FrancophonIA/ELRC3.0 huggingface dataset:
English: Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd
Slovenian: obsesivno kompulzivna motnja, agitiranost d nasilno vedenje/ agresivnost b, dezorientiranost d dopaminski disregulacijski sindrom c,
English: • sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
Slovenian: Pred uporabo zdravila Neupro se pogovorite z zdravnikom, če jemljete • sedative, kot so benzodiazepini ali zdravila za zdravljenje duševnih bolezni ali depresije.
English: Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermal patch
Slovenian: Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h transdermalni obliž rotigotin
English: Nausea, vomiting Constipation, dry mouth, dyspepsia
Slovenian: Bolezni prebavil navzea, bruhanje zaprtje, suha usta, dispepsija bolečine v trebuhu driskac
English: hallucination, hallucination visual, hallucination auditory, illusion), insomnia, sleep disorder, nightmare, abnormal dreams, impulsecontrol disorders a,d
Slovenian: (vključno s halucinacijami, vizualnimi halucinacijami, zvočnimi halucinacijami, iluzijami), nespečnost, motnje spanja, nočne more, nenavadne sanje, motnje pri kontroli dražljajev a,d
English: sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Slovenian: (E223), askorbilpalmitat (E304) in DL-α-tokoferol (E307)
English: The outside is tan-coloured and is imprinted with Neupro 1 mg/24 h or 3 mg/24 h.
Slovenian: Zunanja stran je rumenorjave barve, z natisnjenim napisom Neupro 1 mg/24 h ali 3 mg/24 h.
English: Side effects when using Neupro for Restless Legs Syndrome Tell your doctor or pharmacist if you notice any of the following side effects:
Slovenian: Neželeni učinki pri uporabi zdravila Neupro za zdravljenje sindroma nemirnih nog Če se pojavijo naslednji neželeni učinki, se posvetujte z zdravnikom ali farmacevtom:
English: Neupro may make you feel very sleepy and you may fall asleep very suddenly.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Neupro ste lahko zelo zaspani in lahko povsem nenadno zaspite.
English: At the beginning of the second week, you should take Neupro 4 mg (package marked with “Week 2”).
Slovenian: Na začetku drugega tedna zdravljenja uporabite zdravilo Neupro 4 mg (pakiranje označeno z nalepko “2.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine.
Slovenian: Bolniki in negovalci se morajo zavedati, da se lahko pri bolnikih, zdravljenih z agonisti dopamina, vključno z rotigotinom, pojavijo vedenjski simptomi motenj kontrole dražljajev kot so patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prehranjevanje.
English: Vision blurrede, visual impairmente, photopsiae
Slovenian: Očesne bolezni zamegljen vid okvara vida, fotopsija
English: • Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Slovenian: • poli(dimetilsiloksan, trimetilsililsilikat)-kopolimerizat, povidon K90, natrijev metabisulfit (E223), askorbilpalmitat (E304) in DL-α-tokoferol (E307).
English: • Thigh or hip.
Slovenian: • Stegno ali kolk.
English: What Neupro is Neupro contains the active substance rotigotine.
Slovenian: Zdravilo Neupro vsebuje učinkovino rotigotin.
English: syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsione
Slovenian: (vključno s sinkopo, vazovagalno sinkopo, izgubo zavesti) diskinezija, posturalna omotica, letargija konvulzija sindrom padajoče glave c
English: The outside is tan-coloured and is imprinted with Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/ 24 h.
Slovenian: Zunanja stran je rumenorjave barve, z natisnjenim napisom Neupro 4 mg/24 h, Neupro 6 mg/24 h ali Neupro 8 mg/24 h.
English: Neupro was not investigated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo jetrno okvaro zdravila Neupro niso raziskovali.
English: Do not breast-feed during treatment with Neupro.
Slovenian: Ne dojite med zdravljenjem z zdravilom Neupro, saj lahkorotigotin prehaja v mleko in učinkuje na otroka.
English: This is because rotigotine may pass into your breast milk and affect your baby.
Slovenian: Ne dojite med zdravljenjem z zdravilom Neupro, saj lahko rotigotin prehaja v mleko in učinkuje na otroka.
English: 7 transdermal patches of Neupro 8 mg/24 h
Slovenian: 7 transdermalnih obližev Neupro 8 mg/24 h
English: Neupro may cause other behaviours and abnormal thinking.
Slovenian: Zdravilo Neupro lahko povzroči tudi druge spremembe vedenja ali razmišljanja.
English: pathological gambling, stereotypy/ punding, binge eating/eating disorder b, compulsive shopping c)
Slovenian: (vključno s patološkim hazardiranjem, ponavljanjem nesmiselnih dejanj, prenajedanjem/ motnjami prehranjevanja b kompulzivnim nakupovanjemc)
English: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and
Slovenian: poli(dimetilsiloksan, trimetilsililsilikat)-kopolimerizat, povidon K90, natrijev metabisulfit (E223), askorbilpalmitat (E304) in
English: 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'.
Slovenian: 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'.
English: 7 transdermal patches of Neupro 4 mg/24 h
Slovenian: 7 transdermalnih obližev Neupro 4 mg/24 h
English: Neupro 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 8 mg/24 h'.
Slovenian: Neupro 8 mg/24 h transdermalni obliž Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Neupro 8 mg/24 h'.
English: Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Slovenian: En obliž s površino 30 cm2 vsebuje 13,5 mg rotigotina.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Neupro.
Slovenian: Pred začetkom uporabe zdravila Neupro se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, saj:
English: Each patch of 10 cm contains 4.5 mg of rotigotine.
Slovenian: Vsak obliž s površino 10 cm vsebuje 4,5 mg rotigotina.
English: 7 transdermal patches of Neupro 6 mg/24 h
Slovenian: 7 transdermalnih obližev Neupro 6 mg/24 h
English: Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Slovenian: En obliž s površino 40 cm2 vsebuje 18,0 mg rotigotina.
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)
Slovenian: (vključno z eritemom, pruritusom, draženjem, izpuščajem , dermatitisom, mehurji, bolečino, ekcemom, vnetjem, oteklino, razbarvanjem, papulami, lupljenjem, koprivnico, preobčutljivostjo)
English: Hiccups e
Slovenian: fotopsija e
English: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90,
Slovenian: • poli(dimetilsiloksan, trimetilsililsilikat)-kopolimerizat, povidon K90, natrijev metabisulfit
English: Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Slovenian: En obliž s površino 5 cm2 vsebuje 2,25 mg rotigotina.
English: Neupro 1 mg/24 h transdermal patch EU/1/05/331/038
Slovenian: Neupro 1 mg/24 h transdermalni obliž EU/1/05/331/038
English: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h'.
Slovenian: Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Neupro 2 mg/24 h'.
English: Each patch of 5 cm contains 2.25 mg of rotigotine.
Slovenian: Vsak obliž s površino 5 cm vsebuje 2,25 mg rotigotina.
English: Neupro 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h'.
Slovenian: Neupro 6 mg/24 h transdermalni obliž Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Neupro 6 mg/24 h'.
English: The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Slovenian: Zunanja stran je rumenorjave barve, z natisnjenim napisom Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h ali 8 mg/24 h.
English: h may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Slovenian: dnevni odmerek 10 mg se lahko doseže z uporabo enega obliža jakosti 6 mg/24 h in enega obliža jakosti 4 mg/24 h.
English: The backing layer of Neupro contains aluminium.
Slovenian: Zdravilo Neupro vsebuje natrijev metabisulfit.
English: Neupro 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h'.
Slovenian: Neupro 4 mg/24 h transdermalni obliž Zunanja stran oporne plasti je rumenorjave barve, z natisnjenim napisom ‘Neupro 4 mg/24 h'.
English: Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
Slovenian: Neupro 6 mg/24 h transdermalni obliž EU/1/05/331/007
English: • Do not cut the Neupro patches into pieces.
Slovenian: • Obliža zdravila Neupro ne razrežite na dele.
English: • 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
Slovenian: • 4 mg/24 h: Vsak obliž sprosti 4 mg rotigotina v 24 urah.
English: Sleep attacks/sudden onset of sleep, sexual desire disordersa (incl.
Slovenian: Psihiatrične motnje napadi spanca/nenaden spanec, motnje spolnega poželenja a
English: Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Slovenian: Neupro 3 mg/24 h transdermalni obliž EU/1/05/331/047
English: The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
Slovenian: Zunanja stran je rumenorjave barve, z natisnjenim napisom Neupro 2 mg/24 h.
English: Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Slovenian: Neupro 4 mg/24 h transdermalni obliž EU/1/05/331/004
English: Neupro 8 mg/24 h transdermal patch EU/1/05/331/010
Slovenian: Neupro 8 mg/24 h transdermalni obliž EU/1/05/331/010
English: Each patch releases 6 mg of rotigotine per 24 hours.
Slovenian: Vsak obliž sprosti 6 mg rotigotina v 24 urah.
English: AST, ALT, GGT), weight increased, heart rate increased, CPK increasedd
Slovenian: Neznana telesne mase, pospešeno bitje srca, zvišan CPK
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation,
Slovenian: (vključno z eritemom, pruritusom, draženjem, izpuščajem, dermatitisom, mehurji, bolečino, ekcemom,
English: EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
Slovenian: EU/1/05/331/047 [7 transdermalnih obližev] EU/1/05/331/049 [28 transdermalnih obližev] EU/1/05/331/050 [30 transdermalnih obližev] EU/1/05/331/058 [14 transdermalnih obližev]
English: Neupro 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Slovenian: Neupro 4 mg/24 h transdermalni obliž En obliž sprosti 4 mg rotigotina v 24 urah.
English: Disturbances in consciousness NEC
Slovenian: Bolezni živčevja glavobol somnolenca omotica e, motnje zavesti NEC
English: EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
Slovenian: EU/1/05/331/038 [7 transdermalnih obližev] EU/1/05/331/040 [28 transdermalnih obližev] EU/1/05/331/041 [30 transdermalnih obližev] EU/1/05/331/056 [14 transdermalnih obližev]
English: EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
Slovenian: EU/1/05/331/010 [7 transdermalnih obližev] EU/1/05/331/011 [28 transdermalnih obližev] EU/1/05/331/033 [30 transdermalnih obližev] EU/1/05/331/061 [14 transdermalnih obližev]
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
Slovenian: (vključno s sinkopo, vazovagalno sinkopo, izgubo zavesti) diskinezija a,
English: Warnings and precautions Talk to your doctor or pharmacist before using Neupro.
Slovenian: Pred začetkom uporabe zdravila Neupro se posvetujte z zdravnikom ali farmacevtom, saj:
English: Vertigo e
Slovenian: d,e
English: EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
Slovenian: EU/1/05/331/004 [7 transdermalnih obližev] EU/1/05/331/005 [28 transdermalnih obližev] EU/1/05/331/021 [30 transdermalnih obližev] EU/1/05/331/059 [14 transdermalnih obližev]
English: Irritability, oedema peripheral swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditionsa (incl.
Slovenian: Neznana vnetjem, oteklino, razbarvanjem, papulami, lupljenjem, koprivnico, preobčutljivostjo ), astenična stanja a
English: Neupro 1 mg/24 h transdermal patch rotigotine
Slovenian: Neupro 1 mg/24 h transdermalni obliž rotigotin
English: EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
Slovenian: EU/1/05/331/001 [7 transdermalnih obližev] EU/1/05/331/002 [28 transdermalnih obližev] EU/1/05/331/015 [30 transdermalnih obližev] EU/1/05/331/057 [14 transdermalnih obližev]
English: EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
Slovenian: EU/1/05/331/007 [7 transdermalnih obližev] EU/1/05/331/008 [28 transdermalnih obližev] EU/1/05/331/027 [30 transdermalnih obližev] EU/1/05/331/060 [14 transdermalnih obližev]
English: Neupro 8 mg/24 h transdermal patch rotigotine
Slovenian: Neupro 8 mg/24 h transdermalni obliž rotigotin
English: • From the second week, your daily dose may be increased by 1 mg each week until you get to the right maintenance dose for you.
Slovenian: • Od drugega tedna dalje se vam lahko dnevni odmerek po zdravnikovih navodilih zvišuje po 1 mg vsak teden, dokler se ne bo dosegel za vas ustrezen vzdrževalni odmerek.
English: Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch
Slovenian: Neupro 1 mg/24 h transdermalni obliž Neupro 3 mg/24 h transdermalni obliž rotigotin
English: For most patients with advanced-stage Parkinson's disease the right dose is reached within 3 to 7 weeks, at doses of 8 mg per day up to a maximum dose of 16 mg per day.
Slovenian: Večina bolnikov v napredovali fazi Parkinsonove bolezni doseže ustrezni odmerek v 3 do 7 tednih, pri odmerkih od 8 mg na dan do največjega odmerka 16 mg na dan. Za odmerke, večje od 8 mg/24 h (odmerke, ki jih je predpisal zdravnik in so večji od razpoložljivih jakosti), je treba uporabiti več obližev za doseg končnega odmerka.
English: EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
Slovenian: EU/1/05/331/018 [84 transdermalnih obližev (3 pakiranja po 28)]
English: What Neupro is used for
Slovenian: Zakaj se uporablja zdravilo Neupro
English: Neupro 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Neupro 1 mg/24 h transdermalni obliž En obliž sprosti 1 mg rotigotina v 24 urah.
English: EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
Slovenian: EU/1/05/331/036 [84 transdermalnih obližev (3 pakiranja po 28)]
English: Neupro 3 mg/24 h transdermal patch rotigotine
Slovenian: Neupro 3 mg/24 h transdermalni obliž rotigotin
English: If you are treated with Neupro and levodopa at the same time, some side effects may get more serious.
Slovenian: Če se sočasno zdravite z zdravilom Neupro in levodopo, lahko nekateri neželeni učinki postanejo resnejši, na primer videnje ali slišanje stvari, ki niso resnične (halucinacije), nekontrolirani gibi,
English: Neupro 2 mg/24 h transdermal patch rotigotine
Slovenian: Neupro 2 mg/24 h transdermalni obliž rotigotin
English: Neupro 6 mg/24 h transdermal patch rotigotine
Slovenian: Neupro 6 mg/24 h transdermalni obliž rotigotin
English: Dizzinesse, disturbances in consciousness NECe (incl.
Slovenian: Bolezni živčevja somnolenca, omotica, glavobol motnje zavesti NEC
English: To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Slovenian: Če je treba pri bolniku opraviti magnetnoresonančno slikanje (MRI) ali kardioverzijo, obliž zdravila Neupro odstranimo, da preprečimo opekline kože.
English: Convulsion Dropped head syndrome c
Slovenian: blodnja d, delirij d dopaminski disregulacijski sindrom c
English: EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
Slovenian: EU/1/05/331/053 [84 transdermalnih obližev (3 pakiranja po 28)]
English: EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
Slovenian: EU/1/05/331/024 [84 transdermalnih obližev (3 pakiranja po 28)]
English: Neupro 8 mg/24 h transdermal patch
Slovenian: 8 mg/24 h transdermalni obliž
English: EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
Slovenian: EU/1/05/331/030 [84 transdermalnih obližev (3 pakiranja po 28)]
English: Neupro 4 mg/24 h transdermal patch Rotigotine
Slovenian: Neupro 4 mg/24 h transdermalni obliž rotigotin
English: EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
Slovenian: EU/1/05/331/044 [84 transdermalnih obližev (3 pakiranja po 28)]
English: • Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms,
Slovenian: • Sindroma nemirnih nog (RLS - Restless Legs Syndrome ), ki je lahko povezan z nelagodjem v vaših nogah ali rokah, s potrebo po premikanju, motnjami spanja in občutkom utrujenosti ali zaspanosti čez dan. Ti simptomi se bodisi omilijo ali pa se njihovo trajanje skrajša ob zdravljenju z zdravilom Neupro.
English: Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch
Slovenian: Neupro 4 mg/24 h transdermalni obliž Neupro 6 mg/24 h transdermalni obliž Neupro 8 mg/24 h transdermalni obliž rotigotin
English: Neupro 2 mg/24 h transdermal patch
Slovenian: Neupro 2 mg/24 h transdermalni obliž
English: System/organ classes acc. to
Slovenian: agitiranost d vedenje/ agresivnost b,
English: Erythema e, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Slovenian: Bolezni kože in podkožja pruritus eritem e, hiperhidroza e,
English: Fall e a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson's disease
Slovenian: Opaženo v bazi podatkov dvojno slepe s placebom nadzorovane študije iz leta 2011 Opis izbranih neželenih učinkov
English: Ref.: EMEA/356088/2009 EMEA/H/C/1053
Slovenian: : EMEA/484228/2009 EMEA/H/C/1053
English: It is available as pink tablets (75 mg).
Slovenian: Na voljo je v obliki tablet rožnate barve (75 mg).
English: Clopidogrel Teva clopidogrel EPAR summary for the public
Slovenian: Clopidogrel Teva klopidogrel Povzetek EPAR za javnost
English: Clopidogrel Teva can be given to the following groups of patients:
Slovenian: Zdravilo Clopidogrel Teva se lahko daje naslednjim skupinam bolnikov:
English: This means that Clopidogrel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je zdravilo Clopidogrel Teva podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Slovenian: Pri akutnem koronarnem sindromu se zdravilo Clopidogrel Teva uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih 75-miligramskih tablet.
English: The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food.
Slovenian: Običajni odmerek zdravila Clopidogrel Teva je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: Clopidogrel Teva is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel Teva se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: Other information about Clopidogrel Teva:
Slovenian: Druge informacije o zdravilu Clopidogrel Teva:
English: What are the benefit and risk of Clopidogrel Teva?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Teva?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Teva has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Teva primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: Because Clopidogrel Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Clopidogrel Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Clopidogrel Teva can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel Teva se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: Clopidogrel Teva is a ‘generic medicine'.
Slovenian: Clopidogrel Teva je „generično zdravilo“.
English: The Committee recommended that Clopidogrel Teva be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Clopidogrel Teva odobri dovoljenje za promet.
English: Clopidogrel Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Slovenian: Zdravilo Clopidogrel Teva se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
English: Clopidogrel Teva can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Clopidogrel Teva se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: Because Clopidogrel Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Clopidogrel Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or ‘non-Q-wave' myocardial infarction.
Slovenian: Lahko se uporablja tudi pri bolnikih, ki nimajo tega nenormalnega zapisa na EKG, če imajo nestabilno angino (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez zobca Q. Zdravilo se dobi samo na recept.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma B.V.
English: Why has Clopidogrel Teva been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel Teva odobreno?
English: The active substance in Clopidogrel Teva, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel Teva, klopidogrel, je zaviralec agregacije trombocitov.