FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal and urinary disorders: difficulty and pain when passing urine, involuntary leakage of urine,
Slovenian: Bolezni sečil: ovirano in boleče uriniranje, nezmožnost zadrževati urin
English: • cataract surgery.
Slovenian: • operacijo katarakte
English: In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of travoprost has been reported.
Slovenian: V kontroliranih kliničnih preskušanjih so v povezavi z uporabo travoprosta poročali o potemnitvi kože okoli očesa, potemnitvi kože vek ali obojega.
English: In a 6-week controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of DuoTrav (polyquaternium-1-preserved) dosed once daily in the morning was 8 mmHg and equivalent to that of DuoTrav (benzalkonium chloride-preserved).
Slovenian: V šesttedenski kontrolirani klinični študiji pri bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo ter začetno srednjo vrednostjo očesnega tlaka od 24 do 26 mmHg je bil srednji učinek zdravila DuoTrav (konzerviranega s polikvaternijem-1), danega enkrat na dan zjutraj, na zmanjšanje očesnega tlaka 8 mmHg in je bil enak učinku zdravila DuoTrav, konzerviranega z benzalkonijevim kloridom.
English: Summary of the safety profile
Slovenian: 4.8 Neželeni učinki Povzetek profila varnosti zdravila
English: The non-inferiority of DuoTrav as compared to latanoprost 50 micrograms/mL + timolol 5 mg/mL in the mean IOP reduction was demonstrated across all time-points at all visits.
Slovenian: Ob vseh obiskih in v vseh časovnih točkah so ugotovili, da zdravilo DuoTrav ni nič slabše od latanoprosta 50 mikrogramov/ml + timolola 5 mg/ml, kar zadeva zmanjšanje srednje vrednosti očesnega tlaka.
English: • coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure.
Slovenian: • koronarno srčno bolezen (bolezenski znaki so lahko bolečine v prsnem košu ali stiskanje,
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops travoprost/timolol
Slovenian: DuoTrav 40 mikrogramov/ml + 5 mg/ml kapljice za oko travoprost/timolol
English: DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
Slovenian: Zdravilo DuoTrav vsebuje makrogolglicerol hidroksistearat, ki lahko povzroči kožne reakcije.
English: Do not use DuoTrav
Slovenian: Ne uporabljajte zdravila DuoTrav:
English: Rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling sensation, palpitations, swelling in the lower limbs, bad taste.
Slovenian: Splošni neželeni učinki izpuščaj, srčno popuščanje, bolečine v prsih, možganska kap, omedlevica, depresija, astma, povečana srčna frekvenca, občutek odrevenelosti ali mravljincev, palpitacije, otekanje spodnjih okončin, motnje okušanja
English: In two three-month controlled clinical studies in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily in the morning was 7 to 9 mmHg.
Slovenian: V dveh trimesečnih kontroliranih kliničnih študijah pri bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo ter začetno srednjo vrednostjo očesnega tlaka od 23 do 26 mmHg je bil srednji učinek zdravila DuoTrav, danega enkrat na dan zjutraj, na zmanjšanje očesnega tlaka od 7 do 9 mmHg.
English: How to store DuoTrav
Slovenian: Shranjevanje zdravila DuoTrav
English: Uveitis, conjunctival follicles, eye discharge, periorbital oedema, eyelids pruritus, ectropion, cataract, iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, halo vision, hypoaesthesia eye, anterior chamber pigmentation, mydriasis, eyelash hyperpigmentation, eyelash thickening, visual field defect
Slovenian: Očesne bolezni uveitis, konjunktivalni folikli, izcedek iz očesa, periorbitalni edem, pruritus vek, ektropij, katarakta, iridociklitis, očesni herpes simpleks, vnetje očesa, fotopsija, ekcem vek, odsev v obliki kolobarjev (halo), hipoestezija očesa, pigmentacija v sprednjem očesnem prekatu, midriaza, hiperpigmentacija trepalnic, odebelitev trepalnic, izpad vidnega polja
English: In a twelve-month controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily in the morning was 8 to 10 mmHg.
Slovenian: V dvanajstmesečni kontrolirani klinični študiji pri bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo ter začetno srednjo vrednostjo očesnega tlaka od 25 do 27 mmHg je bil srednji učinek zdravila DuoTrav, danega enkrat na dan zjutraj, na zmanjšanje očesnega tlaka od 8 do 10 mmHg.
English: Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta blockers.
Slovenian: Po uporabi nekaterih očesnih zaviralcev adrenergičnih receptorjev beta so poročali o učinkih na dihala, vključno s smrtjo zaradi bronhospazma pri bolnikih z astmo.
English: Asthma aggravated, rhinitis allergic, epistaxis, respiratory disorder, nasal congestion, nasal dryness
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora poslabšanje astme, alergijski rinitis, epistaksa, bolezni dihal, kongestija nosne sluznice, suhost nosne sluznice
English: Nausea, dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting
Slovenian: Bolezni prebavil navzea, dispepsija, driska, suha usta, bolečine v trebuhu, bruhanje
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution
Slovenian: DuoTrav 40 mikrogramov/ml + 5 mg/ml kapljice za oko, raztopina
English: Peptic ulcer reactivated, gastrointestinal disorder, diarrhoea, constipation, dry mouth, abdominal pain, nausea, vomiting
Slovenian: Bolezni prebavil ponovitev peptičnega ulkusa, prebavne motnje, diareja, zaprtje, suha usta, bolečine v trebuhu, navzea, bruhanje
English: Potentiated systemic beta blockade (e.g. decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Slovenian: Pri sočasnem zdravljenju z zaviralci izoencima CYP2D6 (npr. kinidinom, fluoksetinom, paroksetinom) in timolola so poročali o okrepljeni sistemski beta blokadi (npr. zmanjšani srčni frekvenci, depresiji).
English: Blood pressure diastolic decreased, blood pressure systolic increased
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica, tinitus Žilne bolezni znižan diastolični krvni tlak, zvišan sistolični krvni tlak
English: • Bring the bottle dropper close to the eye. Use the mirror if it helps.
Slovenian: Če vam pomaga, uporabite ogledalo.
English: However, this effect was not observed during the clinical trials and is considered to be species specific.
Slovenian: Študije na opicah so pokazale, da povzroči travoprost blago povečanje palpebralne fisure, vendar tega učinka niso opažali v kliničnih preskušanjih pri človeku in menijo, da je specifičen za to živalsko vrsto.
English: Consideration should be given to patient convenience and their likely compliance when recommending morning vs. evening dosing.
Slovenian: Pri odločitvi, ali naj bolniku priporočite odmerjanje zjutraj ali zvečer, upoštevajte, kaj je bolj ugodno za bolnika in kaj bo verjetno bolj upošteval.
English: 6 x 2.5 ml - PP bottle
Slovenian: 6 x 2,5 ml - PP kapalni vsebnik
English: 1 x 2.5 ml - PP bottle
Slovenian: 1 x 2,5 ml - PP kapalni vsebnik
English: This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).
Slovenian: Z zaprtjem nazolakrimalnega kanala ali vek za dve minuti bolnik zmanjša sistemsko absorpcijo zdravila, kar lahko vodi tudi do zmanjšanja njegovih sistemskih neželenih učinkov in do močnejšega lokalnega delovanja (glejte poglavje 4.4).
English: 3 x 2.5 ml - PP bottle
Slovenian: 3 x 2,5 ml - PP kapalni vsebnik
English: Inflammation of the eye surface, inflammation of the eyelid, swollen conjunctiva, increased growth of eyelashes, iris inflammation, eye inflammation, sensitivity to light, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, eyelid colour change, skin darkening (around the eye).
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) Učinki na oko vnetje površine očesa, vnetje očesne veke, otekla veznica, povečana rast trepalnic, vnetje šarenice, vnetje očesa, občutljivost na svetlobo, zmanjšan vid, utrujene oči, očesna alergija, otekanje oči, povečano nastajanje solz, rdečina vek, sprememba barve vek, potemnitev kože (okrog očesa)
English: 6 x 2.5 ml - LDPE bottle
Slovenian: 6 x 2,5 ml - LDPE kapalni vsebnik
English: 1 x 2.5 ml - LDPE bottle
Slovenian: 1 x 2,5 ml - LDPE kapalni vsebnik
English: 3 x 2.5 ml - LDPE bottle
Slovenian: 3 x 2,5 ml - LDPE kapalni vsebnik
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution travoprost/timolol
Slovenian: DuoTrav 40 mikrogramov/ml + 5 mg/ml kapljice za oko, raztopina travoprost/timolol
English: What DuoTrav contains
Slovenian: Kaj vsebuje zdravilo DuoTrav
English: Gastrointestinal: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting and constipation.
Slovenian: Prebavila: motnje okušanja, slabost, slaba prebava, driska, suha usta, bolečine v trebuhu, bruhanje in zaprtje
English: Ophthalmic beta blockers may induce dryness of eyes.
Slovenian: Očesni zaviralci adrenergičnih receptorjev beta lahko povzročijo suhost oči, zato je treba bolnike z boleznimi roženice zdraviti previdno.
English: Dysphonia, bronchospasm, cough, throat irritation, oropharyngeal pain, nasal discomfort Not known Asthma
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni dispneja, kapljanje izcedka ob zadnji strani žrela redki disfonija, bronhospazem, kašelj, draženje žrela, orofaringealne bolečine, neprijeten občutek v nosu neznana astma
English: Psychiatric disorders
Slovenian: Bolezni roženice
English: Renal and urinary disorders Rare
Slovenian: Bolezni sečil redki kromaturija
English: This summary was last updated in 04-2016.
Slovenian: Pregled je bil nazadnje posodobljen 08-2018.
English: The full EPAR for Epoetin Alfa Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Nadaljnje informacije o zdravilu Epoetin Alfa Hexal so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For patients with kidney failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Slovenian: Pri bolnikih z odpovedjo ledvic, mielodisplastičnimi sindromi ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočenih vrednosti (od 10 do 12 gramov na deciliter pri odraslih in od 9,5 do 11 gramov na deciliter pri otrocih).
English: When Epoetin Alfa Hexal is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Slovenian: Kadar se zdravilo Epoetin Alfa Hexal uporablja za avtologno transfuzijo krvi, je treba upoštevati omejitve, ki so običajno povezane s to vrsto transfuzije.
English: What measures are being taken to ensure the safe and effective use of Epoetin Alfa Hexal?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Epoetin Alfa Hexal?
English: The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Slovenian: Pri vseh bolnikih je treba preveriti raven železa in s tem zagotoviti, da njihove vrednosti niso prenizke, ter po potrebi dajati dodatke, ki vsebujejo železo.
English: It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Slovenian: Zdravilo se uporablja pri bolnikih z normalnimi ravnmi železa, pri katerih lahko pride do zapletov pri transfuziji krvi, če pred kirurškim posegom ne darujejo lastne krvi, pričakovane izgube pa znašajo od 900 do 1 800 ml;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epoetin Alfa Hexal on 28 August 2007.
Slovenian: Za zdravilo Epoetin Alfa Hexal je bilo 28. avgusta 2007 izdano dovoljenje za promet, veljavno po vsej EU.
English: • patients undergoing surgery who cannot receive medicines for the prevention of blood clots.
Slovenian: • bolnikih, pri katerih bo izveden kirurški poseg in ne morejo prejemati zdravil za preprečevanje nastajanja krvnih strdkov;
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo, ali tistih z ledvičnimi težavami lahko anemijo povzroči pomanjkanje eritropoetina ali nezadostna odzivnost telesa na naravno prisotni eritropoetin.
English: The most common side effects with Epoetin Alfa Hexal (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Epoetin Alfa Hexal (ki se lahko pojavijo pri več kot 1 bolniku od 10) so navzeja (slabost), driska, bruhanje, povišana telesna temperatura in glavobol.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Slovenian: Za več informacij o podobnih bioloških zdravilih glejte tukaj.
English: The dose, the frequency of injection and how long it is used for also depend on why Epoetin Alfa Hexal is being used and on the patient's bodyweight, and are adjusted according to the patient's response.
Slovenian: Odmerek, pogostost injiciranja in trajanje uporabe zdravila Epoetin Alfa Hexal so odvisni tudi od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
English: It must not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Slovenian: • bolnikih, ki so tik pred zahtevnejšim ortopedskim kirurškim posegom in imajo resne kardiovaskularne (srčno-žilne) težave, vključno z nedavnim srčnim napadom ali možgansko kapjo.
English: The active substance in Epoetin Alfa Hexal, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells from the bone marrow.
Slovenian: Učinkovina v zdravilu Epoetin Alfa Hexal, epoetin alfa, je kopija hormona eritropoetina in deluje popolnoma enako kot naravni hormon pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu.
English: All of the patients had been receiving Eprex/Erypo injected into a vein for at least eight weeks before they were either switched to Epoetin Alfa Hexal or remained on Eprex/Erypo.
Slovenian: Vsem bolnikom so zdravilo Eprex/Erypo injicirali v veno vsaj osem tednov, preden so bodisi začeli prejemati zdravilo Epoetin Alfa Hexal bodisi so še naprej jemali zdravilo Eprex/Erypo.
English: The injection under the skin may be given by the patient or their carer if they have been appropriately trained.
Slovenian: Bolnik si zdravilo lahko v podkožje injicira sam ali mu ga injicira negovalec, če sta za to ustrezno usposobljena.
English: This means that Epoetin Alfa Hexal is similar to and contains the same active substance as a biological medicine that is already authorised in the European Union (EU), which is known as the ‘reference medicine'.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: For the full list of all side effects reported with Epoetin Alfa Hexal, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Epoetin Alfa Hexal, glejte navodilo za uporabo.
English: The reference medicine for Epoetin Alfa Hexal is Eprex/Erypo.
Slovenian: Referenčno zdravilo za zdravilo Epoetin Alfa Hexal je zdravilo Eprex/Erypo.
English: Other information about Epoetin Alfa Hexal
Slovenian: Druge informacije o zdravilu Epoetin Alfa Hexal
English: What benefit has Epoetin Alfa Hexal shown during the studies?
Slovenian: Kakšne koristi zdravila Epoetin Alfa Hexal so se pokazale v študijah?
English: What is the risk associated with Epoetin Alfa Hexal?
Slovenian: Kakšna tveganja so povezana z zdravilom Epoetin Alfa Hexal?
English: For more information about treatment with Epoetin Alfa Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Epoetin Alfa Hexal glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Treatment with Epoetin Alfa Hexal must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for.
Slovenian: Predpisovanje in izdaja zdravila Epoetin Alfa Hexal je le na recept, zdravljenje z njim pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z boleznimi, za katere se to zdravilo uporablja.
English: Epoetin Alfa Hexal is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated.
Slovenian: Zdravilo Epoetin Alfa Hexal je na voljo v napolnjenih injekcijskih brizgah različnih jakosti in se daje z injiciranjem v veno ali podkožje, kar je odvisno od bolezenskega stanja bolnika, ki se zdravi.
English: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin;
Slovenian: • bolnikih, pri katerih se je po zdravljenju z eritropoetinom razvila aplazija rdečih krvnih celic
English: Why has Epoetin Alfa Hexal been approved?
Slovenian: Zakaj je bilo zdravilo Epoetin Alfa Hexal odobreno v EU?
English: Epoetin Alfa Hexal must not be used in the following groups:
Slovenian: Epoetin Alfa Hexal je zdravilo, ki se uporablja v naslednjih primerih:
English: In these cases, epoetin alfa is used to replace the missing hormone or to increase red blood cell counts.
Slovenian: V teh primerih se za povečanje števila rdečih krvnih celic uporablja epoetin alfa.
English: The CHMP concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Epoetin Alfa Hexal po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Eprex/Erypo in da se po telesu enako prenaša.
English: Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
Slovenian: Agencija je zato menila, da koristi zdravila Epoetin Alfa Hexal enako kot pri zdravilu Eprex/Erypo odtehtajo znana tveganja in da se zdravilo lahko odobri.
English: The study in patients with chronic kidney failure showed that Epoetin Alfa Hexal was safe and effective when given under the skin.
Slovenian: V dodatni študiji so pri 416 bolnikih s kronično odpovedjo ledvic dokazali, da je zdravilo Epoetin Alfa Hexal pri injiciranju v podkožje varno in učinkovito.
English: In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo.
Slovenian: Bolniki, ki so prešli na jemanje zdravila Epoetin Alfa Hexal, so ohranili vrednosti hemoglobina na enaki ravni kot bolniki, ki so nadaljevali zdravljenje z zdravilom Eprex/Erypo.
English: Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Slovenian: V eni glavni študiji, ki je vključevala 479 bolnikov z anemijo, povezano z obolenjem ledvic, so zdravilo Epoetin Alfa Hexal, injicirano v veno, primerjali z referenčnim zdravilom.
English: Epoetin Alfa Hexal is a ‘biosimilar' medicine.
Slovenian: Zdravilo Epoetin Alfa Hexal vsebuje učinkovino epoetin alfa in je „podobno biološko zdravilo“.
English: What is Epoetin Alfa Hexal used for?
Slovenian: Kaj je zdravilo Epoetin Alfa Hexal in za kaj se uporablja?
English: Epoetin Alfa Hexal was as effective as Eprex/Erypo in increasing and maintaining red blood cell counts.
Slovenian: Poleg tega so v več študijah dokazali, da je zdravilo Epoetin Alfa Hexal pri zviševanju in ohranjanju števila rdečih krvnih celic enako učinkovito kot zdravilo Eprex/Erypo.
English: How is Epoetin Alfa Hexal used?
Slovenian: Kako se zdravilo Epoetin Alfa Hexal uporablja?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epoetin Alfa Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Epoetin Alfa Hexal upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The study in patients receiving chemotherapy showed that Epoetin Alfa Hexal was also as effective as Eprex/Erypo when it was injected under the skin.
Slovenian: Druga študija pri 114 bolnikih z rakom, ki so se zdravili s kemoterapijo, je pokazala, da je bilo zdravilo Epoetin Alfa Hexal, injicirano v podkožje, enako učinkovito pri ohranjanju ravni hemoglobina kot zdravilo Eprex/Erypo.
English: How does Epoetin Alfa Hexal work?
Slovenian: Kako zdravilo Epoetin Alfa Hexal deluje?
English: Epoetin Alfa Hexal was studied to show that it is comparable to the reference medicine, Eprex/Erypo.
Slovenian: Laboratorijske študije, v katerih so zdravilo Epoetin Alfa Hexal primerjali z referenčnim zdravilom Eprex/Erypo, so pokazale, da je učinkovina v zdravilu Epoetin Alfa Hexal po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Eprex/Erypo.
English: The company also presented the results of a study comparing the effects of Epoetin Alfa Hexal injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Slovenian: Poleg tega so študije dokazali še, da so učinki tega zdravila pri zviševanju in ohranjanju ravni krvnih celic pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, enakovredni učinkom zdravila Eprex/Erypo.
English: Dr Enzmann (Germany)
Slovenian: dr. Enzmann (Nemčija)
English: 1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Slovenian: 1 Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev zaradi različnih odločitev, ki so jih sprejele države članice.
English: Dr Calvo-Rojas (Spain)
Slovenian: dr. Calvo-Rojas (Španija)
English: The main areas harmonised include:
Slovenian: Glavna področja, ki jih je treba uskladiti, so:
English: Protium is authorised in the EU via national procedures.
Slovenian: Zdravilo Protium je v EU odobreno z nacionalnimi postopki.
English: 6 April 2009, 24 August 2009 and 19 October
Slovenian: 6. aprila 2009, 24. avgusta 2009 in 19. oktobra
English: The company that markets these medicines is Nycomed.
Slovenian: Družba, ki trži ta zdravila, je Nycomed.
English: What is Protium?
Slovenian: Kaj je zdravilo Protium?
English: The dose of the tablets may be doubled in cases where there has been no response to treatment.
Slovenian: Odmerek tablet se lahko podvoji, kadar ni odziva na zdravljenje.
English: Why was Protium reviewed?
Slovenian: Zakaj je bilo zdravilo Protium pregledano?