FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination.
Slovenian: Študije, v katerih so sodelovale osebe z normalno in preveliko telesno maso, so pokazale, da se neabsorbirano zdravilo izloča pretežno z blatom.
English: In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups.
Slovenian: V 2-letnih študijah in 4-letni študiji so bolniki skupaj z zdravljenjem s placebom ali orlistatom prejemali tudi nizkokalorično dieto.
English: MARKETING AUTHORISATION NUMBERS EU/1/98/071/001-006
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/98/071/001-006
English: Each capsule contains 120 mg of orlistat.
Slovenian: Vsaka kapsula vsebuje 120 mg orlistata.
English: The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.
Slovenian: Ovoj kapsule vsebuje želatino, barvili indigotin (E132), titanov dioksid (E171) in barvila za potiskanje.
English: However, there was an unexplained increase in the incidence of bone fractures (6 % versus 2.8 % in the orlistat and placebo groups, respectively).
Slovenian: Neželeni učinki so bili v splošnem podobni kot pri odraslih, prišlo pa je do nepojasnjenega povečanja v incidenci zlomov kosti (6 % v skupini, ki je prejemala orlistat, in 2,8 % v skupini, ki je prejemala placebo).
English: Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
Slovenian: Zelo pogosti neželeni učinki (prizadenejo več kot 1 od 10 uporabnikov) Glavobol, bolečina/neudobje v trebuhu, nujna ali povečana potreba po odvajanju blata, vetrovi z izcedkom, oljnat izcedek, oljnato ali mastno blato, tekoče blato, nizka raven sladkorja v krvi (pri nekaterih osebah s sladkorno boleznijo tipa 2).
English: Oxalate nephropathy that may lead to renal failure
Slovenian: Oksalatna nefropatija, ki lahko vodi do odpovedi ledvic.
English: Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.
Slovenian: Če zdravila niste jemali natančno tako, kot vam je predpisal zdravnik, ga o tem obvestite, sicer bo menil, da zdravilo ni učinkovito ali da ga slabo prenašate in vam po nepotrebnem spremenil zdravljenje.
English: More patients on orlistat or placebo lost baseline body weight of at least 5 % at 12 weeks or 10 % at one year in the XENDOS study than in the five 2-year studies.
Slovenian: V študiji XENDOS je več bolnikov, ki je jemalo orlistat ali placebo izgubilo najmanj 5 % izhodiščne telesne mase po 12 tednih zdravljenja ali 10 % po enem letu kot pa v petih 2-letnih študijah.
English: Medicinal product subject to medical prescription.
Slovenian: Izdaja zdravila je le na recept
English: Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat.
Slovenian: Osem ur po peroralnem vnosu je bila koncentracija nespremenjenega orlistata v plazmi nemerljiva (< 5 ng/ml).
English: Data from the 4-year XENDOS clinical trial showed that 60 % of orlistat patients and 35 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment.
Slovenian: V kliničnem preskušanju XENDOS, ki je potekalo 4 leta, je 60 % bolnikov, ki so jemali orlistat in 35 % bolnikov, ki so jemali placebo, izgubilo najmanj 5 % izhodiščne telesne mase po 12 tednih zdravljenja.
English: Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Slovenian: Študije, v katerih so sodelovale osebe z normalno in preveliko telesno maso, so pokazale, da se absorbira le minimalna količina orlistata.
English: A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly.
Slovenian: Pri majhnem številu zdravih prostovoljcev so po enkratnem odmerku amiodarona in sočasnem jemanju orlistata opazili rahlo zmanjšanje koncentracij amiodarona v plazmi.
English: Xenical has no influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Xenical nima vpliva na sposobnost za vožnjo in upravljanje s stroji.
English: How to take XENICAL
Slovenian: Kako jemati zdravilo Xenical
English: What you need to know before you take XENICAL
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xenical Ne jemljite zdravila Xenical
English: • The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium laurilsulfate and talc.
Slovenian: • Pomožne snovi so mikrokristalna celuloza (E460), natrijev karboksimetilškrob (tip A), povidon (E1201), natrijev lavrilsulfat in smukec.
English: Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Slovenian: Pri bolnikih, ki so se sočasno zdravili z orlistatom in antiepileptiki, npr.valproatom ali lamotriginom, so poročali o konvulzijah.
English: * only unique treatment adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in obese type 2 diabetic patients.
Slovenian: Pogosti: anksioznost * le enkratni neželeni učinki, ki so se pojavili s pogostnostjo > 2 % in incidenco ≥ 1 % v primerjavi s placebom pri bolnikih s preveliko telesno maso, ki imajo sladkorno bolezen tipa II.
English: It can be taken immediately before, during a meal or up to one hour after a meal.
Slovenian: Kapsulo lahko vzamete tik pred obrokom, med njim ali do eno uro po njem.
English: The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose.
Slovenian: Skupna količina presnovkov orlistata, ki se izloči skozi ledvice, znaša manj kot 2 % vnesenega odmerka.
English: Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.
Slovenian: Pojavi se lahko hipotiroidizem in/ali poslabša nadzor nad njim;
English: In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
Slovenian: mladostnikov z debelostjo randomiziranih v skupino, ki je 52 tednov trikrat na dan kot dodatek nizkokalorični dieti in telesni aktivnosti prejemala ali 120 mg orlistata (n = 357) ali placebo (n = 182).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER PACKS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA PRETISNE OMOTE
English: Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5 % of your body weight as measured at the start of treatment with Xenical.
Slovenian: Če se vaša telesna masa po 12 tednih zdravljenja z zdravilom Xenical ne bo zmanjšala vsaj za pet odstotkov, vam bo zdravnik zdravljenje z zdravilom Xenical ukinil.
English: Bleeding from the back passage (rectum).
Slovenian: Krvavitev iz danke (rektuma).
English: Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions.
Slovenian: Orlistat lahko deluje na zdravljenje epilepsije tako, da zmanjša absorpcijo antiepileptikov, kar lahko vodi do konvulzij (epileptičnih napadov).
English: Antiretrovirals for HIV: Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.5).
Slovenian: Protiretrovirusne učinkovine za zdravljenje okužbe s HIV: orlistat lahko morda zmanjša absorpcijo protiretrovirusnih učinkovin za zdravljenje okužbe s HIV in negativno vpliva na njihovo učinkovitost
English: After 1 year of treatment, 41 % of the orlistat treated patients versus 21 % of placebo treated patients lost ≥ 10 % of body weight with a mean difference of 4.4 kg between the two groups.
Slovenian: Po enem letu zdravljenja je 41 % bolnikov, ki je jemalo orlistat in 21 % bolnikov, ki je jemalo placebo, izgubilo ≥ 10 % telesne mase s povprečno razliko med skupinama 4,4 kg.
English: Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration.
Slovenian: Izsledki študije, v kateri so sodelovali bolniki s preveliko telesno maso, so pokazali, da v majhnem deležu sistemsko absorbirane količine zdravila dva poglavitna presnovka M1 (hidrolizirani 4-členski laktonski obroč) in M3 (M1 z
English: The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
Slovenian: Za preprečitev morebitne neuspešnosti peroralnih kontracepcijskih sredstev, ki se lahko pojavi ob hudi driski, je priporočljivo uporabljati dodatne kontracepcijske metode.
English: The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Slovenian: Kaže, da je izločanje orlistata pri prostovoljcih z normalno telesno maso in pri tistih s preveliko, podobno.
English: In orlistat-treated patients, the mean difference from placebo in weight loss was 1.83 kg to 3.06 kg and the mean difference from placebo in HbA1c reduction was 0.18 % to 0.55 %.
Slovenian: Povprečna razlika v zmanjšanju HbA1c v primerjavi s placebom pa je znašala 0,18 do 0,55 %.
English: Gallstones.
Slovenian: Žolčni kamni.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: Abdominal pain/discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/oily stool Flatulence
Slovenian: bolečina/neudobje v trebuhu oljni madeži iz rektuma flatus z izcedkom nujno odvajanje mastno/oljnato blato flatulenca tekoče blato oljnato odvajanje povečana pogostnost odvajanja bolečina/neudobje v rektumu mehko blato inkontinenca pri odvajanju abdominalna distenzija* bolezni zob bolezni dlesni
English: Of these, 62 % of orlistat treated patients and 52 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Slovenian: Od teh je 62 % bolnikov, ki so jemali orlistat in 52 % bolnikov, ki so jemali placebo, po enem letu zdravljenja izgubilo 10 % ali več izhodiščne telesne mase.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/071/004 21 capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/98/071/004 21 kapsul
English: EU/1/98/071/006 84 capsules
Slovenian: EU/1/98/071/006 84 kapsul
English: Keep the container tightly closed in order to protect from moisture
Slovenian: Vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred vlago
English: There is no relevant indication for use of Xenical in children.
Slovenian: Ustreznih indikacij za uporabo zdravila Xenical pri otrocih ni. 4.3 Kontraindikacije
English: Losing weight may mean you need adjustments to the dose of these medicines.
Slovenian: Zaradi hujšanja je treba včasih prilagoditi njihov odmerek.
English: EU/1/98/071/005 42 capsules
Slovenian: EU/1/98/071/005 42 kapsul
English: Hypersensitivity (e.g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis)
Slovenian: Bolezni imunskega sistema preobčutljivost (npr. pruritus, izpuščaj, urtikarija,
English: 9.5 % of the orlistat treated patients versus 3.3 % of the placebo treated patients lost ≥ 10 % of body weight after 1 year with a mean difference of 2.6 kg between the two groups.
Slovenian: Po 1 letu je 9,5 % bolnikov, zdravljenih z orlistatom, in 3,3 % bolnikov, ki so prejemali placebo, izgubilo ≥ 10 % telesne mase s povprečno razliko 2,6 kg med skupinama.
English: NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules
Slovenian: IME ZDRAVILA Xenical 120 mg trde kapsule
English: Reproductive system and breast disorders Common: Menstrual irregularity
Slovenian: Pogosti: neredna menstruacija
English: NAME OF THE MARKETING AUTHORISATION HOLDER CHEPLAPHARM Arzneimittel GmbH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CHEPLAPHARM Arzneimittel GmbH
English: Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10 % or more of their body weight was 20 % with orlistat 120 mg compared to 8 % of patients taking placebo.
Slovenian: Skupno je po enoletnem zdravljenju v skupini, ki je jemala 120 mg orlistata, 20 % bolnikov shujšalo za 10 % ali več, medtem ko je bilo v kontrolni skupini takih bolnikov 8 %.
English: Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat.
Slovenian: Ob jemanju orlistata mora biti zdravljenje z antidiabetiki skrbno nadzorovano.
English: Capsule filling: microcrystalline cellulose (E460) sodium starch glycolate (type A) povidone (E1201) sodium laurilsulfate talc
Slovenian: Vsebina kapsule: mikrokristalna celuloza (E460), natrijev karboksimetilškrob (tip A), povidon (E1201), natrijev lavrilsulfat, smukec.
English: Orlistat, M1 and M3 are all subject to biliary excretion.
Slovenian: Orlistat, M1 in
English: Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 4 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Slovenian: Nasprotno pa se je izkazalo, da je od bolnikov, ki jim po 12 tednih zdravljenja ni uspelo izgubiti 5 % izhodiščne telesne mase, po enem letu zdravljenja uspelo izgubiti 10 % ali več izhodiščne telesne mase le 5 % bolnikom, ki so jemali orlistat in 4 % bolnikom, ki so jemali placebo.
English: NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules Orlistat
Slovenian: IME ZDRAVILA Xenical 120 mg trde kapsule Orlistat
English: Of these, 49 % of orlistat treated patients and 40 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Slovenian: Od tega je 49 % bolnikov, ki so jemali orlistat in 40 % bolnikov, ki so jemali placebo, po enem letu zdravljenja izgubilo 10 % ali več izhodiščne telesne mase.
English: If a meal is missed or contains no fat, the dose of orlistat should be omitted.
Slovenian: Če obrok ne vsebuje maščob, ali ga bolnik izpusti,
English: Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat.
Slovenian: Med zdravljenjem z zdravilom Xenical morate uživati uravnovešeno hrano z veliko sadja in zelenjave ter nadzorovati vnos kalorij.
English: • If you get any of the side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four oneyear clinical trials showed that the percentage of responders (≥ 10 % of body weight loss) was 11.3 % with orlistat as compared to 4.5 % with placebo.
Slovenian: V štirih enoletnih študijah bolnikov s preveliko telesno maso, ki so imeli z antiadiabetiki neustrezno zdravljeno sladkorno bolezen tipa II, je v skupini, zdravljeni z orlistatom, znašala odzivnost 11,3 % (opredeljena kot zmanjšanje telesne mase za 10 % ali več) v primerjavi s 4,5 % pri placebu.
English: The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell.
Slovenian: Poročali so tudi o naslednjih neželenih učinkih, vendar iz razpoložljivih podatkov ni mogoče določiti njihove pogostnosti: Alergijske reakcije, katerih glavni simptomi so srbenje, izpuščaj, mehurji (rahlo privzdignjeni srbeči kožni predeli, ki so bolj bledi ali bolj rdeči kot preostala koža), hude težave pri dihanju, slabost, bruhanje in slabo počutje.
English: Xenical is a medicine used to treat obesity.
Slovenian: Kaj je zdravilo Xenical in za kaj ga uporabljamo Zdravilo Xenical je namenjeno zdravljenju debelosti.
English: Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
Slovenian: IMETNIK DOVOLJENJA ZA PROMET CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
English: - Cholestasis.
Slovenian: - holestaza, - dojenje.
English: Glass bottles
Slovenian: Stekleničke
English: When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Slovenian: Pri sočasnem jemanju varfarina ali drugih antikoagulantov in orlistata moramo nadzorovati vrednosti
English: Fat soluble vitamins
Slovenian: Vitamini, topni v maščobi
English: Common: Urinary tract infection
Slovenian: Pogosti: okužba sečil
English: - Hypersensitivity to the active substance or to any of the excipients.
Slovenian: - Znana preobčutljivost na zdravilno učinkovino ali katero koli sestavino zdravila, - kronični malabsorpcijski sindrom,
English: Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Xenical Vsebina pakiranja in dodatne informacije
English: Blisters: Do not store above 25 °C.
Slovenian: Pretisni omoti: shranjujte pri temperaturi do 25 °C.
English: Xenical 120mg hard capsules Orlistat
Slovenian: IME ZDRAVILA Xenical 120 mg trde kapsule orlistat
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: NAVODILO ZA UPORABO Xenical 120 mg trde kapsule orlistat Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
English: How to store XENICAL
Slovenian: Shranjevanje zdravila Xenical
English: Pregnancy and breast-feeding
Slovenian: Presnovne in prehranske motnje
English: Your doctor may suggest you take a multivitamin supplement.
Slovenian: Včasih zdravnik med zdravljenjem predpiše multivitaminski pripravek.
English: Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.
Slovenian: Če se telesna masa bolnika po 12 tednih ne zmanjša vsaj za 5 % izhodiščne telesne mase, je treba zdravljenje z orlistatom ukiniti.
English: Effects on clotting with anti-coagulants.
Slovenian: Učinki na strjevanje krvi med zdravljenjem z zdravili, ki zavirajo strjevanje krvi.
English: Always take Xenical exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Xenical natančno upoštevajte zdravnikova navodila.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 120 mg orlistat.
Slovenian: Ena trda kapsula vsebuje 120 mg orlistata.
English: The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).
Slovenian: Ker je med hudo drisko lahko peroralna kontracepcija neučinkovita, je v tem primeru priporočljiva uporaba dodatne metode kontracepcije (glejte poglavje 4.5).
English: - Chronic malabsorption syndrome.
Slovenian: uporabimo multivitaminske pripravke.
English: Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37 % of orlistat patients and 19 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment.
Slovenian: Združeni rezultati petih 2 leti trajajočih študij orlistata in hipokalorične diete so pokazali, da je 37 %
English: Do not take XENICAL
Slovenian: naj orlistata ne vzame.
English: In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
Slovenian: njegove koncentracije pa skrajno nizke (< 10 ng/ml ali 0,02 µmol).
English: Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 2 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Slovenian: 5 % izhodiščne telesne mase, po enem letu zdravljenja uspelo izgubiti 10 % ali več izhodiščne telesne mase le 5 % bolnikom, ki so jemali orlistat in 2 % bolnikom, ki so jemali placebo.
English: OUTER CARTON AND BOTTLE LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI ZUNANJA OVOJNINA IN NALEPKA NA STEKLENIČKI
English: Prescribers should investigate further in case of severe and/or persistent symptoms.
Slovenian: Če so simptomi hudi ali dolgotrajni ali oboje, naj zdravniki raziščejo njihov vzrok.
English: 8 August 2012
Slovenian: 8. avgust 2012
English: The European Commission issued a decision on 8 August 2012.
Slovenian: Evropska komisija je odločbo izdala dne 8. avgusta 2012.
English: Flolan is marketed in the following EU Member States: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, the Netherlands, Spain, United Kingdom, as well as Norway.
Slovenian: Zdravilo Flolan se trži v naslednjih državah članicah EU: v Avstriji, Belgiji, na Češkem, Danskem, v Estoniji, Franciji, na Irskem, v Italiji, Luksemburgu, na Malti, Nizozemskem, v Španiji, Združenem kraljestvu in na Norveškem.
English: Why was Flolan reviewed?
Slovenian: Zakaj je bilo zdravilo Flolan pregledano?
English: Flolan is authorised in the EU via national procedures.
Slovenian: Zdravilo Flolan je bilo odobreno v EU z nacionalnimi postopki.
English: It is also available under the trade name Epoprostenol.
Slovenian: Na voljo je tudi pod tržnim imenom Epoprostenol.
English: • haemodialysis in emergency situations when the use of heparin carries a high risk of causing or exacerbating bleeding, or when heparin is otherwise contraindicated.
Slovenian: • hemodializo v nujnih primerih, kadar uporaba heparina pomeni veliko tveganje za povzročitev ali poslabšanje krvavitve ali kadar je heparin kako drugače kontraindiciran.
English: What is Flolan?
Slovenian: Kaj je zdravilo Flolan?
English: On 24 May 2012, the European Medicines Agency completed a review of Flolan.
Slovenian: Evropska agencija za zdravila je 24. maja 2012 končala pregled zdravila Flolan.
English: The company that markets these medicines is GlaxoSmithKline.
Slovenian: Ti zdravili trži družba GlaxoSmithKline.
English: Flolan is a medicine that contains the active substance epoprostenol.
Slovenian: Flolan je zdravilo, ki vsebuje zdravilno učinkovino epoprostenol.
English: On 15 June 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Flolan in the EU.
Slovenian: Evropska komisija je 15. junija 2011 zadevo napotila na odbor CHMP, ki naj bi uskladil dovoljenja za promet z zdravilom Flolan v EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Flolan in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti informacije o predpisovanju zdravila Flolan v Evropski uniji (EU).
English: The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation), 4.5 (Interaction with Other Medicinal Products and Other Forms of Interaction) and 4.8 (side effects).
Slovenian: Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), 4.6 (Nosečnost in dojenje) in 4.8 (Neželeni učinki).