natgillin/translations-raw huggingface dataset:
Close monitoring of renal function is also recommended in these patients (see section 4.2).
Pri teh bolnikih se priporoča tudi natančno spremljanje delovanja ledvic (glejte poglavje 4.2).
Dogs receiving oral doses of trientine up to 300 mg/kg/day, showed neurological and/or musculo-skeletal clinical symptoms (abnormal gait, ataxia, weak limbs, body tremors) in repeat-dose toxicity studies, attributed to the copper-depleting activity of trientine.
Pri psih, ki so trientin prejemali peroralno v odmerkih do 300 mg/kg/dan, so se v študijah toksičnosti ponavljajočih se odmerkov izrazili nevrološki in mišično-skeletni klinični simptomi (nenormalna hoja, ataksija, šibkost udov, telesni tremor), ki so bili pripisani zmanjševanju količine bakra zaradi trientina.
96 film-coated tablets
96 filmsko obloženih tablet
The pharmaceutical form is not suitable for administration to children < 5 years.
Farmacevtska oblika ni primerna za uporabo pri otrocih, mlajših od 5 let.
The association of trientine with another medicine that contains zinc is not recommended.
Kombiniranje trientina z zdravilom, ki vsebuje cink, se ne priporoča.
Tablet film-coating: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate (Type I), iron oxide yellow (E172) and sodium laurilsulfate
Filmska obloga: polivinil alkohol, smukec, titanov dioksid (E171), glicerol monokaprilat monokaprinat (tip I), rumeni železov oksid (E172) in natrijev lavrilsulfat.
A large overdose of 40 g of trientine base resulted in selflimiting dizziness and vomiting with no other clinical sequelae or significant biochemical abnormalities reported.
Znatno preveliko odmerjanje trientinijeve baze nad 40 g je povzročilo omotico in bruhanje, ki sta izzvenela sama od sebe. O kakšnih drugih kliničnih posledicah ali pomembnih biokemijskih nenormalnostih niso poročali.
Positive results for sensitization potential in Guinea pig maximization tests were reported.
V preskusih maksimizacije pri morskih prašičkih so poročali o pozitivnih rezultatih pri preskusih maksimizacije.
There is limited information in patients with renal impairment.
Podatki o uporabi zdravila pri bolnikih z okvaro ledvic so omejeni.
What you need to know before you take Cuprior
Kaj morate vedeti, preden boste vzeli zdravilo Cuprior
It is unknown whether trientine is excreted in human milk.
Ni znano, ali se trientin izloča v materino mleko.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cuprior therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Cuprior, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
It may also attach to copper in the gut and so reduce the amount taken up into the body.
Na baker se lahko veže tudi v črevesu in tako zmanjša količino, ki jo privzema telo.
The film-coated tablet can be divided into equal doses.
Filmsko obložena tableta se lahko deli na enake odmerke.
Other medicines and Cuprior Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The rat NOAEL was considered 50 mg/kg/day for females, a NOAEL was not established for males.
NOAEL je bil pri podganah ocenjen na 50 mg/kg/dan pri samicah, pri samcih pa ni bil ocenjen.
If you are pregnant and taking Cuprior, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels.
Če ste noseči in jemljete zdravilo Cuprior, bodo v nosečnosti preverjali možne učinke na plod in spremembe ravni bakra.
Since copper is required for proper growth and mental development, dose adjustments may be required to ensure that the foetus will not become copper deficient and close monitoring of the patient is essential (see section 4.4).
Ker je baker potreben za primerno rast in duševni razvoj, bo za preprečitev pomanjkanja bakra pri plodu odmerek morda treba prilagoditi, poleg tega je nujno natančno spremljanje bolnice (glejte poglavje 4.4).
Fertility It is unknown whether trientine has an effect on human fertility.
Plodnost Ni znano, ali ima zdravilo Cuprior učinke na plodnost pri človeku.
Tablet core: mannitol, colloidal anhydrous silica and glycerol dibehenate.
Jedro tablete: manitol, koloidni brezvodni silicijev dioksid in glicerolov dibehenat.
Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.
Rumene podolgovate filmsko obložene tablete velikosti 16 mm × 8 mm z zarezo na vsaki strani.
If you were already taking another trientine medicine, your doctor may modify your daily dose, the number of tablets or the number of intake in the day when switching to Cuprior treatment.
Če že jemljete katero drugo zdravilo, ki vsebuje trientin, bo zdravnik pri prehodu na zdravljenje z zdravilom Cuprior morda prilagodil dnevni odmerek, število tablet ali število jemanj dnevno.
You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Z zdravnikom se temeljito pogovorite o možnih koristih in tveganjih zdravljenja.
If you forget to take Cuprior
Če ste pozabili vzeti zdravilo Cuprior
50 mg/kg/day resulting in safety margins of about 4 in males and 17 in females, towards human therapeutic exposures.
NOAEL je bil določen pri 50 mg/kg/dan z varnostno rezervo 4 pri samcih in 17 pri samicah glede na terapevtsko izpostavljenost pri ljudeh.
Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.
Zdravljenje z zdravilom Cuprior sme uvesti le zdravnik specialist z izkušnjami z zdravljenjem Wilsonove bolezni.
DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux France
DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux Francija
If you take iron supplements, make sure that at least two hours have passed between taking Cuprior and taking your iron supplements.
Če jemljete dodatke železa, poskrbite, da bosta med jemanjem zdravila Cuprior in jemanjem dodatkov železa minili vsaj dve uri.
Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Trientin lahko baker kelira tudi v prebavnem traktu in tako zavira absorpcijo bakra.
Serious iron deficiency anaemia and severe colitis may occur during treatment.
Pri zdravljenju se lahko pojavita resna anemija in hud kolitis.
- skin rashes - itching
- kožni izpuščaj - srbenje
Your doctor will then help you decide whether to stop breast-feeding or to stop taking Cuprior, considering the benefit of breast-feeding to the baby and the benefit of Cuprior to the mother.
Zdravnik vam bo pomagal sprejeti odločitev o prenehanju dojenja ali prenehanju jemanja zdravila Cuprior; pri tem bo upošteval koristi dojenja za otroka in koristi zdravila Cuprior za mater.
What Cuprior is and what it is used for
Kaj je zdravilo Cuprior in za kaj ga uporabljamo
If you stop taking Cuprior
Če ste prenehali jemati zdravilo Cuprior
Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Paris
Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Pariz
Hematopoietic cell proliferation was seen in the spleen of males.
V vranici samcev je bila ugotovljena proliferacija hematopoetskih celic.
There is no antidote for trientine acute overdose.
Za akutno preveliko odmerjanje trientina ni antidota.
Close monitoring is required to optimise the dose or to adapt treatment if necessary (see section 4.4).
Za optimizacijo odmerka ali morebitno prilagoditev zdravljenja, je potrebno natančno spremljanje (glejte poglavje 4.4).
Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Paris, France
Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Pariz, Francija
The dose that you will take is usually lower than for an adult and depends on your age and body weight.
Odmerek je pri otrocih običajno manjši in je odvisen od starosti in telesne mase.
These effects are possibly due to trientine induced-copper and zinc deficiency.
Ti učinki so se morda pojavili zaradi s trientinom povzročenega pomanjkanja bakra in cinka.
When rodents were fed throughout pregnancy a diet containing trientine, the frequency of resorptions and the frequency of abnormal fetuses at term showed a dose-related increase.
Pri hranjenju glodavcev med brejostjo s hrano, ki je vsebovala trientin, sta pogostost resorpcij in pogostost nenormalnih plodov ob kotitvi pokazali z odmerkom povezano povečanje.
How to take Cuprior
Kako jemati zdravilo Cuprior
- feeling sick (nausea)
- Siljenje na bruhanje (navzea)
In adults of all ages, the recommended total daily dose is 3 to 6½ tablets per day (making a total of between 450 and 975 mg).
Pri odraslih je priporočeni skupni dnevni odmerek od 3 do 6½ tablete na dan (skupno od 450 mg do 975 mg).
Unabsorbed trientine is eliminated through faecal excretion.
Neabsorbirani trientin se iz telesa odstranjuje z izločanjem blata.
NAME OF THE MARKETING AUTHORISATION HOLDER gmp-orphan SA
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM gmp-orphan SA
These findings were not reversible.
Te spremembe so bile ireverzibilne.
NAME OF THE MEDICINAL PRODUCT Cuprior 150 mg film-coated tablets
IME ZDRAVILA Cuprior 150 mg filmsko obložene tablete
The most commonly reported adverse reaction with trientine is nausea.
Najpogosteje poročani neželeni učinek trientina je navzea.
Cuprior is for oral use.
Zdravilo Cuprior je namenjeno peroralni uporabi.
You should tell your doctor if you get any side effects as this may indicate that your dose of Cuprior needs to be adjusted up or down.
Če se bodo ob tem pojavili kateri koli neželeni učinki, morate o tem obvestiti zdravnika, saj pomeni, da je treba odmerek zdravila Cuprior zvišati ali znižati.
Cuprior 150 mg film-coated tablets trientine
Cuprior 150 mg filmsko obložene tablete trientin
If you think you may have taken more Cuprior than you were told to, contact your doctor or pharmacist.
Če menite, da ste vzeli več zdravila Cuprior, kot vam je bilo določeno, se obrnite na zdravnika ali farmacevta.
Patients with renal impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Pri bolnikih z okvaro ledvic je potreben reden zdravniški nadzor za ustrezno obvladovanje simptomov in ravni bakra.
Children ≥ 5 years
Otroci, mlajši od 5 let
This medicine is not recommended for children aged below 5 years of age.
Uporaba zdravila Cuprior ni priporočljiva pri otrocih, mlajših od 5 let.
Marketing Authorisation Holder gmp-orphan SA
Imetnik dovoljenja za promet z zdravilom gmp-orphan SA
Worsening of clinical symptoms, including neurological deterioration, may occur at the beginning of chelation therapy due to excess of free serum copper during the initial response to treatment.
Ob začetku kelacijskega zdravljenja se lahko zaradi presežka prostega bakra v serumu med začetnim odzivom na zdravljenje pojavi slabšanje kliničnih simptomov, vključno z nevrološkim poslabšanjem.
In silico data predict that trientine displays irritating and sensitising properties.
Podatki in silico napovedujejo, da ima trientin dražilne in senzibilizirajoče lastnosti.
Swallow the tablets with water on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicines, food, or milk.
Tablete pogoltnite z vodo na prazen želodec vsaj eno uro pred obrokom ali dve uri po obroku in v razmiku vsaj ene ure od jemanja drugega zdravila, hrane ali mleka.
The active substance is trientine.
Učinkovina je trientin.
What Cuprior contains
Kaj vsebuje zdravilo Cuprior
Skin and subcutaneous tissue disorder
Bolezni kože in podkožja
Uncommon (may affect up to 1 in 100 people)
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
Patients receiving Cuprior should remain under regular medical supervision and be monitored for appropriate control of symptoms and copper levels in order to optimise the dose (see section 4.2).
Pri bolnikih, ki prejemajo zdravilo Cuprior, sta za obvladovanje simptomov in zagotovitev optimalnega odmerka potrebna reden zdravniški nadzor ter spremljanje simptomov in ravni bakra (glejte poglavje 4.2).
The recommended dose is between 450 mg and 975 mg (3 to 6½ film-coated tablets) per day in 2 to 4 divided doses.
Priporočeni odmerek je med 450 mg in 975 mg (3 do 6½ filmsko obložene tablete) na dan, razdeljen v 2 do 4 enake odmerke.
OTHER SPECIAL WARNING(S), IF NECESSARY Take on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicine, food, or milk.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Jemljite na prazen želodec vsaj eno uro pred obrokom ali dve uri po njem in v razmiku vsaj ene ure od jemanja drugega zdravila, hrane ali mleka.
Driving and using machines Cuprior is not expected to affect your ability to drive a car or use any tools or machines.
Vpliv na sposobnost vožnje in upravljanja strojev Učinek zdravila Cuprior na sposobnost vožnje in upravljanja strojev se ne pričakuje.
The dose is usually between 225 mg and 600 mg per day (1½ to 4 film-coated tablets) in 2 to 4 divided doses.
Odmerek je običajno med 225 mg in 600 mg na dan (1½ do 4 filmsko obložene tablete), razdeljen v 2 do 4 enake odmerke.
Kidney and body weights were reduced in males as was the incidence of renal cytoplasmic vacuolisation.
Pri samcih sta bili zmanjšani masa ledvic in telesna masa ter incidenca citoplazemske vakuolizacije.
The NOAEL was established at approximately 92 mg/kg/day for males and 99 mg/kg/day for females.
Najvišji odmerek, pri katerem niso opazili neželenih učinkov (NOAEL), je bil pri samcih 92 mg/kg/dan, pri samicah pa 99 mg/kg/dan.
In mice administered in drinking water, trientine displayed increased frequencies of inflammation of the lung interstitium and liver periportal fatty infiltration.
Pri miših, ki so trientin prejemale s pitno vodo, sta bila pogostejša vnetje pljučnega intersticija in vnetje periportalnega maščevja.
Blood and lymphatic system disorders
Razvrstitev po organskih sistemih Neželeni učinki Bolezni krvi in limfnega sistema
The usual total daily dose is between 225 and 600 mg (1½ to 4 tablets daily), which will be divided into 2 to 4 smaller doses to be taken during the day.
Običajni dnevni odmerek je od 225 mg do 600 mg (1½ do 4 tablete dnevno), razdeljen v 2 do 4 manjše dnevne odmerke.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 150 mg trientina v obliki trientinijevega tetraklorida.
The measurement of copper excretion in the urine may be performed during therapy.
Med zdravljenjem se lahko meri izločanje bakra z urinom.
It is important that Cuprior is given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other medicinal product, food, or milk (see section
Pomembno je, da se zdravilo Cuprior jemlje na prazen želodec vsaj eno uro pred obrokom ali dve uri po njem in v razmiku vsaj ene ure od jemanja drugega zdravila, hrane ali mleka (glejte poglavje 4.5).
Uncommon: skin rash, pruritus, erythema.
Občasni: kožni izpuščaj, pruritus, eritem Neznani: urtikarija
It is not known if Cuprior can pass into breast milk.
Ni še znano, ali se to zdravilo izloča v materino mleko.
Not known: urticaria.
- urtikarija (koprivnica ali izpuščaji)
Manufacturer Delpharm Evreux 5 rue du Guesclin
Izdelovalec Delpharm Evreux 5 rue du Guesclin 27000 Evreux Francija
In vivo, trientine was however negative in the mouse micronucleus test.
V testu mikrojeder pri miših in vivo, je bil trientin negativen.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
- inflammation of the gut which may lead to e.g. abdominal pain, recurring diarrhoea and blood in stools (colitis) - decrease in the number of red blood cells due to low iron level in your blood (iron deficiency anaemia) - urticaria (nettle rash or hives).
(kolitis) - zmanjšanje števila eritrocitov zaradi nizke ravni železa v krvi (anemija zaradi pomanjkanja železa)
How to store Cuprior
Shranjevanje zdravila Cuprior
Each film-coated tablet (tablet) contains trientine tetrahydrochloride equivalent to 150 mg trientine.
Ena filmsko obložena tableta (tableta) vsebuje 150 mg trientina v obliki trientinijevega tetraklorida.
Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine.
Pri nekaterih bolnikih, ki so na jemanje trientina prešli po jemanju penicilamina, so se pojavile lupusu podobne reakcije (simptomi lahko vključujejo trdovraten izpuščaj, vročino, bolečine v sklepih in utrujenost).
- stomach upsets and discomfort, including severe stomach pains (duodenitis)
- trebušne motnje in nelagodje, vključno s hudimi bolečinami v trebuhu (duodenitis) - vnetje črevesja, ki lahko povzroči bolečine v trebuhu, ponavljajočo se drisko ter kri v blatu
The following adverse reactions have been reported with the use of trientine for Wilson's disease.
Pri uporabi trientina za zdravljenje Wilsonove bolezni so poročali o naslednjih neželeni učinkih.
Common: nausea.
Pogosti: navzea
Tablet core:
Navodilo shranite.
It is important to tell your doctor if you are breast-feeding or plan to do so.
Če dojite ali načrtujete dojenje, je pomembno, da zdravnika seznanite s tem.
Iron oxide yellow (E172).
Filmska obloga tablete: polivinil alkohol smukec titanov dioksid (E171) glicerol monokaprilat monokaprinat (tip I) rumeni železov oksid (E172) natrijev lavrilsulfat
If you take more Cuprior than you should
Če ste vzeli večji odmerek zdravila Cuprior, kot bi smeli Zdravilo Cuprior jemljite samo tako, kot vam je bilo predpisano.
Colloidal anhydrous silica.
Jedro tablete: manitol koloidni brezvodni silicijev dioksid glicerolov dibehenat
Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package size
Farmacevtska oblika Pot uporabe zdravila Ovojnina Vsebina (koncentracija)
It is available as tablets (0.088, 0.18, 0.35, 0.7 and 1.1 mg).
Na voljo je v obliki tablet (0,088, 0,18, 0,35, 0,7 in 1,1 mg).
If treatment is stopped for any reason, the dose should be decreased gradually.
Če se zdravljenje iz katerega koli razloga prekine, je treba odmerek zmanjševati postopoma.
The maximum daily dose is three 1.1 mg tablets.
Največji dnevni odmerek so tri 1,1-miligramske tablete.
The full EPAR for Pramipexole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pramipexole Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pramipexole Accord have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Pramipexole Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Pramipexole Accord must be given less often in patients who have problems with their kidneys.
Zdravilo Pramipexole Accord je treba dajati manj pogosto pri bolnikih, ki imajo težave z ledvicami.
This is a summary of the European public assessment report (EPAR) for Pramipexole Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pramipexole Accord.
For more information about treatment with Pramipexole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pramipexole Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the European Union for Pramipexole Accord on 30 September 2011.
Evropska komisija je dovoljenje za promet z zdravilom Pramipexole Accord, veljavno po vsej Evropski uniji, izdala 30. septembra 2011.
Pramipexole Accord can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Zdravilo Pramipexole Accord se lahko uporablja samostojno ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v katerem koli stadiju bolezni, tudi v poznem stadiju, ko začne učinek levodope popuščati.
This means that Pramipexole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Mirapexin.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Mirapexin.
What measures are being taken to ensure the safe and effective use of Pramipexole Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pramipexole Accord?
Because Pramipexole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pramipexole Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pramipexole Accord.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Pramipeksol stimulira možgane enako kot dopamin, tako da lahko bolniki spet nadzirajo svoje gibe in kažejo manj znakov in simptomov Parkinsonove bolezni, kot so tresenje, okorelost in upočasnjeno izvajanje gibov.
Pramipexole Accord is used to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Zdravilo Pramipexole Accord se uporablja za zdravljenje simptomov Parkinsonove bolezni, napredujoče okvare možganov, ki povzroča tresenje, upočasnjeno izvajanje gibov in otrplost mišic.
Pramipexole Accord pramipexole
Pramipexole Accord pramipeksol
What are the benefits and risks of Pramipexole Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Pramipexole Accord?
The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to have comparable quality and to be bioequivalent to Mirapexin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pramipexole Accord primerljivo raven kakovosti kot zdravilo Mirapexin ter da mu je biološko enakovredno.
Pramipexole Accord is a ‘generic medicine'.
Zdravilo Pramipexole Accord je „generično zdravilo“.
The Committee recommended that Pramipexole Accord be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pramipexole Accord izda dovoljenje za promet.
Other information about Pramipexole Accord
Druge informacije o zdravilu Pramipexole Accord
Because Pramipexole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mirapexin.
Ker je zdravilo Pramipexole Accord generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Mirapexin.