FrancophonIA/ELRC3.0 huggingface dataset:
English: To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Slovenian: Za zdravljenje astme vam bo zdravnik predpisal inhalator Budezonid/formoterol Teva skupaj z ločenim inhalatorjem z olajševalcem, npr. salbutamolom.
English: Budesonide/Formoterol Teva contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Slovenian: Zdravilo Budezonid/formoterol Teva vsebuje učinkovini formoterol in budezonid, ki imata različna mehanizma delovanja, njuni učinki pri zmanjšanju pogostnosti poslabšanj astme pa so aditivni.
English: COPD
Slovenian: KOPB
English: How to take an inhalation
Slovenian: Kako vdihniti zdravilo
English: When used for asthma, your doctor will prescribe Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Slovenian: Za zdravljenje astme vam bozdravnik vam bo predpisal inhalator Budezonid/formoterol Teva skupaj z ločenim »inhalatorjem z olajševalcem«, npr. salbutamolom.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Budesonide/Formoterol Teva pharmacokinetic profile
Slovenian: Farmakokinetični profil zdravila Budezonid/formoterol Teva
English: The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Slovenian: Podatki iz študije kažejo, da so otroci, mladostniki in odrasli z astmo ter bolniki s KOPB neodvisno od starosti in resnosti osnovne bolezni dosegli primerljive stopnje vdišnega toka z inhalatorjem Spiromax in drugim inhalatorjem s suhim praškom v večkratnem odmerku na trgu.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično občasni mišični krči skeletnega sistema in vezivnega tkiva
English: The fixed-dose combination of budesonide and formoterol, and the corresponding monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide and formoterol, respectively.
Slovenian: Dokazali so, da so kombinacija budezonida in formoterola v fiksnem odmerku ter ustrezajoča zdravila, ki vsebujejo samo budezonid ali samo formoterol biološko ekvivalentni glede sistemske izpostavljenosti budezonidu in formoterolu.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol Teva.
Slovenian: Ko dosežemo ustrezen nadzor simptomov astme, je treba razmisliti o postopnem zmanjšanju odmerka zdravila Budezonid/formoterol Teva.
English: Contents of the pack and other information (page 19)
Slovenian: Shranjevanje zdravila Budezonid/formoterol Teva (stran 19) Vsebina pakiranja in dodatne informacije (stran 19)
English: The safety and efficacy of Budesonide/Formoterol Teva in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Budezonid/formoterol Teva pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
English: • Pneumonia (infection to the lung) in COPD patients.
Slovenian: • pljučnica (okužba pljuč) pri bolnikih s KOPB (pogost neželen učinek)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat
English: Variations in blood pressure
Slovenian: Žilne bolezni zelo redki spremembe krvnega tlaka
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Slovenian: Psihiatrične motnje agresija, psihomotorična hiperaktivnost, anksioznost, motnje spanja depresija, vedenjske spremembe (pretežno pri otrocih)
English: Patients should be advised to have their rescue inhaler available at all times.
Slovenian: Bolnikom svetujte, naj imajo inhalator z olajševalcem vedno pri roki.
English: Budesonide/Formoterol Teva is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Slovenian: Zdravljenje z zdravilom Budezonid/formoterol Teva ni ustrezno pri odraslih bolnikih z blago obliko astme, ki ni ustrezno nadzorovana z inhalacijskim kortikosteroidi in inhalacijskimi kratkodelujočimi agonisti adrenoreceptorjev β2, ki se uporabljajo po potrebi.
English: Asthma Budesonide/formoterol maintenance therapy
Slovenian: Astma Vzdrževalno zdravljenje astme z budezonidom/formoterolom
English: Since Budesonide/Formoterol Teva contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Slovenian: Ker zdravilo Budezonid/formoterol Teva vsebuje tako budezonid kot formoterol, lahko pri bolnikih pričakujemo enak vzorec neželenih učinkov, kot so jih opažali pri posameznih učinkovinah.
English: Do not use Budesonide/Formoterol Teva 320/9 micrograms as a ‘reliever inhaler'.
Slovenian: Ne uporabljajte inhalatorja Budezonid/formoterol Teva 320/9 mikrogramov kot olajševalca.
English: Peak Inspiratory Flow Rate through the Spiromax Device
Slovenian: Najvišja stopnja vdišnega toka s inhalatorjem Spiromax
English: Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Budesonide/Formoterol Teva remains optimal.
Slovenian: Zdravljenje bolnikov mora redno ovrednotiti zdravnik, ki predpisuje zdravilo, tako da odmerek zdravila Budezonid/formoterol Teva ostane optimalen.
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva.
Slovenian: Ko so simptomi astme dobro obvladani, bo vaš zdravnik morda predlagal, da odmerek zdravila Budezonid/formoterol Teva postopoma zmanjšate.
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using Budesonide/Formoterol Teva due to the lactose excipient.
Slovenian: Bolnikom svetujte tudi, naj si po inhaliranju sperejo usta z vodo (glejte poglavje 4.4).
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Slovenian: Pri bolnikih s KOPB, ki so prejemali inhalacijske kortikosteroide, so opažali večjo pojavnost pljučnice, tudi pljučnice, ki je zahtevala sprejem v bolnišnico.
English: Budesonide/Formoterol Teva is indicated for use in adults 18 years of age and older only.
Slovenian: Zdravilo Budezonid/formoterol Teva je namenjeno izključno za uporabo pri odraslih osebah, starih 18 let in več.
English: Preparing your new Budesonide/Formoterol Teva
Slovenian: Priprava novega inhalatorja Budezonid/formoterol Teva
English: Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of Budesonide/Formoterol Teva remains optimal.
Slovenian: Zdravnik , ki predpisuje zdravilo, mora bolnike redno ocenjevati, tako da odmerek zdravila Budezonid/formoterol Teva ostane optimalen.
English: Hypokalaemia Hyperglycaemia
Slovenian: Presnovne in prehranske motnje hipokaliemija hiperglikemija
English: Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.
Slovenian: Zdravilo Budezonid/formoterol Teva je indicirano izključno pri odraslih, starih 18 let in več.
English: • Mild sore throat, coughing and a hoarse voice.
Slovenian: • blago vnetje žrela, kašelj in hripavost,
English: This medicine should not be used in children or adolescents under the age of 18 years.
Slovenian: Otroci in mladostniki, mlajši od 18 let, tega zdravila ne smejo uporabljati.
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder
Slovenian: Budezonid/formoterol Teva 320 mikrogramov/9 mikrogramov prašek za inhaliranje
English: Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder
Slovenian: Budezonid/formoterol Teva 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje
English: Budesonide/Formoterol Teva 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: Budezonid/formoterol Teva 320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Slovenian: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full.
Slovenian: • Kazalnik odmerkov kaže, koliko odmerkov (inhalacij) je še v inhalatorju.
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Slovenian: En dovedeni odmerek (odmerek, ki pride iz ustnika Spiromax) vsebuje 160 mikrogramov budezonida in 4,5 mikrogramov formoterolijevega fumarata dihidrata.
English: Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Slovenian: En dovedeni (inhalirani) odmerek vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
English: Budesonide/Formoterol Teva 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: Budezonid/formoterol Teva 160 mcg/4,5 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: Fertility
Slovenian: FOLIJA
English: Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Slovenian: Sprednja ploskev: Ta dovedeni odmerek je enakovreden odmerjenemu odmerku 400 mikrogramov budezonida in 12 mikrogramov formoterolijevega fumarata dihidrata.
English: You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva.
Slovenian: Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Budezonid/formoterol Teva.
English: Date of latest renewal:
Slovenian: DRUGI PODATKI Začetek:
English: If you get any side effects, talk to your doctor,pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Slovenian: Budezonid/formoterol Teva 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Slovenian: Budezonid/formoterol Teva 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
English: • Disturbed sleep.
Slovenian: • motnje spanja,
English: Inhalation powder.
Slovenian: • mišični krči.
English: - in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Slovenian: - pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z inhalacijskimi kortikosteroidi ter kratkodelujočimi inhalacijskimi agonisti adrenergičnih receptorjev β2, ki so predpisani za uporabo po potrebi.
English: Budesonide/Formoterol Teva is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Slovenian: Zdravilo Budezonid/formoterol Teva ni indicirano za uporabo pri otrocih, starih 12 let ali manj, ali mladostnikih, starih od 13 do 17 let.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Budesonide/Formoterol Teva .
Slovenian: Če po uvedbi zdravila Budezonid/formoterol Teva simptomi astme niso nadzorovani ali se poslabšajo, naj bolniki nadaljujejo z zdravljenjem in poiščejo zdravniško pomoč.
English: Package leaflet: Information for the patient Budesonide/Formoterol Teva 160 micrograms/4.5 micrograms, inhalation powder
Slovenian: Navodilo za uporabo Budezonid/formoterol Teva 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje
English: Adults (18 years and older): 1 inhalation twice daily
Slovenian: Odrasli (18 let in več): 1 vdih dvakrat na dan
English: Adults (18 years and older): • 1 inhalation twice a day.
Slovenian: Odrasli (18 let in več): • 1 vdih dvakrat na dan.
English: Package leaflet: Information for the patient Budesonide/Formoterol Teva 320 micrograms/9 micrograms, inhalation powder
Slovenian: Navodilo za uporabo Budezonid/formoterol Teva 320 mikrogramov/9 mikrogramov, prašek za inhaliranje
English: • Feeling dizzy.
Slovenian: • omotica,
English: Adults (18 years and older): 1-2 inhalations twice daily.
Slovenian: Odrasli (18 let in več): 1-2 vdiha dvakrat na dan.
English: What you need to know before you use Budesonide/Formoterol Teva (page 5) 3.
Slovenian: Kaj je zdravilo Budezonid/formoterol Teva in za kaj ga uporabljamo (stran 3) Kaj morate vedeti, preden boste uporabili zdravilo Budezonid/formoterol Teva (stran 5) Kako uporabljati zdravilo Budezonid/formoterol Teva (stran 8) Možni neželeni učinki (stran 16)
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Slovenian: V tem primeru je treba zdravljenje z zdravilom Budezonid/formoterol Teva takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja.
English: Palpitations
Slovenian: INHALATOR
English: Adults (18 years and older): 1 inhalation twice daily.
Slovenian: Odrasli (18 let in več): 1 vdih dvakrat na dan.
English: Adults (18 years and older): 2 inhalations twice a day.
Slovenian: Odrasli (18 let in več): 2 vdiha dvakrat na dan.
English: Advising the patient to rinse the mouth out with water after each dose will minimise the risk.
Slovenian: Tveganje za ta neželeni učinek lahko zmanjšate, če bolniku naročite, naj si po vsakem odmerku spere usta z vodo.
English: • Low levels of potassium in your blood.
Slovenian: • nizka koncentracija kalija v krvi, • neenakomerno bitje srca.
English: CLINICAL PARTICULARS
Slovenian: Posebne skupine bolnikov:
English: Lactose monohydrate.
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat
English: Paradoxical bronchospasm
Slovenian: Delovanje nadledvične žleze
English: Talk to your doctor, pharmacist or nurse before taking Budesonide/Formoterol Teva if
Slovenian: Pred začetkom uporabe zdravila Budezonid/formoterol Teva se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: 13 February 2012
Slovenian: 13. februar 2012
English: The European Commission issued a decision on 13 February 2012.
Slovenian: Evropska komisija je izdala odločbo dne 13. februarja 2012.
English: Outcome of a procedure under Article 107 of Directive 2001/
Slovenian: Izid postopka v skladu s členom 107 Direktive 2001/83/ES
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se pogovorijo s svojim zdravnikom ali farmacevtom.
English: Buflomedil is authorised in Austria, Belgium, Cyprus, France, Germany Luxembourg, the Netherlands, Poland, Portugal and Spain, under the invented na trade names.
Slovenian: Buflomedil je odobren v Avstriji, Belgiji, na Cipru, v Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, na Nizozemskem, Poljskem, Portugalskem in v Španiji pod izmišljenim imenom Loftyl in drugimi tržnimi imeni.
English: Questions and answers on the suspension of buflomedil-containing medicines EMA/CHMP/560863/2011 rev1
Slovenian: Vprašanja in odgovori o začasnem umiku zdravil, ki vsebujejo buflomedil EMA/CHMP/560863/2011 rev1
English: What is buflomedil?
Slovenian: Kaj je buflomedil?
English: Questions and answers on the suspension of buflomedilcontaining medicines
Slovenian: Vprašanja in odgovori o začasnem umiku zdravil, ki vsebujejo buflomedil
English: Buflomedil-containing medicines have been authorised in the EU since the 1970s vi procedures.
Slovenian: Zdravila, ki vsebujejo buflomedil, so bila v EU odobrena z nacionalnimi postopki od sedemdesetih let prejšnjega stoletja dalje.
English: These side effects mainly occurred in elderly patients or in patients with kidney problems who did not receive the appropriately reduced dose and whose kidney function was not suitably monitored.
Slovenian: Ti stranski učinki so se pojavljali predvsem pri starejših bolnikih z ledvičnimi težavami, ki niso prejemali ustrezno zmanjšanega odmerka in pri katerih delovanja ledvic niso ustrezno spremljali.
English: • Patients currently using buflomedil-containing medicines should speak to their doctor to review their treatment.
Slovenian: • Bolniki, ki trenutno uporabljajo zdravila, ki vsebujejo buflomedil, naj se posvetujejo s svojim zdravnikom, ki bo pregledal njihovo zdravljenje.
English: Why was buflomedil reviewed?
Slovenian: Zakaj je bilo zdravilo buflomedil pregledano?
English: In February 2011, the French medicines regulatory agency suspended the marketing authorisations for buflomedil-containing medicines because of serious and sometimes fatal side effects seen with these medicines.
Slovenian: Februarja 2011 je francoska regulatorna agencija za zdravila začasno umaknila dovoljenja za promet z zdravili, ki vsebujejo buflomedil, zaradi resnih in včasih usodnih neželenih učinkov, ki so jih opazili pri teh zdravilih.
English: These included neurological disorders such as convulsions and status epilepticus (a dangerous condition where the brain is in a persistent state of seizure), and cardiac disorders such as accelerated heart rate and cardiac arrest.
Slovenian: Ti so vključevali nevrološke motnje, kakršne so konvulzije in status epilepticus (nevarno stanje, pri katerem so možgani v stanju nenehnega napada) in srčne bolezni, kot sta povišan srčni utrip in srčni zastoj.
English: These include managing underlying health problems which can increase the risk of PAOD, such as diabetes, high cholesterol, high blood pressure as well as smoking.
Slovenian: Le-ta vključujejo urejanje osnovnih zdravstvenih težav, ki lahko povečajo tveganje za pojav periferne arterijske okluzivne bolezni, kakršne so sladkorna bolezen, visok holesterol, visok krvni tlak in kajenje.
English: France had previously taken d not been sufficient to e 107, France informed the CHMP of its latest action to suspend the marketing mmittee could prepare an opinion on whether the marketing authorisations for products containing buflomedil should be maintained, changed, suspended or
Slovenian: Francija je v skladu s členom 107 obvestila odbor CHMP o svojem najnovejšem ukrepu za začasni umik dovoljenj za promet v Franciji, da bi odbor lahko pripravil mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo buflomedil, v vsej EU ohraniti, spremeniti, preklicati ali umakniti.
English: The European Medicines Agency has completed a review of the safety and effectiveness of buflomedilboth oral and injectable, due to serious side effects seen with buflomedil.
Slovenian: Evropska agencija za zdravila je opravila pregled varnosti in učinkovitosti zdravil, ki vsebujejo buflomedil, v peroralnih in injekcijskih pripravkih, zaradi resnih neželenih učinkov, ki so jih opazili v zvezi z buflomedilom.
English: Based on the evaluation of the currently available data and the scientific disc Committee, the CHMP concluded that the benefits of bufl their risks, and recommended that all marketing authorisations for medicines co should be suspe
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo buflomedil, ne odtehtajo z njim povezanih tveganj, in priporočil, da se vsa dovoljenja za promet s temi zdravili v vsej EU začasno prekličejo.
English: The CHMP noted that there was a risk of seriou buflomedil is used normally, due to the small difference between the treatin can harm elderly patients or people with certain conditions such as kidney problem common in patients with PAOD.
Slovenian: Odbor CHMP je ugotovil, da obstaja tveganje za resne nevrološke in srčne neželene učinke pri bolnikih ob običajni uporabi buflomedila zaradi majhne razlike med odmerkom zdravljenja in odmerkom, ki lahko starejšim bolnikom ali osebam z določenimi boleznimi, kakršne so npr. ledvične težave, ki so pri bolnikih s periferno arterijsko okluzivno boleznijo pogoste, škoduje.
English: In spite of measures put in place by regulatory authori been shown to have a limited benefit for patients, measured in term studies also had a number of methodological weaknesses.
Slovenian: Odbor CHMP je ugotovil tudi, da je bila za zdravilo dokazana le omejena korist za bolnike, izmerjena v smislu prehojene razdalje, ter da so imele študije številne metodološke slabosti.
English: 2011, as well as information requested fro and the published literature, as well as from poison control centres in Europe on cases of severe poisoning with buflomedil.
Slovenian: Vključeni so bili tudi podatki iz kliničnih preskušanj z buflomedilom, nadzor v obdobju trženja in objavljena literatura, kakor tudi podatki iz centrov za zastrupitve v Evropi o primerih hudih zastrupitev z buflomedilom.
English: Agency's Committee for Medicinal Products for Human Use (CHMP) concluded buflomedil do not outweigh its risks, and has recommended that all marketing au medicines containing buflomedil should be suspended throughout the European
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) agencije EMA je ugotovil, da koristi buflomedila ne odtehtajo z njim povezanih tveganj, in priporočil začasni umik vseh dovoljenj za promet z zdravili, ki vsebujejo buflomedil, v vsej Evropski uniji (EU).
English: Buflomedil is available in the form of tablets, an oral solution or a s
Slovenian: Buflomedil je na voljo v obliki tablet, peroralne raztopine ali raztopine za injiciranje.
English: Buflomedil is a vasoactive agent, a medicine which has an effect on blood c increases the blood flow to the brain and other parts of the body by widening the bl used to treat the symptoms of peripheral arterial occlusive disease (PAOD), a cond the legs.
Slovenian: Buflomedil poveča pretok krvi v možgane in druge dele telesa, tako da razširi krvne žile.
English: Buflomedil is used in pat pain when walking relatively short distances.
Slovenian: Buflomedil se uporablja pri bolnikih s periferno arterijsko okluzivno boleznijo tipa II, kar pomeni, da imajo hude bolečine, že če prehodijo razmeroma kratko razdaljo.
English: The CHMP considered the benefit-risk assessments previously carried out, including by France in 2010
Slovenian: Odbor CHMP je upošteval predhodno izvedene ocene razmerja med tveganji in koristmi, vključno z oceno, ki je bila izvedena v Franciji v letih 2010 in 2011, kakor tudi informacije, pridobljene od družb, ki v EU tržijo zdravila, ki vsebujejo buflomedil.
English: • Doctors should stop prescribing buflomedil and co
Slovenian: • Zdravniki naj prenehajo predpisovati buflomedil in razmislijo o alternativnih možnostih zdravljenja.
English: Buflomedil can build up in the body and there is only a small difference between the treating dose and the dose that can harm certain patients, such as those with
Slovenian: Buflomedil se v telesu lahko kopiči, razlika med odmerkom zdravljenja in