FrancophonIA/ELRC3.0 huggingface dataset:
English: Busulfan Fresenius Kabi must be diluted prior to administration.
Slovenian: Zdravilo Busulfan Fresenius Kabi je potrebno pred uporabo razredčiti.
English: Headache Nervous system disorders [Not Elsewhere Classified]
Slovenian: Bolezni živčevja glavobol, bolezni živčevja [nerazvrščene možganska krvavitev, encefalopatija drugje]
English: This medicine contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Slovenian: Kaj je zdravilo Busulfan Fresenius Kabi in za kaj ga uporabljamo To zdravilo vsebuje aktivno učinkovino busulfan, ki spada v skupino zdravil, imenovanih alkilirajoče učinkovine.
English: Periodic monitoring of renal function should be considered during therapy with busulfan (see section
Slovenian: Med terapijo z busulfanom je potreben občasen nadzor ledvične funkcije (glejte poglavje 4.8).
English: Liver disorders.
Slovenian: Bolezni jeter.
English: Therefore, men treated with busulfan are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with busulfan.
Slovenian: Priporočljivo je, da se moški pred zdravljenjem z busulfanom posvetujejo glede shranitve semena z zamrznitvijo, saj zaradi zdravljenja obstaja možnost trajne neplodnosti.
English: Hypoalbuminaemia Electrolyte disturbance Hyperglycaemia
Slovenian: Presnovne in prehranske motnje hipoalbuminemija, motnje elektrolitov, hiperglikemija anoreksija
English: Busulfan Fresenius Kabi must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Slovenian: Zdravila Busulfan Fresenius Kabi ne smete dati v intravensko vrečko, v kateri ni 0,9 % raztopine natrijevega klorida za injiciranje (9 mg/ml) ali 5 % raztopine glukoze za injiciranje.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busulfan Fresenius Kabi 6 mg/ml sterile concentrate busulfan
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Busulfan Fresenius Kabi 6 mg/ml sterilen koncentrat busulfan intravenska uporaba po redčenju
English: PROCEDURE FOR PROPER DISPOSAL
Slovenian: PRIPOROČILA ZA VARNO RAVNANJE
English: A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimen-related toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Slovenian: Pri bolnikih, kjer je bil čas zakasnitve med zadnjim peroralnim odmerkom busulfana in prvim odmerkom ciklofosfamida večji 24 ur, so opazili zmanjšano pojavnost veno-okluzivne bolezni jeter (Hepatic VenoOcclusive Disease - HVOD) in drugih toksičnosti, povezanih z njuno uporabo.
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni:
English: NAME OF THE MEDICINAL PRODUCT Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Busulfan Fresenius Kabi 6 mg/ml koncentrat za raztopino za infundiranje
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use after dilution.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Diluted Busulfan Fresenius Kabi is a clear colourless solution.
Slovenian: Razredčeno zdravilo Busulfan Fresenius Kabi je prozorna, brezbarvna raztopina.
English: Busulfan Fresenius Kabi in combination with fludarabine The recommended dose of busulfan is 3.2 mg/kg Each infusion will last 3 hours
Slovenian: Zdravilo Busulfan Fresenius Kabi v kombinaciji s fludarabinom - Priporočeni odmerek zdravila Busulfan Fresenius Kabi je 3,2 mg/kg.
English: Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion busulfan
Slovenian: Busulfan Fresenius Kabi 6 mg/ml koncentrat za raztopino za infundiranje busulfan
English: • Quantity of diluent: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent
Slovenian: • Količina redčila: (A ml zdravila Busulfan Fresenius Kabi) x (10) = B ml redčila Za pripravo končne raztopine za infundiranje dodajte (A) ml zdravila Busulfan Fresenius Kabi v (B) ml redčila (0,9 % raztopina natrijevega klorida za injiciranje (9 mg/ml) ali 5 % raztopina glukoze za injiciranje).
English: STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml koncentrata vsebuje 6 mg busulfana, po redčenju je koncentracija busulfana 0,5 mg/ml.
English: The median time to neutropenia was 4 days for both autologous and allogeneic patients.
Slovenian: Pri avtolognih in alogenskih bolnikih je bil mediani čas do nevtropenije 4 dni.
English: Femoral artery thrombosis Capillary leak
Slovenian: Žilne bolezni hipertenzija hipotenzija tromboza vazodilacija femoralna arterijska tromboza sindrom kapilarnega prepuščanja
English: Immune system disorders
Slovenian: Bolezni imunskega sistema:
English: How to store Busulfan Fresenius Kabi
Slovenian: Shranjevanje zdravila Busulfan Fresenius Kabi
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le s posebnim režimom.
English: In adults The recommended dose and schedule of administration is:
Slovenian: Priporočeni odmerek in razpored uporabe busulfana:
English: Pulmonary haemorrhage
Slovenian: Žilne bolezni hipertenzija
English: • Quantity of Busulfan Fresenius Kabi: Y (kg) x D (mg/kg)
Slovenian: • Količina zdravila Busulfan Fresenius Kabi: (Y (kg) x D (mg/kg)) / (6 (mg/kg)) = A ml zdravila Busulfan Fresenius Kabi, ki ga morate redčiti Y: telesna masa bolnika v kilogramih
English: No age effect on busulfan clearance was evidenced from available intravenous busulfan data in patients over 60 years.
Slovenian: Glede na razpoložljive podatke o intravenski uporabi busulfana pri bolnikih, starejših od 60 let, starost ne vpliva na očistek busulfana.
English: Similar targeting rate is achieved within the daily exposure of 3600 - 6000 µmol/L.minute following the administration of intravenous busulfan 3.2 mg/kg once daily.
Slovenian: Podoben ciljni delež je bil dosežen z dnevno izpostavljenostjo od 3.600 do 6.000 µmol/l.
English: The terminal half life ranged from 2.26 to 2.52 h. Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively.
Slovenian: Odstopanja pri izpostavljenosti v plazmi so bila med bolniki manjša od 20 %, pri posameznem bolniku pa manjša od 10 %.
English: Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Slovenian: Prebavila: slabost, vnetje ustne sluznice, bruhanje, bolečina v trebuhu, driska, zaprtje, zgaga, bolečine v zadnjiku, tekočina v trebuhu.
English: Agitation Confusional state Hallucination
Slovenian: Psihiatrične motnje agitiranost, stanje zmedenosti, halucinacije
English: For any information about this medicine, please contact the Marketing Authorisation Holder This leaflet was last revised in {MM/YYYY} Other sources of information
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Slovenian: Prebavila: vnetje sluznice požiralnika, paraliza črevesja, bruhanje krvi.
English: Adequate contraceptive precautions should be used when either partner is receiving Busulfan Fresenius Kabi.
Slovenian: Če kateri koli od partnerjev prejema zdravilo Busulfan Fresenius Kabi, morata poskrbeti za ustrezno kontracepcijo.
English: There is no common metabolism pathway between busulfan and fludarabine.
Slovenian: Busulfan in fludarabin nimata nobene skupne poti presnove.
English: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5).
Slovenian: - sledi ciklofosfamid 60 mg/kg/dan 2 dni, vsaj 24 ur po 16. odmerku busulfana (glejte poglavje
English: Viral infection CMV reactivation EBV reactivation Bacterial infection
Slovenian: Infekcijske in parazitske bolezni virusna okužba, reaktivacija CMV, reaktivacija EBV, bakterijska okužba invazivna glivična okužba, okužba pljuč možganski absces, celulitis, sepsa
English: the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
Slovenian: Z ne-polikarbonatno brizgo, na kateri je nameščena igla: - izračunan volumen zdravila Busulfan Fresenius Kabi morate odstraniti iz viale, - vsebino brizge morate prestaviti v vrečko (ali brizgo) za intravensko uporabo, v katero ste prej že dali izračunano količino izbranega redčila.
English: Read this guide prior to the preparation and administration of Busulfan Fresenius Kabi.
Slovenian: Pred pripravo in uporabo zdravila Busulfan Fresenius Kabi preberite to navodilo.
English: Mild/moderate fever was reported in 76% of patients.
Slovenian: Pri 76 % bolnikov so poročali o blago/zmerno povišani telesni temperaturi.
English: Medicinal product subject to restricted medical prescription.
Slovenian: DRUGI PODATKI Citotoksično zdravilo.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija bolečina v hrbtu artralgija
English: Cerebral haemorrhage Encephalo-pathy
Slovenian: Bolezni živčevja glavobol omotica epileptični napad encefalopatija cerebralna hemoragija
English: Neutropenia Thrombocytopenia Febrile neutropenia Anaemia
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija febrilna nevtropenija anemija
English: Transaminases increased Bilirubine increased Alkaline phosphatases increased
Slovenian: Preiskave povišane vrednosti transaminaz povišane vrednosti bilirubina povišane vrednosti GGT povišane vrednosti alkalnih fosfataz povečanje telesne mase neobičajni zvoki pri dihanju povišane vrednosti kreatinina povišan dušik sečnine v krvi zmanjšan iztisni delež prekata
English: Gastro-intestinal haemorrhage Tooth hypoplasia*
Slovenian: Bolezni sečil hemoragični cistitis** ledvična motnja oligurija
English: Tabulated lists of adverse reactions
Slovenian: Pregled neželenih učinkov v preglednici
English: Nervous system disorders
Slovenian: Priprava raztopine za infundiranje
English: Busulfan has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter raziskav busulfana niso opravljali.
English: It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with Busulfan Fresenius Kabi.
Slovenian: Po zdravljenju z zdravilom Busulfan Fresenius Kabi se lahko zgodi, da ne boste mogli več zanositi (neplodnost).
English: Oliguria
Slovenian: viala
English: Linearity
Slovenian: Viale
English: Nausea Vomiting Diarrhoea Stomatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov veno-okluzivna bolezen jeter zlatenica, bolezni jeter
English: Busulfan in combination with cyclophosphamide
Slovenian: Klinična učinkovitost in varnost Busulfan v kombinaciji s ciklofosfamidom Odrasli
English: Stomatitis Diarrhoea Abdominal pain Nausea
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatomegalija zlatenica veno-okluzivna jetrna bolezen*
English: This will help protect them against infectious bronchitis.
Slovenian: To jim bo pomagalo pri zaščiti pred kužnim bronhitisom.
English: In the future if the animals are exposed to the virus the immune system will be able to respond more quickly.
Slovenian: Ob ponovni izpostavitvi živali virusu v prihodnosti se bo imunski sistem tako hitreje odzval.
English: There are no precautions for the person, but it is recommended to wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
Slovenian: Previdnostnih ukrepov za ljudi ni, vendar je priporočljivo, da si oseba po dajanju cepiva umije in razkuži roke in pripomočke, da prepreči širjenje virusa.
English: In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls.
Slovenian: V enem preskušanju je po treh tednih 100 % piščancev razvilo protitelesa proti virusu IB 4-91 v primerjavi s 17 % v kontrolni skupini.
English: For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration.
Slovenian: Za podaljšano imunost je treba cepljenje piščancev ponavljati vsakih šest tednov.
English: The main measures of effectiveness included the development of antibodies to the IB 4-91 virus, the overall death rate of the chickens and the percentage of chicken rejected because of disease.
Slovenian: Glavna merila učinkovitosti so bila razvoj protiteles proti virusu IB 4-91, celokupna stopnja smrtnosti piščancev in odstotek piščancev, zavrnjenih zaradi bolezni.
English: It is also the time allowed after administration of the medicine before eggs may be used for human consumption.
Slovenian: Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko jajca uporabijo za prehrano ljudi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 on 9 June 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nobilis IB 4-91, veljavno po vsej Evropski uniji, izdala 9. junija 1998.
English: The vaccine virus may spread from vaccinated to non-vaccinated chickens, so care should be taken to separate vaccinated from non-vaccinated chickens.
Slovenian: Cepni virus se lahko razširi s cepljenih na necepljene piščance, zato je treba ti skupini piščancev ločiti.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Slovenian: Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter meso uporabi za prehrano ljudi.
English: Avian infectious bronchitis vaccine (live attenuated)
Slovenian: cepivo proti kužnemu bronhitisu perutnine (živo, atenuirano)
English: The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials.
Slovenian: Cepivo Nobilis IB 4-91 so proučevali v različnih shemah cepljenja v številnih preskušanjih.
English: Nobilis IB 4-91 can cause mild respiratory signs of disease which may last for a few days depending on the health and condition of the chickens.
Slovenian: Zdravilo Nobilis IB 4-91 lahko povzroči blage oblike znakov obolenja dihalnih poti, ki lahko trajajo nekaj dni, odvisno od zdravja in splošnega stanja piščancev.
English: Nobilis IB 4-91 vaccine has also been compared with controls, i.e. chickens that were not vaccinated.
Slovenian: Cepivo Nobilis IB 4-91 so primerjali tudi s kontrolno skupino, tj. s piščanci, ki niso bili cepljeni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 exceed the risks for the approved indication and recommended that Nobilis IB 4-91 should be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Nobilis IB 4-91 večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
English: The vaccine was given by coarse spray to chicken of various ages.
Slovenian: Cepivo je bilo dajano z razpršilnikom z večjimi kapljicami piščancem različnih starosti.
English: The avian infectious bronchitis virus in Nobilis IB 4-91 has been attenuated (weakened) so that it does not cause disease.
Slovenian: Virus kužnega bronhitisa perutnine v cepivu Nobilis IB 4-91 je bil atenuiran (oslabljen), tako da ne povzroča bolezni.
English: Nobilis IB 4-91 is a vaccine.
Slovenian: Zdravilo Nobilis IB 4-91 je cepivo.
English: The vaccine can be administered to future layers and breeders from day old onwards via intranasal/ocular route or coarse spray.
Slovenian: Bodočim nesnicam in matičnim jatam se lahko cepivo daje od starosti enega dneva intranazalno/okularno ali z razpršilnikom z večjimi kapljicami.
English: Nobilis IB 4-91 can be given to 1-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration.
Slovenian: Zdravilo Nobilis IB 4-91 se lahko enodnevnim in starejšim piščancem daje z razpršilnikom z večjimi kapljicami, intranazalno (z vdihavanjem skozi nos) ali okularno (z absorpcijo skozi oči).
English: Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens.
Slovenian: Zdravilo Nobilis IB 4-91 se uporablja za imunizacijo piščancev z namenom zmanjšanja respiratornih znakov kužnega bronhitisa, ki ga povzroča različica seva IB 4-91, ki povzroča kužni bronhitis pri piščancih.
English: Other information about Nobilis IB 4-91:
Slovenian: Druge informacije o zdravilu Nobilis IB 4-91:
English: The vaccine can be given to 7-day and older chickens in their drinking water.
Slovenian: Piščancem, starejšim od sedem dni, se lahko cepivo daje v vodo za pitje.
English: When Nobilis IB 4-91 is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Slovenian: Ko piščance cepimo z zdravilom Nobilis IB 4-91, imunski sistem virus prepozna kot „tujek“ in proti njemu razvije protitelesa.
English: What benefit has Nobilis IB 4-91 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nobilis IB 4-91 izkazalo med študijami?
English: Nobilis IB 4-91 is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus.
Slovenian: Zdravilo Nobilis IB 4-91 je cepivo za uporabo v veterinarski medicini, ki vsebuje žive, atenuirane (oslabljene) viruse kužnega bronhitisa perutnine.
English: What is the risk associated with Nobilis IB 4-91?
Slovenian: Kakšna tveganja so povezana z zdravilom Nobilis IB 4-91?
English: Why has Nobilis IB 4-91 been approved?
Slovenian: Zakaj je bilo zdravilo Nobilis IB 4-91 odobreno?
English: The withdrawal period for Nobilis IB 4-91 for chickens is zero days.
Slovenian: Karenca za cepivo Nobilis IB 4-91 pri piščancih je nič dni.
English: What is Nobilis IB 4-91?
Slovenian: Kaj je zdravilo Nobilis IB 4-91?
English: How has Nobilis IB 4-91 been studied?
Slovenian: Kako je bilo zdravilo Nobilis IB 4-91 raziskano?
English: What is Nobilis IB 4-91 used for?
Slovenian: Za kaj se zdravilo Nobilis IB 4-91 uporablja?
English: How does Nobilis IB 4-91 work?
Slovenian: Kako zdravilo Nobilis IB 4-91 deluje?
English: Nobilis IB 4-91 is available as a lyophilisate (freeze-dried powder) which is to be made up into a suspension.
Slovenian: Na voljo je v obliki liofilizata (praška, posušenega v zamrznjenem stanju) za pripravo raztopine za injiciranje.
English: 1 bottle + 30 syringes + 1 syringe adapter + 1 carrying case
Slovenian: 1 steklenica + 30 brizg + 1 adapter za brizgo + 1 priročna škatla za prenašanje
English: 1 mg/ml
Slovenian: 1 mg/ml peroralna raztopina peroralna uporaba steklenica (steklo)
English: The standard dose of Clopidogrel Qualimed is one 75 mg tablet once a day, taken with or without
Slovenian: Običajni odmerek zdravila Clopidogrel Qualimed je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: This means that Clopidogrel Qualimed is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je zdravilo Clopidogrel Qualimed podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: Clopidogrel Qualimed is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel Qualimed se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also
Slovenian: Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
English: Clopidogrel Qualimed can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel Qualimed se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Qualimed to Qualimed on 23 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Qualimed, veljavno po vsej Evropski uniji, odobrila družbi Qualimed dne 23. septembra .
English: Because Clopidogrel Qualimed 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 Qualimed generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Qualimed 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 Qualimed primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: Clopidogrel Qualimed is a ‘generic medicine'.
Slovenian: Clopidogrel Qualimed je „generično zdravilo“.
English: What are the benefit and risk of Clopidogrel Qualimed?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Qualimed?
English: Clopidogrel Qualimed can be given to the following groups of
Slovenian: Zdravilo Clopidogrel Qualimed se lahko daje naslednjim skupinam bolnikov:
English: Clopidogrel Qualimed can be started between seven days and six months after
Slovenian: Zdravilo Clopidogrel Qualimed se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: Because Clopidogrel Qualimed 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 Qualimed generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: The Committee recommended that Clopidogrel Qualimed be given marketing
Slovenian: Odbor je zato priporočil, da se za zdravilo Clopidogrel Qualimed odobri dovoljenje za promet.
English: Other information about Clopidogrel Qualimed:
Slovenian: Druge informacije o zdravilu Clopidogrel Qualimed:
English: Clopidogrel Qualimed is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel Qualimed je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: The full EPAR for Clopidogrel Qualimed can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Qualimed je na voljo tukaj.
English: The active substance in Clopidogrel Qualimed, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel Qualimed, klopidogrel, je zaviralec agregacije trombocitov.
English: Why has Clopidogrel Qualimed been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel Qualimed odobreno?
English: What is Clopidogrel Qualimed used for?
Slovenian: Za kaj se zdravilo Clopidogrel Qualimed uporablja?