mg of rotigotine.
En obliž s površino 40 cm2 vsebuje 18, 0 mg rotigotina.
The outside of the backing layer is tan-coloured and imprinted with Neupro 8 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 8 mg/ 24 h.
Dosing in patients with early stage Parkinson’ s disease:
Odmerjanje pri bolnikih v zgodnji fazi Parkinsonove bolezni:
51 Treatment discontinuation Neupro should be discontinued gradually.
53 Prekinitev zdravljenja Zdravljenje z obližem zdravila Neupro je treba prekiniti postopno.
52 Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
54 Pri bolnikih, zdravljenih z agonisti dopamina, vključno z rotigotinom, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
53 Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg / day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
55 Sočasna uporaba omeprazola (inhibitor CYP2C19) v odmerkih 40 mg/ dan nima nobenega vpliva na farmakokinetiko in metabolizem rotigotina pri zdravih prostovoljcih.
Co-administration of rotigotine (3 mg/ 24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03mg ethinylestradiol, 0.15mg levonorgestrel).
Sočasna uporaba rotigotina (3 mg/ 24 h) ni vplivala na farmakodinamiko in farmakokinetiko peroralnih kontraceptivov (0, 03 mg etinilestradiol, 0, 15 mg levonorgestrel).
Immune system disorder
preobčutljivost Bolezni imunskega
hypersensitivity
56 Organski sistem po
54 Metabolism and nutrition disorders
Zelo pogosti
anorexia, decreased appetite a
Pogosti
Psychiatric
Občasni
perception
MedDRA
b
> 1/ 10
sleep attacks,
> 1/ 100, ≤1/ 10
disorders
> 1/ 1. 000, ≤1/ 100
disturbances
≤1/ 1. 000
a
sistema anoreksija, Presnovne in zmanjšan apetit prehranske motnje Psihiatrične motnje
psychotic disorder
motnje percepcijeb
(hallucination, visual a hallucination,
napadi spancaa,
(including paranoid psychosis), compulsive
(halucinacijea, vizualne halucinacijea, zvočne halucinacije, iluzije), zmedenost, nenavadne sanjea, nespečnosta
auditory hallucination, illusion), confusion state, abnormal a dreams, insomnia
psihotične motnje (vključno s paranoidno psihozo), kompulzivne motnje (vključno s patološkim hazardiranjem in ponavljanjem nesmiselnih dejanj), povečan libido (vključno s hiperseksualnostjo), tesnoba, motnje spanjaa, nočne more, dezorientiranost
disorders (including pathologic gambling, punding), increased
Bolezni živčevja
a
somnolencaa,
libido (including hypersexuality), anxiety, sleep a disorder, nightmares, disorientation
diskinezijaa,
a
sinkopa,
a
konvulzija, izguba
Nervous system disorders
Očesne bolezni
somnolence, a dizziness
omoticaa
dyskinesia, dizziness postural, a headache
posturalna omotica, glavobola
syncope, vasovagal convulsion, loss of syncope, dystonia, consciousness hypersomnia, lethargia, disturbance in attention, memory impaired, paraesthesia, dysgeusia, balance disorder, tremor
vazovagalna sinkopa, distonija, hipersomnija, letargija, motnje pozornosti, poslabšanje spomina, parestezija, disgevzija, motnje ravnotežja, tremor motnje vida,
Eye disorders (see section 4.4)
(glejte poglavje 4. 4)
visual disturbance, photopsia, blurred vision
fotopsija, zamegljen vid
vertigo (incl. positional) atrial fibrillation, supraventricular heart rate increased, tachycardia palpitations a
vrtoglavica Ušesne bolezni, (vključno s vključno z pozicijsko) motnjami labirinta supraventrikularna atrijska fibrilacija, Srčne bolezni tahikardija pospešeno bitje srca, palpitacije ortostatska hipotenz hipertenzijaa, Žilne bolezni ija (glejte poglavje hipotenzija 4. 4) kašelj, kolcanjea, Bolezni dihal, dispneja prsnega koša in mediastinalnega prostora Bolezni prebavil
Vascular disorders
navzeaa,
orthostatic hypotension (see section 4.4)
bruhanjea, driskaa,
hypertension, hypotension a
bolečine v trebuhu
Respiratory, thoracic and mediastinal disorders
zaprtjea, dispepsijaa, suha ustaa
cough, hiccup, dyspnoea
(vklj. z bolečinami v zgornjem predelu trebuha), neprijeten občutek v želodcu
a
57 Organski sistem po
Gastrointestinal disorders
Zelo pogosti
nausea
Pogosti
vomiting, a diarrhoea,
Občasni
abdominal pain (incl. upper
Redki
constipationa, a
MedDRA
abdominal pain),
> 1/ 10
dyspepsia, dry a mouth
> 1/ 100, ≤1/ 10
stomach discomfort
> 1/ 1. 000, ≤1/ 100
Hepato-biliary disorder
≤1/ 1. 000
hepatic enzyme increased (including GGT, ALAT, ASAT)
povišanje jetrnih Bolezni jeter, encimov (vključno žolčnika in z γ- GT, ALT, AST) žolčevodov Bolezni kože in
55 Skin and subcutaneous tissue disorders
izpuščaj (vključno
Musculoskeletal and connective tissue disorder
podkožja
joint swelling
z alergijskim
Reproductive system and breast disorder
kontaktni
erectile dysfunction
Bolezni mišično - skeletnega sistema in vezivnega tkiva Motnje reprodukcije in dojk
a
izpuščajem, makuloznim izpuščajem, eksantemom) (glejte poglavje 4. 4), eritema, pruritus, hiperhidrozaa
The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
58 Bolnika je treba skrbno nadzorovati, vključno s frekvenco bitja srca, srčnim ritmom in krvnim tlakom.
56 5.1 Pharmacodynamic properties
5. 1 Farmakodinamične lastnosti
An improvement of 20% was seen in 52% of the subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects receiving placebo (Difference rotigotine versus placebo 21.7%; CI95% 11.1%; 32.4%, difference ropinirole versus placebo 38.4% CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%; CI95% .7.6%; 25.7%). The mean improvement in the UPDRS score (Parts II + III) was 6.83 points (baseline 33.2 points) in the rotigotine arm, 10.78 point in the ropinirole arm (baseline 32.2 points) and 2.33 points in the placebo arm (baseline 31.3 points).
Vse razlike med aktivnimi
All differences between the active treatments and placebo were statistically significant.
59 zdravljenji in placebom so bile statistično pomembne.
At the end of the maintenance treatment an improvement of at least 30% was seen
Na koncu vzdrževalnega zdravljenja so opazili vsaj 30 - odstotno izboljšanje pri 57% bolnikov, ki so prejemali 8 mg rotigotina/ 24 h, pri 55% bolnikov, ki so prejemali 12 mg rotigotina/ 24 h, in pri 34% bolnikov, ki so prejemali placebo (pri skupini, ki je prejemala 8 mg rotigotina/ 24 h, je bila razlika 22%; CI95% 10% - 35%, pri skupini, ki je prejemala 12 mg rotigotina/ 24 h, pa 21%; CI95% 8% - 33%, p < 0, 001 pri obeh skupinah, ki sta prejemali rotigotin).
57 in 57% and 55% of the subjects receiving rotigotine 8 mg/ 24 h and 12 mg/ 24 h, respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively CI95% 10%; 35% and 8%; 33%, respectively, p < 0.001 for both rotigotine groups).
Pri rotigotinu je bila srednja vrednost zmanjšanja časa » izklop « 2, 7 ure pri skupini, ki je prejemala 8 mg rotigotina/ 24 h, in 2, 1 ure pri skupini, ki je prejemala 12 mg rotigotina/ 24 h.
Metabolism Rotigotine is metabolised to a great extent.
60 Presnova Rotigotin se presnavlja v veliki meri.
58 Because therapy with Neupro is initiated at a low dose and gradually titrated according to clinical tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, or age is not necessary.
Posebne skupine bolnikov Zdravljenje z zdravilom Neupro se začne z majhnim odmerkom, ki se za doseganje optimalnega učinka zdravljenja postopno povečuje glede na klinično toleranco, zato prilagajanje odmerka glede na spol, telesno maso ali starost ni potrebno.
59 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Neupro 2 mg/ 24 h 4 mg/ 24 h 6 mg/ 24 h 8 mg/ 24 h Transdermal patch
Neupro 2 mg/ 24 h 4 mg/ 24 h 6 mg/ 24 h 8 mg/ 24 h Transdermalni obliž
Neupro 2 mg/ 24 h transdermal patch Each patch releases 2 mg of rotigotine per 24 hours.
Neupro 2 mg/ 24 h transdermalni obliž En obliž sprosti 2 mg rotigotina v 24 urah.
Neupro 4 mg/ 24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 4 mg/ 24 h transdermalni obliž En obliž sprosti 4 mg rotigotina v 24 urah.
Neupro 6 mg/ 24 h transdermal patch Each patch releases 6 mg of rotigotine per 24 hours.
Neupro 6 mg/ 24 h transdermalni obliž En obliž sprosti 6 mg rotigotina v 24 urah.
Neupro 8 mg/ 24 h transdermal patch Each patch releases 8 mg of rotigotine per 24 hours.
Neupro 8 mg/ 24 h transdermalni obliž En obliž sprosti 8 mg rotigotina v 24 urah.
The outside of the backing layer is tan-coloured and imprinted with Neupro 2 mg/ 24 h, 4 mg/ 24 h, 6 mg/ 24 h or 8 mg/ 24 h.
Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom Neupro 2 mg/ 24 h, 4 mg/ 24 h, 6 mg/ 24 h ali 8 mg/ 24 h.
61 Dosage The dose recommendations made are in nominal dose.
Odmerjanje Priporočila za odmerjanje so v nominalnih odmerkih.
Dosing in patients with early stage Parkinson’ s disease:
64 Odmerjanje pri bolnikih v zgodnji fazi Parkinsonove bolezni:
Depending on the patient’ s response, not all of the following dose steps may be required or additional higher doses may be needed after week 4, which are not covered by this package.
Odvisno od bolnikovega odziva morda ne bodo potrebni vsi koraki povečevanja odmerjanja ali pa bodo po 4. tednu potrebni dodatni višji odmerki, ki jih komplet ne vsebuje.
On the first day of treatment the patient starts with Neupro 2 mg/ 24 h.
Prvi dan zdravljenja bolnik začne z obližem zdravila Neupro 2 mg/ 24 h.
During the second week, the patient takes Neupro 4 mg/ 24 h.
V drugem tednu uporablja zdravilo Neupro 4 mg/ 24 h.
During the third week, he or she takes Neupro 6 mg/ 24 h and during the fourth week Neupro 8 mg/ 24 h.
Tretji teden uporablja zdravilo Neupro 6 mg/ 24 h, četrti teden pa zdravilo Neupro 8 mg/ 24 h.
The packages are marked with “ Week 1 (2, 3 or 4 )”.
(2., 3. ali 4.) teden ”.
62 4.3 Contraindications
4. 3 Kontraindikacije
4.4 Special warnings and precautions for use
65 4. 4 Posebna opozorila in previdnostni ukrepi
Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotiogotine.
Pri bolnikih, zdravljenih z agonisti dopamina, vključno z rotigotinom, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
63 If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals.
Če se zaradi transdermalnega sistema pojavijo kožni izpuščaji ali je koža razdražena, se je treba izogibati izpostavljanju tega mesta neposredni sončni svetlobi, dokler se koža ne zaceli.
If a generalised skin reaction (e. g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
66 Če se pojavijo splošne kožne reakcije (npr. alergijski izpuščaj, vključno z eritematoznim, makuloznim ali papuloznim izpuščajem ali pruritus), povezane z uporabo obliža zdravila Neupro, je treba zdravljenje z zdravilom Neupro prekiniti.
The incidence of some dopaminergic adverse events, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson’ s patients.
Pogostnost nekaterih dopaminergičnih neželenih učinkov, kot so halucinacije, diskinezija in periferni edem, je na splošno večja pri uporabi v kombinaciji z L- dopo, pri bolnikih s Parkinsonovo boleznijo.
4.8 Undesirable effects
67 4. 8 Neželeni učinki
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.
Z analizo zbranih, s placebom nadzorovanih kliničnih preskušanj, v katerih je sodelovalo 1. 083 bolnikov, zdravljenih z zdravilom Neupro, in 508 bolnikov, ki so prejemali placebo, so ugotovili, da se je pri 73, 0% bolnikov, ki so prejemali zdravilo Neupro, in pri 56, 3% bolnikov, ki so prejemali placebo, pojavil vsaj en neželen učinek.
sleep attacks,
diskinezijaa,
a
omoticaa
psychotic disorder
posturalna omotica, glavobola
(hallucination, visual a hallucination,
vazovagalna sinkopa, distonija, hipersomnija, letargija, motnje pozornosti, poslabšanje spomina, parestezija,
(including paranoid psychosis), compulsive
zavesti
auditory hallucination, illusion), confusion state, abnormal a dreams, insomnia
68
disorders (including pathologic gambling, punding), increased
Organski sistem po
libido (including hypersexuality), anxiety, sleep a disorder, nightmares, disorientation
Pogosti
Nervous system disorders
MedDRA
dyskinesia, dizziness postural, headachea
> 1/ 1. 000, ≤1/ 100
syncope, vasovagal convulsion, loss of syncope, dystonia, consciousness hypersomnia, lethargia, disturbance in attention, memory impaired, paraesthesia, dysgeusia, balance disorder, tremor
≤1/ 1. 000
Eye disorders (see section 4.4)
disgevzija, motnje ravnotežja, tremor motnje vida, Očesne bolezni (glejte poglavje 4. 4)
65 Ear and labyrinth disorders
vrtoglavica Ušesne bolezni, (vključno s vključno z pozicijsko) motnjami labirinta Srčne bolezni
vertigo (incl. positional)
atrijska fibrilacija,
Cardiac disorders
supraventrikularna
atrial fibrillation, heart rate increased, palpitations a
pospešeno bitje srca, palpitacije
supraventricular tachycardia
tahikardija
orthostatic hypotension (see section 4.4)
ortostatska hipotenz
hypertension, hypotension a
hipertenzijaa,
a
ija (glejte poglavje 4. 4)
cough, hiccup, dyspnoea
hipotenzija kašelj, kolcanjea, dispneja
nauseaa
navzeaa,
vomiting, a diarrhoea,
bruhanjea, driskaa,
abdominal pain (incl. upper
bolečine v trebuhu
constipationa, a
zaprtjea, dispepsijaa, (vklj. z bolečinami Bolezni jeter, žolčnika in žolčevodov
Hepato-biliary disorder
izpuščaj (vključno
Musculoskeletal and connective tissue disorder
69 Organski sistem po
joint swelling
Zelo pogosti
Reproductive system and breast disorder
Pogosti
erectile dysfunction
Občasni
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.
Pri bolnikih, zdravljenih z agonisti dopamina, vključno z zdravilom Neupro, so poročali o znakih patološkega hazardiranja, povečanega libida in hiperseksualnosti, ki so pa bili po navadi reverzibilni po zmanjšanju odmerka ali po prekinitvi zdravljenja.
The effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies.
70 Učinkovitost zdravila Neupro pri zdravljenju znakov in simptomov idiopatične Parkinsonove bolezni so ocenili v večnacionalnem programu za razvoj zdravila, sestavljenem iz štirih ključnih, vzporednih, randomiziranih, dvojno slepih s placebom nadzorovanih kliničnih študij.
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.
Na koncu vzdrževalnega zdravljenja je bil optimalni odmerek pri 92% bolnikov, ki so prejemali rotigotin, največji dovoljeni odmerek, tj.
With rotigotine, the mean reductions in “ off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
Pri
68 The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Porazdelitev Vezava rotigotina na beljakovine v plazmi in vitro je približno 92%.
However, a contribution of these metabolites to clinical effects is unlikely.
72 Ravni konjugatov rotigotina in njegovih presnovkov po dealkilaciji v plazmi se pri okvarjenem delovanju ledvic povečajo, vendar ni vpliva teh presnovkov na klinične učinke.
6.3 Shelf life
73 6. 3 Rok uporabnosti
71 ANNEX II
74 DODATEK II
Shannon Industrial Estate Shannon, Co. Clare Ireland
Clare Irska
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.
Dovoljenja za promet z zdravilom, postavljen in da deluje, preden in medtem ko je zdravilo že na trgu.
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.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v Farmakovigilančnem načrtu, v skladu s soglasjem v različici 6 (18. 4. 2008) Načrta upravljanja tveganja (RMP – Risk Management Plan), predstavljenega v Modulu 1. 8. 2 Dovoljenja za promet z zdravilom in prav tako katerekoli naknadne posodobitve RMP dogovorjene na CHMP.
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).
V skladu s smernico CHMP o Sistemih upravljanja tveganja za zdravila za uporabo v humani medicini je treba predložiti posodobljen RMP hkrati z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR - Periodic Safety Update Report).
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
Prav tako je treba predložiti posodobljen RMP: • Ko se pridobi dodatne informacije, ki lahko vplivajo na sedanjo specifikacijo o varnosti, Farmakovigilančni načrt ali aktivnosti za zmanjševanja tveganja. • V roku 60 dni od dosega pomembnega mejnika (farmakovigilančnega ali zmanjševanje tveganja). • Na zahtevo EMEA- e.
In order to address the quality defect in relation to the crystal formation in the patches, the MAH commits to:
V izogib oz. v primeru neustrezne kakovosti zdravila, povzročene zaradi nastankov kristalov v obližih, se MAH obvezuje, da bo: • Shranjevanje, transport in distribucija vseh Neupro obližev potekala z uporabo neprekinjene hladne verige (2°C- 8°C). • Nadomestil trenutno zalogo zdravila na trgu znotraj 3 mesečnega časovnega okvira.
• Pursuing further optimization of the manufacturing process and to submitting the results and necessary variations for assessment to CHMP
76 • Predložil vse spremembe dovoljenja za promet, povezane s specifikacijo, rokom uporabnosti in pogoji shranjevanja. • Sledil nadaljnji optimizaciji postopka izdelave zdravila ter posredoval rezultate in potrebne spremembe v oceno CHMP.
74 ANNEX III
77 DODATEK III
75 A.
78 A.
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
79 PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z “ BLUE BOXOM ”) (RAZEN PAKIRANJ Z VEČ OBLIŽI) ŠKATLA S 7 [20] [28] [30] [56] [60] [90] OBLIŽI
Neupro 1 mg/24 h transdermal patch Rotigotine
Neupro 1 mg/ 24 h transdermalni obliž Rotigotin
Each patch of 5 cm2 contains 2.25 mg of rotigotine.
En obliž s površino 5 cm2 vsebuje 2. 25 mg rotigotina.
Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)
Poli( dimetilsiloksan, trimetilsililsilikat) - kopolimerizat, povidonK90, E171, E223, E304, E307, fluoropolimer, poliester, silicij, aluminij, barvila (rumeno barvilo 95, rdeče barvilo 166, rdeče barvilo 144, črno barvilo 7).
7 transdermal patches 20 transdermal patches 28 transdermal patches 30 transdermal patches 56 transdermal patches 60 transdermal patches 90 transdermal patches
7 transdermalnih obližev 20 transdermalnih obližev 28 transdermalnih obližev 30 transdermalnih obližev 56 transdermalnih obližev 60 transdermalnih obližev 90 transdermalnih obližev
Shannon, Industrial Estate, Co.Clare, Ireland
Clare, Irska
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 transdermalnih obližev] EU/ 1/ 05/ 331/ 040 [28 transdermalnih obližev] EU/ 1/ 05/ 331/ 039 [20 transdermalnih obližev] EU/ 1/ 05/ 331/ 041 [30 transdermalnih obližev] EU/ 1/ 05/ 331/ 042 [56 transdermalnih obližev] EU/ 1/ 05/ 331/ 043 [60 transdermalnih obližev] EU/ 1/ 05/ 331/ 045 [90 transdermalnih obližev]
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
81 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “ BLUE BOXOM ”) ŠKATLA S 84 [100] OBLIŽI, KI VSEBUJE 2 ŠKATLI S PO 42 [50] OBLIŽI
84 transdermal patches, multipack, containing 2 boxes with 42 patches each 100 transdermal patches, multipack, containing 2 boxes with 50 patches each
100 transdermalnih obližev.
EU/1/05/331/044 [84 transdermal patches] EU/1/05/331/046 [100 transdermal patches]
EU/ 1/ 05/ 331/ 044 [84 transdermalnih obližev] EU/ 1/ 05/ 331/ 046 [100 transdermalnih obližev]
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY INTERMEDIATE CARTON (WITHOUT BLUE BOX) BOX OF 42 [50] PATCHES
83 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI VMESNA OVOJNINA (BREZ “ BLUE BOXA ”) ŠKATLA Z 42 [50] OBLIŽI
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
50 transdermalnih obližev Del večjega pakiranja, sestavljenega iz 2 škatel po 50 transdermalnih obližev.
82 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
85 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SACHET LABEL
NALEPKA NA ZAŠČITNI VREČKI
Neupro 1 mg/24 h transdermal patch Rotigotine Transdermal use.
Neupro 1 mg/ 24 h transdermalni obliž Rotigotin Transdermalna uporaba.
1 transdermal patch.
1 transdermalni obliž.
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
86 PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (Z “ BLUE BOXOM ”) (RAZEN PAKIRANJ Z VEČ OBLIŽI) ŠKATLA S 7 [20] [28] [30] [56] [60] [90] OBLIŽI
Neupro 2 mg/24 h transdermal patch Rotigotine
Neupro 2 mg/ 24 h transdermalni obliž Rotigotin
84 9.
87 9.
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 transdermalnih obližev] EU/ 1/ 05/ 331/ 002 [28 transdermalnih obližev] EU/ 1/ 05/ 331/ 014 [20 transdermalnih obližev] EU/ 1/ 05/ 331/ 015 [30 transdermalnih obližev] EU/ 1/ 05/ 331/ 016 [56 transdermalnih obližev] EU/ 1/ 05/ 331/ 017 [60 transdermalnih obližev] EU/ 1/ 05/ 331/ 019 [90 transdermalnih obližev]
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
88 PODATKI NA ZUNANJI OVOJNINI SAMO PAKIRANJA Z VEČ OBLIŽI ZUNANJA NALEPKA (Z “ BLUE BOXOM ”) ŠKATLA S 84 [100] OBLIŽI, KI VSEBUJE 2 ŠKATLI S PO 42 [50] OBLIŽI
EU/1/05/331/018 [84 transdermal patches] EU/1/05/331/003 [100 transdermal patches]
EU/ 1/ 05/ 331/ 018 [84 transdermalnih obližev] EU/ 1/ 05/ 331/ 003 [100 transdermalnih obližev]